KNOWLEDGE AND PRACTICES GOVERNING THE IMPLEMENTATION OF NASOGASTRIC TUBE FEEDING AS A TEMPORARY UNDERNUTRITION MANAGEMENT MEASURE IN ACUTE GERIATRIC CARE: A QUALITATIVE RESEARCH-BASED ANALYSIS

E. Fercot¹, L. Marty², C. Bouteloup³, Y. Lepley⁴, J. Bohatier¹, M. Bonnefoy⁴, B. Lesourd⁵, Y. Boirie⁶, S. Dadet⁷

1. Gérontopôle, CHU Clermont-Ferrand, Clermont-Ferrand, France;
2. Anthropologue de la santé, Département de Médecine Générale, Université Clermont Ferrand Auvergne, Clermont-Ferrand, France; 3. Université Clermont Auvergne, INRA, UNH,Unité de Nutrition Humaine, CHU Clermont-Ferrand, Service de médecine digestive et hépatobiliaire, CRNH Auvergne, Clermont-Ferrand, France; 4. Université Claude Bernard Lyon 1, Faculté Lyon-Sud, France, Inserm U1060, Université Lyon 1, France, Service de médecine gériatrique, Hospices civils de Lyon, France; 5. Université Clermont Auvergne, Clermont-Ferrand, France; 6. Université Clermont Auvergne, INRA, UNH, Unité de Nutrition Humaine, CHU Clermont-Ferrand, Service de Nutrition Clinique, CRNH Auvergne, Clermont-Ferrand, France; 7. Université Clermont Auvergne, INRA, UNH, Unité de Nutrition Humaine, CHU Clermont-Ferrand, CHU Clermont-Ferrand, Gérontopôle, CHU Clermont-Ferrand, France.

Corresponding Author: Elise Fercot, Gérontopôle, CHU Clermont-Ferrand, F-63000 Clermont-Ferrand, France, fercote@hotmail.fr

J Aging Res Clin Practice 2018;7:115-122
Published online October 15, 2018, http://dx.doi.org/10.14283/jarcp.2018.20

Abstract

Introduction: Nasogastric tube feeding appears underused in acute geriatric care units. The objective of this study was to identify the knowledge, practice, fears or behaviors of care givers governing implementation. Material and Methods: Multicentric qualitative research study based on interviews with geriatricians and care staff. Coding of patterns and thematic analysis of the data were used to extract key concepts tied to the objective. Results: Ten geriatricians and eleven care staff were interviewed individually and in a focus-group setting. Undernutrition was perceived as a prognosis-worsening comorbidity, not a disease. Early screening for undernutrition appeared essential, but care management and monitoring was within the remit of downstream structures. A handful of indications are reported to justify moves to start nasogastric tube feeding, often as part of adjuvant care, when real benefit is expected, when the individualized feeding plan is part of a comprehensive care plan, with the patient consciously involved and after consulting with the family. Patients’ fear of complications, cognitive disorders, and uncertain life expectancy often fuel concerns of a form of unreasonable obstinacy. Finally, doctors and care staff alike think that decisions on nasogastric intubation in this patient population require a multidisciplinary-team process. Conclusion: Nasogastric tube feeding in acute geriatric care remains fraught with issues. It looks a viable option, but should be part of a comprehensive care plan, based on multidisciplinary decision-making by appropriately-trained teams, where the goals of care are the patient’s comfort and quality of life.

Key words: Enteral nutrition, frailty, care management, geriatrics, malnutrition, quality of life.

Introduction

According to French health authorities (HAS-Haute Autorité de Santé) figures, the prevalence of hospital undernutrition in France approaches 30–70% in patients over 80 years (1, 2). Acute illnesses increase protein-energy needs, while intakes are often inadequate due to episodic loss of appetite, eating difficulties or malabsorption (1, 3). This deficit can lead to protein-energy undernutrition, which increases the risk of sarcopenia, frailty (4), loss of functional capabilities (5), infectious risk (6), length of stay at hospital (7) impair functional outcomes and recovery (8) and mortality (9, 10). Effective nutritional management is therefore necessary, and various academic societies have proposed strategies that include artificial nutrition (1, 11, 12). These care decision strategies can be constructed as decision trees, such as that of the French society for clinical nutrition and metabolism (SFNEP), but are rarely adapted to very old patients (13). The HAS and the European society for clinical nutrition and metabolism (ESPEN) issued guidelines in 2006 and 2007 specifically addressing factors unique to geriatric care : patient life expectancy, functional capabilities, frailty, neurocognitive disorders and comorbidities (1, 12). In practice, while nasogastric tube (NGT) feeding for enteral nutrition (EN) may be recommended in acute-phase hospital care, it is a lot more problematic in the acute geriatric care unit (AGCU) (13) and reluctance for a enteral nutrition may exist because of lack of education, knowledge, communication, or team work (14). In an effort to improve nutrition management in these units, an improvement in a deeper understanding of the practices and of the difficulties among the clinicians and care staff teams is expected.
Therefore, the objective of the present study was to identify the knowledge and practices governing the implementation of NGT feeding in AGCU wards. The aim was to survey geriatric care professionals to capture their opinion on nutrition management, evaluate their knowledge of the issue, characterize their expectations and perceptions, and identify the reasons that frustrate or facilitate the process of prescribing NGT placement.

Matherials and methods

Description of the study

This multicentric qualitative research study was led in AGCU wards at different Main City Hospitals (MCH) in the Auvergne region, France.

Choice of method

Qualitative research explores complex phenomena, arising from the ‘human factor’ of care delivery, in their natural environment. It attempts to make sense of the participant experiences and interpret the meanings they attribute to them. The process of analysis is approached inductively, in contrast to deductive approaches that systematically verify a pre-determined hypothesis. The method of inquiry used is based on the 32-item COREQ 2007 criteria, spanning 3 domains: research team and reflexivity, study design, and analysis and findings (15). Data was collected through semi-structured interviews-either individual or in focus-group format. Individual interviews give interviewees the freedom to open up and express themselves, while focus groups enable interaction based on group-effect dynamics and dialogue, thus facilitating the emergence of knowledge, opinion and experience by bringing different personal perspectives together. The open-ended questions addressed topics defined in an interview guide. People interviewed were free to address other concepts not initially agendaed. The study secured approval from the local French ethics committee (‘CPP’ Sud-Est VI) for the protection of human subjects.

Sampling

The sample of geriatric doctors and care staff (Registered Nurses (RN) and Registered Nursing Care Assistants (RNCA))-all of whom were volunteers-had to be heterogeneous in order to capture the broadest possible range of opinions, experiences and practices. Age, gender, place of practice, career path, time in the job, and further training and education had to be as varied as possible. We continued to include material until thematic saturation.

Interview guide

Two interview guides were developed and tested to fit each professional (one for doctors and one for care staff, both of which served for the individual interviews and the focus group) in order to explore the various themes exposed in the literature on enteral nutrition. The guides were modified after the early exploratory interviews, as the questions were not open-ended enough, which hinded in free-flowing conversation. Likewise, certain questions asking about the knowledge held by doctors and care staff were deleted to rule out any value judgment.

Process and flow of the interviews

The interviewers opened by explaining the aim of the interview or focus group and the objectives targeted. They then had the time to outline the interview process, guaranteeing that everything shared would be anonymous and confidential and in no way critical or judgemental. The interviewer then collected the credentials of the people interviewed and their consent to record the conversation.
a) Process and flow of a semi-structured individual interview:
The interview started with the interviewee telling their story of an experience-whether good or bad-with NGT feeding. The questions were then cued by the interview guide until all the themes had been addressed. The same interviewer, mainly at the participants’ place of work, conducted all the interviews.
b) Process and flow of a semi-structured focus group:
The focus group was asked to talk over one or more experiences concerning NGT feeding. Two investigators were mobilized to take part in the focus group-one as facilitator, the other as observer to collect expressions of nonverbal communication. The moderator used a set of questions to keep dialogue and discussion focused, making sure that all the focal topics in the interview guide were addressed.

Collection of the data material

All the interviews were recorded end-to-end on an OLYMPUS-brand digital dictaphone. All digital capture was transcribed in depersonalized format into a verbatim-record Microsoft Word document. No digital data records were kept.

Method of analysis

The process of thematic analysis based on verbatim accounts started right from the first interview. The content of the verbalized conversation was collapsed into themes that were then subcategorized. The interview transcripts were then re-read and reviewed a second time using this list.

Results

Description of the people interviewed

The interviews were conducted from February to August 2015.

Interviews with doctors

Interviews were led in-hospital, in 5 different MCH including 4 AGCU, on the 10 geriatric doctors reported in Table 1, thus compiling 4h22 of recorded material. The sample was positively heterogeneous for age, gender, experience and place of practice. The focus of background training tended to be on palliative care and neurodegenerative diseases. Only one of the doctors had been university-trained on nutrition.

Table 1
Doctor characteristics

Interviews with care staff

Interviews were led in the same MCH hosting 3 different AGCU, on the 11 care staff reported in Table 2, thus compiling 4h04 of recorded material. Two participants were interviewed by phone and one at home. The sample was positively heterogeneous for age, gender, and professional experience. The most common focus of background training was palliative care and neurodegenerative diseases, and only two of the 11 care staff had been given training on nutrition.

Table 2
Care staff characteristics

RN¹ Registered Nurse, NCA² Nursing Care Assistant

Analysis of the main findings

Various major themes and concepts emerged.

Knowledge and training levels of the geriatric care professionals

Interviews with doctors

The geriatric doctors claim they are undertrained on nutrition. “You can’t say ‘trained’. You learn on the job.” (Doctor #5) “By our department heads and colleagues.” (Doctor #6)

Interviews with care staff

The RN feel undertrained on EN, especially on technical procedure. “I think the nurses in general don’t know enough about placing the NGT, because, it’s true, at nursing school you only get a brief look at it” (RN #1) “Er, the training goes back 15 years ago […] but the first one I got to place, that was later on, once I had started work” (RN #2).

Nutrition in hospital practice

Screening for undernutrition

Screening appears to be a routine phase, but with different approaches. “It’s a routine practice on the admission tests for all elderly subjects”. (Doctor #1) “Weight, height, body mass index chemistry panel-systematically” (Doctor #4). The geriatricians also think they are more undernutrition-aware than other speciality practitioners. “We screen them as soon as they come in […] We’re optimal on that, we’re in good shape”(Doctor #1). However, there is variability in the resources mobilized for the nutritional status assessment, and the doctors voiced their issues, given how exhaustive investigation is just not feasible. “It’s always made hard by the fact they already have some kind of inflammatory syndrome, so we struggle to quantify their baseline nutritional status” (Doctor #3) “It only really starts getting useful if you’ve got past weight figures”. (Doctor #3). Close monitoring of food intakes is voiced more by the care staff, who also feel they are screening-aware. “We generally do the 3-day food and drink record chart” (RN #3). “If they don’t eat anything, there are written messages, verbal messages, it gets flagged up.” (RNCA #1).

Management of undernutrition

For the doctors, oral nutrition remains the best care plan going forward. “So if oral intake is possible, then you put them straight on oral nutritional supplements (ONS) already […] you maintain oral feeding, which takes priority” (Doctor #1). “In most cases, elderly patients are undernourished. So what I sometimes do is, rather than wait to get low blood Proteins, I put them straight on refeeding protocol with two ONS/day.” (Doctor #1) Certain hypercatabolic-syndrome settings nevertheless prompt them to start thinking oral nutrition is not enough. “When pressure ulcers or cancers come back, these situations where you know you need far higher intakes-where you have no time to lose.” (Doctor #2)

Follow-up on undernutrition care throughout the hospital stay

Some geriatricians feel that undernutrition management should be pushed back to later. “In the AGCU, you assess: the hospital stay is too short to re-assess your NS-backed feeding programme […]. When you come to re-assess, they are often already be in Subacute Care and Rehabilitation (SCR)” (Doctor #2). However, they do feel that they could also push their engagement further to prepare the ground for enteral feeding when the nutritional management rolls over into SCR “Say, OK, this patient has a severe undernutrition, to be re-assessed in x amount of time and if not reversed, place the NGT.” (Doctor #2). The care staff, though, manifestly voice a disconnect between their routine nursing and the medical management process. “You do food record charts for people who are eating loads, and when you flag up that the person isn’t eating, you don’t do a food record chart […] there’s a gap there, and you tell yourself nothing gets done.” (RNCA #7)

Elements considered for medical decision

Indications for NGT placement

The doctors appear to share a consensus that it is essential to optimally feed patients admitted for pressure ulcer, dysphagia after a stroke, or to ready for surgery or chemotherapy. “After that, deep pressure ulcer might be an issue” (Doctor #3) “a lady who had a haemorrhagic stroke, there it’s undeniably a good indication […] there is hope for recovery once the hematoma resorbs” (Doctor #5) “It’s presurgery nutrition to support better tolerance.” (Doctor #9). Anorexia against a background of depression with decline in general status also emerges as a consensus indication. “We were clearly looking at a care plan including antidepressants, and it worked out that way.” (Doctor #7). There is no clear consensus for infection management, even though the geriatricians appeared to recognize this indication. “I think that one of the best indications is to get through an acute-phase flare of infection or inflammation when you know it is likely to resolve.” (Doctor #3) This was voiced in the focus group without any objection from the co-attendees, and again in individual interview. “It’s in situations of acute stress-where there are going to be difficulties over one week, difficulties getting enough intake during major hypercatabolism-may be situations like that where, from time to time, we could be proposing the patient artificial nutritional support, but we don’t.” (Doctor #10)

Patient information and consent

All the doctors interviewed uphold and respect the principle that the patient’s wishes come ahead of any medical rationale. “Me, I work to the principle that if they are against it, then I don’t fit it” (Doctor #10). Many doctors reported that even when patients are fully informed and give their consent, they will still rip their NGT out eventually. “He ripped the catheter out, we offered to re-place it, and as he answered a very clear ‘no’, we didn’t do it” (Doctor #2) Over and above consent, the decisive factor is ultimately active patient participation. “A patient who was really engaged in cooperation, active collaboration, which makes everything so much easier […] he really was a stakeholder in his own care plan”. (Doctor #5)

Relationship with the family

The family holds a central position as the primary caregivers to go through when communication or decision-making are out of the older patient’s reach, when no advance care directives to go on. “She didn’t want any artificial support, so we held off the enteral nutrition in accordance with the directive that the patient had-supposedly-left but that her two daughters had passed on” (Doctor #5). That said, the opinion of the caregivers can put the practitioner in a difficult position, under pressure from the family to provide an enteral nutrition that the practitioner sees as unreasonable. “The family is always all for it, because their perception is that the nutrition is what is going to save them” (Doctor #10) Conversely, at other times, the family may be against an enteral nutrition that the doctor wants to implement. “We were pretty much pushing-and this was against the family’s wishes-to keep the enteral feeding going, and what ultimately happened was that the patient almost completely recovered as she was able to resumed normal feeding.” (Doctor #5) Even if the family are a primary proxy in geriatrics, the patient remains the primary decision-maker. “He is cognitively healthy, so we don’t need to call the family in-it’s his decision.” (Doctor #1). There is a unanimous view that it is vital to inform the family to foster their acceptance and participation in care. “If you explain everything properly, there’s no reason the family won’t accept it. Information is actually the be-all and end-all.” (Doctor #3)

Care-team decision-making

A collegial forum is something that the doctors and especially the care staff want. “These are still tough decisions to make, so I do find that the staff meeting helps get a clear picture of the issues.” (Doctor #2) Care staff want to be involved in the decision process, to understand it, as their assessments sometimes diverge from those made by the doctors. “Us, the nurses and nursing care assistants, as a rule, it just gets done, no-one asks us for any input. You show up in the morning, NGTs have been placed without anyone asking us if it’s a good idea, a bad idea” (RNCA #6) “When you don’t get consulted, you don’t necessarily understand […] whereas if you’re involved, whether you agree with it or not, at least you can understand.” (RNCA #6)

Benefits expected

The doctors are unable to give a clear picture of the real benefit expected from NGT feeding as a nutrition support measure in this population. “What really clouds the issue is that we just can’t properly measure the impact” (Doctor #5) “My feeling would be that more often than not it’s a failure” (Doctor #3). There appears to be some kind of dichotomy between the confirmed need for a NGT and doubts over the benefit expected. “Is always reasoning in terms of the patient’s best interests, over and above any biological formula or loss of weight, really going to bring them something?” (Doctor #10).

Importance of the care plan

The comprehensive care plan approach is a mainstay of geriatric medicine. “Either way, more than any kind of across-the-board assessment, it’s really going to be typically geriatric, […] What do they want? Is it worth it?” (Doctor #7) The majority of geriatricians was for including nutrition management and NGT feeding into a coherent comprehensive care plan as one of the factors of the parameters of geriatric patient assessment-quality-of-life included. “Geriatrics is never all about a nutrition plan. For me, it’s always about a plan for the future, a plan to make it out of the acute-care period.” (Doctor #7) “What is the plan, what is the potential for recovery?” (Doctor #5).

Prescription practice influenced by geriatric-ward experience

Those practitioners most exposed to care dependency and pathological aging are quick to confide how it may colour their thinking. “Personally I think I have been also conditioned by my experience of long-term hospital care […] a dozen patients on enteral feeding for months, years sometimes, all spent fighting with the adverse effects […] I’ve seen all the negatives of extended enteral, the ethics conversations, the families who just want it all to stop”. (Doctor #5) “Often, with the patients we have here at the AGCU, it’s hard to really go for it when you know the complications” (Doctor #2).

Barriers to implementing EN

Factors connected to the geriatric care environment

Preconceptions and perceptions of geriatricians

The perception seems to be that undernutrition is a comorbidity rather than an independent disease, and the doctors anticipate how patients will react to a problem they often ignore. “The patient’s going to turn round and say ‘but I’ve got no complaint. All I want is to not be in pain, the infection is under control, and right now I don’t feel I’m suffering from undernutrition’ ” (Doctor #5) As a rule, the geriatricians feel that they do start thinking about EN, but often too late on. “Let’s just say that if you start asking yourself whether you should be putting them on it, then it’s that things are already a bit desperate.” (Doctor #3) This delay may be explained by their doubts over the benefit expected and their overriding concern to put patient quality-of-life first. “I firmly believe that for someone extremely undernourished, trying desperately to refeed them is already a stupid idea-it just won’t work” (Doctor #3). The time factor thus emerges as essential, and for many geriatricians, as soon as the patient is taking even a little food on board, the decision to engage a nutritional intervention can be pushed back to later. “The crux of the issue in AGCU care is that even if you register severe undernutrition, regardless of the criteria you base it on, if food intakes are any good at all, then you can use up time to attempt to recorrect through oral feeding” (Doctor #2).

Preconceptions and perceptions of care staff

The care staff tend to consider that a drop in food intakes is a normal sign of the natural ageing process, culminating in a form of anorexia synonymous with refusal of care: “the person is in her early nineties, you can see that she’s tired of life and that the refusal to eat is her way of showing that she’s had enough” (RN 1). This means that nutrition management decisions-regardless of whether for or against intervention-are often misunderstood, and can sometimes even add a burden of distress to care staff teams who want to be kept informed and their voice heard. “Me, if there’s things I struggle to accept, I go and see the doctors, because if no-one tells me what’s happening, I can’t let it go” (RNCA #11) “sometimes, as care staff, we really struggle when we see someone for weeks, like the guy who died this morning, for weeks he wasn’t eating, and we kept telling them, telling them […] So you get the impression no-one listened to a word we say, nothing gets done about it, that you’re letting them starve to death”. (RNCA #9) That said, even in the situations where the care staff feel disarmed, there is still some ambivalence over the NGT. “I must say, I do find that at it’s still a procedure that is quite violent, in that it’s, after all, still an invasive procedure” (RN #1) The geriatric care teams remain underfamiliarized with using it, and they often experience placing the NGT as an assault on the patient. “I’m still not real comfortable with it, because-well, sure, I haven’t placed many, and as interventions go, it can’t be easy to live with” (RN #4). Today’s better hardware has nevertheless brought tangible progress, which the teams readily accept. “You have these special catheters now, with guidewires, that make procedure so much easier” (RN #2).

Fear of complications

Geriatrics, more than any other ward, seems to suffer the stigma of the incidence of complications. “It’s mainly inhaling stuff, yeah-I had the case of a patient who suffered a major aspiration pneumonia, which he never recovered from”(Doctor #10) “You’re often reluctant to place catheters-you can’t just place catheters and be done, without mulling it over” (Doctor #1).

Difficulties in practice

Interviewees raised several difficulties unique to geriatric care, such as tube feeding at night, the risk of prolonging the hospital stay and difficulties home-front continuation of care, although they also gave some positive feedback. “I’m personally not too happy with them being fed at night because there’s one nurse for 33 patients” (RN #2). “The NGT is not something you can go back home with-not unless you’re on in-home care” (Doctor #4) “I have already had two reports back from a care provider following her at home, and with that, she’s absolutely fine with her NGT” (Doctor #10).

The alternative-parenteral nutrition

Parenteral nutrition (PN) is not perceived as an alternative to NGT feeding, and appears to be rarely used in practice. “Personally I never put a patient on parenteral. Either I decide to talk about the nasogastric tube and then a Percutaneous Endoscopic Gastrostomy (PEG), or it’s a no.” (Doctor #2) Some doctors find that PN may be indicated when the care plan has not be clearly established or when it is difficult to gauge the patient’s acceptance. “Why not use parenteral nutrition more in acute cases when you’re not sure of where you’re going, rather than placing a NGT?”(Doctor #6).

Factors connected to the elderly population

Very old age and unreasonable obstinacy

Many doctors and care staff alike challenge the ethical soundness of starting this type of treatment in very old age, when patients are dependent on care and life expectancy is short, often to the point that it crosses the border into unreasonable obstinacy. “You have to admit that in paediatrics you are thinking about a life ahead, so there’s nothing distressing about putting a feeding tube on a baby in neonatal care because it’s just something you have to do to give them every chance of making it through, whereas in geriatrics you tend to hold back on it, because is NGT really worth it, is the patient consenting?” (Doctor #4) Practitioners regularly struggle with lingering doubts over the outcome of this type of care protocol. “Is it really going to bring the patient some kind of relief, because we’ve all had times when we’ve set up nutrition in patients who deceased shortly after.” (Doctor #10)

Cognitive disorders

The prevalence of cognitive disorders in the geriatric-care population emerges as a real barrier to the use of EN. “They’re just going to rip it out, because they just don’t understand what’s going on.” (Doctor #7) “When you have to fit wrist restraints just to keep the NGT in place, I consider that we’ve lost all sight of common sense and that we’re bordering on abuse to get someone feeding” (Doctor #10). The doctors remain well aware of the risk of under-evaluating the right indications for enteral nutrition. “You get so conditioned by all these patients who are very old or have cognitive disorders […] it prompts behaviours in patients who would likely benefit and we maybe end up overcompensating and excluding them.” (Doctor #5)

The long-term-care perspective

The geriatric doctors appear to fear the withdrawal of the NGT or the risk of having to move to a long-term PEG they feel is unreasonable. “You are withdrawing food, which in people’s minds means you are killing the patient […] Withdrawing it is a really tough call.” (Doctor #6) “Why didn’t we put him on PEG? You have to do something to stop short of overaggressive obstinacy […] there are situations where you have to know when it’s time to stop, because once you take the road of a nutrition management process, after there’s no turning back.” (Doctor #4)

Patient comfort and quality of life

The staff struggle to square integrating an invasive protocol like NGT feeding into a care plan where the goals are supposed to be the patient’s comfort and quality of life. “You feel like you’re creating them unnecessary hassle, given that in 10 days’ time, they’ll be back at home.” (Doctor #5)

Discussion

Main findings

The objective of this study was to analyze the knowledge and practices governing implementation of nasogastric tube feeding as an enteral nutrition support measure in AGCU wards. Our findings highlight a number of factors that create a disconnection between real-life bedside care practices and guidelined medical nutrition management. Even though practitioners can lead on HAS and ESPEN guidelines, our study effectively shows that the issue remains fraught with complexity-a complexity that can be translated into several explanatory concepts to help better grasp the difficulties faced by geriatric health care teams.
Foremost, the geriatric health care teams are essentially trained in the management of cognitive disorders and end-of-life care, which revolves around a comprehensive care plan approach focused on the patient’s comfort and quality of life. Our results do show that undernutrition is perceived as a latent phenomenon, commonly emerging in elderly patients, and patterned perhaps more as a comorbidity to be dealt with than a disease to be treated. The most common care consists in screening and oral nutrition, and geriatricians often think that Subacute Care and Rehabilitation is a better ward for nutrition care than AGCU. NGT feeding does not appear to be considered a solution to improve way to improved protein-energy intakes. It does feature in the therapeutic arsenal of geriatric medicine, but does not appear to get used unless to support adjuvant care for other diseases when framed within a comprehensive care plan (13). It is perceived as an invasive, aggressive therapeutic measure, which increases the risk of confusion, and often leads geriatric care teams to feel they are going against their primary goals of care, i.e. the patient’s comfort and quality of life.
Then, when its use seems needed, several concepts converge to influence medical decision-making in the AGCU ward, and thus determine certain preconditions. Information and consent are vital yet insufficient factors. Active patient participation, which goes further than a straight yes/no consent, is absolutely pivotal and will be dictated by how the NGT intervention plan is presented to the patient, how far the patient can trusts the doctor and how the patient can understand the information. Another concept is the role of the primary caregivers. Even though the medical decision has always been grounded in the wishes of the patient, it appears essential to have their collaborative involvement. The long-term-care perspectives can also prove problematic. Firstly, organizing EN at home for care-dependent patients can prove a real hurdle. Secondly, the uncertainty about the patient’s progress may lead to fear of a form of unreasonable medical care with the risk of becoming forced to look at a PEG. Last but not least, ethical factor remains a key factor being systematically addressed in this population where life expectancy is uncertain and prevalence of cognitive disorders is high. Consequently, the expected benefit of an NGT intervention seems uncertain for care teams and has to be more clear whereas they affraid over crossing the border into unreasonable obstinacy. Thus, the care staff teams-like the doctors-voice their need for a medical decision to be taken by multidisciplinary collegial consensus.
The circumspective position manifested by the geriatricians is probably legitimate given the potential consequences of an NGT in the most frail elderly (16). While the guidelines do not rule out NGT feeding as a very-short-term measure in patients with cognitive impairment, extended long-term delivery of EN via PEG is not advisable (1,12). The ESPEN prompts practitioners to think hard about the expected benefits of EN, and the HAS is equally prudent, advising EN only when expected benefit is considered to outweigh the procedure-related risks (1,12). Furthermore, the legal framework tends to improve comfort-only and support care first (17, 18). Even though the guidelines argue for enteral nutritional support to maintain normal intakes (1,11,12), the literature fails to confirm any real benefit in very old inpatients outside of certain indications for orthopedic surgery or as treatment for pressure ulcers (19-22). Nutritional interventions studies seems effective but often concern younger patients, and few of them bring evidence that would encourage geriatricians to start a nutritional intervention in the oldest age-bracket patients (23-25). A recent review of the literature confirms the struggle to characterize the groups of elderly inpatients most likely to benefit from nutritional support (26). However, the geriatric care teams appear too undertrained on EN to be able to confidently assess this benefit–risk ratio and they have probably to expand their use of EN. Some of the concepts highlighted should be considered in order to initiate an EN as part of a global care project.
The qualitative approach adopted here enabled us to explore complex phenomena beyond the grasp of other scientific approaches. However, this method of inquiry does impose certain limitations, that we sought to minimize here using COREQ criteria (15).

Conclusion

Active nutrition management for undernourished elderly patients in the AGCU is problematic as a process when the goals of the care plan are the patient’s comfort and quality of life. Although various sets of recommendations have been released to help to guide clinicians in their decision-making, there is no solid data to confidently assert the benefit of EN in very-old-age patients and confirm the grounds for its indication. The good use of NGT in AGCU remains to be defined despite the guidelines of ESPEN and HAS.

Ethical standards: The study secured approval from a french committee for the protection of human subjects.

Conflict of Interest: The authors have no conflict of interest.

References

1.   Haute Autorité de Santé – Stratégie de prise en charge en cas de dénutrition protéino-énergétique chez la personne âgée. has-santé.fr. http://www.has.sante.fr/portail/jcms/fc_1249588/fr/accueil-2012
2.    Potter J, Klipstein K, Reilly JJ, Roberts M. The nutritional status and clinical course of acute admissions to a geriatric unit. Age Ageing. 1995;24(2):131-6.
3.    Patel MD, Martin FC. WHY DON’T ELDERLY HOSPITAL INPATIENTS EAT ADEQUATELY? J Nutr Health Aging. 2008;12(4):227-31.
4.    Bonnefoy M, Berrut G, Lesourd B, Ferry M, Gilbert T, Guérin O, et al. Frailty and nutrition: searching for evidence. J Nutr Health Aging. 2015;19(3):250-7.
5.    Galanos AN, Pieper CF, Cornoni-Huntley JC, Bales CW, Fillenbaum GG. Nutrition and function: is there a relationship between body mass index and the functional capabilities of community-dwelling elderly? J Am Geriatr Soc. 1994;42(4):368-73.
6.    Paillaud E, Herbaud S, Caillet P, Lejonc J-L, Campillo B, Bories P-N. Relations between undernutrition and nosocomial infections in elderly patients. Age Ageing. 2005;34(6):619-25.
7.    Herrmann FR, Safran C, Levkoff SE, Minaker KL. Serum albumin level on admission as a predictor of death, length of stay, and readmission. Arch Intern Med. 1992;152(1):125-30.
8.    Sullivan DH. The role of nutrition in increased morbidity and mortality. Clin Geriatr Med. 1995;11(4):661-74.
9.    Wallace JI, Schwartz RS, LaCroix AZ, Uhlmann RF, Pearlman RA. Involuntary weight loss in older outpatients: incidence and clinical significance. J Am Geriatr Soc. 1995;43(4):329-37.
10.    Payette H, Coulombe C, Boutier V, Gray-Donald K. Weight loss and mortality among free-living frail elders: a prospective study. J Gerontol A Biol Sci Med Sci. 1999;54(9):M440-5.
11.    Bouteloup C, Thibault R. Arbre décisionnel du soin nutritionnel. Nutr Clin Metabol 2014;28(1):52-6.
12.    Volkert D, Berner YN, Berry E, Cederholm T, Coti Bertrand P, Milne A, et al. ESPEN Guidelines on Enteral Nutrition: Geriatrics. Clin Nutr 2006; 25(2): 330-60.
13.    Bruhat A, Bos C, Sibony-Prat J, Bojic N. L’assistance nutritionnelle chez les malades âgés dénutris. Presse Med. 2000 ;29(39) :2191-201.
14.    Jaafar MH, Mahadeva S, Subramanian P, Tan MP. Perceptions of Healthcare Professionals on the Usage of Percutaneous Endoscopic Gastrostomy in a Teaching Hospital from a Middle-Income South East Asian Country. J Nutr Health Aging. 2017;21(4):473-479.
15.    Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349.
16.    Lubart E, Leibovitz A, Dror Y, Katz E, Segal R. Mortality after nasogastric tube feeding initiation in long-term care elderly with oropharyngeal dysphagia–the contribution of refeeding syndrome. Gerontology. Karger Publishers; 2009;55(4):393-7.
17.    Loi N. Loi: 303 du 4 mars 2002 relative aux droits des malades… – Google Scholar. Journal officiel; 2002. 1 p.
18.    Aubry R, Puybasset L, Devalois B, Morel V, Viallard M-L. Loi du 2 février 2016 créant de nouveaux droits en faveur des malades et des personnes en fin de vie : analyse et commentaires. Médecine Palliative : Soins de Support – Accompagnement – Éthique. 2016;15(3):165-70.
19.    Bastow MD, Rawlings J, Allison SP. Benefits of supplementary tube feeding after fractured neck of femur: a randomised controlled trial. Br Med J 1983;287(6405):1589-92.
20.    Beattie AH, Prach AT, Baxter JP, Pennington CR. A randomised controlled trial evaluating the use of enteral nutritional supplements postoperatively in malnourished surgical patients. Gut. 2000;46(6):813-8.
21.    Hartgrink HH, Wille J, König P, Hermans J, Breslau PJ. Pressure sores and tube feeding in patients with a fracture of the hip: a randomized clinical trial. Clin Nutr. 1998;17(6):287-92.
22.    Stratton RJ, Ek A-C, Engfer M, Moore Z, Rigby P, Wolfe R, et al. Enteral nutritional support in prevention and treatment of pressure ulcers: a systematic review and meta-analysis. Ageing Res Rev. 2005;4(3):422-50.
23.    Milne AC, Avenell A, Potter J. Meta-analysis: protein and energy supplementation in older people. Ann Intern Med. 2006;144(1):37–48.
24.    Feldblum I, German L, Castel H, Harman-Boehm I, Shahar DR. Individualized nutritional intervention during and after hospitalization: the nutrition intervention study clinical trial. J Am Geriatr Soc. 2011;59(1):10-7.
25.    Hegerová P, Dědková Z, Sobotka L. Early nutritional support and physiotherapy improved long-term self-sufficiency in acutely ill older patients. Nutrition. 2015;31(1):166-70.
26.    de van der Schueren MAE, Wijnhoven HAH, Kruizenga HM, Visser M. A critical appraisal of nutritional intervention studies in malnourished, community dwelling older persons. Clin Nutr. 2016;35(5):1008-14.

FRAILTY, LOSS OF NATURAL TEETH AND QUALITY OF LIFE

I.-C. Lee¹, S.-F. Weng¹, P.-S. Ho²

1. Department of Healthcare Administration and Medical Informatics, Kaohsiung Medical University, Kaohsiung, Taiwan; 2. Department of Oral Hygiene, Kaohsiung Medical University, Kaohsiung, Taiwan.

Corresponding Author: Pei-Shan Ho, Department of Oral Hygiene, Kaohsiung Medical University, Kaohsiung, Taiwan, 100,Shih-Chuan 1st Road, Kaohsiung 807, Taiwan, Email: psho@kmu.edu.tw, Tel: 886-7-3121101 ext.2159,
Fax: 886-7-3157024

J Aging Res Clin Practice 2018;7:85-90
Published online May 24, 2018, http://dx.doi.org/10.14283/jarcp.2018.16

Abstract

Objective: This study investigates whether the loss of natural teeth associate with elderly frailty, as well as their connection with quality of life. Design: This study collected data from January 2012 to April 2013, and the subjects were the elderly over the age of 65 living in community. Setting: Loss of natural teeth and frailty are common issues in elderly and it is noteworthy to address these issues while the investigation of healthy ageing. Participants: The research included 543 elderly people over the age of 65. Measurements: The face-to-face interviews with a structured questionnaire were performed. Results: Elderly people with no natural teeth are more likely to become frail (OR=1.87); the relationship between frailty and quality of life is more significant. After adjusting for all the independent variables, results showed that frailty in elderly leads to poorer quality of life, and oral health status is not correlated with quality of life (P>0.05). The remain of natural teeth is correlated with occurrence of frailty in the elderly. Conclusions: Frailty has a significant and strong influence on oral health-related quality of life. For the elderly, frailty shall be early diagnosed to ensure provision of proper preventive health care.

Key words: Elderly, frailty, loss of natural teeth, OHIP.

Introduction

At present, various countries all around the world are facing the increase of elderly population, and the problem of ageing population structure has been increasingly severe. As of the end of 2012, the proportion of the elderly over the age of 65 in total population in the countries in the Europe and the U.S. was as follows: U.S. (13.7%), U.K. (17.0%), Germany (20.7%), Sweden (19.1%), and Finland (18.8%); and that in Asia is: Japan (24.1%), Korea (11.8%), and Taiwan (11.2%) (1). Among all of the above countries, the speed of population ageing in Taiwan has been considered as the top 1, and Ageing Index has also rapidly increased 32% in 10 years. The problems caused by elderly population certainly will become a trend that cannot be ignored in the society in Taiwan.
Many studies indicated that, the occurrence of loss of natural teeth in the elderly is very common, and 30-40% of the elderly are edentulous (2-4).During food intake, edentulous people tend to experience bradymasesis or fail to chew carefully and swallow slowly, which leads to malnutrition or diseases of digestive system (5-9). After a long period of time, their overall health functions will also be worsened (10-12), and their oral health-related quality of life will be lowered (13-16). In addition to oral health problems, in recent years, there has also been a research trend of investigation on elderly frailty. “Frailty” is not a disease, but merely an alert of loss of balance of health functions. Hamerman indicated that, as long as an elderly person who lives independently experiences the symptoms of frailty, his/her risk of death will be multiplied (17). Many studies found that, the proportion of the elderly with frailty suffering from chronic illness is higher, their overall health functions are poorer (18-19). A consensus on diagnostic criteria for elderly frailty has not been reached. The indices and criteria proposed by Fried et al. are most frequently adopted by experts and scholars internationally (20). The 5 indices include unexpected weight loss (weight loss of 10 pounds within the past year), self-perceived fatigue, weakness, slow walking speed, and reduced physical activities.
In sum, loss of natural teeth and frailty are common health issues in elderly. The association of health problems and quality of life in elderly is also highly focused in research (21-23). Among various assessments of oral health-related quality of life (OHRQoL), Oral Health Impact Profile (OHIP) developed by Slade and Spencer is the most popular evaluation within the field of dentistry research (24). The evaluation content includes the questions asking the subjects whether dental problems, oral problems or dentures affect their activities of daily living, as well as the questions on perceived level of distress. However, in order to increase the convenience and accuracy of clinical evaluation, subsequent researchers continuously developed shortened versions of evaluation tools, such as OHIP-14 and OHIP-EDENT (25-26). OHIP-14 is the short version (14-item) of original OHIP (49-item). OHIP-EDENT is based on OHIP and chooses appropriate questionnaire items for edentulous people, with a total of 19 items.
Frailty is the emerging trend of health issues. The literatures of whether the frailty associates with oral health status or whether the frailty affects oral health-related quality of life still remains limited. Therefore, the main purpose of this study is to investigate the correlation among loss of natural teeth, frailty, and oral health-related quality of life (OHRQoL) and provide the research results as reference for promotion of elderly oral health and planning of healthy ageing policies.

Material and Methods

Healthy ageing means to extend the life of being independent and to decrease the probability of being dysfunction and relying on others in elderly. The elderly aged over 65 years and walk independently, with or without cane, were enrolled as targeted subjects; whereas the elderly with diagnosed dementia were excluded. This study collected data from January 2012 to April 2013, and the subjects were the elderly over the age of 65 in San-Ming district of Kaohsiung City. This study selected the places where the elderly usually gather to engage in activities, such as parks and community activity centers. It is hoped to screen the high risk individuals from health elderly population. Researchers recruited the targeted subjects from the locations mentioned above to obtain their health-related information. The researchers who had received the training of questionnaire interviews performed face-to-face interviews with the elderly individually. The inter-rater agreement of these results reaches 94%. After the interviews, the researchers measured the subjects’ objective data, such as walking speed and grip strength. Under certain conditions, the questionnaire might be completed by interviewers based on subjective responses of elderly who have low vision and cannot fill out the forms independently. This study enrolled a total of 543 subjects. This study was approved by the Institutional Review Board of Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH-IRB-20120196). The study design, methodological procedure and administrative protocol were carried out in “accordance” with the approved guidelines. Informed consent was obtained from all subjects prior to data collection.
This study used a structured questionnaire to perform interviews. There are 135 items which derived from many validated assessments (e.g., ADL, and MNA) in this questionnaire to assess the health functional status in elderly. It takes 20 minutes to complete this questionnaire. According to the main research objectives, this study extracted some of the data for analysis. The detailed explanations on variables analyzed are given as follows:
(1) Demographic characteristics: age, gender, province of family register, educational background, economic status, and number of chronic diseases.
(2) Oral health status: this variable was mainly used to understand whether there were natural teeth in the mouths of the elderly. Due to the good accessibility of medical services in Taiwan and the welfare policy of “Dentures for the Elders Using Public Funding” provided by the government, elderly people with loss of natural teeth would usually obtain prosthetic treatment for free. The participants were categorized as dentulous group and edentulous group in this study. The dentulous group consists of the elderly who have natural teeth remained in the mouth, with unknown number of the natural teeth remained; whereas the edentulous group consists of the elderly who have no natural teeth remained in the mouth and these with complete denture.
(3) Frailty status: Fried (2001) used indices, such as weight loss, perceived fatigue, weakness, slow walking speed, and reduced physical activities to evaluate whether the elderly are frail. Because it is difficult to collect questionnaires on physical activities, this study used other 4 indices to understand the status of elderly frailty. In literatures, the indicators of frailty have not been standardized yet. Thus, the indicators of frailty that used in this study, described as follows, were modified from the indicators proposed by Fried et al. (2001).
This study asked the subjects about “whether he/she experienced weight loss within the last three months” and “whether they perceived fatigue within the last three months.” If the answers were “Yes,” the subjects experienced the signs of frailty. This study used electronic gripping device to measure the value of grip strength, in order to understand whether the elderly experienced the sign of weakness. Because the performance of grip strength varies with gender, this study divided the subjects into two groups: male subjects and female subjects. The 20% of subjects with the lowest value in each group were deemed weak subjects, namely, the high risk group of frailty. For the index of slow walking speed, this study asked the elderly to walk back and forth for 3 meters, and measured the time it took. Because the height of subjects might affect step size and waking speed, this study used the average height of all of the subjects as the baseline for division of groups. This study divided the elderly into two groups: tall and short groups. The 20% of subjects with the slowest walking speed were classified as frail subjects. The signs reflected by the said 4 indices were elderly frailty. This study summed up the total number of items of frailty. The subjects whose number of items of frailty ≥2 were deemed the subjects “with” frailty. These ways of discriminants are considerably valid that people with diagnosed frailty are comparatively unhealthy (27).
(4) Quality of life: This study used the short form version of OHIP-EDENT developed by Allen and Locker (2002) (Oral Health Impact Profile appropriate for use in edentulous patients) for measurement. This version can be used to understand the influence of general oral health problems on daily living. Moreover, some items were added to evaluate the influence of edentulousness on activities of daily living. The reliability and validity of testing of version in Chinese are very good as well(28). The higher the score was, the higher the perceived distress and influence of oral problems on daily living were and the poorer the quality of life was.

This study used the statistical software SPSS19.0 version to perform statistical analyses, and used Chi-square, t-test, and one-way ANOVA to understand the differences in demographic characteristics, frailty status, oral status, and quality of life (OHIP-EDENT). In addition, this study used logistic regression model to assess whether the oral health status associates with frailty; and used multiple linear regression model to investigate the influence of frailty status and oral status on quality of life.

Results

Table 1 shows that compared with those in non-frail group, frail group has higher percentage of subjects over the age of 80 years (40.4% vs. 14.4%), higher percentage of subjects with illiteracy and with educational level under elementary school (70.3% v.s 54.5%), and higher percentage of edentulous subjects (44.1% v.s 24.0%)(P<0.05).

Table 1
Demographic characteristics, oral status and frailty

Note: This table is the results of Chi-square analysis

There are no relationship between the gender, native place with the scores of quality of life, whereas other variables demonstrate the significant difference on the scores of quality of life (P<0.05), as shown on Table 2.

Table 2
Demographic characteristics, oral status, numbers of diseases, frailty and OHIP-edent

Note: This table is the results of t-test, one-way ANOVA and Scheffes’ post-hoc method

Tables 3 and 4 investigated the correlation among oral status, frailty and quality of life. After demographic variables were adjusted, compared with subjects with natural teeth in their mouth, edentulous elderly were much easier to turn into being frail (OR=1.87). In the regression model of exploring quality of life and relevant factors, any signs of being frail in elderly correlates positively with the scores of quality of life, whereas no significant difference on scores of quality of life no matter any of natural teeth remains in elderly (Table 4). After all of the independent variables were adjusted, frail group of elderly has much poorer quality of life than those in non-frail group of elderly. This study compared the correlation between two variables, frailty and oral health status, and quality of life, and found that, the correlation between frailty and quality of life was stronger (β=0.21) and significant (P<0.05). Oral health status correlates much less with quality of life (β=0.05) and did not reach the significant level (P>0.05).

Table 3
Logistic regression model of frailty

Table 4
The multiple linear regression model of OHIP-edent

R2=0.200

Discussion

This study found that, age, province of family register, and oral status were correlated with the occurrence of frailty (Table3). Elderly with increased age might much easier become frailty. Literature(18,29)indicates that physical functions also decline day by day with the increase of age, and the elderly may easily experience symptoms of frailty, such as fatigue, weakness, and slow walking speed. Elderly with no natural teeth remained might much easier turn into being frailty. Some literature(6,30-31)show that elderly with poor oral health status may demonstrate malnutrition, weight loss, and frailty due to their poor chewing capability. The elderly whose province of family register is not Taiwan are also less likely to experience symptoms of frailty. This phenomenon is the same as ethnic factor abroad. In Chinese society, living styles and dietary culture of people vary with their province of family register, which may lead to the difference in health status (32).
The main objective of this study was to investigate the correlation among frailty, oral health status, and quality of life. The association of frailty and oral health status was previously mentioned. The frailty and oral health were served as variables within the regression model of quality of life scores to clarify their associations with quality of life. As results shown that the elderly with frailty have poor quality of life whereas the oral health status has not related with quality of life. Even though frailty and oral health problems are the common issues in elderly population, their impacts on quality of life is different. “Frailty” is only a health alert. In the field of clinical medicine, diagnostic criteria and treatment guidelines for signs of frailty have not been developed. Therefore, medical therapeutic intervention usually will not be immediately implemented for the symptoms of frailty in the elderly. The quality of life may get worse if individual’s frailty status does not improve (18, 33). In contrast, this study divided oral health status into two groups, edentulous subjects and dentulous subjects. Due to the development of current medical technology, dental materials have been gradually stabilized. Also, there is the welfare policy for funding the free denture placement of elderly in Taiwan, thus, most edentulous elderly may wear the whole set of removable denture. Therefore, the perceived distress and influence of oral problems in daily living were less significant. Compared with the strength of influence of frailty, the correlation between edentulousness and quality of life was weaker. Therefore, quality of life was not affected by it (14, 34).
In addition to frailty and oral health status, the results also demonstrated the difference in age, educational background, economic status, and the numbers of diagnosed chronic diseases would lead to the difference in score of OHIP-EDENT (Table 4). It is suggested taking the above variables into consideration in the future study for further investigation of oral-related quality of life. The associations of these variables and quality of life were synthesized as follows. The score increased with the increase of age, suggesting that, the subjects’ quality of life was poorer and they perceived increased distress in daily living due to oral health problems. In addition to the loss of natural teeth, other oral health-related problems increase with age, and lead to the gradual decline of quality of life (19, 35-36). People with better education may comprehend health-related knowledge better (37-39), leads to the oral health problems not affect their activities of daily living that much. The people with poorer economic status tend to experience economic barriers and fail to obtain sufficient medical care services. Thus, the daily living of these people might be disturbed by the oral health related problems, then further affects their quality of life (35-36). The oral health status of people suffering from chronic illness may become poorer due to side effects of drugs or the influence of illness(37,40). Therefore, they will perceive distress in activities of daily living, which affects their quality of life.

Conclusions

The health care issues in elderly population are important and shall be addressed in the future. In order to slow down the speed of growth of medical expenses and enrich the quality of life, the concept of healthy ageing shall be globally promoted. It is highly important that clinical professionals can early detect the high risk elderly population. Frailty is the alert of unbalanced health functions. Although it is not deemed a disease, it will trigger a series of negative health outcomes and further affect oral health-related quality of life. Dentists and oral health care-related personnel shall devote themselves to the oral health treatments in order to maintain and improve the oral health-related quality of life in elderly population. The extra attention shall also be paid on whether the elderly experience symptoms of frailty. This could be beneficial to the early detection of these elderly with frailty. Furthermore, it is hope that the proper preventive cares and health promotion services can be provided in advance to ensure the achievement of healthy ageing.

Ethics approval: This study was approved by the Institutional Review Board of Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH-IRB-20120196). The study design, methodological procedure and administrative protocol were carried out in accordance with the ethical approved guidelines. Informed consent was obtained from all subjects prior to data collection.

Availability of data and materials: All datasets on which the conclusions of the manuscript presented in the main paper.

Competing interests: The authors declare no conflict of interest.

Funding: Not applicable.

Authors’ contributions: I-Chen Lee defined the research theme and mainly contributed to study design, literature synthesis, data collection, statistical analysis, manuscript-writing and formation; Shih-Feng Weng mainly contributed to study design, statistical analysis, manuscript-writing and formation; served as consultants in advanced statistical analysis, data interpretation ; Pei-Shan Ho served as consultants in data interpretation and manuscript refinement. All authors read and approved the final version of the manuscript submitted for publication.

Acknowledgements: Sincere appreciation will be given to all individuals who participate in this study.

References

1.   Ministry of the Interior , Department of Statistics. Available at http://sowf.moi.gov.tw/stat/national/list.htm (accessed 17 October 2015).
2.   Montal S, Tramini P, Triay JA , Valcarce J. Oral hygiene and the need for treatment of the dependent institutionalized elderly. Gerodontology. 2006;23:67-72.
3.   Islas-Granillo H., Borges-Yañez S.A., Lucas-Rincón S.E.et al. Edentulism risk indicators among Mexican elders 60-year-old and older. Arch Gerontol Geriatr. 2011;53:258-262.
4.   Gaio EJ, Haas AN, Carrard VC, Oppermann RV, Albandar J, Susin C. Oral health status in elders from South Brazil: a population-based study. Gerodontology. 2012;29:214-223.
5.   Pouyssegur V, Brocker P, Schneider SM et al. An innovative solid oral nutritional   supplement to fight weight loss and anorexia: open, randomised controlled trial of efficacy in institutionalized, malnourished older adults. Age Ageing. 2015;44:245-51.
6.   Saarela, R. K., Lindroos, E., Soini, H., Hiltunen, K., Muurinen, S., Suominen, M. H., & Pitkälä, K. H. Dentition, nutritional status and adequacy of dietary intake among older residents in assisted living facilities. Gerodontology. 2016;33(2):225-232.
7.   Han, S. Y., & Kim, C. S. Does denture-wearing status in edentulous South Korean elderly persons affect their nutritional intakes?. Gerodontology. 2016;33(2): 169-176.
8.   Hunt RJ, Beck JD, Lemke JH, Kohout FJ, Wallace RB. Edentulism and Oral Health Problems among Elderly Rural Iowans: The Iowa 65+ Rural Health Study. Am J Publ Health. 1985;75:1177-1181.
9.   Picos AM, Picos A, Nicoara P, Craitoiu MM. Dental Erosion In a Partially Edentulous Patient With Gastroesophageal Reflux Disease: A Case Report. Clujul Medical. 2014;87:284-287.
10.   Slade GD, Akinkugbe AA, Sanders AE. Projections of U.S. Edentulism prevalence following 5 decades of decline. J Dent Res. 2014;93:959-965.
11.   Yu YH, Lai YL, Cheung WS, Kuo HK. Oral Health Status and Self-Reported Functional Dependence in Community-Dwelling Older Adults. J Am Geriatr Soc. 2011;59: 519-523.
12.   Medina-Solís CE, Pontigo-Loyola AP, Pérez-Campos E et al. Edentulism and other variables associated with self-reported health status in Mexican adults. Med Sci Monit. 2014;2:843-852.
13.   Lee IC, Yang YH, Ho PS, Lee IC. Chewing ability, nutritional status and quality of life. J Oral Rehabil. 2014;41:79-86.
14.   Sivakumar I, Sajjan S, Ramaraju AV, Rao B. Changes in oral health-related quality of life in elderly edentulous patients after complete denture therapy and possible role of their initial expectation: a follow-up study. J Prosthodont. 2015;24:452-456.
15.   Makhija SK, Gilbert GH, Boykin MJ et al. The relationship between sociodemographic factors and oral health–related quality of life in dentate and edentulous community-dwelling older adults. J Am Geriatr Soc. 2006;54:1701-1712.
16.   Visscher CM, Lobbezoo F, Schuller AA. Dental status and oral health-related quality of life. A population-based study. J Oral Rehabil. 2014;41: 416-422.
17.   Hamerman D. Toward an understanding of frailty. Ann Intern Med. 1999;130:945-950.
18.   Bagshaw SM, Stelfox HT, Johnson JA et al. Long-term association between frailty and health-related quality-of-life among survivors of critical illness: a prospective multicenter cohort study. Crit Care Med. 2015;43:973-982.
19.   Byard RW. Frailty syndrome – Medicolegal considerations. J Forensic Leg Med. 2015;30: 34-38.
20.   Fried LP, Tangen CM, Walston J et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56:M146-156.
21.   Ngoenwiwatkul Y, Chatrchaiwiwatana S, Chaiprakarn K. Dental status and its impact on the quality of life of elderly in Phon Sawan, Nakhon Phanom Province. Southeast Asian J Trop Med Public Health. 2014;45:236-243.
22.   Clijmans, M., Lemiere, J., Fieuws, S., & Willems, G. Impact of self-esteem and personality traits on the association between orthodontic treatment need and oral health-related quality of life in adults seeking orthodontic treatment. European journal of orthodontics. 2015;37(6), 643-650.
23.   Vel Aacute Zquez-Olmedo LB, Ort Iacute Z-Barrios LB, Cervantes-Velazquez A, C Aacute Rdenas-Bahena AN, Garc Iacute A-Pe Ntilde A C, S Aacute Nchez-Garc Iacute A S. Quality of life related to oral health in older people. Evaluation instruments. Rev Med Inst Mex Seguro Soc. 2014;52:448-456.
24.   Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994;11:3-11.
25.   Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997;25:284–290.
26.   Allen F, Locker D. A modified short version of the oral health impact profile for assessing health-related quality of life in edentulous adults. Int J Prosthodont. 2002;15:446–450.
27.   Lee, I. C., Chiu, Y. H., & Lee, C. Y. Exploration of the importance of geriatric frailty on health-related quality of life. Psychogeriatrics. 2016;16(6):368-375.
28.   Kuo HC, Kuo YS, Lee IC, Wang JC, Yang YH. The association of responsiveness in oral and general health related quality of life with patients’ satisfaction of new complete dentures. Qual Life Res. 2013;22:1665-1674.
29.    Lin CH, Chou CY, Liu CS, Huang CY, Li TC, Lin CC. Association between frailty and subclinical peripheral vascular disease in a community-dwelling geriatric population: Taichung Community Health Study for Elders. Geriatr Gerontol Int. 2015;15: 261-267.
30.    Madhuri S, Hegde SS, Ravi S, Deepti A, Simpy M. Comparison of chewing ability, oral health related quality of life and nutritional status before and after insertion of complete denture amongst edentulous patients in a Dental College of Pune. Ethiop J Health Sci. 2014;24, 253-260.
31.    Gil-Montoya JA, Ponce G, Sánchez LI, Barrios R, Llodra JC, Bravo M. Association of the oral health impact profile with malnutrition risk in Spanish elders. Arch Gerontol Geriatr. 2013;57:398-402.
32.    Tung HJ, Mutran EJ. Ethnicity and Health Disparities Among the Elderly in Taiwan. Res Aging. 27:327-354.
33.    Kanauchi M, Kubo A, Kanauchi K, Saito Y. Frailty, health-related quality of life and mental well-being in older adults with cardiometabolic risk factors. Int J Clin Pract. 2008;62:1447-1451.
34.    Kuoppala R, Näpänkangas R, Raustia A. Quality of Life of Patients Treated With Implant-Supported Mandibular Overdentures Evaluated With the Oral Health Impact Profile (OHIP-14): a Survey of 58 Patients. J Oral Maxillofac Res. 2013;4: 1-6.
35.    Maida CA, Marcus M, Spolsky VW, Wang Y, Liu H. Socio-behavioral predictors of self-reported oral health-related quality of life. Qual Life Res. 2013;22:559-566.
36.    Silva AE, Demarco FF, Feldens CA. Oral health-related quality of life and associated factors in Southern Brazilian elderly. Gerodontology. 2015;32: 35-45.
37.    Saltnes SS, Storhaug K, Borge CR, Enmarker I, Willumsen T. Oral health-related quality-of-life and mental health in individuals with chronic obstructive pulmonary disease (COPD). Acta Odontol Scand. 2015;73: 14-20.
38.    Gabardo MC, Moysés SJ, Moysés ST, Olandoski M, Olinto MT, Pattussi MP. Multilevel analysis of self-perception in oral health and associated factors in Southern Brazilian adults: a cross-sectional study. Cad Saude Publica. 2015;31:49-59.
39.    Gabardo, Marilisa Carneiro Leão, Simone Tetu Moysés, and Samuel Jorge Moysés. Self-rating of oral health according to the Oral Health Impact Profile and associated factors: a systematic review. Rev Panam Salud Publica. 2013;33:439-445.
40.    Abnet CC, Qiao YL, Dawsey SM, Dong ZW, Taylor PR, Mark SD. Tooth loss is associated with increased risk of total death and death from upper gastrointestinal cancer, heart disease, and stroke in a Chinese population-based cohort. Int J Epidemiol. 2005;34: 467-474.

THE RELATIONSHIP BETWEEN MARKERS OF MALNUTRITION AND MUSCLE WASTING WITH FRAILTY AND PHYSICAL FUNCTION IN OLDER CARE HOME RESIDENTS

A. Slee¹, T. Ahmed², L. Storey², L. Wilkinson², G. Wilson², G. Garden³

1. Institute for Liver and Digestive Health, UCL Medical School, Royal Free Campus, Rowland Hill Street, Hampstead, London, NW3 2PF; 2. United Lincolnshire Hospitals NHS Trust, Lincoln County Hospital, Greetwell Road Lincoln, LN2 5QY; 3. St Barnabas Hospice, 36 Nettleham Road, Lincoln, LN2 1RE

Corresponding Author: Dr Adrian Slee, Institute for Liver and Digestive Health, UCL Medical School, Royal Free Campus, Rowland Hill Street, Hampstead, London, NW3 2PF, United Kingdom, email: adrianslee@hotmail.co.uk.

J Aging Res Clin Practice 2017;6:176-181
Published online September 14, 2017, http://dx.doi.org/10.14283/jarcp.2017.23

Abstract

Background: Older care homes residents may suffer from malnutrition and muscle wasting within a background of varying degrees of frailty, comorbidity and disability. Hence, malnutrition is complicated by co-presence of sarcopenia, cachexia and inactivity-induced muscle atrophy. Objectives: (1) to assess the prevalence of malnutrition in care home residents using different methodologies. (2) To examine the relationship between measurements of nutritional status and muscle mass with frailty and physical function; Design: initial pilot study. Setting: care homes for older people. Participants: 73 participants, 46 female and 27 male; Intervention: observational study. Measurements: height (m), weight (kg), body mass index (BMI) (kg), bioelectrical impedance assessment (BIA) of fat free mass index (FFMI) (kg/m2), mid upper arm muscle circumference (MUAMC) (cm), Edmonton Frailty Scale (EFS) and Barthel Index (BI). Results: There was a relatively high prevalence of malnutrition depending on measure used. MNA-SF 0-7 score was 30% for females and 28% males. Low MUAMC was found in 41% females and 53% males; low BIA FFMI in 37% females and 52% males. Good correlation (P<0.001) was found for most measures including against EFS and BI for MNA-SF and MUAMC. Conclusions: Malnutrition prevalence was relatively high. MNA-SF and MUAMC correlated well with functional status and frailty EFS measures. FFMI by BIA correlated well with MNA-SF and MUAMC. This range of practical techniques should be explored further for determining malnutrition risk and muscle wasting in relation to functionality and frailty in care home residents

Key words: Malnutrition, sarcopenia, cachexia, frailty, muscle wasting.

Introduction

Older people in care homes have varying degrees of comorbidity, frailty and impaired functional ability which may be associated with clinical outcomes (1). Malnutrition, a serious concern for this population group, is a component of the frailty cycle, and may be linked to worse outcomes (2, 3), therefore screening for malnutrition with simple tools has high clinical value (4, 5). There is debate however, regarding which methods to use and specific cut-off points (e.g. body mass index, BMI) (6). Furthermore, differentiating the different states of cachexia, sarcopenia and disuse atrophy is complex (7-10). Older people with varying degrees of frailty, comorbidity (and associated inflammation etc.) and poor physical function may suffer from a combination of states and be difficult to assess. Regardless of origin, these states lead to skeletal muscle mass (SMM) loss and a reduction in nutritional status making an older person more susceptible to malnutrition and risk of morbidity and mortality. Recently, the term ‘muscle wasting disease’ has been suggested as an umbrella term to encompass all forms of muscle loss (11).
Regarding techniques of assessment for malnutrition risk, the mini nutritional assessment (MNA) and abbreviated short-form (MNA-SF) have been validated and suggested for use in older people (4) and uses BMI with significant weight loss and other specific questions. Previous studies in older people have also utilised bioelectrical impedance assessment (BIA) to estimate nutritional status, measuring fat free mass (FFM) and FFM index (FFMI in kg/m2) (5, 12-14). Recently, an ESPEN consensus statement, produced for the assessment of malnutrition discussed specific cut-off points for BMI, weight loss and use of FFMI. Muscle wasting can be estimated by FFMI as an indicator of SMM. It can also be measured practically by the mid upper arm muscle circumference (MUAMC). The MUAMC was used in a large Italian study (n = 357) by Landi et al (IlSIRENTE Study) which investigated the relationship between MUAMC in community-dwelling older people with physical performance and mortality (15).
One area of research has been the development of tools and measures for frailty status and the relationship with health and specific aspects such as muscle loss in ageing, sarcopenia. The Edmonton Frailty Scale (EFS) was developed as a brief, valid and reliable tool which can be used to identify multi-domain frailty by clinical staff without training in geriatric medicine (16). The usefulness of the EFS in care homes and relationship with markers of nutritional status, malnutrition and muscle wasting has yet to be ascertained. Furthermore, the relationship between these different markers with measurements of the Activities of Daily Living (ADLs) is also of high interest. The Barthel Index (BI) is commonly used by geriatricians to indicate functional ability/disability (17).
This study aimed to (1) investigate malnutrition prevalence in care home residents using different methods and (2) investigate the relationship between markers of nutritional status, frailty and physical function.

Methods

Participants and study design

This study was undertaken between October 2015 and May 2016 and is part of an ongoing care home service evaluation, the Frailty and Nutrition Study in Lincoln (FANS). Study was cleared through NHS research ethics committee in September 2015. Care home residents underwent Comprehensive Geriatric Assessment (CGA) in four care homes in Lincoln, United Kingdom. Patients were diagnosed with different levels of frailty and with a range of comorbidities including; cardiovascular disease, chronic heart failure, chronic kidney disease, chronic obstructive pulmonary disorder, cancer, diabetes, arthritis, and dementia. Most residents were being treated with multiple drugs. The aim was to recruit 100 to 150 patients in line with other similar studies; however the designated study time restraints dictated the current number. Measurements were collected by members of a multidisciplinary care team.

Anthropometric measurements

Height (in m) was estimated using ulnar length and conversion tables (BAPEN, UK). Weight (in kg) was measured and body mass index (BMI in kg/m2) calculated. Mid upper arm circumference (MUAC) was measured using a tape measure around the mid-point of the upper arm. Measurements were taken on the right side of the participant’s body unless affected by disability or disease.

Bioelectrical impedance assessment measurements

BIA measurements were taken using a single-frequency (50 kHz) Maltron 916 S, bioelectrical impedance analyser (Maltron International Ltd., Rayleigh, Essex, UK). Measurements were taken using a standard hand-to-foot tetra-polar technique with participants in the supine position, in accordance with the manufacturer’s guidelines. Raw impedance measurements of resistance (R) and reactance (Xc) in ohms and PA were recorded.
The BIA estimation of FFM was completed using the following BIA equation (Kyle equation (18)):
FFM = -4.104 1 (0.518 x height2 /R) + (0.231 x weight) + (0.130 x Xc) + (4.229 x sex: men = 1, women = 0). Height is in cm and weight in kg.

Nutritional assessment: MNA-SF screening

MNA-SF screening was undertaken by clinical staff according to instructions and scores recorded. Scores were converted into categories for nutritional status using MNA scoring criteria either low risk/normal (12–14), medium risk/at risk (8–11) and high risk/malnourished (0–7).

Mid-upper arm muscle circumference calculation

The MUAMC was calculated using the formula:
MUAMC = mid-upper arm circumference – (3.14 X triceps skinfold thickness)
Measurement of triceps skinfold thickness (to the nearest 0.2 mm) was made using Harpenden skinfold calliper (range: 0.00– 50.00 mm; minimum graduation: 0.20 mm).
Using reference data from Landi et al, the lowest tertiles for males (< 21.1 cm) and for females (< 19.2 cm) were used as cut-off points to indicate low muscle mass.

Malnutrition prevalence

Prevalence of malnutrition was assessed by BMI, MNA-SF score and FFMI. A BMI of < 20 kg/m2 was used as the population is older and high presence of comorbid chronic conditions. E.g. in the cachexia definition by Evans et al. a BMI < 20 kg/m2 is used as a cut-off point when there is presence of a chronic disease (7).

Edmonton frailty scale

The EFS was undertaken by clinical staff as part of routine CGA in participants. The EFS 10 domain test as described by Rolfson et al with maximum score of 17 was undertaken (16). Higher scoring indicates increasing frailty.
Barthel index

The BI was undertaken by clinical staff as part of routine CGA in participants. A standard 10 question BI with a maximum of 20 point scoring was undertaken (17). Lower scoring indicates increasing disability.

Statistical analysis

Data was analysed as a group and individually for males and females. Cut-off points were assigned for malnutrition risk and low MUAMC. Number of residents and percentage (%) was calculated for prevalence. Correlations were performed on all variables using Pearson test and Spearman for nonparametric data. All statistical tests were performed using IBM SPSS Statistics Version 21.

Results

There were 73 resident participants recruited over 4 separate care homes. The characteristics of the older care home residents can be seen in Table 1. MNA-SF and BIA was completed in all residents, MUAMC in 58, EFS in 49 and BI in 52.

Table 1
Participant characteristics and variables. Mean +/- standard deviation, median [ ], minimum and maximum ( )

All residents had gait speed and grip strength below the cut-off points for the European Working Group on Sarcopenia in Older Persons (EWGSOP) definition for sarcopenia (9).
Prevalence of malnutrition was assessed by BMI and MNA-SF score (see Table 2). Prevalence of low MUAMC indicative of muscle wasting can be found in Table 2 along with low FFMI.

Table 2
Prevalence of malnutrition, low MUAMC and low FFMI

*Low MUAMC: <19.2 cm for females and <21.1 cm for males. †Low FFMI: <15 kg/m2 for females and <17 kg/m2 males.

Correlations

There was good correlation between most measures (Table 3). However, there was no significant correlation between FFMI with Edmonton EFS or Barthel Index BI. Figures 1-3 depicts key correlations for (1) MNA-SF score, (2) MUAMC and (3) FFMI.

Table 3
Correlations between variables with correlation coefficient, r and significance, P values shown

Figure 1
Graphs to show the relationship between MNA-SF score and (a) BMI, (b) EFS and (c) BI. Closed circles indicates female residents and triangles, males. Correlation results can be found within Table 3

Figure 2
Graphs to show the relationship between MUAMC and (a) BMI, (b) MNA-SF score and (c) EFS and (d) BI. Closed circles indicates female residents and triangles, males. Correlation results can be found within Table 3

Figure 3
Graphs to show the relationship between FFMI and (a) BMI, (b) MUAMC and (c) MNA-SF score. Closed circles indicates female residents and triangles, males. Correlation results can be found within Table 3

Discussion

In this study, 73 care home residents were screened for malnutrition using BMI, the MNA-SF and BIA estimation of FFMI (Table 2). Malnutrition by BMI was 24% in females and 22% in males. A BMI cut-off point of 20 kg/m2 was used to indicate malnutrition rather than 18.5 kg/m2. This was due to the age of the participants (86 +/- 6.5 years) with similar studies using a higher cut-off point for older people, as does the MNA-SF tool. Furthermore, the cachexia definition by Evans et al, utilises a cut-off point of 20 kg/m2 in the presence of a chronic condition, e.g. heart failure or cancer etc. (7). The population group that were assessed in this study had a high prevalence of comorbidity and chronic disease conditions. An ESPEN consensus paper recently suggested using 18.5 kg/m2 OR significant unintentional weight loss (> 10% indefinite of time, or >5% over the last 3 months) combined with either BMI (<20 kg/m2 if <70 years of age, or <22 kg/m2 if ≥70 years of age) or FFMI (<15 kg/m2 and 17 kg/m2 in women and men, respectively) (6). In this participant group, weight loss was difficult to assess accurately as it was highly dependent on robust records being kept within the care home itself (e.g. previous carers etc.). Weight loss is a component of frailty, a strong predictor of outcomes and in particular, the presence of cachexia wasting. As described above, due to high comorbidity and chronic disease prevalence it is likely that cachexia prevalence was relatively high despite not having the weight loss data to confirm this.
Identifying malnutrition by MNA-SF found that 30% females and 28% males were classified as malnourished (0-7 score) and 35% females and 48% males as ‘at risk’ (score 8-11). This was a higher prevalence than using BMI. Based upon the nature of the MNA-SF and the questions it contains, it may be suggested that a person who has greater frailty, comorbidity and physical disability will score worse with a greater risk of malnutrition. Interestingly, the correlation results tend to confirm this relationship with BMI (r = 0.68, P < 0.001), EFS (r = -0.75, P< 0.001) and BI (r = 0.58, P < 0.001) (Figure 1).

BIA estimation of FFMI identified that 37% females and 52% males had a low FFMI. Cut-off points of <15 kg/m2 for females and <17 kg/m2 males were utilised as suggested from the ESPEN consensus paper to indicate a low FFMI (6). BIA estimations of FFMI prove to be useful in this study similar to previous work (5). In the previous study, BIA estimation of FFMI was used alongside MNA-SF to better categorise malnutrition risk compared to using the standard UK Malnutrition Universal Screening Tool (MUST). With regards to accuracy of BIA, dual energy x-ray absorptiometry is the gold standard technique for measuring FFMI, but is difficult to use in the older population group in long term care and is also expensive. BIA is inexpensive and portable and can be used at the bed side (e.g. bed-bound residents). Drawbacks to its use however, include errors due to hydration abnormalities leading to false FFM estimations. In this study, 2 residents were omitted from FFMI estimation due to hydration abnormalities. Also, the presence of an electronic cardiac pacemaker is contraindicated for BIA use, and which is more likely to be prevalent in this population. Within the ESPEN consensus paper it was suggested that FFMI should be used as a possible measure of nutritional status, alongside weight loss (6). It may also be suggested however that FFMI alone may be useful in situations when it is impossible to gather accurate weight loss information.
In terms of skeletal muscle mass (SMM) the FFMI is a useful predictor of both nutritional status and an indicator of overall SMM. FFM consists of all mass other than fat mass and obviously the large body compartment of SMM makes up a high proportion of FFM. Therefore, we may assume under normal circumstances that a low FFM and FFMI may be indicative of a poor nutritional status and also low SMM. The FFMI was positively correlated with BMI (r = 0.72, P < 0.001), MNA-SF (r = 0.43, P < 0.001) and MUAMC (r = 0.51, P < 0.001) in residents. MUAMC was measured as a practical means of estimating SMM and muscle wasting. Using the lower tertiles in a study by Landi et al as cut-off points, the relative muscle mass and number of people with a lower MUAMC was determined. The number of participants with a low MUAMC was 41% females and 53% males. In particular, interestingly the prevalence rates were quite similar to the low FFMI levels (37% females and 52% males). Hence, this data may support the concept of FFMI as an estimation of SMM. Landi et al found in community-dwelling older people that those with a higher MUAMC tertile had better physical performance (measured using a 4 m walk speed test, Short Physical Performance Battery score and hand grip strength) and a lower risk of death (adj. hazard ratio 0.45; 95% confidence interval 0.23-0.87). In our study, residents either had a low walking speed and hand grip strength below EWGSOP sarcopenia cut-off points (data not shown here), or presence of disability. Interestingly, there was a significant correlation between MUAMC with EFS (r = -0.61, P<0.001) and BI (r = 0.43, P = 0.01).
The reduced muscle mass may be the result of a combination of age-related sarcopenia, chronic disease, e.g. cachexia, and physical inactivity/disability (7-11). Practically however, this is difficult to untangle and the overarching term of muscle wasting disease which has recently been suggested by Von Haehling et al may be important here (11). Dupuy et al, found in a large cohort of older women (n=3025) that sarcopenia prevalence can vary greatly depending on the method used (19). Hence, there needs to be a standardisation in the terminologies and methods used in measuring sarcopenia and overall muscle loss.
The EFS was measured in participants to assess frailty. The EFS is a simple tool which can be used by non-geriatrician staff to assess multi-domain frailty which includes sections on cognition, mood, medications and functional status. The mean score of the participants was 11.2 +/- 2.8, which indicates a moderate level of frailty. As stated earlier, significant correlations were found between EFS and MNA-SF and with MUAMC. Furthermore, a significant negative correlation was found between BMI and EFS (r = -0.53, P < 0.001) (Table 3). This data fits well with the concept of the frailty cycle. Fried et al, describe this relationship in detail in (3). Nutritional status and malnutrition risk are key components of frailty due to the impact of a variety of factors including, the dysregulation of energy balance with ageing (anorexia of ageing) and illness (inflammation driven changes in appetite and metabolism). Furthermore, sarcopenia is also a major component. Interestingly, in this study there was no correlation with FFMI which was perhaps unexpected. This may be due to low study participant numbers. The EFS was evaluated in a recent study by Perna et al with 366 hospitalised older patients (20). EFS scores were associated with cognition, functional independence, medications, nutritional status by MNA, functional performance by BI and hand grip strength. They also found a significant difference in female patients with sarcopenia (SMM Index by DEXA). They concluded that the EFS may be a helpful tool for stratifying the state of fragility in this population group.
Frailty and sarcopenia increases the risk of disability (1,3). In this study the BI was taken as a method of measuring ADLs and hence physical functional status. The mean score of the participants was 10.3 +/- 6.6 which may indicate a moderately impaired level of functional ability, but there was also a high level of variance between participants. EFS score highly correlated (negatively) with BI (r = -0.71, P < 0.001) (Table 3), such that increasing frailty was associated with worsening of physical function. As stated earlier, significant correlations were found between BI and MNA-SF and with MUAMC. Furthermore, a significant positive correlation was found between BMI and BI (r = 0.27, P < 0.063) (Table 3). This data would suggest that functional decline relates to poor nutritional status and muscle mass. Villafane et al found that BI was positively associated with MNA-SF score in 344 older rehabilitation centre patients (i.e. higher scoring indicating better functional status and nutritional status etc.) (21). In addition, similar results were found in a large Spanish study with 895 institutionalised older residents across 34 nursing homes, whereby MNA was positively associated with BI (22). Zuliani et al, performed a 2 year longitudinal nursing home study in Italy with 98 participants (23). They found that malnutrition predicted further worsening of functional status and that the decline in body cell mass (measured by BIA) was proportional to the loss in ADLs. Furthermore, Cereda et al specifically investigated the relationship between the MNA score and nutritional status with functional status by BI in 123 older people in long term care (24). MNA significantly correlated with BI (r = 0.55, P < 0.0001) and a poorer functional status was associated with low BMI, low MUAMC and reduced oral intake. Hence, this data corroborates findings from our study.
This study suggests that multi-domain screening for nutritional status, muscle mass, frailty and functionality is important in this population group. Regular screening may improve diagnosis and guide treatment opportunities, e.g. nutritional and protein supplementation. Further studies are required to confirm this and to evaluate specific methods e.g. determination of malnutrition prevalence.

Conclusion

This pilot study found that prevalence of malnutrition was dependent on the method used to determine. There was a high prevalence of malnutrition by MNA-SF and FFMI and high levels of muscle wasting by MUAMC and FFMI. Those residents with poor nutritional status (by BMI, MNA-SF and FFMI) had lower muscle mass, greater frailty (by EFS) and worse physical function (by BI). Future studies should be performed to confirm or refute these relationships and their meaning.

Funding: The Bromhead Medical Charity, Lincoln, part-funded this study. The sponsors had no role in the design and conduct of the study; in the collection, analysis, and interpretation of data; in the preparation of the manuscript; or in the review or approval of the manuscript.

Conflict of interest: The authors declare that they have no conflicts of interest.

Statement of Authorship: AS is the lead author and designated study Chief Investigator. GG and TA played key roles in the design and development of the study and in writing of the paper. LS, LW and GW were co-investigators primarily involved in data acquisition.

Acknowledgements: We wish to thank all of the care home staff and residents and the Bromhead Medical Charity, Lincoln.

Ethical standards: Full UK NHS research ethics guidelines were followed in this study.

References

1.   Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, Frailty, and Comorbidity: Implications for improved targeting and care. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. 2004;59(3):M255–M263.
2.   Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clinical Nutrition. 2008;27(1):5–15. doi:10.1016/j.clnu.2007.10.007.
3.   Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001;56:M146-56.
4.   Rubenstein LZ, Harker JO, Salva A, Guigoz Y, Vellas B. Screening for undernutrition in geriatric practice: developing the short-form mini nutritional assessment (MNA-SF). J Geront 2001;56 A:M366–77.
5.   Slee A, Birch D, Stokoe D. A comparison of the malnutrition screening tools, MUST, MNA and bioelectrical impedance assessment in frail older hospital patients. Clin Nutr. 2015; 34(2):296-301. doi: 10.1016/j.clnu.2014.04.013.
6.   Cederholm T, Bosaeus I, Barazzoni R, Bauer J, Van Gossum A, Klek S et al. Diagnostic criteria for malnutrition – An ESPEN consensus statement. Clin Nutr 2015; 34:441-47.
7.   Evans WJ, Morley JE, Argiles J, et al. Cachexia: A new definition. Clin Nutr. 2008; 27: 793-799.
8.   Muscaritoli M, Anker SD, Argilés J, Aversa Z, Bauer JM, Biolo G et al. Consensus definition of sarcopenia, cachexia and pre-cachexia: joint document elaborated by Special Interest Groups (SIG) “cachexia-anorexia in chronic wasting diseases” and “nutrition in geriatrics”. Clin Nutr. 2010; 29(2): 154-9.
9.   Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F et al. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing 2010; 39(4): 412-423.
10.   Evans WJ. Skeletal muscle loss: Cachexia, sarcopenia, and inactivity. American Journal of Clinical Nutrition. 2010;91(4):1123S–1127S.
11.   Von Haehling S, Morley JE, Coats AJS, Anker SD, Rosano G, Bernabei R, K. Kalantar-Zadeh K. Muscle wasting disease: a proposal for a new disease classification. J Cachexia Sarcopenia Muscle 2014; 5:1–3.
12.   Slee A. Estimating nutritional status in a small cohort of elderly care home residents using MUST, MNA and bioelectrical impedance phase angle and vector analysis. J Aging Res Clin Practice 2013;2(1):65-70.
13.   Slee A. Screening for sarcopenia in a small cohort of elderly care home residents using handgrip strength dynamometry; and bioelectrical impedance assessment of skeletal muscle mass and fat free mass. J Aging Res Clin Practice 2012;1(3):219-224.
14.   Slee, A, Birch D, Stokoe D. The relationship between malnutrition risk and clinical outcomes in a cohort of frail older hospital patients. Clin Nutr ESPEN. 2016; 15: 57 – 62.
15.   Landi F, Russo A, Liperoti R, Pahor M, Tosato M, Capoluongo E et al. Midarm muscle circumference, physical performance and mortality: results from the aging and longevity study in the Sirente geographic area (ilSIRENTE study). Clin Nutr 2010;29(4):441-7.
16.   Rolfson DB, Majumdar SR, Tsuyuki RT, Tahir A and Rockwood K. Validity and reliability of the Edmonton Frail Scale. Age Ageing 2006; 35(5): 526-9.
17.   Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61-63.
18.   Kyle UG, Genton L, Karsegard L, Slosman DO, Pichard C. Single prediction equation for bioelectrical impedance analysis in adults aged 20-94. Nutrition 2001;17:248-53.
19.   Dupuy C, Lauwers-Cances V, Guyonnet S, et al. Searching for a relevant definition of sarcopenia: Results from the cross-sectional EPIDOS study. Journal of Cachexia, Sarcopenia and Muscle. 2015;6(2):144–154. doi:10.1002/jcsm.12021.
20.   Perna S, Francis MD, Bologna C, et al. Performance of Edmonton frail scale on frailty assessment: Its association with multi-dimensional geriatric conditions assessed with specific screening tools. BMC Geriatrics. 2017;17(1).
21.   Villafañe JH, Pirali C, Dughi S, et al. Association between malnutrition and Barthel index in a cohort of hospitalized older adults article information. Journal of Physical Therapy Science. 2016;28(2):607–612.
22.   Serrano-Urrea R, García-Meseguer MJ: Relationships between nutritional screening and functional impairment in institutionalized Spanish older people. Maturitas, 2014, 78: 323–328.
23.   Zuliani G, Romagnoni F, Volpato S, et al. Nutritional parameters, body composition, and progression of disability in older disabled residents living in nursing homes. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. 2001;56(4):M212–M216.
24.   Cereda E, Valzolgher L, Pedrolli C. Mini nutritional assessment is a good predictor of functional status in institutionalised elderly at risk of malnutrition. Clinical Nutrition. 2008;27(5):700–705.

HEALTH-FUNCTION INDICATORS FOR THE PREDICTION OF ELDERLY FRAILTY

I-C. Lee¹, Y.-H. Chiu¹, I-N. Lee¹, C.-Y.Lee²

1. Department of Healthcare Administration and Medical Informatics, Kaohsiung Medical University, Kaohsiung, Taiwan; 2. Department of Family Medicine, Kaohsiung Medical University Chung-Ho, Memorial Hospital, Kaohsiung, Taiwan.

Corresponding Author: I-Nong Lee, Department of Healthcare Administration and Medical Informatics, Kaohsiung Medical University, 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan (R.O.C.). Email: leei@kmu.edu.tw, TEL: 886-7-3121101 ext.2648, FAX: 886-7-313-7487

J Aging Res Clin Practice 2017;6:88-93
Published online May 4, 2017, http://dx.doi.org/10.14283/jarcp.2017.8

Abstract

Objectives: It is crucially worth noticing of how to assess elderly frailty in recent years. This study explores 16 common indicators of health function to investigate the relationship between these indicators and frailty. It ranks the indicators as reference for frailty assessments. Design: Cross-sectional study. Setting: Regional frailty study. Participants : The sample comprised 597 elderly people who residence in the community. Measurements: This study commenced in 2012. By June 2014, 597 people aged over 65 years participated in this study. With the permission of the subjects, the trained interviewer conducted a face-to-face survey and measured the subjects’ walking speed and the strength of their grip. The statistical methods were t-test, Chi-square, logistic regression analysis and the decision tree. Results: In this study, there is 31.7% of elderly demonstrating the symptoms of frailty. Of the health-function indicators, the relationship between decreased appetite and frailty is the strongest, followed by IADL disability, declining cognitive function, malnutrition and pain. Poor eyesight and falling do not show a significant relationship to frailty. Conclusion: Among 16 health-function indicators, the association between nutritional problems and frailty in elderly people is the most significant. Future assessments of frailty should consider the importance of health-function indicators in order to enhance the scope. Screening at-risk elderly people for potential frailty will enable proper health-care planning to achieve the goal of healthy ageing.

Key words: Decision tree , elderly, frailty, health-function, nutrition.

Introduction

The rapid growth of the elderly population has become the trend in many countries in the world. In 2012, there is 11% of total population aged over 65 years in Taiwan, with the Aging Index of 76.2% [AI = (population aged over 65 years/population aged under 14 years)x100]. For now, Taiwan could be considered as having the fastest aging speed of population in the world. In the future, the elderly will become the most important group in Taiwan. According to data from the Ministry of Health and Welfare (2012),11% of people in Taiwan were 65 years or older; however, their medical expenditure was 35%.Further, during the past ten years, the consumption of medical resources increased to 121%. With an increase in the number of elderly people, the health of the elderly becomes an extremely important issue.
Recently, more and more attention has been put on the association of frailty and health of elderly. Pel-littel et al. (2009) suggested that when the elderly have health-related or other problems, it might only require one sudden breakdown to precipitate more severe situations (1). Elderly people who have health problems can be called frail. Their general functioning and health might deteriorate rapidly in a short period of time, affecting their ability to be independent and autonomous. According to Palmer (1999) , physically frail elderly people were a high risk for function degeneration and the necessity of long-term care (2). Elderly frailty is associated with function degeneration, decreased quality of life and increased utilization of medical resources (3, 4). Further, many studies have indicated that frailty is related to diabetes, cardiovascular disease and dementia [(5, 6). Unlike clinical diseases which are based on standard indicators, definitions and measurement tools for frailty are not consistent. There are several tools to measure frailty. For instance, Rockwood et al.(2005) proposed 70 clinical symptoms related to diseases; the total number of symptoms present indicates the degree frailty (7). Fried et al.(2001) introduced five indicators: unintentional weight loss, weak grip, weakness, slowness and limited physical activity; a person displaying three of these indicators would be considered to be frail. Most international studies measure frailty according to the indicators proposed by Fried (2001) (8).
However, these indicators might not be globally suitable to use in all countries. For instance, an unintentional ten-pound weight loss in the past year is considered to be a symptom of frailty. In Asia, elderly people are generally thin and have little body fat; therefore, a ten-pound loss of weight would be considered to be serious (9). Despite of Fried’s five indicators, there is no other diagnosis indicators of frailty have been commonly accepted and standardized. Thus, whether any other health function indicators may use to early detect the frailty remains unknown and is worth to clarify. Therefore, the aims of this study are the following: (1) to investigate the genotype of elderly frailty in Taiwan; (2) to collate current common health-related or functional scales, such as assessments of insomnia or nutrition, in order to investigate the relationship between health-function indicators and frailty and develop indicators of frailty.

Materials and Methods

This study commenced in 2012. By June 2014, 597 people aged over 65 years participated in this study. Due to the constraints of limited funds and manpower, only one administrative district of Kaohsiung City was selected. The researcher selected the places where the elderly tended to congregate for activities. With the permission of the subjects, the trained interviewer conducted a face-to-face survey and measured the subjects’ walking speed and the strength of their grip. This study was approved by the Institutional Review Board of Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH-IRB-20120196). The study design, methodological procedure and administrative protocol were carried out in accordance with the ethical approved guidelines. Informed consent was obtained from all subjects prior to data collection.
The research tool used was a structured questionnaire designed by the research team. The questionnaire included not only questions asking basic information, but also questions that investigated current common health functions or scales. Based on the aims of the research, statistical analysis was conducted on some items of the questionnaire. The analytical variables are given below:
(1) Demographic characteristics: age, gender, location and educational level.
(2) Frailty: The indicators of frailty use in this study have been modified from the indicators proposed by Fried et al. (2001), and in hence, these modified indicators for the indication of frailty have good validity as well (10). We assessed frailty according to unintentional weight loss, fatigue, weakness and walking speed. A positive response to “unintentional weight loss in the past three months” and “exhaustion in the past three months”, meant the subjects have symptoms of unintentional weight loss and fatigue. Weakness was assessed by grip strength. Since males and females have different levels of grip strength, the researcher divided the subjects into two groups. Follow the standard set by Fried (2001), in each group, the 20% of subjects with the weakest grip were designated as having weakness. To measure walking speed, the most common way used is the time taken for the subjects to walk three meters. Since height is related to walking speed, the subjects were divided into either a tall group or a short group, according to their height. Refers to Fried’s standard, in each group, the 20% of subjects with the slowest walking speed were designated as being slow walkers.
In the Fried’s definition, a person displaying three of these five indicators would be categorized as “frail” person. Meanwhile, a person displaying one or two of these five indicators would be categorized as “pre-frail” person. There are four indicators used to assess frailty in this study. In this study, the subjects who displayed two or more symptoms of frailty were considered to be “frail” and also apparently demonstrated less healthy in general, whereas those with one or no symptom were considered to be “normal” (10).
(3)Health function: there are 16 health-function indicators consist of three aspects of health status in physical, mental and social domains. Indicators are pain, Activities of Daily Life(ADL), Charlson score(CCI), Instrumental Activities of Daily Life(IADL), malnutrition, reduced appetite, falling, poor vision, poor hearing, incontinence, insomnia, declining cognitive function, depression, role functioning-physical (RP), role functioning-emotional (RE) and social functioning (SF) on the MOS 36-Item Short-Form General Health Survey Measures (SF-36) developed by Ware et al. (1992) indicates participative capacity in social activities (11). Please refer to the Table 1 for the detail descriptions of all items and scoring information of subdomains.
In order to clarify which indicators can be used to predict frailty, univariate
analysis, multivariate analysis and decision trees were performed to assess the importance of health function indicators (i.e., independent variable) on the prediction of frailty (i.e., dependent variable). SPSS (Statistical Product and Service Solutions)19.0 was applied to run the univariate analysis (i.e., t-test, chi-square test), and multivariate analysis (i.e., logistic regression). J48 decision trees running on the Weka3.5 data mining software were applied to identify important health-function variables related to frailty (12). All the significance tests and classification results of each variable were ranked and compared separately with individual methods. There will be prioritized and ranked when the statistic results reach the significant level (P<0.05). Based on the ranking of degree of significance (P value), in the results of the univariate analysis, 1 means the significance is the highest (P<0.001). Based on the ranking of OR(odds ratio) value, in the results of the multivariate analysis, 1 means the highest OR value. In decision-tree analysis, ranking is according to the level-order that variable displays on decision tree (i.e., 1 means the variable that displays on the first level of decision tree). A lower ranked variable indicates a stronger relationship with frailty. The rank of 16 will be noted to the indicator when the statistic results do not reach the significant level (P>0.05). In sum of these three numbers of ranking, the indicator with the smaller sum was considered to be more important on the prediction of frailty. This multiple-analysis approach was used to decrease inconsistencies as a result of the analysis methods and data.

Results

According to the genotype of frailty in this study, fatigue was the most common symptom of frailty, with 74.2% of the subjects reporting that they experienced fatigue. This is followed by slow walking (22.6%), weakness (19.1%) and unintentional weight loss (12.7%).Considering the subjects’ performance in these four indicators, 31.7% of elderly people fell into the frail group. Compared with the normal group, those in the frail group are, on average, older (78.2 years) and have a lower level of education. Most are illiterate or went no further than elementary school (19% and 51.3%). Frailty is not significantly associated with gender and place of birth.

Table 1
The 16 health-function indicators and their definition

ADL﹕Activities of Daily Life; CCI﹕Charlson score; IADL﹕Instrumental Activities of Daily Life; RP﹕role functioning-physical; RE ﹕role functioning-emotional; SF﹕social functioning

Using univariate analysis, this study explored the relationship between frailty and health-function indicators. The results (Table 2) show that CCI, falling, reduced vision, incontinence and depression and not significantly associated with frailty. The other 11 health-function indicators are related to frailty. Subjects who fall into the frail group have an inferior outcome of health-function indicators. Based on the logistic regression model (Table 3), after adjusting the demographic characteristics, the researcher included all health-function indicators in the model for calculation. It was demonstrated that the evidence of frailty would be more likely if elderly people presented IADL disability, malnutrition, reduced appetite or declining cognitive function. For instance, those with a reduced appetite during the previous three month have a 4.85 higher probability of becoming frail compared to those with a normal appetite.

Table 2
Frailty and health-function indicators

a: Analytical result of t-test; b: Analytical result of Chi-square

Using univariate analysis, multivariate analysis and a decision tree, this study reviewed degrees of the relationship between 16 health-function indicators and frailty. According to the results shown in Table 4, the relationship between reduced appetite and frailty is the highest. The total ranking figure is three. This means that when using different statistical methods, the ranking of the indicator is always the first. After reduced appetite, IADL disability, declining cognitive function, malnutrition and pain are the next most important indicators. In these three analyses, the sum of indicator ranking (falling and poor vision) is 48 which indicate that their relationship with frailty is the weakest.

Table 3
The logistic regression model of frailty

Data of demographics were adjusted; *It is a continuity variable. Reference groups of other variables refer to those with normal IADL and without the problems of nutrition, reduced appetite, falling, poor vision, poor hearing, incontinence, insomnia, declining cognitive function and depression

Table 4
Importance ranking of 16 health-function indicators to predict frailty

(a) Based on the ranking of degree of significance (P value) in the results of the univariate analysis, 1 means the significance is the highest (P<0.001); (b) Referred to the ranking of OR value from the model of logistic regression; (c) Ranking is according to the indicators display order from decision tree; Note: In the previous three statistical methods, when indicators do not show statistical significance (P<0.05), we indicate the ranking by “16”. The lower the cumulative ranking number, the more important the indicators!

Discussion

According to the study, the percentage of people with symptoms of frailty represent a broad range (4% to 80%) (13-15). As people grow older, the presence of symptoms of frailty will increase. Elderly people who live in communities show fewer symptoms than people who receive out-patient treatment or who live in institutions. The subjects used in this study were elderly people in a community of whom 31.7% displayed symptoms of frailty. This is higher than the figures from other studies. Most foreign literature adopts Fried’s five indicators and divides elderly people into groups of normal, pre-frail and frail. This study selected four indicators and allocated subjects into either a normal group or a frail group. Therefore, the group consisting of frail people may include those who are diagnosed as being pre-frail, thus increasing the percentage of being frailty. However, by the dividing the subjects into these two groups, we can recognize that those people identified as being frail are “less healthy” than those in the normal group.

The 16 health function indicators used in this study are commonly used to assess the health of the elderly. According to the findings in this study, most of the indicators are associated with frailty which are consistent with the literature. When elderly people experience loss of appetite and consequent malnutrition, the probability of them being frail will be higher (15, 16). People who have been identified as being frail show higher scores on pain measurements, indicating that they experience more pain than normal people (6). The ability to manage daily activities is included in ADL and IADL. The results show that frail people are significantly affected in these two indicators (5, 17, 18). Many frail older people experience insomnia or declining cognitive function (19, 20). As well as the physical and psychological parameters, social participative capacity (RP, RE and SF) is significantly related to frailty. Frail elderly people have lower scores in three indicators, compared with the normal group (21, 22). Although this study demonstrates that CCI, incontinence, depression, falling and reduced vision are less significantly related to frailness, some research associates these indicators with frailty. Those who are frail have higher scores of CCI, compared with the normal group. This means that frail people tend to get ill more often and that their illnesses are more serious than those in the normal group (14). In comparison with the normal group, the elderly in the frail group display a greater probability of having health problems, falling, reduced vision or hearing, incontinence, and depression (5, 18, 23-24).
As well as investigating the relationship between health functions and frailty by means of different statistical analysis methods, this study explored the importance of health-function indicators to predict frailty. According to the results, when elderly people have experienced a reduction in appetite in the past three months, the probability of them becoming frail significantly increases. In addition, when the elderly are malnourished, the probability of frailness is not low; this is fourth on the importance ranking. Therefore, the relationship between nutrition, appetite and frailty is the highest. Malnutrition in the elderly is extremely common, which significantly influences their overall health (25-27). This is due to the slowing down of physical functionality, affecting the person’s chewing, swallowing, digesting, and absorption capabilities (25). As well as this, there can be a lack of motivation in preparing meals (26, 27). However, elderly people or their family members usually do not pay attention to their low appetite or malnutrition. Initially, they might show symptoms of frailty such as feeling exhausted, having weakness and walking slowly. If they continue to neglect these symptoms, more serious and complicated health problems could develop. According to the importance ranking of 16 health-function indicators shown in Table 4, IADL disability and declining cognitive function fall in the top two and three. Likewise, elderly people with IADL disability and declining cognitive function might not feel unwell (in the same way as those who are malnourished and have decreased appetite) and do not seek medical assistance. In the long term, deterioration of health may occur (28).
Two of the indicators –low vision and falling in the past three months –have the weakest relationship with frailty. This may be due to a more severe health condition caused by falls, such as a fracture and the inability to be independent (29). In such instances, they seek doctors’ help. After the intervention of professional medical care, the negative impact on health will be lower; therefore, the relationship with symptoms of frailty will tend to be low.
Although vision and hearing are both sensory capacities, their relationship with frailty is significantly different. The result of this study shows that poor hearing is more strongly associated with frailty than poor sight, but that poor sight is more significant in respect of daily activities. When the elderly are inconvenienced by their poor sight, they will immediately go to see the doctor to improve their sight. In this case, the impact on health will be controlled before the reduced vision impacts the person’s frailty. Declining hearing in the elderly might not be noticed immediately. However, ignoring this symptom for too long a period without intervention can lead to more health-related problems. For instance, with difficulties in hearing, an elderly person can misunderstand the information about health education, leading to physical discomfort (30).

Conclusions

In conclusion, although frailty is not an illness, it does demonstrate symptoms that could be considered to be a lack of good health. This study adopts 16 common health-function indicators and analyzes the relationship between all the indicators and frailty. Indicators which are more associated with frailty tend to have less of an impact on elderly people’s daily activities or do not cause harm. Take the problems of nutrition (i.e., no appetite, malnutrition) as example, elderly people will not go to the doctor immediately or seek intervention from medical care services. Thus, in the long term, the effect of poor health function will very likely lead to health problems. Compared with illness, symptoms of frailty can be considered to be a warning of potential health problems but the symptoms are usually not noticed by elderly people or their relatives. However, from the perspective of prevention, screening frail elderly people in advance of the development of health problems and providing proper health care intervention will help accomplish the goal of “healthy ageing”. Regarding the measurement of frailty, according to the importance ranking of health-function indicators in this study, as well as the indicators proposed by Fried, we include reduced appetite, nutrition, IADL, cognitive function, pain and participation in social activities. These indicators can enhance the scope of the assessment of frailty and increase the precision of an assessment for screening high-risk elderly people. When frailty is identified, proper health care can be planned. Hopefully this screening can reduce the probability of elderly people becoming disabled or bed-ridden and enhance their quality of life in their old age.

Acknowledgements: Sincere appreciation will be given to all individuals who participate in this study.

Ethical Standards: This study was approved by the Institutional Review Board of Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH-IRB-20120196). The study design, methodological procedure and administrative protocol were carried out in accordance with the ethical approved guidelines. Informed consent was obtained from all subjects prior to data collection. All datasets on which the conclusions of the manuscript presented in the main paper.

Conflict of interest: The authors declare no conflict of interest.

References

1.   Pel-Littel RE, Schuurmans MJ, Emmelot-Vonk MH, Verhaar HJ. Frailty: defining and measuring of a concept. J Nutr Health Aging. 2009;13: 390-394.
2.    Palmer RM : Acute care. In: Hazzard WR, Blass JP, Ettinger WH Jr, eds, Principles of Geriatric Medicine and Gerontology. 4th ed. New York: McGraw-Hill, 1999: 482-492.
3.    Ensrud KE, Ewing SK, Taylor BC, Fink HA, Cawthon PM, Stone KL et al. Comparison of 2 frailty indexes for prediction of falls, disability, fractures, and death in older women. Arch Intern Med. 2008; 68: 382-389.
4.    Rochat S, Cumming RG, Blyth F, Creasey H, Handelsman D, Le Couteur DG et al. Frailty and use of health and community services by community-dwelling older men: the Concord Health and Ageing in Men Project. Age Ageing. 2010; 39: 228-233.
5.    Mello Ade C, Engstrom EM, Alves LC. Health-related and socio-demographic factors associated with frailty in the elderly: a systematic literature review. Cad Saude Publica. 2014; 30: 1143-1168.
6.    Morley JE, Kim MJ, Haren MT, Kevorkian R, Banks WA. Frailty and the aging male. Aging Male. 2005; 8: 135-140.
7.    Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I et al. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005; 73: 489-495.
8.    Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J et al. Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A BiolSci Med Sci. 2001; 6: M146-M156.
9.    Shih-Ping Chen, Li-Ning Peng , Ming-Hsien Lin , Hsiu-Yun Lai , Shinn-Jang Hwang, Liang-Kung Chen. Evaluating probability of cancer among older people with unexplained, unintentional weight loss. Arch Gerontol Geriatr. 2010; 50: S27-S29.
10.    IC Lee, YH Chiu, CY Lee. Exploration of the importance of geriatric frailty on health-related quality of life . Psychogeriatrics. 2016; DOI: 10.1111/psyg.12179.
11.    Ware JE , Sherbourne CD. The MOS 36-ltem short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care. 1992; 30: 473-483.
12.    Witten IH, Frank E. Data Mining: Practical machine learning tools and techniques: Morgan Kaufmann. 2011; 11: 454.
13.    Gale CR, Cooper C, Aihie Sayer A. Prevalence of frailty and disability: findings from the English Longitudinal Study of Ageing. Age Ageing. 2015; 44: 162-165.
14.    Kanwar A, Singh M, Lennon R, Ghanta K, McNallan SM, Roger VL. Frailty and health-related quality of life among residents of long-term care facilit-ies. J Aging Health. 2013; 25: 792-802.
15.    Serra-Prat M, Mans E, Palomera E, Clavé P. Gastrointestinal peptides, gastrointestinal motility, and anorexia of aging in frail elderly persons. Neurogastroenterol Motil. 2013; 25: 291-e245.
16.    Semba RD, Bartali B, Zhou J, Blaum C, Ko CW, Fried LP. Low serum micronutrient concentrations predict frailty among older women living in the community. J Gerontol A Biol Sci Med Sci. 2006; 61: 594-599.
17.    Avila-Funes JA, Helmer C, Amieva H Avila-Funes JA, Helmer C, Amieva H, Barberger-Gateau P et al. Frailty among community-dwelling elderly people in France: the three-city study. J Gerontol A Biol Sci Med Sci. 2008; 63: 1089-1096.
18.    Sousa AC, Dias RC, Maciel ÁC, Guerra RO. Frailty syndrome and associated factors in community-dwelling elderly in Northeast Brazil. Arch Gerontol Geriatr. 2012; 54: e95-e101.
19.    Ensrud KE, Blackwell TL, Redline S, Ancoli-Israel S, Paudel ML, Cawthon PM et al. Sleep disturbances and frailty status in older community-dwelling men. J Am Geriatr Soc. 2009; 57: 2085-2093.
20.    Nishiguchi S, Yamada M, Fukutani N,Adachi D, Tashiro Y, Hotta T et al. Differential Association of Frailty With Cognitive Decline and Sarcopenia in Community-Dwelling Older Adults. J Am Med Dir Assoc. 2015; 16: 120-124.
21.    Lin CC, Li CI, Chang CK, Liu CS, Lin CH, Meng NH et al. Reduced health-related quality of life in elders with frailty: a cross-sectional study of community-dwelling elders in Taiwan. PLoS One. 2011; 6: e21841.
22.    Masel MC, Graham JE, Reistetter TA, Markides KS, Ottenbacher KJ. Frailty and health related quality of life in older Mexican Americans. Health Qual Life Outcomes. 2009; 7: 70.
23.    Klein BE, Klein R, Knudtson MD, Lee KE. Relationship of measures of frailty to visual function: the Beaver Dam Eye Study. Trans Am Ophthalmol Soc. 2003; 101: 191-199.
24.    Makizako H, Shimada H, Doi T, Yoshida D, Anan Y, Tsutsumimoto K et al. Physical Frailty Predicts Incident Depressive Symptoms in Elderly People: Prospective Findings From the ObuStudy of Health Promotion for the Elderly. J Am Med Dir Assoc. 2015; 16: 194-9.
25.    Poisson P, Laffond T, Campos S, Dupuis V, Bourdel-Marchasson I. Relationships between oral health, dysphagia and undernutrition in hospitalized elderly patients. Gerodontology. 2014. doi: 10.1111/ger.12123.
26.    Pereira GF, Bulik CM, Weaver MA, Holland WC, Platts-Mills TF. Malnutrition Among Cognitively Intact, Noncritically Ill Older Adults in the Emergency Department. Ann Emerg Med. 2015; 65: 85-91.
27.    Montejano Lozoya AR, Ferrer Diego RM, Clemente Marín G, Martínez-Alzamora N, Sanjuan Quiles A, Ferrer Ferrándiz E. Nutrition-related risk factors in autonomous non-institutionalized adult elderly people. Nutr Hosp. 2014; 30: 858-869.
28.    d’Orsi E, Xavier AJ, Steptoe A, de Oliveira C, Ramos LR, Orrell M et al. Socioeconomic and lifestyle factors related to instrumental activity of daily living dynamics: results from the English Longitudinal Study of Ageing. J Am Geriatr Soc. 2014; 62: 1630-1639.
29.    Butt DA, Mamdani M, Austin PC, Tu K, Gomes T, Glazier RH. The risk of falls on initiation of antihypertensive drugs in the elderly. Osteoporos Int. 2013; 24: 2649-2657.
30.    Diao M, Sun J, Jiang T, Tian F, Jia Z, Liu Y et al. Comparison between self-reported hearing and measured hearing thresholds of the elderly in China. Ear Hear. 2014; 35: e228-e232.

CARNITINE INSUFFICIENCY IS ASSOCIATED WITH ADVERSE OUTCOMES IN PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION

Y. Kinugasa, S. Sugihara, K. Yamada, M. Miyagi, K. Matsubara, M. Kato, K. Yamamoto

Division of Cardiovascular Medicine, Department of Molecular Medicine and Therapeutics, Faculty of Medicine, Tottori University, Yonago, Japan

Corresponding Author: Yoshiharu Kinugasa, M.D., Ph.D. Division of Cardiovascular Medicine, Department of Molecular Medicine and Therapeutics, Faculty of Medicine, Tottori University 36-1 Nishi-cho, Yonago 683-8504, Japan, Phone: +81-859-38-6517 Fax: +81-859-38-6519 E-mail: ykinugasa-circ@umin.ac.jp

J Aging Res Clin Practice 2016;inpress
Published online September 22, 2016, http://dx.doi.org/10.14283/jarcp.2016.116

Abstract

Background: L-carnitine is an essential nutrient that plays a vital role in fatty acid energy metabolism of the heart and skeletal muscles. Primary or secondary carnitine insufficiency contributes to progressive left ventricular systolic dysfunction and physical frailty. However, the clinical features of patients with heart failure with preserved ejection fraction (HFpEF) and carnitine insufficiency remain unclear. Objectives: The present study aimed to evaluate the clinical characteristics and outcomes of these patients. Design: A prospective cohort study. Setting: Tottori University hospital. Participants: 117 patients who were hospitalized with HFpEF (ejection fraction ≥45%). Measurement: All measurements were obtained at hospital discharge. Carnitine insufficiency was defined as the lowest quantile of free carnitine level (

Key words: L-carnitine, HFpEF, frailty, left ventricular diastolic function, malnutrition.

Introduction

Malnutrition is common in patients with heart failure with preserved ejection fraction (HFpEF) (1). Poor nutrition leads to the development of sarcopenia and frailty, which can cause physical functional decline, decreased quality of life, and poor prognosis (2). Despite the clinical significance of nutritional problems, important nutritional factors to target intervention remain undefined.
L-carnitine is an essential nutrient that is present in red meat, and it plays a vital role in fatty acid energy metabolism of the heart and skeletal muscles (3). Several metabolic disorders, including carnitine transporter (organic cation transporter 2; OCTN2) mutation, poor diet or malabsorption of carnitine, increased renal tubular losses (Fanconi syndrome), haemodialysis, and certain drugs, can cause carnitine insufficiency (3). Primary or secondary carnitine insufficiency contributes to the development of left ventricular systolic dysfunction and muscle weakness (3, 4). Several studies have also shown the beneficial effect of carnitine supplementation on patients with carnitine insufficiency (3, 4).
Our recent study showed decreased free carnitine levels in plasma and left ventricular tissue in a hypertensive HFpEF model rat using quantitative metabolome analysis (5). Carnitine insufficiency is likely to result from acquired downregulation of OCTN2. L-carnitine supplementation in an animal rat model prevented progression of left ventricular fibrosis and stiffening and development of HF, resulting in an improvement of survival rate (5). However, clinical features of human HFpEF with carnitine insufficiency remains unclear. The present study aimed to evaluate the clinical characteristics and outcomes of patients with HFpEF and L-carnitine insufficiency.

Methods

Patients

The present study consecutively enrolled 152 patients who were hospitalized and discharged from Tottori University Hospital with the primary diagnosis of HFpEF from January 2012 to May 2015. Among them, 35 patients were excluded because their informed consent was not obtained. Finally, a total of 117 patients were enrolled in this study.
Patients with HFpEF were defined as follows: 1) patients with symptoms and signs of HF as defined by the Framingham criteria, 2) patients with a left ventricular ejection fraction ≥45% as previously described (6) (7), and 3) patients without HF aetiologies of severe valve disease, congenital disease, complete atrial ventricular block, sick sinus syndrome, pericardial disease, primary pulmonary hypertension, pulmonary artery embolism, and acute myocardial infarction. Patients under chronic dialysis were also excluded.

Data collection

Medical records were reviewed for demography, medical history, comorbidities, laboratory data, echocardiograms, medications, and clinical course. All measurements were taken at discharge. Echocardiographic data were measured by one experienced sonographer as recommended by the American Society of Echocardiography (8). Early diastolic mitral annular velocity (E’) was obtained from the septal site of the mitral leaflet. Early diastolic mitral inflow (E) and E’ in atrial fibrillation (Af) was measured from the cardiac cycle with regular beats. E’ was available in 112 patients. The estimated glomerular filtration rate was calculated as previously described (9). Follow-up data were obtained from medical records or a telephone interview. We evaluated the composite endpoints of cardiac-cause death and unplanned re-hospitalization for HF during the follow-up period.

Measurement of serum L-carnitine levels

Serum L-carnitine levels were measured with enzymatic cycling methods (carnitine assay kit; Kainos Laboratories Co., Tokyo, Japan) as previously described (5). L-carnitine is present mainly in the form of free carnitine (FC) and acylcarnitine (AC). Carnitine insufficiency was defined as a reduced FC level or increased AC to FC ratio, which indicates the presence of abnormal carnitine metabolism, reflecting relative carnitine deficiency to increased demand of fatty acid metabolism as previously described (10). Because normal carnitine levels have not been established in patients with HF, the present study defined carnitine insufficiency as the lowest quantile of FC level (

Geriatric Nutritional Risk Index

The Geriatric Nutritional Risk Index (GNRI) was recently postulated as a nutritional risk screening tool in patients with HFpEF (1) (11). The GNRI was calculated from serum albumin levels and body mass index (BMI) as previously described (1).

Activities of daily living

The Barthel index (BI) was measured by nurses and physical therapists at discharge from hospital. The BI measures a patient’s functional status for basic daily activities, with scores ranging from 0 (total dependence) to 100 points (independent patients) (12, 13).

Clinical outcomes

We evaluated mortality from cardiac causes and unplanned re-hospitalization for HF during the follow-up period. Death from a cardiac cause was defined as death due to HF and sudden death.
The investigation conforms to the principles outlined in the Declaration of Helsinki. The study was approved by the research ethical committee of Tottori University. Written informed consent was provided by each subject.

Statistical analysis

Continuous variables are expressed as means ± standard deviation for normally distributed variables, and median and interquartile ranges for non-normally distributed variables. The normality of distribution was assessed by the Kolmogorov–Smirnov test. Differences in continuous variables were compared using the t-test for normally distributed variables and the Mann–Whitney U test for non-normally distributed variables. Categorical variables were compared using the χ2 test. The event-free survival curve after hospital discharge was estimated by the Kaplan–Meier method and compared using the log-rank test. Cox proportional hazards models were used to assess the effect of reduced L-carnitine levels on the primary outcome and its interaction with each subgroup. Independent predictors of cardiac events were assessed by stepwise regression with forward selection. All baseline variables that were associated with the composite endpoints in univariate analysis (p<0.05) were entered into the model. A p value

Results

Baseline patients’ characteristics

Baseline characteristics of the patients are shown in Table 1. The mean age of the overall cohort was 76±12 years and 52.1% were male. The quantile values of FC levels were <56.3, 56.3–66.9, 67.0-78.2, and >78.2, and those of the AC to FC ratio were <0.20, 0.20–0.25, 0.26-0.35, and >0.35, respectively.

Table 1
Baseline Characteristics of Patients with or without Carnitine Insufficiency

Data are mean±SD or median and (interquartile range), BMI, body mass index; NYHA, New York Heart Association; GNRI, Geriatric Nutritional Risk Index; COPD, chronic obstructive pulmonary disease; BUN, blood urea nitrogen, eGFR, estimated glomerular filtration rate; BNP; B-type natriuretic peptide; FC, free carnitine; AC, acylcarnitine; ACE-I, angiotensin-converting enzyme inhibitor, ARB, angiotensin receptor blocker.

Figure 1
The Effect of Carnitine Insufficiency on Barthel Index and Early Diastolic Mitral Annular Velocity
A: Increased Prevalence of Carnitine Insufficiency with a Decrease in the Barthel Index.
B: The Relationship between Carnitine Insufficiency and Early Diastolic Mitral Annular Velocity in Patients with Sinus Rhythm

Figure 2
The Effect of Carnitine Insufficiency on Clinical Outcomes
A: Event-free Survival Rate in Patients with or without Carnitine Insufficiency.
B: Effect of Carnitine Insufficiency on Primary Outcomes in the Subgroups

Patients with carnitine insufficiency, which was defined as the lowest quantile of FC level (30%), exercise tolerance was significantly improved in the treated group. Furthermore, a recent study with 29 HFpEF patients showed that L-carnitine supplementation for 3 months improved some measures of diastolic function compared with baseline (20). These results suggest that L-carnitine supplementation is a potential therapeutic strategy in patients with HFpEF. However, a recent study showed that intestinal microbiota metabolism of L-carnitine, trimethylamine-N-oxide (TMAO), promotes atherosclerosis and increases the risk of cardiovascular disease (21). In addition, elevated serum TMAO levels are associated with severity of disease and adverse outcome in patients with HF (22). Further investigations are necessary to evaluate the safety and efficiency of L-carnitine supplementation in patients with HFpEF.

Table 2
Echocardiographic Parameters in Patients with or without Carnitine Insufficiency

Data are mean±SD or median and (interquartile range), LVDd, left ventricular diastolic diameter; RWT, relative wall thickness; LVEF, left ventricular ejection fraction; LAD, left atrial diameter; E, early diastolic mitral inflow; E’, early diastolic annular velocity; TRPG, tricuspid regurgitation pressure gradient ; IVC, inferior vena cava.

Table 3
Cox Hazard Analysis for Independent Predictors of Cardiac Events

HR, hazard ratio; CI, confidence interval; NYHA, New York Heart Association; eGFR, estimated glomerular filtration rate; BUN, blood urea nitrogen, BNP; B-type natriuretic peptide.

Our study has several limitations. There is no obvious definition of carnitine insufficiency in patients with HF, but mean FC levels in healthy subjects was reported to be 49.4±13.0 μmol/L (23), indicating that the values below the mean level might be candidate value for carnitine insufficiency. However, FC is excreted from kidney, and its serum levels was affected by renal function (4). Patients with HFpEF often had chronic kidney disease, and renal impairment raises FC levels. Thus, the application of normal FC levels in healthy subjects may lead to underestimation of carnitine insufficiency, and specific criteria is likely to be needed for patients with HFpEF. Another candidate definition of carnitine insufficiency is AC to FC ratio >0.4 as previously described (4). However, its criteria focused on patients with dialysis who often had relatively high AC to FC ratio (4), and its application may also lead to underestimation of carnitine insufficiency. Therefore, in the present study, the definition of carnitine insufficiency was applied by the quantile value of FC and AC to FC ratio that were reliable abnormal value in the study population. However, our study population is relatively small, and further investigations are necessary to determine the definition of carnitine insufficiency in HFpEF. Second limitation was that we had no data on L-carnitine levels in skeletal muscle. Several studies have shown carnitine deficiency in skeletal muscle, regardless of normal plasma levels (4). However, assessment of the AC to FC ratio may attenuate the effects of a lack of data of tissue L-carnitine levels. There were also no data on TMAO and its association with L-carnitine levels and clinical outcomes. Furthermore, we could not assess the relationship between carnitine insufficiency and muscle mass, muscle strength, and exercise performance. Finally, this study was a single-center study with a relatively small sample size. Further investigations are necessary to confirm the effect of carnitine insufficiency on physical performance and clinical outcomes in another large cohort.
Carnitine insufficiency is associated with adverse outcomes in patients with HFpEF.

Acknowledgement: We thank for HF-team in Tottor university hospital.

Conflict of interest: Y Kinugasa received the grant from the Japan Society for the Promotion of Science (JSPS KAKENHI Grant no. 60598944) during the conduct of the study. K Yamamoto received the grants from the Japan Society for the Promotion of Science (JSPS KAKENHI Grant no. 25461058) during the conduct of the study, and grants and personal fees from Otsuka Phamaceutical Co. Ltd outside the submitted work.

Ethical standard: The investigation conforms to the princiles outlined in the declaration of Helsinki. The study was approved by the research ethnical committee of Tottori University.

References

1. Kinugasa Y, Kato M, Sugihara S, Hirai M, Yamada K, Yanagihara K, Yamamoto K. Geriatric nutritional risk index predicts functional dependency and mortality in patients with heart failure with preserved ejection fraction. Circ J. 2013;77(3):705-711.
2. Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA, Cardiovascular Health Study Collaborative Research G. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-156.
3. Flanagan JL, Simmons PA, Vehige J, Willcox MD, Garrett Q. Role of carnitine in disease. Nutr Metab (Lond). 2010;7:30.
4. Ahmad S. L-carnitine in dialysis patients. Semin Dial. 2001 May-Jun;14(3):209-217.
5. Omori Y, Ohtani T, Sakata Y, Mano T, Takeda Y, Tamaki S, Tsukamoto Y, Kamimura D, Aizawa Y, Miwa T, Komuro I, Soga T, Yamamoto K. L-Carnitine prevents the development of ventricular fibrosis and heart failure with preserved ejection fraction in hypertensive heart disease. J Hypertens. 2012 Sep;30(9):1834-1844.
6. Yamada K, Kinugasa Y, Sota T, Miyagi M, Sugihara S, Kato M, Yamamoto K. Inspiratory Muscle Weakness is Associated with Exercise Intolerance in Patients with Heart Failure with Preserved Ejection Fraction: a Preliminary Study. J Card Fail. 2015 Oct 23.
7. Yamamoto K. «The Third Man» in Heart Failure–Heart Failure With Reduce Ejection Fraction Evolved From Heart Failure With Preserved Ejection Fraction. Circ J. 2015;79(10):2108-2109.
8. Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39 e14.
9. Chinda J, Nakagawa N, Kabara M, Matsuki M, Endo H, Saito T, Sawada J, Katayama T, Sato N, Hasebe N. Impact of decreased estimated glomerular filtration rate on Japanese acute stroke and its subtype. Intern Med. 2012;51(13):1661-1666.
10. Carter AL, Abney TO, Lapp DF. Biosynthesis and metabolism of carnitine. J Child Neurol. 1995 Nov;10 Suppl 2:S3-7.
11. Liu M, Fang F, Yu CM. Noncardiac comorbidities in heart failure with preserved ejection fraction – commonly ignored fact. Circ J. 2015;79(5):954-959.
12. Granger CV, Dewis LS, Peters NC, Sherwood CC, Barrett JE. Stroke rehabilitation: analysis of repeated Barthel index measures. Arch Phys Med Rehabil. 1979 Jan;60(1):14-17.
13. Martin-Sanchez FJ, Gil V, Llorens P, Herrero P, Jacob J, Fernandez C, Miro O, Acute Heart Failure Working Group of the Spanish Society of Emergency Medicine Investigation G. Barthel Index-Enhanced Feedback for Effective Cardiac Treatment (BI-EFFECT) Study: contribution of the Barthel Index to the Heart Failure Risk Scoring System model in elderly adults with acute heart failure in the emergency department. J Am Geriatr Soc. 2012 Mar;60(3):493-498.
14. Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, Smiseth OA, Waggoner AD, Flachskampf FA, Pellikka PA, Evangelista A. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. J Am Soc Echocardiogr. 2009 Feb;22(2):107-133.
15. Izawa KP, Watanabe S, Hirano Y, Yamamoto S, Oka K, Suzuki N, Kida K, Suzuki K, Osada N, Omiya K, Brubaker PH, Shimizu H, Akashi YJ. The relation between Geriatric Nutritional Risk Index and muscle mass, muscle strength, and exercise capacity in chronic heart failure patients. Int J Cardiol. 2014 Dec 20;177(3):1140-1141.
16. Crentsil V. Mechanistic contribution of carnitine deficiency to geriatric frailty. Ageing Res Rev. 2010 Jul;9(3):265-268.
17. Costell M, O’Connor JE, Grisolia S. Age-dependent decrease of carnitine content in muscle of mice and humans. Biochem Biophys Res Commun. 1989 Jun 30;161(3):1135-1143.
18. Shah AM, Claggett B, Sweitzer NK, Shah SJ, Anand IS, Liu L, Pitt B, Pfeffer MA, Solomon SD. Prognostic Importance of Impaired Systolic Function in Heart Failure With Preserved Ejection Fraction and the Impact of Spironolactone. Circulation. 2015 Aug 4;132(5):402-414.
19. Study on propionyl-L-carnitine in chronic heart failure. Eur Heart J. 1999 Jan;20(1):70-76.
20. Serati AR, Motamedi MR, Emami S, Varedi P, Movahed MR. L-carnitine treatment in patients with mild diastolic heart failure is associated with improvement in diastolic function and symptoms. Cardiology. 2010;116(3):178-182.
21. Koeth RA, Wang Z, Levison BS, Buffa JA, Org E, Sheehy BT, Britt EB, Fu X, Wu Y, Li L, Smith JD, DiDonato JA, Chen J, Li H, Wu GD, Lewis JD, Warrier M, Brown JM, Krauss RM, Tang WH, Bushman FD, Lusis AJ, Hazen SL. Intestinal microbiota metabolism of L-carnitine, a nutrient in red meat, promotes atherosclerosis. Nat Med. 2013 May;19(5):576-585.
22. Troseid M, Ueland T, Hov JR, Svardal A, Gregersen I, Dahl CP, Aakhus S, Gude E, Bjorndal B, Halvorsen B, Karlsen TH, Aukrust P, Gullestad L, Berge RK, Yndestad A. Microbiota-dependent metabolite trimethylamine-N-oxide is associated with disease severity and survival of patients with chronic heart failure. J Intern Med. 2015 Jun;277(6):717-726.
23. Takahashi M1, Ueda S, Misaki H, Sugiyama N, Matsumoto K, Matsuo N, Murao S. Carnitine determination by an enzymatic cycling method with carnitine dehydrogenase. Clin Chem. 1994 May;40(5):817-21.

DEVELOPMENT OF TECHNOLOGIES FOR HEALTHY AGING: SEARCHING FOR THE RIGHT WAY

A. Piau^1,2,3, E. Campo^2,3, B. Vellas^1,4, F. Nourhashemi^1,4

1. CHU de Toulouse, Gerontopôle, UPS, F-31400 Toulouse, France; 2. CNRS, LAAS, F-31400 Toulouse, France; 3. Univ de Toulouse, UT2J, LAAS, F-31100 Toulouse, France; 4. INSERM, UMR 1027, UPS, F-31400 Toulouse, France

Corresponding Author: A Piau, CHU de Toulouse, Gérontopole, Toulouse, France, piau.a@chu-toulouse.fr

Abstract

Background: Medical imaging (e.g. PET-scan) and interventional (e.g. robotic surgery) technologies seem- to better fit the actual technological progress than do technologies for aging. The commercial market of aging care remains subdued since the introduction of low-technology devices decades ago (e.g. walker). Revisiting the evaluation and development methods of technologies to support healthy aging could help spread innovative technologies in this field. Methods and findings: In literature, a number of publications have been identified that addresses issues about technological devices that target the different needs of the older person. Nevertheless, a successful evaluation and development often remains unmet. This deficiency arises to a large extent from the confrontation of two worlds: that of technology which is not yet well versed in the field of healthy aging intervention, and the medical world which mainly uses the linear pharmaceutical drug development model. Many methods propose to tackle the global multidimensional evaluation of health technologies. However, they do not address the sequencing of the whole development and evaluation processes. In the present paper, we present a framework to help tackle the complexity of healthy aging technologies assessment and development. Conclusion: The evaluation and development methods usually adopted for healthy aging technologies are not appropriate and that all the collaborative multidisciplinary processes have to be revised.

Key words: Frailty, geriatrics, methodology, assessment, technologies.

Introduction

Although the adoption of technologies by older persons is still at an early stage, it provides great expectations. Technologies could promote healthy aging (1), independent living, comfort and safety no matter where the persons live. In nursing homes, technologies are potentially able to improve health care efficiency and quality, and also to protect resident privacy. They also potentially bypass the financial, geographical and organizational barriers restricting access to specific services (2). However, a number of obstacles appear to limit their dissemination (3), in surprising proportions. Several reasons can be reported. They include: the lack of objective assessment of these solutions, – inadequate plan for implementing them into practice and, in most cases, no real proof of efficacy is observed. Revisiting the evaluation and development methods could help spread innovative technologies in this field.

The most documented studies are focused on telemedicine, telehealth and concern chronic illnesses (….). Limited evidence is available on the specific application of technologies dedicated to safety, autonomy or dependency prevention (4). Studies performed in this field rarely meet the usual standards of publications on health (4-8) Many of the trials carried out are too small and the endpoints are often inconsistent. To a large extent, this could arise from the confrontation of two different worlds: that of technology and its business community, which are not yet well versed in the field of health intervention, and that of the medical world, which mainly uses the linear pharmaceutical drug development model (9, 10).
Many authors call for trials which go beyond evaluation of clinical effectiveness (12-15). The point that these methods have in common is that they stress the multidimensional and iterative aspects of the assessement, the need of combining quantitative and qualitative criteria, and the importance of taking into account the setting in which the technology is implemented. Nevertheless, they do not address the sequencing of the development and evaluation processes. Law and Wason suggest adaptive approaches to trial design in telehealth studies (15), in which new decisions can be made about the design or progress of the trial, once the trial is already underway.
In the present brief commented review of literature, we propose a framework to help tackle the complexity of aging technologies development and assessment.

Framework design

Issues to be taken into account

Technical aspects are not only a matter of facing pure technological locks. Information feedback from medical, economic and ethical dimensions must be taken into account at each stage. This is particularly true for the man-machine interface where the end user’s feedback is of primary importance. The medical dimension of evaluation concentrates on the efficacy and security of the technology on the subject. However, it also takes into account its value for public health, which concerns economic and societal dimensions. The difference between efficacy in a controlled context and efficacy in a real context, or effectiveness, seems to provide a greater impact – for technology, since it is highly dependent on the context in which it is deployed. The societal dimension assesses the global effect on society. Evaluation does not only concern a technical device but also its impact on overall management, as part of patient care. If alerts are automatically triggered from a technological device, the common global medical procedure should be well-known and practical implications should be assessed for all those who participate. Early involvement of all stakeholders is required to ensure technology implementation. To a very large extent, the legal and ethical dimensions cross other dimensions also, in particular medical (e.g. deontology) and societal (e.g. basic rights and responsibilities). As soon as the project specifications are decided, advice could be sought from a specialist on these issues and on the possible societal impact of technology. So, before designing a longitudinal evaluation, there is a preliminary question: does the use of the tool respect a legal framework (e.g. biomedical laws), or an ethical framework (e.g. ethics committee)? Should the device of interest be considered as a medical device? Is it necessary to perform the living lab evaluation in an accredited medical research environment? Furthermore, if technology generally carries low intrinsic medical risks, its use may lead to ethical consequences, e.g. geolocation in the case of a 3G-technology device. The economic dimension is a major asset in a highly restrictive economic environment. One of the barriers in implementing technology may be the lack of clear information as to who pays what and for whom.

Phases of development and evaluation

The process of technological development follows a series of phases that is less linear in comparison to that of drug development (see Box 1). We can distinguish a first phase, which corresponds to the phase of specifications. After the identification of a medical need (e.g. promoting healthy aging to prevent disability), the requirements are designed: identification of medical indicators (e.g. gait speed, weight), description of technological tools (e.g. gyroscope), and set up of a preliminary economic model. To better promote future implementation, this phase must involve all those involved in the evaluation, including end users. This could be considered as similar to the preclinical phase in the pharmaceutical process. The second phase corresponds to the technical “lab tests” of the initial solutions proposed. It validates the technical compliance of each “technological brick” in the laboratory with volunteer end users. This phase can be compared to phase I in drug development. The non-technical aspects will remain (Is the solution’s cost economically acceptable? Are indicators of future adherence reported?). At the end of this phase, a first prototype is available. During the third phase, the prototype may be evaluated in a “living lab”, validating clinical and technical feasibility according to the various medical scenarios established. The environment as well as the end user’s attitude is new variables. Acceptability assessment allows iterative modifications before a wider dissemination. A comparison could be made here with phase II in drug development. A more extensive phase could be carried out. It would then match the phase III of drug development. This step could include technology distribution on a larger scale within a real-life context, thus enabling to evaluate the medical and social services rendered and the overall economic impact. All the variables are taken into account: the material and organizational context, the disability or the disease. A real appraisal can be made of the actual uses of the device. This evaluation is rarely carried out for reasons relevant to cost and time. Lastly, on the model of the “residual risk” evaluation that is carried out in post-marketing studies associated with a pharmacovigilance study, a final phase could be designed. It would use “observer” devices to follow-up the technology application in “real life” as part of observational studies. At each phase, information and feedback loops can be applied to modify the technology, the organization, or even the target of the application. This would be impossible in drug development, where per-protocol changes are prohibited for methodological reasons. Table 1 presents relationships between development phases and evaluation dimensions.

Table 1
Relationships between development phases and evaluation dimensions

Box 1

Characteristics of health technologies as compared to drug development

–   Technology evaluation is multidimensional and therefore multidisciplinary;
–   As technology implies a change in overall strategy, rather than the introduction of a new tool, outcomes are reported to be more dependent to the technology’s implementation context;
–   Technology evaluation is non-linear, more iterative, flexible, pragmatic;
–   Feedback loops are more effective in technology evaluation;
–   So-called positivist quantitative research strategies need to be combined with constructivist qualitative strategies for technology evaluation;
–   Less time is available for technology evaluation because of the rapidly changing market.

Conclusion

The evaluation and development methods usually adopted for aging technologies are not appropriate and the all-collaborative multidisciplinary processes have to be revised. Through this multidisciplinary and iterative approach, industrial partners can now be accompanied to develop relevant technologies in the field of healthy aging. It should be beneficial when setting up regional scalable platforms to develop and assess new devices both by academic and private partners. An example of this kind of platform is deployed by the Oregon Center for Aging and Technology at Oregon University. Today, the Toulouse Gérontopôle aims to achieve this approach in cooperation with industrial partners for the benefit of the aging population.

Author Contributions: A.P. and E.C. were involved in the writing of the manuscript’s first draft and in the review of the subsequent drafts. B.V. and F.N. were involved in the conception of the article and reviewed the manuscript.

Sponsor’s Role: no funding sources.

Disclosure statement: No potential conflicts of interest were disclosed.

References

1.   Sparrow D, Gottlieb DJ, Demolles D, Fielding RA. Increases in muscle strength and balance using a resistance training program administered via a telecommunications system in older adults. Gerontol A Biol Sci Med Sci. 2011;66:1251-7.
2.    Niefeld MR, Kasper JD. Access to ambulatory medical and long-term care services among elderly Medicare and Medicaid beneficiaries: organizational, financial, and geographic barriers. Med Care Res Rev 2005;62:300-19
3.    Anderson J. Social, ethical, legal barriers to E-Health. Int J Med Inform 2007;76:480-3
4.    Piau A, Campo E, Rumeau P, et al. Aging society and gerontechnology: a solution for an independent living? J Nutr Health Aging. 2014;18:97-112.
5.    Martin S, Kelly G, Kernohan WG, et al. Smart home technologies for health and social care support. Cochrane Database Syst Rev 2008; 8:CD006412
6.    Barlow J, Singh D, Bayer S, Curry R. A systematic review of the benefits of home telecare for frail elderly people and those with long-term conditions. J Telemed Telecare 2007;13:172-9
7.    Paré G, Moqadem K, Pineau G, St-Hilaire C. Clinical effects of home telemonitoring in the context of diabetes, asthma, heart failure and hypertension: a systematic review. J Med Internet Res 2010; 12: e21.
8.    Whitten PS, Mair FS, Haycox A, et al. Systematic review of cost effectiveness studies of telemedicine interventions. BMJ 2002;324:1434–7.
9.    Medical Research Council. A framework for development and evaluation of RCTs for complex interventions to improve health. [cited 2013 feb 11]. Available from: http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC003372.
10.    Campbell NC, Murray E, Darbyshire J, et al. Designing and evaluating complex interventions to improve health care. BMJ 2007;334:455-9
11.    Sorenson C, Drummond M, Borlum Kristensen F, Busse R. How can the impact of health technology assessments be enhanced? Policy Brief – WHO European Ministerial Conference on Health Systems. Health Systems and Policy Analysis, 2008
12.    Granstrøm Ekeland A, Bowes A, Gammon D. Short version of MethoTelemed. Methodology to assess telemedicine applications. Norwegian Centre for Telemedicine, Norway, 2010. [cited 2012 dec 4]. Available from: http://www.telemed.no/methotelemed.4565273-125741.html
13.    Velasco-Garrido M, Busse R. Health technology assessment, An introduction to objectives, role of evidence, and structure in Europe. World Health Organization, on behalf of the European Observatory on Health Systems and Policies. Policy brief, 2005
14.    Rialle V, Vuillerme N. Outline of a general framework for assessing e-health and gerontechnology applications: Axiological and diachronic dimensions. Gerontechnology 2010;9(2):245
15.    Law LM, Wason JM. Design of telehealth trials – Introducing adaptive approaches. Int J Med Inform. 2014 Dec;83(12):870-880.

A NEW PROPOSAL FOR THE CLINICAL-FUNCTIONAL CATEGORIZATION OF THE ELDERLY: VISUAL SCALE OF FRAILTY (VS-FRAILTY)

E. Nunes de Moraes^1,2, F.M. Lanna², R.R. Santos^1,2, M.A.C. Bicalho^1,2, C.J. Machado^1,3, D.E. Romero⁴

1. Department of Clinical Medicine at the Federal University of Minas Gerais, Brazil; 2. Center for Geriatrics and Gerontology UFMG, Brazil; 3. Department of Preventive and Social Medicine at the Federal University of Minas; 4. Oswaldo Cruz Foundation, Rio de Janeiro, Brasil.

Corresponding Author: Edgar Nunes de Moraes, Professor of the Department of Clinical Medicine at the Federal University of Minas Gerais, Brazil. Director of the Center for Geriatrics and Gerontology UFMG, 117, Alameda Álvaro Celso. Zip Code: 30.150-260, Belo Horizonte. Minas Gerais, Phone: (55) 31 3226-2386, Fax: (55) 31 3226-2386, Email: edgarnmoraes@gmail.com

Abstract

Ageing is closely associated with increasing frailty, and it continues to be defined in various different ways, complicating its practical application in the clinical context. Frailty is commonly used to predict the risk of functional decline, institutionalization or even death. Current models of frailty display significant limitations, because they are unable to encompass all the chronic conditions indicating adverse outcomes. In this article, we propose the Visual Scale of Frailty (VS-Frailty), based on the overall functionality and clinical complexity of elderly individuals. This scale emphasizes the importance of independence in basic, instrumental and advanced Activities of Daily Living (ADL), as well as taking into account the main causes of the functional decline of the elderly, such as sarcopenia syndrome, mild cognitive impairment and multiple comorbidities. The scale places the elderly into 10 categories ranging from completely independent to fully dependent. The scale provides the following advantages over other scales currently used: scope, ease of application, visual clarity, longitudinal monitoring, planning of health services, and the definition of therapeutic goals and prioritization of care. The use of VS-Frailty permits the individualization of the overall diagnosis, thus facilitating continuity of care in a systematized manner, ensuring comprehensive attention to the health of elderly individuals.

Key words: Frailty, disability, classification of the elderly.

Introduction and Motivation

Aging has profound consequences for organization of healthcare systems due to higher incidences of chronic diseases and functional disabilities in elderly populations. However, while diseases may be more common amongst old people, they are not always linked to functional dependency. Ageing, therefore, is not synonymous of disability and dependence, but is related to greater vulnerability.

Aging alone can lead to chronic diseases, but not to functional dependency. Individuals with similar clinical diagnoses may display entirely different functional capacities, and this striking heterogeneity increases with ageing (1). As a result, various authors have asserted the need for a more sophisticated classification of the health status of the elderly (2, 3). We believe that functional capacity should be at the core of any health status classification. Boundaries between the concepts of health, disease, dependency and disability should be also clarified. In this way, health may be defined as a measure of individual’s ability to achieve their aspirations and satisfy their needs, rather than simply as the absence of disease (4).

Well-being and functionality are complementary. Together, they represent the presence of autonomy (individual decision-making power and control over one’s actions, establishing and following one’s own convictions) and independence (the ability to achieve something without external assistance), allowing individuals to look after themselves and their lives. It is important to bear in mind while autonomy and independence are closely related, they are distinct concepts. Physically dependent individuals may still be capable of making their own decisions about daily activities, just as others may be physically able to perform these activities, whilst being incapable of making decisions about the nature of their involvement. According to the International Classification of Functioning, functional decline is defined as a loss of autonomy and/or independence, as it restricts many aspects of life, including social functioning5. Independence and autonomy are thus closely related to complete and harmonious functioning of the following capacities:

• Cognition: the mental capacity to understand and adequately resolve everyday problems;

• Mood/Behaviour: the motivation required to carry out activities and/or participate socially. This includes individual behaviour, which is affected by other mental functions such as sensory perception, thought and conscience.

• Mobility: the individual capacity to move and manipulate one’s environment. This depends on four functional subsystems: aerobic and muscular capacity (mass and function), reach / prehension / grip (upper limbs) and gait / posture / transferring (lower limbs). Control of urinary and fecal sphincters is also considered a pre-requisite for mobility, as incontinence may reduce mobility and restrict the social participation of the individual.

• Communication: the ability to establish a productive relationship with one’s environment, exchange information and express desires, ideas and feelings. This depends on three functional subsystems: vision, hearing and orofacial motor function. The latter refers to the voice, speech and the ability to chew and swallow.

As Moraes (4) writes, the impairment of these systems – manifested in cognitive disability, postural instability, incontinence, immobility and the inability to effectively communicate. These syndromes are known as “geriatric syndromes”. Besides that, presence of chronic medical conditions increases the complexity of clinical management, thus implying increased risk of iatrogenesis. Functional decline and frailty are closely related. The term ‘frailty’ is commonly used to express the degree of vulnerability of the elderly individual to adverse outcomes like functional dependency. It is also used to refer to other levels of vulnerability, such as the risk of institutionalization, or even death. The fact that the term has been defined in several different ways complicates its application in the clinical context (6, 7).

Literature review and multidimensional frailty

Fried and colleagues (8, 9) and Rockwood and colleagues (10, 11) are among the authors who have examined this concept in detail. In 2001, Fried proposed the term ‘frailty’ to represent a geriatric syndrome, of multifactorial nature, characterized by a reduction in energy levels and resistance to stressors, resulting in the cumulative decline of physiological systems. This concept was operationalized in the ‘phenotype of frailty’, validated by the Cardiovascular Health Study. It is characterized by three or more of the following criteria: involuntary weight loss (5 kg in the last year), self-declared exhaustion (according to the Center for Epidemiologic Studies Depression Scale/CES-D), weakness (reduction in muscular strength assessed by grip strength), low level of physical activity (verified by the Minnesota Leisure Time Activities Questionnaire and reduced walking speed (over a timed walk of 4.5 m). The presence of three or more of these features defines the individual as ‘frail’, while the presence of two defines them as ‘pre-frail’. Individuals who do not display any of these criteria are considered robust. This classification excludes individuals suffering from comorbidity and functional dependency and there is a high overlap between the three groups.

In 2005, Rockwood proposed a broader model of frailty, based on the presence of cumulative clinical deficits. This was expressed by the Frailty Index (FI), the result of the application of the Comprehensive Geriatric Assessment. The FI is a weighted measurement, derived from individual accumulation of 30 to 70 clinical problems, including specific diseases (congestive cardiac failure, arterial hypertension, strokes, myocardial infarction, Parkinson’s disease and cancer, among others), symptoms (shaking, bradykinesia, cephalalgia, syncope, among others), functional loss (such as dependence in daily activities, memory loss, problems with mood, changes in gait and balance, falls, immobility and urinary and fecal incontinence) and abnormal laboratory tests. Yet, one criticism that can be made is that the FI is comprehensive, but very broad.

Both Fried’s and Rockwood’s models of frailty have important limitations. Fried’s model is incapable of encompassing all the chronic medical conditions associated with greater risk of functional decline, hospitalization and death. It considers only mobility, in particular, aerobic and muscular capacity, underestimating the importance of other functional capacities such as cognition (12). Moreover, its application requires the use of handgrip equipment, which is not widely available in primary care. Rockwood’s Frailty Index uses a mathematical model based on the accumulation of problems, which are not clearly defined or standardized, and requires the application of a comprehensive geriatric assessment. This assessment brings its own problems, as there is no consensus regarding its structure, and it varies widely in its application. The current challenge, therefore, is to operationalize the concept of frailty, facilitating its recognition and the implementation of actions capable of maximizing individual independence and autonomy and preventing adverse outcomes (13), thereby making the term useful for those considering the prevention of functional disability in the elderly.

Aligned with the idea of understanding frailty in its broader meaning, we propose the concept of multidimensional frailty. It is defined as the reduction of the homeostatic reserve and/or the ability to adapt to biopsychosocial problems, and consequently, greater susceptibility to functional decline. In this multidimensional model, the conditions associated with adverse outcomes can be placed in two categories: clinical-functional and socio-familial. The concept of health, for the elderly individual, should therefore consider information about both these aspects, according to WHO definition of health as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.

Social conditions, including socioeconomic status, the presence of social support, social engagement and the feeling of self-sufficiency, exert a decisive influence on health, and indeed on an individual’s survival, particularly amongst the elderly (14, 15). For this reason, the socio-familial category considers the importance of factors such as gender, race, level of education, marital status, familial arrangements , recent widowhood, if they are themselves a carer, extent of social participation and support, access to health services and employment situation. Some of these considerations are qualitative and difficult to measure, which limits their use in structured scales.

The variables or factors considered in the clinical-functional category are better structured, though a lack of consensus persists. It takes into account biological, physical, cognitive and psychological factors responsible for functional decline in the elderly. Ageing increases the risk of health problems (senility) related to diseases and external causes (such as traumas and accidents), which are usually manifest in the form of multiple comorbidities (polypathology, polypharmacy and recent hospitalization) and represent the principal cause of disability in the elderly. On the other hand, normal ageing (senescence) may also be associated with the decline of homeostatic reserves and increased susceptibility to problems, principally through immunological activation, which generates a chronic pro-inflammatory state. This in turn permits the development of sarcopenia syndrome, manifested in the reduction of aerobic and muscular capacities, which are considered the principal elements in the phenotype of Frailty 8. Senility and senescence may both therefore lead to functional dependence. Disabilities further compromise homeostatic reserves, producing a vicious cycle, leading to progression of the disabilities, hospitalization and even death. In this multidimensional model, we take into account Fried’s and colleagues’ and Rockwood’s and colleagues’ models, as they are not considered mutually exclusive. On the contrary, they are complementary or synergic, and may both be present in the same individual (Figure 1). The model thus preserves the differences between comorbidities, disabilities and the ‘phenotype of Frailty’. It considers all the components of frailty in the elderly, understood as the presence of disabilities and/or chronic conditions associated with functional decline, institutionalization and/or death.

Figure 1 Ageing and Frailty

Functional decline is therefore the main target of geriatric-gerontological assessment and therapeutic interventions. In this model, functional decline is posited as established and imminent. Imminent functional decline is understood as the presence of chronic conditions indicative of functional dependency, such as sarcopenia and the presence of multiple comorbidities (polypathology, polypharmacy and recent hospitalization).

It is worth re-emphasizing the distinction between sarcopenia as a process and sarcopenia as a syndrome. The process of sarcopenia, understood as the reduction of muscular mass, is the result of neuroendocrine alterations which are responsible for changes to the composition of the ageing body. Such changes include reductions in muscular mass, bone mass and body water content, as well as an increase in fat. The syndrome of sarcopenia, on the other hand, is characterized by the presence of changes in muscular mass and function (strength and muscular performance), that is strictly related to the ‘phenotype of frailty’. In the proposed model, the criteria for the diagnosis of sarcopenia include the presence of three of more features from the phenotype of frailty (weight loss, exhaustion, grip strength, low level of physical activity and a reduction in walking pace), as well as quantitative measurements of muscular mass, associated with measurements of muscular function, such as grip force and walking speed.

A reduction in gait speed is one of the principal determinants of sarcopenia / dynapenia, defined as a gait speed equal to or less than 0.8 m/s. Another strong indication of sarcopenia is a calf circumference equal to or less than 31 cm. Other indications of sarcopenia are significant non-intentional weight loss, or low body mass index (BMI) (less than 22 kg/m2) (16-18). Recently, some authors have suggested that the reduction in neuropsychological reserve is another indication of adverse outcomes in the cognitive area. ‘Cognitive Frailty’ is defined as a heterogeneous clinical syndrome characterized by the presence of physical Frailty (‘phenotype of Frailty’) associated with cognitive decline involving mild cognitive impairment (CDR 0.5) (19).

The presence of multiple medical conditions is related to increasing use of healthcare systems and higher risk of iatrogenesis, disabilities, institutionalization and even death (20). Thus, multiple medical conditions contribute to imminent functional decline. However, the definition of multimorbidity, and its operationalization, have yet to be clearly established. Multimorbidity can be defined as a combination of acute and/or chronic medical conditions, associated with a range of biopsychosocial risk factors, such as polypharmacy, lifestyle habits, and excessive use of healthcare systems, among others (21). In the model proposed here, we define multimorbidity as the presence of one or more of three clinical conditions: polypathology (simultaneous presence of five or more chronic medical conditions, attacking different physiological systems); polypharmacy (regular and systemic use of five or more medications per day for different chronic conditions); or recent hospitalization (in the last six months).

In addition to the presence of multiple comorbidities, evidence of sarcopenia syndrome and mild cognitive impairment, we include the presence of established functional decline as a determinant of Frailty. As such, functional dependency may be considered both a cause, and at the same time, an effect of Frailty (22, 23).

The overall functionality of the individual has always been fundamental for any classification of the elderly. In 1943, Marjory Warren, considered the ‘mother of geriatrics’ (24), proposed a classification based on the presence of various types of disability, such as postural instability, immobility, urinary incontinence and cognitive disability. This pioneering classification of elderly patients at an infirmary enabled the planning of the human and material resources necessary to implement specific actions for each group of elderly individuals. In 1963, Katz developed an index capable of categorizing individuals according to the level of dependence in Activities of Daily Living (ADL) related to self-care (25). The Katz index made a clear distinction between independent and dependent individuals in ADL, and included a hierarchy for the dependent individuals. Elderly individuals may therefore be categorized as:

• Independent: capable of carrying out basic daily activities in an independent manner;

• Semi-dependent: displays difficulty in carrying out one of the functions influenced by culture and learning (bathing and/or getting dressed and/or using the toilet);

• Incomplete dependent: displays impairment in one of the simple vegetative functions (transferring and/or continence), as well as requiring assistance in bathing, getting dressed and using the toilet. The isolated presence of urinary incontinence should not be taken into account, as it is a function rather than an activity;

• Complete dependent: displays impairment in all functions influenced by culture and learning, as well as in simple vegetative functions, including the ability to eat without assistance. This is the maximum degree of functional dependence.

In 1969, Lawton and Brody (26) confirmed the importance of assessing the functionality of the individual in their basic daily tasks, but they also proposed the assessment of more complex abilities, denominated instrumental ADL, related to self-maintenance. Elderly individuals may therefore be independent, partly dependent or completely dependent in instrumental ADL. Usually, functional decline follows a hierarchy, beginning with the more complex (advanced and instrumental) ADL, until the impairment of activities related to self-care (basic ADL). Moreover, it may be a consequence of impairment in isolated functions or connected functional areas. Clinico-functional classification of the elderly individual depends directly upon this functional classification. These scales (Katz’s and Lawton-Brody’s scales) are vital for the objective assessment of the elderly individual, and for the creation, implementation and evaluation of a care plan.

The VS-Frailty proposal

While ageing is closely linked to the frailty there is no direct cause and effect relation between the two. The two phenomena do not follow the same pattern of evolution, and elderly individuals of the same age may display highly heterogeneous conditions (27). Thus, age alone is not a good indication of Frailty.

To express more clearly the various sub-groups of elderly individuals, we propose the use of the Visual Scale of Frailty (VS-Frailty), based on their functionality and clinical complexity. Visual analogic scales have been used to assess a range of issues related to human health, particularly those of a multidimensional nature and those which display a dynamic character over time, such as pain, mood and dyspnoea, among others28. This permits continuous measurement within an established set of values, in a linear and proportional manner, taking into account both objective and subjective factors. The VS-Frailty thus encompasses extremes, from the maximum and minimum degree of vitality (homeostatic reserve) and frailty (vulnerability). These extremes are linked by a straight line, continuous and declining, upon which the health of the elderly individual may be marked. Ten clinical-functional categories were defined, which vary continuously within the pre-established range of values. Elderly individuals may therefore be categorized as illustrated in Figure 2.

Figure 2 Visual Analogue Scale of Frailty (VAS-Frailty)

ROBUST: Elderly individuals who display good homeostatic reserve, being therefore capable of managing their lives in an independent and autonomous manner. They do not display any functional disability or any chronic medical condition associated with greater vulnerability. Care must be directed towards the maintenance of the individual’s autonomy and independence, through measures which promote health, as well as primary and secondary preventive measures and appropriate clinical management of diseases according to their respective established guidelines. This group is divided into three sub-categories:

• Category 1: Elderly individuals who display the maximum degree of vitality. They retain independence in all advanced, instrumental and basic ADL, as well as being free of illness and other risk factors apart from their age. They do not display any medical conditions indicative of adverse outcomes.

• Category 2: Elderly individuals independent in all ADL, but who display medical conditions of low clinical complexity, such as arterial hypertension (without complications) and/or the presence of risk factors such as tobacco smoking, dyslipidaemia and osteopenia, among others.

• Category 3: Elderly individuals independent in all ADL, but who display well-established chronic degenerative diseases of higher clinical complexity, such as complicated arterial hypertension, diabetes mellitus, a history of transient ischemic attacks, strokes (without further consequences), chronic renal disorder, heart failure, chronic obstructive pulmonary disease, osteoarthritis; coronary artery disease, with or without acute myocardial infarction; peripheral artery disease, cancer, osteoporosis and atrial fibrillation, among others. In these individuals, the presence of these conditions is not associated with functional limitation, and in general, they appear in isolation. Individuals displaying one or two criteria of the ‘phenotype of Frailty’ also fall into this category.

AT RISK OF FRAILTY: Elderly individuals capable of managing their life in an independent and autonomous manner, who remain in a dynamic state between senescence and senility, resulting in the presence of certain functional limitations (imminent functional decline), but without functional dependency. They display one or more of the chronic medical conditions indicative of adverse outcomes, such as evidence of sarcopenia syndrome, mild cognitive impairment and/or the presence of multiple comorbidities. The aim of treatment must be to prevent functional decline through the correct handling or correct approach to managing polypathology and polypharmacy, with an emphasis on the following, in order of importance: suspension of inappropriate medication, definition of personalized therapeutic goals, prioritization of care, diagnosis and treatment of underdiagnosed and/or undertreated medical conditions, rehabilitation, primary and secondary prevention. This group corresponds to categories four and five of the VS-Frailty:

• Category 4: These are elderly individuals who display symptoms of sarcopenia syndrome, mild cognitive impairment (MCI) and/or multiple comorbidities (polypathology, polypharmacy or recent hospitalization), but who remain independent in all ADL, including advanced ADL, defined as activities related to social integration, productive, recreational and/or social activities.

• Category 5: These are elderly individuals who display symptoms of sarcopenia syndrome, mild cognitive impairment and/or multiple comorbidities, and who also have begun to display functional decline in advanced ADL. However, they remain independent in instrumental and basic ADL.

From Category 6 on, classification is essentially based on the presence of established functional decline, which is the consequence of major geriatric syndromes such as cognitive disability, postural instability, incontinence and communicative disability. These patients are also associated with iatrogenesis and family insufficiency, and are likely to suffer from other chronic medical conditions.

FRAIL: Elderly individuals suffering from established functional decline, who are incapable of managing their own lives, as a result of single or multiple disabilities. The aim of treatment should be the recovery of the individual’s autonomy and independence. This group corresponds to the categories six, seven, eight, nine and ten of the VS-Frailty:

• Category 6: Individuals who display partial functional decline in the instrumental activities of daily living, but who remain independent in basic ADL.

• Category 7: Individuals who display functional decline in all the instrumental activities of daily living, but who remain independent in basic ADL.

• Category 8: Individuals who display total functional decline in instrumental ADL, as well as semi-dependence in basic ADL: impairment of one of the functions influenced by culture and learning (bathing, getting dressed and/or using the toilet).

• Category 9: Individuals who display total dependence in instrumental ADL, alongside partial dependency in basic ADL: impairment of one of the simple vegetative functions (movement and/or continence), as well as requiring assistance to bathe, get dressed and use the toilet. The isolated presence of urinary incontinence should not be taken into account, as it is a function and not an activity.

• Category 10: Individuals who display the maximum degree of Frailty, and therefore the highest level of functional dependence. They require assistance even to eat. On Katz’s index, they are classified at Stage G (25).

Definition of the clinical-functional category should consider the best current performance of ADL. So, if the individual is capable of various instrumental ADL, they should be placed in category 7, even if they are unable to carry out a basic ADL. As well as functional heterogeneity, frail individuals also display differences regarding clinical complexity and the need for specialized geriatric-gerontological assistance. In this sense, frail individuals may also be categorized according to the following definitions:

o Low Complex Frail Individual: Displays established functional decline, with low potential for clinical-functional reversibility. With these individuals, intense geriatric-gerontological assistance is not required and the aim of treatment should be the prevention of functional deterioration.

o Highly Complex Frail Individual: Displays functional dependency in ADL, together with medical conditions that are difficult to manage as a result of doubts regarding diagnosis or therapy. The term ‘Highly Complex’ suggests high potential for clinico-functional reversibility or quality of life. These individuals benefit most from intensive monitoring by teams of geriatric-gerontological specialists.

o Frail Individual in Final Stage of Life: Displays a high degree of functional dependency and life expectancy is estimated at less than six months. Despite the existence of a clear link between higher levels of functional decline and higher mortality rates, some individuals may be able to function relatively well despite suffering from diseases that present a high risk of mortality, such as certain types of neoplasia (terminally ill). The aim of treatment should be palliative care, based on the comfort of the patient and their family members.

The scale provides the following advantages over the scales already discussed and currently used:

• Scope: the scale is based on the multidimensionality of factors that determine geriatric health (29, 30), without minimizing the importance of diseases or physical changes, including the frailty indicators as described by Fried and colleagues (9), as well as diseases, polypathology and polypharmacy;

• Ease of application: it does not require any sophisticated or hard-to-obtain tools, and may be applied in any environment of geriatric care, such as outpatients’ clinics, patients’ homes, care homes, day centres and hospitals. It unites objective and subjective aspects in its assessment of elderly individuals.

• Visual clarity: the scale is visual and it incorporates fundamental concepts for the understanding of the ageing process, such as senescence, senility, vitality, frailty, functional decline and ADL. The categories 1 to 10 take into account the heterogeneity of elderly individuals of the same age group;

• Longitudinal monitoring: permits longitudinal monitoring of the health of the elderly individual, facilitating the visualization of the results of geriatric-gerontological treatment;

• Planning of health services: the scale establishes objective criteria for geriatric-gerontological care;

• Definition of therapeutic goals and prioritization of care: the clinico-functional categorization permits the definition of personal and specific objectives for each patient. With robust individuals, therapeutic goals will be similar to clinical guidelines regarding diseases. By contrast, with highly dependent individuals, or with individuals reaching the end of their life, therapeutic goals must prioritize comfort, as functional loss is critical, and classical preventive strategies should be revised.

The use of VS-Frailty makes possible the individualization of the overall diagnosis of the individual, thus facilitating continuity of care in a systematized manner, ensuring comprehensive attention to the health of the elderly individual.

Conflict of interest: No potential conflicts of interest were disclosed.

Author Contributions: Edgar N. Moraes: study concept and design, preparation of paper. Flávia M. Lanna: study concept and design, preparation of paper. Rodrigo R. Santos: study concept and design, preparation of paper. Maria A.C Bicalho: study concept and design, preparation of paper. Carla J. Machado: study concept and design, preparation of paper. Dália E. Romero: study concept and design

References

1. Veras RP. Gerenciamento de doença crônica: equívoco para o grupo etário dos idosos. Rev Saúde Pública 2012; 46: 929-34.

2. Ramos LR. Fatores determinantes do envelhecimento saudável em idosos residentes em centro urbano: Projeto Epidoso, São Paulo. Cad. Saúde Pública 2003; 19: 793-798.

3. Cesari M, Gambassi G, Van Kan GA, Vellas B. The frailty phenotype and the frailty index: different instruments for different purposes. Age and Ageing 2014; 43: 10-12.

4. Moraes EN. Atenção à Saúde do Idoso: Aspectos Conceituais. Brasília: Organização Pan-Americana da Saúde, 2012.

5. Organização Mundial de Saúde / Organização Panamericana de Saúde. CIF – Classificação Internacional de Funcionalidade, Incapacidade e Saúde: Universidade de São Paulo; 2003.

6. Rodrígues-Mañas LR, Féart C, Mann G et al. Searching for an Operational Definition of Frailty: A Delphi Method Consensus Statement. The Frailty Operative Definition-Consensus Conference Project. J Gerontol A Biol Sci Med Sci 2013; 68: 62-67.

7. Gordon AL, Masud T, Gladman JRF. Now that we have a definition for physical frailty, what shape should frailty medicine take? Age and Ageing 2014; 32: 8-9.

8. Fried LP et al. Frailty in older adults: evidence for a phenotype. J. Gerontol. A. Biol. Sci. Med. Sci. 2001; 56: M146-156.

9. Fried LP et al. Untangling the Concept of Disability, Frailty and Comorbidity: Implications for Improved Targeting and Care. J. Gerontol. A. Biol. Sci. Med. Sci. 2004; 59: 255-263.

10. Rockwood K et al. A global clinical measure of fitness and frailty in elderly people. CMAJ 2005; 173: 489-495.

11. Rockwood K, Mitnitski A. Frailty defined by deficit accumulation and geriatric medicine defined by frailty. Clin Geriatr Med 2011; 27: 17-26.

12. Martin FC, Brighton P. Frailty: different tools for differents purposes? Age and Ageing 2008; 37: 129-131.

13. Clegg A et al. Frailty in elderly people. Lancet 2013; 8: 1-11.

14. Andrew MK et al. The impact of social vulnerability on the survival of the fittest older adults. Age Ageing 2012; 41: 161-165.

15. Gobbens RJJ et al. Towards an integral conceptual model of frailty. J Nutr Health Aging 2010; 14: 175-81.

16. Sayer AA et al. New horizons in the pathogenesis, diagnosis and management of sarcopenia. Age and ageing 2013; 42:145-150.

17. Cruz-Jenkoft AJ et al. Sarcopenia: European consensus on definition and diagnosis. Age and Ageing 2010; 39: 412-423.

18. Fielding RA et al. Sarcopenia: An Undiagnosed Condition in Older Adults. Current Consensus Definition: Prevalence, Etiology, and Consequences. International Working Group on Sarcopenia. J Am Med Dir Assoc 2011; 12: 249-256.

19. Kelaiditi E, Cesari M, Canevelli M. et al. Cognitive Frailty: Rational and Definition from an (I.A.N.A./I.A.G.G.) International Consensus Group. The Journal of Nutrition, Health & Aging 2013; 17: 726-734.

20. American Geriatrics Society Expert Panel on The Care of Older Adults With Multimorbidity. Patient-Centered Care for Older Adults with Multiple Chronic ,Conditions: A Stepwise Approach from the American Geriatrics Society 2012.

21. Reste JYL, Nabbe P, Manceau B. et al. The European General Practice Research Network Presents a Comprehensive Definition of Multimorbidity in Family Medicine and Long Term Care, Following a Systematic Review of Relevant Literature. JAMDA 2013; 14: 319-325.

22. Landi F Liperoti R, Russ et al. A Disability, more than multimorbidity, was predictive of mortality among older persons aged 80 years and older Journal of Clinical Epidemiology 2010; 63: 752-759.

23. Sternberg AS, Schwartz AW, Karunananthan S. et al. The identification of Frailty: A Systematic Literature Review. JAGS 2011; 59: 2129-2138.

24. Warren MW. Care of Chronic Sick: a case for treating chronic sick in blocks in a general hospital. British Medical Journal 1943; ii:822-823.

25. Katz S. Ford AB, Moskowitz RW et at. Studies of Illness in the Aged. The Index of ADL: A Standardized Measure of Biological and Psychosocial Function. JAMA, 1963; 185:94-99.

26. Lawton MP, Brody EM. Assessment of Older People: Self-Maintaning and Instrumental Activities of Daily Living. Gerontologist 1969; 9: 179-185.

27. Lacas A; Rockwood K. Frailty in primary care: a review of its conceptualization and implications for practice. BMC Med 2012; 10, n. 4, 11.

28. Wewers ME, Lowe NK. A Critical Review of Visual Analogue Scales in the Measurement of Clinical Phenomena. Research in Nursing & Healty 1990; 13: 227-236.

29. Morley JE, Vellas B, Abellan VKG et al. Frailty Consensus: A Call to Action. JAMDA 2013; 14: 393-397.

30. Berrut G., Andrieu S., Carvalho A.I. et al. Promoting access to innovation for frail old persons. The Journal of Nutrition, Health &Aging 2013;7:1-6.