Search

Background: Data sharing improves the value, synthesis, and integrity of research, but rates are low. Data sharing might be improved if data sharing policies were prominent and actionable at every stage of research. We aimed to systematically describe the epidemiology of data sharing policies across the health research lifecycle. Methods: This was a cross‐sectional analysis of the data sharing policies of the largest health research funders, all national ethics committees, all clinical trial registries, the highest‐impact medical journals, and all medical research data repositories. Stakeholders' official websites, online reports, and other records were reviewed up to May 2022. The strength and characteristics of their data sharing policies were assessed, including their policies on data sharing intention statements (a.k.a. data accessibility statements) and on data sharing specifically for coronavirus disease studies. Data were manually extracted in duplicate, and policies were descriptively analysed by their stakeholder and characteristics. Results: Nine hundred and thirty‐five eligible stakeholders were identified: 110 funders, 124 ethics committees, 18 trial registries, 273 journals, and 410 data repositories. Data sharing was required by 41% (45/110) of funders, no ethics committees or trial registries, 19% (52/273) of journals and 6% (24/410) of data repositories. Among funder types, a higher proportion of private (63%, 35/55) and philanthropic (67%, 4/6) funders required data sharing than public funders (12%, 6/49). Conclusion: Data sharing requirements, and even recommendations, were insufficient across health research. Where data sharing was required or recommended, there was limited guidance on implementation. We describe multiple pathways to improve the implementation of data sharing. Public funders and ethics committees are two stakeholders with particularly important untapped opportunities. [ABSTRACT FROM AUTHOR]

Increasing integrity concerns in medical research have prompted the development of tools to detect untrustworthy studies. Existing tools primarily assess published aggregate data (AD), though scrutiny of individual participant data (IPD) is often required to detect trustworthiness issues. Thus, we developed the IPD Integrity Tool for detecting integrity issues in randomised trials with IPD available. This manuscript describes the development of this tool. We conducted a literature review to collate and map existing integrity items. These were discussed with an expert advisory group; agreed items were included in a standardised tool and automated where possible. We piloted this tool in two IPD meta‐analyses (including 116 trials) and conducted preliminary validation checks on 13 datasets with and without known integrity issues. We identified 120 integrity items: 54 could be conducted using AD, 48 required IPD, and 18 were possible with AD, but more comprehensive with IPD. An initial reduced tool was developed through consensus involving 13 advisors, featuring 11 AD items across four domains, and 12 IPD items across eight domains. The tool was iteratively refined throughout piloting and validation. All studies with known integrity issues were accurately identified during validation. The final tool includes seven AD domains with 13 items and eight IPD domains with 18 items. The quality of evidence informing healthcare relies on trustworthy data. We describe the development of a tool to enable researchers, editors, and others to detect integrity issues using IPD. Detailed instructions for its application are published as a complementary manuscript in this issue. [ABSTRACT FROM AUTHOR]

Increasing concerns about the trustworthiness of research have prompted calls to scrutinise studies' Individual Participant Data (IPD), but guidance on how to do this was lacking. To address this, we developed the IPD Integrity Tool to screen randomised controlled trials (RCTs) for integrity issues. Development of the tool involved a literature review, consultation with an expert advisory group, piloting on two IPD meta‐analyses (including 73 trials with IPD), preliminary validation on 13 datasets with and without known integrity issues, and evaluation to inform iterative refinements. The IPD Integrity Tool comprises 31 items (13 study‐level, 18 IPD‐specific). IPD‐specific items are automated where possible, and are grouped into eight domains, including unusual data patterns, baseline characteristics, correlations, date violations, patterns of allocation, internal and external inconsistencies, and plausibility of data. Users rate each item as having either no issues, some/minor issue(s), or many/major issue(s) according to decision rules, and justification for each rating is recorded. Overall, the tool guides decision‐making by determining whether a trial has no concerns, some concerns requiring further information, or major concerns warranting exclusion from evidence synthesis or publication. In our preliminary validation checks, the tool accurately identified all five studies with known integrity issues. The IPD Integrity Tool enables users to assess the integrity of RCTs via examination of IPD. The tool may be applied by evidence synthesists, editors and others to determine whether an RCT should be considered sufficiently trustworthy to contribute to the evidence base that informs policy and practice. [ABSTRACT FROM AUTHOR]

The Eating Disorders In weight-related Therapy (EDIT) Collaboration brings together data from randomised controlled trials of behavioural weight management interventions to identify individual participant risk factors and intervention strategies that contribute to eating disorder risk. We present a protocol for a systematic review and individual participant data (IPD) meta-analysis which aims to identify participants at risk of developing eating disorders, or related symptoms, during or after weight management interventions conducted in adolescents or adults with overweight or obesity. We systematically searched four databases up to March 2022 and clinical trials registries to May 2022 to identify randomised controlled trials of weight management interventions conducted in adolescents or adults with overweight or obesity that measured eating disorder risk at pre- and post-intervention or follow-up. Authors from eligible trials have been invited to share their deidentified IPD. Two IPD meta-analyses will be conducted. The first IPD meta-analysis aims to examine participant level factors associated with a change in eating disorder scores during and following a weight management intervention. To do this we will examine baseline variables that predict change in eating disorder risk within intervention arms. The second IPD meta-analysis aims to assess whether there are participant level factors that predict whether participation in an intervention is more or less likely than no intervention to lead to a change in eating disorder risk. To do this, we will examine if there are differences in predictors of eating disorder risk between intervention and no-treatment control arms. The primary outcome will be a standardised mean difference in global eating disorder score from baseline to immediately post-intervention and at 6- and 12- months follow-up. Identifying participant level risk factors predicting eating disorder risk will inform screening and monitoring protocols to allow early identification and intervention for those at risk. [ABSTRACT FROM AUTHOR]

Summary: This systematic review examined change in eating disorder risk during weight management interventions. Four databases and clinical trials registries were searched in March and May 2022, respectively, to identify behavioral weight management intervention trials in adults with overweight/obesity measuring eating disorder symptoms at pre‐ and post‐intervention or follow‐up. Random effects meta‐analyses were conducted examining within group change in risk. Of 12,023 screened, 49 were eligible (n = 6337, mean age range 22.1 to 59.9 years, mean (SD) 81(20.4)% female). Interventions ranged from 4 weeks to 18 months, with follow‐up of 10 weeks to 36 months post‐intervention. There was a within group reduction in global eating disorder scores (20 intervention arms; Hedges' g = −0.27; 95% CI −0.36, −0.17; I2 67.1%) and binge eating (49 intervention arms; −0.66; 95% CI −0.76, −0.56; I2 82.7%) post‐intervention, both maintained at follow‐up. Of 14 studies reporting prevalence or episodes of binge eating, all reported a reduction. Four studies reported eating disorder symptoms, not present at baseline, in a subset of participants (0%–6.5%). Overall, behavioral weight management interventions do not increase eating disorder symptoms for most adults; indeed, a modest reduction is seen post‐intervention and follow‐up. A small subset of participants may experience disordered eating; therefore, monitoring for the emergence of symptoms is important. [ABSTRACT FROM AUTHOR]

Background: Clinicians favour low oxygen concentrations when resuscitating preterm infants immediately after birth despite inconclusive evidence to support this practice. Prospective meta‐analysis (PMA) is a novel approach where studies are identified as eligible for inclusion in the meta‐analysis before their results are known. Aims: To explore whether high (60%) or low (30%) oxygen is associated with greater efficacy and safety for the initial resuscitation (immediately after birth) of preterm infants born at <29 weeks' gestation. Methods: We will conduct a prospective meta‐analysis (PMA) with individual participant data (IPD). We will perform a systematic search to identify ongoing RCTs including infants <29 weeks' gestation randomised to high (60%) or low (30%) oxygen for initial resuscitation after birth. IPD will be sought for all infants randomised for the purpose of meta‐analysis. We will employ a one‐stage random‐effects approach to IPD meta‐analysis. Potential heterogeneity and the differential effect of high or low oxygen will be explored through subgroup and interaction analyses. The primary outcome of this study is all‐cause mortality prior to hospital discharge. There will be a follow‐up analysis of neurodevelopmental outcomes once available. Results/Conclusion: The results of neonatal outcomes at hospital discharge are expected by 2025, and neurodevelopmental outcomes by 2027. [ABSTRACT FROM AUTHOR]

Objectives: We aimed to synthesise evidence from prospective studies of digital breast tomosynthesis (DBT) screening to assess its effectiveness compared to digital mammography (DM). Specifically, we examined whether DBT reduces interval cancer rates (ICRs) in population breast cancer screening.We performed a systematic review and meta-analysis of DBT screening studies (identified from January 2013 to March 2024). We included both RCTs and non-randomised prospective studies that used an independent comparison for our primary outcome ICRs. The risk of bias was assessed with QUADAS-2. We compared the ICR, cancer detection rate (CDR), and recall rate of DBT and DM screening using random effects meta-analysis models. Subgroup analyses estimated outcomes by study design. Sensitivity analyses estimated absolute effects from relative effects.Ten prospective studies (three RCTs, seven non-randomised) were eligible; all had a low risk of bias. There were 205,245 DBT-screened and 306,476 DM-screened participants with follow-up for interval cancer data. The pooled absolute ICR did not significantly differ between DBT and DM: −2.92 per 10,000 screens (95% CI: −6.39 to 0.54); however subsequent subgroup analysis indicated certain study designs may have biased this ICR estimate. Pooled ICR from studies that only sampled groups from the same time and region indicated DBT led to 5.50 less IC per 10,000 screens (95% CI: −9.47 to −1.54). Estimates from subgroup analysis that compared randomised and non-randomised trials did not significantly differ.This meta-analysis provides suggestive evidence that DBT decreases ICR relative to DM screening; further evidence is needed to reduce uncertainty regarding ICR differences between DBT and DM.QuestionDoes DBT have long-term benefits over standard DM?FindingWe find suggestive evidence in our primary analysis and stronger evidence in a follow-up analysis that DBT reduces interval cancers.Clinical relevanceThis meta-analysis provides the first indication that DBT may detect additional cancers that are clinically meaningful, based on suggestive evidence of a reduction in ICR. This finding does not preclude the simultaneous possibility of overdiagnosis.Materials and methods: We aimed to synthesise evidence from prospective studies of digital breast tomosynthesis (DBT) screening to assess its effectiveness compared to digital mammography (DM). Specifically, we examined whether DBT reduces interval cancer rates (ICRs) in population breast cancer screening.We performed a systematic review and meta-analysis of DBT screening studies (identified from January 2013 to March 2024). We included both RCTs and non-randomised prospective studies that used an independent comparison for our primary outcome ICRs. The risk of bias was assessed with QUADAS-2. We compared the ICR, cancer detection rate (CDR), and recall rate of DBT and DM screening using random effects meta-analysis models. Subgroup analyses estimated outcomes by study design. Sensitivity analyses estimated absolute effects from relative effects.Ten prospective studies (three RCTs, seven non-randomised) were eligible; all had a low risk of bias. There were 205,245 DBT-screened and 306,476 DM-screened participants with follow-up for interval cancer data. The pooled absolute ICR did not significantly differ between DBT and DM: −2.92 per 10,000 screens (95% CI: −6.39 to 0.54); however subsequent subgroup analysis indicated certain study designs may have biased this ICR estimate. Pooled ICR from studies that only sampled groups from the same time and region indicated DBT led to 5.50 less IC per 10,000 screens (95% CI: −9.47 to −1.54). Estimates from subgroup analysis that compared randomised and non-randomised trials did not significantly differ.This meta-analysis provides suggestive evidence that DBT decreases ICR relative to DM screening; further evidence is needed to reduce uncertainty regarding ICR differences between DBT and DM.QuestionDoes DBT have long-term benefits over standard DM?FindingWe find suggestive evidence in our primary analysis and stronger evidence in a follow-up analysis that DBT reduces interval cancers.Clinical relevanceThis meta-analysis provides the first indication that DBT may detect additional cancers that are clinically meaningful, based on suggestive evidence of a reduction in ICR. This finding does not preclude the simultaneous possibility of overdiagnosis.Results: We aimed to synthesise evidence from prospective studies of digital breast tomosynthesis (DBT) screening to assess its effectiveness compared to digital mammography (DM). Specifically, we examined whether DBT reduces interval cancer rates (ICRs) in population breast cancer screening.We performed a systematic review and meta-analysis of DBT screening studies (identified from January 2013 to March 2024). We included both RCTs and non-randomised prospective studies that used an independent comparison for our primary outcome ICRs. The risk of bias was assessed with QUADAS-2. We compared the ICR, cancer detection rate (CDR), and recall rate of DBT and DM screening using random effects meta-analysis models. Subgroup analyses estimated outcomes by study design. Sensitivity analyses estimated absolute effects from relative effects.Ten prospective studies (three RCTs, seven non-randomised) were eligible; all had a low risk of bias. There were 205,245 DBT-screened and 306,476 DM-screened participants with follow-up for interval cancer data. The pooled absolute ICR did not significantly differ between DBT and DM: −2.92 per 10,000 screens (95% CI: −6.39 to 0.54); however subsequent subgroup analysis indicated certain study designs may have biased this ICR estimate. Pooled ICR from studies that only sampled groups from the same time and region indicated DBT led to 5.50 less IC per 10,000 screens (95% CI: −9.47 to −1.54). Estimates from subgroup analysis that compared randomised and non-randomised trials did not significantly differ.This meta-analysis provides suggestive evidence that DBT decreases ICR relative to DM screening; further evidence is needed to reduce uncertainty regarding ICR differences between DBT and DM.QuestionDoes DBT have long-term benefits over standard DM?FindingWe find suggestive evidence in our primary analysis and stronger evidence in a follow-up analysis that DBT reduces interval cancers.Clinical relevanceThis meta-analysis provides the first indication that DBT may detect additional cancers that are clinically meaningful, based on suggestive evidence of a reduction in ICR. This finding does not preclude the simultaneous possibility of overdiagnosis.Conclusion: We aimed to synthesise evidence from prospective studies of digital breast tomosynthesis (DBT) screening to assess its effectiveness compared to digital mammography (DM). Specifically, we examined whether DBT reduces interval cancer rates (ICRs) in population breast cancer screening.We performed a systematic review and meta-analysis of DBT screening studies (identified from January 2013 to March 2024). We included both RCTs and non-randomised prospective studies that used an independent comparison for our primary outcome ICRs. The risk of bias was assessed with QUADAS-2. We compared the ICR, cancer detection rate (CDR), and recall rate of DBT and DM screening using random effects meta-analysis models. Subgroup analyses estimated outcomes by study design. Sensitivity analyses estimated absolute effects from relative effects.Ten prospective studies (three RCTs, seven non-randomised) were eligible; all had a low risk of bias. There were 205,245 DBT-screened and 306,476 DM-screened participants with follow-up for interval cancer data. The pooled absolute ICR did not significantly differ between DBT and DM: −2.92 per 10,000 screens (95% CI: −6.39 to 0.54); however subsequent subgroup analysis indicated certain study designs may have biased this ICR estimate. Pooled ICR from studies that only sampled groups from the same time and region indicated DBT led to 5.50 less IC per 10,000 screens (95% CI: −9.47 to −1.54). Estimates from subgroup analysis that compared randomised and non-randomised trials did not significantly differ.This meta-analysis provides suggestive evidence that DBT decreases ICR relative to DM screening; further evidence is needed to reduce uncertainty regarding ICR differences between DBT and DM.QuestionDoes DBT have long-term benefits over standard DM?FindingWe find suggestive evidence in our primary analysis and stronger evidence in a follow-up analysis that DBT reduces interval cancers.Clinical relevanceThis meta-analysis provides the first indication that DBT may detect additional cancers that are clinically meaningful, based on suggestive evidence of a reduction in ICR. This finding does not preclude the simultaneous possibility of overdiagnosis.Key Points: We aimed to synthesise evidence from prospective studies of digital breast tomosynthesis (DBT) screening to assess its effectiveness compared to digital mammography (DM). Specifically, we examined whether DBT reduces interval cancer rates (ICRs) in population breast cancer screening.We performed a systematic review and meta-analysis of DBT screening studies (identified from January 2013 to March 2024). We included both RCTs and non-randomised prospective studies that used an independent comparison for our primary outcome ICRs. The risk of bias was assessed with QUADAS-2. We compared the ICR, cancer detection rate (CDR), and recall rate of DBT and DM screening using random effects meta-analysis models. Subgroup analyses estimated outcomes by study design. Sensitivity analyses estimated absolute effects from relative effects.Ten prospective studies (three RCTs, seven non-randomised) were eligible; all had a low risk of bias. There were 205,245 DBT-screened and 306,476 DM-screened participants with follow-up for interval cancer data. The pooled absolute ICR did not significantly differ between DBT and DM: −2.92 per 10,000 screens (95% CI: −6.39 to 0.54); however subsequent subgroup analysis indicated certain study designs may have biased this ICR estimate. Pooled ICR from studies that only sampled groups from the same time and region indicated DBT led to 5.50 less IC per 10,000 screens (95% CI: −9.47 to −1.54). Estimates from subgroup analysis that compared randomised and non-randomised trials did not significantly differ.This meta-analysis provides suggestive evidence that DBT decreases ICR relative to DM screening; further evidence is needed to reduce uncertainty regarding ICR differences between DBT and DM.QuestionDoes DBT have long-term benefits over standard DM?FindingWe find suggestive evidence in our primary analysis and stronger evidence in a follow-up analysis that DBT reduces interval cancers.Clinical relevanceThis meta-analysis provides the first indication that DBT may detect additional cancers that are clinically meaningful, based on suggestive evidence of a reduction in ICR. This finding does not preclude the simultaneous possibility of overdiagnosis.Graphical Abstract: We aimed to synthesise evidence from prospective studies of digital breast tomosynthesis (DBT) screening to assess its effectiveness compared to digital mammography (DM). Specifically, we examined whether DBT reduces interval cancer rates (ICRs) in population breast cancer screening.We performed a systematic review and meta-analysis of DBT screening studies (identified from January 2013 to March 2024). We included both RCTs and non-randomised prospective studies that used an independent comparison for our primary outcome ICRs. The risk of bias was assessed with QUADAS-2. We compared the ICR, cancer detection rate (CDR), and recall rate of DBT and DM screening using random effects meta-analysis models. Subgroup analyses estimated outcomes by study design. Sensitivity analyses estimated absolute effects from relative effects.Ten prospective studies (three RCTs, seven non-randomised) were eligible; all had a low risk of bias. There were 205,245 DBT-screened and 306,476 DM-screened participants with follow-up for interval cancer data. The pooled absolute ICR did not significantly differ between DBT and DM: −2.92 per 10,000 screens (95% CI: −6.39 to 0.54); however subsequent subgroup analysis indicated certain study designs may have biased this ICR estimate. Pooled ICR from studies that only sampled groups from the same time and region indicated DBT led to 5.50 less IC per 10,000 screens (95% CI: −9.47 to −1.54). Estimates from subgroup analysis that compared randomised and non-randomised trials did not significantly differ.This meta-analysis provides suggestive evidence that DBT decreases ICR relative to DM screening; further evidence is needed to reduce uncertainty regarding ICR differences between DBT and DM.QuestionDoes DBT have long-term benefits over standard DM?FindingWe find suggestive evidence in our primary analysis and stronger evidence in a follow-up analysis that DBT reduces interval cancers.Clinical relevanceThis meta-analysis provides the first indication that DBT may detect additional cancers that are clinically meaningful, based on suggestive evidence of a reduction in ICR. This finding does not preclude the simultaneous possibility of overdiagnosis. [ABSTRACT FROM AUTHOR]

Individual participant data meta-analyses enable detailed checking of data quality and more complex analyses than standard study-level synthesis of summary data based on publications. However, there is limited existing guidance on the specific systematic checks that should be undertaken to confirm and enhance data quality for individual participant data meta-analyses and how to conduct these checks. We aim to address this gap by developing a checklist of items for data quality checking and cleaning to be applied to individual participant data meta-analyses of randomised trials. This study will comprise three phases: 1) a scoping review to identify potential checklist items; 2) two e-Delphi survey rounds among an invited panel of experts followed by a consensus meeting; and 3) pilot testing and refinement of the checklist, including development of an accompanying R-markdown program to facilitate its uptake. [ABSTRACT FROM AUTHOR]

An auditory event is often accompanied by characteristic visual information. For example, the sound level produced by a vigorous handclap may be related to the speed of hands as they move toward collision. Here, we tested the hypothesis that visual information about the intensity of auditory signals are capable of altering the subsequent neurophysiological response to auditory stimulation. To do this, we used EEG to measure the response of the human brain (n = 28) to the audiovisual delivery of handclaps. Depictions of a weak handclap were accompanied by auditory handclaps at low (65 dB) and intermediate (72.5 dB) sound levels, whereas depictions of a vigorous handclap were accompanied by auditory handclaps at intermediate (72.5 dB) and high (80 dB) sound levels. The dependent variable was the amplitude of the initial negative component (N1) of the auditory evoked potential. We find that identical clap sounds (intermediate level; 72.5 dB) elicited significantly lower N1 amplitudes when paired with a video of a weak clap, compared with when paired with a video of a vigorous clap. These results demonstrate that intensity predictions can affect the neural responses to auditory stimulation at very early stages (<100 msec) in sensory processing. Furthermore, the established sound-level dependence of auditory N1 amplitude suggests that such effects may serve the functional role of altering auditory responses in accordance with visual inferences. Thus, this study provides evidence that the neurally evoked response to an auditory event results from a combination of a person's beliefs with incoming auditory input. [ABSTRACT FROM AUTHOR]

The optimal cord management strategy at birth for each preterm baby is still unknown, despite more than 100 randomized controlled trials (RCTs) undertaken on this question. To address this, we brought together all RCTs examining cord management strategies at preterm birth in the iCOMP (i ndividual participant data on CO rd M anagement at P reterm birth) Collaboration, to perform an individual participant data network meta-analysis. In this paper, we describe the trials and tribulations around obtaining individual participant data to resolve controversies around cord clamping, and we derive key recommendations for future collaborative research in perinatology. To reliably answer outstanding questions, future cord management research needs to be collaborative and coordinated, by aligning core protocol elements, ensuring quality and reporting standards are met, and carefully considering and reporting on vulnerable sub-populations. The iCOMP Collaboration is an example of the power of collaboration to address priority research questions, and ultimately improve neonatal outcomes worldwide. [ABSTRACT FROM AUTHOR]

Summary Objective Methods Results Conclusion To describe pathways to eating disorder (ED) development that have been evaluated in people with overweight and obesity.Four databases were searched to identify studies testing ED development models in adolescents (10–19 years) or adults (>19 years) with overweight and obesity. Explanatory variables were thematically grouped into constructs to describe pathways to each ED outcome.Of 2226 studies screened, 46 (10 adolescent; 36 adult) were included. Study samples were predominantly female, ranging from 22 to 2236 participants and mean age 12.3 to 56.0 years. In total, 207 explanatory variables were grouped into 18 constructs to summarize 107 pathways that were identified. The most common ED outcome was binge eating (n = 24 studies), followed by global ED psychopathology (n = 10 studies). Across pathways to ED development, negative affect was the most proposed construct, followed by preoccupation with weight/shape and weight stigma.Pathways to ED development in people with overweight and obesity are complex and may include more than 18 different explanatory factors of which negative affect, preoccupation with weight/shape, and weight stigma are the most common. More research on adolescents, males, and the spectrum of ED in diverse populations is required for early identification and intervention. [ABSTRACT FROM AUTHOR]