Bias due to MEasurement Reactions In Trials to improve health (MERIT)

protocol for research to develop MRC guidance

Lisa M. Miles, Diana Elbourne, Andrew Farmer, Martin C. Gulliford, Louise Locock, Jim McCambridge, Stephen Sutton, David P French (Corresponding Author)

Research output: Contribution to journalArticle

1 Citation (Scopus)
4 Downloads (Pure)

Abstract

Background
There is now clear systematic review evidence that measurement can affect the people being measured; much of this evidence focusses on how asking people to complete a questionnaire can result in changes in behaviour. Changes in measured behaviour and other outcomes due to this reactivity may introduce bias in otherwise well-conducted randomised controlled trials (RCTs), yielding incorrect estimates of intervention effects. Despite this, measurement reactivity is not currently adequately considered in risk of bias frameworks. The present research aims to produce a set of guidance statements on how best to avoid or minimise bias due to measurement reactivity in studies of interventions to improve health, with a particular focus on bias in RCTs.

Methods
The MERIT study consists of a series of systematic and rapid reviews, a Delphi study and an expert workshop to develop guidance on how to minimise bias in trials due to measurement reactivity. An existing systematic review on question-behaviour effects on health-related behaviours will be updated and three new rapid reviews will be conducted to identify (1) existing guidance on measurement reactivity; (2) systematic reviews of studies that have quantified the effects of measurement on outcomes relating to behaviour and affective outcomes in health and non-health contexts and (3) trials that have investigated the effects of objective measurements of behaviour on concurrent or subsequent behaviour itself. A Delphi procedure will be used to combine the views of experts with a view to reaching agreement on the scope of the guidance statements. Finally, a workshop will be held in autumn 2018, with the aim of producing a set of guidance statements that will form the central part of new MRC guidance on how best to avoid bias due to measurement reactivity in studies of interventions to improve health.

Discussion
Our ambition is to produce MRC guidance on measurement reactions in trials which will be used by future trial researchers, leading to the development of trials that are less likely to be at risk of bias.
Original languageEnglish
Article number653
Number of pages8
JournalTrials
Volume19
DOIs
Publication statusPublished - 26 Nov 2018

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Health
Research
Randomized Controlled Trials
Delphi Technique
Education
Research Personnel
Surveys and Questionnaires

Keywords

  • measurement
  • reactivity
  • measurement reactions
  • guidance
  • trials
  • bias
  • Hawthorne effect

Cite this

Bias due to MEasurement Reactions In Trials to improve health (MERIT) : protocol for research to develop MRC guidance. / Miles, Lisa M.; Elbourne, Diana; Farmer, Andrew; Gulliford, Martin C.; Locock, Louise; McCambridge, Jim; Sutton, Stephen; French, David P (Corresponding Author).

In: Trials, Vol. 19, 653, 26.11.2018.

Research output: Contribution to journalArticle

Miles, Lisa M. ; Elbourne, Diana ; Farmer, Andrew ; Gulliford, Martin C. ; Locock, Louise ; McCambridge, Jim ; Sutton, Stephen ; French, David P. / Bias due to MEasurement Reactions In Trials to improve health (MERIT) : protocol for research to develop MRC guidance. In: Trials. 2018 ; Vol. 19.
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abstract = "BackgroundThere is now clear systematic review evidence that measurement can affect the people being measured; much of this evidence focusses on how asking people to complete a questionnaire can result in changes in behaviour. Changes in measured behaviour and other outcomes due to this reactivity may introduce bias in otherwise well-conducted randomised controlled trials (RCTs), yielding incorrect estimates of intervention effects. Despite this, measurement reactivity is not currently adequately considered in risk of bias frameworks. The present research aims to produce a set of guidance statements on how best to avoid or minimise bias due to measurement reactivity in studies of interventions to improve health, with a particular focus on bias in RCTs.MethodsThe MERIT study consists of a series of systematic and rapid reviews, a Delphi study and an expert workshop to develop guidance on how to minimise bias in trials due to measurement reactivity. An existing systematic review on question-behaviour effects on health-related behaviours will be updated and three new rapid reviews will be conducted to identify (1) existing guidance on measurement reactivity; (2) systematic reviews of studies that have quantified the effects of measurement on outcomes relating to behaviour and affective outcomes in health and non-health contexts and (3) trials that have investigated the effects of objective measurements of behaviour on concurrent or subsequent behaviour itself. A Delphi procedure will be used to combine the views of experts with a view to reaching agreement on the scope of the guidance statements. Finally, a workshop will be held in autumn 2018, with the aim of producing a set of guidance statements that will form the central part of new MRC guidance on how best to avoid bias due to measurement reactivity in studies of interventions to improve health.DiscussionOur ambition is to produce MRC guidance on measurement reactions in trials which will be used by future trial researchers, leading to the development of trials that are less likely to be at risk of bias.",
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author = "Miles, {Lisa M.} and Diana Elbourne and Andrew Farmer and Gulliford, {Martin C.} and Louise Locock and Jim McCambridge and Stephen Sutton and French, {David P}",
note = "Acknowledgements The authors would like to acknowledge Dr. Angela Rodrigues and Prof. Falko Sniehotta who are co-authors working on the systematic review of the question-behaviour effect on health-related behaviours and Dr. Katerina Kassavou who is a co-author of the three rapid reviews described in this protocol. Funding The MERIT study is funded by the MRC/NIHR Methodology Research Programme (reference MC_PC_17229); funders have had no role in the design of the study or the writing of this manuscript.",
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AU - Farmer, Andrew

AU - Gulliford, Martin C.

AU - Locock, Louise

AU - McCambridge, Jim

AU - Sutton, Stephen

AU - French, David P

N1 - Acknowledgements The authors would like to acknowledge Dr. Angela Rodrigues and Prof. Falko Sniehotta who are co-authors working on the systematic review of the question-behaviour effect on health-related behaviours and Dr. Katerina Kassavou who is a co-author of the three rapid reviews described in this protocol. Funding The MERIT study is funded by the MRC/NIHR Methodology Research Programme (reference MC_PC_17229); funders have had no role in the design of the study or the writing of this manuscript.

PY - 2018/11/26

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N2 - BackgroundThere is now clear systematic review evidence that measurement can affect the people being measured; much of this evidence focusses on how asking people to complete a questionnaire can result in changes in behaviour. Changes in measured behaviour and other outcomes due to this reactivity may introduce bias in otherwise well-conducted randomised controlled trials (RCTs), yielding incorrect estimates of intervention effects. Despite this, measurement reactivity is not currently adequately considered in risk of bias frameworks. The present research aims to produce a set of guidance statements on how best to avoid or minimise bias due to measurement reactivity in studies of interventions to improve health, with a particular focus on bias in RCTs.MethodsThe MERIT study consists of a series of systematic and rapid reviews, a Delphi study and an expert workshop to develop guidance on how to minimise bias in trials due to measurement reactivity. An existing systematic review on question-behaviour effects on health-related behaviours will be updated and three new rapid reviews will be conducted to identify (1) existing guidance on measurement reactivity; (2) systematic reviews of studies that have quantified the effects of measurement on outcomes relating to behaviour and affective outcomes in health and non-health contexts and (3) trials that have investigated the effects of objective measurements of behaviour on concurrent or subsequent behaviour itself. A Delphi procedure will be used to combine the views of experts with a view to reaching agreement on the scope of the guidance statements. Finally, a workshop will be held in autumn 2018, with the aim of producing a set of guidance statements that will form the central part of new MRC guidance on how best to avoid bias due to measurement reactivity in studies of interventions to improve health.DiscussionOur ambition is to produce MRC guidance on measurement reactions in trials which will be used by future trial researchers, leading to the development of trials that are less likely to be at risk of bias.

AB - BackgroundThere is now clear systematic review evidence that measurement can affect the people being measured; much of this evidence focusses on how asking people to complete a questionnaire can result in changes in behaviour. Changes in measured behaviour and other outcomes due to this reactivity may introduce bias in otherwise well-conducted randomised controlled trials (RCTs), yielding incorrect estimates of intervention effects. Despite this, measurement reactivity is not currently adequately considered in risk of bias frameworks. The present research aims to produce a set of guidance statements on how best to avoid or minimise bias due to measurement reactivity in studies of interventions to improve health, with a particular focus on bias in RCTs.MethodsThe MERIT study consists of a series of systematic and rapid reviews, a Delphi study and an expert workshop to develop guidance on how to minimise bias in trials due to measurement reactivity. An existing systematic review on question-behaviour effects on health-related behaviours will be updated and three new rapid reviews will be conducted to identify (1) existing guidance on measurement reactivity; (2) systematic reviews of studies that have quantified the effects of measurement on outcomes relating to behaviour and affective outcomes in health and non-health contexts and (3) trials that have investigated the effects of objective measurements of behaviour on concurrent or subsequent behaviour itself. A Delphi procedure will be used to combine the views of experts with a view to reaching agreement on the scope of the guidance statements. Finally, a workshop will be held in autumn 2018, with the aim of producing a set of guidance statements that will form the central part of new MRC guidance on how best to avoid bias due to measurement reactivity in studies of interventions to improve health.DiscussionOur ambition is to produce MRC guidance on measurement reactions in trials which will be used by future trial researchers, leading to the development of trials that are less likely to be at risk of bias.

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KW - bias

KW - Hawthorne effect

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