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The COVID-19 pandemic led to a proliferation of remote-proctored (or "at-home") assessments. The lack of standardized setting, device, or in-person proctor during at-home testing makes it markedly distinct from testing at a test center. Comparability studies of at-home and test center scores are important in understanding whether these distinctions impact test scores. This study found no significant differences in at-home versus test center test scores on a large-scale admissions test using either a randomized controlled trial or an observational study after adjusting for differences in sample composition along baseline characteristics. [ABSTRACT FROM AUTHOR]

Background: Obsessive-compulsive disorder (OCD) is a prevalent and burdensome mental health condition, often resistant to conventional treatments. Agomelatine (Valdoxan), a compound acting on serotonin and melatonin systems, has shown promise in treating those with treatment-resistant OCD based on anecdotal reports and case studies. Methods: A randomized, double-blind controlled trial was conducted with 60 patients diagnosed with treatment-resistant OCD. Participants were randomized into an intervention group (receiving agomelatine 50 mg/day) and a control group (receiving placebo). OCD symptoms were assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) over a 12-week period. Results: There were no significant differences in age, gender, or baseline Y-BOCS scores between intervention and control groups. Agomelatine did not demonstrate a significant improvement in OCD symptoms compared to placebo. Adverse events were comparable between groups, and liver enzyme levels remained within the normal range. Conclusion: This study, while not confirming superior efficacy compared to placebo, underscores the need for continued investigation into agomelatine's potential for treating specific subgroups of OCD patients, underscoring the need for more comprehensive and well-controlled trials in the future. [ABSTRACT FROM AUTHOR]

Providing consistent, individualized feedback to teachers is essential for improving instruction but can be prohibitively resource-intensive in most educational contexts. We develop M-Powering Teachers, an automated tool based on natural language processing to give teachers feedback on their uptake of student contributions, a high-leverage dialogic teaching practice that makes students feel heard. We conduct a randomized controlled trial in an online computer science course (N = 1,136 instructors), to evaluate the effectiveness of our tool. We find that M-Powering Teachers improves instructors' uptake of student contributions by 13% and present suggestive evidence that it also improves students' satisfaction with the course and assignment completion. These results demonstrate the promise of M-Powering Teachers to complement existing efforts in teachers' professional development. [ABSTRACT FROM AUTHOR]

Introduction: The aim of the study was to evaluate undergraduate medical students' knowledge and self-confidence to perform abscess incision after virtual reality-simulation or video lecture. Pre and post-knowledge assessment was conducted. Materials and Methods: This was a multicentre randomised controlled trial from October 2021 to January 2022. The study was carried out at two universities providing medical education. Undergraduate medical students were randomized into either fully immersive head mounted display virtual reality-simulation (VR) or video lecture. Pre- and post-learning surveys probed self-confidence and student's own assessment of competence. Participants were third-, fourth- and fifth-year medical students from the University of Eastern Finland and the University of Helsinki. All students were sent an email informing them of the opportunity to participate in this voluntary study. All willing students were included in the study. Results: 42 medical students participated in the study. Most were fourth year medical students, 52% of the participants had previously used VR in some context and the mean age of participants was around 25 years. Both methods increased knowledge and self-confidence equally. In VR subgroup, those with technical support available experienced greater learning than those without. Conclusions: Interestingly, in the present study, both VR and video lecture increased knowledge and professional self-confidence equally. [ABSTRACT FROM AUTHOR]

Scalable and accessible professional development programs have the potential to address the opportunity gap many teachers experience. Yet many asynchronous online programs lack interaction with and timely feedback to teachers. We addressed this problem by developing a virtual, interactive program that uses intelligent tutoring systems to provide just‐in‐time feedback to teachers. We conducted a randomized controlled trial with teachers across the United States in which teachers were assigned to either this program or no additional training. We found that teachers who completed our program (N = 29) used mathematically richer tasks and created a more coherent, connected learning environment for students to build conceptual understandings than did teachers who were in the business‐as‐usual condition (N = 23). [ABSTRACT FROM AUTHOR]

Background: It is necessary to better understand the structural characteristics of the supraspinatus tendon and associated muscle after rotator cuff repair and in the event of retear. Purpose: To study structural differences between the repaired and contralateral shoulders 1 year after rotator cuff repair in patients who received either progressive exercise therapy (PR) or usual care (UC) in a randomized controlled trial and to investigate whether there was interaction with tendon retear and limb dominance. Study Design: Cohort study; Level of evidence, 2. Methods: Patients with surgically repaired traumatic full-thickness rotator cuff tears involving the supraspinatus tendon were included. After surgery, they were randomized to PR or UC (active from postoperative week 2 or 6, respectively). The subacromial structures (acromiohumeral distance, supraspinatus tendon thickness, and vascularity) and the supraspinatus muscle thickness were examined with ultrasound at the 1-year follow-up. Results: A total of 79 patients were included. The characteristics of the 2 intervention groups (PR and UC) were comparable, including the Western Ontario Rotator Cuff Index score and number of retears. The authors found significantly thinner supraspinatus tendon (PR, P <.001; UC, P =.003) and reduced acromiohumeral distance (PR, P =.023; UC, P =.025) in the repaired versus the contralateral shoulders in both intervention groups. For neovascularization, there was no interlimb difference in either of the groups or between groups (PR vs UC). In patients with intact tendons, there was no interlimb difference in the muscle thickness, but in patients with tendon retear the muscle was significantly thinner on the repaired side (P =.024 and P <.001, respectively). When the dominant supraspinatus tendon was repaired (both groups), it was significantly thinner than the nondominant healthy tendon, but this difference was not seen when the nondominant supraspinatus tendon was repaired (P =.006). Conclusion: One year after rotator cuff surgery, the repaired supraspinatus tendon was significantly thinner and the corresponding acromiohumeral distance was reduced. In patients with retear, the supraspinatus muscle was significantly thinner on the repaired side and early initiation of tendon-loading exercises did not affect these findings. Registration: NCT02969135 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Introduction: The aim of this research was to investigate the effects of telerehabilitation-based remote supervised or unsupervised structured exercise therapy on pain, disability, and quality of life related to chronic nonspecific neck pain. Method: The study was designed as a single-blinded randomized controlled trial. Sixty-six eligible chronic nonspecific neck pain patients were randomized across three groups: remote supervised group (RSG, n = 22), unsupervised group (UG, n = 22), and waitlist control group (CG, n = 22). Progressive structured exercise therapy program was delivered weekly to patients in remote supervised group and unsupervised group to perform four days a week for four weeks. Remote supervised group was supervised by videoconference and text message. Pain, disability, and quality of life of participants were assessed at baseline, week 2, and post-therapy. Results: Post-therapy pain and disability total change scores were −3.64 (95% CI −4.85 to −2.42) and −7.27 (95% CI −11.05 to −3.50) for remote supervised group compared with a change of −2.44 (95% CI −3.46 to −1.43) and −5.77 (95% CI −8.54 to −3.01) for unsupervised group, respectively. Post-therapy, quality of life improvements were greater for remote supervised group than unsupervised group overall (general health; remote supervised group: 19.01 (95% CI 6.86 to 31.16), unsupervised group: 12.50 (95% CI 4.79 to 20.21), and physical health; remote supervised group: 18.35 (95% CI 10.35 to 26.35), unsupervised group: 7.31 (95% CI 0.01 to 14.60)). Significant improvements in psychological health and environment-telerehabilitation for remote supervised group were not seen for unsupervised group and outcomes differences did not reach significance for control group (p > 0.05) post-therapy, except environment-telerehabilitation. Discussion: Structured exercise therapy can improve chronic nonspecific neck pain outcomes when remotely supervised or unsupervised. Structured exercise therapy content and frequent communication are important for remote chronic nonspecific neck pain management. [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]

This pragmatic randomized controlled trial compared lunocapitate fusion (LCF) and four-corner fusion (4CF) for scapholunate advanced collapse (SLAC) and scaphoid nonunion advanced collapse (SNAC) in 64 patients. The primary outcome was change in grip strength from preoperative to 1 year postoperatively. The secondary outcomes were Disability of the Hand, Arm, and Shoulder score, Patient Rated Wrist Evaluation score, EuroQol-5D-3L, range of motion, key pinch strength and complications 12 months postoperatively. Grip strength improved only to a small extent and there was no difference between the groups. No differences were found in the secondary outcomes. In conclusion, LCF is not inferior to 4CF regarding strength, range of motion or patient-reported outcome measures. [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]

Study Design: Randomized controlled trial Objective: Percutaneous transforaminal endoscopic discectomy (PTED) was introduced as a less invasive procedure to treat sciatica. Even though the PTED has a small scar size, it is unknown if PTED also leads to better scar-related patient-reported outcomes. Therefore, we aimed to compare scar-related outcomes between patients undergoing PTED vs open microdiscectomy. Methods: Patients with at least 6 weeks of radiating leg pain were randomized in a 1:1 ratio to PTED or open microdiscectomy. Scar-related patient-reported outcomes were measured using the Body Image Score (BIS), Cosmesis Scale (CS) and a 0-10 numeric rating scale (NRS) on scar esthetic. Results: Of the 530 included patients, 286 patients underwent PTED and 244 underwent open microdiscectomy as allocated. At 12 months of follow-up, 95% of the patients had data available. At 12 months, the BIS was 6.2 ± 1.7 in the PTED-group and 6.6 ± 1.9 in the open microdiscectomy group (between-group difference.4, 95% CI.2 to.7). CS was 21.3 ± 3.0 in the PTED-group and 18.6 ± 3.4 in the open microdiscectomy group (between-group difference −2.7, 95% CI −3.1 to −2.3). Average NRS for scar esthetic was 9.2 ± 1.3 and 7.8 ± 1.6 in the PTED and open microdiscectomy groups, respectively (between-group difference −1.4, 95% CI −1.6 to −1.2) Conclusions: PTED leads to a higher self-rated scar esthetic as compared to open microdiscectomy, while self-reported body image seems to be comparable between both groups. Therefore, from an esthetic point, PTED seems to be the preferred technique to treat sciatica. [ABSTRACT FROM AUTHOR]

Targeted school-based programs seem to be a promising approach to help adolescents in need. Nevertheless, successful implementation and evaluation of such programs is challenging. However, there is limited knowledge about (overcoming) the challenges of implementation and experimental evaluation of school-based programs. The goal of the present paper is, therefore, to improve future research by describing the challenges encountered and lessons learned during two randomized controlled trials (RCTs) to study the effectiveness of two skills-training programs reducing school or social stress. In this way, we aim to inform others who plan to implement and evaluate such programs in schools using an RCT design. Some of the challenges encountered apply to all effectiveness studies, such as the recruitment and retention of participants; others are more "intervention at school" specific, such as scheduling the programs and assessments. Our experiences show that it is possible to effectively implement and evaluate targeted programs promoting adolescent mental health in secondary schools with RCTs, even during a worldwide health pandemic, but that it requires investing sufficient time in keeping close and regular contact as well as clear communication between the involved parties. Moreover, high levels of flexibility are needed in adjusting scheduled meetings for intervention and research while keeping track of the entire process for each school and individual participant. [ABSTRACT FROM AUTHOR]

Background: Cannabidiol (CBD) has been shown recently to positively affect patient pain and satisfaction immediately after arthroscopic rotator cuff repair (ARCR). However, it is unclear whether the addition of CBD to a perioperative regimen could affect postoperative outcomes. Purpose: To evaluate patient-reported outcomes among patients who underwent ARCR and received buccally absorbed CBD or an identical placebo for early postoperative pain management at 1-year follow-up. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Eligible patients had previously participated in a multicenter, placebo-controlled, randomized, double-blinded trial that evaluated the analgesic effects of CBD in the immediate postoperative period after ARCR. The experimental group received 25 mg of CBD 3 times/day if <80 kg and 50 mg of CBD 3 times/day if >80 kg for 14 days, with the control group receiving an identical placebo. The following outcomes were assessed at minimum 1-year follow-up: visual analog scale (VAS) for pain, American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE), and patient satisfaction. The rates of achievement of the Patient Acceptable Symptom State (PASS) were compared based on ASES at latest follow-up. Continuous and categorical variables were compared with the Mann-Whitney U test and Fisher exact test, respectively. Results: Follow-up was obtained from 83 of 99 patients (83.8%) who completed the original trial. There were no significant differences between the CBD and control groups with respect to age, sex, body mass index, rate of concomitant procedures, or number of anchors used intraoperatively. At 1-year follow-up, there were no significant differences between the CBD and control groups in VAS pain (0.8 vs 1.2, P =.38), ASES (93.0 vs 91.1, P =.71), SANE (87.6 vs 90.1, P =.24), or satisfaction (97.4 vs 95.4, P =.41). A majority of patients achieved the PASS (81.0% [CBD] vs 77.5% [control]; P =.79). Conclusion: Perioperative use of CBD for pain control among patients undergoing ARCR did not result in any significant deficits in pain, satisfaction, or patient-reported outcomes at 1-year postoperatively compared with a placebo control group. These findings suggest that CBD can be considered in a postoperative multimodal pain management regimen without detrimental effects on outcome. Registration: NCT04672252 (ClinicalTrials.gov identifier). [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: 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]

Background: Randomized controlled trials (RCTs) are crucial in comparative research, and a careful approach to randomization methodology helps minimize bias. However, confounding variables like socioeconomic status (SES) and race are often underreported in orthopaedic RCTs, potentially affecting the generalizability of results. This study aimed to analyze the reporting trends of SES and race in RCTs pertaining to Achilles tendon pathology, considering 4 decades of data from top-tier orthopaedic journals. Methods: This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and used PubMed to search 10 high-impact factor orthopaedic journals for RCTs related to the management of Achilles tendon pathology. The search encompassed all articles from the inception of each journal until July 11, 2023. Data extraction included year of publication, study type, reporting of SES and race, primary study location, and intervention details. Results: Of the 88 RCTs identified, 68 met the inclusion criteria. Based on decade of publication, 6 articles (8.8%) reported on SES, whereas only 2 articles (2.9%) reported on race. No RCTs reported SES in the pre-1999 period, but the frequency of reporting increased in subsequent decades. Meanwhile, all RCTs reporting race were published in the current decade (2020-2030), with a frequency of 20%. When considering the study location, RCTs conducted outside the United States were more likely to report SES compared with those within the USA. Conclusion: This review revealed a concerning underreporting of SES and race in Achilles tendon pathology RCTs. The reporting percentage remains low for both SES and race, indicating a need for comprehensive reporting practices in orthopaedic research. Understanding the impact of SES and race on treatment outcomes is critical for informed clinical decision making and ensuring equitable patient care. Future studies should prioritize the inclusion of these variables to enhance the generalizability and validity of RCT results. [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]

Controversy remains regarding the optimal technique and suture type for wound closure after carpal tunnel surgery. Adult patients undergoing open carpal tunnel release were prospectively randomized to receive either interrupted, buried Monocryl sutures or traditional nylon horizontal mattress sutures for their wound closures. At the 2-week and 6-week postoperative visits, Patient and Observer Scar Assessment Scale questionnaires were completed. At 2 weeks, patients and observers had a significantly better opinion of incisions closed with Monocryl. By 6 weeks, neither patients nor observers found a difference between suture types in any category. Scars of wounds closed with Monocryl did not change appreciably in appearance between 2 and 6 weeks. However, patients and observers noted significant improvement in scar appearance in the nylon group over time. Monocryl suture represents an effective method for carpal tunnel closure that leads to improved patient- and observer-reported outcome scores in the early postoperative period compared with nylon. Level of evidence: II [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]

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]

Background: Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer (CRC). However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese medicine practice. Aim: The aim of this study was to examine the efficacy and safety of electroacupuncture (EA) for the alleviation of CIPN in CRC patients. Design: This was a pilot single-blinded, randomized, sham-controlled trial. Setting/participants: Sixty eligible patients, who had been diagnosed with CRC and were undergoing oxaliplatin-based chemotherapy, were randomized in a ratio of 1:1 to the EA intervention group or sham acupuncture (SA) control group. During a 12-week treatment period, patients in the EA group received EA once a week, while patients in the SA group received SA; both groups were followed up for 12 weeks. Results: Compared with the SA group, the EA group exhibited significant alleviation of CIPN severity during chemotherapy. Moreover, EA also improved the physical function, role function, and social function of CRC patients. However, there were no significant differences in tests of vibration or light touch sensation. In addition, EA appeared to be a safe treatment for CIPN and was both feasible and acceptable to CRC patients during chemotherapy. Conclusion: This study showed preliminary evidence for the efficacy and safety of EA in acute CIPN among CRC patients, although further studies are needed to verify these effects and to further explore the potential role of EA in chronic CIPN (effects on which remain unclear). Trial registration number: NCT03582423 (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]

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]

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]

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]

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]

The purpose of this study was to investigate the necessity for surgical fixation of basal fractures of the ulnar styloid without distal radioulnar joint (DRUJ) instability, after stabilization of associated distal radial fractures using an anterior plate. This single-centre, prospective, randomized controlled trial, conducted between 2015 to 2021, included 43 patients in each study arm who were randomized to either fixation (Group A) or non-operative treatment (Group B) of the ulnar styloid. The mean follow-up period was 24 months (SD 5.2) in Group A and 23.9 months (SD 5.5) in Group B. At the final follow-up, patients were evaluated by the Disabilities of the Shoulder, Arm, and Hand (DASH) score, the Modified Mayo Wrist Score (MMWS), the visual analogue scale (VAS) for pain, the grip strength, wrist range of motion. The DASH score was 6 (SD 2.6) in Group A and 6 (SD 2.4) in Group B; the MMWS was 87 (SD 5.6) in Group A and 87 (SD 5.6) in Group B; and the grip strength was 88% (SD 9.4) in Group A and 87% (SD 7.7) in Group B. In conclusion, fixation of basal ulnar styloid fractures is not mandatory if the DRUJ is stable after rigid fixation of the associated fracture of the distal radius. Level of evidence: II [ABSTRACT FROM AUTHOR]

Background: Many Gulf War (GW) Veterans report chronic symptoms including pain, fatigue, and cognitive impairment, commonly defined as Gulf War Illness (GWI). Complementary and integrative health (CIH) therapies may potentially improve multiple symptoms of GWI. Objective: To examine the effectiveness of combining 2 commonly available CIH therapies, mindfulness meditation and auricular acupuncture, in improving health-related functioning and multiple symptom domains of GWI (e.g., pain, fatigue). Methods: This study was a randomized controlled trial in which Veterans with GWI were randomly assigned to either the intervention group (n = 75), wherein they received 2 distinct CIH therapies – mindfulness meditation and auricular acupuncture, or the active control group, wherein they received a GW Health Education (GWHE) program (n = 74), each lasting 8 weeks. Self-report health measures were assessed at baseline, endpoint, and 3 month follow-up. Results: In the intention-to-treat analyses, there were significant between-group differences for mental-health related functioning, fatigue, depression symptoms, and Kansas total severity scores for symptoms in which the CIH group had improved scores for these outcomes at endpoint compared to the GWHE group (all P ≤.05). The CIH group also had significant reductions in pain interference at endpoint and follow-up compared to baseline (estimated marginal mean difference: −2.52 and −2.22, respectively; all P =.01), whereas no significant changes were observed in the GWHE group. For pain characteristics, the GWHE group had a worsening of pain at endpoint compared to baseline (estimated marginal mean difference: +2.83; P =.01), while no change was observed in the CIH group. Conclusion: Findings suggest a possible beneficial effect of combining 2 CIH therapies, mindfulness meditation and auricular acupuncture, in reducing overall symptom severity and individual symptom domains of fatigue, musculoskeletal, and mood/cognition in Veterans with GWI. Trial Registration: Clinical Trials identifier NCT02180243 [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]

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]

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]

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]

Background: People aging with long-term physical disabilities are living longer and experiencing the challenges of aging, including the onset of secondary and age-related health conditions. People aging with long-term physical disabilities are at high risk of falls, fall injuries, diminished functional abilities, and compromised participation. However, no available programs support people aging with long-term physical disabilities to participate safely at home and in the community. The proposed study is to examine the feasibility and efficacy of an adapted intervention: removing environmental barriers to independent living. Method/Design: A single-blinded randomized controlled trial will be conducted. Participants who are 45–65 years old; self-report difficulty with ⩾2 daily activities; have had a physical disability for ⩾5 years; and live within 60 mi of the research lab are eligible. All participants will receive an initial in-home evaluation before randomization. The treatment group will receive removing environmental barriers to independent living (total five visits) intervention, which is tailored. The waitlist control group will be offered the same intervention after 6-month follow-up. Expected outcomes are high acceptability, fidelity, and adherence; low safety risk; improved community participation and daily activities performance; and fewer environmental barriers and fall hazards. Discussion: Findings will serve as preliminary evidence for occupational therapy community practice. Outcomes will also inform future large, pragmatic trials. Trial Registration: ClinicalTrials.gov identifier NCT04589988 [ABSTRACT FROM AUTHOR]

To investigate the potential use of cyclooxygenase-2 (COX-2) inhibitors in the treatment of lower urinary tract symptoms (LUTS) in male patients, we conducted a comprehensive meta-analysis. Our study involved the identification and collection of randomized controlled trials (RCTs) from leading databases including PubMed, MEDLINE, EMBASE, and Cochrane Library. The primary objective of this analysis was to evaluate the effectiveness of COX-2 inhibitors for the treatment of LUTS. Our analysis involved six short-term (within 3 months) RCTs involving 707 patients. We found that COX-2 inhibitor treatment significantly improved the International Prostate Symptom Score (IPSS) of patients (mean difference [MD] = −2.99, 95% confidence interval (CI): −3.65 to −2.33, p <.00001), nocturia frequency (MD = −1.90; 95% CI: −3.18 to −0.61, p =.004), and maximum flow rate (Qmax) (MD = 1.02; 95% CI: 0.06 to 1.98, p =.04). However, no significant differences were found between patients in terms of changes in prostate-specific antigen (PSA) (MD = 0.02; 95% CI: −0.39 to 0.43, p =.92) and total prostate volume (TPV) (MD = −2.93; 95% CI: −6.45 to 0.59, p =.10). Therefore COX-2 inhibitors are an effective treatment for LUTS. [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]

Laboratory investigations are essential models responsible for science development. However, laboratory discoveries must be confirmed in a clinical environment where many known and unknown variables and complex mechanisms are involved. Using conclusions from laboratory studies to make clinical recommendations can lead to widespread "unreliable truths" or so-called myths in any field of knowledge. These myths may increase the costs (financial and time) or even cause harm (side effects) that would be unnecessary, given that the current protocol or conduct was previously evaluated in a more complex and complete clinical setting. This article will discuss certain myths in dentin bonding that may influence clinical decision-making, bringing some principles of evidence-based practice to allow a more critical evaluation of the literature findings. [ABSTRACT FROM AUTHOR]

Background: Scalp acupuncture has been found to be effective at improving motor function after ischemic stroke, but few studies examining its central mechanisms of action have been carried out. The aim of this study was to investigate the clinical effects of scalp acupuncture on motor dysfunction and changes in spontaneous brain activity in patients with ischemic stroke. Methods: This was an evaluator- and analyst-blinded, multi-center randomized controlled trial. A total of 108 convalescent-stage ischemic stroke patients with motor dysfunction were allocated to receive either scalp acupuncture combined with rehabilitation treatment (SR group) or rehabilitation treatment alone (RE group). Patients in both groups received treatment 5 times per week for 8 weeks. The primary outcome measure was the Fugl-Meyer assessment (FMA). Secondary outcome measures included the modified Barthel index (mBI), modified Rankin scale (mRS) and values of fractional amplitude of low frequency fluctuation (fALFF) acquired using a resting-state functional magnetic resonance imaging (rs-fMRI) technique. Results: Both groups showed significant improvements in motor function, daily life ability and degree of disability, as measured by FMA, mRS and mBI (p < 0.05), and the SR group showed a significantly greater improvement (p < 0.05). Compared with the RE group, the areas where the fALFF values increased in the SR group were located in the cerebellum, praecuneus, precentral gyrus, superior frontal gyrus and parietal lobe. The improvement in FMA scores had the strongest correlation with the baseline fALFF values of the ipsilateral precentral gyrus. Conclusion: Scalp acupuncture improved motor function in convalescent-period ischemic stroke patients, and effects were correlated with regulation of motor-relevant brain regions. The fALFF value of the ipsilateral precentral and postcentral gyri could be potential clinical indices for prognostication of motor dysfunction. Trial registration number: NCT03120650 (http://www.clinicaltrials.gov). [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: The evidence available on the association between social support and prevention of depression has been basically obtained from observational studies. Aim: We evaluated the effectiveness of social support-based interventions for the prevention of depression in people without clinical depression. Methods: Systematic review and meta-analysis (SR/MA) of randomized controlled trials (RCT), which were searched for in MEDLINE, EMBASE, CENTRAL, WOS, PsycINFO, OpenGrey and other sources from the inception dates to June 8, 2022. We selected RCTs that assessed the effectiveness of social support-based interventions as compared to controls, included subjects without baseline clinical depression, and measured as results a reduction in depressive symptoms and/or the incidence of new cases of depression. Pooled standardized mean differences (SMDs) were calculated from random effects models. Results: Nine RCTs involving 927 patients from North America, Asia and Europe were included. The pooled SMD was −0.43 [95% confidence interval (CI) −0.82 to −0.04; p =.031]. Sensitivity analyses confirmed the robustness of results. Heterogeneity was substantial [ I 2 = 80% (95% CI: 64% to 89%)]. A meta-regression model that included usual care as comparator and the continent (Europe), explained 53% of heterogeneity. Eight RCTs had a moderate overall risk of bias and one had a high risk of bias. Follow-up was ⩾1 year in only three RCTs. There was no statistical evidence of publication bias. The quality of evidence, as measured on GRADE guidelines, was low. Conclusion: Social support-based interventions had a small preventive effect on depression. Longer RCTs with a low risk of bias are necessary. [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]

Because a relationship has been reported between masticatory behavior, obesity, and postprandial blood glucose, it is recommended to chew well and take a longer time to eat. The purpose of this study was to examine the possibility of changing masticatory behavior using a small ear-hung wearable chewing counter, which can monitor masticatory behavior without disturbing daily meals. In total, 235 healthy volunteers participated in a 4-wk randomized controlled trial and were divided into 3 groups. All participants were instructed about the importance of mastication at the first visit. During the intervention, group B used the chewing counter without an algorithm during each meal (notification of the number of chews after meal), and group C used the chewing counter with a masticatory behavior change algorithm (setting a target value and displaying the number of chews in real time). Group A was set as the control group. The number of chews and the meal time when consuming 1 rice ball (100 g) were measured before and after the intervention using the chewing counter, and the rate of change in these values was evaluated. Participants also provided a subjective evaluation of their changes in masticatory behavior. The number of chews and the meal time of 1 rice ball increased significantly in groups B and C compared with before the intervention, and the rate of change was significantly higher in group C than in group A and group B. In addition, the subjective evaluation of the change in the number of chews was highest in group C. Self-monitoring of masticatory behavior by providing a target value and the degree of achievement for the number of chews using a wearable chewing counter with a behavioral change algorithm could promote effective change in masticatory behavior and lead to an increased number of chews. (Trial ID: UMIN000034476) [ABSTRACT FROM AUTHOR]

Objective: We examined whether neuropsychological function in ADHD can be improved by the New Forest Parenting Programme (NFPP), that combines standard parenting strategies with self-regulatory skills training, or predict ADHD and quality of life (QoL) treatment effects. Method: Participants were 93 medication-naive preschool children with ADHD (3–7 years) randomized to either NFPP (n = 49) or treatment as usual (TAU; n = 44) in a recent randomized trial. Laboratory measures of executive function, reaction time variability, and delay of gratification were collected along with parent ratings of ADHD and QoL at baseline and post treatment. Ratings were collected again at 3-month follow-up. Results: NFPP did not improve neuropsychological function (compared to TAU), and baseline neuropsychological function did not predict treatment-related ADHD or QoL effects. Conclusion: Although NFPP includes a neuropsychological training element and has been shown to improve several clinical outcomes, it did not improve the neuropsychological functions it targets. [ABSTRACT FROM AUTHOR]