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Excessive sugar intake poses a significant risk factor for non-communicable diseases. A positive healthy eating (PHE) intervention was developed to promote low-sugar dietary practices in families. The PHE intervention capitalized on positive psychological constructs to overcome barriers to health behavior change by helping families associate feelings of joy, gratitude, and savoring with healthy eating. In a cluster randomized controlled trial, 1983 participants from 1467 families were recruited in Hong Kong. PHE included a core and booster session. Data were collected at pre-intervention, post-intervention, and at 1-month and 3-month follow-up. Compared to the control, PHE showed greater increase in intention to change at post-intervention, engagement in low-sugar dietary practices individually and with family members at 3-month follow-up, and greater reduction in sugar-sweetened beverage intake at 1-month and 3-month follow-up. Intentions to change mediated PHE's effects on low-sugar dietary practices. Focus group interviews revealed the behavior-change process and family quality of life. [ABSTRACT FROM AUTHOR]

Objectives: Designing cancer screening trials for multi-cancer early detection (MCED) tests presents a significant methodology challenge, as natural histories of cell-free DNA-shedding cancers are not yet known. A microsimulation model was developed to project the performance and utility of an MCED test in cancer screening trials. Methods: Individual natural history of preclinical progression through cancer stages for 23 cancer classes was simulated by a stage-transition model under a broad range of cancer latency parameters. Cancer incidences and stage distributions at clinical presentation in simulated trials were set to match the data from Surveillance, Epidemiology, and End Results program. One or multiple rounds of annual screening using a targeted methylation-based MCED test (Galleri Ⓡ) was conducted to detect preclinical cancers. Mortality benefit of early detection was simulated by a stage-shift model. Results: In simulated trials, accounting for healthy volunteer effect and varying test sensitivity, positive predictive value in the prevalence screening round reached 48% to 61% in 6 natural history scenarios. After 3 rounds of annual screening, the cumulative proportions of stage I/II cancers increased by approximately 9% to 14%, the incidence of stage IV cancers was reduced by 37% to 46%, the reduction of stages III and IV cancer incidences was 9% to 24%, and the reduction of mortality reached 13% to 16%. Greater reductions of late-stage cancers and cancer mortality were achieved by five rounds of MCED screening. Conclusions: Simulation results guide trial design and suggest that adding this MCED test to routine screening in the United States may shift cancer detection to earlier stages, and potentially save lives. [ABSTRACT FROM AUTHOR]

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]

There are 200+ tested interventions for care partners (family, friends, and fictive kin) of people living with dementia (PLWD). But these interventions do not systematically cover relevant settings. Nor do these interventions affect all relevant outcomes that matter to people and healthcare systems. We present an evidence map of settings and outcomes from translated interventions to identify gaps. Of 190 studies identified, 31 unique interventions were retained in the evidence map. Identified setting gaps included studies set solely in hospitals/medical centers or set in multiple settings. Identified outcome gaps included interventions that improved care partner beliefs about providing care, care partner negative coping strategies, PLWD resources (e.g., social support), and PLWD coping strategies. Armed with an understanding of present gaps, we call on researchers to fill the identified gaps to ensure systematic coverage of settings and evaluation of outcomes that matter to people and healthcare systems. [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: 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: 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]

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]

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]

Study Design: Prospective randomized controlled trial. Objectives: No prospective studies have directly compared clinical and radiographic outcomes of unilateral vs bilateral instrumented lateral lumbar interbody fusion (LLIF) for lumbar degenerative disease (LDD). We compared the short-term radiographic, clinical outcomes, and some complications of the unilateral percutaneous pedicle screw (PPS) (UPS) vs bilateral PPS (BPS) fixation in short-level spinal fusion with LLIF for LDD. Methods: This was a prospective randomized controlled study of 33 patients who underwent UPS or BPS fixation after LLIF for LDD; 18 patients were assigned to the UPS group and 15 patients to the BPS group. Clinical outcomes, complication rates, and fusion rates were assessed. Results: The two groups were similar in age, sex, preoperative diagnosis, and level of surgery. Blood loss, length of hospital stay, and numeric rating scale score one year after surgery did not differ between groups. The operative time was longer in the BPS than UPS group (120.2 vs 88.8 min, respectively; P =.029). Both groups showed improvement in disc height and dural sac in the immediate postoperative computed tomography and magnetic resonance imaging, which did not differ significantly between groups. The subsidence grade and fusion rate did not differ, but cage subsidence was more severe in the UPS than BPS group. Conclusion: Unilateral and bilateral PPS fixation after LLIF yielded similar short-term clinical and radiological outcomes. However, severe cage subsidence was more common in the UPS group, which suggests that BPS fixation after LLIF may be a better choice over the long term. [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]

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]

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]

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]

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]

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]

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: 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]

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]

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]

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]

Background: Although many mothers initiate breastfeeding, supplementation with human-milk substitutes (formula) during the birth hospitalization is common and has been associated with early breastfeeding cessation. Colostrum hand expressed in the last few weeks before birth, known as antenatal colostrum expression (ACE), can be used instead of human-milk substitutes. However, evidence is lacking on the efficacy of ACE on breastfeeding outcomes and in non-diabetic mothers. Methods and Planned Analysis: This multicenter stepped-wedge cluster (nested) randomized controlled trial aims to recruit 945 nulliparous pregnant individuals. The trial is conducted in two phases. During Phase 1, control group participants are under standard care. During Phase 2, participants are randomized to ACE instruction via a pre-recorded online video or a one-on-one session with a midwife. Adjusted logistic regression analysis will be used to examine the relationship between ACE instruction and breastfeeding outcomes. Research Aims and Questions: Primary aim: (1) Does advising pregnant individuals to practice ACE and providing instruction improve exclusive breastfeeding rates at 4 months postpartum? Secondary research questions: (2) Do individuals who practice ACE have higher rates of exclusive breastfeeding during the initial hospital stay after birth? (3) Is teaching ACE via an online video non-inferior to one-on-one instruction from a midwife? (4) Does expressing colostrum in pregnancy influence time to secretory activation, or (5) result in any differences in the composition of postnatal colostrum? Discussion: Trial findings have important implications for maternity practice, with the online video providing an easily accessible opportunity for ACE education as part of standard antenatal care. [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]

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]

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]

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]

Many individuals with progressive multiple sclerosis (PMS) are challenged by reduced manual dexterity and limited rehabilitation options. Transcranial direct current stimulation (tDCS) during motor training can improve rehabilitation outcomes. We developed a protocol for remotely supervising tDCS to deliver sessions of stimulation paired with training at home.This study evaluated the effectiveness of at-home tDCS paired with manual dexterity training for individuals with PMS.Sixty-five right-hand dominant participants with PMS and hand impairment were randomized to receive either active or sham M1-SO tDCS paired with manual dexterity training over 4 weeks. Clinical outcomes were measured by the changes in Nine-Hole Peg Test (9-HPT) and Dellon-Modified-Moberg-Pick-Up Test (DMMPUT).The intervention had high rates of adherence and completion (98% of participants completed at least 18 of 20 sessions). The active tDCS group demonstrated significant improvement for the left hand compared with baseline in 9-HPT (−5.85 ± 6.19 vs −4.23 ± 4.34, p = 0.049) and DMMPUT (−10.62 ± 8.46 vs −8.97 ± 6.18, p = 0.049). The active tDCS group reported improvements in multiple sclerosis (MS)-related quality of life (mean increase: 5.93 ± 13.04 vs −0.05 ± −8.27; p = 0.04).At-home tDCS paired with manual dexterity training is effective for individuals with PMS, with M1-SO tDCS enhancing training outcomes and offering a promising intervention for improving and preserving hand dexterity. [ABSTRACT FROM AUTHOR]

There are limited data regarding gamma-aminobutyric acid (GABA) allosteric modulator sleep-aid medications in persons with depression, insomnia, and suicidal ideation (SI).This secondary analysis examined the relationship of age to insomnia and the impact of age on the treatment of insomnia with zolpidem extended-release (zolpidem-ER) in depressed suicidal patients. A prior report found that the addition of zolpidem-ER promoted significantly superior reductions in global severity of insomnia in depressed outpatients with insomnia and SI over 8 weeks, but here we report the differences among early, middle, and late insomnia.This secondary analysis examined the three early, middle, and late insomnia items of the Hamilton Rating Scale for Depression (HRSD) and their relationship to age and responsiveness to treatment with zolpidem-ER. One hundred and three patients with major depression, SI, and insomnia received open-label serotonin reuptake inhibitors and were randomly allocated 1:1 to receive zolpidem-ER or placebo at bedtime. Results: Older age at baseline was associated with worse middle and late insomnia, but not with early insomnia. Subsequent treatment with zolpidem-ER produced superior improvement in early and middle insomnia, but not late insomnia.These findings are consistent with the known age-related advancement of sleep timing in the general population and depressed outpatients and with the expected effects of a short half-life GABA allosteric modulator sleep aid. By implication, prescribers of pharmacologic treatment of insomnia in depressed patients should consider an alternative to zolpidem-ER when late insomnia is a concern.Trial registration number: ClinicalTrials.gov Identifier: NCT01689909. [ABSTRACT FROM AUTHOR]

The indications for hip arthroscopy in patients aged ≥40 years remain controversial, as observational studies have suggested that advanced age portends poor functional outcomes, poor durability of improvement, and high rates of conversion to total hip arthroplasty.To compare hip arthroscopy versus nonoperative management for symptomatic labral tears in patients aged ≥40 years with limited radiographic osteoarthritis.Randomized controlled trial; Level of evidence, 1.This single-surgeon, parallel randomized controlled trial included patients aged ≥40 years with limited osteoarthritis (Tönnis grades 0-2) who were randomized 1:1 to arthroscopic surgery with postoperative physical therapy (SPT) or physical therapy alone (PTA). Patients who received PTA and achieved unsatisfactory improvement were permitted to cross over to SPT after completing ≥14 weeks of physical therapy (CO). The primary outcomes were the International Hip Outcome Tool-33 score and modified Harris Hip Score at 24 months after surgery, and secondary outcomes included other patient-reported outcome measures and the visual analog scale for pain. The primary analysis was performed on an intention-to-treat basis using linear mixed-effects models. Sensitivity analyses included modified as-treated and treatment-failure analyses.A total of 97 patients were included, with 52 (53.6%) patients in the SPT group and 45 (46.4%) patients in the PTA group. Of the patients who underwent PTA, 32 (71.1%) patients crossed over to arthroscopy at a mean of 5.10 months (SD, 3.3 months) after physical therapy initiation. In both intention-to-treat and modified as-treated analyses, the SPT group displayed superior mean patient-reported outcome measure and pain scores across the study period for nearly all metrics relative to the PTA group. In the treatment-failure analysis, the SPT and CO groups showed greater improvement across all metrics compared with PTA; however, post hoc analyses revealed no significant differences in improvement between the SPT and CO groups. No significant differences were observed between groups in rates of total hip arthroplasty conversion.In patients ≥40 years of age with limited osteoarthritis, hip arthroscopy with postoperative physical therapy led to better outcomes than PTA at a 24-month follow-up. However, additional preoperative physical therapy did not compromise surgical outcomes and allowed some patients to avoid surgery. When surgery is indicated, age ≥40 years should not be considered an independent contraindication to arthroscopic acetabular labral repair.NCT03909178 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

People with multiple sclerosis (MS) fall frequently. Poor walking aid selection, fit, and use contribute to falls in those who use walking aids.To determine if the Assistive Device Selection, Training, and Education Program (ADSTEP), with six weekly one-on-one virtual sessions with a physical therapist prevents falls and improves other outcomes in people with MS who use walking aids but still fall.A total of 78 people were randomized to ADSTEP or control. Participants recorded falls daily through 6 months post-intervention. Other outcomes were assessed at baseline, intervention completion, and 6 months later. Outcomes were compared between groups.The ADSTEP group’s mean fall rate (falls/person/month) decreased from baseline to intervention completion (ADSTEP = −0.75, control = +0.90, p < 0.001) and to 6 months later (ADSTEP = −1.02, control = +0.03, p = 0.017) compared to controls. At 6 months, the ADSTEP group had improved physical activity (days/week walking ⩾ 10 minutes at a time: ADSTEP = +0.69, control = −0.58, p = 0.007; minutes/day sitting: ADSTEP = −57, control = +56, p = 0.009) and walking aid fit (proportion with good fit: ADSTEP = +25%, control = −13%, p = 0.018) compared to controls.ADSTEP likely reduces falls, increases physical activity, and improves walking aid fit in people with MS who use walking aids and fell in the past year. [ABSTRACT FROM AUTHOR]

Late-stage cancer incidence has been proposed as an early surrogate for mortality in randomized controlled trials (RCTs) of cancer screening; however, its validity has not been systematically evaluated across screening RCTs of different cancers.We conducted a meta-regression analysis of cancer screening RCTs that reported both late-stage cancer incidence and cancer mortality. Based on a systematic literature review, we included 33 RCTs of screening programs targeting seven cancer types, including lung (n = 12), colorectal (n = 8), breast (n = 5), and prostate (n = 4), among others. We regressed the relative reduction of cancer mortality on the relative reduction of late-stage cancer incidence, inversely weighted for each RCT by the variance of estimated mortality reduction.Across cancer types, the relative reduction of late-stage cancer incidence was linearly associated with the relative reduction of cancer mortality. Specifically, we observed this association for lung (R2 = 0.79 and 0.996 in three recent large trials), breast (R2 = 0.94), prostate (R2 = 0.98), and colorectal cancer (R2 = 0.75 for stage III/IV cancers and 0.93 for stage IV cancers). Trials with a 20% or greater reduction in late-stage cancers were more likely to achieve a significant reduction in cancer mortality. Our results also showed that no reduction of late-stage cancer incidence was associated with no or minimal reduction in cancer mortality.Meta-regression of historical screening RCTs showed a strong linear association between reductions in late-stage cancer incidence and cancer mortality. [ABSTRACT FROM AUTHOR]

Based in part on the results of randomized controlled trials (RCTs) that suggest a beneficial effect over alternative treatment options, the use of platelet-rich plasma (PRP) for the management of knee osteoarthritis (OA) is widespread and increasing. However, the extent to which these studies are vulnerable to slight variations in the outcomes of patients remains unknown.To evaluate the statistical fragility of conclusions from RCTs that reported outcomes of patients with knee OA who were treated with PRP versus alternative nonoperative management strategies.Systematic review and meta-analysis; Level of evidence, 2.All RCTs comparing PRP with alternative nonoperative treatment options for knee OA were identified. The fragility index (FI) and reverse FI were applied to assess the robustness of conclusions regarding the efficacy of PRP for knee OA. Meta-analyses were performed to determine the minimum number of patients from ≥1 trials included in the meta-analysis for which a modification on the event status would change the statistical significance of the pooled treatment effect.In total, this analysis included outcomes from 1993 patients with a mean ± SD age of 58.0 ± 3.8 years. The mean number of events required to reverse significance of individual RCTs (FI) was 4.57 ± 5.85. Based on random-effects meta-analyses, PRP demonstrated a significantly higher rate of successful outcomes when compared with hyaluronic acid (P = .002; odds ratio [OR], 2.19; 95% CI, 1.33-3.62), as well as higher rates of patient-reported symptom relief (P = .019; OR, 1.55; 95% CI, 1.07-2.24), not requiring a reintervention after the initial injection treatment (P = .002; OR, 2.17; 95% CI, 1.33-3.53), and achieving the minimal clinically important difference (MCID) for pain improvement (P = .007; OR, 6.19; 95% CI, 1.63-23.42) when compared with all alternative nonoperative treatments. Overall, the mean number of events per meta-analysis required to change the statistical significance of the pooled treatment effect was 8.67 ± 4.50.Conclusions drawn from individual RCTs evaluating PRP for knee OA demonstrated slight robustness. On meta-analysis, PRP demonstrated a significant advantage over hyaluronic acid as well as improved symptom relief, lower rates of reintervention, and more frequent achievement of the MCID for pain improvement when compared with alternative nonoperative treatment options. Statistically significant pooled treatment effects evaluating PRP for knee OA are more robust than approximately half of all comparable meta-analyses in medicine and health care. Future RCTs and meta-analyses should consider reporting FIs and fragility quotients to facilitate interpretation of results in their proper context. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic touched off an unprecedented search for vaccines and treatments. Without question, the development of vaccines to prevent COVID-19 was an enormous scientific accomplishment. Further, the RECOVERY and Solidarity trials identified effective treatments for COVID-19. But all was not success. The urgent need for COVID-19 prevention and treatment fueled an embrace of risks—to research participants and to the reliability of the science itself—as allegedly necessary costs to speed scientific progress. Scientists and (even) ethicists supported overturning longstanding norms protecting healthy volunteers in human challenge trials to speed vaccine development, but these trials led to no vaccines. Physicians, with the approval of research ethics committees, designed hundreds of unblinded, single-center clinical trials at high risk of bias to speed the identification of new treatments. But these clinical trials led to no treatments. The lesson for future pandemics is that the acceptance of greater risks to participants or science does not reliably lead to progress. We are better served by science that upholds the highest ethical and methodological standards. [ABSTRACT FROM AUTHOR]