Shi-Qian Lin1, Chih-Ming Su2,3, Hsueh-Chi Wu2, Yun-Yun Chou4, Yu-Chun Yen5, Ka-Wai Tam6,7,8,9. 1. School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. 2. Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, New Taipei, Taiwan. 3. Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. 4. Shared Decision Making Resource Center, Shuang Ho Hospital, Taipei Medical University, 291, Zhongzheng Road, Zhonghe District, New Taipei City, 23561, Taiwan. 5. Biostatistics and Research Consultation Center, Taipei Medical University, Taipei, Taiwan. 6. Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, New Taipei, Taiwan. kelvintam@h.tmu.edu.tw. 7. Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. kelvintam@h.tmu.edu.tw. 8. Shared Decision Making Resource Center, Shuang Ho Hospital, Taipei Medical University, 291, Zhongzheng Road, Zhonghe District, New Taipei City, 23561, Taiwan. kelvintam@h.tmu.edu.tw. 9. Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan. kelvintam@h.tmu.edu.tw.
Abstract
BACKGROUND: Patients with breast cancer encounter difficulties in making surgical treatment decisions. Shared decision-making (SDM) with patient decision aids (PDAs) can minimize patients' decisional conflicts. However, the effect of PDAs in Asia remains inconclusive. This study investigated the effect of SDM assisted by PDAs on the decisional conflict of patients with breast cancer. METHODS: In this two-group, outcome assessor-blind, randomized controlled trial, 151 patients diagnosed as having breast cancer were assigned to the PDA (SDM with PDA) group or the standard (SDM without PDA) group. Demographic and clinical variables were analyzed to identify variables affecting the treatment choice. The patients' decision-making difficulties were evaluated using the four-item SURE scale during preoperative hospitalization, and decisional conflicts were examined using the five-item Decision Regret scale and Hospital Anxiety and Depression Scale (HADS) 1 month after surgery. RESULTS: The choice of breast conservation therapy and mastectomy did not significantly differ between the PDA and standard groups. The PDA group had a higher level of depression after making decisions (P = 0.029) than did the standard group. No significant difference in the total scores of the SURE scale and Decision Regret scale were noted between the groups. CONCLUSION: PDAs did not assist the patients with breast cancer in making breast surgery-related decisions. Clinicians should focus on SDM grounded in evidence-based medicine with care and help patients consider their individual preferences. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03105076; April 7, 2017 ( http://www. CLINICALTRIALS: gov ).
BACKGROUND: Patients with breast cancer encounter difficulties in making surgical treatment decisions. Shared decision-making (SDM) with patient decision aids (PDAs) can minimize patients' decisional conflicts. However, the effect of PDAs in Asia remains inconclusive. This study investigated the effect of SDM assisted by PDAs on the decisional conflict of patients with breast cancer. METHODS: In this two-group, outcome assessor-blind, randomized controlled trial, 151 patients diagnosed as having breast cancer were assigned to the PDA (SDM with PDA) group or the standard (SDM without PDA) group. Demographic and clinical variables were analyzed to identify variables affecting the treatment choice. The patients' decision-making difficulties were evaluated using the four-item SURE scale during preoperative hospitalization, and decisional conflicts were examined using the five-item Decision Regret scale and Hospital Anxiety and Depression Scale (HADS) 1 month after surgery. RESULTS: The choice of breast conservation therapy and mastectomy did not significantly differ between the PDA and standard groups. The PDA group had a higher level of depression after making decisions (P = 0.029) than did the standard group. No significant difference in the total scores of the SURE scale and Decision Regret scale were noted between the groups. CONCLUSION: PDAs did not assist the patients with breast cancer in making breast surgery-related decisions. Clinicians should focus on SDM grounded in evidence-based medicine with care and help patients consider their individual preferences. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03105076; April 7, 2017 ( http://www. CLINICALTRIALS: gov ).
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