Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions

Jack Wilkinson; Calvin Heal; George A Antoniou; Ella Flemyng; Zarko Alfirevic; Alison Avenell; Virginia Barbour; Nicholas J L Brown; John Carlisle; Mike Clarke; Patrick Dicker; Jo Dumville; Andrew Grey; Steph Grohmann; Lyle C Gurrin; Jill A Hayden; James Heathers; Kylie E Hunter; Toby Lasserson; Emily Lam; Sarah Lensen; Tianjing Li; Wentao Li; Elizabeth Loder; Andreas Lundh; Gideon Meyerowitz-Katz; Ben W Mol; Neil E O' Connell; Lisa Parker; Barbara K Redman; Anna Lene Seidler; Kyle A Sheldrick; Emma Sydenham; David J Torgerson; Madelon van Wely; Rui Wang; Lisa Bero; Jamie J Kirkham

doi:https://doi.org/10.1101/2023.09.21.23295626

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions

Jack Wilkinson, Calvin Heal, George A Antoniou, Ella Flemyng, Zarko Alfirevic, Alison Avenell, Virginia Barbour, Nicholas J L Brown, John Carlisle, Mike Clarke, Patrick Dicker, Jo Dumville, Andrew Grey, Steph Grohmann, Lyle C Gurrin, Jill A Hayden, James Heathers, Kylie E Hunter, Toby Lasserson, Emily LamSarah Lensen, Tianjing Li, Wentao Li, Elizabeth Loder, Andreas Lundh, Gideon Meyerowitz-Katz, Ben W Mol, Neil E O' Connell, Lisa Parker, Barbara K Redman, Anna Lene Seidler, Kyle A Sheldrick, Emma Sydenham, David J Torgerson, Madelon van Wely, Rui Wang, Lisa Bero, Jamie J Kirkham

Research output: Contribution to journal › Article › Academic

Abstract

INTRODUCTION: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INSPECT-SR project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare related interventions.

METHODS AND ANALYSIS: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: 1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, 2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, 3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in 4) a consensus meeting to select checks to be included in a draft tool and to determine its format, 5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies, and will help patients by protecting them from the influence of false data on their healthcare.

Original language	English
Journal	medRxiv
DOIs	https://doi.org/10.1101/2023.09.21.23295626
Publication status	Published - 13 Nov 2023

Access to Document

https://doi.org/10.1101/2023.09.21.23295626

Cite this

Wilkinson, J., Heal, C., Antoniou, G. A., Flemyng, E., Alfirevic, Z., Avenell, A., Barbour, V., Brown, N. J. L., Carlisle, J., Clarke, M., Dicker, P., Dumville, J., Grey, A., Grohmann, S., Gurrin, L. C., Hayden, J. A., Heathers, J., Hunter, K. E., Lasserson, T., ... Kirkham, J. J. (2023). Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions. medRxiv. https://doi.org/10.1101/2023.09.21.23295626

@article{b6f78b3ce4594fea95d561111b02d51c,

title = "Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions",

abstract = "INTRODUCTION: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INSPECT-SR project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare related interventions.METHODS AND ANALYSIS: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: 1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, 2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, 3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in 4) a consensus meeting to select checks to be included in a draft tool and to determine its format, 5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies, and will help patients by protecting them from the influence of false data on their healthcare.",

author = "Jack Wilkinson and Calvin Heal and Antoniou, {George A} and Ella Flemyng and Zarko Alfirevic and Alison Avenell and Virginia Barbour and Brown, {Nicholas J L} and John Carlisle and Mike Clarke and Patrick Dicker and Jo Dumville and Andrew Grey and Steph Grohmann and Gurrin, {Lyle C} and Hayden, {Jill A} and James Heathers and Hunter, {Kylie E} and Toby Lasserson and Emily Lam and Sarah Lensen and Tianjing Li and Wentao Li and Elizabeth Loder and Andreas Lundh and Gideon Meyerowitz-Katz and Mol, {Ben W} and {O' Connell}, {Neil E} and Lisa Parker and Redman, {Barbara K} and Seidler, {Anna Lene} and Sheldrick, {Kyle A} and Emma Sydenham and Torgerson, {David J} and {van Wely}, Madelon and Rui Wang and Lisa Bero and Kirkham, {Jamie J}",

year = "2023",

month = nov,

day = "13",

doi = "https://doi.org/10.1101/2023.09.21.23295626",

language = "English",

journal = "medRxiv",

}

Wilkinson, J, Heal, C, Antoniou, GA, Flemyng, E, Alfirevic, Z, Avenell, A, Barbour, V, Brown, NJL, Carlisle, J, Clarke, M, Dicker, P, Dumville, J, Grey, A, Grohmann, S, Gurrin, LC, Hayden, JA, Heathers, J, Hunter, KE, Lasserson, T, Lam, E, Lensen, S, Li, T, Li, W, Loder, E, Lundh, A, Meyerowitz-Katz, G, Mol, BW, O' Connell, NE, Parker, L, Redman, BK, Seidler, AL, Sheldrick, KA, Sydenham, E, Torgerson, DJ, van Wely, M, Wang, R, Bero, L & Kirkham, JJ 2023, 'Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions', medRxiv. https://doi.org/10.1101/2023.09.21.23295626

TY - JOUR

T1 - Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions

AU - Wilkinson, Jack

AU - Heal, Calvin

AU - Antoniou, George A

AU - Flemyng, Ella

AU - Alfirevic, Zarko

AU - Avenell, Alison

AU - Barbour, Virginia

AU - Brown, Nicholas J L

AU - Carlisle, John

AU - Clarke, Mike

AU - Dicker, Patrick

AU - Dumville, Jo

AU - Grey, Andrew

AU - Grohmann, Steph

AU - Gurrin, Lyle C

AU - Hayden, Jill A

AU - Heathers, James

AU - Hunter, Kylie E

AU - Lasserson, Toby

AU - Lam, Emily

AU - Lensen, Sarah

AU - Li, Tianjing

AU - Li, Wentao

AU - Loder, Elizabeth

AU - Lundh, Andreas

AU - Meyerowitz-Katz, Gideon

AU - Mol, Ben W

AU - O' Connell, Neil E

AU - Parker, Lisa

AU - Redman, Barbara K

AU - Seidler, Anna Lene

AU - Sheldrick, Kyle A

AU - Sydenham, Emma

AU - Torgerson, David J

AU - van Wely, Madelon

AU - Wang, Rui

AU - Bero, Lisa

AU - Kirkham, Jamie J

PY - 2023/11/13

Y1 - 2023/11/13

N2 - INTRODUCTION: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INSPECT-SR project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare related interventions.METHODS AND ANALYSIS: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: 1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, 2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, 3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in 4) a consensus meeting to select checks to be included in a draft tool and to determine its format, 5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies, and will help patients by protecting them from the influence of false data on their healthcare.

AB - INTRODUCTION: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INSPECT-SR project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare related interventions.METHODS AND ANALYSIS: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: 1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, 2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, 3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in 4) a consensus meeting to select checks to be included in a draft tool and to determine its format, 5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies, and will help patients by protecting them from the influence of false data on their healthcare.

U2 - https://doi.org/10.1101/2023.09.21.23295626

DO - https://doi.org/10.1101/2023.09.21.23295626

M3 - Article

C2 - 37873409

JO - medRxiv

JF - medRxiv

ER -