An Investigative Review into the Process of Establishing, Managing and Supporting Independent Reviews in Scotland

Research output: Book/ReportCommissioned report

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Abstract

Executive Summary
A petition on polypropylene mesh medical devices was lodged in April 2014 to the Public Petitions Committee of the Scottish Parliament by Elaine Holmes and Olive McIIroy on behalf of the Scottish Mesh Survivors ‘Hear Our Voice’ campaign.

The Petition was lodged to draw attention to a number of women who had experienced serious complications following procedures to treat pelvic organ prolapse and stress urinary incontinence. This was linked with under-reporting of adverse events and a poor understanding as to why these complications had occurred. It received in excess of 1,700 signatures and 212 comments.

Following further evidence provided by the petitioners, Elaine Holmes and Olive McIlroy, on 17 June 2014, Alex Neil – then the Cabinet Secretary for Health and Wellbeing – informed the Committee that he intended to commission an Independent Review. The Review would not only explore the evidence that the petitioners had provided, but also consider complication rates and under-reporting of adverse events as well as looking at the overall evidence base for mesh devices.

The Scottish Independent Review Group held its first meeting on 25 August 2014.

On 27 March 2017, the Scottish Government published the Mesh Review’s Final Report, entitled The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women.[1] This was preceded by an Interim Report which was published on 2 October 2015.

Prior to the publication of the Final Report, the first chair resigned and a second chair was appointed. Three further members of the Mesh Review Group resigned. The publication of the Final Report generated widespread criticism. Concerns ranged from the evaluation and exclusion of certain evidence, to the independence of the review process, and in particular to the inclusion of the petitioners’ input to the Final Report, despite their resignation and request for their contribution to be removed.

In response to these concerns, on 18 May 2017, the then Cabinet Secretary for Health and Sport, Shona Robison, advised the Public Petitions Committee of the Scottish Parliament that the process by which the Mesh Review Group came to its conclusions would in itself, be examined. An Investigative Review would be commissioned to undertake this task.

This report presents the findings of that Investigative Review. The task of this investigation has not been to reconsider the merits of the Mesh Review’s substantive conclusions on the safety and efficacy of transvaginal mesh implants, nor have we sought to apportion individual blame for any failing or omissions. That was not our remit. We have however, attempted to discover what caused the Mesh Review to be received in the way that it was.

Our Report comprises 10 chapters. It takes a chronological approach, from the commissioning of the Mesh Review until its publication. The balance of this chapter introduces key information about the composition of this Investigative Review Group and our methodology. Each subsequent chapter discusses key areas in which we have identified failures or mistakes as well as lessons which can usefully be learned from the Mesh Review for the establishment, management and support of future independent reviews.
Original languageEnglish
PublisherGlasgow Caledonian University
Commissioning bodyScottish Government
ISBN (Electronic)ISBN: 9781787813342
Publication statusPublished - 25 Oct 2018

Fingerprint

Scotland
Pelvic Organ Prolapse
Publications
Stress Urinary Incontinence
Olea
Safety
Equipment and Supplies
Polypropylenes
Health
Sports
Survivors
Therapeutics

Keywords

  • investigative review
  • supporting independent reviews
  • Scottish Government

Cite this

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title = "An Investigative Review into the Process of Establishing, Managing and Supporting Independent Reviews in Scotland",
abstract = "Executive SummaryA petition on polypropylene mesh medical devices was lodged in April 2014 to the Public Petitions Committee of the Scottish Parliament by Elaine Holmes and Olive McIIroy on behalf of the Scottish Mesh Survivors ‘Hear Our Voice’ campaign.The Petition was lodged to draw attention to a number of women who had experienced serious complications following procedures to treat pelvic organ prolapse and stress urinary incontinence. This was linked with under-reporting of adverse events and a poor understanding as to why these complications had occurred. It received in excess of 1,700 signatures and 212 comments.Following further evidence provided by the petitioners, Elaine Holmes and Olive McIlroy, on 17 June 2014, Alex Neil – then the Cabinet Secretary for Health and Wellbeing – informed the Committee that he intended to commission an Independent Review. The Review would not only explore the evidence that the petitioners had provided, but also consider complication rates and under-reporting of adverse events as well as looking at the overall evidence base for mesh devices.The Scottish Independent Review Group held its first meeting on 25 August 2014.On 27 March 2017, the Scottish Government published the Mesh Review’s Final Report, entitled The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women.[1] This was preceded by an Interim Report which was published on 2 October 2015.Prior to the publication of the Final Report, the first chair resigned and a second chair was appointed. Three further members of the Mesh Review Group resigned. The publication of the Final Report generated widespread criticism. Concerns ranged from the evaluation and exclusion of certain evidence, to the independence of the review process, and in particular to the inclusion of the petitioners’ input to the Final Report, despite their resignation and request for their contribution to be removed.In response to these concerns, on 18 May 2017, the then Cabinet Secretary for Health and Sport, Shona Robison, advised the Public Petitions Committee of the Scottish Parliament that the process by which the Mesh Review Group came to its conclusions would in itself, be examined. An Investigative Review would be commissioned to undertake this task.This report presents the findings of that Investigative Review. The task of this investigation has not been to reconsider the merits of the Mesh Review’s substantive conclusions on the safety and efficacy of transvaginal mesh implants, nor have we sought to apportion individual blame for any failing or omissions. That was not our remit. We have however, attempted to discover what caused the Mesh Review to be received in the way that it was.Our Report comprises 10 chapters. It takes a chronological approach, from the commissioning of the Mesh Review until its publication. The balance of this chapter introduces key information about the composition of this Investigative Review Group and our methodology. Each subsequent chapter discusses key areas in which we have identified failures or mistakes as well as lessons which can usefully be learned from the Mesh Review for the establishment, management and support of future independent reviews.",
keywords = "investigative review, supporting independent reviews, Scottish Government",
author = "Alison Britton",
note = "Report published by GCU, FT uploaded on request by author. ET 19/6/19",
year = "2018",
month = "10",
day = "25",
language = "English",
publisher = "Glasgow Caledonian University",

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An Investigative Review into the Process of Establishing, Managing and Supporting Independent Reviews in Scotland. / Britton, Alison.

Glasgow Caledonian University, 2018.

Research output: Book/ReportCommissioned report

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N2 - Executive SummaryA petition on polypropylene mesh medical devices was lodged in April 2014 to the Public Petitions Committee of the Scottish Parliament by Elaine Holmes and Olive McIIroy on behalf of the Scottish Mesh Survivors ‘Hear Our Voice’ campaign.The Petition was lodged to draw attention to a number of women who had experienced serious complications following procedures to treat pelvic organ prolapse and stress urinary incontinence. This was linked with under-reporting of adverse events and a poor understanding as to why these complications had occurred. It received in excess of 1,700 signatures and 212 comments.Following further evidence provided by the petitioners, Elaine Holmes and Olive McIlroy, on 17 June 2014, Alex Neil – then the Cabinet Secretary for Health and Wellbeing – informed the Committee that he intended to commission an Independent Review. The Review would not only explore the evidence that the petitioners had provided, but also consider complication rates and under-reporting of adverse events as well as looking at the overall evidence base for mesh devices.The Scottish Independent Review Group held its first meeting on 25 August 2014.On 27 March 2017, the Scottish Government published the Mesh Review’s Final Report, entitled The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women.[1] This was preceded by an Interim Report which was published on 2 October 2015.Prior to the publication of the Final Report, the first chair resigned and a second chair was appointed. Three further members of the Mesh Review Group resigned. The publication of the Final Report generated widespread criticism. Concerns ranged from the evaluation and exclusion of certain evidence, to the independence of the review process, and in particular to the inclusion of the petitioners’ input to the Final Report, despite their resignation and request for their contribution to be removed.In response to these concerns, on 18 May 2017, the then Cabinet Secretary for Health and Sport, Shona Robison, advised the Public Petitions Committee of the Scottish Parliament that the process by which the Mesh Review Group came to its conclusions would in itself, be examined. An Investigative Review would be commissioned to undertake this task.This report presents the findings of that Investigative Review. The task of this investigation has not been to reconsider the merits of the Mesh Review’s substantive conclusions on the safety and efficacy of transvaginal mesh implants, nor have we sought to apportion individual blame for any failing or omissions. That was not our remit. We have however, attempted to discover what caused the Mesh Review to be received in the way that it was.Our Report comprises 10 chapters. It takes a chronological approach, from the commissioning of the Mesh Review until its publication. The balance of this chapter introduces key information about the composition of this Investigative Review Group and our methodology. Each subsequent chapter discusses key areas in which we have identified failures or mistakes as well as lessons which can usefully be learned from the Mesh Review for the establishment, management and support of future independent reviews.

AB - Executive SummaryA petition on polypropylene mesh medical devices was lodged in April 2014 to the Public Petitions Committee of the Scottish Parliament by Elaine Holmes and Olive McIIroy on behalf of the Scottish Mesh Survivors ‘Hear Our Voice’ campaign.The Petition was lodged to draw attention to a number of women who had experienced serious complications following procedures to treat pelvic organ prolapse and stress urinary incontinence. This was linked with under-reporting of adverse events and a poor understanding as to why these complications had occurred. It received in excess of 1,700 signatures and 212 comments.Following further evidence provided by the petitioners, Elaine Holmes and Olive McIlroy, on 17 June 2014, Alex Neil – then the Cabinet Secretary for Health and Wellbeing – informed the Committee that he intended to commission an Independent Review. The Review would not only explore the evidence that the petitioners had provided, but also consider complication rates and under-reporting of adverse events as well as looking at the overall evidence base for mesh devices.The Scottish Independent Review Group held its first meeting on 25 August 2014.On 27 March 2017, the Scottish Government published the Mesh Review’s Final Report, entitled The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women.[1] This was preceded by an Interim Report which was published on 2 October 2015.Prior to the publication of the Final Report, the first chair resigned and a second chair was appointed. Three further members of the Mesh Review Group resigned. The publication of the Final Report generated widespread criticism. Concerns ranged from the evaluation and exclusion of certain evidence, to the independence of the review process, and in particular to the inclusion of the petitioners’ input to the Final Report, despite their resignation and request for their contribution to be removed.In response to these concerns, on 18 May 2017, the then Cabinet Secretary for Health and Sport, Shona Robison, advised the Public Petitions Committee of the Scottish Parliament that the process by which the Mesh Review Group came to its conclusions would in itself, be examined. An Investigative Review would be commissioned to undertake this task.This report presents the findings of that Investigative Review. The task of this investigation has not been to reconsider the merits of the Mesh Review’s substantive conclusions on the safety and efficacy of transvaginal mesh implants, nor have we sought to apportion individual blame for any failing or omissions. That was not our remit. We have however, attempted to discover what caused the Mesh Review to be received in the way that it was.Our Report comprises 10 chapters. It takes a chronological approach, from the commissioning of the Mesh Review until its publication. The balance of this chapter introduces key information about the composition of this Investigative Review Group and our methodology. Each subsequent chapter discusses key areas in which we have identified failures or mistakes as well as lessons which can usefully be learned from the Mesh Review for the establishment, management and support of future independent reviews.

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