Although long-term opioid therapy (LTOT) has its own risks, opioid discontinuation could pose harm for high-risk Veterans Health Administration (VHA) patients receiving LTOT. There is limited information on the impact of a mandate requiring providers to perform case reviews on high-risk patients with an active opioid prescription (ie, mandated case review policy) on opioid discontinuation and mortality.
Our study is a secondary data analysis of a 23-month stepped-wedge cluster randomized controlled trial between April 2018 and March 2020. The study included 10 685 LTOT patients with a predicted risk of a serious adverse event between the top 1% to 5% nationally who entered the risk range between 4/18/2018 and 11/9/2019. We examined whether the mandated case review policy had an impact on opioid discontinuation and mortality for the patients.
Among 10 685 LTOT patients (88.2% male; mean [SD] age, 61.1 [11.7] years), 29.1% experienced discontinuation and the mortality rate was 9.5%. Patients under mandated case review had a decreased risk of opioid discontinuation (average marginal effect [AME], -11.16 [95% CI, -15.30 to -7.01] percentage points) and all-cause mortality (AME, -3.31 [95% CI, -5.63 to -1.00] percentage points), relative to patients who were not under the mandate.
The VHA mandated case review policy was associated with lower probability of discontinuation and all-cause mortality for high-risk patients receiving LTOT. Interventions that maintain care engagement while optimizing pain management for high-risk patients may be beneficial for minimizing mortality and other risks associated with discontinuation.

UNASSIGNED: Head-to-head comparisons through randomized controlled trials (RCTs) provide high-quality evidence to inform healthcare decisions. In their absence, indirect comparisons are often performed; however, evidence is limited on how valid matching-adjusted indirect comparison (MAIC)-based comparative efficacy estimates are vs. RCT-based estimates.
UNASSIGNED: Compare MAIC and RCT results of guselkumab vs. secukinumab and ixekizumab to provide insight into the validity of results generated using MAIC methods.
UNASSIGNED: Previously reported results from MAICs of guselkumab vs. secukinumab and ixekizumab were compared with results from ECLIPSE and IXORA-R RCTs based on risk differences between Psoriasis Area and Severity Index (PASI) 90 response rates.
UNASSIGNED: Risk difference (95% confidence interval) in PASI 90 response rates at week 48 for guselkumab vs. secukinumab was 14.4% (9.4%; 19.4%) in ECLIPSE and 9.4% (4.7%; 14.0%) in the MAIC. The risk difference at week 24 for guselkumab vs. ixekizumab was 0.0% (-5.4%; 5.4%) in IXORA-R and 0.7% (-5.1%; 6.4%) in the MAIC.
UNASSIGNED: Comparative efficacy results were consistent between MAICs and RCTs of guselkumab vs. secukinumab and ixekizumab. This analysis demonstrates that MAIC methods can provide valid relative treatment effect estimates when direct comparisons are lacking, particularly when trials with similar designs and patient populations inform the analysis.

The Veterans Health Administration (VHA) implemented the Stratification Tool for Opioid Risk Mitigation (STORM) to reduce the risk of serious adverse events (SAE) among patients with opioid analgesic prescriptions. VHA facilities were mandated to case review patients identified as high risk by STORM. The aim of this study was to measure the effect of this mandate on all-cause mortality and SAEs among VHA patients newly diagnosed with opioid use disorder (OUD).
Secondary analysis of a stepped-wedged cluster randomized controlled trial conducted at all 140 VHA facilities, with facility as the unit of randomization, from 2018 to 2020.
United States VHA facilities were randomized to case review the top 1 or 5% of high-risk patients prescribed opioid analgesics identified by STORM. A total of 28 251 patients were diagnosed with OUD during the trial and were considered control or treatment depending on the status of the facility where they received their OUD diagnosis. Post-hoc analyses among patients who had at least one opioid analgesic prescription in the 90 days prior to diagnosis were conducted and were then stratified by receipt of a prescription in the 90 days following diagnosis to assess the sensitivity of results to opioid discontinuation.
All-cause mortality and opioid-related, drug-related, suicide-related and other SAEs within 90 days of OUD diagnosis.
Mandated case review increased the odds of 90-day mortality [odds ratio (OR) = 1.74, 95% confidence interval (CI) = 1.06, 2.87], but did not significantly change the odds of SAEs. Among patients who received an opioid prescription prior to but not after OUD diagnosis, the odds of all-cause mortality within 90 days was 5.87 (95% CI = 1.85, 18.58) relative to control patients.
Veterans Health Administration patients newly diagnosed with opioid use disorder experienced increased all-cause mortality following expansion of a case review mandate for high-risk patients prescribed opioids.

Trauma within Native American communities compromises parents\' parenting capacity; thus, increasing childrens\' risk for substance use and suicide over the lifespan. The objective of this manuscript is to describe the Wakȟáŋyeža (Little Holy One) intervention and evaluation protocol, that is designed to break cycles of intergenerational trauma, suicide, and substance use among Fort Peck Assiniboine and Sioux parents and their children.
A randomized controlled trial with an embedded single-case experimental design will be used to determine effectiveness of the modular prevention intervention on parent-child outcomes and the added impact of unique cultural lesson-components. Participants include 1) Fort Peck Assiniboine and Sioux parents who have had adverse childhood experiences, and 2) their children (3-5 years). Parent-child dyads are randomized (1:1) to Little Holy One or a control group that consists of 12 lessons taught by Indigenous community health workers. Lessons were developed from elements of 1) the Common Elements Treatment Approach and Family Spirit, both evidence-based interventions, and 2) newly created cultural (intervention) and nutrition (control group only) lessons. Primary outcomes are parent (primary caregiver) trauma symptoms and stress. Secondary outcomes include: Parent depression symptoms, parenting practices, parental control, family routines, substance use, historical loss, communal mastery, tribal identity, historical trauma. Child outcomes include, externalizing and internalizing behavior and school attendance. Primary analysis will follow an intent-to-treat approach, and secondary analysis will include examination of change trajectories to determine impact of cultural lessons and exploration of overall effect moderation by age and gender of child and type of caregiver (e.g., parent, grandparent).
Many Native American parents have endured adverse childhood experiences and traumas that can negatively impact capacity for positive parenting. Study results will provide insights about the potential of a culturally-based intervention to reduce parental distress - an upstream approach to reducing risk for childrens\' later substance misuse and suicidality. Intervention design features, including use of community health workers, cultural grounding, and administration in Head Start settings lend potential for feasibility, acceptability, sustainability, and scalability.
ClinicalTrials.gov: NCT04201184 . Registered 11 December 2019.

BACKGROUND: A novel randomized controlled trial tested the efficacy of a technology-assisted case management program in a low income, rural population previously where nurses titrated medication over the phone instead of in a clinic. The primary analysis showed significant improvement in glycemic control at 6 months post-randomization decreasing hemoglobin A1c by 1%. This study aimed to test if the intervention was also effective at decreasing blood pressure without compromising quality of life.
METHODS: A total of 113 adults with poorly controlled diabetes (hemoglobin A1c ≥ 8%) were randomly assigned to the technology-assisted case management intervention or usual care. Participants received a 2-in-1 telehealth system to monitor glycemic and blood pressure control, which was uploaded daily to a central server. A nurse case manager was trained to titrate medication under physician supervision every 2 weeks based on the readings. Outcomes were blood pressure and quality of life (12-item Short-Form Health Survey) at 6 months. Baseline adjusted mixed models using a random intercept were used to evaluate change at 6 months for the technology-assisted case management intervention group compared to usual care.
RESULTS: There were no statistically significant differences in systolic blood pressure, physical component of quality of life, or mental component of quality of life between the technology-assisted case management and control group. However, there was a significant change in diastolic blood pressure over time, with the technology-assisted case management group decreasing at 6 months (p = .05), whereas the control group remained stable.
CONCLUSIONS: Technology-assisted case management by a nurse with medication titration under physician supervision was efficacious in improving diastolic blood pressure without compromising quality of life in low-income rural adults with diabetes.

The journal received a request to retract a paper reporting the results of a triple-blind randomized placebo-controlled trial. The present and immmediate past editors expand on the journal\'s decision not to retract this paper in spite of undisputable evidence of scientific misconduct on behalf of one of the investigators.
The editors present an ethical reflection on the request to retract this randomized clinical trial with consideration of relevant guidelines from the Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) applied to the unique contextual issues of this case.
In this case, scientific misconduct by a blinded provider of a homeopathy intervention attempted to undermine the study blind. As part of the study, the integrity of the study blind was assessed. Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo. Central to the decision not to retract the paper was the fact that the rigorous scientific design provided evidence that the outcome of the study was not affected by the misconduct. The misconduct itself was thought to be insufficient reason to retract the paper.
Retracting a paper of which the outcome is still valid was in itself considered unethical, as it takes away the opportunity to benefit from its results, rendering the whole study useless. In such cases, scientific misconduct is better handled through other professional channels.

BACKGROUND: Case-based learning (CBL), in contrast to traditional lecture-based learning (LBL), is an andragogical method carrying an earnest teaching approach that uses demonstration of clinical cases as an active learning tool.
OBJECTIVE: To compare the effectiveness of knowledge delivery and student satisfaction between CBL and LBL strategies to diagnose orthodontic cases.
METHODS: A single-blinded randomized controlled trial was performed. The sample of dental undergraduate students was randomly divided into 2 groups. Average GPA among the groups was compared to establish the baseline measure. Visual slides of 6 orthodontic diagnostic cases were presented to the students after implementing the teaching strategies, and a rubrics-based assessment method was adopted to assess the effectiveness in diagnosis. A questionnaire was distributed to compare the level of satisfaction between the groups exposed to CBL and LBL. A t-test was performed to assess the difference in effectiveness, while Cochran-Armitage trend analysis was performed to analyze the difference in the level of satisfaction between LBL and CBL experiences.
RESULTS: We detected no significant (P = 0.11) relation of gender with effective orthodontic diagnosis. The orthodontic diagnostic ability of students for the 6 cases was significantly different (P < 0.05) in the CBL and LBL groups. The satisfaction score obtained for the CBL group was higher than for the LBL group (P < 0.05).
CONCLUSIONS: The current study provides evidence that CBL is an effective and acceptable teaching strategy in comparison to traditional LBL among undergraduate dental students embarking on an orthodontic diagnostic course.

Research suggests that children identified with impaired motor skills can respond well to intensive therapeutic interventions delivered via occupational and physical therapy services. There is, however, a need to explore alternative approaches to delivering interventions outside traditional referral-based clinic settings because limited resources mean such health services often struggle to meet demand. This review sets out to systematically assess the evidence for and against school-based interventions targeted at improving the motor skills of children aged between 3 and 12 years old.
Five electronic databases were searched systematically (AMED, CINAHL, Cochrane, Medline, and PsycINFO) for peer-reviewed articles published between January 2012 and July 2018. Studies were eligible if they implemented a school-based motor skill intervention with a randomized or case-controlled trial design that objectively measured motor skills as an outcome, which were not specific to an athletic or sporting skill. Participants had to be aged between 3 and 12 years old and free from neurological disorders known to affect muscle function. Risk of bias was assessed using the Cochrane risk of bias tool.
Twenty-three studies met the inclusion criteria. These studies encompassed interventions targeted at training: fundamental movement skills, handwriting, fine, and global motor skills. The majority of these studies reported beneficial impact on motor function specifically, but some interventions also assessed subsequent impacts on activity and participation (but not well-being). A number of the studies had methodological shortcomings that means these results need to be interpreted with caution.
Schools appear to be an effective setting for motor skill interventions, but the extent of benefit likely depends on the type of intervention. Moreover, confirmation is needed as to whether benefits extend beyond motor function into everyday activities, participation, and well-being. Future research should include follow-up measures to assess the longer term efficacy of school-based interventions.

Case reports are a valuable though oft-underestimated source of clinical knowledge, even wisdom. They are extremely valuable to clinicians faced with new diseases, new investigations, and new therapies, where they provide the initial information, which serves as a basis to plan a detailed comparative study to provide definitive answers. The publication of cases and images-related reports is undoubtedly a gain for all, including medical students, medical teachers, the scientific community, medical professionals, healthcare managers, and patients.