Inappropriate statistical method in a parallel-group randomized controlled trial results in unsubstantiated conclusions.
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ABSTRACT:
SUBMITTER: Dimova RB
PROVIDER: S-EPMC4893839 | biostudies-other | 2016
REPOSITORIES: biostudies-other
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Project description:Bipolar depression (BD) is a highly prevalent condition with limited therapeutic options. Deep (H1-coil) transcranial magnetic stimulation (dTMS) is a novel TMS modality with established efficacy for unipolar depression. We conducted a randomized sham-controlled trial to evaluate the efficacy and safety of dTMS in treatment-resistant BD patients. Patients received 20 sessions of active or sham dTMS over the left dorsolateral prefrontal cortex (H1-coil, 55 18?Hz 2?s 120% MT trains). The primary outcome was changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline to endpoint (week 4). Secondary outcomes were changes from baseline to the end of the follow-up phase (week 8), and response and remission rates. Safety was assessed using a dTMS adverse effects questionnaire and the Young Mania Rating Scale to assess treatment-emergent mania switch (TEMS). Out of 50 patients, 43 finished the trial. There were 2 and 5 dropouts in the sham and active groups, respectively. Active dTMS was superior to sham at end point (difference favoring dTMS=4.88; 95% CI 0.43 to 9.32, p=0.03) but not at follow-up. There was also a trend for greater response rates in the active (48%) vs sham (24%) groups (OR=2.92; 95% CI=0.87 to 9.78, p=0.08). Remission rates were not statistically different. No TEMS episodes were observed. Deep TMS is a potentially effective and well-tolerated add-on therapy in resistant bipolar depressed patients receiving adequate pharmacotherapy.
| S-EPMC5686495 | biostudies-literature
Project description:BackgroundThere is a strong rationale for the use of agents with film-forming protective properties, like xyloglucan, for the treatment of acute diarrhea. However, few data from clinical trials are available.MethodsA randomized, controlled, open-label, parallel group, multicentre, clinical trial was performed to evaluate the efficacy and safety of xyloglucan, in comparison with diosmectite and Saccharomyces in adult patients with acute diarrhea due to different causes. Patients were randomized to receive a 3-day treatment. Symptoms (stools type, nausea, vomiting, abdominal pain and flatulence) were assessed by a self-administered ad-hoc questionnaire 1, 3, 6, 12, 24, 48 and 72 h following the first dose administration. Adverse events were also recorded.ResultsA total of 150 patients (69.3 % women and 30.7 % men, mean age 47.3 ± 14.7 years) were included (n = 50 in each group). A faster onset of action was observed in the xyloglucan group compared with the diosmectite and S. bouliardii groups. At 6 h xyloglucan produced a statistically significant higher decrease in the mean number of type 6 and 7 stools compared with diosmectite (p = 0.031). Xyloglucan was the most efficient treatment in reducing the percentage of patients with nausea throughout the study period, particularly during the first hours (from 26 % at baseline to 4 % after 6 and 12 h). An important improvement of vomiting was observed in all three treatment groups. Xyloglucan was more effective than diosmectite and S. bouliardii in reducing abdominal pain, with a constant improvement observed throughout the study. The clinical evolution of flatulence followed similar patterns in the three groups, with continuous improvement of the symptom. All treatments were well tolerated, without reported adverse events.ConclusionsXyloglucan is a fast, efficacious and safe option for the treatment of acute diarrhea.Trial registrationEudraCT number 2014-001814-24 (date: 2014-04-28) ISRCTN number: 90311828.
| S-EPMC4628347 | biostudies-literature
Project description:BackgroundAccording to recent polling, public trust in the healthcare sector remains low relative to other industries globally. The implications of low healthcare trust permeate throughout the industry in a number of ways, most visibly by discouraging therapy compliance.MethodsThis study investigated four putative determinants of trust in healthcare-related scenarios: individuals vs. collective groups as communicators of healthcare advice; expert vs. laypeople as providers of healthcare communication; public vs. private healthcare sector; and positive vs. negative information. Two hundred seventy-four participants were recruited via Prolific Academic and were presented with four statements in random order, related to a positive reflection of the public healthcare sector, a negative reflection of the public healthcare sector, a positive reflection of the private healthcare sector and a negative reflection of the private healthcare sector. According to these reflection, participants were repeatedly asked to rate the system on its trustworthiness. Trust outcomes were constructed using a four-dimension framework, consisting of benevolence, reliability, competence and predictability.ResultsClaims relating to the public sector had a significantly stronger impact on benevolence and reliability than claims relating to the private sector; claims from individuals had a significantly stronger impact on all trust variables than claims from collectives; and claims from laypeople had a significantly greater impact on reliability and competence ratings than claims from experts.ConclusionsThe findings in this study offer insight into the patterns with which trust decisions are made in healthcare contexts. More importantly, this research offers a novel perspective of how different factors interact to affect the various facets of trust. These results provide a foundation for future study in this evolving area, and offer insights into designing effective communication strategies that cultivate greater levels of individual trust in the healthcare sector.Supplementary informationThe online version contains supplementary material available at 10.1007/s10389-021-01620-z.
| S-EPMC8274661 | biostudies-literature
Project description:Changes in gene expression were consistent with mechanism of action and show that clinical response to treatment with belimumab is associated with significant decrease in profibrotic genes and pathways. Additional study is needed to determine the role of belimumab in the treatment of dcSSc
2018-03-01 | GSE97248 | GEO
Project description:Background: Hyponatremia is the most common electrolyte disorder with a prevalence of up to 30% in hospitalized patients. In contrast to acute hyponatremia where the need for immediate treatment is well-recognized, chronic hyponatremia is often considered not clinically relevant. This is illustrated by reports showing that appropriate laboratory tests are ordered in <50% of patients and that up to 75% are still hyponatremic at discharge. At the same time, emerging evidence suggests an association between hyponatremia and adverse events including increased risk of mortality and rehospitalization. Methods: This is a randomized (1:1 ratio) controlled, superiority, parallel-group international multi-center trial with blinded outcome assessment. In total 2,278 participants will be enrolled. Participants will be randomly assigned to undergo either targeted correction of plasma sodium levels or standard of care during hospitalization. The primary outcome is the combined risk of death or re-hospitalization within 30 days. Discussion: All data on hyponatremia and mortality are derived from observational studies and often lack methodologic robustness. Consequently, the direct impact of hyponatremia on mortality and rehospitalization risk is still debated, resulting in a clinical equipoise whether in-hospital chronic hyponatremia should be treated or not. Therefore, a randomized controlled trial is required to study whether targeted plasma sodium correction reduces the risk of mortality and rehospitalization associated with hyponatremia. Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03557957.
| S-EPMC8450416 | biostudies-literature
Project description:BackgroundVaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for people who use electronic cigarettes (EC) and want to quit. The objective is to evaluate the efficacy and safety of varenicline (1 mg BID, administered for 12 weeks, with follow-up to week 24) combined with vaping cessation counseling in exclusive daily EC users intending to quit vaping.MethodsDesign: Double-blind, randomized, parallel-group, placebo-controlled trial.SettingThe study took place at a University-run smoking cessation center.ParticipantsPeople who exclusively use ECs daily and intend to quit vaping.InterventionA total of 140 subjects were randomized to either varenicline (1 mg, administered twice daily for 12 weeks) plus counseling or placebo treatment (administered twice daily, for 12 weeks) plus counseling. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up, nontreatment phase.Main outcomes and measuresThe primary efficacy endpoint of the study was biochemically validated continuous abstinence rate (CAR) at weeks 4 to 12. Secondary efficacy end points were CAR at weeks 4 to 24 and 7-day point prevalence of vaping abstinence at weeks 12 and 24.ResultsCAR was significantly higher for varenicline vs placebo at each interval: weeks 4-12, 40.0% and 20.0%, respectively (OR = 2.67, 95% CI = [1.25-5.68], P = 0.011); weeks 4-24, 34.3% for varenicline with counseling and 17.2% for placebo with counseling (OR = 2.52, 95% CI = [1.14-5.58], P = 0.0224). The 7-day point prevalence of vaping abstinence was also higher for the varenicline than placebo at each time point. Serious adverse events were infrequent in both groups and not treatment-related.ConclusionsThe findings of the present RCT indicate that inclusion of varenicline in a vaping cessation program for people who use electronic cigarettes and intending to quit may result in prolonged abstinence. These positive findings establish a benchmark of intervention effectiveness, may support the use of varenicline combined with counseling in vaping cessation programs, and may also help guiding future recommendations by health authorities and healthcare providers.Trial registrationThe study has been registered in EUDRACT with Trial registration ID: 2016-000339-42.
| S-EPMC10321010 | biostudies-literature
Project description:BackgroundEye-drop administration errors occur in the majority of patients and increase the risk for treatment failure or systemic adverse events. While lacking knowledge is the principal error cause, most patients overestimate their skills and are unaware of often substantial knowledge gaps. Therefore, the impact of including motivational patient education on long-term eye-drop administration skills of patients was investigated.MethodsThis is a cluster-randomized controlled trial in German community pharmacies. Patient education in both groups comprised observation of the patient during eye-drop administration to identify individual errors, pharmaceutical counseling, and teach-back evaluation of the training. In the intervention group, motivational communication techniques were included to increase error awareness and readiness for patient education. In addition, intervention patients were trained on repeated errors until administration was performed correctly. In contrast, patients in the control group only received feedback on erroneous administration steps without another assessment and reinforced training.ResultsIn total, 152 adult patients were eligible to the study and 91 patients (intervention group N = 46) agreed to participate in a 1-month, 6-month, and 12-month follow-up. Patient education significantly increased the proportion of patients correctly administering eye-drops from 6% (7 out of 56 intervention patients, 1 out of 82 control patients) at baseline to 35% (12 out of 30 intervention patients, 12 out of 39 control patients, p ≤ 0.001) at the 1-month follow-up, and 64% (11 out of 15 intervention patients, 17 out of 29 control patients, p ≤ 0.001) at the 6-month follow-up irrespective of group allocation. In some patients previously resolved errors recurred during follow-up visits. This emphasizes the need for periodical reevaluation of patient administration skills and the provision of prevention strategies besides education.ConclusionPatient education that included demonstration of administration skills and verbal and written counseling on observed errors improved eye-drop administration skills irrespective of the communication technique applied. Whereof, high drop-out rates limited the power to detect a difference between groups. In particular, periodic demonstration of administration skills seemed important for sustainable improvement of administration skills. However, further error prevention strategies such as additional education materials or support by a caregiver may be necessary in some patients.
| S-EPMC6383939 | biostudies-literature
Project description:BackgroundsFluctuation in glycemia due to hormonal changes, growth periods, physical activity, and emotions make diabetes management difficult during adolescence. Our objective was to show that a close control of patients' self-management of diabetes by nurse-counseling could probably improve metabolic control in adolescents with type 1 diabetes.MethodsWe designed a multicenter, randomized controlled, parallel group, clinical trial. Seventy seven adolescents aged 12-17 years with A1C >8% were assigned to either an intervention group (pediatrician visit every 3 months + nurse visit and phone calls) or to the control group (pediatrician visit every 3 months). The primary outcome was the evolution of the rate of A1C during the 12 months of follow-up. Secondary outcomes include patient's acceptance of the disease (evaluated by visual analog scale), the number of hypoglycemic or ketoacidosis episodes requiring hospitalization, and evaluation of A1C rate over time in each group.ResultsSeventy-seven patients were enrolled by 10 clinical centers. Seventy (89.6%) completed the study, the evolution of A1C and participants satisfaction over the follow-up period was not significantly influenced by the nurse intervention.ConclusionNurse-led intervention to improve A1C did not show a significant benefit in adolescents with type 1 diabetes because of lack of power. Only psychological management and continuous glucose monitoring have shown, so far, a slight but significant benefit on A1C. We did not show improvements in A1C control in teenagers by nurse-led intervention.Trial registrationClinical Trials.gov registration number: NCT00308256, 28 March 2006.
| S-EPMC4563922 | biostudies-literature
Project description:This randomized, double-blind, placebo-controlled Phase 2 clinical trial explored NorLeu(3)-A(1-7) (DSC127) safety and healing efficacy in diabetic foot ulcers. Patients with chronic, noninfected, neuropathic, or neuroischemic plantar Wagner Grade 1 or 2 foot ulcers (n = 172) were screened for nonhealing. Subjects were randomized to receive 4 weeks' once-daily topical treatment with 0.03% DSC127 (n = 26), 0.01% DSC127 (n = 27), or Placebo (n = 24), followed by 20 weeks' standard of care. DSC127 was assessed for safety (including laboratory values and adverse events), primary efficacy (% ulcers completely epithelialized at Week 12), and durability of effect. Baseline, demography, and safety parameters were compared between intent-to-treat groups and were comparable. Dose-response curves for DSC127 effect on % area reduction from baseline at Week 12 (40% placebo; 67% 0.01% DSC127; 80% 0.03% DSC127) and 24 (23% placebo; 53% 0.01% DSC127; 95% 0.03% DSC127) followed a log-linear pattern for both intent-to-treat and per-protocol populations. Covariate analysis compared reduction in ulcer area, depth, and volume from baseline; reductions in the 0.03% DSC127 group were greater at Weeks 12 and 24. Placebo-treated ulcers healed in a median 22 weeks vs. 8.5 weeks for 0.03%DSC127 (p = 0.04). This study provides preliminary evidence that DSC127 is safe and effective in accelerating the healing of diabetic foot ulcers.
| S-EPMC6314814 | biostudies-literature
Project description:BackgroundTraditional face-to-face training (FFT) for basic surgical skills is inaccessible and resource-intensive. Noninteractive computer-based learning is more economical but less educationally beneficial. Virtual classroom training (VCT) is a novel method that permits distanced interactive expert instruction. VCT may optimize resources and increase accessibility.ObjectiveWe aim to investigate whether VCT is superior to computer-based learning and noninferior to FFT in improving proficiency in basic surgical skills.MethodsThis is a protocol for a parallel-group, noninferiority, randomized controlled trial. A sample of 72 undergraduates will be recruited from 5 medical schools in London. Participants will be stratified by subjective and objective suturing experience level and allocated to 3 intervention groups at a 1:1:1 ratio. VCT will be delivered using the BARCO weConnect software, and FFT will be provided by expert instructors. Optimal student-to-teacher ratios of 12:1 for VCT and 4:1 for FFT will be maintained. The assessed task will be interrupted suturing with hand-tied knots.ResultsThe primary outcome will be the postintervention Objective Structured Assessment of Technical Skills score, adjudicated by 2 experts blinded to the study and adjusted for baseline proficiency. The noninferiority margin (δ) will be defined using historical data.ConclusionsThis study will serve as a comprehensive appraisal of the suitability of virtual basic surgical skills classroom training as an alternative to FFT. Our findings will assist the development and implementation of further resource-efficient, accessible, virtual basic surgical skills training programs during the COVID-19 pandemic and in the future.Trial registrationInternational Standard Randomized Controlled Trial Number ISRCTN12448098; https://www.isrctn.com/ISRCTN12448098.International registered report identifier (irrid)PRR1-10.2196/28671.
| S-EPMC8367109 | biostudies-literature