Development of a novel neurogenic bowel patient reported outcome measure: the Spinal Cord Injury Patient Reported Outcome Measure of Bowel Function & Evacuation (SCI-PROBE)

Abstract

Study design

Outcome measure item generation and reduction.

Objectives

To develop a patient reported outcome measure (PROM) addressing the impact of neurogenic bowel dysfunction (NBD) on individuals living with traumatic or nontraumatic spinal cord injury (SCI).

Setting

Tertiary rehabilitation center in Toronto, Canada.

Methods

A PROM based on the International Classification of Functioning, Disability and Health (ICF) framework was developed using the following steps: (a) item generation, (b) item refinement through iterative review, (c) completion of items by individuals living with SCI and NBD followed by cognitive interviewing, and (d) further item refinement, item reduction, and construction of the preliminary PROM.

Results

Following initial item generation and iterative review, the investigative team agreed on 55 initial items. Cognitive interviewing, additional revisions, and item reduction yielded an instrument comprised of 35 items; while ensuring at least two items were retained for each of the 16 previously identified challenges of living with NBD following the onset of a SCI. Scoring for the preliminary PROM ranges from 0 to 140.

Conclusions

A preliminary PROM informed by the ICF for assessing the impact of NBD post-SCI has been devised, which can be used to inform clinicians and decision-makers on optimal ways to treat this serious secondary health complication. Future work will assess the validity and clinimetric properties of the PROM.

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Data availability

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Funding

This study was funded by The Rick Hansen Institute (RHI #G2015-28).

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Authors

Contributions

ASB was responsible for designing the study protocol, participating in the outcomes advisory committee, advising on data analysis, interpreting the data, and drafting the report. JJD was responsible for designing the study protocol, recruiting study participants, completing data collection, extracting and analyzing data, interpreting results, and drafting the methods and results sections of the report. SLH was responsible for designing the study protocol, participating in the outcomes advisory committee, and reviewing the report. BCC was responsible for designing the study protocol, participating in the outcomes advisory committee, and reviewing the report. JS was responsible participating in the outcomes advisory committee, and reviewing the report.

Corresponding author

Correspondence to Anthony S. Burns.

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The authors declare that they have no conflict of interest.

Ethics

We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers/animals were followed during the course of this research. All study procedures were approved by the University Health Network research ethics board (#15-9461).

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Burns, A.S., Delparte, J.J., Hitzig, S.L. et al. Development of a novel neurogenic bowel patient reported outcome measure: the Spinal Cord Injury Patient Reported Outcome Measure of Bowel Function & Evacuation (SCI-PROBE). Spinal Cord (2020). https://doi.org/10.1038/s41393-020-0467-x

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