How systematic reviews and meta-analyses based on individual participant data can inform trial design and conduct

IntroductionThe heterogeneity in people with borderline personality disorder (BPD) and the range of specialised psychotherapies means that people with certain BPD characteristics might benefit more or less from different types of psychotherapy. Identifying moderating characteristics of individuals is a key to refine and tailor standard treatments so they match the specificities of the individual participant. The objective of this is to improve the quality of care and the individual outcomes. We will do so by performing three systematic reviews with meta-analyses of individual participant data (IPD). The aim of these reviews is to investigate potential predictors and moderating patient characteristics on treatment outcomes for patients with BPD.Methods and analysisWe performed comprehensive searches in 22 databases and trial registries up to October 6th 2020. These will be updated with a top-up search up until June 2021. Our primary meta-analytic method will be the one-stage random-effects approach. To identify predictors, we will use the one-stage model that accounts for interaction between covariates and treatment allocation. Heterogeneity in case-mix will be assessed with a membership model based on a multinomial logistic regression where study membership is the outcome. A random-effects meta-analysis is chosen to account for expected levels of heterogeneity.Ethics and disseminationThe statistical analyses will be conducted on anonymised data that have already been approved by the respective ethical committees that originally assessed the included trials. The three IPD reviews will be published in high-impact factor journals and their results will be presented at international conferences and national seminars.PROSPERO registration numberCRD42021210688.

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Faculty Opinions recommendation of Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718026256.793488360 ◽

2013 ◽

Author(s):

Andreas Sandner-Kiesling

Keyword(s):

Individual Participant Data ◽

Randomised Trials ◽

Individual Participant ◽

Inflammatory Drugs ◽

Anti Inflammatory ◽

Meta Analyses ◽

Upper Gastrointestinal

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Faculty Opinions recommendation of Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718026256.793480879 ◽

2013 ◽

Author(s):

Ian Beales

Keyword(s):

Individual Participant Data ◽

Randomised Trials ◽

Individual Participant ◽

Inflammatory Drugs ◽

Anti Inflammatory ◽

Meta Analyses ◽

Upper Gastrointestinal

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Diet and physical activity in pregnancy to prevent gestational diabetes: a protocol for an individual participant data (IPD) meta-analysis on the differential effects of interventions with economic evaluation

BMJ Open ◽

10.1136/bmjopen-2020-048119 ◽

2021 ◽

Vol 11 (6) ◽

pp. e048119

Author(s):

Dyuti Coomar ◽

Jonathan M Hazlehurst ◽

Frances Austin ◽

Charlie Foster ◽

Graham A Hitman ◽

...

Keyword(s):

Physical Activity ◽

Cost Effectiveness ◽

Gestational Diabetes ◽

Systematic Reviews ◽

Meta Analysis ◽

Individual Participant Data ◽

Randomised Trials ◽

Diet And Physical Activity ◽

Individual Participant ◽

In Pregnancy

IntroductionMothers with gestational diabetes mellitus (GDM) are at increased risk of pregnancy-related complications and developing type 2 diabetes after delivery. Diet and physical activity-based interventions may prevent GDM, but variations in populations, interventions and outcomes in primary trials have limited the translation of available evidence into practice. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to assess the differential effects and cost-effectiveness of diet and physical activity-based interventions in preventing GDM and its complications.MethodsThe International Weight Management in Pregnancy Collaborative Network database is a living repository of IPD from randomised trials on diet and physical activity in pregnancy identified through a systematic literature search. We shall update our existing search on MEDLINE, Embase, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects and Health Technology Assessment Database without language restriction to identify relevant trials until March 2021. Primary researchers will be invited to join the Network and share their IPD. Trials including women with GDM at baseline will be excluded. We shall perform a one and two stage random-effect meta-analysis for each intervention type (all interventions, diet-based, physical activity-based and mixed approach) to obtain summary intervention effects on GDM with 95% CIs and summary treatment–covariate interactions. Heterogeneity will be summarised using I2 and tau2 statistics with 95% prediction intervals. Publication and availability bias will be assessed by examining small study effects. Study quality of included trials will be assessed by the Cochrane Risk of Bias tool, and the Grading of Recommendations, Assessment, Development and Evaluations approach will be used to grade the evidence in the results. A model-based economic analysis will be carried out to assess the cost-effectiveness of interventions to prevent GDM and its complications compared with usual care.Ethics and disseminationEthics approval is not required. The study is registered on the International Prospective Register of Systematic Reviews (CRD42020212884). Results will be submitted for publication in peer-reviewed journals.

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Arm Based on LEg blood pressures (ABLE-BP): can systolic leg blood pressure measurements predict systolic brachial blood pressure? Protocol for an individual participant data meta-analysis from the INTERPRESS-IPD Collaboration

BMJ Open ◽

10.1136/bmjopen-2020-040481 ◽

2021 ◽

Vol 11 (3) ◽

pp. e040481

Author(s):

Sinead T J McDonagh ◽

James P Sheppard ◽

Fiona C Warren ◽

Kate Boddy ◽

Leon Farmer ◽

...

Keyword(s):

Blood Pressure ◽

Public Involvement ◽

Meta Analysis ◽

Patient And Public Involvement ◽

Prognostic Models ◽

Individual Participant Data ◽

Dissemination Strategy ◽

Cross Sectional ◽

Individual Participant ◽

Meta Analyses

IntroductionBlood pressure (BP) is normally measured on the upper arm, and guidelines for the diagnosis and treatment of high BP are based on such measurements. Leg BP measurement can be an alternative when brachial BP measurement is impractical, due to injury or disability. Limited data exist to guide interpretation of leg BP values for hypertension management; study-level systematic review findings suggest that systolic BP (SBP) is 17 mm Hg higher in the leg than the arm. However, uncertainty remains about the applicability of this figure in clinical practice due to substantial heterogeneity.AimsTo examine the relationship between arm and leg SBP, develop and validate a multivariable model predicting arm SBP from leg SBP and investigate the prognostic association between leg SBP and cardiovascular disease and mortality.Methods and analysisIndividual participant data (IPD) meta-analyses using arm and leg SBP measurements for 33 710 individuals from 14 studies within the Inter-arm blood pressure difference IPD (INTERPRESS-IPD) Collaboration. We will explore cross-sectional relationships between arm and leg SBP using hierarchical linear regression with participants nested by study, in multivariable models. Prognostic models will be derived for all-cause and cardiovascular mortality and cardiovascular events.Ethics and disseminationData originate from studies with prior ethical approval and consent, and data sharing agreements are in place—no further approvals are required to undertake the secondary analyses proposed in this protocol. Findings will be published in peer-reviewed journal articles and presented at conferences. A comprehensive dissemination strategy is in place, integrated with patient and public involvement.PROSPERO registration numberCRD42015031227.

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