Luc Dubois1, Teresa V Novick2, Adam H Power2, Guy DeRose2, Thomas L Forbes2. 1. Division of Vascular Surgery, London Health Sciences Centre and Western University, London, Ontario, Canada. Electronic address: luc.dubois@lhsc.on.ca. 2. Division of Vascular Surgery, London Health Sciences Centre and Western University, London, Ontario, Canada.
Abstract
OBJECTIVE: Relatively few outcomes have been examined in randomized comparisons of endovascular and open aortic aneurysm repair, and no patient input was obtained in the selection of these outcomes. The aim of this study was to identify patient-derived, potentially novel outcomes that may be used to guide future clinical trials in aneurysm surgery. METHODS: Focus group interviews were conducted with patients who had undergone endovascular or open aortic aneurysm repair. The discussions were transcribed and the transcript was analyzed by two indexers using constant-comparison analysis and grounded theory to identify potentially novel, patient-derived outcomes. Other potential themes relating to the patients' experience and their decision-making were also sought. RESULTS: Six focus groups were conducted (three with endovascular aneurysm repair patients and three with open aortic aneurysm repair patients), with a median of six participants, 2 to 12 months from surgery. Functional outcomes were most commonly mentioned and emphasized by patients. Recovery time and energy level were most frequently verbalized as important in the decision-making process between endovascular and open aneurysm repair. Other potential outcomes identified as important to patients included postoperative pain, time to walking normally, loss of appetite, extent and location of incisions, impact on cognition, being able to go home after surgery, and impact on caregivers. In addition to these outcomes, we identified three themes relating to the patient's experience: undervaluing or underappreciating the risk of death during surgery, differing informational needs and level of involvement in decision-making, and unrealistic patient expectations about the risks of and recovery after the procedure. CONCLUSIONS: Functional outcomes emerged as most important during qualitative analysis of patients' experiences with aneurysm repair. Perceived differences in recovery time were identified as an important consideration for aneurysm patients in deciding between open and endovascular repair. More work needs to be done clarifying the concept of recovery and other related functional outcomes for the development of methods to assess and to evaluate these in prospective clinical trials.
OBJECTIVE: Relatively few outcomes have been examined in randomized comparisons of endovascular and open aortic aneurysm repair, and no patient input was obtained in the selection of these outcomes. The aim of this study was to identify patient-derived, potentially novel outcomes that may be used to guide future clinical trials in aneurysm surgery. METHODS: Focus group interviews were conducted with patients who had undergone endovascular or open aortic aneurysm repair. The discussions were transcribed and the transcript was analyzed by two indexers using constant-comparison analysis and grounded theory to identify potentially novel, patient-derived outcomes. Other potential themes relating to the patients' experience and their decision-making were also sought. RESULTS: Six focus groups were conducted (three with endovascular aneurysm repair patients and three with open aortic aneurysm repair patients), with a median of six participants, 2 to 12 months from surgery. Functional outcomes were most commonly mentioned and emphasized by patients. Recovery time and energy level were most frequently verbalized as important in the decision-making process between endovascular and open aneurysm repair. Other potential outcomes identified as important to patients included postoperative pain, time to walking normally, loss of appetite, extent and location of incisions, impact on cognition, being able to go home after surgery, and impact on caregivers. In addition to these outcomes, we identified three themes relating to the patient's experience: undervaluing or underappreciating the risk of death during surgery, differing informational needs and level of involvement in decision-making, and unrealistic patient expectations about the risks of and recovery after the procedure. CONCLUSIONS: Functional outcomes emerged as most important during qualitative analysis of patients' experiences with aneurysm repair. Perceived differences in recovery time were identified as an important consideration for aneurysmpatients in deciding between open and endovascular repair. More work needs to be done clarifying the concept of recovery and other related functional outcomes for the development of methods to assess and to evaluate these in prospective clinical trials.