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Avoidable waste related to inadequate methods and incomplete reporting of interventions: a systematic review of randomized trials performed in Sub-Saharan Africa.

ABSTRACT: Randomized controlled trials (RCTs) are needed to improve health care in Sub-Saharan Africa (SSA). However, inadequate methods and incomplete reporting of interventions can prevent the transposition of research in practice which leads waste of research. The aim of this systematic review was to assess the avoidable waste in research related to inadequate methods and incomplete reporting of interventions in RCTs performed in SSA.We performed a methodological systematic review of RCTs performed in SSA and published between 1 January 2014 and 31 March 2015. We searched PubMed, the Cochrane library and the African Index Medicus to identify reports. We assessed the risk of bias using the Cochrane Risk of Bias tool, and for each risk of bias item, determined whether easy adjustments with no or minor cost could change the domain to low risk of bias. The reporting of interventions was assessed by using standardized checklists based on the Consolidated Standards for Reporting Trials, and core items of the Template for Intervention Description and Replication. Corresponding authors of reports with incomplete reporting of interventions were contacted to obtain additional information. Data were descriptively analyzed.Among 121 RCTs selected, 74 (61%) evaluated pharmacological treatments (PTs), including drugs and nutritional supplements; and 47 (39%) nonpharmacological treatments (NPTs) (40 participative interventions, 1 surgical procedure, 3 medical devices and 3 therapeutic strategies). Overall, the randomization sequence was adequately generated in 76 reports (62%) and the intervention allocation concealed in 48 (39%). The primary outcome was described as blinded in 46 reports (38%), and incomplete outcome data were adequately addressed in 78 (64%). Applying easy methodological adjustments with no or minor additional cost to trials with at least one domain at high risk of bias could have reduced the number of domains at high risk for 24 RCTs (19%). Interventions were completely reported for 73/121 (60%) RCTs: 51/74 (68%) of PTs and 22/47 (46%) of NPTs. Additional information was obtained from corresponding authors for 11/48 reports (22%).Inadequate methods and incomplete reporting of published SSA RCTs could be improved by easy and inexpensive methodological adjustments and adherence to reporting guidelines.

SUBMITTER: Ndounga Diakou LA

PROVIDER: S-EPMC5497345 | biostudies-other | 2017 Jul

REPOSITORIES: biostudies-other

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Avoidable waste related to inadequate methods and incomplete reporting of interventions: a systematic review of randomized trials performed in Sub-Saharan Africa.

Ndounga Diakou Lee Aymar LA Ntoumi Francine F Ravaud Philippe P Boutron Isabelle I

Trials 20170705 1

<h4>Background</h4>Randomized controlled trials (RCTs) are needed to improve health care in Sub-Saharan Africa (SSA). However, inadequate methods and incomplete reporting of interventions can prevent the transposition of research in practice which leads waste of research. The aim of this systematic review was to assess the avoidable waste in research related to inadequate methods and incomplete reporting of interventions in RCTs performed in SSA.<h4>Methods</h4>We performed a methodological syst ...[more]

PMID: 28676066

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Project description:Sub-Saharan Africa represents 69% of the total number of individuals living with HIV infection worldwide and 72% of AIDS deaths globally. Pulmonary infection is a common and frequently fatal complication, though little is known regarding the lower airway microbiome composition of this population. Our objectives were to characterize the lower airway microbiome of Ugandan HIV-infected patients with pneumonia, to determine relationships with demographic, clinical, immunological, and microbiological variables and to compare the composition and predicted metagenome of these communities to a comparable cohort of patients in the US (San Francisco). Bronchoalveolar lavage samples from a cohort of 60 Ugandan HIV-infected patients with acute pneumonia were collected. Amplified 16S ribosomal RNA was profiled and aforementioned relationships examined. Ugandan airway microbiome composition and predicted metagenomic function were compared to US HIV-infected pneumonia patients. Among the most common bacterial pulmonary pathogens, Pseudomonas aeruginosa was most prevalent in the Ugandan cohort. Patients with a richer and more diverse airway microbiome exhibited lower bacterial burden, enrichment of members of the Lachnospiraceae and sulfur-reducing bacteria and reduced expression of TNF-alpha and matrix metalloproteinase-9. Compared to San Franciscan patients, Ugandan airway microbiome were significantly richer, and compositionally distinct with predicted metagenomes that encoded a multitude of distinct pathogenic pathways e.g secretion systems. Ugandan pneumonia-associated airway microbiome is compositionally and functionally distinct from those detected in comparable patients in developed countries, a feature which may contribute to adverse outcomes in this population. Please note that the data from the comparable cohort of patients in the USUS data was published as supplemental material of PMID: 22760045 but not submitted to GEO The 'patient_info.txt' contains 12 clinical, 7 immunological and 3 microbiological variables for each patient.

Project description:ObjectiveTo assess the waste of research related to inadequate methods in trials included in Cochrane reviews and to examine to what extent this waste could be avoided. A secondary objective was to perform a simulation study to re-estimate this avoidable waste if all trials were adequately reported.DesignMethodological review and simulation study.Data sourcesTrials included in the meta-analysis of the primary outcome of Cochrane reviews published between April 2012 and March 2013.Data extraction and synthesisWe collected the risk of bias assessment made by the review authors for each trial. For a random sample of 200 trials with at least one domain at high risk of bias, we re-assessed risk of bias and identified all related methodological problems. For each problem, possible adjustments were proposed that were then validated by an expert panel also evaluating their feasibility (easy or not) and cost. Avoidable waste was defined as trials with at least one domain at high risk of bias for which easy adjustments with no or minor cost could change all domains to low risk. In the simulation study, after extrapolating our re-assessment of risk of bias to all trials, we considered each domain rated as unclear risk of bias as missing data and used multiple imputations to determine whether they were at high or low risk.ResultsOf 1286 trials from 205 meta-analyses, 556 (43%) had at least one domain at high risk of bias. Among the sample of 200 of these trials, 142 were confirmed as high risk; in these, we identified 25 types of methodological problem. Adjustments were possible in 136 trials (96%). Easy adjustments with no or minor cost could be applied in 71 trials (50%), resulting in 17 trials (12%) changing to low risk for all domains. So the avoidable waste represented 12% (95% CI 7% to 18%) of trials with at least one domain at high risk. After correcting for incomplete reporting, avoidable waste due to inadequate methods was estimated at 42% (95% CI 36% to 49%).ConclusionsAn important burden of wasted research is related to inadequate methods. This waste could be partly avoided by simple and inexpensive adjustments.

Project description:BackgroundCommunity-based interventions are increasingly being implemented in Sub-Saharan Africa (SSA) for stillbirth prevention, but the nature of these interventions, their reporting and acceptability are poorly assessed. In addition to understanding their effectiveness, complete reporting of the methods, results and intervention acceptability is essential as it could potentially reduce research waste from replication of inadequately implemented and unacceptable interventions. We conducted a systematic review to investigate these aspects of community-based interventions for preventing stillbirths in SSA.MethodsIn this systematic review, eight databases (MEDLINE(OvidSP), Embase (OvidSP), Cochrane Central Register of Controlled Trials, Global Health, Science Citation Index and Social Science Citation index (Web of Science Core Collection), CINAHL (EBSCOhost) and Global Index Medicus) and four grey literature sources were searched from January 1, 2000 to July 7, 2023 for relevant quantitative and qualitative studies from SSA (PROSPERO-CRD42021296623). Following deduplication, abstract screening and full-text review, studies were included if the interventions were community-based with or without a health facility component. The main outcomes were types of community-based interventions, completeness of intervention reporting using the TIDier (Template for Intervention Description and replication) checklist, and themes related to intervention acceptability identified using a theoretical framework. Study quality was assessed using the Cochrane risk of bias and National Heart, Lung and Blood Institute's tools.FindingsThirty-nine reports from thirty-four studies conducted in 18 SSA countries were eligible for inclusion. Four types of interventions were identified: nutritional, infection prevention, access to skilled childbirth attendants and health knowledge/behaviour of women. These interventions were implemented using nine strategies: mHealth (defined as the use of mobile and wireless technologies to support the achievement of health objectives), women's groups, community midwifery, home visits, mass media sensitisation, traditional birth attendant and community volunteer training, community mobilisation and transport vouchers. The completeness of reporting using the TIDier checklist varied across studies with a very low proportion of the included studies reporting the intervention intensity, dosing, tailoring and modification. The quality of the included studies were graded as poor (n = 6), fair (n = 14) and good (n = 18). Though interventions were acceptable, only 4 (out of 7) studies explored women's perceptions, mostly focusing on perceived intervention effects and how they felt, omitting key constructs like ethicality, opportunity cost and burden of participation.InterpretationDifferent community-based interventions have been tried and evaluated for stillbirth prevention in SSA. The reproducibility and implementation scale-up of these interventions may be limited by incomplete intervention descriptions in the published literature. To strengthen impact, it is crucial to holistically explore the acceptability of these interventions among women and their families.FundingClarendon/Balliol/NDPH DPhil scholarship for UGA. MN is funded by a Medical Research Council Transition Support Award (MR/W029294/1).

Project description:BackgroundPoorly managed animal faecal waste can result in detrimental environmental and public health implications. Limiting human exposure to animal waste through Animal inclusive Water Sanitation and Hygiene (A-WASH) strategies is imperative to improve public health in livestock keeping households but has received little attention to date. A small number of A-WASH interventions have previously been identified through a systematic review by another research team, and published in 2017. To inform intervention design with the most up-to-date information, a scoping study was conducted to map the existing evidence for A-WASH in sub-Saharan Africa (SSA) emerging since the previous review.MethodsThis review followed PRISMA guidelines to identify interventions in SSA published between January 2016 to October 2022. Databases searched included PubMed, PMC Europe, CabDirect and Web of Science. Studies were eligible for inclusion if they were written in English and documented interventions limiting human contact with animal faecal material in the SSA context. Key data extracted included: the intervention itself, its target population, cost, measure of effectiveness, quantification of effect, assessment of success, acceptability and limitations. These data were synthesized into a narrative, structured around the intervention type.FindingsEight eligible articles were identified. Interventions to reduce human exposure to animal faecal matter were conducted in combination with 'standard' human-centric WASH practices. Identified interventions included the management of human-animal co-habitation, educational programs and the creation of child-safe spaces. No novel A-WASH interventions were identified in this review, beyond those identified by the review in 2017. Randomised Controlled Trials (RCTs) were used to evaluate six of the eight identified interventions, but as effect was evaluated through various measures, the ability to formally compare efficacy of interventions is lacking.ConclusionThis study indicates that the number of A-WASH studies in SSA is increasing and the use of RCTs suggests a strong desire to create high-quality evidence within this field. There is a need for standardisation of effect measures to enable meta-analyses to be conducted to better understand intervention effectiveness. Evaluation of scalability and sustainability of interventions is still lacking in A - WASH research.

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Avoidable waste related to inadequate methods and incomplete reporting of interventions: a systematic review of randomized trials performed in Sub-Saharan Africa.

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Avoidable waste related to inadequate methods and incomplete reporting of interventions: a systematic review of randomized trials performed in Sub-Saharan Africa.

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