scholarly journals Microcredit and willingness to pay for environmental quality: Evidence from a randomized-controlled trial of finance for sanitation in rural Cambodia

2017 ◽  
Vol 86 ◽  
pp. 121-140 ◽  
Author(s):  
Ariel Ben Yishay ◽  
Andrew Fraker ◽  
Raymond Guiteras ◽  
Giordano Palloni ◽  
Neil Buddy Shah ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Willingness To Pay ◽  
Environmental Quality ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Quality Evidence

The Effectiveness of Dorsal Root Ganglion Neurostimulation for the Treatment of Chronic Pelvic Pain and Chronic Neuropathic Pain of the Lower Extremity: A Comprehensive Review of the Published Data

Pain Medicine ◽  
2020 ◽  
Author(s):  
Ameet Nagpal ◽  
Nathan Clements ◽  
Belinda Duszynski ◽  
Brian Boies
Keyword(s):  
Randomized Controlled Trial ◽  
Dorsal Root Ganglion ◽  
Dorsal Root ◽  
Chronic Pelvic Pain ◽  
Controlled Trial ◽  
Chronic Neuropathic Pain ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Quality Evidence

Abstract Objective To evaluate the effectiveness of dorsal root ganglion neurostimulation for the treatment of refractory, focal pain in the pelvis and lower extremities. Design Systematic review. Outcome Measures The primary outcome was ≥50% pain relief. Secondary outcomes were physical function, mood, quality of life, opioid usage, and complications. Results One pragmatic randomized controlled trial, four prospective cohort studies, and eight case series met the inclusion criteria. A worst-case scenario analysis from the randomized controlled trial reported ≥50% pain relief in 74% of patients with dorsal root ganglion neurostimulation vs. 51% of patients who experienced at least 50% relief with spinal cord stimulation at 3 months. Cohort data success rates ranged from 43% to 83% at ≤6 months and 27% to 100% at >6 months. Significant improvements were also reported in the secondary outcomes assessed, including mood, quality of life, opioid usage, and health care utilization, though a lack of available quantitative data limits further statistical analysis. Complication rates vary, though the only randomized controlled trial reported a higher rate of adverse events than that seen with traditional neurostimulation. Conclusions In accordance with the Grades of Recommendation, Assessment, Development, and Evaluation system, low-quality evidence supports dorsal root ganglion neurostimulation as a more effective treatment than traditional neurostimulation for pain and dysfunction associated with complex regional pain syndrome or causalgia. Very low-quality evidence supports dorsal root ganglion neurostimulation for the treatment of chronic pelvic pain, chronic neuropathic groin pain, phantom limb pain, chronic neuropathic pain of the trunk and/or limbs, and diabetic neuropathy.

scholarly journals Don’t abandon RCTs in IVF. We don’t even understand them

2019 ◽  
Vol 34 (11) ◽  
pp. 2093-2098 ◽  
Author(s):  
J Wilkinson ◽  
D R Brison ◽  
J M N Duffy ◽  
C M Farquhar ◽  
S Lensen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Status Quo ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Infertility Treatments ◽  
The Status ◽  
Quality Evidence

Abstract The conclusion of the Human Fertilisation and Embryology Authority that ‘add-on’ therapies in IVF are not supported by high-quality evidence has prompted new questions regarding the role of the randomized controlled trial (RCT) in evaluating infertility treatments. Critics argue that trials are cumbersome tools that provide irrelevant answers. Instead, they argue that greater emphasis should be placed on large observational databases, which can be analysed using powerful algorithms to determine which treatments work and for whom. Although the validity of these arguments rests upon the sciences of statistics and epidemiology, the discussion to date has largely been conducted without reference to these fields. We aim to remedy this omission, by evaluating the arguments against RCTs in IVF from a primarily methodological perspective. We suggest that, while criticism of the status quo is warranted, a retreat from RCTs is more likely to make things worse for patients and clinicians.

scholarly journals A Self-Help App for Syrian Refugees With Posttraumatic Stress (Sanadak): Randomized Controlled Trial

10.2196/24807 ◽  
2021 ◽  
Vol 9 (1) ◽  
pp. e24807
Author(s):  
Susanne Röhr ◽  
Franziska U Jung ◽  
Alexander Pabst ◽  
Thomas Grochtdreis ◽  
Judith Dams ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Willingness To Pay ◽  
Posttraumatic Stress ◽  
Controlled Trial ◽  
Syrian Refugees ◽  
Significant Group ◽  
Randomized Controlled ◽  
Self Help ◽  
Secondary Outcomes

Background Syrian refugees residing in Germany often develop posttraumatic stress as a result of the Syrian civil war, their escape, and postmigration stressors. At the same time, there is a lack of adequate treatment options. The smartphone-based app Sanadak was developed to provide cognitive behavioral therapy–based self-help in the Arabic language for Syrian refugees with posttraumatic stress. Objective The aim of this study was to evaluate the effectiveness and cost-effectiveness of the app. Methods In a randomized controlled trial, eligible individuals were randomly allocated to the intervention group (IG; app use) or control group (CG; psychoeducational reading material). Data were collected during structured face-to-face interviews at 3 assessments (preintervention/baseline, postintervention/after 4 weeks, follow-up/after 4 months). Using adjusted mixed-effects linear regression models, changes in posttraumatic stress and secondary outcomes were investigated as intention-to-treat (ITT) and per-protocol (PP) analysis. Cost-effectiveness was evaluated based on adjusted mean total costs, quality-adjusted life years (QALYs), and cost-effectiveness acceptability curves using the net benefit approach. Results Of 170 screened individuals (aged 18 to 65 years), 133 were eligible and randomized to the IG (n=65) and CG (n=68). Although there was a pre-post reduction in posttraumatic stress, ITT showed no significant differences between the IG and CG after 4 weeks (Posttraumatic Diagnostic Scale for DSM-5, Diff –0.90, 95% CI –0.24 to 0.47; P=.52) and after 4 months (Diff –0.39, 95% CI –3.24 to 2.46; P=.79). The same was true for PP. Regarding secondary outcomes, ITT indicated a treatment effect for self-stigma: after 4 weeks (Self-Stigma of Mental Illness Scale/SSMIS–stereotype agreement: d=0.86, 95% CI 0.46 to 1.25; stereotype application: d=0.60, 95% CI 0.22 to 0.99) and after 4 months (d=0.52, 95% CI 0.12 to 0.92; d=0.50, 95% CI 0.10 to 0.90), the IG showed significantly lower values in self-stigma than the CG. ITT showed no significant group differences in total costs and QALYs. The probability of cost-effectiveness was 81% for a willingness-to-pay of €0 per additional QALY but decreased with increasing willingness-to-pay. Conclusions Sanadak was not more effective in reducing mild to moderate posttraumatic stress in Syrian refugees than the control condition nor was it likely to be cost-effective. Therefore, Sanadak is not suitable as a standalone treatment. However, as the app usability was very good, no harms detected, and stigma significantly reduced, Sanadak has potential as a bridging aid within a stepped and collaborative care approach. Trial Registration German Clinical Trials Register DRKS00013782; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013782 International Registered Report Identifier (IRRID) RR2-10.1186/s12888-019-2110-y

scholarly journals A Self-Help App for Syrian Refugees With Posttraumatic Stress (Sanadak): Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Susanne Röhr ◽  
Franziska U Jung ◽  
Alexander Pabst ◽  
Thomas Grochtdreis ◽  
Judith Dams ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Willingness To Pay ◽  
Posttraumatic Stress ◽  
Controlled Trial ◽  
Syrian Refugees ◽  
Significant Group ◽  
Randomized Controlled ◽  
Self Help ◽  
Secondary Outcomes

BACKGROUND Syrian refugees residing in Germany often develop posttraumatic stress as a result of the Syrian civil war, their escape, and postmigration stressors. At the same time, there is a lack of adequate treatment options. The smartphone-based app Sanadak was developed to provide cognitive behavioral therapy–based self-help in the Arabic language for Syrian refugees with posttraumatic stress. OBJECTIVE The aim of this study was to evaluate the effectiveness and cost-effectiveness of the app. METHODS In a randomized controlled trial, eligible individuals were randomly allocated to the intervention group (IG; app use) or control group (CG; psychoeducational reading material). Data were collected during structured face-to-face interviews at 3 assessments (preintervention/baseline, postintervention/after 4 weeks, follow-up/after 4 months). Using adjusted mixed-effects linear regression models, changes in posttraumatic stress and secondary outcomes were investigated as intention-to-treat (ITT) and per-protocol (PP) analysis. Cost-effectiveness was evaluated based on adjusted mean total costs, quality-adjusted life years (QALYs), and cost-effectiveness acceptability curves using the net benefit approach. RESULTS Of 170 screened individuals (aged 18 to 65 years), 133 were eligible and randomized to the IG (n=65) and CG (n=68). Although there was a pre-post reduction in posttraumatic stress, ITT showed no significant differences between the IG and CG after 4 weeks (Posttraumatic Diagnostic Scale for DSM-5, Diff –0.90, 95% CI –0.24 to 0.47; <i>P</i>=.52) and after 4 months (Diff –0.39, 95% CI –3.24 to 2.46; <i>P</i>=.79). The same was true for PP. Regarding secondary outcomes, ITT indicated a treatment effect for self-stigma: after 4 weeks (Self-Stigma of Mental Illness Scale/SSMIS–stereotype agreement: <i>d</i>=0.86, 95% CI 0.46 to 1.25; stereotype application: <i>d</i>=0.60, 95% CI 0.22 to 0.99) and after 4 months (<i>d</i>=0.52, 95% CI 0.12 to 0.92; <i>d</i>=0.50, 95% CI 0.10 to 0.90), the IG showed significantly lower values in self-stigma than the CG. ITT showed no significant group differences in total costs and QALYs. The probability of cost-effectiveness was 81% for a willingness-to-pay of €0 per additional QALY but decreased with increasing willingness-to-pay. CONCLUSIONS Sanadak was not more effective in reducing mild to moderate posttraumatic stress in Syrian refugees than the control condition nor was it likely to be cost-effective. Therefore, Sanadak is not suitable as a standalone treatment. However, as the app usability was very good, no harms detected, and stigma significantly reduced, Sanadak has potential as a bridging aid within a stepped and collaborative care approach. CLINICALTRIAL German Clinical Trials Register DRKS00013782; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&amp;TRIAL_ID=DRKS00013782 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12888-019-2110-y

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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