Dataset Information

The Landscape of Randomised Controlled Trials of Therapies in Breast Cancer in Low and Middle Income Countries.

ABSTRACT: Objectives. The objectives of this study were to identify the randomised controlled trials in breast cancer occurring in low and middle income countries (LMICs) generally and within Sub-Saharan Africa specifically, to describe the current status and identify opportunities for further research in these areas. Materials and Methods. Data for this study were obtained from ClinicalTrials.gov. The search term "Breast Cancer Research" was used, and relevant information extracted and analysed. Results. 2414 trials were identified, of which 1099 were eligible for inclusion. 69 of these trials occurred in LMICs. Of the 52 LMICs globally, 30% were participating in breast cancer research. Of the 17 LMICs in Africa, 77% are situated in Sub-Saharan Africa; 23% were participating in breast cancer research, which accounted for 9% of total Sub-Saharan African studies. Conclusion. This study provides current evidence for the need for breast cancer research in LMICs globally and within Sub-Saharan Africa. Within LMIC regions where research is active, the type and numbers of studies are unevenly distributed. High quality research within such areas should be encouraged as the results may have both local and global applications, particularly in the provision of affordable health care.

SUBMITTER: Lynch-Kelly K

PROVIDER: S-EPMC5401736 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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The Landscape of Randomised Controlled Trials of Therapies in Breast Cancer in Low and Middle Income Countries.

Lynch-Kelly Katharine K Singer Matthew M Williams Norman R NR

International journal of breast cancer 20170409

<i>Objectives</i>. The objectives of this study were to identify the randomised controlled trials in breast cancer occurring in low and middle income countries (LMICs) generally and within Sub-Saharan Africa specifically, to describe the current status and identify opportunities for further research in these areas. <i>Materials and Methods</i>. Data for this study were obtained from ClinicalTrials.gov. The search term "Breast Cancer Research" was used, and relevant information extracted and anal ...[more]

PMID: 28487775

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Project description:ObjectiveTo evaluate evidence from published randomised controlled trials (RCTs) for the use of task-shifting strategies for cardiovascular disease (CVD) risk reduction in low-income and middle-income countries (LMICs).DesignSystematic review of RCTs that utilised a task-shifting strategy in the management of CVD in LMICs.Data sourcesWe searched the following databases for relevant RCTs: PubMed from the 1940s, EMBASE from 1974, Global Health from 1910, Ovid Health Star from 1966, Web of Knowledge from 1900, Scopus from 1823, CINAHL from 1937 and RCTs from ClinicalTrials.gov.Eligibility criteria for selecting studiesWe focused on RCTs published in English, but without publication year. We included RCTs in which the intervention used task shifting (non-physician healthcare workers involved in prescribing of medications, treatment and/or medical testing) and non-physician healthcare providers in the management of CV risk factors and diseases (hypertension, diabetes, hyperlipidaemia, stroke, coronary artery disease or heart failure), as well as RCTs that were conducted in LMICs. We excluded studies that are not RCTs.ResultsOf the 2771 articles identified, only three met the predefined criteria. All three trials were conducted in practice-based settings among patients with hypertension (2 studies) and diabetes (1 study), with one study also incorporating home visits. The duration of the studies ranged from 3 to 12 months, and the task-shifting strategies included provision of medication prescriptions by nurses, community health workers and pharmacists and telephone follow-up posthospital discharge. Both hypertension studies reported a significant mean blood pressure reduction (2/1 mm Hg and 30/15 mm Hg), and the diabetes trial reported a reduction in the glycated haemoglobin levels of 1.87%.ConclusionsThere is a dearth of evidence on the implementation of task-shifting strategies to reduce the burden of CVD in LMICs. Effective task-shifting interventions targeted at reducing the global CVD epidemic in LMICs are urgently needed.

Project description:ObjectivesTo assess the effectiveness of cardiac rehabilitation (CR) in low- and middle-income countries (LMICs), given previous reviews have included scant trials from these settings and the great need there.MethodsSix electronic databases (PubMed, Medline, Embase, CINAHL, Cochrane Library, and APA PsycINFO) were searched from inception-May 2020. Randomised controlled CR (i.e., at least initial assessment and structured exercise; any setting; some Phase II) trials with any clinical outcomes (e.g., mortality and morbidity, functional capacity, risk factor control and psychosocial well-being) or cost, with usual care (UC) control or active comparison (AC), in acute coronary syndrome with or without revascularization or heart failure patients in LMICs were included. With regard to data extraction and data synthesis, two reviewers independently vetted identified citations and extracted data from included trials; Risk of bias was assessed using Cochrane's tool. Certainty of evidence was ascertained based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. A random-effects model was used to calculate weighted mean differences and 95% confidence intervals (CI).ResultsTwenty-six trials (6380 participants; 16.9% female; median follow-up = 3 months) were included. CR meaningfully improved functional capacity (VO2peak vs UC: 5 trials; mean difference [MD] = 3.13 ml/kg/min, 95% CI = 2.61 to 3.65; I2 = 9.0%); moderate-quality evidence), systolic blood pressure (vs UC: MD = -5.29 mmHg, 95% CI = -8.12 to -2.46; I2 = 45%; low-quality evidence), low-density lipoprotein cholesterol (vs UC: MD = -16.55 mg/dl, 95% CI = -29.97 to -3.14; I2 = 74%; very low-quality evidence), body mass index (vs AC: MD = -0.84 kg/m2, 95% CI = -1.61 to -0.07; moderate-quality evidence; I2 = 0%), and quality of life (QoL; vs UC; SF-12/36 physical: MD = 6.05, 95% CI = 1.77 to 10.34; I2 = 93%, low-quality evidence; mental: MD = 5.38, 95% CI = 1.13 to 9.63; I2 = 84%; low-quality evidence), among others. There were no evidence of effects on mortality or morbidity. Qualitative analyses revealed CR was associated with lower percutaneous coronary intervention, myocardial infarction, better cardiovascular function, and biomarkers, as well as return to life roles; there were other non-significant effects. Two studies reported low cost of home-based CR.ConclusionsLow to moderate-certainty evidence establishes CR as delivered in LMICs improves functional capacity, risk factor control and QoL. While more high-quality research is needed, we must augment access to CR in these settings.Systematic review registrationPROSPERO (CRD42020185296).

Project description:ObjectiveDiabetes poses serious health threats and economic burdens to patients, especially in low-income and middle-income countries (LMICs). This systematic review searches for non-pharmacological interventions for the prevention of type-2 diabetes mellitus (T2DM) among patients who are non-diabetic and pre-diabetic from LMICs.SettingsLMICs.ParticipantsAdult population aged over 18 years without having diabetes.Primary and secondary outcomesPrimary outcome is to measure the change in the incidence of T2DM. The secondary outcome is to measure changes in glycated haemoglobin (HbA1c) level, weight/body mass index (BMI), fasting glucose level and 2-hour glucose from baseline of the included randomised controlled trials.MethodsThis review has been conducted following the standard systematic review guidelines. A total of six electronic databases including MEDLINE, Embase, the Cochrane Library, Web of Science, ClinicalTrials.gov and International Clinical Trials Registry Platform were searched in February 2021 using a comprehensive search strategy.Two sets of independent reviewers performed screening, risk of bias (ROB) assessment using the Cochrane ROB tool and data extraction. Narrative coalescence of selected articles was demonstrated using tables. No meta-analysis was performed due to the lack of homogenous intervention strategies and study settings.ResultA total of five studies were included for the review with a combined population of 1734 from three countries. Three of the studies showed a significant reduction in T2DM incidence after the intervention of physical training and dietary modifications. Four of the studies also demonstrated a significant reduction of different secondary outcomes like weight, BMI, fasting and 2-hour plasma glucose and HbA1c. All the studies demonstrated a low ROB in most of the bias assessment domains with some unclear results in allocation concealments.ConclusionsEmphasising non-pharmacological interventions for T2DM prevention can improve health outcomes and lessen the economic burdens, which will be of paramount importance in LMICs.Systematic review registration numberCRD42020191507.

Project description:BackgroundTuberculosis (TB) remains a leading cause of death worldwide, with 98% of cases occurring in low- and middle-income countries (LMICs). The only vaccine licenced for the prevention of TB has limited protection for adolescents, adults and vulnerable populations. A safe and effective vaccine for all populations at risk is imperative to achieve global elimination of TB. We aimed to systematically review the efficacy and safety of TB vaccine candidates in late-phase clinical trials conducted in LMICs.MethodsMedline, Embase, CENTRAL, PubMed, Clinicaltrials.gov and Greylit.org were searched in June 2021 to identify phase 2 or later clinical randomised controlled trials that report the efficacy or safety (adverse events) of TB vaccine candidates with participants of any age living in an LMIC. TB vaccine candidates listed in the 2020 WHO Global TB Report were eligible for inclusion aside from BCG revaccination. Trials were excluded if all participants had active TB at baseline. Two reviewers independently assessed papers for eligibility, and for bias and quality using the Risk of Bias 2 tool and GRADE guidelines, respectively. We report efficacy rates and frequencies of adverse events from each included trial where available and qualitatively synthesise the findings.ResultsThirteen papers representing eleven trials met our inclusion criteria. Seven vaccine candidates were reviewed across seven countries: M72/AS01, RUTI, VPM1002, H56:IC31, MTBVAC, DAR-901 and ID93 + GLA-SE. Two trials reported on efficacy: an efficacy rate of 54% (95% CI 11.5, 76.2) was reported for M72/AS01 in adults with latent TB and 3% (95% CI -13.9, 17.7) for DAR-901 in healthy adolescents. However, the latter trial was underpowered. All vaccine candidates had comparable occurrences of adverse events between treatment arms and demonstrated acceptable safety profiles; though, RUTI resulted in one serious complication in a person living with HIV. M72/AS01 was the only vaccine considered safe across a diverse group of people including people living with HIV or latent TB and healthy infants and adolescents.ConclusionFurther efficacy trials for M72/AS01 are warranted to include additional populations at risk where safety has been demonstrated. Further safety trials are needed for the remaining vaccine candidates to confirm safety in vulnerable populations.

Project description:Summary Background Surgical 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. Methods FALCON 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. Findings Between 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. Interpretation This 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. Funding National Institute for Health Research (NIHR) Global Health Research Unit Grant, BD.

Project description:OBJECTIVE:Although there is an overall reduction in underfive mortality rate, the progress in reducing neonatal mortality rate has been very slow. Over the last 20 years, preterm births have steadily increased in low-income and medium-income countries (LMICs) particularly in sub-Saharan Africa and South Asia. Preterm birth is associated with increased mortality and morbidity, particularly in LMICs. Based on systematic reviews of randomised controlled trials (RCTs), many neonatal units in high-income countries have adopted probiotics as standard of care for preterm neonates. We aimed to systematically review the safety and efficacy of probiotics in reducing mortality and morbidity in preterm neonates in LMICs. DESIGN:Systematic review and meta-analysis of RCTs. DATA SOURCES:Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and E-abstracts from Pediatric Academic Society meetings and other paediatric and neonatal conference proceedings were searched in January 2017. ELIGIBILITY CRITERIA:RCTs comparing probiotics versus placebo/no probiotic in preterm neonates (gestation<37 weeks) conducted in LMICs. RESULTS:Total 23 (n=4783) RCTs from 4 continents and 10 LMICs were eligible for inclusion in the meta-analysis using fixed effect model. The risk of necrotising enterocolitis (NEC greater than or equal to stage?II) (risk ratio (RR) 0.46 (95% CI 0.34 to 0.61), P<0.00001, numbers needed to treat (NNT) 25 (95% CI 20 to 50)), late-onset sepsis (LOS) (RR 0.80 (95% CI 0.71 to 0.91), P=0.0009, NNT 25 (95% CI 17 to 100)) and all-cause mortality (RR 0.73 (95% CI 0.59 to 0.90), P=0.003, NNT 50 (95% CI 25 to 100)) were significantly lower in probiotic supplemented neonates. The results were significant on random effects model analysis and after excluding studies with high risk of bias. No significant adverse effects were reported. CONCLUSION:Probiotics have significant potential to reduce mortality and morbidity (eg, NEC, LOS) in preterm neonates in LMICs.

Dataset Information

The Landscape of Randomised Controlled Trials of Therapies in Breast Cancer in Low and Middle Income Countries.

Publications

The Landscape of Randomised Controlled Trials of Therapies in Breast Cancer in Low and Middle Income Countries.

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