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 Murkin; Leila Rooshenas; Neil Smart; I R Daniels; Tom Pinkney; Jamshed Shabbir; Timothy Rockall; Joanne Bennett; Jared Torkington; Jonathan Randall; H T Brandsma; Barnaby 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 Murkin, Leila Rooshenas, Neil Smart, I R Daniels, Tom Pinkney, Jamshed Shabbir, Timothy Rockall, Joanne Bennett, Jared Torkington, Jonathan Randall, H T Brandsma, Barnaby Reeves, Jane Blazeby, Natalie S Blencowe^*

^*Corresponding author for this work

Applied Health Sciences

Research output: Contribution to journal › Article › peer-review

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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.

Trial registration number: ISRCTN17573805.

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

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Murkin, C., Rooshenas, L., Smart, N., Daniels, I. R., Pinkney, T., Shabbir, J., Rockall, T., Bennett, J., Torkington, J., Randall, J., Brandsma, H. T., Reeves, B., 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{f81bd471cb564e82a1415f821b98ed91,

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.Trial registration number: ISRCTN17573805.",

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

year = "2022",

month = oct,

day = "5",

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

language = "English",

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issn = "2044-6055",

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Murkin, C, Rooshenas, L, Smart, N, Daniels, IR, Pinkney, T, Shabbir, J, Rockall, T, Bennett, J, Torkington, J, Randall, J, Brandsma, HT, Reeves, B, 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

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

AU - Rooshenas, Leila

AU - Smart, Neil

AU - Daniels, I R

AU - Pinkney, Tom

AU - Shabbir, Jamshed

AU - Rockall, Timothy

AU - Bennett, Joanne

AU - Torkington, Jared

AU - Randall, Jonathan

AU - Brandsma, H T

AU - Reeves, Barnaby

AU - Blazeby, Jane

AU - Blencowe, Natalie S

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.Trial registration number: ISRCTN17573805.

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.Trial registration number: ISRCTN17573805.

UR - http://europepmc.org/abstract/med/36198447

U2 - 10.1136/bmjopen-2022-061300

DO - 10.1136/bmjopen-2022-061300

M3 - Article

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.

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