Development and application of novel methods to inform surgical study design

: a case study in parastomal hernia prevention

  • Charlotte Murkin

Student thesis: Master's ThesisMaster of Science (MSc)

Abstract

Surgical interventions are complex and consequently designing studies to evaluate their outcomes is challenging. A key obstacle is the variability within surgical interventions. Variations in surgical procedure and peri-operative care can act independently or collectively to influence outcomes. Understanding these variations and their ability to affect outcomes is fundamental to the success of any surgical research and deciding what data to collect to adequately capture variability is a difficult question.
This Masters addresses the challenge of collecting data on surgical interventions through applying and developing novel methods to develop case report forms. This research was performed as feasibility work for the CIPHER study, a large cohort study investigating risk factors for the development of parastomal hernias. The feasibility work aimed to identify all possible variations in terms of the surgical intervention and peri-operative care, which could be incorporated into a comprehensive data collection tool for use within the main study.
A literature review using snowballing methods, and mixed qualitative research methods including interviews and non-participant observations were employed to identify the ‘known’ and ‘unknown’ variations respectively, and ensure all possible variations were understood and explored. The variations formed a long-list of data items for consideration within the CIPHER study. A consensus meeting of experts prioritised this list into a manageable number of ‘essential’ data items ready to be used in the final case report forms for the cohort study.
The findings of this study demonstrated the lack of consensus among surgeons regarding factors that influence parastomal hernia development, and considerable variations in surgical techniques for stoma formation. This supported the need for the CIPHER study, and justified the value of such detailed feasibility work to be completed. The combination of research methods was successful and provided unique findings that could not have been identified if only one method of data collection had been employed. These methods can be adapted for future research studies involving complex interventions such as surgery.
Surgical interventions are complex and consequently designing studies to evaluate their outcomes is challenging. A key obstacle is the variability within surgical interventions. Variations in surgical procedure and peri-operative care can act independently or collectively to influence outcomes. Understanding these variations and their ability to affect outcomes is fundamental to the success of any surgical research and deciding what data to collect to adequately capture variability is a difficult question.
This Masters addresses the challenge of collecting data on surgical interventions through applying and developing novel methods to develop case report forms. This research was performed as feasibility work for the CIPHER study, a large cohort study investigating risk factors for the development of parastomal hernias. The feasibility work aimed to identify all possible variations in terms of the surgical intervention and peri-operative care, which could be incorporated into a comprehensive data collection tool for use within the main study.
A literature review using snowballing methods, and mixed qualitative research methods including interviews and non-participant observations were employed to identify the ‘known’ and ‘unknown’ variations respectively, and ensure all possible variations were understood and explored. The variations formed a long-list of data items for consideration within the CIPHER study. A consensus meeting of experts prioritised this list into a manageable number of ‘essential’ data items ready to be used in the final case report forms for the cohort study.
The findings of this study demonstrated the lack of consensus among surgeons regarding factors that influence parastomal hernia development, and considerable variations in surgical techniques for stoma formation. This supported the need for the CIPHER study, and justified the value of such detailed feasibility work to be completed. The combination of research methods was successful and provided unique findings that could not have been identified if only one method of data collection had been employed. These methods can be adapted for future research studies involving complex interventions such as surgery.
Date of Award6 Nov 2018
Original languageEnglish
Awarding Institution
  • The University of Bristol
SupervisorJane M Blazeby (Supervisor), Natalie S Blencowe (Supervisor) & Leila Rooshenas (Supervisor)

Cite this

Development and application of novel methods to inform surgical study design: a case study in parastomal hernia prevention
Murkin, C. (Author). 6 Nov 2018

Student thesis: Master's ThesisMaster of Science (MSc)