METHODS: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.
RESULTS: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority).
CONCLUSIONS: Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).
METHODS AND DESIGN: A randomised, single blind controlled trial will be conducted. Twenty-eight patients aged 18 years and above with a recent grade-2 hamstring injury will be invited to take part. Participants will be randomised to receive either autologous PRP injection with rehabilitation programme, or rehabilitation programme only. Participants will be followed up at day three of study and then weekly for 16 weeks. At each follow up visit, participants will be assessed on readiness to return-to-play using a set of criteria. The primary end-point is when participants have fulfilled the return-to-play criteria or end of 16 weeks.The main outcome measure of this study is the duration to return-to-play after injury.
CONCLUSION: This study protocol proposes a rigorous and potential significant evaluation of PRP use for grade-2 hamstring injury. If proven effective such findings could be of great benefit for patients with similar injuries.
TRIAL REGISTRATION: Current Controlled Trials ISCRTN66528592.
METHODS: Adults with HIV, who have been taking ART for more than 3 months were randomly assigned to receive either a pharmacist-led intervention or their usual care. Measures of adherence were collected at 1) baseline 2) just prior to delivery of intervention and 3) 8 weeks later. The primary outcomes were CD4 cell count and self-reported adherence measured with the AIDS Clinical Trial Group (ACTG) questionnaire.
RESULTS: Post-intervention, the intervention group showed a statistically significant increase in CD4 cell counts as compared to the usual care group (p = 0.0054). In addition, adherence improved in the intervention group, with participants being 5.96 times more likely to report having not missed their medication for longer periods of time (p = 0.0086) while participants in the intervention group were 7.74 times more likely to report missing their ART less frequently (p
OBJECTIVE: This study developed, implemented and evaluated the outcome of a chemotherapy counseling module among oncology patients by pharmacists based on their psychological effects (depression, anxiety) and selfesteem.
METHODS: A randomized, single blind, placebo controlled study was conducted among 162 patients undergoing chemotherapy in a government hospital in Malaysia.
INTERVENTION: Counseling sessions were conducted using the 'Managing Patients on Chemotherapy' module for oncology patients undergoing chemotherapy at each treatment cycle.
OUTCOME: The outcome of repetitive chemotherapy counseling using the module was determined at baseline, first follow-up, second follow-up and third follow-up.
RESULTS: The findings revealed that there was significant improvement in the intervention group as compared to the control group with large effect size on depression (p = 0.001, partial η(2) = 0.394), anxiety (p = 0.001, partial η(2) = 0.232) and self-esteem (p = 0.001, partial η(2) = 0.541).
CONCLUSION: Repetitive counseling using the 'Managing Patients on Chemotherapy' module was found to be effective in improving psychological effects and self-esteem among patients undergoing chemotherapy.
METHODS: 10 010 high-risk noncardiac surgical patients were randomized aspirin or placebo and clonidine or placebo. Neuraxial block was defined as intraoperative spinal anaesthesia, or thoracic or lumbar epidural anaesthesia. Postoperative epidural analgesia was defined as postoperative epidural local anaesthetic and/or opioid administration. We used logistic regression with weighting using estimated propensity scores.
RESULTS: Neuraxial block was not associated with the primary outcome [7.5% vs 6.5%; odds ratio (OR), 0.89; 95% CI (confidence interval), 0.73-1.08; P=0.24], death (1.0% vs 1.4%; OR, 0.84; 95% CI, 0.53-1.35; P=0.48), myocardial infarction (6.9% vs 5.5%; OR, 0.91; 95% CI, 0.74-1.12; P=0.36) or stroke (0.3% vs 0.4%; OR, 1.05; 95% CI, 0.44-2.49; P=0.91). Neuraxial block was associated with less clinically important hypotension (39% vs 46%; OR, 0.90; 95% CI, 0.81-1.00; P=0.04). Postoperative epidural analgesia was not associated with the primary outcome (11.8% vs 6.2%; OR, 1.48; 95% CI, 0.89-2.48; P=0.13), death (1.3% vs 0.8%; OR, 0.84; 95% CI, 0.35-1.99; P=0.68], myocardial infarction (11.0% vs 5.7%; OR, 1.53; 95% CI, 0.90-2.61; P=0.11], stroke (0.4% vs 0.4%; OR, 0.65; 95% CI, 0.18-2.32; P=0.50] or clinically important hypotension (63% vs 36%; OR, 1.40; 95% CI, 0.95-2.09; P=0.09).
CONCLUSIONS: Neuraxial block and postoperative epidural analgesia were not associated with adverse cardiovascular outcomes among POISE-2 subjects.
METHODS: This single-blind, prospective, randomized, controlled trial involved intraoperative measurements for 271 femoral component implantations from 3 contemporary TKA systems, with 2 systems offering narrow sizing options. The difference between femoral component dimensions and the resected surface of distal femur was measured in millimeters at 5 distinct zones.
RESULTS: Overhang of standard femoral component was common in the anterior-medial condyle and anterior-lateral condyle ranging from 50.8% to 99.0% and 21.5% to 88.0%, respectively. With narrow femoral components, the rate of overhang reduced to 21.5%-30.2% and 9.2%-32.1%. Conversely, underhang rates were higher over the anterior flange width, middle medial-lateral and posterior medial-lateral zones. Standard components displayed higher underhang rates at these zones compared to narrow components. The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%. System with narrow option sizing increases the underhang rates in males, while improving the component fit among females at similar zones with rate ranging from 5.2% to 52.9%.
CONCLUSION: Currently available TKA implant designs may not provide a perfect match for the distal femoral shape of the Korean population. The availability of implants with standard and narrow options can substantially improve the optimal fitting of femoral components in the Korean population.
MATERIALS AND METHODS: A randomised control study with a two-group, single-blind design and baseline evaluation was selected. Social media sites were used to advertise for participants, who were then admitted after meeting the requirements. Participants who met the eligibility requirements were randomly split into two groups. Each group received a total of three sessions of online therapy (MT or CT), once every two weeks, as well as one phone call per week as reinforcement. At the beginning and end of the intervention, participants completed questionnaires (1st week and 5th week). Generalized Estimating Equation (GEE) statistical analysis was used to analyse all the variables.
RESULTS: The MT group experienced a statistically significant decrease in cigarette consumption (β: -3.50, 95% Wald CI: - 4.62, -2.39) compared to the CT group over time. Furthermore, the MT group demonstrated significant improvements in their scores for the AAQ-2, anxiety, stress, depression and mindfulness compared to the CT group.
CONCLUSION: Online MT is more successful at assisting smokers in lowering their daily cigarette intake and supporting their mental health during the smoking cessation process. Further longitudinal comparisons of the effectiveness of online MT should be undertaken using online platforms in future studies.
METHODS: We report 12-month post-treatment data from a single-blind, active-controlled trial (October 2017-August 2019) where 327 Myanmar refugees in Malaysia were assigned to either six sessions of IAT (n = 164) or cognitive behavioral treatment (CBT) (n = 163). Primary outcomes were posttraumatic stress disorder (PTSD), depression, anxiety, and persistent complex bereavement disorder (PCBD) symptom scores at treatment end and 12-month post-treatment. Secondary outcome was functional impairment.
RESULTS: 282 (86.2%) participants were retained at 12-month follow-up. For both groups, large treatment effects for common mental disorders (CMD) symptoms were maintained at 12-month post-treatment compared to baseline (d = 0.75-1.13). Although participants in IAT had greater symptom reductions and larger effect sizes than CBT participants for all CMDs at treatment end, there were no significant differences between treatment arms at 12-month post-treatment for PTSD [mean difference: -0.9, 95% CI (-2.5 to 0.6), p = 0.25], depression [mean difference: 0.1, 95% CI (-0.6 to 0.7), p = 0.89), anxiety [mean difference: -0.4, 95% CI (-1.4 to 0.6), p = 0.46], and PCBD [mean difference: -0.6, 95% CI (-3.1 to 1.9), p = 0.65]. CBT participants showed greater improvement in functioning than IAT participants at 12-month post-treatment [mean difference: -2.5, 95% CI (-4.7 to -0.3], p = 0.03]. No adverse effects were recorded for either therapy.
CONCLUSIONS: Both IAT and CBT showed sustained treatment gains for CMD symptoms amongst refugees over the 12-month period.
METHODS AND ANALYSIS: 370 pregnant women (aged 18 years old and above) will be recruited with International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form. Ten clusters (primary care clinics) will be randomly assigned to either PFMT or usual care in a 1:1 ratio by an independent researcher (sealed envelope). The primary outcome will be urinary incontinence, and the secondary outcomes (quality of life; PFMT adherence, psychological status and mobile apps' usability) will be assessed at four measurement time points (t0: baseline) and postintervention (t1: 4 weeks, t2: 8 weeks and t3: 8 weeks postnatal). T-test analysis will determine any significant differences at the baseline between the control and intervention groups. The mixed-model analysis will determine the effectiveness of the intervention at the population-average level for both the primary and secondary outcomes. For the cost-effectiveness analysis, expenditures during the study and 6 months after the intervention will be compared between the groups using the multiway sensitivity analysis. The recruitment planned will be in December 2020, and the planned end of the study will be in August 2021.
ETHICS AND DISSEMINATION: This study protocol was approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia (JKEUPM-2019-368) and Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, NMRR-19-412-47116 (IIR) with the ANZCTR registration. This study will obtain informed written consent from all the study participants. The results which conform with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials will be published for dissemination in peer-reviewed journals and conference proceedings.
TRIAL REGISTRATION NUMBER: ACTRN12619000379112.