Core Outcome Measures in Effectiveness Trials

Patient-Reported Outcome Measures after inguinal hernia repair

General Information

Summary:
Inguinal hernia is an exceedingly common illness world-wide, as 27% of the world’s male population will acquire an inguinal hernia during their lifetime. Inguinal hernia is a frequent cause of chronic pain, and can be an immensely debilitating condition causing poor quality of life. Consequently, surgical hernia repair is one of the most frequently performed surgical procedures. In hernia surgery, recurrence has traditionally been the most important outcome to measure, but recently many hernia surgeons and researchers have gained an increasing interest in patient-reported outcome. Thus, creating a need for reliable and properly validated PROMs for this specific purpose.

Unfortunately, there are currently no clear guidelines for selection and application of PROMs for patients with inguinal hernia, even though several PROMs have been developed specifically for these patients. Additionally, there are many generic PROMs that can be applied to a wide range of conditions, including inguinal hernia.

We hypothesize that the current usage of PROMs for patients with inguinal hernia is characterized by a high degree of inconsistency due to the absence of guidelines, and we assert that this is unfavorable to the transparency and comparability of otherwise similar studies. We speculate that many studies use generic PROMs, due to a lack of awareness about the advantages of hernia-specific PROMs. Moreover, many PROMs have not yet been sufficiently validated for use in the inguinal hernia population, hence any conclusion drawn from these may be of doubtful quality.

This emphasizes the demand for clarity and uniformity, and the need for further research. Denmark is generally regarded as a leading country in the field of hernia research, with a great scientific heritage rooted in the Danish Hernia Database, and we intent to maintain this leading position by pioneering the development and standardization of PROMs within hernia research.

We aim to determine which patient-reported outcomes are most essential for inguinal hernia patients, and we intent to contribute to the establishment of a Core Outcome Set (COS), by formulating clear evidence-based recommendations on which patient-reported outcomes should be included in a future COS.

Contributors:
Mr. Anders Gram-Hanssen, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Denmark

Mr. Anders Asbjørn Bæk Tolstrup, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Denmark

Dr. Dennis Zetner, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Denmark

Ms. Cecilie Bøge Paulsen, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Denmark

Professor Jacob Rosenberg, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Denmark

Further Study Information

Current Stage:
Ongoing
Date:
January 2019 - April 2020
Funding source(s):
None

Health Area

Disease Category
Gastroenterology

Disease Name
Hernia

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Interview
Systematic review

Phase I: A systematic review on the current usage of PROMs for patient with inguinal hernia. We will present our results as a complete inventory of all PROMs for these patients.
Phase II: A second systematic review, in which we will systematically assess the quality and validity of PROMS for patients with inguinal hernia. The review be performed according to the COSMIN guideline.
Phase: III: A qualitative study of patient interviews aimed at identifying patient-reported outcomes of interest.
Phase IV: A Cochrane review. Through a synthesis of results from our previous studies, we will provide final recommendations on which patient-reported should be included in a COS.


Stakeholders Involved

Consumers (patients)

Study Type

COS Patient Reported Outcomes

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