Assessing bias in osteoarthritis trials included in Cochrane reviews: protocol for a meta-epidemiological study

Julie Bolvig Hansen, Carsten Bogh Juhl, Isabelle Boutron, Peter Tugwell, Elizabeth A T Ghogomu, Jordi Pardo Pardo, Tamara Rader, George A Wells, Alain Mayhew, Lara Maxwell, Hans Lund, Robin Christensen, Editorial Board of the Cochrane Musculoskeletal Group

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

INTRODUCTION: The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta-analyses of interventions used for treating pain in osteoarthritis (OA). From the findings, we hope to consolidate guidance on interpreting OA trials in systematic reviews based on empirical evidence from Cochrane reviews.

METHODS AND ANALYSIS: Only systematic reviews that compare experimental interventions with sham, placebo or no intervention control will be considered eligible. Bias will be assessed with the risk of bias tool, used according to the Cochrane Collaboration's recommendations. Furthermore, center status, trial size and funding will be assessed. The primary outcome (pain) will be abstracted from the first appearing forest plot for overall pain in the Cochrane review. Treatment effect sizes will be expressed as standardised mean differences (SMDs), where the difference in mean values available from the forest plots is divided by the pooled SD. To empirically assess the risk of bias in treatment benefits, we will perform stratified analyses of the trials from the included meta-analyses and assess the interaction between trial characteristics and treatment effect. A relevant study-level covariate is defined as one that decreases the between-study variance (τ(2), estimated as Tau-squared) as a consequence of inclusion in the mixed effects statistical model.

ETHICS AND DISSEMINATION: Meta-analyses and randomised controlled trials provide the most reliable basis for treatment of patients with OA, but the actual impact of bias is unclear. This study will systematically examine the methodological quality in OA Cochrane reviews and explore the effect estimates behind possible bias. Since our study does not collect primary data, no formal ethical assessment and informed consent are required.

TRIAL REGISTRATION NUMBER: PROSPERO (CRD42013006924).

Original languageEnglish
Article numbere005491
JournalBMJ Open
Volume4
ISSN2044-6055
DOIs
Publication statusPublished - 2014

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Epidemiologic Studies
Meta-Analysis
Statistical Models
Informed Consent
Randomized Controlled Trials
Placebos

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Hansen, J. B., Juhl, C. B., Boutron, I., Tugwell, P., Ghogomu, E. A. T., Pardo Pardo, J., ... Editorial Board of the Cochrane Musculoskeletal Group (2014). Assessing bias in osteoarthritis trials included in Cochrane reviews: protocol for a meta-epidemiological study. BMJ Open, 4, [e005491]. https://doi.org/10.1136/bmjopen-2014-005491
Hansen, Julie Bolvig ; Juhl, Carsten Bogh ; Boutron, Isabelle ; Tugwell, Peter ; Ghogomu, Elizabeth A T ; Pardo Pardo, Jordi ; Rader, Tamara ; Wells, George A ; Mayhew, Alain ; Maxwell, Lara ; Lund, Hans ; Christensen, Robin ; Editorial Board of the Cochrane Musculoskeletal Group. / Assessing bias in osteoarthritis trials included in Cochrane reviews : protocol for a meta-epidemiological study. In: BMJ Open. 2014 ; Vol. 4.
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title = "Assessing bias in osteoarthritis trials included in Cochrane reviews: protocol for a meta-epidemiological study",
abstract = "INTRODUCTION: The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta-analyses of interventions used for treating pain in osteoarthritis (OA). From the findings, we hope to consolidate guidance on interpreting OA trials in systematic reviews based on empirical evidence from Cochrane reviews.METHODS AND ANALYSIS: Only systematic reviews that compare experimental interventions with sham, placebo or no intervention control will be considered eligible. Bias will be assessed with the risk of bias tool, used according to the Cochrane Collaboration's recommendations. Furthermore, center status, trial size and funding will be assessed. The primary outcome (pain) will be abstracted from the first appearing forest plot for overall pain in the Cochrane review. Treatment effect sizes will be expressed as standardised mean differences (SMDs), where the difference in mean values available from the forest plots is divided by the pooled SD. To empirically assess the risk of bias in treatment benefits, we will perform stratified analyses of the trials from the included meta-analyses and assess the interaction between trial characteristics and treatment effect. A relevant study-level covariate is defined as one that decreases the between-study variance (τ(2), estimated as Tau-squared) as a consequence of inclusion in the mixed effects statistical model.ETHICS AND DISSEMINATION: Meta-analyses and randomised controlled trials provide the most reliable basis for treatment of patients with OA, but the actual impact of bias is unclear. This study will systematically examine the methodological quality in OA Cochrane reviews and explore the effect estimates behind possible bias. Since our study does not collect primary data, no formal ethical assessment and informed consent are required.TRIAL REGISTRATION NUMBER: PROSPERO (CRD42013006924).",
author = "Hansen, {Julie Bolvig} and Juhl, {Carsten Bogh} and Isabelle Boutron and Peter Tugwell and Ghogomu, {Elizabeth A T} and {Pardo Pardo}, Jordi and Tamara Rader and Wells, {George A} and Alain Mayhew and Lara Maxwell and Hans Lund and Robin Christensen and {Editorial Board of the Cochrane Musculoskeletal Group}",
note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.",
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doi = "10.1136/bmjopen-2014-005491",
language = "English",
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Hansen, JB, Juhl, CB, Boutron, I, Tugwell, P, Ghogomu, EAT, Pardo Pardo, J, Rader, T, Wells, GA, Mayhew, A, Maxwell, L, Lund, H, Christensen, R & Editorial Board of the Cochrane Musculoskeletal Group 2014, 'Assessing bias in osteoarthritis trials included in Cochrane reviews: protocol for a meta-epidemiological study', BMJ Open, vol. 4, e005491. https://doi.org/10.1136/bmjopen-2014-005491

Assessing bias in osteoarthritis trials included in Cochrane reviews : protocol for a meta-epidemiological study. / Hansen, Julie Bolvig; Juhl, Carsten Bogh; Boutron, Isabelle; Tugwell, Peter; Ghogomu, Elizabeth A T; Pardo Pardo, Jordi; Rader, Tamara; Wells, George A; Mayhew, Alain; Maxwell, Lara; Lund, Hans ; Christensen, Robin; Editorial Board of the Cochrane Musculoskeletal Group.

In: BMJ Open, Vol. 4, e005491, 2014.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Assessing bias in osteoarthritis trials included in Cochrane reviews

T2 - protocol for a meta-epidemiological study

AU - Hansen, Julie Bolvig

AU - Juhl, Carsten Bogh

AU - Boutron, Isabelle

AU - Tugwell, Peter

AU - Ghogomu, Elizabeth A T

AU - Pardo Pardo, Jordi

AU - Rader, Tamara

AU - Wells, George A

AU - Mayhew, Alain

AU - Maxwell, Lara

AU - Lund, Hans

AU - Christensen, Robin

AU - Editorial Board of the Cochrane Musculoskeletal Group

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2014

Y1 - 2014

N2 - INTRODUCTION: The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta-analyses of interventions used for treating pain in osteoarthritis (OA). From the findings, we hope to consolidate guidance on interpreting OA trials in systematic reviews based on empirical evidence from Cochrane reviews.METHODS AND ANALYSIS: Only systematic reviews that compare experimental interventions with sham, placebo or no intervention control will be considered eligible. Bias will be assessed with the risk of bias tool, used according to the Cochrane Collaboration's recommendations. Furthermore, center status, trial size and funding will be assessed. The primary outcome (pain) will be abstracted from the first appearing forest plot for overall pain in the Cochrane review. Treatment effect sizes will be expressed as standardised mean differences (SMDs), where the difference in mean values available from the forest plots is divided by the pooled SD. To empirically assess the risk of bias in treatment benefits, we will perform stratified analyses of the trials from the included meta-analyses and assess the interaction between trial characteristics and treatment effect. A relevant study-level covariate is defined as one that decreases the between-study variance (τ(2), estimated as Tau-squared) as a consequence of inclusion in the mixed effects statistical model.ETHICS AND DISSEMINATION: Meta-analyses and randomised controlled trials provide the most reliable basis for treatment of patients with OA, but the actual impact of bias is unclear. This study will systematically examine the methodological quality in OA Cochrane reviews and explore the effect estimates behind possible bias. Since our study does not collect primary data, no formal ethical assessment and informed consent are required.TRIAL REGISTRATION NUMBER: PROSPERO (CRD42013006924).

AB - INTRODUCTION: The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta-analyses of interventions used for treating pain in osteoarthritis (OA). From the findings, we hope to consolidate guidance on interpreting OA trials in systematic reviews based on empirical evidence from Cochrane reviews.METHODS AND ANALYSIS: Only systematic reviews that compare experimental interventions with sham, placebo or no intervention control will be considered eligible. Bias will be assessed with the risk of bias tool, used according to the Cochrane Collaboration's recommendations. Furthermore, center status, trial size and funding will be assessed. The primary outcome (pain) will be abstracted from the first appearing forest plot for overall pain in the Cochrane review. Treatment effect sizes will be expressed as standardised mean differences (SMDs), where the difference in mean values available from the forest plots is divided by the pooled SD. To empirically assess the risk of bias in treatment benefits, we will perform stratified analyses of the trials from the included meta-analyses and assess the interaction between trial characteristics and treatment effect. A relevant study-level covariate is defined as one that decreases the between-study variance (τ(2), estimated as Tau-squared) as a consequence of inclusion in the mixed effects statistical model.ETHICS AND DISSEMINATION: Meta-analyses and randomised controlled trials provide the most reliable basis for treatment of patients with OA, but the actual impact of bias is unclear. This study will systematically examine the methodological quality in OA Cochrane reviews and explore the effect estimates behind possible bias. Since our study does not collect primary data, no formal ethical assessment and informed consent are required.TRIAL REGISTRATION NUMBER: PROSPERO (CRD42013006924).

U2 - 10.1136/bmjopen-2014-005491

DO - 10.1136/bmjopen-2014-005491

M3 - Journal article

C2 - 25280805

VL - 4

JO - B M J Open

JF - B M J Open

SN - 2044-6055

M1 - e005491

ER -