International Journal of Medicine and Pharmaceutical Sciences (IJMPS) ISSN(P): 2250-0049; ISSN(E): 2321-0095 Vol. 4, Issue 5, Oct 2014, 21-30 © TJPRC Pvt. Ltd.
DEVELOPMENT OF SIMPLE DIAGNOSTIC CRITERIA FOR FRAILTY SYNDROME IN INDIAN ELDERLY POPULATION CHATTERJEE P1, KANDEL R2, DESAI G3, CHELLAIYAN V G4, BISWAS A5 & DEY AB6 1,2,3,6
Department of Geriatric Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India 4
Department of Community Medicine, Vardhman Mahavir Medical College, New Delhi, India 5
Department of Statistics, Indian Statistical Institute, Chennai, Tamil Nadu, India
ABSTRACT Introduction Frailty; a lamenting geriatric giant, is slowly emerging as an epidemic worldwide with a rapid demographic shift. Despite extensive research in this field, defining the phenotype objectively has remained challenging and controversial. Fried et al Criteria, the most validated criteria has been successfully applied in the developed countries. However, it has significant shortcomings while being used in the developing world. Some of the components of the criteria rely too much on subjective assessment. Cultural differences, occupation and leisure time activity further dilute the accuracy of certain criteria like grip strength and weight loss. A new set of criteria is being mooted to increase reliability, validity and comprehensibility. This includes a set of major, minor as well as essential criteria. The validation of this new scale would help medical personnel to identify a frail patient at an early stage and enable timely intervention. Methodology A cross sectional study will be conducted in 2013 – 2014 at a village located in North India (single visit). Around 300 elderly people (≥ 60 years) belonging to the local populace, would be assessed by a team of Geriatrician and other medical personnel. In addition to obtaining socio-demographic and health profile, a few investigations would be done with informed consent. Serum sample will be collected for assessing IL-6. Along with Comprehensive Geriatric Assessment (CGA), frailty will be assessed as per Linda Fried et al’s criteria as well as the New Indian criteria (By Chatterjee and Dey). Relevant statistical analysis would be done for validation Ethics and Dissemination The protocol has been approved by the Institutional Ethics Committee of AIIMS. (Ref No- IEC/NP-350/2012) Funding National Programme for the Health Care for the Elderly, Government of India
KEYWORDS: Frailty, Geriatric Giant, Phenotype of Frailty INTRODUCTION Background Frailty is the most lamenting geriatric giant emerging as an epidemic for the elderly population globally. Despite occupying centre stage in modern day geriatric forum for its substantial impact on elderly persons, care-givers, and health care resources; its definitive aetiology, objective diagnostic criteria and practical management is still www.tjprc.org
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Chatterjee P, Kandel R, Desai G, Chellaiyan V G, Biswas A & Dey Ab
lacking1.With an increasing cohort of frail population; management of their health needs with the limited resources will have profound implications for the planning and delivery of health and social care. Moreover, Frailty is the most important impediment to the successful implementation of the concept of “active aging”. This phenomena has been conceptualized as a 'multidimensional syndrome of loss of reserves (energy, physical ability, cognition, health) that gives rise to vulnerability to stressors, as well as high risk for serious adverse health outcomes including disability, dependency, and mortality.2, 3 Between a quarter and a half of the people over 85 years are estimated to be frail, and these people have a substantially increased risk of falls, disability, long-term care and death.4 Due to the profound functional, medical, and socioeconomic consequences of the Frailty syndrome, it is imperative to identify this syndrome in its incipient stage. With the simultaneous advancement in our understanding of this concept, it should now be possible to develop a validated diagnostic criteria and interventional strategies. Among the many researchers, who tried to explain the phenotype of frailty, the most accepted objective criteria has been postulated by Dr Linda Fried, from John Hopkins Institute (2001). According to her, the components constituting Frailty are i) Impairment of grip strength, ii) Decrease in gait speed, iii) Unintentional weight loss, iv) Self-reported fatigue in last week and v) Diminished physical activity in last three months. According to this, any individual who scores 1 or 2 among the five is classified as Pre-frail, and the ones who score 3 or more as frail 3 Although Fried’s criteria have been replicated successfully in many developed countries, their reproducibility and validity deserves some extra care and considerations in the developing world. Among the five components of the criteria; Self-reported fatigue and Diminished physical activity for last 3 months are very subjective and necessitates a lot of recall and cultural bias which can result in an increased false positivity, especially in cohorts with a large number of illiterate and socio-economically challenged elders. Unintentional weight loss is a component of the frailty phenotype, but reporting of intention to lose weight is not straightforward as knowing the direction of weight change may bias patient’s response. Studies suggest that weight loss; both intentional and unintentional has been associated with an increased risk of disease in older people.3 In addition, quantifying weight loss (during index visit) in developing country is questionable as only a small proportion of the population have their weight checked on a periodic basis. Furthermore, as described by Rokhood et al, in the continuum of frailty, weight loss could itself be a manifestation of severe frailty. Hence there is a high chance of missing the pre-frail patients based on Fried criteria. Grip strength, one of the most validated diagnostic criteria of frailty assessment, is an isometric test of torque around a joint, assessing explosive power or maximum force generated without movement, i.e. largely type II fibre activity. It depends on the usage of small muscles of hand, which is confounded by occupation, leisure time activity or health fitness exercise and the environmental factors. (For example a retired farmer may be frail with normal or hyper normal grip strength whereas a retired executive with sedentary life style without any specific exercise may have decreased grip strength without frailty). In contrast isotonic tests measure concentric and eccentric muscle activity during movements which are more representative of daily activities like walking, climbing stairs, lifting and carrying objects. They assess both endurance as well as maximum force, i.e. both type I and II fibre function5. Isotonic tests may therefore provide a more complete and relevant assessment of muscle function in patients with Sarcopenia. Rachel Cooper et al in their systemic review on physical capability concluded that there was evidence of association of grip strength and mortality in short term follow up only. In their result they also mentioned that the findings could be validated only with the age and sex Impact Factor (JCC): 5.1064
Index Copernicus Value (ICV): 3.0
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Development of Simple Diagnostic Criteria for Frailty Syndrome in Indian Elderly Population
adjustment.6 It is a fact that the Frail patients (who are usually diagnosed by Geriatricians) can visit any department according to their morbidity; therefore the need of the hour is to quantify frailty objectively and make this syndrome universally recognizable by all the clinicians at every health set-up. Operational definition has to be easy, validated and accepted universally. Only then will it be possible to apply it in the primary care setup as well as the community (which is the major catchment area of frail elders). With this vision, we tried to create new scale on valid models of frailty which allowed epidemiological investigations that show the association between frailty and adverse health outcomes. The various physical domains which are affected maximum in frail patient are Strength, Nutrition, Endurance, Mobility, Physical activity, Cognition. Representation of Fried criteria of various domains – 1) Gait speed – mobility ;2) Grip strength – Strength ; 3) Weight loss –Nutrition ;4)Self Reported Exhaustion regarding last week- Endurance and energy ;5) Low Physical Activity (in the past three months) -Physical activity. As sarcopenia is central to the pathogenesis of frailty, we took 3 physical performance measurement as major criteria and replaced Grip strength with some easily doable isotonic physical performance scale (as described previously), not biased by socio cultural practice .They are ‘1kg arm lift in 30 s’- which is a well validated test for upper limb proximal muscle weakness (uses both type I and type II muscle fibre) and “Standing from chair without any support in 30 s”- other validated test for lower limb proximal muscle and a good measures of physical performance, not confounded by socio cultural or educational status as demonstrated by Rikli and Jones.7 As subjective questionnaire is always dependent on the educational, cultural and cognitive status, we tried to make the subjective questionnaire more simple and understandable for all and make them as minor criteria. Most studies report a positive, and potentially bidirectional, association between depressive symptoms and frailty status. Despite being primarily characterized by nutritive and functional decline, the current concept of the pathogenesis of frailty, also reflects an integration of physical, functional, social, and psychological aspects of health8. A sense of hopelessness and helplessness reflects a negative view of an individual which can affect self-confidence and belief. This denotes negative energy and low mood. So we valued self reported question - ‘‘do you feel hopeless and helpless? ’’, regarding mood as a subjective criteria for frailty. We also attempted a single question ‘‘Do you find that previously easy tasks are now difficult ’’ for energy status which is a simple, understandable not influenced by education or cognitive status. Regarding nutrition, which is an important parameter of frailty, we added a simple validated question, "What has your appetite been like?" "Have you been eating less than usual?" by Romero-Ortuno et al. 9 A large number of studies have also shown that frail patients have heightened chronic inflammatory pathways. Interleukin-6 (IL-6), the geriatric cytokine, is the best pro-inflammatory marker directly associated with chronic systemic inflammation, reduced muscle mass and strength (sarcopenia). Robust scientific evidence also suggest elevated IL-6 levels
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Chatterjee P, Kandel R, Desai G, Chellaiyan V G, Biswas A & Dey Ab
(age, race, and sex-matched) predicts a significantly higher risk for the development of physical disability, declining motor performance and slowed walking speed; which are all central components of the frailty syndrome.10 So to strengthen the diagnostic criteria, we added IL-6 as essential criteria for frailty. Though the author accepts the availability and cost of IL-6 may be an issue of criticism at present, but its inclusion would greatly increase the specificity and positive predictive value of this criteria.
Figure 1: Interrelation between Various Determinants We Attempt to Postulate Physical and Mental Performance Score with Biological Markers (Indian Criteria by Chatterjee and Dey) Table 1 Major Slow gait speed ‘1kg arm lift in 30 s’ “Standing from chair without any support in 30 s” Minor (Asking the Patient (about last one month) ‘‘Do you find that previously easy tasks are now difficult ’’ ‘‘Do you feel hopeless and helpless’’ "What has your appetite been like?" "Have you been eating less than usual?"
Domains Slowness Strength Strength and Endurance Energy Mood Nutritional assessment
Essential Criteria Increased IL6 (Patient has no medical cause /signs of inflammation) Table 2 Probable Frail Three major criteria or Any two major with any minor criteria or Any major criteria with three minor criteria
Probable Pre-frail Any major criteria or any three minor criteria or 1 major and 1 minor or 1 major + 2 minor or 2 major + 0 minor
Diagnosis Anybody with Diagnosis of Probable Frail or Probable Pre-Frail with Positive IL6 Would Be Classified as Definite Frail or Pre-Frail Respectively If we can validate this new scale, it will help clinician and even paramedics to find out probable frail patient at
Impact Factor (JCC): 5.1064
Index Copernicus Value (ICV): 3.0
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Development of Simple Diagnostic Criteria for Frailty Syndrome in Indian Elderly Population
early stage to direct them to the Geriatrician for early intervention.
METHODOLOGY 1st Phase (Development of New Scale) During conceptualization of new scale initially we outlined the domain of new construct, did through literature review, took feedback from literate target group (frail patient), generation of item pool for the questionnaire then we formed a panel of expert to review the questionnaire and appropriate changes in the draft. Our panel of reviewer were experienced and qualified individuals or SME (subject matter expert). This Committee consist of geriatricians, public health consultants, clinical psychologist, nutritionist, occupational therapist, physiotherapist and statistician. Content Validity - Quantitative assessment was done by experts or the selected jurors. For computing the content validity, content validity ratio (CVR) is calculated. In this method, panels of SME’s go through the items of the questionnaire and indicate whether the individual items are essential for the theoretical construct of the scale, keeping the objectives of the study and the domains to be measured in mind. The experts rate the items as follows: Essential, Useful but not essential and Not essential. After receiving each expert’s ratings, the Content validity ratio (CVR) is calculated according to the formula developed by Lawshe et al. CVR= (Ne-N/2)/ (N/2), where CVR = Content validity ratio, Ne =number of experts rated an item as essential, N =Total no. of experts in the panel Calculated CVR are between 0.8- 1. So all the six parameter are acceptable statistically to develop the scale. In Phase Two After establishment of the content validity, an initial study will be done on 15 cases. Based on the result of the initial study, suitable amendments will be made in the questionnaire. Then a cross sectional study will be conducted in a rural village North India. Elderly people (≥ 65 years) of that village and surrounding 4-5 villages will be informed about the date and day of the assessment. After informing the participants about the purpose of the visit, following details will be collected. •
Socio-demographic details including age, sex, marital status, family type, living arrangements and religion, number of living children, educational qualification and occupation will be recorded. Socio-economic status will be assessed by Modified GB Prasad scale.11
•
Financial status concerning the current employment status, retirement benefits, pension and other sources of income. Various sources of income were computed together to arrive at a composite figure.
•
Study of health status will include: •
Medical records if available with the respondents will be scrutinized by a trained nurse to confirm medical conditions.
•
Details of vision, hearing, mood by Geriatric depression scale – short form (Hindi version)12,
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Chatterjee P, Kandel R, Desai G, Chellaiyan V G, Biswas A & Dey Ab
cognitive impairment by MINICOG sale
13
, activities of daily living (Barthel Activity of Daily Living)14,
Instrumental Activity of Daily Living (Lawton and Brody IADL)15, co-morbidities (self reported), current medication, h/o hospitalization in last one month, h/o fall in last one year, addiction, oral problems will be ascertained . •
Other than examining vitals and problem related systemic examination; gait speed (explained later), hand grip strength (by hand dynamometer), waist hip ratio will be assessed. The respondents will be asked about self reported quality of life.
•
ECG, Bone mineral density (g/cm2) was measured in the lumbar spine by dual energy x ray absorptiometry with a Lunar DPX densitometer (Lunar Radiation Corporation, Madison, Wisconsin, USA), spirometric analysis (MIR Spiro Lab III),random blood sugar (by gluco-meter Acucheck) will be done after obtaining informed consent.
•
IL-6 will be assessed in the serum of the participants. Blood was centrifuged 10 min after collection and separated serum or plasma was immediately frozen at -20 degrees C will be analyzed later by ELISA method.
•
Frailty will be assessed as per Linda Fried’s criteria as well as the Indian criteria for Frailty after excluding the following details•
Patient with acute illness
•
Severe obstructive airway disease (FEV1 < 30%)
•
Patient with severe painful upper limb and lower limb conditions,
•
Patient with severe cognitive impairment (MINICOG score 0) or severe depression (GDS >11). Table 3 Linda Fried’s Scale
Indian Criteria Major Slow gait speed
• •
Slow gait speed Hand grip strength: less than 2SD for age and BMI matched controls
•
Weight loss
Standing from chair without any support in 30 s: less than 2SD for age matched age and height
•
Self reported exhaustion regarding last week Low physical activity regarding last 3 months
Minor (Asking the patient (about last one month)
•
1kg arm lift for 30 s
Do you find that previously easy tasks are now difficult? Do you feel hopeless and helpless? "What has your appetite been like?" "Have you been eating less than usual? Essential criteria: Raised IL-6 level
To define normal gait speed in Indian population, 200 (Male: female =1:1) consenting healthy elderly individuals Impact Factor (JCC): 5.1064
Index Copernicus Value (ICV): 3.0
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Development of Simple Diagnostic Criteria for Frailty Syndrome in Indian Elderly Population
will be instructed to walk a distance of 4 metre in their normal pace. Because walking speed is strongly related to sex16, we will categorise it into sex dependent thirds to maintain balanced sample sizes in men and women (cut offs will be defined by tertiles of the distributions in men and women). For the Evaluation of the Gait-Speed then the participant will be asked to walk a distance of 4m on his/her usual pace. The time taken to travel this distance will be recorded and the gait speed will be calculated. The slowest 20% of the population will be defined at baseline, based on time to walk 4 metre, adjusting for gender and standing height. For the Evaluation of 1 kg Arm Lift - the study subject sits in a chair holding a 1 kg weight with the shoulder adducted, the elbow in full flexion and the forearm in supination (Figure 1). He/she is asked to lift the arm above the head until the elbow is fully extended for a period minimum of 30 seconds. Not being able to do this manoeuvre, qualifies the criteria.
Figure 2: 1 kg Arm Lift The ‘30 s Chair Stand’ Test The subject will be asked to stand upright from a chair with their arms folded across the chest, then to sit down again and then repeat the action at his/her own pace over a 30 s period (Figure 2). The height of the chair from the floor will be selected to be 16"-18" which was in accordance with the average height of Indian males 5 feet 6 inches and Indian females 5feet and 4 inches. (The thighs would be between 90-95 degrees to the upright body.) The final test score is the number of times that the subject rises to a full stand from the seated position with arms folded within 30 s. (Cut off will be < 2SD of age and sex matched healthy control).17
Figure 3: 30s Chair Rising Test Then patient will be given necessary medication or physiotherapy and for long term management patient will be referred to nearest primary, secondary or tertiary care hospital. After completing health camp at various economic and environmental varied rural elderly statistical analyses will be done by statistician.
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Chatterjee P, Kandel R, Desai G, Chellaiyan V G, Biswas A & Dey Ab
Ethics and Dissemination The
protocol
has
been
approved
by
the
Institutional
Ethics
Committee
of
AIIMS
with
the
Ref. No- IEC/NP-350/2012 for the project “Health profile of rural geriatric population in North India- A cross sectional study” Confidentially of the information gathered will be respected. Statistical Analysis Reliability of the new Indian scale would be evaluated by factor analysis (principal component extraction from a pool of items - used to identify items that may have scale coherence), Cronbach's alpha (evaluate scale consistency). Validity of the scale would be evaluated by concurrent validity (to what extent does the tool relate to other established and/or independent measures) and predictive validity (to what extent does a tool provide measurements that can be applied to predicting another measure or more importantly a specific behaviour or empirical outcome).
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