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ObjectiveThere is sparse data on the prevalence of frailty from rural parts of India. Our aim was to estimate prevalence of frailty among community-dwelling older people in rural South Indian population and explore socio-demographic factors associated with frailty. We further explored the associations between frailty with fear of falling and falls.DesignCommunity based cross-sectional study.SettingFour villages in Thanjavur district of Southern India.ParticipantsRandom sample of adults aged 60 years and above from four villages.MethodsWe sampled community-dwelling older adults from the electoral list of four villages using stratified random sampling. We report prevalence of frailty as defined by physical definition (Fried’s Phenotype), accumulation of deficits (Frailty Index) and multi-domain definition (Tilburg Frailty Indicator). We report proportion of agreement of frailty status between the frailty tools. We used logistic regressions with robust SEs to examine the associations between socio-demographic determinants with frailty and the association between frailty with fear of falling and falls.ResultsAmong the 408 participants, the weighted (non-response and poststratification for sex) prevalence and 95% CI of frailty was 28% (18.9 to 28.1) for physical definition, 59% (53.9 to 64.3) for accumulation of deficits and 63% (57.4 to 67.6) for multi-domain definition. Frailty Index and Tilburg Frailty Indicator had good agreement (80%). Age, female, lower education, lower socioeconomic status, minimum physical activity in routine work were independently associated with frailty irrespective of the frailty definitions. Frail elderly had higher odds of falls as well as fear of falling compared with non-frail, irrespective of the definitions.ConclusionPrevalence of frailty among older people in rural Thanjavur district of South India was high compared with low-income and middle-income countries. Understanding the modifiable determinants of frailty can provide a valuable reference for future prevention and intervention.

Most randomized controlled trials (RCTs) and meta-analyses of RCTs examine effect modification (also called a subgroup effect or interaction), in which the effect of an intervention varies by another variable (e.g., age or disease severity). Assessing the credibility of an apparent effect modification presents challenges; therefore, we developed the Instrument for assessing the Credibility of Effect Modification Analyses (ICEMAN). To develop ICEMAN, we established a detailed concept; identified candidate credibility considerations in a systematic survey of the literature; together with experts, performed a consensus study to identify key considerations and develop them into instrument items; and refined the instrument based on feedback from trial investigators, systematic review authors and journal editors, who applied drafts of ICEMAN to published claims of effect modification. The final instrument consists of a set of preliminary considerations, core questions (5 for RCTs, 8 for meta-analyses) with 4 response options, 1 optional item for additional considerations and a rating of credibility on a visual analogue scale ranging from very low to high. An accompanying manual provides rationales, detailed instructions and examples from the literature. Seventeen potential users tested ICEMAN; their suggestions improved the user-friendliness of the instrument. The Instrument for assessing the Credibility of Effect Modification Analyses offers explicit guidance for investigators, systematic reviewers, journal editors and others considering making a claim of effect modification or interpreting a claim made by others.

The safety and efficacy of convalescent plasma in severe coronavirus disease 2019 (COVID-19) remain uncertain. To support a guideline on COVID-19 management, we conducted a systematic review and meta-analysis of convalescent plasma in COVID-19 and other severe respiratory viral infections. In March 2020, we searched international and Chinese biomedical literature databases, clinical trial registries and prepublication sources for randomized controlled trials (RCTs) and nonrandomized studies comparing patients receiving and not receiving convalescent plasma. We included patients with acute coronavirus, influenza and Ebola virus infections. We conducted a meta-analysis using random-effects models and assessed the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Of 1099 unique records, 6 studies were eligible, and none of these included patients with COVID-19. One nonrandomized study (n = 40) on convalescent plasma in severe acute respiratory syndrome coronavirus (SARS-CoV) provided uninformative results regarding mortality (relative risk [RR] 0.10, 95% confidence interval [CI] CI 0.01 to 1.70). Pooled estimates from 4 RCTs on influenza (n = 572) showed no convincing effects on deaths (4 RCTs, RR 0.94, 95% CI 0.49 to 1.81), complete recovery (2 RCTs, odds ratio 1.04, 95% CI 0.69 to 1.64) or length of stay (3 RCTs, mean difference −1.62, 95% CI −3.82 to 0.58, d). The quality of evidence was very low for all efficacy outcomes. Convalescent plasma caused few or no serious adverse events in influenza RCTs (RR 0.85, 95% CI 0.56 to 1.29, low-quality evidence). Studies of non-COVID-19 severe respiratory viral infections provide indirect, very low-quality evidence that raises the possibility that convalescent plasma has minimal or no benefit in the treatment of COVID-19 and low-quality evidence that it does not cause serious adverse events.

AbstractObjectiveTo develop an instrument to evaluate the credibility of anchor based minimal important differences (MIDs) for outcome measures reported by patients, and to assess the reliability of the instrument.DesignInstrument development and reliability study.Data sourcesInitial criteria were developed for evaluating the credibility of anchor based MIDs based on a literature review (Medline, Embase, CINAHL, and PsycInfo databases) and the experience of the authors in the methodology for estimation of MIDs. Iterative discussions by the team and pilot testing with experts and potential users facilitated the development of the final instrument.ParticipantsWith the newly developed instrument, pairs of masters, doctoral, or postdoctoral students with a background in health research methodology independently evaluated the credibility of a sample of MID estimates.Main outcome measuresCore credibility criteria applicable to all anchor types, additional criteria for transition rating anchors, and inter-rater reliability coefficients were determined.ResultsThe credibility instrument has five core criteria: the anchor is rated by the patient; the anchor is interpretable and relevant to the patient; the MID estimate is precise; the correlation between the anchor and the outcome measure reported by the patient is satisfactory; and the authors select a threshold on the anchor that reflects a small but important difference. The additional criteria for transition rating anchors are: the time elapsed between baseline and follow-up measurement for estimation of the MID is optimal; and the correlations of the transition rating with the baseline, follow-up, and change score in the patient reported outcome measures are satisfactory. Inter-rater reliability coefficients (ĸ) for the core criteria and for one item from the additional criteria ranged from 0.70 to 0.94. Reporting issues prevented the evaluation of the reliability of the three other additional criteria for the transition rating anchors.ConclusionsResearchers, clinicians, and healthcare policy decision makers can consider using this instrument to evaluate the design, conduct, and analysis of studies estimating anchor based minimal important differences.

ObjectivesFew studies have examined frailty in Indian adults, despite an increasing population of older adults and an escalating burden of chronic diseases. We aimed to study the prevalence and correlates of frailty in middle-aged and older Indian adults.SettingCross-sectional data from Wave 1 of Longitudinal Ageing Study in India, conducted in 2017–2018 across all states and union territories, were used.ParticipantsThe final analytical sample included 57 649 participants aged 45 years and above who had information on frailty status.Primary outcome measureThe deficits accumulation approach to measuring frailty was employed, creating a frailty index between 0 and 1, based on 40 deficits. Individuals with a frailty index of 0.25 or more were defined as ‘frail’.ResultsPrevalence of frailty among 45+ adults was 30%. 60+ women were two times as likely to be frail compared with 60+ men, after adjusting for a wide range of sociodemographic, economic and lifestyle factors. The sex difference was more pronounced in adults aged 45–59 years. Odds of hospitalisation in the last 12 months, and having falls in the past 2 years, were two times as high in frail adults compared with non-frail adults. Frail middle-aged and older adults had 33% and 39% higher odds, respectively, of having poor cognition than non-frail adults. The relative increase was higher in women for all three outcomes, although not statistically significant.ConclusionsThere needs to be careful consideration of sex differences when addressing frailty, particularly for optimising frailty interventions. Frailty, although typically assessed in older adults, was shown in this study to be also prevalent and associated with adverse outcomes in middle-aged Indian adults. More research into assessment of frailty in younger populations, its trajectory and correlates may help develop public health measures for prevention of frailty.

Cement dust is a significant source of occupational exposure affecting lung function and respiratory health. A higher burden of respiratory morbidity is known among factory workers involved in cement production. Globally or from India, there are no estimates of this burden from informal workers exposed to cement dust. To assess difference in lung function and respiratory symptoms among informal workers exposed to cement and those unexposed, using a comparative community based cross-sectional study from purposively selected areas in Delhi, India. Using a portable spirometer we measured lung function and collected respiratory symptoms from conveniently sampled informal workers (n = 100) exposed to cement dust, 50 indoor informal workers (tailors), and 50 outdoor (vegetable) vendors. Regression analyses were performed to compare respiratory symptom score and lung function parameters, adjusted for age, body mass index, smoking, socioeconomic status, and years of occupational exposure. Exposed workers had significantly lower lung function (PEF = -750 ml/s and -810 ml/s and FEV1/FVC (%) = -3.87 and -2.11) compared to indoor and outdoor groups, with three times higher chronic respiratory symptoms when compared to the unexposed groups. The cement dust exposure was observed to be associated with PEF (mean difference (MD) = -0.75L, 95%CI = -1.36 to -0.15, p = 0.01), %FEV1/FVC (MD = -3.87, 95%CI = -6.77 to -0.96, p = 0.03) and respiratory symptoms (p < 0.001). This study generates evidence regarding the respiratory burden of occupational exposure among vulnerable informal workers. There is an urgent need for policy reforms to safeguard health from occupational exposures, especially among informal workers.

The objective of the study was to develop an inventory summarizing all anchor-based minimal important difference (MID) estimates for patient-reported outcome measures (PROMs) available in the medical literature. We searched MEDLINE, EMBASE, CINAHL, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database internal library (January 1989–October 2018). We included primary studies empirically calculating an anchor-based MID estimate for any PROM in adults and adolescents. Pairs of reviewers independently screened and selected studies, extracted data, and evaluated the credibility of the MIDs. We identified 585 eligible studies, the majority conducted in Europe (n = 211) and North America (n = 179), reporting 5,324 MID estimates for 526 distinct PROMs. Investigators conducted their studies in the context of patients receiving surgical (n = 105, 18%), pharmacological (n = 85, 15%), rehabilitation (n = 65, 11%), or a combination of interventions (n = 194, 33%). Of all MID estimates, 59% (n = 3,131) used a global rating of change anchor. Major credibility limitations included weak correlation (n = 1,246, 23%) or no information regarding the correlation (n = 3,498, 66%) between the PROM and anchor and imprecision in the MID estimate (n = 2,513, 47%). A large number of MIDs for assisting in the interpretation of PROMs exist. The MID inventory will facilitate the use of MID estimates to inform the interpretation of the magnitude of treatment effects in clinical research and guideline development.

IntroductionMonitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.Methods and analysisConsecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.Ethics and disseminationThe protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.Trial registration numberCTRI/2024/06/068838.

Successful post-knee replacement rehabilitation requires adequate access to health information, social support, and periodic monitoring by a health professional. Mobile health (mHealth) and computer-based technologies are used for rehabilitation and remote monitoring. The extent of technology use and its function in post-knee replacement rehabilitation care in low and middle-income settings are unknown. To inform future mHealth intervention development, we conducted a scoping review to map the features and functionality of existing technologies and determine users' perspectives on telerehabilitation and technology for self-management. We followed the Joanna Briggs Institute methodology for scoping reviews. We searched the Embase, Medline, PsycINFO via OVID, and Cochrane Central Register of Controlled Trials databases for manuscripts published from 2001 onward. We included original research articles reporting the use of mobile or computer-based technologies by patients, health care providers, researchers, or family members. Studies were divided into the following 3 categories based on the purpose: validation studies, clinical evaluation, and end user feedback. We extracted general information on study design, technology features, proposed function, and perspectives of health care providers and patients. The protocol for this review is accessible in the Open Science Framework. Of the 5960 articles, 158 that reported from high-income settings contributed to the qualitative summary (64 studies on mHealth or telerehabilitation programs, 28 validation studies, 38 studies describing users' perceptions). The highest numbers of studies were from Europe or the United Kingdom and North America regarding the use of a mobile app with or without wearables and reported mainly in the last decade. No studies were from low and middle-income settings. The primary functions of technology for remote rehabilitation were education to aid recovery and enable regular, appropriate exercises; monitoring progress of pain (n=19), activity (n=20), and exercise adherence (n=30); 1 or 2-way communication with health care professionals to facilitate the continuum of care (n=51); and goal setting (n=23). Assessment of range of motion (n=16) and gait analysis (n=10) were the commonly validated technologies developed to incorporate into a future rehabilitation program. Few studies (n=14) reported end user involvement during the development stage. We summarized the reasons for satisfaction and dissatisfaction among users across various technologies. Several existing mobile and computer-based technologies facilitate post-knee replacement rehabilitation care for patients and health care providers. However, they are limited to high-income settings and may not be extrapolated to low-income settings. A systematic needs assessment of patients undergoing knee replacement and health care providers involved in rehabilitation, involving end users at all stages of development and evaluation, with clear reporting of the development and clinical evaluation can make post-knee replacement rehabilitation care in resource-poor settings accessible and cost-effective.

Background The steep increase in knee arthroplasties in lower- and middle-income countries has increased demand for personalised rehabilitation care. Technology-based rehabilitation programs offer potential to replace or augment conventional face-to-face rehabilitation for providing continuum of care. We aimed to systematically develop a theory, evidence-driven, contextualised, and user-centred mobile health platform for people undergoing knee arthroplasty to facilitate monitoring progress during rehabilitation. Methods We followed the UK Medical Research Council’s framework and adopted a behaviour design thinking approach, consisting of five steps; (1) conduct multiple literature reviews and cross-sectional surveys to determine the needs and problems experienced during the rehabilitation phase by healthcare professionals and individuals with replaced knees, (2) identify target behaviours along with barriers and facilitators, integrated within the Capability, Opportunity, Motivation-Behaviour (COM-B) framework, (3) identify intervention functions and components, behaviour change techniques, and features for the mobile application, selected after discussions with orthopaedic surgeons, physiotherapists and behavioural experts, (4) develop a prototype application for end-users, and a web-based platform for healthcare professionals, and (5) pilot test the intervention for end-users’ feedback on usability of the application and to identify possible strategies for implementing the intervention package. Results Using the COM-B model, education, training, persuasion, enablement, and modelling were chosen as intervention functions for improving adherence to exercise protocol during early-phase of rehabilitation. The application featured five interlinked components; education, training, goal setting and self-management, communication, and a personalized therapy plan utilising 13 behaviour change techniques. An education booklet, exercise videos, text messaging, video consultation, and a digital tool for measuring range of motion were incorporated into the application. Feedback on the interactive prototype and education material was sought from ten patient volunteers and a physiotherapist. Pilot testing in a convenient sample with broad eligibility criteria ( n  = 30) indicated importance of digital literacy and dedicated time for remote consultation by healthcare provider within the existing clinical work. Overall, the intervention was well received and valued by the end users. Conclusion This paper demonstrates the development of a contextualised digital behavioural intervention grounded in behavioural theory and evidence from literature to improve end-user’s engagement with rehabilitation protocols after knee arthroplasty in lower- and middle-income country context. Trial registration Study registered prospectively (on 16 February 2023) at Clinical Trials Registry of India (CTRI/2023/02/049792).