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Background: Neuroendoscopy is a minimally invasive procedure for clot evacuation in intracerebral hemorrhage (ICH) which may have advantages compared with open surgical evacuation procedures. The application of neuroendoscopy in ICH has attracted increasing attention in recent years. However, it remains unclear whether it could improve outcomes in patients with ICH. Objective: The aim of this study is to explore the efficacy and safety of neuroendoscopic hematoma evacuation surgery compared with standard conservative treatment for spontaneous deep supratentorial cerebral hemorrhage. Methods: The Efficacy and safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage (NESICH) Trial is a multicenter, randomized, controlled, open-label, blinded-endpoint clinical trial. Up to 560 eligible subjects with acute deep supratentorial ICH will be randomly assigned (1:1) to receive either neuroendoscopic hematoma evacuation or standard conservative treatment at more than 30 qualified neurosurgery centers in China. Outcomes: The primary endpoint is the proportion of patients with a good functional outcome (mRS score 0–3) in both groups at 180 days after onset. The main safety endpoints include all-cause mortality at 7, 30, and 180 days, rebleeding at 3, 7, and 30 days, and serious complications within 180 days. Discussion: NESICH will provide high-quality evidence for the efficacy and safety of neuroendoscopic hematoma evacuation surgery in ICH patients. Trial registration: ClinicalTrials.gov NCT05539859. [ABSTRACT FROM AUTHOR]

What solutions can we find in the research literature for preventing sexual violence, and what psychological theories have guided these efforts? We gather all primary prevention efforts to reduce sexual violence from 1985 to 2018 and provide a bird's-eye view of the literature. We first review predominant theoretical approaches to sexual-violence perpetration prevention by highlighting three interventions that exemplify the zeitgeist of primary prevention efforts at various points during this time period. We find a throughline in primary prevention interventions: They aim to change attitudes, beliefs, and knowledge (i.e., ideas) to reduce sexual-violence perpetration and victimization. Our meta-analysis of these studies tests the efficacy of this approach directly and finds that although many interventions are successful at changing ideas, behavior change does not follow. There is little to no relationship between changing attitudes, beliefs, and knowledge and reducing victimization or perpetration. We also observe trends over time, including a shift from targeting a reduction in perpetration to targeting an increase in bystander intervention. We conclude by highlighting promising new strategies for measuring victimization and perpetration and calling for interventions that are informed by theories of behavior change and that center sexually violent behavior as the key outcome of interest. [ABSTRACT FROM AUTHOR]

Purpose: Poverty continues to be a pervasive social problem within the United States despite a plethora of services and government assistance programs. Currently, universal and guaranteed basic income programs are being actively promoted. Method: This review incorporated universal or guaranteed basic income primary reports open to any country and in English from four academic databases including grey literature between January 1, 2013, and April 8, 2023, using randomized controlled trials or quasi-experimental study designs with no specified outcome. Results: Out of an initial 147 articles, four of the primary studies utilized a randomized controlled trial and one used a quasi-experimental design. One study occurred in the United States. Discussion: Despite the increasing implementation of such programs throughout the United States and their associated high cost, evidence is lacking based on their long-term impact and effectiveness. Further study is recommended including stronger evaluations of current and future programs. [ABSTRACT FROM AUTHOR]

Purpose: Depressive symptoms are prevalent among Chinese adolescents. However, there is a lack of effective prevention programs to reduce depressive symptoms. Methods: A pilot cluster randomized controlled trial was implemented in a sample of senior secondary school adolescents. Participants in the intervention group (N = 148) received a 6-week universal prevention course, whereas the control group (N = 131) received a routine course focusing on career development. Results: The linear mixed models showed that the group × time interaction was significant for depressive symptoms measured by DASS-21 (F (2, 550) = 5.72, p =.003) and marginally significant for that measured by SMFQ (F (2, 549) = 2.41, p =.09). Likewise, the level of anxiety and stress were significantly reduced after the program, but not maintained in the follow-up. Conclusions: This pilot study showed that a universal prevention program is promising in reducing adolescent depressive symptoms. [ABSTRACT FROM AUTHOR]

University students were at an increased risk for psychological distress during the COVID-19 pandemic. Using a randomized controlled trial, we examined the efficacy of an online Kundalini Yoga intervention on students' psychological functioning. Healthy university students (N = 106) were randomly assigned to a Kundalini Yoga group, an active control group, or a passive control group in a 1:1:1 ratio. The experimental group attended six Yoga sessions over 6 weeks and the active control group attended to six autogenic relaxation sessions over 6 weeks. All participants completed the study protocol, which involved answering questionnaires related to psychological distress, emotion regulation, self-compassion, self-concept, spiritual well-being, and subjective happiness at three different time points: baseline, at the end of the intervention, and at 1-month follow-up. Results showed that Yoga contributed to improving self-compassion, extrinsic affect improving, and personal and communal spiritual well-being, in comparison to the control groups. [ABSTRACT FROM AUTHOR]

Background: Persistent cognitive impairment is frequent across bipolar disorder (BD) and major depressive disorder (MDD), highlighting an urgent need for pro-cognitive treatments. Aim: This study investigated effects of erythropoietin (EPO) on cognitive impairment and dorsal prefrontal cortex (dPFC) activity in affective disorders. Methods: In this randomized, double-blinded, placebo-controlled trial, cognitively impaired patients with remitted BD or MDD received 1 weekly recombinant human EPO (40,000 IU/mL) or saline infusion for a 12-week period. Assessments were conducted at baseline, after 2 weeks of treatment (week 3), immediately after treatment (week 13) and at 6-months follow-up. Participants underwent functional MRI during performance on a n-back working memory (WM) task at baseline and week 3, and for a subgroup 6 weeks post-treatment (week 18). The primary outcome was a cognitive composite score at week 13, whereas secondary outcomes comprised sustained attention and functioning. WM-related dPFC activity was a tertiary outcome. Results: Data were analysed for 101 of the 103 included patients (EPO, n = 58; saline, n = 43). There were no effects of EPO over saline on any cognitive or functional outcomes or on WM-related dPFC activity. Conclusions: The absence of treatment-related changes in cognition and neural activity was unexpected and contrasts with multiple previous preclinical and clinical studies. It is possible that the lack of effects resulted from a recent change in the manufacturing process for EPO. Nevertheless, the findings support the validity of dPFC target engagement as a biomarker model for pro-cognitive effects, according to which treatments that do not improve cognition should not modulate dPFC activity. Trial registrations: EudraCT no.: 2016–004023-24; ClinicalTrials.gov identifier: NCT03315897. [ABSTRACT FROM AUTHOR]

Background: Pragmatic trials are increasingly recognized for providing real-world evidence on treatment choices. Objective: The objective of this study is to investigate the use and characteristics of pragmatic trials in multiple sclerosis (MS). Methods: Systematic literature search and analysis of pragmatic trials on any intervention published up to 2022. The assessment of pragmatism with PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary-2) is performed. Results: We identified 48 pragmatic trials published 1967–2022 that included a median of 82 participants (interquartile range (IQR) = 42–160) to assess typically supportive care interventions (n = 41; 85%). Only seven trials assessed drugs (15%). Only three trials (6%) included >500 participants. Trials were mostly from the United Kingdom (n = 18; 38%), Italy (n = 6; 13%), the United States and Denmark (each n = 5; 10%). Primary outcomes were diverse, for example, quality-of-life, physical functioning, or disease activity. Only 1 trial (2%) used routinely collected data for outcome ascertainment. No trial was very pragmatic in all design aspects, but 14 trials (29%) were widely pragmatic (i.e. PRECIS-2 score ⩾ 4/5 in all domains). Conclusion: Only few and mostly small pragmatic trials exist in MS which rarely assess drugs. Despite the widely available routine data infrastructures, very few trials utilize them. There is an urgent need to leverage the potential of this pioneering study design to provide useful randomized real-world evidence. [ABSTRACT FROM AUTHOR]

Objective: The treatment of bipolar depression remains challenging due to the limited effective and safe therapeutic options available; thus, developing newer treatments that are effective and well tolerable is an urgent unmet need. The objective of the present trial was to test 150 to 300 mg/day of cannabidiol as an adjunctive treatment for bipolar depression. Method: A randomized, double-blind, placebo-controlled pilot study to assess the efficacy of adjunctive cannabidiol in bipolar depression was used. Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 8. Secondary outcomes included response and remission rates, changes in anxiety and psychotic symptoms, and changes in functioning. Patients continued double-blind treatment until week 12 to monitor for adverse effects, laboratory analysis, and manic symptoms. Study registry: NCT03310593. Results: A total of 35 participants were included. MADRS scores significantly decreased from baseline to the endpoint (placebo, −14.56; cannabidiol, −15.38), but there was no significant difference between the groups. Similarly, there were no other significant effects on the secondary outcomes. However, an exploratory analysis showed a significant effect of cannabidiol 300 mg/day in reducing MADRS scores from week 2 to week 8 (placebo, −6.64; cannabidiol, −13.72). There were no significant differences in the development of manic symptoms or any other adverse effects. Conclusion: Cannabidiol did not show significantly higher adverse effects than placebo. Despite the negative finding on the primary outcome, an exploratory analysis suggested that cannabidiol should be further studied in bipolar depression in higher doses of at least 300 mg/day and under research designs that could better control for high placebo response. [ABSTRACT FROM AUTHOR]

Chinese immigrant survivors of men's violence experience both significant mental health impacts from abuse and barriers to formal services. Therefore, we examined the preliminary efficacy of an innovative mobile-based empowerment-based intervention (self-compassion, health, and empowerment; SHE) that specifically focuses on abused Chinese immigrant women in the US. This pilot study used a two-arm randomized controlled design with repeated measures. A convenience sample (N = 50) of Chinese immigrant women who experienced past year intimate partner violence (IPV) were recruited online and randomly assigned to the intervention or control group (25 per group). We assessed IPV exposure, safety behaviors, depressive symptoms, anxiety symptoms, post-traumatic stress disorder (PTSD) symptoms, and self-compassion at baseline, post-intervention, and 8-week follow-up. Of 95 eligible participants, 50 (52.6%) agreed to participate and completed baseline data collection; intervention completion rate was 64%. We found a significant group and time interaction for self-judgment (a self-compassion component), with a significant reduction seen in the intervention group compared to the control group. Despite no other significant group differences observed over time, the intervention group showed consistent trends toward improvements in most outcome measures, including specific types of IPV (i.e., negotiation, psychological aggression, and sexual coercion), depressive and PTSD symptoms, self-compassion, and certain components of self-compassion (i.e., isolation and over-identification) when compared to the control group. Our findings suggest that the SHE intervention shows promise in improving the mental health well-being of Chinese immigrant survivors. However, a fully powered randomized controlled trial is warranted to determine its efficacy. Our intervention has the potential to be translated in the Chinese immigrant populations with the necessary organizational support. [ABSTRACT FROM AUTHOR]

Objective: To systematically evaluate the evidence relating to acupuncture on the sleep quality of patients with Parkinson's disease. Data sources: Six English-language (PubMed, Cochrane Library, EBSCOhost, Embase, OVID MEDLINE, and Web of Science) and four Chinese-language (China National Knowledge Infrastructure, SinoMed, China Scientific Journals Database, and Wanfang) databases were searched for pertinent studies published from database inception to 11 October 2023. Methods: Two researchers independently screened eligible studies and extracted relevant data using custom data extraction tables. Methodological quality assessment of the included studies was performed using Cochrane Handbook 5.1.0. Meta-analysis was performed using Cochrane Review Manager version 5.4. Results: Twenty-four studies (1701 participants) met inclusion criteria. The meta-analysis showed that acupuncture improved the Parkinson's Disease Sleep Scale, Pittsburgh Sleep Quality Index, Hamilton Anxiety Scale, Hamilton Depression Scale, Self-Rating Depression Scale, and Parkinson's Disease Questionnaire 39 scores compared with controls (all P < 0.05). Conclusion: This review showed that acupuncture improved sleep quality, anxiety and depressive symptoms, and quality of life of patients with Parkinson's disease relative to controls. [ABSTRACT FROM AUTHOR]

Background: e-Health tools using validated questionnaires to assess outcomes may facilitate measurement-based care for psychiatric disorders. MoodFX was created as a free online symptom tracker to support patients for outcome measurement in their depression treatment. We conducted a pilot randomized evaluation to examine its usability, and clinical utility. Methods: Patients presenting with a major depressive episode (within a major depressive or bipolar disorder) were randomly assigned to receive either MoodFX or a health information website as the intervention and control condition, respectively, with follow-up assessment surveys conducted online at baseline, 8 weeks and 6 months. The primary usability outcomes included the percentage of patients with self-reported use of MoodFX 3 or more times during follow up (indicating minimally adequate usage) and usability measures based on the System Usability Scale (SUS). Secondary clinical outcomes included the Quick Inventory of Depressive Symptomatology, Self-Rated (QIDS-SR) and Patient Health Questionnaire (PHQ-9). Results: Forty-nine participants were randomized (24 to MoodFX and 25 to the control condition). Of the 23 participants randomized to MoodFX who completed the user survey, 18 (78%) used MoodFX 3 or more times over the 6 months of the study. The mean SUS score of 72.7 (65th–69th percentile) represents good usability. Compared to the control group, the MoodFX group had significantly better improvement on QIDS-SR and PHQ-9 scores, with large effect sizes and higher response rates at 6 months. There were no differences between conditions on other secondary outcomes such as functioning and quality of life. Conclusion: MoodFX demonstrated good usability and was associated with reduction in depressive symptoms. This pilot study supports the use of digital tools in depression treatment. Plain Language Summary: E-health tools may be useful for measuring and tracking symptoms and other outcomes during treatment for depression. This study is a randomized evaluation of MoodFX, a free web-based app that helps patients track their symptoms using validated questionnaires, and also offers depression information and self-management tips. A total of 49 participants with clinical depression were randomized to using MoodFX or a health information website, for 6 months. In a survey, the participants that used MoodFX found it easy and useful to use. In addition, the participants that used MoodFX had greater improvement in depressive symptoms after 6 months, compared to those who used the health information website. These results suggest that MoodFX may be a useful tool to monitor outcomes and support depression treatment. [ABSTRACT FROM AUTHOR]

Background: Prescription-type opioid use disorder (POUD) is often accompanied by comorbid anxiety, yet the impact of anxiety on retention in opioid agonist therapy (OAT) is unclear. Therefore, this study investigated whether baseline anxiety severity affects retention in OAT and whether this effect differs by OAT type (methadone maintenance therapy (MMT) vs. buprenorphine/naloxone (BNX)). Methods: This secondary analysis used data from a pan-Canadian randomized trial comparing flexible take-home dosing BNX and standard supervised MMT for 24 weeks. The study included 268 adults with POUD. Baseline anxiety was assessed using the Beck Anxiety Inventory (BAI), with BAI ≥ 16 indicating moderate-to-severe anxiety. The primary outcomes were retention in assigned and any OAT at week 24. In addition, the impact of anxiety severity on retention was examined, and assigned OAT was considered an effect modifier. Results: Of the participants, 176 (65%) reported moderate-to-severe baseline anxiety. In adjusted analyses, there was no significant difference in retention between those with BAI ≥ 16 and those with BAI < 16 assigned (29% vs. 28%; odds ratio (OR) = 2.03, 95% confidence interval (CI) = 0.94–4.40; P = 0.07) or any OAT (35% vs. 34%; OR = 1.57, 95% CI = 0.77–3.21; P = 0.21). In addition, there was no significant effect modification by OAT type for retention in assigned (P = 0.41) or any OAT (P = 0.71). In adjusted analyses, greater retention in treatment was associated with BNX (vs. MMT), male gender identity (vs. female, transgender, or other), enrolment in the Quebec study site (vs. other sites), and absence of a positive urine drug screen for stimulants at baseline. Conclusions: Baseline anxiety severity did not significantly impact retention in OAT for adults with POUD, and there was no significant effect modification by OAT type. However, the overall retention rates were low, highlighting the need to develop new strategies to minimize the risk of attrition from treatment. Clinical Trial Registration: This study was registered in ClinicalTrials.gov (NCT03033732). [ABSTRACT FROM AUTHOR]

Background: Cognitive behavioural therapy (CBT) reduces MS-related fatigue. However, studies on the long-term effects show inconsistent findings. Objective: To evaluate whether a blended booster programme improves the outcome of CBT for MS-related fatigue on fatigue severity at 1-year follow-up. Method: A multicentre randomized clinical trial in which 126 patients with MS were allocated to either a booster programme or no booster programme (control), after following 20-week tailored CBT for MS-related fatigue. Primary outcome was fatigue severity assessed with the Checklist Individual Strength fatigue subscale 1 year after start of treatment (T52). Mixed model analysis was performed by a statistician blinded for treatment-allocation to determine between-group differences in fatigue severity. Results: Fatigue severity at 1-year follow-up did not differ significantly between the booster (N = 62) and control condition (N = 64) (B = −2.01, 95% confidence interval (CI) = −4.76 to 0.75). No significant increase in fatigue severity was found at T52 compared with directly post-treatment (T20) in both conditions (B = 0.44, 95% CI = −0.97 to 1.85). Conclusion: Effects of CBT were sustained up to 1 year in both conditions. The booster programme did not significantly improve the long-term outcome of CBT for MS-related fatigue. Trial registration: Dutch Trial Register (NTR6966), registered 18 January 2018 https://www.trialregister.nl/trial/6782 [ABSTRACT FROM AUTHOR]

Aim: To assess the incremental cost-effectiveness ratio (ICER) of group transdiagnostic cognitive-behavioural therapy (tCBT) added to treatment as usual (TAU) for anxiety disorders compared to TAU only from the healthcare system perspective over a 1-year time horizon. Methods: Data from a pragmatic multisite randomized controlled trial where adults (18–65 years) with an anxiety disorder were randomized to tCBT + TAU (n = 117) or TAU (n = 114). Group tCBT is a 12-week (2h weekly sessions) community-based intervention. Health service utilization and related costs were captured from medico-administrative data and included those for the intervention, ambulatory visits, hospitalizations and medications. Effectiveness was based on quality-adjusted life years (QALYs). The study included measures at baseline, 4, 8, and 12 months. Intention-to-treat and complete case analyses were carried out. Missing data were imputed using multiple imputation analyses. Seemingly unrelated regression analyses were used to assess the effect of the intervention on total costs and QALYs while also adjusting for baseline confounders. The probability of cost-effectiveness of the intervention was assessed according to different willingness-to-pay (WTP) thresholds using the net benefit regression method. Results: The ICER of tCBT + TAU as compared to TAU in the intention-to-treat analysis was $6,581/QALY. Complete case analyses showed a similar ICER of $6,642/QALY. The probability at a WTP threshold of $20,000 and $40,000 that tCBT + TAU as compared to TAU is cost-effective is 93.0% and 99.9%. Conclusion: tCBT added to TAU appears to be cost-effective from the healthcare system perspective for treating adult patients with anxiety disorders. Larger trials including young and older adults as well as a range of anxiety disorders are needed to further investigate the cost-effectiveness of tCBT in different patient populations. [ABSTRACT FROM AUTHOR]

This study sought to evaluate the impact of the subcutaneous tunneling technique on peripherally inserted central catheter (PICC) placement. We randomized 694 patients who needed PICC placement to either the tunneled PICCs (experimental group) or the non-tunneled PICCs (control group) from August to December 2021. The cumulative frequency of complications was assessed as the primary outcome. Secondary outcomes comprised of the amount of bleeding, catheter insertion time, self-reported pain score, and one-puncture success rate. After 6 months of follow-up, the tunneled PICCs group showed a significant decrease in the frequency of total complications, especially in infection (3.0% vs. 7.1%, p =.021) and catheter-related thrombosis (3.3% vs. 8.3%, p =.008), although approximately 0.5 ml bleeding and 3.5 min time were increased. This randomized multicenter study supports the efficacy of subcutaneous tunneling technology in reducing PICC-related complications, enhancing patient comfort, and encouraging using subcutaneous tunneling technology for PICC placement. [ABSTRACT FROM AUTHOR]

Background: Subgroup analyses are widely used to evaluate the heterogeneity of treatment effects in randomized clinical trials. However, there is a limited investigation of the quality of prespecified and reported subgroup analyses in stroke trials. This study evaluated the credibility of subgroup analyses in stroke trials. Methods and analysis: We searched Medline/PubMed, Embase, the Cochrane Central Register of Controlled Trials, and the Web of Science from inception to 24 March 2021. Three reviewers screened, extracted, and analyzed the data from the publications. Primary publications of stroke trials that reported at least one subgroup effect and had published corresponding study protocols were included. The Instrument for Assessing the Credibility of Effect Modification Analyses (ICEMAN) was used to examine the quality of the subgroup effects reported, with each subgroup effect assigned a credibility rating ranging from very low to high. Subgroup effects with two or more "definitely no" responses received a low credibility rating. The risk of bias was assessed using the Cochrane Risk-of-Bias tool for randomized trials version 2. Results: Seventy-four articles met the inclusion criteria and reported a combined total of 647 subgroup effects. The median sample size was 1264 (interquartile range (IQR): 380–3876), and the median number of subgroups prespecified in the protocol was 6 (IQR: 2–10). Sixty-one (82%) studies used the univariate test of interaction. Of the total 647 subgroup effects reported in these studies, 319 (49%) were reported in acute stroke trials, while 423 (65%) had low credibility. Conclusion: The quality of subgroup analysis reporting in stroke trials remains poor. More effort is needed to train trialists on the best methods for designing and performing subgroup analyses, and how to report the results. Trial registration number: We prospectively registered the review with International Prospective Register for Systematic Reviews (registration number: CRD42020223133) [ABSTRACT FROM AUTHOR]

Self-compassion is regarded as a mediating or moderating variable in mindfulness-based interventions (MBI). However, few studies have investigated the role of self-compassion on MBI. Therefore, we conducted a randomized controlled trial to examine whether (1) MBI decreases depression and trait anxiety, while increasing trait mindfulness, trait self-compassion, self-compassionate behaviors (SC behaviors), mindful behaviors, and mood after behaviors; and (2) SC behaviors moderate the effect of mindful behaviors on mood in daily life. Participants were patients with depression and/or anxiety (N =19) in Japan. Of the 27 participants recruited, 19 participated in the study. Using stratified randomization, we allocated 10 participants to the intervention group, with an 8-week standard MBI, and nine to the waitlist control group. Depression, trait anxiety, trait mindfulness, and trait self-compassion were assessed using questionnaires, while SC behaviors, mindful behaviors, and mood were measured using an ecological momentary assessment—a method used to repeatedly record events and behaviors in daily life. The results revealed that depression, trait anxiety, trait mindfulness, and trait self-compassion did not significantly change. However, SC behaviors, mindful behaviors, and mood significantly improved with MBI. Moreover, the interaction between SC behaviors and mindful behaviors was significantly shown in the pre-intervention, suggesting that SC behaviors moderate the effect of mindful behaviors on mood in daily life. [ABSTRACT FROM AUTHOR]

Background: Fatigue can be a disabling multiple sclerosis (MS) symptom with no effective treatment options. Objective: Determine whether a low-fat diet improves fatigue in people with MS (PwMS). Methods: We conducted a 16-week randomized controlled trial (RCT) and allocated PwMS to a low-fat diet (active, total daily fat calories not exceeding 20%) or wait-list (control) group. Subjects underwent 2 weeks of baseline diet data collection (24-hour diet recalls (24HDRs)), followed by randomization. The active group received 2 weeks of nutrition counseling and underwent a 12-week low-fat diet intervention. One set of three 24HDRs at baseline and week 16 were collected. We administered a food frequency questionnaire (FFQ) and Modified Fatigue Impact Scale (MFIS) every 4 weeks. The control group continued their pre-study diet and received diet training during the study completion. Results: We recruited 39 PwMS (20—active; 19—control). The active group decreased their daily caloric intake by 11% (95% confidence interval (CI): −18.5%, −3.0%) and the mean MFIS by 4.0 (95% CI: −12.0, 4.0) compared to the control (intent-to-treat). Sensitivity analysis strengthened the association with a mean MFIS difference of −13.9 (95% CI: −20.7, −7.2). Conclusions: We demonstrated a significant reduction in fatigue with a low-fat dietary intervention in PwMS. [ABSTRACT FROM AUTHOR]

Background: Industry funding and corporate sponsorship have played a significant role in the advancement of orthopaedic research and technology. However, this relationship raises concerns for how industry association may bias research findings and influence clinical practice. Purpose: To determine whether industry affiliation plays a role in the outcomes of randomized controlled trials (RCTs) investigating platelet-rich plasma (PRP). Study Design: Meta-analysis; Level of evidence, 2. Methods: A search of the PubMed, Cochrane, and MEDLINE databases for RCTs published between 2011 and the present comparing PRP versus hyaluronic acid, corticosteroid, or placebo for the treatment of knee osteoarthritis was performed. To determine industry affiliation, the conflict of interest, funding, and disclosure sections of publications were assessed, and all authors were assessed through the American Academy of Orthopaedic Surgeons disclosure database and the Centers for Medicare & Medicaid Services open payments database. Studies were classified as industry affiliated (IA) or non–industry affiliated (NIA). The outcomes of each study were rated as favorable, analogous, or unfavorable according to predefined criteria. Results: A total of 37 studies (6 IA and 31 NIA) were available for analysis. Overall, 19 studies (51.4%) reported PRP as favorable compared with other treatment options, while 18 studies (48.6%) showed no significant differences between PRP and other treatment methods. There was no significant difference in qualitative conclusions between the IA and NIA groups, with the IA group having 3 favorable studies and 3 analogous studies and the NIA group having 16 favorable studies and 15 analogous studies (P =.8881). When comparing IA versus NIA studies using 6- and 12-month Western Ontario and McMaster Universities Arthritis Index and International Knee Documentation Committee scores, there were no significant differences in outcomes. Conclusion: The results of this study demonstrated that qualitative conclusions and outcome scores were found to not be associated with industry affiliation. Although the results of this study suggest that there is no influence of industry involvement on RCTs examining PRP, it is still necessary to carefully evaluate pertinent commercial affiliations when reviewing recommendations from studies before adopting new treatment approaches, such as the use of PRP for knee osteoarthritis. [ABSTRACT FROM AUTHOR]

The sharp increase in the number of experimental studies evaluating development programs raises the need for accurate intraclass correlations (ICC) to conduct power calculations so that researchers can design studies to detect meaningful effects with sufficient statistical power. The intraclass correlation is an important parameter for determining the statistical power of cluster-randomized trials. The parameter is rarely available to researchers planning a study until after the design is set and data are already collected. This paper takes an important step towards helping researchers working in sub-Saharan Africa to accurately estimate appropriate sample sizes for their clustered RCTs. The study draws from rich data sets in Kenya, Malawi, Zambia, and Zimbabwe. We present ICCs for a wide range of domains common for development research. Our results suggest that ICCs for commonly studied indicators in sub-Saharan Africa are lower than is often assumed in power calculations. ICC values are especially low for indicators associated with child nutrition and food security, suggesting that cluster-RCTs might be a viable design even when faced with limited budgets because sample size requirements are not much different from an individual random assignment design. [ABSTRACT FROM AUTHOR]

Background: Poor gait and static balance performance may be associated with trunk muscles in individuals with Parkinson's disease. Aim: The study aims at evaluating the effects of a home-based trunk exercise program on gait and balance performance in Parkinson's disease. Methods: A randomized controlled trial was conducted with 28 individuals with Parkinson's disease with Hoehn & Yahr stage II–IV. The control group (n = 14) performed upper and lower limb exercises, while the experimental group (n = 14) engaged in a trunk exercise program. Both groups performed home-based exercises three times daily for 3 weeks. At the end of interventions (post-training) and 4 weeks after post-training (follow-up), static balance (force plate) and gait (motion capture system) were evaluated. Mixed analysis of variance compared time × group interaction (α = 5%). Results: No time × group interaction was observed in the center of pressure displacement, center of pressure mean velocity, and anteroposterior and mediolateral center of pressure range during bipedal support with eyes opened and closed; and gait speed, hip, knee, and ankle range of motion during gait analysis. No intragroup differences were found. Conclusion: Trunk strengthening exercises did not improve gait and balance compared with upper and lower limb exercises. The non-adherence rate (33%) to the remote intervention may have also hindered our results. [ABSTRACT FROM AUTHOR]

Objectives: We investigated whether a specific exercise program for the neck–shoulder region reduces headache intensity, frequency, and duration, and how it influences neck disability among women with chronic headache compared to a control group. Design: Two-center randomized controlled trial. Subjects: 116 working-age women. Intervention: The exercise group (n = 57) performed a home-based program with six progressive exercise modules, over 6 months. The control group (n = 59) underwent six placebo-dosed transcutaneous electrical nerve stimulation sessions. Both groups performed stretching exercises. Main measures: The primary outcome was pain intensity of headache, assessed using the Numeric Pain Rating Scale. Secondary outcomes were frequency and duration of weekly headaches, and neck disability assessed using the Neck Disability Index. Generalized linear mixed models were used. Results: Mean pain intensity at baseline was 4.7 (95% CI 4.4 to 5.0) in the exercise group and 4.8 (4.5 to 5.1) in the control group. After 6 months the decrease was slight with no between-group difference. Headache frequency decreased from 4.5 (3.9 to 5.1) to 2.4 (1.8 to 3.0) days/week in the exercise group, and from 4.4 (3.6 to 5.1) to 3.0 (2.4 to 3.6) in the control group (between-group p = 0.017). Headache duration decreased in both groups, with no between-group difference. Greater improvement in the Neck Disability Index was found in the exercise group (between-group change −1.6 [95% CI −3.1 to −0.2] points). Conclusion: The progressive exercise program almost halved headache frequency. The exercise program could be recommended as one treatment option for women with chronic headache. [ABSTRACT FROM AUTHOR]

Purpose: Cancer-related pain (CRP) is a common and distressing symptom experienced by many patients receiving palliative care. The purpose of this trial was to evaluate the effectiveness of the progressive muscle relaxation (PMR) technique in reducing CRP in patients receiving palliative care. Methods: A total of 148 patients diagnosed with cancer and receiving palliative care were randomly allocated to either an intervention or control group. The intervention group received a 4-week daily course of PMR technique, while the control group received only usual care. Data was collected using a demographic and clinical characteristics form, as well as the Brief Pain Inventory (BPI). Blind evaluations were conducted prior to the start of the intervention (T0), at the end of the 4-week PMR intervention (T1), and at 1-month follow-up (T2). Results: The results of this trial demonstrated a significant decrease in pain intensity scores for the PMR group compared to the control group at both T1 and T2 (p < 0.05). Furthermore, the PMR group also exhibited significant improvements in pain interference with general activity, mood, relations with others, sleep, and enjoyment of life scores compared to the control group at both T1 and T2 (p < 0.05). Conclusion: The results of this trial suggest that the PMR technique may be an effective intervention for reducing pain intensity and improving pain interference with life activities in cancer patients receiving palliative care. However, further research is needed to provide more robust evidence for the effectiveness of this intervention. Clinical trial registration number: NCT04436705. Registered at ClinicalTrials.gov [ABSTRACT FROM AUTHOR]

The randomized controlled trial (RCT) is considered the gold standard for evaluating the effectiveness of interventions or treatments across fields of physical and psychological medicine. While the RCT is well-placed for issues best addressed with a medical model approach—its origin story, the study and treatment of scurvy, an ideal exemplar—its stature and use must be challenged in cases of experiential phenomena, such as posttraumatic stress disorder (PTSD), where there is no one answer, treatment, or approach that suits all persons. Uncontested, its evidentiary superiority threatens to have deleterious effects on determining best practices for the treatment of PTSD. [ABSTRACT FROM AUTHOR]

Most victims' cases are not progressed through the criminal justice system, which is a phenomenon linked to low satisfaction with police performance. Little is known about how police can fairly and effectively "let victims down." One mechanism is a call-back, which is prevalent in other professions but less so in policing and could be applied specifically for victims who experience case attrition at early stages. By proactively contacting victims following their initial report, the call-back may offer reassurance and lead to improved levels of satisfaction. We tested this approach with 1326 victims of vehicle and bicycle crimes in a block randomized controlled trial in London, UK. Based on follow-up telephone surveys, the findings suggest that a reassurance call-back policy increases the satisfaction of bicycle theft victims by 5%–15%, but not for victims of vehicle theft, who are largely unaffected by the call-back. The findings are likely driven by the victims' expectations: vehicle theft victims expect their reported cases to progress through the justice system, whereas bicycle theft victims do not; thus, the former remain as disappointed as the participants who did not receive a call-back. These findings are promising, as they offer a new tool for policing that can provide more care to victims of crime. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to provide a general overview of mental health randomized controlled trials (RCTs) and summarize the temporal trends in terms of the number of studies, median sample sizes, and median effect sizes using data collected from the Cochrane Database of Systematic Reviews (CDSR). Methods: Using data collected from the CDSR, the temporal trends are compared in terms of the number of studies, median sample sizes, and median effect sizes between two broad categories of interventions: pharmacological RCT (ph-RCT) and non-pharmacological RCT (nph-RCT), and in conjunction with major mental disorder categories. Results: Chronologically, the number of mental health RCTs reported in publications has increased exponentially from 1955 to 2020. While ph-RCT comprised a majority of mental health RCTs in the earlier years, the proportion of nph-RCTs increased more quickly over time and markedly exceeded ph-RCT after 2010. The median sample size for all 6,652 mental health RCTs was 61, with 61 for ph-RCT and 60 for nph-RCT. Over time, the median fluctuated but an increasing trend was observed over the past 60+ years. The median of the effect size, measured by Pearson's r, for overall RCTs was 0.18, and nph-RCT (0.19) had a larger median effect size compared to ph-RCT (0.16). Over the years, the nph-RCT had a larger median effect size than the ph-RCT. Differences in the median effect sizes among the categories of mental disorders were also noted. Schizophrenia had the most RCTs, with a median Pearson's r value of 0.17. Mood disorder had the second largest number of RCTs and a median Pearson's r value of 0.15. Neurotic/stress-related mental disorder had the third largest number of RCTs with the highest median Pearson's r being 0.23. Conclusions: This study provides meaningful information and filled the knowledge gap in mental health RCTs. [ABSTRACT FROM AUTHOR]

Purpose: We assessed an educational intervention to reduce the number of emergency department (ED) and inpatient stays for cardiovascular diagnoses, among South Carolina adult Medicaid Members with intellectual and developmental disability and hypertension (Members). Design: This Randomized Controlled Trial (RCT) included Members or the person who helped them with their medications (Helpers). Participants, who included Members and/or their Helpers, were randomly assigned to an Intervention or Control group. Setting: South Carolina Department of Health and Human Services, which administers Medicaid, identified eligible Members. Sample: 412 Medicaid Members - 214 Intervention (54 Members participating directly; 160 Helpers participating in lieu of Members) who received the messages about hypertension and surveys about knowledge and behavior and 198 Controls (62 Members; 136 Helpers) who only received surveys of knowledge and behavior. Intervention: Educational intervention about hypertension included a flyer and monthly text or phone messages for one year. Measures: Input measures - characteristics of the Members; Outcome measures - hospital emergency department (ED) and inpatient visits for cardiovascular conditions. Analysis: Quantile regression tested the association of Intervention/Control group status with ED and inpatient visits. We also estimated models using Zero-inflated Poisson (ZIP) models for sensitivity analysis. Results: Participants in the Intervention group with highest baseline hospital use (top 20% ED; top 15% Inpatient) had significant reductions in Year 1 (.57 fewer ED and 2 fewer inpatient days) compared to the Control group. For ED visits, improvement continued in year two. Conclusion: The intervention reduced the frequency of cardiovascular disease-related ED visits and Inpatient days for participants in the Intervention group in the highest quantiles of hospital use, and the improvement was better for those who had a Helper. [ABSTRACT FROM AUTHOR]

Residents of cities face housing instability due to high housing costs. We conduct a randomized experiment evaluating the impacts of a flexible "shallow subsidy" among 668 qualified renters with recent housing instability. This local subsidy provides $7,200 a year directly to families earning less than 30 percent of the median family income, who choose how much assistance to use each month. Using administrative data, we track outcomes for the first year of program administration. After one year, the program has no statistically significant effect on homelessness, cash benefit receipt, or emergency rental assistance utilization, demonstrating no harm when compared to alternatives. However, the program leads to a 29 percentage point decrease in participants' use of other types of local government housing services, which they must weigh against the shallow subsidy. We show that the program can be administratively cost-saving, but is not always beneficial for a very low-income subset of applicants. [ABSTRACT FROM AUTHOR]

Background: Anti-inflammatory therapy using colchicine has reduced recurrent vascular events in patients with coronary heart disease. Design: Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3) is a randomized, double-blind, placebo-controlled multicenter trial, in which 8,238 patients with acute minor-to-moderate ischemic stroke (NIHSS ⩽ 5) or high-risk transient ischemic attack (TIA) (ABCD2 score ⩾4) and a high-sensitivity CRP (hsCRP) level of ⩾2 mg/L will be randomly assigned within 24 h of symptom onset to colchicine (1 mg daily on days 1–3, followed by 0.5 mg daily for a total of 90 days) or matching placebo, on a background of optimal medical therapy. The study will have 90% power to detect a 25% reduction in the primary efficacy outcome of any stroke within 3 months of randomization. Adverse events potentially related to the use of colchicine will also be analyzed. The primary analysis will be by intention to treat. Trial registry name: Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3); URL: https://clinicaltrials.gov/ct2/show/NCT05439356?cond=CHANCE-3&draw=2&rank=1; Registration number : NCT05439356. [ABSTRACT FROM AUTHOR]

The last two decades have seen a dramatic increase in randomized controlled trials (RCTs) conducted in community colleges. Yet, there is limited empirical information on the design parameters necessary to plan the sample size for RCTs in this context. For a blocked student-level random assignment research design, key design parameters for the minimum detectable true effect (MDTE) are the within-block outcome standard deviation (σ | S) and the within-block outcome variance explained by baseline covariates like student characteristics (R | S 2). We provide empirical estimates of these key design parameters, discussing the pattern of estimates across outcomes (enrollment, credits earned, credential attainment, and grade point average), semesters, and studies. The main analyses use student-level data from 8 to 14 RCTs including 5,649–7,099 students (depending on the outcome) with follow-up data for 3 years. The following patterns are observed: the within-block standard deviation (σ | S) and therefore the MDTE can be much larger in later semesters for enrollment outcomes and cumulative credits earned; there is substantial variation across studies in σ | S for degree attainment; and baseline covariates explain less than 10% of the variation in student outcomes. These findings indicate that when planning the sample size for a study, researchers should be mindful of the follow-up period, use a range of values to calculate the MDTE for outcomes that vary across studies, and assume a value of R | S 2 between 0 and 0.05. A public database created for this paper includes parameter estimates for additional RCTs and students. [ABSTRACT FROM AUTHOR]

A possible unintended consequence of episode payment models is provider consolidation, which can, in turn, increase prices for commercially insured enrollees. We assess the effect of Medicare's Comprehensive Care for Joint Replacement (CJR) model on provider consolidation. Hospitals in randomly assigned metropolitan statistical areas were mandated to participate during the first 2 years of the model and a subset of hospitals were mandated for later years. We used a difference-in-differences approach to assess whether CJR affected consolidation, as measured by hospital ownership of practices, the number and size of practices, the Herfindahl–Hirschman Index, and the four-firm concentration ratio. Given limited sample sizes, our results are only suggestive that CJR was not associated with changes in consolidation. Our strongest results suggest null effects for changes in hospital ownership and practice size. These findings suggest that concerns regarding the role alternative payment models play in consolidation may have been overstated. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to investigate the effectiveness of solution-focused group counseling (SFGC) to reduce depressive symptoms and improve cognitive functions among Chinese rural older adults. Method: In a cluster randomized controlled trial, 290 participants were randomly assigned to a 12-session SFGC intervention or a control group. the Center for Epidemiological Studies Depression Scale and Mini-Mental State Examination was adopted to measure depressive symptoms and cognitive functions, respectively, at pretest and posttest. Results: Repeated measure ANOVAs showed a significant group by time effect for both measures. Paired sample t-tests showed that depressive symptoms significantly decreased in the intervention group, but not in the control group. Cognitive functions did not change in the intervention group, but significantly declined in the control group. Conclusions: Our findings support the feasibility and effectiveness of a culturally adapted SFGC for reducing depressive symptoms and protecting cognitive functions among the disadvantaged older adults in a developing country. [ABSTRACT FROM AUTHOR]

Collaboration between Doctor of Nursing Practice (DNP) scholars and Doctor of Philosophy (PhD) scholars is crucial to efficiently advance and disseminate nursing science. Also, DNP-PhD collaboration can help achieve priorities outlined in the recent National Institute of Nursing Research (NINR) Strategic Plan. The purpose of this series of case studies is to describe exemplars of ongoing DNP-PhD collaborations across three NINR-funded trials (1 completed, 2 ongoing) testing physical activity interventions for women at risk for cardiovascular disease. In our three physical activity intervention trials for women, we categorized examples of DNP-PhD collaboration by the four phases of the team-based research model (development, conceptualization, implementation, and translation). Across all three trials, DNP and PhD scholars contributed successfully to all phases of research in an iterative manner. Future work should focus on expanding DNP-PhD collaboration in behavioral trials, which can inform adapted, contemporary models of iterative DNP-PhD collaboration. [ABSTRACT FROM AUTHOR]

Background: Tirofiban is a glycoprotein IIb/IIIa receptor inhibitor that has been shown to be effective in the treatment of acute coronary syndromes. However, it remains unknown whether it improves outcomes in patients with acute ischemic stroke. Objective: This trial investigates the efficacy and safety of tirofiban compared with aspirin for acute ischemic stroke within 24 h after symptom onset. Methods and design: The Efficacy and Safety of Tirofiban Compared with Aspirin in the Treatment of Acute Ischemic Stroke (RESCUE BT 2) Trial is an investigator-initiated, prospective, randomized, double-blind, double-dummy, multicenter clinical trial. Up to 1158 eligible patients will be consecutively randomized to receive antiplatelet therapy with tirofiban or aspirin in 1:1 ratio across approximately 100 stroke centers in China. Outcomes: The primary endpoint is the proportion of patients with excellent functional outcomes defined as a modified Rankin scale score of 0 to 1 at 90 days after randomization. Lead safety endpoints include mortality at 90 days and symptomatic intracerebral hemorrhage within 48 h after treatment. Trial registry number: ChiCTR2000029502 (www.chictr.org.cn). [ABSTRACT FROM AUTHOR]

Objectives: Distal forearm fractures are the most common pediatric fractures. This study aimed to investigate the effectiveness of below-elbow cast treatment for displaced distal forearm fractures in children compared to above-elbow cast through meta-analysis of randomized controlled trials. Methods: Several databases from January 1, 2000 until October 1, 2021 were searched for randomized controlled trials that assessed below versus above-elbow cast treatment of displaced distal forearm fractures in pediatric patients. The main meta-analysis comparison was based on the relative risk of loss of fracture reduction between children undergoing below versus above-elbow cast treatment. Other outcome measures including re-manipulation and cast-related complications were also investigated. Results: Nine studies were eligible of the 156 articles identified, with a total of 1049 children. Analysis was undertaken for all included studies with a sensitivity analysis conducted for studies with high quality. In the sensitivity analysis, the relative risks of loss of fracture reduction (relative risk = 0.6, 95% confidence interval = 0.38, 0.96) and re-manipulation (relative risk = 0.3, 95% confidence interval = 0.19, 0.48) between the below and above-elbow cast groups were in favor of below-elbow cast and statistically significant. Cast-related complications were in favor of below-elbow cast but did not attain statistical significance (relative risk = 0.45, 95% confidence interval = 0.05, 3.99). Loss of fracture reduction was noted in 28.9% of patients treated with above-elbow cast and 21.5% in below-elbow cast. Re-manipulation was attempted in 48.1% versus 53.8% of children who lost fracture reduction in the below-elbow cast and above-elbow cast groups, respectively. Conclusion: Below-elbow cast treatment was favored, with statistical significance, in terms of loss of fracture reduction and re-manipulation, and was not associated with a higher risk of cast-related complications. The accumulative evidence currently does not support above-elbow cast treatment and below-elbow cast treatment should be the mainstay for displaced distal forearm fractures in children. Level of evidence: Level I, meta-analysis of therapeutic level I studies. [ABSTRACT FROM AUTHOR]

Background: While growing evidence suggests the efficacy of various behavioral approaches to the preventive treatment of migraine, it remains largely unclear which behavioral interventions are indicated for which type of patient. This exploratory study aimed to identify moderators for the outcome between migraine-specific cognitive-behavioral therapy and relaxation training. Methods: In this secondary analysis of an open-label randomized controlled trial, the data of N = 77 adults (completer sample) with migraine (mean age = 47.4, SD = 12.2, 88% female), who were allocated to either migraine-specific cognitive-behavioral therapy or relaxation training, was examined. Outcome was the frequency of headache days at the 12-month follow-up. We analyzed baseline demographic or clinical characteristics and headache-specific variables (disability, emotional distress, trigger sensitivity and avoidance, pain acceptance, self-efficacy) as candidate moderators. Results: Higher headache-related disability (assessed via the Headache Impact Test, HIT-6, B = –0.41 [95% CI: –0.85 to –0.10], p =.047), higher anxiety (assessed via the subscale Anxiety of the Depression, Anxiety and Stress scales, DASS-A, B = –0.66 [95% CI: –1.27 to –0.02], p =.056), and the presence of a comorbid mental disorder (B = –4.98, [95% CI: –9.42 to –0.29], p =.053), moderated the outcome in favor of migraine-specific cognitive-behavioral therapy. Conclusion: Our findings contribute to an individualized treatment selection and suggest that preference for complex behavioral treatment (migraine-specific cognitive-behavioral therapy) should be given to patients with high headache-related disability, increased anxiety, or a comorbid mental disorder. Study Registration: Original study registered in the German Clinical Trials Register (https://drks.de/search/de; DRKS-ID: DRKS00011111). [ABSTRACT FROM AUTHOR]

Objective: To systematically review the effects of extracorporeal shock wave therapy (ESWT) for shoulder pain after stroke. Data sources: A systematic review of Cochrane Central Register of Controlled Trials (CENTRAL), Embase, PubMed, Web of Science, CNKI, SinoMed, WanFang Data, VIP, and ClinicalTrials.gov from the establishment of the database to 20 December 2022 was carried out. Review methods: The bibliography was screened to identify randomized controlled trials (RCTs) that applied extracorporeal shock waves to shoulder pain after stroke. Two researchers independently searched, screened, and extracted data from each database according to the search strategy and resolved any disagreements through negotiation. Results: A total of 18 RCTs were included (1248 individuals). Meta-analysis showed that the ESWT group had better visual analogue scale (VAS) scores (mean difference (MD) = − 1.19, 95% confidence interval (CI) [ − 1.43, − 0.95], p < 0.00001), Fugl-Meyer assessment upper extremity scale (FMA-UE) scores (MD = 6.25, 95% CI [4.64, 7.87], p < 0.00001), active range of motion (AROM) assessment (MD = 11.28, 95% CI [5.26, 17.30], p = 0.0002), and functional comprehensive assessment (FCA) scores (MD = 5.47, 95% CI [4.45, 6.49], p < 0.00001) comparative to the control group; no statistical significance in Constant-Murley score (CMS) (MD = 0.98, 95% CI [ − 11.05, 13.02], p = 0.87) and descriptive analysis of modified Barthel Index (MBI) only. Conclusion: The ESWT improves pain levels, motor function, active mobility, comprehensive function of shoulder, and activities of daily living (ADL) better than conventional treatment in patients with shoulder pain after stroke. [ABSTRACT FROM AUTHOR]

A randomized controlled trial was conducted to determine whether a simple educational intervention targeting parents of young infants could have an impact on the consumption of juice and sugar-sweetened beverages (SSBs) in early childhood and decrease overweight and obesity rates. Parents of 2- to 4-month-old infants were randomized into intervention (n = 67) and control (n = 77) groups. Parents completed questionnaires about juice and SSB consumption and knowledge at baseline and 1-year follow-up. Intervention parents received informational handouts and watched videos about the health effects of juice and SSBs. Knowledge about juice increased significantly in the intervention group compared with control (P <.01) and was significantly higher in black/African American parents (P <.05) and those with some college education (P <.05). The intervention had a significant impact on the knowledge gained by parents about the health effects of juice and SSBs but did not decrease the consumption of sugary drinks or change children's weight status. [ABSTRACT FROM AUTHOR]

Background: When stable osteochondritis dissecans (OCD) lesions of the femoral condyle in a skeletally immature patient fail to heal with nonoperative methods, the standard of care treatment is condylar OCD drilling. Two primary OCD drilling techniques have been described, but no prospective studies have compared their relative effectiveness. Purpose/Hypothesis: The purpose of this study was to compare the healing and function after transarticular drilling (TAD) with that after retroarticular drilling (RAD). It was hypothesized that there would be no difference in rate or time to healing, rate or time to return to sports, patient-reported outcomes (PROs), or secondary OCD-related surgery. Study Design: Randomized controlled clinical trial; Level of evidence, 1. Methods: Skeletally immature patients with magnetic resonance imaging–confirmed stable OCD lesions of the medial femoral condyle who did not demonstrate substantial healing after a minimum of 3 months of nonoperative treatment were prospectively enrolled by 1 of 17 surgeon-investigators at 1 of 14 centers. Patients were randomized to the TAD or RAD group. Tourniquet time, fluoroscopy time, and complications were compared between the treatment groups. Postoperatively, serial radiographs were obtained every 6 weeks to assess healing, and PROs were obtained at 6 months, 12 months, and 24 months. Results: A total of 91 patients were included, consisting of 51 patients in the TAD and 40 patients in the RAD group, who were similar in age, sex distribution, and 2-year PRO response rate. Tourniquet time and fluoroscopy time were significantly shorter with TAD (mean, 38.1 minutes and 0.85 minutes, respectively) than RAD (mean, 48.2 minutes and 1.34 minutes respectively) (P =.02; P =.004). In the RAD group, chondral injury from K-wire passage into the intra-articular space was reported in 9 of 40 (22%) patients, but no associated postoperative clinical sequelae were identified in these patients. No significant differences between groups were detected in follow-up Pediatric–International Knee Documentation Committee, Lysholm, Marx Activity Scale, or Knee injury and Osteoarthritis Outcome Score Quality of Life scores. Healing parameters were superior at 6 months and 12 months in the TAD group, compared with the RAD group, and secondary OCD surgery occurred in 4% of patients who underwent TAD and 10% of patients who underwent RAD (P =.40). Patients in the TAD group returned to sports earlier than those in the RAD group (P =.049). Conclusion: TAD showed shorter operative time and fluoroscopy time and superior healing parameters at 6 and 12 months, but no differences were seen in 24-month healing parameters or PROs at all follow-up time points, when compared with RAD. Registration: NCT01754298 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effects of transcutaneous electrical acupoint stimulation (TEAS) on upper limb motor recovery during post-stroke rehabilitation. Design: Single-blind, randomized controlled trial. Setting: Four inpatient rehabilitation facilities. Subjects: A total of 204 stroke patients with unilateral upper limb motor impairment were randomly 1:1 allocated to TEAS or sham TEAS group. Baseline demographic and clinical characteristics were comparable between the two groups. Interventions: Both groups received conventional physical and occupational therapies. TEAS and sham TEAS therapy were administered to two acupoints (LI10 and TE5) with a pulse duration of 300 µ s at 2 Hz on the affected forearm for 30 times over 6 weeks. Outcome measures: The upper-extremity Fugl-Meyer score (primary outcome), manual muscle testing, modified Ashworth scale, Lindmark hand function score, and Barthel index were evaluated by blinded assessors at baseline, 2, 4, 6, 10, and 18 weeks. Results: The number of patients who completed the treatment was 99 and 97 in the TEAS and the sham group. No significant between-group difference was found in the Upper-Extremity Fugl-Meyer score, Modified Ashworth Scale, Lindmark hand function score, and Barthel Index after intervention and during follow-up. However, the TEAS group exhibited 0.29 (95% CI 0.02 to 0.55) greater improvements in Manual Muscle Testing of wrist extension than the sham group (p = 0.037) at 18 weeks. Conclusions: Administration of TEAS therapy to hemiplegic forearm could not improve the upper extremity motor recovery. However, TEAS on the forearm might provide potential benefits for strength improvement of the wrist [ABSTRACT FROM AUTHOR]

This pilot randomized controlled trial (RCT) examined preliminary effects of an 8-week videoconferencing acceptance and commitment therapy (ACT) program supplemented with psychoeducation materials on distressed family caregivers of persons living with dementia (PLWD) compared to the control group provided with psychoeducation materials only. Nineteen family caregivers of PLWD in the USA were randomly assigned to the ACT group or the control group. Data was collected at pretest, posttest, and 1-month follow-up (F/U). Compared to the control group, the ACT group showed a significantly larger reduction in grief at posttest, with a medium effect size. Small effects of ACT were found in anxiety, psychological quality of life, and engagement in meaningful activities at posttest and grief, engagement in meaningful activities, and psychological flexibility at F/U compared to the control group. These promising findings warrant a full-scale RCT with adequate power to measure the efficacy of videoconferencing ACT for caregivers of PLWD. [ABSTRACT FROM AUTHOR]

Introduction: Using a safety wire during trans-ureteral lithotripsy (TUL) might minimize ureteral injuries. Conversely, others suggest safety wire itself may increase the risk of ureteral injuries that its routine use is not mandatory in all cases. This randomized clinical trial was conducted to compare the outcome of TUL in the presence or absence of a safety guidewire. Methods: This randomized clinical trial was conducted on patients referred to our center with a ureteral stone less than 1.5 cm; candidate for TUL after not passing the stone after 2 weeks of conservative management and had no sign of infections or anatomic abnormalities. The primary outcome was the rate of ureteral injuries. Patients were randomly divided into two groups; using safety wire (SGW) and not using safety wire (NSGW). Patients, the data collecting physician, and the Statistical analyst; were concealed from the randomization process. Demographic factors were recorded for each participant. Patients were followed up for at least 1 month; registering intra-operative and post-operative complications. Results: From 2020 to 2021, 348 patients were randomized in two arms. Considering the lost cases during the study, 124 patients were finally analyzed in the SGW and 96 patients in the NSGW. Complications were not different between the two groups (p > 0.05); though, operation time was significantly longer in the SGW group (31.7 min in SGW vs 28 min in NSGW p = 0.02) Conclusion: The safety guidewire seems to add no significant benefit to the TUL procedure outcomes in uncomplicated cases. [ABSTRACT FROM AUTHOR]

This randomized trial compared the first online parent training program for an evidence-supported executive function intervention for autism to in-person parent training with the same dose and content. Parents of autistic children (8–12 years-old; Full Scale IQ above 70) were randomized to in-person (n = 51) or online (n = 46) training. Training acceptability and feasibility were rated highly by parents, without significant differences between groups. The completion rate was lower for parents in the online versus the in-person training condition, but neither the total time spent with training materials, nor parent and child outcomes differed by condition. Parents reported that training resulted in a reduction in caregiver strain (Cohen's d = 0.66) and modest improvements in child flexibility, emotional control and global EF, but not planning and organization. Dose of parent training had a significant positive effect on child planning and organization problems. These findings did not support the hypothesized superiority of online to in-person training, but they did indicate online is as effective as in-person training at helping parents learn to improve their autistic children's EF abilities and reduce their own experience of parenting strain. Implications included increased access to training for parents who experience barriers to receiving in-person care. Trial Registration: clinicaltrials.gov Identifier: NCT02708069 This study compared the first online parent training program for executive function intervention for autism to in-person parent training on the same content. Participants were parents of autistic children, who were between 8 and 12 years of age and did not have intellectual disability. Parents were randomized to the in-person (n = 51) or online (n = 46) training conditions. Both trainings were developed with stakeholder (parents and autistic people) guidance. In this trial, most parents reported that they liked both trainings and that they were able to implement what they learned with their children. Parents in both groups spent equivalent amounts of time (about 8 hours) with the training materials, but while 94% of parents in the in-person training attended both parent trainings, only 59% of parents in the online group completed all 10 online modules. Parents reported that it was difficult to stay motivated to complete the online trainings over the 10-week trial. Parent and child outcomes did not differ significantly between the groups. Overall, parents reported that the trainings resulted in a reduction in their own parenting strain and improvements in their child's flexibility, emotional control, and global executive function, but not planning and organization. These findings indicated brief in-person and online training can help parents learn to support and improve their autistic children's executive function abilities, reducing their own experience of parenting strain. The finding that the online training was equivalent to the in-person trainings is important because it is accessible to parents who encounter barriers to in-person care. [ABSTRACT FROM AUTHOR]

Children with low performance in early numeracy are at risk of facing learning difficulties in mathematics, but few trials have examined how this can be ameliorated. A total of 120 first-grade children (Mage = 6.4 years) were randomly assigned to an intervention or a control condition. The 14-week intervention targeted early numeracy skills and was delivered in small groups three times a week. Immediately after the initial 8-week intervention phase, moderate and positive effects were found on early numeracy (d = 0.19), word problem solving (d = 0.41), and approximate number sense (d = 0.35). However, only the effects on word problems were significant, and all effects disappeared after the children undertook a second 6-week intervention phase. Overall, results indicate that (a) early numeracy skills are malleable in low-performing children, but (b) frequent and long-term interventions are needed for the positive effects to last. [ABSTRACT FROM AUTHOR]

Guided by vested interest theory, we assessed whether a lack of stake explains the discrepancy between people having positive attitudes toward their loved one's recovery from depression and the provision of support. We further investigated whether increasing the perceived personal consequences of providing support (i.e. stake) increased willingness to provide support. A stake-boosting message had no direct, but significant indirect effects on willingness to provide support when compared to a control and comparison condition. In summary, increasing stake in a loved one's recovery indirectly increases intentions to provide support. [ABSTRACT FROM AUTHOR]

We describe a new command, artcat, that calculates sample size or power for a randomized controlled trial or similar experiment with an ordered categorical outcome, where analysis is by the proportional-odds model. artcat implements the method of Whitehead (1993, Statistics in Medicine 12: 2257–2271). We also propose and implement a new method that 1) allows the user to specify a treatment effect that does not obey the proportional-odds assumption, 2) offers greater accuracy for large treatment effects, and 3) allows for noninferiority trials. We illustrate the command and explore the value of an ordered categorical outcome over a binary outcome in various settings. We show by simulation that the methods perform well and that the new method is more accurate than Whitehead's method. [ABSTRACT FROM AUTHOR]

Background: Despite recent advances in arthroscopic rotator cuff repair, the retear rate remains high. New methods to optimize healing rates must be sought. Bone channeling may create a quicker and more vigorous healing response by attracting autologous mesenchymal stem cells, cytokines, and growth factors to the repair site. Hypothesis: Arthroscopic rotator cuff repair with bone channeling would result in a higher healing rate compared with arthroscopic rotator cuff repair without adjuvant channeling. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Our primary objective was to compare healing rates in patients undergoing arthroscopic rotator cuff repair for degenerative tears, with and without bone channeling. Secondary objectives included comparisons of the Western Ontario Rotator Cuff Index (WORC) score, American Shoulder and Elbow Surgeons (ASES) score, Constant score, Constant strength subscore, and visual analog scale (VAS) for pain score between groups. Patients undergoing arthroscopic rotator cuff repair were recruited at 3 sites and were randomized to receive either bone channeling augmentation or standard repair. Healing was determined via ultrasound at 24 months postoperatively. WORC, ASES, and Constant scores were compared between groups at baseline and at 3, 6, 12, and 24 months postoperatively. Results: A total of 168 patients were enrolled between 2013 and 2018. Intention-to-treat analysis revealed no statistical differences in healing rates between the 2 interventions at 24 months postoperatively. Statistically significant improvements occurred in both groups from preoperatively to all time points for the WORC, the ASES score, the Constant score or Constant strength subscore, and the VAS for pain (P <.0001). No differences were observed between the bone channeling and control groups in WORC, ASES, Constant, and VAS pain scores at any time point. Conclusion: This trial did not demonstrate the superiority of intraoperative bone channeling in rotator cuff repair over standard rotator cuff repair at 24 months postoperatively. Healing rates, patient-reported function, and quality-of-life outcomes were similar between groups. Registration: NCT01877772 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Objective: Does short-term use of pneumatic compression devices (PCD) and off-the-shelf compression alleviate symptoms and improve quality of life in women with lipedema and secondary lipolymphedema? Methods: Prospective, randomized controlled, industry-sponsored, proof-in-principle study comparing PCD plus conservative care (PCD+CC) to CC alone (control). Adult females with bilateral lipedema and secondary lymphedema were randomized to PCD+CC or CC. Outcome measures were lower limb and truncal circumferential measurements, bioimpedance, and quality-of-life, symptom, and pain intensity questionnaires. Results: Both groups experienced improvements in leg circumference and bioimpedance with more improvement in the PCD+CC group than the CC group. Pain scores of the SF-36 survey and numerical rating scales were improved in the PCD+CC group. Wong–Baker Faces scores showed trends toward improvement in both groups. Conclusions: This proof-in-principle study supports conservative management with graduated compression and with or without PCD for improvement in leg circumference, bioimpedance measurements, and pain in patients with lipedema. [ABSTRACT FROM AUTHOR]

RE-AIM is an implementation science framework that provides a structure to promote data collection and analysis in the domains of R each, E fficacy/ E ffectiveness, A doption, I mplementation, and M aintenance. The RE-AIM approach promotes more data collection and reporting than typical evaluations so potential adopters can determine the potential program fit for their setting. RE-AIM has been used to evaluate a variety of programs; however, there are few resources that provide strategies for conducting a RE-AIM evaluation in the school setting. The purpose of this article is to inform future studies by elucidating experiences conducting a large, complex, multisite, longitudinal RE-AIM evaluation in schools in partnership with the state's Departments of Education and Health, and to share strategies for overcoming obstacles. With the long-term goal of facilitating the translation of school-based intervention research into practice, we provide key considerations and recommend strategies for school-based RE-AIM evaluation success. [ABSTRACT FROM AUTHOR]

Objective: To study the effect of the birthing room design on nulliparous women's childbirth experience up to 1 year after birth. Background: Although it is known that the birth environment can support or hinder birth processes, the impact of the birthing room design on maternal childbirth experience over time is insufficiently studied. Methods: The Room4Birth randomized controlled trial was conducted at a labor ward in Sweden. Nulliparous women in active stage of spontaneous labor were randomized (n = 406) to either a regular birthing room (n = 202) or a new birthing room designed with more person-centered considerations (n = 204). Childbirth experiences were measured 2 hr, 3 months, and 12 months after birth by using a Visual Analogue Scale of Overall Childbirth Experience (VAS-OCE), the Fear of Birth Scale (FOBS), and the Childbirth Experience Questionnaire (CEQ2). Results: Women randomized to the new room had a more positive childbirth experience reported on the VAS-OCE 3 months (p =.002) and 12 months (p =.021) after birth compared to women randomized to a regular room. Women in the new room also scored higher in the total CEQ2 score (p =.039) and within the CEQ2 subdomain own capacity after 3 months (p =.028). The remaining CEQ2 domains and the FOBS scores did not differ between the groups. Conclusions: These findings show that a birthing room offering more possibilities to change features and functions in the room according to personal needs and requirements, positively affects the childbirth experience of nulliparous women 3 and 12 months after they have given birth. [ABSTRACT FROM AUTHOR]