Commentary on 'Case for BJOG compliance with prospective trial registration

Prospective registration of clinical trials before enrolment of the first participant is an ethical and scientific. Registering clinical trials reduces duplication of research and aids better identification of gaps in our knowledge, as when all research on a topic can be identified it is easier to know when a new study is not needed, as the question has already been answered; and if all research is identified it becomes easier to see where there are gaps, and so where new studies are needed. Prospective registration of clinical trials reduces publication bias and bias due to selective reporting of studies with equivocal or ‘negative’ results, since studies are identified and registered before their results are known, and there is less likelihood that our understanding of research evidence is distorted by studies that have disappeared without a trace, or are slow to appear. Prospective registration of trials additionally reduces bias due to selective reporting of outcomes that are ‘positive’ as outcomes are disclosed at registration and can be compared with published reports. Prospective registration thus contributes to less scientific misconduct, as failure to report research findings accurately and make them publicly available, is a betrayal of trust of the people who participated in that research, and can lead to harm in patient care. Prospective registration also makes it harder to fabricate research results, and can result in less scientific frau

Commentary on 'Case for BJOG compliance with prospective trial registration

Prospective registration of clinical trials before enrolment of the first participant is an ethical and scientific. Registering clinical trials reduces duplication of research and aids better identification of gaps in our knowledge, as when all research on a topic can be identified it is easier to know when a new study is not needed, as the question has already been answered; and if all research is identified it becomes easier to see where there are gaps, and so where new studies are needed. Prospective registration of clinical trials reduces publication bias and bias due to selective reporting of studies with equivocal or ‘negative’ results, since studies are identified and registered before their results are known, and there is less likelihood that our understanding of research evidence is distorted by studies that have disappeared without a trace, or are slow to appear. Prospective registration of trials additionally reduces bias due to selective reporting of outcomes that are ‘positive’ as outcomes are disclosed at registration and can be compared with published reports. Prospective registration thus contributes to less scientific misconduct, as failure to report research findings accurately and make them publicly available, is a betrayal of trust of the people who participated in that research, and can lead to harm in patient care. Prospective registration also makes it harder to fabricate research results, and can result in less scientific frau

Non-specialist health worker interventions for the care of mental, neurological and substance-abuse disorders in low- and middle-income countries.

BACKGROUND: Many people with mental, neurological and substance-use disorders (MNS) do not receive health care. Non-specialist health workers (NSHWs) and other professionals with health roles (OPHRs) are a key strategy for closing the treatment gap. OBJECTIVES: To assess the effect of NSHWs and OPHRs delivering MNS interventions in primary and community health care in low- and middle-income countries. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register) (searched 21 June 2012); MEDLINE, OvidSP; MEDLINE In Process & Other Non-Indexed Citations, OvidSP; EMBASE, OvidSP (searched 15 June 2012); CINAHL, EBSCOhost; PsycINFO, OvidSP (searched 18 and 19 June 2012); World Health Organization (WHO) Global Health Library (searched 29 June 2012); LILACS; the International Clinical Trials Registry Platform (WHO); OpenGrey; the metaRegister of Controlled Trials (searched 8 and 9 August 2012); Science Citation Index and Social Sciences Citation Index (ISI Web of Knowledge) (searched 2 October 2012) and reference lists, without language or date restrictions. We contacted authors for additional studies. SELECTION CRITERIA: Randomised and non-randomised controlled trials, controlled before-and-after studies and interrupted-time-series studies of NSHWs/OPHR-delivered interventions in primary/community health care in low- and middle-income countries, and intended to improve outcomes in people with MNS disorders and in their carers. We defined an NSHW as any professional health worker (e.g. doctors, nurses and social workers) or lay health worker without specialised training in MNS disorders. OPHRs included people outside the health sector (only teachers in this review). DATA COLLECTION AND ANALYSIS: Review authors double screened, double data-extracted and assessed risk of bias using standard formats. We grouped studies with similar interventions together. Where feasible, we combined data to obtain an overall estimate of effect. MAIN RESULTS: The 38 included studies were from seven low- and 15 middle-income countries. Twenty-two studies used lay health workers, and most addressed depression or post-traumatic stress disorder (PTSD). The review shows that the use of NSHWs, compared with usual healthcare services: 1. may increase the number of adults who recover from depression or anxiety, or both, two to six months after treatment (prevalence of depression: risk ratio (RR) 0.30, 95% confidence interval (CI) 0.14 to 0.64; low-quality evidence); 2. may slightly reduce symptoms for mothers with perinatal depression (severity of depressive symptoms: standardised mean difference (SMD) -0.42, 95% CI -0.58 to -0.26; low-quality evidence); 3. may slightly reduce the symptoms of adults with PTSD (severity of PTSD symptoms: SMD -0.36, 95% CI -0.67 to -0.05; low-quality evidence); 4. probably slightly improves the symptoms of people with dementia (severity of behavioural symptoms: SMD -0.26, 95% CI -0.60 to 0.08; moderate-quality evidence); 5. probably improves/slightly improves the mental well-being, burden and distress of carers of people with dementia (carer burden: SMD -0.50, 95% CI -0.84 to -0.15; moderate-quality evidence); 6. may decrease the amount of alcohol consumed by people with alcohol-use disorders (drinks/drinking day in last 7 to 30 days: mean difference -1.68, 95% CI -2.79 to -0.57); low-quality evidence).It is uncertain whether lay health workers or teachers reduce PTSD symptoms among children. There were insufficient data to draw conclusions about the cost-effectiveness of using NSHWs or teachers, or about their impact on people with other MNS conditions. In addition, very few studies measured adverse effects of NSHW-led care - such effects could impact on the appropriateness and quality of care. AUTHORS' CONCLUSIONS: Overall, NSHWs and teachers have some promising benefits in improving people's outcomes for general and perinatal depression, PTSD and alcohol-use disorders, and patient- and carer-outcomes for dementia. However, this evidence is mostly low or very low quality, and for some issues no evidence is available. Therefore, we cannot make conclusions about which specific NSHW-led interventions are more effective

The COVID guidelines India project: A rapid living evidence synthesis during a pandemic in a LMIC setting

Background COVID-19 has had an unprecedented impact worldwide. Evidence for management interventions emerged rapidly but was difficult for clinicians and others to assess and decide how to use. Our team in India set up a national and international collaboration preparing guidance in real time to help guide clinical practice in the country during a pandemic setting. We describe our methods and the product in this paper. Methods Specialized groups comprising core, steering, methodology, evidence synthesis, dissemination and intervention expert working groups were formed. A Cochrane Rapid Review approach was used for prioritised questions in areas of clinical equipoise in management of COVID-19. GRADE methodology was incorporated into this process and expert working groups tailored guidelines for India using the WHO Evidence to Decision framework. This was then disseminated on a widely accessible platform: indiacovidguidelines.org. A questionnaire was then used to obtain end-user feedback on the guidelines. Results Since May 2021, a total of 20 guidelines have been developed spanning pharmacological, respiratory and other supportive interventions for management of COVID-19, with over 83,600 unique page views up to December 2023. Results from a pilot survey suggest usefulness of the guidelines, but also highlighted areas for improvement. A key output was adoption of our anticoagulation recommendation in state level COVID-19 guidelines (Kerala, India). National and institutional capacity for evidence synthesis and guidelines was strengthened. Conclusions The COVID Guidelines India project successfully developed contextually relevant, nationally applicable, evidence-based guidelines in a timely manner, and disseminated these freely through a dedicated website while successfully building capacity amongst Indian clinicians for evidence-based guideline development. Throughout the ongoing COVID Guidelines India project, the team has maintained a 'living' approach, continuously updating and refining recommendations in response to emerging evidence during the ever-evolving pandemic landscape