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Psychiatric hospital reform in low-income and middle-income countries Structured Individualised inTervention And Recovery (SITAR): a two-arm pragmatic randomised controlled trial study protocol.

ABSTRACT: INTRODUCTION:Low-income and middle-income settings like India have large treatment gaps in mental healthcare. People with severe mental disorders face impediments to their clinical and functional recovery, and have large unmet needs. The infrastructure and standards of care are poor in colonial period psychiatric hospitals, with no clear pathways to discharge and successfully integrate recovered individuals into the community. Our aim is to study the impact of psychiatric hospital reform on individual patient outcomes in a psychiatric hospital in India. METHODS AND ANALYSIS:Structured Individualised inTervention And Recovery (SITAR) is a two-arm pragmatic randomised controlled trial, focusing on patients aged 18-60 years with a hospital stay of 12-120 months and a primary diagnosis of psychosis. It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life. A computer-generated permuted block randomisation schedule will allocate recruited subjects to the two study arms. We aim to recruit 100 people into each trial arm. Baseline and outcome measures will be undertaken by trained researchers independent to the case managers providing the individual intervention. A health economic analysis will determine the costing of implementing the individually tailored recovery plan. ETHICS AND DISSEMINATION:The study will provide answers to important questions around the nature and process of reforms in institutional care that promote recovery while being cognizant of protecting human rights, and dignity. Ethical approval for SITAR was obtained from a registered ethics committee in India (Institutional Ethics Committee VikasAnvesh Foundation, VAF/2018-19/012 dated 6 December 2018) and the University of Warwick's Biomedical and Scientific Research Ethics Committee (REGO-2019-2332, dated 21 March 2019), and registered on the Central Trial Registry of India (CTRI/2019/01/017267). Trial results will be published in accordance to CONSORT guidelines.

SUBMITTER: Raja T

PROVIDER: S-EPMC7228526 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Psychiatric hospital reform in low-income and middle-income countries Structured Individualised inTervention And Recovery (SITAR): a two-arm pragmatic randomised controlled trial study protocol.

Raja Tasneem T Tuomainen Helena H Madan Jason J Mistry Dipesh D Jain Sanjeev S Singh Swaran S

BMJ open 20200505 5

<h4>Introduction</h4>Low-income and middle-income settings like India have large treatment gaps in mental healthcare. People with severe mental disorders face impediments to their clinical and functional recovery, and have large unmet needs. The infrastructure and standards of care are poor in colonial period psychiatric hospitals, with no clear pathways to discharge and successfully integrate recovered individuals into the community. Our aim is to study the impact of psychiatric hospital reform ...[more]

PMID: 32371518

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Project description:BackgroundSurgical site infection (SSI) is the most common postoperative complication worldwide. WHO guidelines to prevent SSI recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures, but called for assessment of both interventions in low-resource settings. This study aimed to test both interventions in low-income and middle-income countries.MethodsFALCON was a 2 × 2 factorial, randomised controlled trial stratified by whether surgery was clean-contaminated, or contaminated or dirty, including patients undergoing abdominal surgery with a skin incision of 5 cm or greater. This trial was undertaken in 54 hospitals in seven countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa). Patients were computer randomised 1:1:1:1 to: (1) 2% alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and non-coated suture, or (4) 10% aqueous povidone-iodine and triclosan-coated suture. Patients and outcome assessors were masked to intervention allocation. The primary outcome was SSI, reported by trained outcome assessors, and presented using adjusted relative risks and 95% CIs. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03700749.FindingsBetween Dec 10, 2018, and Sept 7, 2020, 5788 patients (3091 in clean-contaminated stratum, 2697 in contaminated or dirty stratum) were randomised (1446 to alcoholic chlorhexidine and non-coated suture, 1446 to alcoholic chlorhexidine and triclosan-coated suture, 1447 to aqueous povidone-iodine and non-coated suture, and 1449 to aqueous povidone-iodine and triclosan-coated suture). 14·0% (810/5788) of patients were children and 66·9% (3873/5788) had emergency surgery. The overall SSI rate was 22·0% (1163/5284; clean-contaminated stratum 15·5% [454/2923], contaminated or dirty stratum 30·0% [709/2361]). For both strata, there was no evidence of a difference in the risk of SSI with alcoholic chlorhexidine versus povidone-iodine (clean-contaminated stratum 15·3% [223/1455] vs 15·7% [231/1468], relative risk 0·97 [95% CI 0·82-1·14]; contaminated or dirty stratum 28·3% [338/1194] vs 31·8% [371/1167], relative risk 0·91 [95% CI 0·81-1·02]), or with triclosan-coated sutures versus non-coated sutures (clean-contaminated stratum 14·7% [215/1459] vs 16·3% [239/1464], relative risk 0·90 [95% CI 0·77-1·06]; contaminated or dirty stratum 29·4% [347/1181] vs 30·7% [362/1180], relative risk 0·98 [95% CI 0·87-1·10]). With both strata combined, there were no differences using alcoholic chlorhexidine or triclosan-coated sutures.InterpretationThis trial did not show benefit from 2% alcoholic chlorhexidine skin preparation compared with povidone-iodine, or with triclosan-coated sutures compared with non-coated sutures, in preventing SSI in clean-contaminated or contaminated or dirty surgical wounds. Both interventions are more expensive than alternatives, and these findings do not support recommendations for routine use.FundingNational Institute for Health Research (NIHR) Global Health Research Unit Grant, BD.

Project description:BackgroundThe expansion of childhood vaccination programs in low and middle income countries has been a substantial public health success story. Indicators of the performance of intervention programmes such as coverage levels and numbers covered are typically measured through national statistics or at the scale of large regions due to survey design, administrative convenience or operational limitations. These mask heterogeneities and 'coldspots' of low coverage that may allow diseases to persist, even if overall coverage is high. Hence, to decrease inequities and accelerate progress towards disease elimination goals, fine-scale variation in coverage should be better characterized.MethodsUsing measles as an example, cluster-level Demographic and Health Surveys (DHS) data were used to map vaccination coverage at 1?km spatial resolution in Cambodia, Mozambique and Nigeria for varying age-group categories of children under five years, using Bayesian geostatistical techniques built on a suite of publicly available geospatial covariates and implemented via Markov Chain Monte Carlo (MCMC) methods.ResultsMeasles vaccination coverage was found to be strongly predicted by just 4-5 covariates in geostatistical models, with remoteness consistently selected as a key variable. The output 1?×?1?km maps revealed significant heterogeneities within the three countries that were not captured using province-level summaries. Integration with population data showed that at the time of the surveys, few districts attained the 80% coverage, that is one component of the WHO Global Vaccine Action Plan 2020 targets.ConclusionThe elimination of vaccine-preventable diseases requires a strong evidence base to guide strategies and inform efficient use of limited resources. The approaches outlined here provide a route to moving beyond large area summaries of vaccination coverage that mask epidemiologically-important heterogeneities to detailed maps that capture subnational vulnerabilities. The output datasets are built on open data and methods, and in flexible format that can be aggregated to more operationally-relevant administrative unit levels.

Project description:BackgroundPsychiatric disorders are reported to be present in 80% to 90% of suicide deaths in high-income countries (HIC), but this association is less clear in low- and middle-income countries (LMIC). There has been no previous systematic review of this issue in LMIC. The current study aims to estimate the prevalence of psychiatric morbidity in individuals with suicidal behaviour in LMIC.Methods and findingsPubMed, PsycINFO, and EMBASE searches were conducted to identify quantitative research papers (any language) between 1990 and 2018 from LMIC that reported on the prevalence of psychiatric morbidity in suicidal behaviour. We used meta-analytic techniques to generate pooled estimates for any psychiatric disorder and specific diagnosis based on International classification of disease (ICD-10) criteria. A total of 112 studies (154 papers) from 26 LMIC (India: 25%, China: 15%, and other LMIC: 60%) were identified, including 18 non-English articles. They included 30,030 individuals with nonfatal suicidal behaviour and 4,996 individuals who had died by suicide. Of the 15 studies (5 LMIC) that scored highly on our quality assessment, prevalence estimates for psychiatric disorders ranged between 30% and 80% in suicide deaths and between 3% and 86% in those who engaged in nonfatal suicidal behaviour. There was substantial heterogeneity between study estimates. Fifty-eight percent (95% CI 46%-71%) of those who died by suicide and 45% (95% CI 30%-61%) of those who engaged in nonfatal suicidal behaviour had a psychiatric disorder. The most prevalent disorder in both fatal and nonfatal suicidal behaviour was mood disorder (25% and 21%, respectively). Schizophrenia and related disorders were identified in 8% (4%-12%) of those who died by suicide and 7% (3%-11%) of those who engaged in nonfatal suicidal behaviour. In nonfatal suicidal behaviour, anxiety disorders, and substance misuse were identified in 19% (1%-36%) and 11% (7%-16%) of individuals, respectively. This systematic review was limited by the low number of high-quality studies and restricting our searches to databases that mainly indexed English language journals.ConclusionsOur findings suggest a possible lower prevalence of psychiatric disorders in suicidal behaviour in LMIC. We found very few high-quality studies and high levels of heterogeneity in pooled estimates of psychiatric disorder, which could reflect differing study methods or real differences. There is a clear need for more robust evidence in order for LMIC to strike the right balance between community-based and mental health focussed interventions.

Project description:Background: Given the limited healthcare resources in low and middle income countries (LMICs), effective rehabilitation strategies that can be realistically adopted in such settings are required. Objective: A systematic review of literature was conducted to identify pragmatic solutions and outcomes capable of enhancing stroke recovery and quality of life of stroke survivors for low- and middle- income countries. Methods: PubMed, HINARI, and Directory of Open Access Journals databases were searched for published Randomized Controlled Trials (RCTs) till November 2018. Only completed trials published in English with non-pharmacological interventions on adult stroke survivors were included in the review while published protocols, pilot studies and feasibility analysis of trials were excluded. Obtained data were synthesized thematically and descriptively analyzed. Results: One thousand nine hundred and ninety six studies were identified while 347 (65.22% high quality) RCTs were found to be eligible for the review. The most commonly assessed variables (and outcome measure utility) were activities of daily living [75.79% of the studies, with Barthel Index (37.02%)], motor function [66.57%; with Fugl Meyer scale (71.88%)], and gait [31.12%; with 6 min walk test (38.67%)]. Majority of the innovatively high technology interventions such as robot therapy (95.24%), virtual reality (94.44%), transcranial direct current stimulation (78.95%), transcranial magnetic stimulation (88.0%) and functional electrical stimulation (85.00%) were conducted in high income countries. Several traditional and low-cost interventions such as constraint-induced movement therapy (CIMT), resistant and aerobic exercises (R&AE), task oriented therapy (TOT), body weight supported treadmill training (BWSTT) were reported to significantly contribute to the recovery of motor function, activity, participation, and improvement of quality of life after stroke. Conclusion: Several pragmatic, in terms of affordability, accessibility and utility, stroke rehabilitation solutions, and outcome measures that can be used in resource-limited settings were found to be effective in facilitating and enhancing post-stroke recovery and quality of life.

Dataset Information

Psychiatric hospital reform in low-income and middle-income countries Structured Individualised inTervention And Recovery (SITAR): a two-arm pragmatic randomised controlled trial study protocol.

Publications

Psychiatric hospital reform in low-income and middle-income countries Structured Individualised inTervention And Recovery (SITAR): a two-arm pragmatic randomised controlled trial study protocol.

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