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How is your proctology patient really doing? Outcome measurement in proctology: development, design and validation study of the Proctoprom

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Abstract

Background

The aim of the present study was to develop and evaluate the reliability and validity of proctology patient-reported outcome measurements (PROM): Proctoprom.

Methods

Development of the Proctoprom was based on interview rounds with experts (n = 4) and patients (n = 19) in open informal interview rounds regarding content and form. Once consensus was achieved on five items, data were collected between July 2014 and August 2016 from 991 patients recruited consecutively in a specialized proctology center. Reliability, construct validity and responsiveness of the PROM were determined through exploratory factor analysis, test–retest analysis and anchor-based hypothesis testing. We also estimated discriminant validity, standard error of measurement (SEM), minimal detectable change (MDC95%) and minimal clinically important difference (MCID).

Results

The five items loaded on one factor that reflected good internal consistency (Cronbach’s α 0.81). Test–retest analysis showed good reliability with intraclass correlation of 0.81. Construct validity measurement resulted in AUCs of 0.85 and 0.90. Responsiveness measurement resulted in AUCs of > 0.76 for both hypotheses. SEM was estimated at 3.0 points and MDC at 4.8 points. We estimated an MCID of 10 points.

Conclusions

Proctoprom is a valid and reliable tool that is responsive to change and that meets consensus-based standards for the selection of health measurement instruments. It can be used to evaluate disease burden and effect of treatment in all adult proctology patients regardless of their proctologic diagnosis.

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Authors and Affiliations

  1. Proctos Kliniek, Bilthoven, The Netherlands

    G. J. Vander Mijnsbrugge & C. Molenaar

  2. Vrije Universiteit Brussel, Brussels, Belgium

    R. Buyl

  3. Radboud University Medical Centre, Radboud Institute of Health Sciences, IQ Healthcare, Nijmegen, The Netherlands

    G. Westert & P. J. van der Wees

Authors
  1. G. J. Vander Mijnsbrugge
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  2. C. Molenaar
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  3. R. Buyl
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  4. G. Westert
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  5. P. J. van der Wees
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Corresponding author

Correspondence to G. J. Vander Mijnsbrugge.

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Conflict of interest

There are no conflicts of interest to declare.

Ethical approval

This study was assessed by the Medical Ethics Committee of the MEC-U, Nieuwegein, Netherlands, with reference number W 15.098 and conducted in accordance with the Handbook for Good Clinical Research Practice of the World Health Organization and Declaration of Helsinki principles. They confirmed that the Medical Research Involving Human Subjects Act (WMO) does not apply to the above mentioned study and that, therefore, an official approval of this study by the MEC-U is not required under the WMO.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Vander Mijnsbrugge, G.J., Molenaar, C., Buyl, R. et al. How is your proctology patient really doing? Outcome measurement in proctology: development, design and validation study of the Proctoprom. Tech Coloproctol 24, 291–300 (2020). https://doi.org/10.1007/s10151-020-02156-2

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  • DOI: https://doi.org/10.1007/s10151-020-02156-2

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