scholarly journals Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide

2019 ◽  
Author(s):  
Matthew Ventresca ◽  
Holger J Schünemann ◽  
Fergus Macbeth ◽  
Mike Clarke ◽  
Lehana Thabane ◽  
...  
Keyword(s):  
Data Sharing ◽  
Scoping Review ◽  
Data Retrieval ◽  
Current Data ◽  
Cochrane Library ◽  
European Federation ◽  
Individual Participant Data ◽  
Policy And Practice ◽  
Individual Participant ◽  
Pharmaceutical Industries

Abstract Background Shifts in data sharing policy have increased researchers’ access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the challenges of retrieving IPD for an IPDMA and provide practical guidance based on a review of the literature and practical examples and observations. Methods We systematically searched MEDLINE, Embase, and the Cochrane Library to identify publications focused on strategies to obtain IPD. In addition, we searched pharmaceutical websites and contacted industry organizations for supplemental information pertaining to recent advances in industry policy and practice. Finally, we documented setbacks and solutions encountered while completing a comprehensive IPDMA and drew on previous experiences related to seeking and using IPD. Results Our scoping review identified 16 articles directly relevant for the conduct of IPDMAs. We present short descriptions of these articles alongside overviews of IPD sharing policies and procedures of pharmaceutical companies which display certification of Principles for Responsible Clinical Trial Data Sharing via Pharmaceutical Research and Manufacturers of America or European Federation of Pharmaceutical Industries and Associations websites. Advances in data sharing policy and practice affected the way in which data is requested, obtained, stored and analyzed For our IPDMA it took 6.5 years to collect and analyze relevant IPD and navigate additional administrative barriers. Delays in obtaining data were largely due to challenges in communication with study sponsors, frequent changes in data sharing policies of study sponsors, and the requirement for a diverse skillset related to research, administrative, statistical and legal issues. Conclusions Knowledge of current data sharing practices and platforms as well as anticipation of necessary tasks and potential obstacles may reduce time and resources required for an IPDMA. Sufficient project funding and timeline flexibility are pre-requisites for successful collection and analysis of IPD. IPDMA researchers must acknowledge the additional and unexpected responsibility they are placing on study authors or data sharing administrators and should offer assistance in readying data for sharing.

scholarly journals Status, use and impact of sharing individual participant data from clinical trials: a scoping review

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e049228
Author(s):  
Christian Ohmann ◽  
David Moher ◽  
Maximilian Siebert ◽  
Edith Motschall ◽  
Florian Naudet
Keyword(s):  
Clinical Trials ◽  
Data Sharing ◽  
Scoping Review ◽  
Citation Index ◽  
Actual Data ◽  
Cochrane Library ◽  
Individual Participant Data ◽  
Shared Data ◽  
Individual Participant ◽  
The Impact

ObjectivesTo explore the impact of data-sharing initiatives on the intent to share data, on actual data sharing, on the use of shared data and on research output and impact of shared data.Eligibility criteriaAll studies investigating data-sharing practices for individual participant data (IPD) from clinical trials.Sources of evidenceWe searched the Medline database, the Cochrane Library, the Science Citation Index Expanded and the Social Sciences Citation Index via Web of Science, and preprints and proceedings of the International Congress on Peer Review and Scientific Publication. In addition, we inspected major clinical trial data-sharing platforms, contacted major journals/publishers, editorial groups and some funders.Charting methodsTwo reviewers independently extracted information on methods and results from resources identified using a standardised questionnaire. A map of the extracted data was constructed and accompanied by a narrative summary for each outcome domain.Results93 studies identified in the literature search (published between 2001 and 2020, median: 2018) and 5 from additional information sources were included in the scoping review. Most studies were descriptive and focused on early phases of the data-sharing process. While the willingness to share IPD from clinical trials is extremely high, actual data-sharing rates are suboptimal. A survey of journal data suggests poor to moderate enforcement of the policies by publishers. Metrics provided by platforms suggest that a large majority of data remains unrequested. When requested, the purpose of the reuse is more often secondary analyses and meta-analyses, rarely re-analyses. Finally, studies focused on the real impact of data-sharing were rare and used surrogates such as citation metrics.ConclusionsThere is currently a gap in the evidence base for the impact of IPD sharing, which entails uncertainties in the implementation of current data-sharing policies. High level evidence is needed to assess whether the value of medical research increases with data-sharing practices.

scholarly journals A scoping review of considerations and practices for benefit sharing in biobanking

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Allan Sudoi ◽  
Jantina De Vries ◽  
Dorcas Kamuya
Keyword(s):  
Scoping Review ◽  
Health Research ◽  
Empirical Studies ◽  
Benefit Sharing ◽  
Cochrane Library ◽  
Policy And Practice ◽  
Online Databases ◽  
Expected Benefits ◽  
Future Policy ◽  
Distinct Features

Abstract Background Despite the rapid global growth of biobanking over the last few decades, and their potential for the advancement of health research, considerations specific to the sharing of benefits that accrue from biobanks have received little attention. Questions such as the types and range of benefits that can arise in biobanking, who should be entitled to those benefits, when they should be provided, by whom and in what form remain mostly unanswered. We conducted a scoping review to describe benefit sharing considerations and practices in biobanking in order to inform current and future policy and practice. Methods Drawing on the Arksey and O’Malley framework, we conducted a scoping review of the literature in three online databases (PubMed, Cochrane library, and Google Scholar). We extracted and charted data to capture general characteristics, definitions and examples of benefits and benefit sharing, justification for benefit sharing, challenges in benefit sharing, governance mechanisms as well as proposed benefit sharing mechanisms. Results 29 articles published between 1999 and 2020 met the inclusion criteria for the study. The articles included 5 empirical and 24 non-empirical studies. Only 12 articles discussed benefit sharing as a stand-alone subject, while the remaining 17 integrated a discussion of benefits as one issue amongst others. Major benefit sharing challenges in biobanking were found to be those associated with uncertainties around the future use of samples and in resultant benefits. Conclusion Most of the benefit sharing definitions and approaches currently in use for biobanking are similar to those used in health research. These approaches may not recognise the distinct features of biobanking, specifically relating to uncertainties associated with the sharing and re-use of samples. We therefore support approaches that allow decisions about benefit sharing to be made progressively once it is apparent who samples are to be shared with, the intended purpose and expected benefits. We also highlight gaps in key areas informing benefit sharing in biobanking and draw attention to the need for further empirical research.

scholarly journals Guided or self-guided internet-based cognitive–behavioural therapy (iCBT) for depression? Study protocol of an individual participant data network meta-analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e026820 ◽  
Author(s):  
Eirini Karyotaki ◽  
Toshi A Furukawa ◽  
Orestis Efthimiou ◽  
Heleen Riper ◽  
Pim Cuijpers
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Meta Analysis ◽  
Substantial Reduction ◽  
Behavioural Therapy ◽  
Cochrane Library ◽  
Individual Participant Data ◽  
Relative Efficacy ◽  
Patient Level ◽  
Cognitive Behavioural ◽  
Individual Participant

IntroductionAlthough guided forms of internet-based cognitive–behavioural therapy (iCBT) result in a substantial reduction in depression, it seems that the most scalable way to deliver iCBT is without guidance. However, direct evidence on the comparison between guided and self-guided iCBT is scarce. Moreover, it is unclear which types of patients may benefit more from each of these two forms of iCBT. Network meta-analysis (NMA) using individual participant data (IPD) offers a way to assess the relative efficacy of multiple (>2) interventions. Moreover, it maximises our power to detect patient-level characteristics (covariates) that have an important effect on the efficacy of interventions. This protocol describes the procedures of an IPD-NMA, which aims at examining the relative efficacy of guided compared with self-guided iCBT and at identifying predictors and moderators of treatment outcome.Methods and analysisWe will use an existing database on psychotherapies for adult depression to identify eligible studies. This database has been updated up to 1 January 2018, through literature searches in PubMed, Embase, PsycINFO and Cochrane Library. The outcome of this IPD-NMA is reduction in depressive symptoms severity. We will fit the model in a Bayesian setting. After fitting the model, we will report the relative treatment effects for different types of patients, and we will discuss the clinical implications of our findings. Based on the results from the IPD-NMA model, we will develop and validate a personalised prediction model, aiming to provide patient-level predictions about the effects of the interventions.Ethics and disseminationAn ethical approval is not required for this study. The results will be published in a peer-review journal. These results will guide clinical decisions about the most efficient way to allocate iCBT resources, thereby increasing the scalability of this innovative therapeutic approach.

scholarly journals Reducing Self-harm in Adolescents. An individual participant data meta-analysis (RISA-IPD): systematic review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e049255
Author(s):  
Alexandra Wright-Hughes ◽  
Rebecca Walwyn ◽  
Judy M Wright ◽  
Amanda Farrin ◽  
Peter Fonagy ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Therapeutic Interventions ◽  
Sensitivity Analyses ◽  
Collaborative Group ◽  
Cochrane Library ◽  
Advisory Group ◽  
Individual Participant Data ◽  
Individual Participant ◽  
Self Harm

IntroductionUp to 10% of adolescents report self-harm in the previous year. Non-fatal repetition is common (18% in 1 year), death from any cause shows a fourfold and suicide a 10-fold excess. Despite the scale of the problem, there is insufficient evidence for effective interventions for self-harm. Those who self-harm do so for a variety of different reasons. Different treatments may be more effective for subgroups of adolescents; however, little is known about which subgroups are appropriate for further study. This protocol outlines a systematic review and individual participant data meta-analysis (IPD-MA) to identify subgroups of adolescents for which therapeutic interventions for self-harm show some evidence of benefit.Methods and analysisA systematic literature search was conducted in August 2019 (including Cochrane Library, Embase, trial registers and other databases). An update search is planned. Study selection will identify randomised controlled trials examining interventions to reduce self-harm in adolescents who have self-harmed and presented to services. Identified research teams will be invited to contribute data and form a collaborative group. Two-stage IPD-MA will be used to evaluate effectiveness of different therapeutic interventions compared with any active or non-active control on repetition of self-harm, general psychopathology, depression, suicidal ideation, quality of life and death. Subgroup analyses will identify adolescent subgroups in whom different therapeutic interventions may be more effective. Meta-regression will explore moderating study and intervention effects. Sensitivity analyses will incorporate aggregate data from studies lacking IPD and test the robustness of results to methods for handling missing data, within-study clustering, non-adherence and study quality.Ethics and disseminationEthical approval is provided by the University of Leeds, Faculty of Medicine and Health Ethics Committee (18-098). Outcomes will inform research recommendations and will be disseminated internationally through the collaborative group, a service user advisory group, open-access peer-reviewed publication and conference presentations.PROSPERO registration numberCRD42019152119.

scholarly journals Classification of processes involved in sharing individual participant data from clinical trials

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 138 ◽  
Author(s):  
Christian Ohmann ◽  
Steve Canham ◽  
Rita Banzi ◽  
Wolfgang Kuchinke ◽  
Serena Battaglia
Keyword(s):  
Clinical Trials ◽  
Data Sharing ◽  
Cultural Change ◽  
Process Model ◽  
Group Processes ◽  
Major Type ◽  
Published Data ◽  
Individual Participant Data ◽  
Comprehensive List ◽  
Individual Participant

Background: In recent years, a cultural change in the handling of data from research has resulted in the strong promotion of a culture of openness and increased sharing of data. In the area of clinical trials, sharing of individual participant data involves a complex set of processes and the interaction of many actors and actions. Individual services/tools to support data sharing are available, but what is missing is a detailed, structured and comprehensive list of processes/subprocesses involved and tools/services needed. Methods: Principles and recommendations from a published data sharing consensus document are analysed in detail by a small expert group. Processes/subprocesses involved in data sharing are identified and linked to actors and possible services/tools. Definitions are adapted from the business process model and notation (BPMN) and applied in the analysis. Results: A detailed and comprehensive list of individual processes/subprocesses involved in data sharing, structured according to 9 main processes, is provided. Possible tools/services to support these processes/subprocesses are identified and grouped according to major type of support. Conclusions: The list of individual processes/subprocesses and tools/services identified is a first step towards development of a generic framework or architecture for sharing of data from clinical trials. Such a framework is strongly needed to give an overview of how various actors, research processes and services could form an interoperable system for data sharing.

scholarly journals Primed to comply: Individual participant data sharing statements on ClinicalTrials.gov

PLoS ONE ◽  
2020 ◽  
Vol 15 (2) ◽  
pp. e0226143
Author(s):  
Emily E. Statham ◽  
Sarah A. White ◽  
Bhagyashree Sonwane ◽  
Barbara E. Bierer
Keyword(s):  
Data Sharing ◽  
Individual Participant Data ◽  
Individual Participant

Factors Associated with Mortality Following Burns Complicated by Necrotizing Skin and Soft Tissue Infections: A Systematic Review and Meta-analysis of Individual Participant Data

2021 ◽  
Author(s):  
Kevin M Klifto ◽  
Caresse F Gurno ◽  
Stella M Seal ◽  
C Scott Hultman
Keyword(s):  
Soft Tissue ◽  
Graft Survival ◽  
Burn Injury ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Individual Participant Data ◽  
Soft Tissue Infections ◽  
Factors Associated ◽  
Burn Center ◽  
Individual Participant

Abstract We reviewed studies with individual participant data of patients who sustained burn injury and subsequently developed necrotizing skin and soft tissue infections (NSTI). Characteristics and managements were compared between patients who lived and patients who died to determine factors associated with mortality. Six databases (PubMed, EMBASE, Cochrane Library, Web of Science, Scopus and CINAHL) were searched. PRISMA-IPD guidelines were followed throughout the review. Eligible patients sustained a burn injury, treated in any setting, and diagnosed with a NSTI following burn injury. Comparisons were made between burned patients who lived “non-mortality” and burned patients who died “mortality” following NSTI using non-parametric univariate analyses. Fifty-eight studies with 78 patients were published from 1970 through 2019. Non-mortality resulted in 58 patients and mortality resulted in 20 patients. Patients with mortality had significantly greater median %TBSA burned (45%[IQR:44-64%] versus 35%[IQR:11-59%],p=0.033), more intubations (79% versus 43%,p=0.013), less debridements (83% versus 98%,p=0.039), less skin excisions (83% versus 98%,p=0.039), more complications (100% versus 50%,p<0.001), management at a burn center (100% versus 71%,p=0.008), underwent less flap surgeries (5% versus 35%,p=0.014), less graft survival (25% versus 86%,p<0.001), and less healed wounds (5% versus 95%,p<0.001), compared to patients with non-mortality, respectively. Non-mortality patients had more debridements, skin excised, systemic antimicrobials, skin graft survival, flaps, improvement following surgery and healed wounds compared to mortality patients. Mortality patients had greater %TBSA burned, intubations, management at a burn center and complications compared to non-mortality patients.

scholarly journals Hydroxychloroquine/Chloroquine for the Treatment of Hospitalized Patients with COVID-19: An Individual Participant Data Meta-Analysis

2022 ◽  
Author(s):  
Leon Di Stefano ◽  
Elizabeth L Ogburn ◽  
Malathi Ram ◽  
Daniel O Scharfstein ◽  
Tianjing Li ◽  
...  
Keyword(s):  
Adverse Event ◽  
Data Sharing ◽  
Meta Analysis ◽  
Hospitalized Patients ◽  
Ordinal Scale ◽  
Individual Participant Data ◽  
Individual Study ◽  
Data Set ◽  
Principal Investigators ◽  
Individual Participant

Importance: Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data (IPD), including unanalyzed data from trials terminated early, enables further investigation of the efficacy and safety of HCQ/CQ. Objective: To assess efficacy of HCQ/CQ in patients hospitalized with COVID-19, both overall and in prespecified subgroups. Data Sources: ClinicalTrials.gov was searched multiple times in May-June 2020. Principal investigators of US-based RCTs evaluating HCQ/CQ in hospitalized COVID-19 patients were invited to collaborate in this IPD meta-analysis. Study Selection: RCTs in which: (1) HCQ/CQ was a treatment arm; (2) patient informed consent and/or individual study IRB approval allowed for data sharing; (3) principal investigators/their institutions signed a data use agreement for the present study; and (4) the outcomes defined in this study were recorded or could be extrapolated. Data Extraction and Synthesis: Wherever possible, harmonized de-identified data were collected via a common template spreadsheet sent to each principal investigator, then shared via a secure online data sharing platform to create a pooled data set. When this was not possible, individual study data were harmonized and merged manually. Data were analyzed by fitting a prespecified Bayesian ordinal regression model and standardizing the resulting predictions. Main Outcome(s) and Measure(s): 7-point ordinal scale, measured between day 28 and 35 post-enrollment. Results: Eight of 19 trials met eligibility criteria and agreed to participate. Patient-level data were available from 770 participants (412 HCQ/CQ vs 358 control). Baseline characteristics were similar between groups. We found no evidence of a difference in ordinal scores between days 28 and 35 post-enrollment in the pooled patient population (odds ratio, 0.97; 95% credible interval, 0.76-1.24; higher favors HCQ/CQ), and no convincing evidence of meaningful treatment effect heterogeneity among prespecified subgroups. Adverse event and serious adverse event rates were numerically higher with HCQ/CQ vs control (0.39 vs 0.29 and 0.13 vs 0.09 per patient, respectively). Conclusions and Relevance: The findings of this IPD meta-analysis reinforce those of individual RCTs that HCQ/CQ is not efficacious for treatment of COVID-19 in hospitalized patients.

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