Lesley A Stewart

The University of York · Centre for Reviews and Dissemination

This chapter presents the preparatory phase of an individual participant data (IPD) meta-analysis project and provides guidance for planning and initiation. It outlines the importance of carefully refining the research question to be addressed through development of a project scope, building the collaborative framework for the project, and establis...

This chapter overviews those elements of an individual participant data (IPD) meta-analysis project that differ from a conventional meta-analysis of aggregate data. It describes the advantages and challenges of the IPD approach. IPD meta-analysis projects follow many of the same principles and research processes as conventional systematic reviews a...

The CheckMAP tool provides a list of signalling questions to consider when checking and appraising an individual participant data (IPD) meta-analysis project, and answers of ‘yes’ to questions are indicative of higher quality. A summary of the CheckMAP assessment provides a useful overview of the quality of a particular IPD meta-analysis project. A...

This chapter provides guidance on the preparations needed just prior to the collection of individual participant data (IPD) and how to go about establishing and maintaining collaboration with IPD providers. It discusses various aspects that should be considered when preparing to collect IPD. Negotiating and maintaining collaborations with trial inv...

The main purpose of evidence synthesis within healthcare is to generate reliable research-based evidence to inform decisions that ultimately improve the health and care of individuals. This chapter outlines how to report the methods and findings of individual participant data (IPD) meta analysis projects in technical reports and journal articles, a...

This chapter presents the differences between individual participant data (IPD) and aggregate data, and outline why IPD meta-analysis projects are increasingly needed. An IPD meta-analysis project, therefore, involves the collection, checking, harmonisation and synthesis of IPD from multiple studies to answer particular research questions. A conven...

Obtaining individual participant data (IPD) can reduce many of the potential biases facing conventional meta-analyses of published aggregate data. This chapter describes how researchers can examine the potential impact of biases on IPD meta-analysis results by using sensitivity analyses, funnel plots, and a combination of IPD and aggregate data. Pu...

Background: Funded health research is being published in journals that many regard as “predatory”, deceptive, and non-credible. We do not currently know whether funders provide guidance on how to select a journal in which to publish funded health research. Methods: We identified the largest 46 philanthropic, public, development assistance, public-p...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

The methods and results of systematic reviews should be reported in sufficient detail to allow users to assess the trustworthiness and applicability of the review findings. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was developed to facilitate transparent and complete reporting of systematic reviews an...

Matthew Page and co-authors describe PRISMA 2020, an updated reporting guideline for systematic reviews and meta-analyses.

Medical interventions may be more effective in some types of individuals than others and identifying characteristics that modify the effectiveness of an intervention is a cornerstone of precision or stratified medicine. The opportunity for detailed examination of treatment-covariate interactions can be an important driver for undertaking an individ...

Background Preterm birth is a global health priority. Using a progestogen during high-risk pregnancy could reduce preterm birth and adverse neonatal outcomes. Methods We did a systematic review of randomised trials comparing vaginal progesterone, intramuscular 17-hydroxyprogesterone caproate (17-OHPC), or oral progesterone with control, or with ea...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update t...

Background: Funded health research is being published in journals that many regard as “predatory”, deceptive, and non-credible. We do not currently know whether funders provide guidance on how to select a journal in which to publish funded health research. Methods: We identified the largest 46 philanthropic, public, development assistance, public-p...

Lay abstract: Early intensive applied behaviour analysis-based interventions are designed to support young autistic children's learning and development. Unfortunately, the available evidence about the effectiveness of these interventions remains unclear. Several reviews have focused on the published findings rather than contacting the authors to c...

Objective To characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally. Design Qualitative interview...

Background: The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) Statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did and what they found. Over the last decade, there have been many advances in systematic review methodology and terminolo...

The methods and results of systematic reviews should be reported in sufficient detail to allow users to assess the trustworthiness and applicability of the review findings. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was developed to facilitate transparent and complete reporting of systematic reviews an...

Background As production of rapid reviews (RRs) increases in healthcare, knowing how to efficiently convey RR evidence to various end-users is important given they are often intended to directly inform decision-making. Little is known about how often RRs are produced in the published or unpublished domains, and what and how information is structure...

Background Early intensive applied behaviour analysis-based interventions are intensive interventions for autistic children that are often delivered on a one-to-one basis for 20–50 hours per week. Objectives To evaluate the clinical effectiveness and cost-effectiveness of early intensive applied behaviour analysis-based interventions for autistic...

Introduction: Reducing treatment intensity for pediatric low risk febrile neutropenia may improve quality of life, and reduce hospital-acquired infections and costs. Key stakeholders' attitudes toward early discharge regimens are unknown. This study explored perceptions of reduced therapy regimens in the United Kingdom. Materials and methods: Th...

Background It remains unclear when standard systematic reviews and meta-analyses that rely on published aggregate data (AD) can provide robust clinical conclusions. We aimed to compare the results from a large cohort of systematic reviews and meta-analyses based on individual participant data (IPD) with meta-analyses of published AD, to establish w...

Objective: To identify and summarise 1) appraisal tools and other guides which address conflicts of interest in medical research studies; and 2) top journals with policies on managing conflicts of interest in journal papers. Study design and setting: Systematic review. We searched bibliographic databases, other sources and websites of 30 top med...

The revised edition of the Handbook offers the only guide on how to conduct, report and maintain a Cochrane Review. The second edition of The Cochrane Handbook for Systematic Reviews of Interventions contains essential guidance for preparing and maintaining Cochrane Reviews of the effects of health interventions. Designed to be an accessible resou...

Assessment of risk of bias is regarded as an essential component of a systematic review on the effects of an intervention. The most commonly used tool for randomised trials is the Cochrane risk-of-bias tool. We updated the tool to respond to developments in understanding how bias arises in randomised trials, and to address user feedback on and limi...

Objectives: The aim of the study was to examine the effect of providing a financial incentive to authors of randomized clinical trials (RCTs) to obtain individual patient data (IPD). Study design and setting: Parallel-group RCT with authors identified in the RCTs eligible for two systematic reviews. The authors were randomly allocated to the int...

The journal recently celebrated its fifth anniversary. Like systematic reviews themselves, the journal is thriving and publishing a variety of protocols, reviews, and methods papers. We have also had success in publishing-themed series.

Scoping reviews, a type of knowledge synthesis, follow a systematic approach to map evidence on a topic and identify main concepts, theories, sources, and knowledge gaps. Although more scoping reviews are being done, their methodological and reporting quality need improvement. This document presents the PRISMA-ScR (Preferred Reporting Items for Sys...

Reporting bias is a major threat to the validity and credibility of systematic reviews. This article outlines the rationale for accessing clinical study reports and other regulatory documents (regulatory data) as a means of addressing reporting bias and identifies factors that may help decide whether (or not) to include regulatory data in systemati...

Background: Clinical study reports (CSRs) are produced for marketing authorisation applications. They often contain considerably more information about, and data from, clinical trials than corresponding journal publications. Use of data from CSRs might help circumvent reporting bias, but many researchers appear to be unaware of their existence or...

Objectives A systematic review of paediatric low-risk febrile neutropenia found that outpatient care is safe, with low rates of treatment failure. However, this review, and a subsequent meta-ethnography, suggested that early discharge of these patients may not be acceptable to key stakeholders. This study aimed to explore experiences and perception...

Purpose (stating the main purposes and research question): Many children have no significant sequelae of febrile neutropenia. A systematic review of clinical studies demonstrated patients at low risk of septic complications can be safely treated as outpatients using oral antibiotics with low rates of treatment failure. Introducing earlier discharg...

Background: Preterm birth is the most common cause of death and harm to newborn babies. Babies that are born early may have difficulties at birth and experience health problems during early childhood. Despite extensive study, there is still uncertainty about the effectiveness of progestogen (medications that are similar to the natural hormone prog...

Objectives The effective exploitation of what are often called big data is increasingly important. They provide the evidence in evidence-based health care and underpin scientific progress in many domains including social/economic policy. Typically, an optimal analysis involves working directly with microdata; i.e. the detailed data relating to each...

Background It is uncertain whether the replication of systematic reviews, particularly those with the same objectives and resources, would employ similar methods and/or arrive at identical findings. We compared the results and conclusions of two concurrent systematic reviews undertaken by two independent research teams provided with the same object...

A peer-reviewed journal would not survive without the generous time and insightful comments of the reviewers, whose efforts often go unrecognized. Although final decisions are always editorial, they are greatly facilitated by the deeper technical knowledge, scientific insights, understanding of social consequences, and passion that reviewers bring...

Background: Risk-stratified management of febrile neutropenia (FN) allows intensive management of high-risk cases and early discharge of low-risk cases. Most risk stratification systems predicting severe infection from admission variables have been derived from childhood or adult populations and consequently their value in adolescents/young adults...

Cancer-associated thromboembolism is a substantial problem in clinical practice. An increase in the level of fibrinopeptide A (a substance associated with hypercoagulable states) has been observed in humans exposed to fluorouracil. Anti-EGFR monoclonal antibodies cetuximab and panitumumab, which are now widely used in patients with metastatic color...

Purpose: Reduced intensity therapy for children with low-risk febrile neutropenia may provide benefits to both patients and the health service. We have explored the safety of these regimens and the effect of timing of discharge. Methods: Multiple electronic databases, conference abstracts and reference lists were searched. Randomised controlled...

The BJC is owned by Cancer Research UK, a charity dedicated to understanding the causes, prevention and treatment of cancer and to making sure that the best new treatments reach patients in the clinic as quickly as possible. The journal reflects these aims. It was founded more than fifty years ago and, from the start, its far-sighted mission was to...

Objectives: To examine outcome reporting bias of systematic reviews registered in PROSPERO. Study design and setting: Retrospective cohort study. The primary outcomes from systematic review publications were compared with those reported in the corresponding PROSPERO records; discrepancies in the primary outcomes were assessed as upgrades, additi...

Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating diff...

Background: Risk-stratified management of fever with neutropenia (FN), allows intensive management of high-risk cases and early discharge of low-risk cases. No single, internationally validated, prediction model of the risk of adverse outcomes exists for children and young people. An individual patient data (IPD) meta-analysis was undertaken to de...

Contributing reviewers A peer-reviewed journal would not survive without the generous time and insightful comments of the reviewers, whose efforts often go unrecognized. Although final decisions are always editorial, they are greatly facilitated by the deeper technical knowledge, scientific insights, understanding of social consequences, and passio...

Jayne Tierney and colleagues offer guidance on how to spot a well-designed and well-conducted individual participant data meta-analysis.

Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to sh...

To establish the extent to which systematic reviews and meta-analyses of individual participant data (IPD) are being used to inform the recommendations included in published clinical guidelines. Descriptive study. Database maintained by the Cochrane IPD Meta-analysis Methods Group, supplemented by records of published IPD meta-analyses held in a se...

To evaluate the effects of administering chemotherapy following surgery, or following surgery plus radiotherapy (known as adjuvant chemotherapy) in patients with early stage non-small cell lung cancer (NSCLC),we performed two systematic reviews and meta-analyses of all randomised controlled trials using individual participant data. Results were fir...

Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting...

Protocols of systematic reviews and meta-analyses allow for planning and documentation of review methods, act as a guard against arbitrary decision making during review conduct, enable readers to assess for the presence of selective reporting against completed reviews, and, when made publicly available, reduce duplication of efforts and potentially...

: Protocols of systematic reviews and meta-analyses allow for planning and documentation of review methods, act as a guard against arbitrary decision making during review conduct, enable readers to assess for the presence of selective reporting against completed reviews, and, when made publicly available, reduce duplication of efforts and potential...

Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting...

PROSPERO is the open access prospective register for systematic review protocols launched by NIHR Centre for Reviews and Dissemination in February 2011. The key aims of the register are to facilitate transparency in the review process by prospectively recording planned methods and to provide a searchable database of ongoing reviews that will assist...

Background Febrile neutropenia is a common complication of therapy in children with cancer. Some patients are at low risk of complications, and research has considered reduction in therapy for these patients. A previous systematic review broadly considered whether outpatient treatment and oral antibiotics were safe in this context and concluded tha...

Waugh is correct1—we cannot completely prevent unscrupulous use of content with an open register. However, there is no evidence that people are using PROSPERO records to plunder others’ ideas and scoop publication. But there are examples of unnecessary duplication being avoided, including the National Institute for Health Research Health Technology...

About a year ago we launched the Journal. During its first year we have been delighted by its growth and rate of development. At the time of writing we have published 84 articles. Of these, 42 were protocols, 17 completed systematic reviews, 9 methods papers, and 16 were other types of articles including two overviews. Twenty articles have been hig...

It has been suggested that individual participant data (IPD) meta-analyses of randomised controlled trials are the ‘gold standard’ approach to systematic review, allowing the most robust and unbiased assessment of research evidence to provide the most accurate information regarding the efficacy of a therapy.1 Such projects aim to collect raw line b...

To investigate whether published results of industry funded trials of recombinant human bone morphogenetic protein 2 (rhBMP-2) in spinal fusion match underlying trial data by comparing three different data sources: individual participant data, internal industry reports, and publicly available journal publications and conference abstracts. The manuf...

Overview of available sources of data for Metronic rhBMP-2

Outcomes reported in peer reviewed journal articles compared with Medtronic internal reports

Adverse events occurring in Medtronic studies, as reported in published journal articles