What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention

Charlotte E Murkin; Leila Rooshenas; Neil  Smart; R Daniels; Tom Pinkney; Jamshed Shabbir; Timothy Rockall; Joanne Bennett; Jared Torkington; Jonathan K Randall; HT Brandsma; Barnaby C Reeves; Jane Blazeby; Natalie S Blencowe

doi:10.1136/bmjopen-2022-061300

What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention

Charlotte E Murkin
, Leila Rooshenas
, Neil Smart
, R Daniels
, Tom Pinkney
, Jamshed Shabbir
, Timothy Rockall
, Joanne Bennett
, Jared Torkington
, Jonathan K Randall
, HT Brandsma
, Barnaby C Reeves
, Jane Blazeby
, Natalie S Blencowe^*

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

2 Citations (Scopus)

82 Downloads (Pure)

Abstract

Objectives
To describe the development and application of methods to optimise the design of case report forms (CRFs) for clinical studies evaluating surgical procedures,
illustrated with an example of abdominal stoma formation.

Design
(1) Literature reviews, to identify reported variations in surgical components of stoma formation, were supplemented by (2) intraoperative qualitative
research (observations, videos and interviews), to identify unreported variations used in practice to generate (3) a ‘long list’ of items, which were rationalised using (4) consensus methods, providing a pragmatic list of CRF items to be captured in the Cohort study to Investigate the Prevention of parastomal HERnias (CIPHER) study.
Setting
Two secondary care surgical centres in England. Participants Patients undergoing stoma formation, surgeons undertaking stoma formation and stoma nurses.
Outcome measures
Successful identification of key CRF items to be captured in the CIPHER study.
Results
59 data items relating to stoma formation were identified and categorised within six themes: (1) surgical approach to stoma formation; (2) trephine formation; (3)
reinforcing the stoma trephine with mesh; (4) use of the stoma as a specimen extraction site; (5) closure of other wounds during the procedure; and (6) spouting the stoma.
Conclusions
This study used multimodal data collection to understand and capture the technical variations in stoma formation and design bespoke CRFs for a multicentre cohort study. The CIPHER study will use the CRFs to examine associations between the technical variations in stoma formation and risks of developing a parastomal hernia.

Original language	English
Article number	e061300
Number of pages	13
Journal	BMJ Open
Volume	12
Issue number	10
Early online date	5 Oct 2022
DOIs	https://doi.org/10.1136/bmjopen-2022-061300
Publication status	Published - 5 Oct 2022

Bibliographical note

Funding Information:
This work was performed as part of the National Institute for Health and Care Research (NIHR) funded UK Cohort study to Investigate the prevention of Parastomal HERnia (CIPHER) Study: Understanding surgery and current practice in stoma formation and developing Patient Reported Outcome Measures for Parastomal Hernia to inform Phase B of CIPHER. Part A was led by JB and supported by the Bristol-based CTEU, Royal College of Surgeons surgical trials centre, the MRC ConDuCT-II Hub for Trials Methodology Research and the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston National Health Service (NHS) Foundation Trust and the University of Bristol.

Publisher Copyright:
© 2022 BMJ Publishing Group. All rights reserved.

Research Groups and Themes

BTC (Bristol Trials Centre)

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Murkin, C. E., Rooshenas, L., Smart, N., Daniels, R., Pinkney, T., Shabbir, J., Rockall, T., Bennett, J., Torkington, J., Randall, J. K., Brandsma, HT., Reeves, B. C., Blazeby, J., & Blencowe, N. S. (2022). What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention. BMJ Open, 12(10), Article e061300. https://doi.org/10.1136/bmjopen-2022-061300

@article{e2065a6d2d1646318530a965362e7e3c,

title = "What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention",

abstract = "Objectives To describe the development and application of methods to optimise the design of case report forms (CRFs) for clinical studies evaluating surgical procedures, illustrated with an example of abdominal stoma formation. Design (1) Literature reviews, to identify reported variations in surgical components of stoma formation, were supplemented by (2) intraoperative qualitative research (observations, videos and interviews), to identify unreported variations used in practice to generate (3) a {\textquoteleft}long list{\textquoteright} of items, which were rationalised using (4) consensus methods, providing a pragmatic list of CRF items to be captured in the Cohort study to Investigate the Prevention of parastomal HERnias (CIPHER) study. Setting Two secondary care surgical centres in England. Participants Patients undergoing stoma formation, surgeons undertaking stoma formation and stoma nurses. Outcome measures Successful identification of key CRF items to be captured in the CIPHER study. Results 59 data items relating to stoma formation were identified and categorised within six themes: (1) surgical approach to stoma formation; (2) trephine formation; (3) reinforcing the stoma trephine with mesh; (4) use of the stoma as a specimen extraction site; (5) closure of other wounds during the procedure; and (6) spouting the stoma. Conclusions This study used multimodal data collection to understand and capture the technical variations in stoma formation and design bespoke CRFs for a multicentre cohort study. The CIPHER study will use the CRFs to examine associations between the technical variations in stoma formation and risks of developing a parastomal hernia.",

author = "Murkin, \{Charlotte E\} and Leila Rooshenas and Neil Smart and R Daniels and Tom Pinkney and Jamshed Shabbir and Timothy Rockall and Joanne Bennett and Jared Torkington and Randall, \{Jonathan K\} and HT Brandsma and Reeves, \{Barnaby C\} and Jane Blazeby and Blencowe, \{Natalie S\}",

note = "Funding Information: This work was performed as part of the National Institute for Health and Care Research (NIHR) funded UK Cohort study to Investigate the prevention of Parastomal HERnia (CIPHER) Study: Understanding surgery and current practice in stoma formation and developing Patient Reported Outcome Measures for Parastomal Hernia to inform Phase B of CIPHER. Part A was led by JB and supported by the Bristol-based CTEU, Royal College of Surgeons surgical trials centre, the MRC ConDuCT-II Hub for Trials Methodology Research and the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston National Health Service (NHS) Foundation Trust and the University of Bristol. Publisher Copyright: {\textcopyright} 2022 BMJ Publishing Group. All rights reserved.",

year = "2022",

month = oct,

day = "5",

doi = "10.1136/bmjopen-2022-061300",

language = "English",

volume = "12",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "10",

}

Murkin, CE, Rooshenas, L, Smart, N, Daniels, R, Pinkney, T, Shabbir, J, Rockall, T, Bennett, J, Torkington, J, Randall, JK, Brandsma, HT, Reeves, BC, Blazeby, J & Blencowe, NS 2022, 'What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention', BMJ Open, vol. 12, no. 10, e061300. https://doi.org/10.1136/bmjopen-2022-061300

What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention. / Murkin, Charlotte E; Rooshenas, Leila; Smart, Neil et al.
In: BMJ Open, Vol. 12, No. 10, e061300, 05.10.2022.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - What should be included in case report forms? Development and application of novel methods to inform surgical study design

T2 - a mixed methods case study in parastomal hernia prevention

AU - Murkin, Charlotte E

AU - Rooshenas, Leila

AU - Smart, Neil

AU - Daniels, R

AU - Pinkney, Tom

AU - Shabbir, Jamshed

AU - Rockall, Timothy

AU - Bennett, Joanne

AU - Torkington, Jared

AU - Randall, Jonathan K

AU - Brandsma, HT

AU - Reeves, Barnaby C

AU - Blazeby, Jane

AU - Blencowe, Natalie S

N1 - Funding Information: This work was performed as part of the National Institute for Health and Care Research (NIHR) funded UK Cohort study to Investigate the prevention of Parastomal HERnia (CIPHER) Study: Understanding surgery and current practice in stoma formation and developing Patient Reported Outcome Measures for Parastomal Hernia to inform Phase B of CIPHER. Part A was led by JB and supported by the Bristol-based CTEU, Royal College of Surgeons surgical trials centre, the MRC ConDuCT-II Hub for Trials Methodology Research and the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston National Health Service (NHS) Foundation Trust and the University of Bristol. Publisher Copyright: © 2022 BMJ Publishing Group. All rights reserved.

PY - 2022/10/5

Y1 - 2022/10/5

N2 - Objectives To describe the development and application of methods to optimise the design of case report forms (CRFs) for clinical studies evaluating surgical procedures, illustrated with an example of abdominal stoma formation. Design (1) Literature reviews, to identify reported variations in surgical components of stoma formation, were supplemented by (2) intraoperative qualitative research (observations, videos and interviews), to identify unreported variations used in practice to generate (3) a ‘long list’ of items, which were rationalised using (4) consensus methods, providing a pragmatic list of CRF items to be captured in the Cohort study to Investigate the Prevention of parastomal HERnias (CIPHER) study. Setting Two secondary care surgical centres in England. Participants Patients undergoing stoma formation, surgeons undertaking stoma formation and stoma nurses. Outcome measures Successful identification of key CRF items to be captured in the CIPHER study. Results 59 data items relating to stoma formation were identified and categorised within six themes: (1) surgical approach to stoma formation; (2) trephine formation; (3) reinforcing the stoma trephine with mesh; (4) use of the stoma as a specimen extraction site; (5) closure of other wounds during the procedure; and (6) spouting the stoma. Conclusions This study used multimodal data collection to understand and capture the technical variations in stoma formation and design bespoke CRFs for a multicentre cohort study. The CIPHER study will use the CRFs to examine associations between the technical variations in stoma formation and risks of developing a parastomal hernia.

AB - Objectives To describe the development and application of methods to optimise the design of case report forms (CRFs) for clinical studies evaluating surgical procedures, illustrated with an example of abdominal stoma formation. Design (1) Literature reviews, to identify reported variations in surgical components of stoma formation, were supplemented by (2) intraoperative qualitative research (observations, videos and interviews), to identify unreported variations used in practice to generate (3) a ‘long list’ of items, which were rationalised using (4) consensus methods, providing a pragmatic list of CRF items to be captured in the Cohort study to Investigate the Prevention of parastomal HERnias (CIPHER) study. Setting Two secondary care surgical centres in England. Participants Patients undergoing stoma formation, surgeons undertaking stoma formation and stoma nurses. Outcome measures Successful identification of key CRF items to be captured in the CIPHER study. Results 59 data items relating to stoma formation were identified and categorised within six themes: (1) surgical approach to stoma formation; (2) trephine formation; (3) reinforcing the stoma trephine with mesh; (4) use of the stoma as a specimen extraction site; (5) closure of other wounds during the procedure; and (6) spouting the stoma. Conclusions This study used multimodal data collection to understand and capture the technical variations in stoma formation and design bespoke CRFs for a multicentre cohort study. The CIPHER study will use the CRFs to examine associations between the technical variations in stoma formation and risks of developing a parastomal hernia.

U2 - 10.1136/bmjopen-2022-061300

DO - 10.1136/bmjopen-2022-061300

M3 - Article (Academic Journal)

C2 - 36198447

SN - 2044-6055

VL - 12

JO - BMJ Open

JF - BMJ Open

IS - 10

M1 - e061300

ER -

What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention

Abstract

Bibliographical note

Research Groups and Themes

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