Laparascopic cholecystectomy: cystic duct occlusion with titanium clips or ligature? A prospective randomized study. Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study. Randomized trial of a decision aid for patients with cystic fibrosis considering lung transplantation.
During laparoscopic cholecystectomy (LC), cystic duct occlusion can be done with titanium clips or laparoscopically tied knots. However, till date, there is no randomized, controlled study reported in the literature that has prospectively compared the outcome using either of these methods. In the present study, 105 patients who were to undergo LC were randomly assigned to two groups. Group I comprised patients undergoing cystic duct occlusion with clips while group II comprised those undergoing cystic duct occlusion with knots. Our aim was to compare the postoperative outcome in both the cases. The incidence of overall bile leak following LC was 4 out of 105 (3.8%) while the leak rate following cystic duct occlusion with clips was 2 out 52 (3.9%), and that following ligature was 2 out of 53 (3.8%). The procedure using ligature took slightly longer time than that using clips. There was no significant difference in the postoperative outcome in either group. The use of ligature is a feasible, safe and cost-effective alternative to the use of titanium clips for cystic duct occlusion during LC. Enhanced airway clearance is thought to result in better-maintained pulmonary function in cystic fibrosis (CF). Postural drainage, percussion, and vibration (PDPV) have been the primary airway clearance technique (ACT) employed in CF for over 40 years. Two new airway clearance modalities are high-frequency chest wall oscillation (HFCWO) and oscillating positive expiratory pressure (OPEP). This pilot study was undertaken to evaluate the efficacy of these techniques during home use, assess patient satisfaction with them as compared to PDPV, and assess the feasibility of performing a definitive comparative trial. The prospective, randomized, multicenter crossover trial was conducted at three urban academic CF Care Centers. Twenty-nine CF patients, 9-39 years of age, participated. Subjects performed 4 weeks each of HFCWO and OPEP following 2-week lead-in/washout periods. Spirometry, lung volumes, National Institutes of Health and Petty Scores, and a satisfaction survey were performed at baseline and after each treatment period. An ACT preference survey was completed at the conclusion of the study. Twenty-four subjects completed both therapies. There were no statistically significant differences between therapies for spirometry, lung volumes, or clinical scores. No significant safety issues arose during the study period. Compliance between therapies was similar. Significant differences among therapies existed in patient satisfaction. Given a choice of therapy, 50% of subjects chose HFCWO, 37% OPEP, and 13% PDPV. This study suggests that HFCWO and OPEP are safe and as effective as patients' routine therapies when used for airway clearance in a home setting. Patient satisfaction and preference differ among ACTs and should be considered when prescribing home therapy. A definitive, multi-center, comparative study evaluating long-term efficacy of these techniques is feasible.
                Copyright 2001 Wiley-Liss, Inc. We developed an evidence-based decision aid for patients with advanced cystic fibrosis considering referral for lung transplantation.
                To prospectively evaluate whether use of the decision aid increased knowledge about the options, improved realistic expectations, and decreased decisional conflict in adult patients.
                We performed a single-blind randomized controlled trial involving 149 adult patients with cystic fibrosis with an FEV(1) <or= 40% predicted from 14 Canadian and Australian centers. All participants received an education and counseling session from their cystic fibrosis team and were then randomized to receive the decision aid or usual care. The decision aid is available online at http://decisionaid.ohri.ca/decaids.html.
                The primary end points measured were participants' knowledge, realistic expectations, and decisional conflict evaluated 3 weeks after randomization. Patients randomized to the decision aid had greater knowledge about their options (P < 0.0001) and had more realistic expectations about the benefits and risks of lung transplantation (P < 0.0001) compared with those randomized to usual care. The total decisional conflict score was significantly lower in the decision aid group 3 weeks postrandomization compared with the usual care group (11.6 vs. 20.4; P = 0.0007). Decisions were durable; 88% of patients in the decision aid group and 75% in the usual care group maintained the same choice 12 months after randomization (P = 0.06).
                Use of a decision aid for patients with cystic fibrosis considering referral for lung transplantation, in addition to usual education and counseling, improves patient knowledge, realistic expectations, decisional conflict, and patient satisfaction. Clinical trial registered with www.clinicaltrials.gov (NCT00345449).
We are unable to determine the benefits and harms of different methods of cystic duct occlusion because of the small sample size, short period of follow-up, and lack of reporting of important outcomes in the included trials. Adequately powered randomised trials with low risk of bias and with long periods of follow-up and assessing all of the important outcomes for patients and professionals are necessary.