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.
RCT Entities:
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.
Authors: Hanns-Peter Knaebel; Markus K Diener; Moritz N Wente; Hartwig Bauer; Markus W Büchler; Matthias Rothmund; Christoph M Seiler Journal: Langenbecks Arch Surg Date: 2005-02-22 Impact factor: 3.445
Authors: T H Rockwood; J M Church; J W Fleshman; R L Kane; C Mavrantonis; A G Thorson; S D Wexner; D Bliss; A C Lowry Journal: Dis Colon Rectum Date: 1999-12 Impact factor: 4.585
Authors: Michael King; Irwin Nazareth; Fiona Lampe; Peter Bower; Martin Chandler; Maria Morou; Bonnie Sibbald; Rosalind Lai Journal: JAMA Date: 2005-03-02 Impact factor: 56.272
Authors: Christoph M Seiler; Andreas Deckert; Markus K Diener; Hanns-Peter Knaebel; Markus A Weigand; Norbert Victor; Markus W Büchler Journal: Ann Surg Date: 2009-06 Impact factor: 12.969
Authors: Margot A Reidel; Hanns-Peter Knaebel; Christoph M Seiler; Christine Knauer; Johann Motsch; Norbert Victor; Markus W Büchler Journal: BMC Surg Date: 2003-11-13 Impact factor: 2.102
Authors: Nuh N Rahbari; Phillip Knebel; Meinhard Kieser; Thomas Bruckner; Detlef K Bartsch; Helmut Friess; Andre L Mihaljevic; Josef Stern; Markus K Diener; Sabine Voss; Inga Rossion; Markus W Büchler; Christoph M Seiler Journal: Trials Date: 2012-05-30 Impact factor: 2.279