Inclusion of participants from low-income and middle-income countries in core outcome sets development: a systematic review.
Ontology highlight
ABSTRACT:
SUBMITTER: Karumbi J
PROVIDER: S-EPMC8527127 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:INTRODUCTION:Sepsis is the leading cause of death in children worldwide and has recently been declared a major global health issue. New interventions and a concerted effort to enhance our understanding of sepsis are required to address the huge burden of disease, especially in low- and middle-income countries (LMIC) where it is highest. An opportunity therefore exists to ensure that ongoing research in this area is relevant to all stakeholders and is of consistently high quality. One method to address these issues is through the development of a core outcome set (COS). METHODS AND ANALYSIS:This study protocol outlines the phases in the development of a core outcome set for paediatric sepsis in LMIC. The first step involves performing a systematic review of all outcomes reported in the research of paediatric sepsis in low middle-income countries. A three-stage international Delphi process will then invite a broad range of participants to score each generated outcome for inclusion into the COS. This will include an initial two-step online survey and finally, a face-to-face consensus meeting where each outcome will be reviewed, voted on and ratified for inclusion into the COS. ETHICS AND DISSEMINATION:No core outcome sets exist for clinical trials in paediatric sepsis. This COS will serve to not only highlight the heavy burden of paediatric sepsis in this setting and aid collaboration and participation between all stakeholders, but to promote ongoing essential high quality and relevant research into the topic. A COS in paediatric sepsis in LMIC will advocate for a common language and facilitate interpretation of findings from a variety of settings. A waiver for ethics approval has been granted by University of British Columbia Children's and Women's Research Ethics Board.
| S-EPMC7245395 | biostudies-literature
Project description:IntroductionThe burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist. These are required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at preventing and treating multimorbidity in adults in LMICs.MethodsTo generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries. Consensus meetings were used to reach agreement on the two final COS.Registrationhttps://www.comet-initiative.org/Studies/Details/1580.ResultsThe systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention and 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) adverse events, (2) development of new comorbidity, (3) health risk behaviour and (4) quality of life; and four for the treatment COS: (1) adherence to treatment, (2) adverse events, (3) out-of-pocket expenditure and (4) quality of life.ConclusionFollowing established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs.Prospero registration numberCRD42020197293.
| S-EPMC11340216 | biostudies-literature
Project description:BackgroundOne way to achieve universal health coverage (UHC) in low- and middle-income countries (LMIC) is the implementation of health insurance schemes. A robust and up to date overview of empirical evidence assessing and substantiating health equity impact of health insurance schemes among specific vulnerable populations in LMICs beyond the more common parameters, such as income level, is lacking. We fill this gap by conducting a systematic review of how social inclusion affects access to equitable health financing arrangements in LMIC.MethodsWe searched 11 databases to identify peer-reviewed studies published in English between January 1995 and January 2018 that addressed the enrolment and impact of health insurance in LMIC for the following vulnerable groups: female-headed households, children with special needs, older adults, youth, ethnic minorities, migrants, and those with a disability or chronic illness. We assessed health insurance enrolment patterns of these population groups and its impact on health care utilization, financial protection, health outcomes and quality of care.ResultsThe comprehensive database search resulted in 44 studies, in which chronically ill were mostly reported (67%), followed by older adults (33%). Scarce and inconsistent evidence is available for individuals with disabilities, female-headed households, ethnic minorities and displaced populations, and no studies were yielded reporting on youth or children with special needs. Enrolment rates seemed higher among chronically ill and mixed or insufficient results are observed for the other groups. Most studies reporting on health care utilization found an increase in health care utilization for insured individuals with a disability or chronic illness and older adults. In general, health insurance schemes seemed to prevent catastrophic health expenditures to a certain extent. However, reimbursements rates were very low and vulnerable individuals had increased out of pocket payments.ConclusionDespite a sizeable literature published on health insurance, there is a dearth of good quality evidence, especially on equity and the inclusion of specific vulnerable groups in LMIC. Evidence should be strengthened within health care reform to achieve UHC, by redefining and assessing vulnerability as a multidimensional process and the investigation of mechanisms that are more context specific.
| S-EPMC6714392 | biostudies-literature
Project description:To review the current literature around the potential impact, effectiveness and perceptions of plain packaging in low income settings.A systematic review of the literature.9 databases (PubMed, Global Health, Social Policy and Practice, Applied Social Sciences Index and Abstracts (ASSIA), CINAHL, PsycINFO, British Library for Development Studies (BLDS), Global Health Library and Scopus) were searched. The terms used for searching combined terms for smoking and tobacco use with terms for plain packaging.Studies investigating the impact of plain packaging on the determinants of tobacco use, such as smoking behaviour, appeal, prominence, effectiveness of health warnings, response to plain packs, attitudes towards quitting or likelihood of smoking in low-income settings, were identified. Studies must have been published in English and be original research of any level of rigour.Two independent reviewers assessed studies for inclusion and extracted data.The results were synthesised qualitatively, with themes grouped under four key headings: appeal and attractiveness; salience of health warnings and perceptions of harm; enjoyment and perceived taste ratings; and perceptions of the impact on tobacco usage behaviour.This review has identified four articles that met the inclusion criteria. Studies identified that tobacco products in plain packaging had less appeal than in branded packaging in low-income settings.This review indicates that plain packaging appears to be successful in reducing appeal of smoking and packets, and supports the call for plain packaging to be widely implemented in conjunction with other tobacco control policies. However, there are considerable gaps in the amount of research conducted outside high-income countries.
| S-EPMC4809104 | biostudies-other
Project description:AimsTo identify and categorise core components of effective stigma reduction interventions in the field of mental health in low- and middle-income countries (LMICs) and compare these components across cultural contexts and between intervention characteristics.MethodsSeven databases were searched with a strategy including four categories of terms ('stigma', 'mental health', 'intervention' and 'low- and middle-income countries'). Additional methods included citation chaining of all papers identified for inclusion, consultation with experts and hand searching reference lists from other related reviews. Studies on interventions in LMICs aiming to reduce stigma related to mental health with a stigma-related outcome measure were included. All relevant intervention characteristics and components were extracted and a quality assessment was undertaken. A 'best fit' framework synthesis was used to organise data, followed by a narrative synthesis.ResultsFifty-six studies were included in this review, of which four were ineffective and analysed separately. A framework was developed which presents a new categorisation of stigma intervention components based on the included studies. Most interventions utilised multiple methods and of the 52 effective studies educational methods were used most frequently (n = 83), and both social contact (n = 8) and therapeutic methods (n = 3) were used infrequently. Most interventions (n = 42) based their intervention on medical knowledge, but a variety of other themes were addressed. All regions with LMICs were represented, but every region was dominated by studies from one country. Components varied between regions for most categories indicating variation between cultures, but only a minority of studies were developed in the local setting or culturally adapted.ConclusionsOur study suggests effective mental health stigma reduction interventions in LMICs have increased in quantity and quality over the past five years, and a wide variety of components have been utilised successfully - from creative methods to emphasis on recovery and strength of people with mental illness. Yet there is minimal mention of social contact, despite existing strong evidence for it. There is also a lack of robust research designs, a high number of short-term interventions and follow-up, nominal use of local expertise and the research is limited to a small number of LMICs. More research is needed to address these issues. Some congruity exists in components between cultures, but generally they vary widely. The review gives an in-depth overview of mental health stigma reduction core components, providing researchers in varied resource-poor settings additional knowledge to help with planning mental health stigma reduction interventions.
| S-EPMC7503169 | biostudies-literature
Project description:IntroductionThe rising incidence of mental illness and its impact on individuals, families, and societies is becoming a major public health concern, especially in resource-constrained countries. Consequently, there is an increasing demand for mental health services in many middle- and low-income countries (LMIC). Challenges such as inequality in access, lack of staff and hospital beds, and underfunding, often present in the LMIC, might in part be addressed by telemental health services. However, little is known about telemental health in the LMIC.MethodsA systematic review was performed, drawing on several electronic databases, including PubMed, PsycINFO, Web of Science, Springer Link, and Google Scholar. Original English language studies on the practice of telemental health in LMIC, involving patients and published between 1 January 2000 and 16 February 2017, were included.ResultsNineteen studies met the inclusion criteria. Most of the articles were recent, which may reflect an increasing focus on telemental health in the LMIC. Eight of these studies were from Asia. Eight of the studies were interventional/randomized controlled trials, and 11 examined general mental health issues. Videoconferencing was the most frequently (6) studied telemental modality. Other modalities studied were online decision support systems (3), text messaging and bibliotherapy (1), e-chatting combined with videoconferencing (1), online therapy (2), e-counseling (1), store-and-forward technology (1), telephone follow-up (1), online discussion groups (1), audiovisual therapy and bibliotherapy (1), and computerized occupational therapy (1). Although many of the studies showed that telemental services had positive outcomes, some studies reported no postintervention improvements.ConclusionThe review shows a rising trend in telemental activity in the LMIC. There is a greater need for telemental health in the LMIC, but more research is needed on empirical and theoretical aspects of telemental activity in the LMIC and on direct comparisons between telemental activity in the LMIC and the non-LMIC.
| S-EPMC6241375 | biostudies-literature
Project description:BackgroundPromotion of physical activity (PA) among populations is a global health investment. However, evidence on economic aspects of PA is sparse and scattered in low-income and middle-income countries (LMICs).ObjectiveThe objective of this study was to summarise the available evidence on economics of PA in LMICs, identify potential target variables for policy and report gaps in the existing economic evidence alongside research recommendations.Data sourcesA systematic review of the electronic databases (Scopus, Web of Science and SPORTDiscus) and grey literature.Study eligibility criteriaCost-of-illness studies, economic evaluations, interventions and descriptive studies on economic factors associated with PA using preset eligibility criteria.Study appraisal and synthesis of methodsScreening, study selection and quality appraisal based on standard checklists performed by two reviewers with consensus of a third reviewer. Descriptive synthesis of data was performed.ResultsThe majority of the studies were from upper-middle-income countries (n=16, 88.8%) and mainly from Brazil (n=9, 50%). Only one economic evaluation study was found. The focus of the reviewed literature spanned the economic burden of physical inactivity (n=4, 22%), relationship between PA and costs (n=6, 46%) and socioeconomic determinants of PA (n=7, 39%). The findings showed a considerable economic burden due to insufficient PA, with LMICs accounting for 75% of disability-adjusted life years (DALYs) globally due to insufficient PA. Socioeconomic correlates of PA were identified, and inverse relationship of PA with the cost of chronic diseases was established. Regular PA along with drug treatment as a treatment scheme for chronic diseases showed advantages with a cost-utility ratio of US$3.21/quality-adjusted life year (QALY) compared with the drug treatment-only group (US$3.92/QALY) by the only economic evaluation conducted in the LMIC, Brazil.LimitationsMeta-analysis was not performed due to heterogeneity of the studies.Conclusions and recommendationsEconomic evaluation studies for PA promotion interventions/strategies and local research from low-income countries are grossly inadequate. Setting economic research agenda in LMICs ought to be prioritised in those areas.Prospero registration numberCRD42018099856.
| S-EPMC7813307 | biostudies-literature
Project description:Harmonization of outcomes to be measured in clinical trials can reduce research waste and enhance research translation. One of the ways to standardize measurement is through development and use of core outcome sets (COS). There is limited involvement of low- and middle-income country (LMIC) stakeholders in COS development and use. This study explores the level of awareness and experiences of LMIC stakeholders in the development and use of COS. We conducted an online survey of LMIC stakeholders. Three existing COS (pre-eclampsia, COVID-19, palliative care) were presented as case scenarios, and respondents asked to state (with reason(s)) if they would or would not use the COS if they were working in that area. Quantitative data were analyzed descriptively while qualitative data were analyzed thematically. Of 81 respondents, 26 had COS experience, 9 of whom had been involved in COS development. Personal research interests and prevalence of disease are key drivers for initiation/participation in a given COS project. Most respondents would use the COS for pre-eclampsia (18/26) and COVID-19 (19/26) since the development process included key stakeholders. More than half of the respondents were not sure or would not use the palliative care COS as they felt stakeholder engagement was limited and it was developed for a different resource setting. Respondents reported that use of COS can be limited by (i) feasibility of measuring the outcomes in the COS, (ii) knowledge on the usefulness and availability of COS and (iii) lack of wide stakeholder engagement in the COS development process including having patients and carers in the development process. To ensure the development and use of COS in LMICs, collaborations are essential in awareness raising on COS utility, training, and COS development. The COS also needs to be made accessible in locally understandable languages and feasible to measure in LMICs.
| S-EPMC10697587 | biostudies-literature
Project description:Accessible and quality reproductive health services are critical for low- and middle-income countries (LMICs). After a decade of waning investment in family planning, interest and funding are growing once again. This article assesses whether introducing, removing, or changing user fees for contraception has an effect on contraceptive use. We conducted a search of 14 international databases. We included randomized controlled trials, interrupted-time series analyses, controlled before-and-after study designs, and cohort studies that reported contraception-related variables as an outcome and a change in the price of contraceptives as an intervention. Four studies were eligible but none was at low risk of bias overall. Most of these, as well as other studies not included in the present research, found that demand for contraception was not cost-sensitive. We could draw no robust summary of evidence, strongly suggesting that further research in this area is needed.
| S-EPMC5434817 | biostudies-other
Project description:ImportanceOveruse of surgical procedures is increasing around the world and harms both individuals and health care systems by using resources that could otherwise be allocated to addressing the underuse of effective health care interventions. In low- and middle-income countries (LMICs), there is some limited country-specific evidence showing that overuse of surgical procedures is increasing, at least for certain procedures.ObjectivesTo assess factors associated with, extent and consequences of, and potential solutions for low-value surgical procedures in LMICs.Evidence reviewWe searched 4 electronic databases (PubMed, Embase, PsycINFO, and Global Index Medicus) for studies published from database inception until April 27, 2022, with no restrictions on date or language. A combination of MeSH terms and free-text words about the overuse of surgical procedures was used. Studies examining the problem of overuse of surgical procedures in LMICs were included and categorized by major focus: the extent of overuse, associated factors, consequences, and solutions.FindingsOf 4276 unique records identified, 133 studies across 63 countries were included, reporting on more than 9.1 million surgical procedures (median per study, 894 [IQR, 97-4259]) and with more than 11.4 million participants (median per study, 989 [IQR, 257-6857]). Fourteen studies (10.5%) were multinational. Of the 119 studies (89.5%) originating from single countries, 69 (58.0%) were from upper-middle-income countries and 30 (25.2%) were from East Asia and the Pacific. Of the 42 studies (31.6%) reporting extent of overuse of surgical procedures, most (36 [85.7%]) reported on unnecessary cesarean delivery, with estimated rates in LMICs ranging from 12% to 81%. Evidence on other surgical procedures was limited and included abdominal and percutaneous cardiovascular surgical procedures. Consequences of low-value surgical procedures included harms and costs, such as an estimated US $3.29 billion annual cost of unnecessary cesarean deliveries in China. Associated factors included private financing, and solutions included social media campaigns and multifaceted interventions such as audits, feedback, and reminders.Conclusions and relevanceThis systematic review found growing evidence of overuse of surgical procedures in LMICs, which may generate significant harm and waste of limited resources; the majority of studies reporting overuse were about unnecessary cesarean delivery. Therefore, a better understanding of the problems in other surgical procedures and a robust evaluation of solutions are needed.
| S-EPMC10630901 | biostudies-literature