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
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 surgica...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/10/e061300.full |
| _version_ | 1827892427731501056 |
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| author | Leila Rooshenas Timothy Rockall Neil Smart Jared Torkington Natalie S Blencowe Jane Blazeby Tom Pinkney Barnaby Reeves Charlotte Murkin Joanne Bennett I R Daniels Jamshed Shabbir Jonathan Randall H T Brandsma |
| author_facet | Leila Rooshenas Timothy Rockall Neil Smart Jared Torkington Natalie S Blencowe Jane Blazeby Tom Pinkney Barnaby Reeves Charlotte Murkin Joanne Bennett I R Daniels Jamshed Shabbir Jonathan Randall H T Brandsma |
| author_sort | Leila Rooshenas |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T21:40:35Z |
| format | Article |
| id | doaj.art-96c1975c986c4c5a8ce2360e20e82acb |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T21:40:35Z |
| publishDate | 2022-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-96c1975c986c4c5a8ce2360e20e82acb2023-07-27T01:50:07ZengBMJ Publishing GroupBMJ Open2044-60552022-10-01121010.1136/bmjopen-2022-061300What 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 preventionLeila Rooshenas0Timothy Rockall1Neil Smart2Jared Torkington3Natalie S Blencowe4Jane Blazeby5Tom Pinkney6Barnaby Reeves7Charlotte Murkin8Joanne Bennett9I R Daniels10Jamshed Shabbir11Jonathan Randall12H T Brandsma13Bristol NIHR Biomedical Research Centre and Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol University, Bristol, UKDepartment of Oesophago-gastric Surgery, The Royal Surrey County Hospital, Guildford, UKExeter Surgical Health Services Research Unit (HeSRU), Royal Devon & Exeter Hospital, Exeter, Devon, UKDepartment of Colorectal Surgery, Cardiff and Vale University Health Board, Cardiff, UKNIHR Bristol Biomedical Research Centre, Population Health Sciences, Bristol Medical School. University of Bristol, Bristol, UKBristol NIHR Biomedical Research Centre and Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol University, Bristol, UKAcademic Department of Surgery, Queen Elizabeth Hospital, University of Birmingham, Birmingham, UKClinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UKBristol NIHR Biomedical Research Centre and Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol University, Bristol, UKDepartment of Colorectal Surgery, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UKExeter Surgical Health Services Research Unit (HeSRU), Royal Devon & Exeter Hospital, Exeter, Devon, UKDepartment of Colorectal Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UKDepartment of Colorectal Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UKDepartment of Surgery, Canisius Wilhelmina Hospital, Nijmegen, NetherlandsObjectives 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.https://bmjopen.bmj.com/content/12/10/e061300.full |
| spellingShingle | Leila Rooshenas Timothy Rockall Neil Smart Jared Torkington Natalie S Blencowe Jane Blazeby Tom Pinkney Barnaby Reeves Charlotte Murkin Joanne Bennett I R Daniels Jamshed Shabbir Jonathan Randall H T Brandsma 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 |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/10/e061300.full |
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