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Ranking of patient and surgeons' perspectives for endpoints in randomized controlled trials—lessons learned from the POVATI trial [ISRCTN 60734227]

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Abstract

Introduction

Surgical trials focus mainly on mortality and morbidity rates, which may be not the most important endpoints from the patient's perspective. Evaluation of expectations and needs of patients enrolled in clinical trials can be analyzed using a procedure called ranking. Within the Postsurgical Pain Outcome of Vertical and Transverse Abdominal Incision randomized trial (POVATI), the perspectives of participating patients and surgeons were assessed as well as the influence of the surgical intervention on patients' needs.

Patients and methods

All included patients of the POVATI trial were asked preoperatively and postoperatively to rank predetermined outcome variables concerning the upcoming surgical procedure (e.g., pain, complication, cosmetic result) hierarchically according to their importance. Preoperatively, the surgeons were asked to do the same.

Results

One hundred eighty two out of 200 randomized patients (71 females, 111 males; mean age 59 years) returned the ranking questionnaire preoperatively and 152 patients (67 females, 85 males; mean age 60 years) on the day of discharge. There were no differences between the two groups with respect to the distribution of ranking variables (p > 0.05). Thirty-five surgeons (7 residents, 6 fellows, and 22 consultants) completed the same ranking questionnaire. The order of the four most important ranking variables for both patients and surgeons were death, avoiding of postoperative complications, avoiding of intraoperative complications, and pain. Surgeons ranked the variable “cosmetic result” significantly as more important compared to patients (p = 0.034, Fisher's exact test).

Conclusion

Patients and surgeons did not differ in ranking predetermined outcomes in the POVATI trial. Only the variable “cosmetic result” is significantly more important from the surgeon's than from the patient's perspective. Ranking of outcomes might be a beneficial tool and can be a proper addition to RCTs.

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Abbreviations

POVATI:

Postsurgical Pain Outcome of Vertical and Transverse Abdominal Incision

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Conflicts of interest

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Authors and Affiliations

  1. Department of Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany

    Lars Fischer, Markus K. Diener, Markus W. Büchler & Christoph M. Seiler

  2. Study Center of the German Surgical Society, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany

    Lars Fischer, Markus K. Diener, Markus W. Büchler & Christoph M. Seiler

  3. Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, 69120, Heidelberg, Germany

    Andreas Deckert

  4. Department of Anesthesiology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany

    Johannes B. Zimmermann

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  1. Lars Fischer
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  2. Andreas Deckert
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  3. Markus K. Diener
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  4. Johannes B. Zimmermann
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  5. Markus W. Büchler
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  6. Christoph M. Seiler
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Correspondence to Lars Fischer.

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Fischer, L., Deckert, A., Diener, M.K. et al. Ranking of patient and surgeons' perspectives for endpoints in randomized controlled trials—lessons learned from the POVATI trial [ISRCTN 60734227]. Langenbecks Arch Surg 396, 1061–1066 (2011). https://doi.org/10.1007/s00423-011-0798-3

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  • DOI: https://doi.org/10.1007/s00423-011-0798-3

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