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 '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.

SUBMITTER: Murkin C 

PROVIDER: S-EPMC9535162 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature