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
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
Affiliations
Leila Rooshenas
Bristol NIHR Biomedical Research Centre and Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol University, Bristol, UK
Timothy Rockall
Department of Oesophago-gastric Surgery, The Royal Surrey County Hospital, Guildford, UK
Neil Smart
Exeter Surgical Health Services Research Unit (HeSRU), Royal Devon & Exeter Hospital, Exeter, Devon, UK
Jared Torkington
Department of Colorectal Surgery, Cardiff and Vale University Health Board, Cardiff, UK
Natalie S Blencowe
NIHR Bristol Biomedical Research Centre, Population Health Sciences, Bristol Medical School. University of Bristol, Bristol, UK
Jane Blazeby
Bristol NIHR Biomedical Research Centre and Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol University, Bristol, UK
Tom Pinkney
Academic Department of Surgery, Queen Elizabeth Hospital, University of Birmingham, Birmingham, UK
Barnaby Reeves
Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK
Charlotte Murkin
Bristol NIHR Biomedical Research Centre and Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol University, Bristol, UK
Joanne Bennett
Department of Colorectal Surgery, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK
I R Daniels
Exeter Surgical Health Services Research Unit (HeSRU), Royal Devon & Exeter Hospital, Exeter, Devon, UK
Jamshed Shabbir
Department of Colorectal Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK
Jonathan Randall
Department of Colorectal Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK
H T Brandsma
Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, Netherlands
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.
