Richard R. W. Brady, FRCSEd, MD, Newcastle Centre for Bowel Disease Research Group, Newcastle Hospitals and Newcastle University, Royal Victoria Hospital, Newcastle, United Kingdom.
Julia Scott, Newcastle Centre for Bowel Disease Research Group, Newcastle Hospitals and Newcastle University, Royal Victoria Hospital, Newcastle, United Kingdom.
Stephanie Grieveson, Newcastle Centre for Bowel Disease Research Group, Newcastle Hospitals and Newcastle University, Royal Victoria Hospital, Newcastle, United Kingdom.
Miriayi Aibibula, PhD, Coloplast Ltd, Peterborough, United Kingdom.
Matthew Cawson, MEnt, Coloplast Ltd, Peterborough, United Kingdom.
Tatjana Marks, MSc, Costello Medical Consulting Ltd, London, United Kingdom.
Jennifer Page, BSc, Costello Medical Consulting Ltd, Manchester, United Kingdom.
Audrey Artignan, MPhil, Costello Medical Consulting Ltd, Cambridge, United Kingdom.
Esben Bo Boisen, MSc, Coloplast A/S, Humlebaek, Denmark.
Correspondence: Richard R. W. Brady, Newcastle Centre for Bowel Disease Research Group Level 5, Leazes Wing, RVI, NE1 4LP Newcastle upon Tyne, United Kingdom ([email protected]).
The manuscript was based on the original study, Clinical Effectiveness Project No. 10889: “A Retrospective Baseline Audit Investigating Incidence of Stoma Related Complications, Interactions With the NHS and Costs for Newly Operated Stoma Patients.”
Authors' Contributions: Substantial contributions to study conception, design, and data acquisition: R.B., J.S., and S.G.; substantial contributions to analysis and interpretation of the data: R.B., E.B.B., M.A., M.C., T.M., J.P., and A.A.; drafting the manuscript or revising it critically for important intellectual content: R.B., J.S., S.G., E.B.B., M.A., M.C., T.M., J.P., and A.A.; final approval of the version of the manuscript to be published: R.B., J.S., S.G., E.B.B., M.A., M.C., T.M., J.P., and A.A.
Conflicts of Interest: R.B. has received consultancy fees from a number of ostomy device manufacturers, including Coloplast. Newcastle Hospitals/Newcastle Centre for Bowel Disease Research Group has received research grants and income from Coloplast in support of research delivery as part of the center's long-term Stoma Research Programme. E.B.B., M.A., and M.C. are Coloplast Ltd employees. A.A., J.P., and T.M. are Costello Medical Ltd employees, whose support was funded by Coloplast Ltd.
Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal's Web site (JWOCNOnline.com).
Ethics Approval and Consent to Participate: The audit was approved by the Trust's Caldicott Guardian and review (ID: 7977); approval and permissions were gained prior to commencement. Ethical approval was not required as retrospective patient data were pseudonymized by the clinical research professionals at the study site before being transmitted outside the Trust. All the results presented in this article are in aggregate form, and no personally identifiable information was used for this study.
Availability of Data and Materials: The data that support the findings of this study are not publicly available as they include sensitive personal healthcare data but may be made available on reasonable request from the corresponding author.
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