RESUMO
Background: Extended-duration thromboprophylaxis is used to decrease risk of venous thromboembolism (VTE) after surgery but may increase the risk of bleeding. The decision to complete a course of extended-duration thromboprophylaxis can be challenging. Objective: The objective of this study was to develop an acceptable patient decision aid (PtDA) to facilitate shared decision making for the use of extended-duration thromboprophylaxis following major abdominal surgery. Methods: An evidence-based, risk-stratified PtDA was created. The evidence on benefits and harms of a 28-day postoperative course of low-molecular-weight heparin (LMWH) versus in-hospital prophylaxis only were synthesized. Outcomes included minor bleeding, major bleeding, clinically significant VTE, and fatal VTE. Risks were calculated and reported by Caprini score. Alpha testing of the PtDA draft with various stakeholders was performed using a 10-question survey to assess acceptability of the PtDA with patients, thrombosis experts, and surgeons. The primary outcome was the acceptability of the PtDA. Results: Acceptability testing was performed with 11 patients, 11 thrombosis experts, and 11 surgeons. Most responders felt the language on the PtDA was easy to follow (28/33, 85%), and that the information was well balanced between management options (9/11 [82%] patients; 17/21 [80%] clinicians). Most patients (9/11, 82%) and clinicians (18/22, 82%) believed it would be a useful clinical tool, and were satisfied with the overall quality of the PtDA (27/33, 82%). Conclusions: A risk-stratified, evidence-based PtDA was created to facilitate shared decision making for the use of extended-duration LMWH following major abdominal surgery. This clinical tool was acceptable with patients and physicians and is available at https://decisionaid.ohri.ca/decaids.html.
RESUMO
BACKGROUND: Despite curative intent resection in patients with non-small cell lung cancer (NSCLC), recurrence leading to mortality remains too common. Melatonin has shown promise for the treatment of patients with lung cancer; however, its effect following cancer resection has not been studied. We evaluated if melatonin taken after complete resection reduces lung cancer recurrence and mortality, or impacts quality of life (QOL), symptomatology or immune function. METHODS: Participants received melatonin (20 mg) or placebo nightly for one year following surgical resection of primary NSCLC. The primary outcome was two-year disease-free survival (DFS). Secondary outcomes included five-year DFS, adverse events, QOL, fatigue, sleep, depression, anxiety, pain, and biomarkers assessing for immune function/inflammation. This study is registered at https://clinicaltrials.gov NCT00668707. FINDINGS: 709 patients across eight centres were randomized to melatonin (n = 356) versus placebo (n = 353). At two years, melatonin showed a relative risk of 1·01 (95% CI 0·83-1·22), p = 0·94 for DFS. At five years, melatonin showed a hazard ratio of 0·97 (95% CI 0·86-1·09), p = 0·84 for DFS. When stratified by cancer stage (I/II and III/IV), a hazard reduction of 25% (HR 0·75, 95% CI 0·61-0·92, p = 0·005) in five-year DFS was seen for participants in the treatment arm with advanced cancer (stage III/IV). No meaningful differences were seen in any other outcomes. INTERPRETATION: Adjuvant melatonin following resection of NSCLC does not affect DFS for patients with resected early stage NSCLC, yet may increase DFS in patients with late stage disease. Further study is needed to confirm this positive result. No beneficial effects were seen in QOL, symptoms, or immune function. FUNDING: This study was funded by the Lotte and John Hecht Memorial Foundation and the Gateway for Cancer Research Foundation.