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Background: The Integrated Palliative Care Outcome Scale (IPOS) validly and reliably measures symptoms and concerns of those receiving palliative care. Aim: To determine the equivalence of the paper version with an electronic version of the IPOS (eIPOS). Design: Multicentre randomised crossover trial (NCT03879668) with a within-subject comparison of the two modes (washout period 30 min). Setting/Participants: Convenience sample of specialist inpatient and palliative home care patients aged over 18 years with cancer and non-cancer conditions was recruited. Scores were compared using intraclass correlation coefficients (ICC), Bland-Altman plots and via a mixed-effects analysis of variance. Results: Fifty patients were randomised to complete paper-electronic (n = 24) and electronic-paper (n = 26) IPOS with median age 69 years (range 24–95), 56% male, 16% non-cancer. The ICCs showed very high concordance for the total score (ICC 0.99, 95% CI 0.98–1.00), lowest ICCs being observed for symptoms 'Appetite loss' and 'Drowsiness' (ICC 0.95, 95% CI 0.92–0.97). Nine of seventeen items had ICCs above 0.98, as did all subscales. No statistically significant mode, order, age, and interaction effects were observed for IPOS total score and subscales, except for 'Communication' (Fmode = 5.9, p = 0.019). Fifty-eight percent preferred the electronic version. In the group 75+ years, 53% preferred the paper version. Only three entries in the free-text main problems differed between the versions. Conclusion: The very high equivalence in scores and free text between the IPOS and the eIPOS demonstrates that eIPOS is feasible and reliable in an older palliative population. [ABSTRACT FROM AUTHOR]

Objective: To determine whether patients with stroke receiving rehabilitation for upper limb deficits using smart technology (video and reminder functions) demonstrate greater adherence to prescribed home exercise programmes and better functional outcomes when compared with traditional paper-based exercise prescription. Design: Randomized controlled trial comparing upper limb home exercise programmes supported by video and automated reminders on smart technology, with standard paper-based home exercise programmes. Setting: A community rehabilitation programme within a large metropolitan health service. Subjects: Patients with stroke with upper limb deficits, referred for outpatient rehabilitation. Interventions: Participants were randomly assigned to the control (paper-based home exercise programme) or intervention group (home exercise programme filmed on an electronic tablet, with an automated reminder). Both groups completed their prescribed home exercise programme for four weeks. Main measures: The primary outcome was adherence using a self-reported log book. Secondary outcomes were change in upper limb function and patient satisfaction. Results: A total of 62 participants were allocated to the intervention (n = 30) and control groups (n = 32). There were no differences between the groups for measures of adherence (mean difference 2%, 95% CI −12 to 17) or change in the Wolf Motor Function Test log transformed time (mean difference 0.02 seconds, 95% CI −0.1 to 0.1). There were no between-group differences in how participants found instructions (p = 0.452), whether they remembered to do their exercises (p = 0.485), or whether they enjoyed doing their exercises (p = 0.864). Conclusions: The use of smart technology was not superior to standard paper-based home exercise programmes for patients recovering from stroke. This trial design was registered prospectively with the Australian and New Zealand Clinical Trials Register, ID: ACTRN 12613000786796. http://www.anzctr.org.au/trialSearch.aspx [ABSTRACT FROM AUTHOR]

Background and objectives: Treatment of spasticity poses a major challenge given the complex clinical presentation and variable efficacy and safety profiles of available drugs. We present a systematic review of the pharmacological treatment of spasticity in multiple sclerosis (MS) patients. Methods: Controlled trials and observational studies were identified. Scientific evidence was evaluated according to pre-specified levels of certainty. Results: The evidence supports the use of baclofen, tizanidine and gabapentin as first-line options. Diazepam or dantrolene could be considered if no clinical improvement is seen with the previous drugs. Nabiximols has a positive effect when used as add-on therapy in patients with poor response and/or tolerance to first-line oral treatments. Despite limited evidence, intrathecal baclofen and intrathecal phenol show a positive effect in severe spasticity and suboptimal response to oral drugs. Conclusion: The available studies on spasticity treatment offer some insight to guide clinical practice but are of variable methodological quality. Large, well-designed trials are needed to confirm the effectiveness of antispasticity agents and to produce evidence-based treatment algorithms. [ABSTRACT FROM AUTHOR]

Background: Haematopoietic stem cell transplantation (HSCT) has been tried in the last 15 years as a therapeutic option in patients with poor-prognosis autoimmune disease who do not respond to conventional treatments. Worldwide, more than 600 patients with multiple sclerosis (MS) have been treated with HSCT, most of them having been recruited in small, single-centre, phase 1–2 uncontrolled trials. Clinical and magnetic resonance imaging outcomes from case series reports or Registry-based analyses suggest that a major response is achieved in most patients; quality and duration of response are better in patients transplanted during the relapsing–remitting phase than in those in the secondary progressive stage.Objectives: An interdisciplinary group of neurologists and haematologists has been formed, following two international meetings supported by the European and American Blood and Marrow Transplantation Societies, for the purpose of discussing a controlled clinical trial, to be designed within the new scenarios of evolving MS treatments.Conclusions: Objectives of the trial, patient selection, transplant technology and outcome assessment were extensively discussed. The outcome of this process is summarized in the present paper, with the goal of establishing the background and advancing the development of a prospective, randomized, controlled multicentre trial to assess the clinical efficacy of HSCT for the treatment of highly active MS. [ABSTRACT FROM AUTHOR]

Objectives: Osteochondral allograft transplantation for cartilage defects of the knee has demonstrated excellent long-term clinical outcomes and survival, which largely depends on successful graft osseointegration. Biologics have been suggested as a viable adjunct to enhance successful healing in several musculoskeletal applications. In the context of OCA, early results have suggested that BMAC may improve cellular repopulation and viability within the osseus portion of an implanted graft. However, few clinical studies to date have investigated the impact of BMAC on patient outcomes following OCA. The purpose of this study was to investigate the effect of bone marrow aspirate concentrate (BMAC) on osseointegration and patient-reported outcome metrics (PROMs) after osteochondral allograft transplantation in a prospective, randomized controlled single-blinded trial. Methods: Patients undergoing osteochondral allograft transplantation of the knee were consented and enrolled. Prior to surgery, patients were randomized into either the BMAC or sham incision groups. In the BMAC group, the osteochondral allograft plug was soaked in BMAC for a minimum of 2 minutes prior to implantation. All patients underwent postoperative computed tomography (CT) scanning at 6 months postoperatively and completed PROMs preoperatively, 6 months, and 1 year postoperatively. Two board-eligible orthopaedic surgeons blinded to treatment allocation independently assessed and graded each CT according to the ACTOCA system proposed by Gelber et al. Results: Thirty-six patients enrolled between April 2018 to December 2020 (17 female, 19 male) were included for analysis. There were no significant differences between the BMAC and non-BMAC groups in graft signal density (Grader 1: p=0.283, Grader 2: p=0.467), osseous integration (both graders: p=0.489), surface percentage with discernible cleft (Grader 1: 0.287, Grader 2: 0.469), or intra-articular fragments (Grader 1: p=0.617, Grader 2: p=0.810) (Table 1). A significantly greater number of patients receiving BMAC demonstrating cystic changes <3 mm (Grader 1: p=0.015, Grader 2: p=0.05) (Figure 1). At 1 year, BMAC patients reported significantly better WOMAC Pain (87.82±14.26 vs 75.80±15.56, p=0.043) and trended towards improved PROMIS Pain (54.14±8.31 vs 61.79±5.24, p=0.09). Conclusions: Patients receiving BMAC soaked OCA grafts demonstrated no difference from controls with respect to graft signal intensity, osseous integration, intra-articular fragments, or discernible graft-host clefts at 6-months postoperatively. BMAC patients had a significantly greater occurrence of small (<3 mm) cystic changes. At 1 year, BMAC patients reported significantly less pain than controls on WOMAC Pain, with similar trends on PROMIS Pain Interference. Table 1. Postoperative Imaging Characteristics (ACTOCA) by Grader. Figure 1. Distribution of cystic changes between BMAC and control groups. [ABSTRACT FROM AUTHOR]

Objectives: During the 21st century, opioid medication prescription and consumption has increased, which has led to an increase in opioid abuse, dependence, and fatal overdoses. Health care providers, particularly surgeons, have recently focused on decreasing the amount of opioids prescribed, as overprescribing is a known cause contributing to the opioid epidemic. Patients undergoing anterior cruciate ligament reconstruction (ACLR) would especially benefit for the identification of an ideal opioid prescription amount for post-op pain, as the average age of patients undergoing ACLR is 29.8 years old, which falls within the age group that experienced the largest increase in opioid related deaths between 2001 and 2016. It is unknown if prescribing patterns change patient behavior related to opioid consumption. The purpose of this randomized, prospective trial was to evaluate the effects of different quantities of prescribed opioid tablets on opioid utilization by patients, post-operative pain, and patient satisfaction following ACL reconstruction. Methods: This study was a prospective, randomized trial enrolling patients undergoing primary ACLR following ACL tear. Patients were randomly assigned to one of 3 prescription groups pre-operatively: 15 tablets, 25 tablets, or 35 tablets of oxycodone-5mg. Standard of care nerve blocks were utilized in all patients in addition to general anesthesia for the surgical procedure. Patients were instructed to take acetaminophen and NSAIDs as needed with the opioid medication to be used for "breakthrough" pain. Exclusion criteria included concomitant procedure other than meniscectomy or meniscal repair, ACL revision, history of chronic pre-operative opioid use, history of substance abuse, pregnancy, or workman's compensation claims. Patients in all 3 groups were asked to complete pain and medication logs 2 times a day for the first 14 days post-operatively, along with an opioid medication satisfaction survey at 2 weeks, and IKDC questionnaires before surgery and up to 6 months post-operatively. Demographics and complication information were gathered from the medical record. Requests for prescription refills were recorded as well. Analysis assessed for statistical differences in post-op pain and medication usage. All usage of narcotics was verified with the state database monitoring system for narcotic pain medication. Results: One hundred thirty patients were included in the analysis (41 who received 15 oxycodone tablets, 40 who received 25 oxycodone tablets, and 49 who received 35 oxycodone tablets). There were no significant differences between the two groups in mean age at surgery (33.6 vs. 31.6 vs 33.3; P=0.328), BMI (27.7 vs 26.1 vs 25.7; P=0.525), or sex ratio (24M/17F, 20M/19F, 25M/24F; P=0.735). There were also no significant preoperative differences in subjective pain and function, as measured by IKDC scores (46.8 vs 48.7 vs 46.5; P=0.794). There were no significant differences in mean total morphine milligram equivalents (MME) consumed between the three groups (72.3 in the 15 tablet group, 61.9 in the 25 tablet group, 78.1 in the 35 tablet group; P>0.05). There was a significant difference between those who received 15 tablets and those who received 25 and 35 tablets when asked if they thought they were prescribed too few/too many narcotics, with a greater percentage of the 15 tablet group reporting that they felt they received too few at 20.6%, (P=0.05) as depicted in Figure 1. Despite this difference, there was no significant difference between the three groups on subjective morning or afternoon pain for the first 14 days after surgery, total opioid pills consumed, patient satisfaction on ability of the narcotic to treat their condition, patient satisfaction on amount of pain relief they experienced since surgery, or patient satisfaction regarding the amount of narcotics initially prescribed after surgery. Finally, there was no difference between the three groups on postoperative function at 2 weeks, 6 weeks, 3 months, and 6 months, as measured by IKDC scores (Figure 2). Conclusions: Despite a significantly larger portion of the group who received 15 oxycodone tablets reporting that they felt they received too few opioid tablets, there was no difference between those who received 15, 25, or 35 oxycodone-5mg tablets in reported pain levels, opioid consumption, or any satisfaction metrics. In addition, there was no difference between the three groups in pain and function as reported in the IKDC surveys. Given these results, giving lower quantities of opioid medication appears to be as effective in appropriately controlling post-operative pain as higher quantities, and may help to limit amount of opioids prescribed and possible diversion of unused prescription opioid medication. [ABSTRACT FROM AUTHOR]

In this article the authors discuss topics related to orthodontics. It talks about a randomized controlled trial which examines the difference between banding and bonding of first permanent molars. It mentions a study which examines the level of knowledge and understanding of the British Orthodontic Society's Training Grades Group about informed consent. It notes a study conducted at South Africa's University of the Witwatersrand which explores the perceptions of facial profile attractiveness.

The article announces that the research paper titled "Banding versus bonding of first permanent molars: a multi-centre randomized controlled trial," by authors including Mariyah Nazir, Tanya Walsh and Nicky A Mandall has received the 2012 Journal of Orthodontics Scientific Paper of the Year Prize.

A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis: the HUmeral shaft fracture FIXation (HU-FIX) study protocol. Quotation errors related to the distal radius acute fracture fixation trial paper. A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis: the HUmeral shaft fracture FIXation (HU-FIX) study protocol. [Extracted from the article]

The article announces the Anaesthesia and Intensive Care Jeanette Thirlwell Best Paper Award for 2019 goes to Gregg Best, and Anaesthesia and Intensive Care Junior Investigator Award has been awarded to Lachlan Miles.

Aim: The aim of this article was to develop and apply an Internet-based headache diary (i-diary) for adolescents and compare it with a paper-diary (p-diary) regarding adherence, user acceptability and recorded headache activity.Methods: In a cross-sectional school-based study, a representative sample of 488 adolescents aged 12-18 years were randomly allocated by cluster sampling to record for three weeks in i-diaries or p-diaries their headache intensity, disability, and use of acute medication.Results: A significantly (p = 0.008) higher proportion of adolescents in the i-diary group used the diary at least once during the 21-day period (86% vs 76% for the p-diary). However, the p-diary group completed a significantly (p < 0.001) higher number of diary days (20.8 vs 15.0 days for the i-diary). The response rate for the i-diary-group was largely evenly distributed over the study period; conversely, approximately two-thirds of the adolescents using the p-diary responded on all 21 days, whereas one-fourth did not respond at all. The two diary types were rated as equal in easiness to remember (p = 0.25), but the i-diaries were more bothersome to use (p = 0.029).Conclusion: Although p-diary users completed a higher proportion of diary days, i-diaries provided more reliable and credible estimates of headache parameters because of better real-time assessment. [ABSTRACT FROM AUTHOR]

Intracerebral hemorrhage (ICH) is a devastating disease, causing high rates of death, disability, and suffering across the world. For decades, its treatment has been shrouded by the lack of reliable evidence, and consequently, the presumption that an effective treatment is unlikely to be found. Neutral results arising from several major randomized controlled trials had established a negative spirit within and outside the stroke community. Frustration among researchers and a sense of nihilism in clinicians has created the general perception that patients presenting with ICH have a poor prognosis irrespective of them receiving any form of active management. All this changed in 2023 with the positive results on the primary outcome in randomized controlled trials showing treatment benefits for a hyperacute care bundle approach (INTERACT3), early minimal invasive hematoma evacuation (ENRICH), and use of factor Xa-inhibitor anticoagulation reversal with andexanet alfa (ANNEXa-I). These advances have now been extended in 2024 by confirmation that intensive blood pressure lowering initiated within the first few hours of the onset of symptoms can substantially improve outcome in ICH (INTERACT4) and that decompressive hemicraniectomy is a viable treatment strategy in patients with large deep ICH (SWITCH). This evidence will spearhead a change in the perception of ICH, to revolutionize the care of these patients to ultimately improve their outcomes. We review these and other recent developments in the hyperacute management of ICH. We summarize the results of randomized controlled trials and discuss related original research papers published in this issue of the International Journal of Stroke. These exciting advances demonstrate how we are now at the dawn of a new, exciting, and brighter era of ICH management. [ABSTRACT FROM AUTHOR]

In 2018, the United States implemented a nationwide law requiring chain restaurants with more than 20 units to post calorie counts next to each of their menu items. Previously, individual cities, counties, and states had passed such laws, and certain chains had voluntarily posted calorie counts. Despite the widespread nature of this practice, the effect of calorie counts on restaurant outcomes is still not well understood. This paper estimates the impact of restaurant menu calorie labels on four important outcomes: 1) restaurant revenue; 2) restaurant profit; 3) the labor time of kitchen staff; and 4) patrons' support for calorie labels. We estimate these impacts by conducting a randomized controlled experiment in two full-service restaurants. The results indicate that posting calorie counts on menus has no detectable negative impact on restaurants – the impacts on revenue, profit, and labor time are indistinguishable from zero. Moreover, exposure to the labels increases patrons' support of restaurant menu calorie labels by 14.3% and reduces their opposition to them by 27.1%. Altogether, these results suggest that posting calorie counts does not harm restaurants, and are appealing to consumers. [ABSTRACT FROM AUTHOR]

Introduction: Reminiscence therapy (RT), which engages individuals to evoke positive memories, has been shown to be effective in improving psychological well-being in older adults suffering from PTSD, depression, and anxiety. However, its impact on brain function has yet to be determined. This paper presents functional magnetic resonance imaging (fMRI) data to describe changes in autobiographical memory networks (AMN) in community-dwelling older adults. Methods: This pilot study used a within-subject design to measure changes in AMN activation in 11 older adults who underwent 6 weeks of RT. In the scanner, participants retrieved autobiographical memories which were either recent or remote, rehearsed or unrehearsed. Participants also underwent a clinical interview to assess changes in memory, quality of life, mental health, and affect. Findings: Compared to pretreatment, anxiety decreased (z = −2.014, p =.040) and activated significant areas within the AMN, including bilateral medial prefrontal cortex, left precuneus, right occipital cortex, and left anterior hippocampus. Conclusion: Although RT had subtle effects on psychological function in this sample with no evidence of impairments, including depression at baseline, the fMRI data support current thinking of the effect RT has on the AMN. Increased activation of right posterior hippocampus following RT is compatible with the Multiple Trace Theory Theory (Nadel & Moscovitch, 1997). [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the efficacy of a multimodal non-opioid analgesic protocol in controlling postoperative pain compared to opioids following a primary arthroscopic rotator cuff repair. Methods: Seventy consecutive patients undergoing a primary rotator cuff repair were assessed eligibility. A prospective randomized controlled trial was designed in accordance with the Consolidated Standards of Reporting Trials 2010 (CONSORT) statement. The two arms of the study included a multimodal non-opioid pain regimen for the experimental group, and a standard of care narcotics for the control group. The primary outcome was visual analog scale (VAS) pain scores for the first ten postoperative days. Secondary outcomes included PROMIS-PI, patient satisfaction, and adverse drug events. Patients were randomized using a random number generator. Whiles patients were not blinded to their treatment group, all reported outcomes were collected by blinded observers. Results: Twenty-six patients either declined to participate or were excluded from the study. Forty-four patients were included in the final analysis. A total of 27 patients were in the traditional group and 17 patients were in the nonopioid group. Patients in the traditional pain control group reported a significantly lower VAS pain score on post-operative day 1 (opioid: 5.7 ± 2, nonopioid: 3.7 ± 2.2, p=0.011) and post-operative day 4 (opioid: 4.4 ± 2.7, nonopioid: 2.4 ± 2.2, p=0.023). No significant difference was seen on any other postoperative day. When mixed measured models were used to control for confounding factors the non-opioid group demonstrated significantly lower VAS and PROMIS-PI scores (p<0.01) at every time point. The most commonly reported side effects for patients in both groups were drowsiness (opioid: 2.7 ± 3.3 days, nonopioid: 1.9 ± 3.3 days) and constipation (opioid: 2.2 ± 2.9 days, nonopioid: 0.2 ± 0.6 days). Patients in the traditional analgesia group reported significantly greater average number of days with constipation (opioid: 2.2 ± 2.9, nonopioid: 0.2 ± 0.6, p=0.003) and days with upset stomach (opioid: 1.3 ± 2.5, nonopioid: 0.0 ± 0.0, p=0.020) than those in the nonopioid group. Conclusions: This study found that a multimodal nonopioid pain protocol provided at least equivalent pain control compared to traditional opioid analgesics in patients undergoing primary arthroscopic rotator cuff repair. Minimal side effects were noted with some improvement in the multimodal nonopioid pain cohort, and all patients reported satisfaction with their pain management. [ABSTRACT FROM AUTHOR]

Introduction: High-quality randomised controlled trials (RCTs) of interventions are essential for determining whether an intervention is effective. However, many RCTs that examine the effectiveness of occupational therapy interventions for adults with mental health conditions or dementia have methodological limitations that reduce confidence in their results. We aimed to systematically review the quality of methods and outcome measures used in RCTs of occupational therapy interventions for adults with a mental health condition or dementia. This will inform future research in this area and enable practitioners to appraise the evidence when selecting interventions. Method: We searched peer-reviewed English language publications from 2000 to 2021 in MEDLINE, PsycINFO, ASSIA, CINAHL and e-thos, and hand-searched 12 journals. We included papers that met pre-specified inclusion criteria, appraised quality using a validated tool and extracted data. We conducted a narrative synthesis. Results: Of thirty-three included papers, 26 reported full or pilot RCTs, two reported secondary analysis or secondary outcomes of included RCTs, three reported process evaluations and two reported economic evaluations. Methodological limitations were found in many studies and outcome measures varied in their psychometric quality. Conclusion: High-quality RCTs of occupational therapy interventions are needed for adults with mental health conditions and dementia. Researchers should follow international guidelines for rigorously developing and evaluating interventions and reporting studies. Practitioners should critically apply RCT evidence when selecting occupational therapy interventions. [ABSTRACT FROM AUTHOR]

Objectives: Pre-clinical and clinical studies supported the use of intra-articular micro-fragmented adipose tissue (MF-AT) injections to address knee osteoarthritis (OA), suggesting their safety and clinical benefits. Nevertheless, no high-level studies investigated the potential of MF-AT over other biological products like platelet-rich plasma (PRP). The aim of this randomized controlled trial (RCT) was to compare a single injection of MF-AT to PRP in terms of clinical outcome and disease-modifying properties in patients with symptomatic knee OA. Methods: A total of 118 patients with symptomatic knee OA were randomly assigned to: single intra-articular MF-AT vs single intra-articular PRP injection. All patients were evaluated before the injection and at 1, 3, 6, 12, and 24 months with the International Knee Documentation Committee (IKDC) subjective score, the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscales, the EuroQol-Visual Analogue Scale (EQ-VAS) and EuroQol-5D (EQ-5D), and the Visual Analogue Scale (VAS). The treated knees were evaluated at baseline and at 6, 12, and 24 months of follow-up with radiographs and high-resolution (1.5 T) magnetic resonance imaging (MRI) with the Whole-Organ Magnetic Resonance Imaging Score (WORMS). Results: Both MF-AT and PRP provided a statistically and clinically significant improvement up to the last follow-up of 24 months. No differences were found between MF-AT and PRP groups in terms of adverse events (18.9% vs 10.9%), failures (15.1% vs 25.5%), and all clinical outcomes at all follow-ups. Radiographs and MRI findings did not show significant changes after the injection, neither as improvement, nor as disease progression, with no intergroup difference. Patients with moderate/severe OA treated with MF-AT showed a significantly higher IKDC improvement at 6 months compared to PRP (15.7±19.0 vs 8.6±14.2, p=0.041). Similarly, more patients with moderate/severe OA treated with MF-AT reached the minimal clinically important difference (MCID) for the IKDC subjective score at 6 months compared to the PRP group (75.0% vs 34.6%, p=0.005). Conclusions: A single intra-articular injection of both MF-AT and PRP provided a significant clinical improvement up to 24 months in patients with symptomatic knee OA. Both treatments showed a comparable low number of failures and adverse events, without signs of disease progression. Overall, no differences could be documented in both clinical and imaging results between the two biological approaches. Compared with PRP, MF-AT provided a higher clinical improvement at 6 months in moderate-severe OA. [ABSTRACT FROM AUTHOR]

The article presents several abstracts related to acupuncture, including abstracts on the use of acupuncture for acute migraine attack, nausea and vomiting in pediatric chemotherapy and radiation-induced nausea. Brief commentaries on the abstracts are also offered.

Objectives: The purpose of this study was to assess and compare the effect of 1) arthroscopic osteochondroplasty with or without labral repair versus 2) arthroscopic lavage with or without labral repair on the time to reoperation in adults aged 18 to 50 with femoroacetabular impingement (FAI) over the 27-months post-operative using a time-to-event analysis. Methods: Using the comprehensive dataset from the multinational Femoroacetabular Impingement Randomized Controlled Trial (FIRST), all reoperations were identified until 27-months post-operative. Subjects were randomized to a treatment of arthroscopic osteochondroplasty or arthroscopic lavage with or without labral repair. The analysis was conducted using a Cox proportional-hazards model, with the percentage of patients with a reoperation analyzed in a time-to-event analysis as the outcome. The independent variable was the procedure, with age and impingement subtype explored as potential covariates. The effects from the Cox model were expressed as the hazard ratio (HR), corresponding 95% confidence interval (CI) and the associated p-value. All tests were two-sided with an alpha level of 0.05. Results: A total of 108 patients in the osteochondroplasty group and 106 in the lavage group were included. The mean age of the patients included in the study was 36.0 (SD=8.5) years. Overall, a total of 27 incident reoperations were identified within 27 months of follow-up for an incidence rate of 6.0 per 100 person years. Within the osteochondroplasty group a total of 8 incident reoperations were identified for incidence rate of 3.4 per 100 person years while within the lavage group, a total of 19 incident reoperations were identified for an incidence rate of 8.7 per 100 person years. The hazard of reoperation for patients undergoing osteochondroplasty is 40% that of patients undergoing lavage (HR=0.40,95% CI=0.17-0.91,p=0.029). Conclusions: This, time-to-event analysis with 27-months follow-up demonstrates that for adults between the ages of 18 and 50 with FAI, arthroscopic osteochondroplasty is associated with a 2.5-fold decrease in the hazard of reoperation at any point in time compared to arthroscopic lavage. [ABSTRACT FROM AUTHOR]

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Background: Understanding of sex differences, especially in terms of the influence of sex on therapeutic interventions, can lead to improved treatment and management for all. Aim: We examined temporal and regional trends in female participation and the reporting of sex differences in stroke randomized controlled trials. Methods: Randomized controlled trials from 1990 to 2018 were identified from ClinicalTrials.gov, using keywords "stroke" and "cerebrovascular accidents." Studies were selected if they enrolled ≥100 participants, included both sexes and were published trials (identified using PubMed, Google Scholar, and Scopus). Results: Of 1700 stroke randomized controlled trials identified, 277 were published and eligible for analysis. Overall, these randomized controlled trials enrolled only 40% females, and in the past 10 years, this percentage barely changed, peaking at 41% in 2008–2009 and 2012–2013. North American randomized controlled trials recruited the most women, at 43%, and Asia the lowest, at 40%. Among the 277 randomized controlled trials, 101 (36%) reported results according to sex, of which 91 (33%) were pre-specified analyses. The increasing trend in the number of studies reporting sex-differentiated results from 2008 to 2018 merely paralleled the increase in the number of papers published during the same time period. North American randomized controlled trials most often reported sex-specific results (42%), and Australia and Europe least often (31%). Conclusion: Little progress has been made in the inclusion of females and the reporting of sex in stroke randomized controlled trials. This highlights the need for key stakeholders, such as funders and journal editors, to provide clear guidance and effective implementation strategies to researchers in the scientific reporting of sex. [ABSTRACT FROM AUTHOR]

Background: Effective recruitment to randomised controlled trials is critically important for a robust, trustworthy evidence base in palliative care. Many trials fail to achieve recruitment targets, but the reasons for this are poorly understood. Understanding barriers and facilitators is a critical step in designing optimal recruitment strategies. Aim: To identify, explore and synthesise knowledge about recruitment barriers and facilitators in palliative care trials using the '6 Ps' of the 'Social Marketing Mix Framework'. Design: A systematic review with narrative synthesis. Data sources: Medline, CINAHL, PsycINFO and Embase databases (from January 1990 to early October 2016) were searched. Papers included the following: interventional and qualitative studies addressing recruitment, palliative care randomised controlled trial papers or reports containing narrative observations about the barriers, facilitators or strategies to increase recruitment. Results: A total of 48 papers met the inclusion criteria. Uninterested participants (Product), burden of illness (Price) and 'identifying eligible participants' were barriers. Careful messaging and the use of scripts/role play (Promotion) were recommended. The need for intensive resources and gatekeeping by professionals were barriers while having research staff on-site and lead clinician support (Working with Partners) was advocated. Most evidence is based on researchers' own reports of experiences of recruiting to trials rather than independent evaluation. Conclusion: The 'Social Marketing Mix Framework' can help guide researchers when planning and implementing their recruitment strategy but suggested strategies need to be tested within embedded clinical trials. The findings of this review are applicable to all palliative care research and not just randomised controlled trials. [ABSTRACT FROM AUTHOR]

School-based body mass index (BMI) screening is required in 50% of states with parent notification letters distributed among 11 of those states. Additional research is needed to effectively communicate screening results to parents. We conducted a pilot investigation of parent acceptability of an electronic, interactive BMI parental notification letter (e-BMI) along with the feasibility of implementing an e-BMI letter in the school setting. In addition, we assessed parental attitudes and practices regarding their child's weight-related behaviors. Electronic letter distribution and parent receipt were consistent with traditional paper letter mailings; however, we did not observe any significant behavioral impacts with either letter format. Parents reported interest in wellness programming offered by the school, a potential opportunity for schools to engage families in healthful practices. Additional research is needed to understand the impact of e-BMI letters and accompanying web-based resources specifically for parents of students with overweight or obesity. [ABSTRACT FROM AUTHOR]

Information and communication technologies are increasingly used for development in the Global South, and mHealth (health assisted by mobile technologies) plays key role. This paper analyzes the particular relationship to science that characterizes a global maternal mHealth program deployed in Ghana and India. Using science and technology studies (STS), this research relies on qualitative interviews conducted between 2014 and 2016 with funders, implementers, and beneficiaries of this mHealth program. This story begins with a randomized controlled trial, a biomedical experiment with a strong positioning regarding science and the production of evidence. But rapidly the scientific stance disappears to give way to the testing and marketing of a product for the digital economy. From science to market, this paper offers to revisit a classical STS topic through the lens of mHealth. It shows how the various experimental forms taken by this project fundamentally diverge from scientific methods and evidence production and at the same time how it nurtures an ongoing instrumental relationship with science. Thus, from clinical research to product marketing, this paper highlights the tenuous link between evidence-based and market-based mHealth in the Global South. [ABSTRACT FROM AUTHOR]

Historically, there has been less research carried out on earwitness than eyewitness testimony. However, in some cases, earwitness evidence might play an important role in securing a conviction. This paper focuses on accent which is a central characteristic of voices in a forensic linguistic context. The paper focuses on two experiments (Experiment 1, n = 41; Experiment 2, n = 57) carried out with participants from a wide range of various locations around the United Kingdom to rate the accuracy and confidence in recognizing accents from voices from England, Scotland, Wales, Northern Ireland, and Ireland as well as looking at specificity of answers given and how this varies for these regions. Our findings show that accuracy is variable and that participants are more likely to be accurate when using vaguer descriptions (such as "Scottish") than being more specific. Furthermore, although participants lack the meta-linguistic ability to describe the features of accents, they are able to name particular words and pronunciations which helped them make their decision. [ABSTRACT FROM AUTHOR]

Introduction: The creation of digestive stomata is associated with a change in people's lives. Causing a strong impact that influences all dimensions of life. This paper reports on the effects of socio-educational interventions on the quality of life (QOL) of people with a digestive ostomy. Objective: To describe the effect of a nursing intervention on the QOL of people with a digestive ostomy. Methods: A quasiexperimental study was conducted whose sample consisted of 12 people who were ostomized in a public hospital in Colombia. Participants were selected through convenience sampling and randomly assigned to the intervention group and the control group. For the control group, an educational process was carried out through a theoretical session with virtual mediation (educational video). The QOL was evaluated before and after the interventions through the Montreux questionnaire. Results: The average age was 57(+7) years. No statistical differences were found between the groups in the QOL index or for any of the dimensions that make up QOL. Pretest and post-test analysis for each intervention separately showed improvement in two dimensions of QOL for each group; in the intervention group body image dimension (p =.017) and the positive coping dimension (p =.027). In the control group, the physical well-being dimension (p =.037) and social concerns dimension (p =.034). Conclusions: The personalized educational intervention or carried out through virtual pedagogical mediation, generated a clinically significant increase in the dimensions of QOL, without statistical differences. The study adds knowledge about the impact that digestive stomata have on the QOL, which is why it is necessary to establish specialized interdisciplinary teams to care for the person's new condition at home during the following months. [ABSTRACT FROM AUTHOR]

Introduction: Persistent postural-perceptual dizziness (PPPD) is a chronic functional vestibular disorder where there is persistent dizziness or unsteadiness occurring on most days for more than 3 months duration. Treatment recommendations for PPPD include vestibular rehabilitation therapy (VRT) with or without medications and/or cognitive behavioral therapy. Objectives: This paper is a pilot study designed to compare the effects of Bal Ex as a home-based VRT on the quality of life (EQ-5D), dizziness handicap (DHI) and mental health (DASS-21) against hospital-based VRT. Design: This was an assessor-blinded, randomized controlled pilot study where PPPD patients were randomly selected to undergo Bal Ex, the home-based VRT (intervention group) or hospital-based (control group) VRT. The participants were reviewed at 4 weeks and 12 weeks after the start of therapy to assess the primary endpoints using the subjective improvement in symptoms as reported by patients, changes in DHI scores, DASS-21 scores and EQ5D VAS scores. Results: Thirty PPPD patients successfully completed the study with 15 in each study group. Within 4 weeks, there were significant improvements in the total DHI scores as well as anxiety levels. By the end of 12 weeks, there were significant improvements in the DHI, DASS-21 and EQ5D. The degree of improvement between Bal Ex and the control was comparable. Conclusion: VRT is an effective modality in significantly improving quality of life, dizziness handicap, depression, and anxiety levels within 3 months in PPPD. Preliminary results show Bal Ex is as effective as hospital-based VRT and should be considered as a treatment option for PPPD. [ABSTRACT FROM AUTHOR]

Background: In 2001, Good and Stafford published a study attempting to show that inpatient palliative medicine is evidence-based. Aim: To critically examine the papers cited in support of the claim that palliative medicine is evidence-based. Method: All the papers cited were re-examined by at least two reviewers. The papers were graded using a tool used in the production of 22 evidence-based national clinical guidelines over the past three years. Differences of opinion about quality were resolved by discussion or independent arbitration. Results: The 41 papers cited by Good and Stafford included 25 randomized controlled trials (RCT), six other controlled studies and 10 uncontrolled studies. Sample size. Mean sample size was 160 (range 9-1404). The median sample size was 56; 19/41(46%) had <50 subjects; 30/41 (73%) had <100. Power calculations. 16/25 (64%) of RCTs, had no power calculations, making it difficult to draw conclusions about true differences between groups. Quality rating and grade of evidence: Of the RCTs 15/25 (60%) had a high risk of bias; of the other controlled studies 5/6 (83%) had a high risk of bias. Applicability. The studies were generally applicable to a population with advanced disease: 30/41 (73%) related with populations with advanced disease. Conclusions: This study demonstrates that studies cited in support of palliative medicine as an evidence-based specialty are of variable, and at times poor quality. This study seems to show that the claim that inpatient palliative medicine is evidence-based is at best tenuous and at worst misleading. [ABSTRACT FROM AUTHOR]

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. [ABSTRACT FROM PUBLISHER]

Background: Process evaluations of randomised controlled trials (RCTs) can provide insight and inform us on the intervention implementation, the causal mechanisms and the contextual factors. This will inform about interventions' success or failure due to their implementation or the interventions themselves. We aim to consolidate the methodology from previous process evaluations of complex interventions upon their findings on facilitators and barriers to address the prevention of type 2 diabetes mellitus among women with gestational diabetes mellitus (GDM). Methods: Comprehensive search will be conducted on electronic databases and reference lists of recent reviews for RCTs of complex interventions which address process evaluations of diabetes prevention intervention (DPI) for women with GDM in healthcare settings. There is no restriction on the language of the papers and year of publication until December 2020. Data from each study will be extracted by two reviewers independently using standardised forms. Data extracted include descriptive items on the study design and the outcomes of process evaluations from the three dimensions: (1) implementation; (2) mechanism of impact and (3) context. The quality of the studies will be assessed using mixed methods appraisal tool which is designed for the appraisal of mixed studies in systematic reviews. A narrative and framework analysis of the findings will be presented to inform the contents of a new DPI for women with GDM. Discussion: The findings from this process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts in future plan. It will give deeper understanding of potential challenges and solutions to aid in the implementation of effective DPIs for GDM in Malaysia. [ABSTRACT FROM AUTHOR]

Purpose: HIV-positive people who inject drugs (PWID) in Kazakhstan face many challenges to antiretroviral therapy (ART) adherence. Interventions that leverage social support from an intimate partner, family member, or friend may be effective in improving ART adherence among this population. The purpose of this paper is to describe the implementation process of a dyad-based intervention among HIV-positive PWID and their treatment support partners. Method: Sixty-six HIV-positive PWID and 66 of their treatment support partners will be enrolled in this pilot randomized controlled trial in Almaty, Kazakhstan, and randomized as dyads to receive an adapted version of the SMART Couples intervention or standard of care. Results: Several implementation strategies were used to facilitate intervention delivery, including remote delivery, training of staff, supervision, technical assistance, quality assurance, and collection of assessments through diverse sources. Discussion: This trial responds to a need for dyad-based ART adherence interventions adapted specifically for HIV-positive PWID. [ABSTRACT FROM AUTHOR]

Randomised controlled trials (RCTs) play an important role in multiple sclerosis (MS) research, ensuring that new interventions are safe and efficacious before their introduction into clinical practice. Trials have been evolving to improve the robustness of their designs and the efficiency of their conduct. Advances in digital and mobile technologies in recent years have facilitated this process and the first RCTs with decentralised elements became possible. Decentralised clinical trials (DCTs) are conducted remotely, enabling participation of a more heterogeneous population who can participate in research activities from different locations and at their convenience. DCTs also rely on digital and mobile technologies which allows for more flexible and frequent assessments. While hospitals quickly adapted to e-health and telehealth assessments during the COVID-19 pandemic, the conduct of conventional RCTs was profoundly disrupted. In this paper, we review the existing evidence and gaps in knowledge in the design and conduct of DCTs in MS. [ABSTRACT FROM AUTHOR]

The introduction of inhibitors of poly-(ADP-ribose) polymerase (PARP) for the treatment of women with epithelial ovarian cancers (EOC) has radically changed the treatment in maintenance setting after responding to first- and second-line chemotherapy. The aim of this paper was to assess the pharmacological costs of PARP inhibitors (olaparib, niraparib, rucaparib and veliparib) in maintenance treatment after responding to first-line chemotherapy in EOC. Incremental cost-effectiveness ratio (ICER) was calculated as the ratio between the difference of the costs in the intervention and in the control groups (pharmacy costs) and the difference between the effect in the intervention and in the control groups (progression-free survival (PFS)). We have considered the pivotal phase III randomized controlled trials (RCTs). Three different populations were considered: the overall population, patients with germline BRCA mutation (gBRCA) and homologous recombination deficiency (HRD) patients non-gBRCA mutation. Three thousand four hundred and twenty patients and 1209 patients were considered in maintenance treatment after responding to first- and second-line chemotherapy in EOC, respectively. At the actual price, the treatment with PARP inhibitors is not cost-effective in maintenance treatment after responding to first-line and second-line chemotherapy in EOC. A reduction in pharmacological costs is mandatory. [ABSTRACT FROM AUTHOR]

Background: Despite the great individual and societal burden associated with multimorbidity, little is known about how to effectively manage it. Objective: The aim of this multicenter randomized controlled trial (RCT) is to investigate the 12-month effects of a personalized exercise therapy and self-management support program in addition to usual care in people with multimorbidity. Design: This is a protocol for a pragmatic, parallel-group (1:1 ratio), superiority RCT conducted at five intervention sites (two hospitals, a private practice physiotherapy clinic and two municipal rehabilitation centers) in Region Zealand, Denmark. A total of 228 persons with multimorbidity aged 18 years or older, will be randomly allocated to one of two groups. Both groups will receive usual care, defined as routine care for multimorbidity at the discretion of the treating doctor, while the intervention group will also participate in a 12-week exercise therapy and self-management support program tailored to people with multimorbidity at one of the intervention sites. The primary outcome will be the between-group difference in change in EQ-5D-5L from baseline to the follow-up at 12 months. Secondary outcomes include objectively-measured physical function and physical activity, inflammatory markers, disease and treatment burden, anxiety, depression, stress, sleep, pain and other self-reported parameters. In parallel with the RCT, an observational cohort will follow persons aged ≥18 years with multimorbidity not adhering to all eligibility criteria, as well as people fulfilling all eligibility criteria, but unwilling to participate in the RCT. This study was approved by the Regional Committee on Health Research Ethics for Region Zealand (SJ-857) and results will be communicated in scientific papers, at relevant conferences and to a broader audience. Discussion: Exercise therapy and self-management support is safe and effective in people with single conditions. However, it is still unclear whether this holds true for individuals with multimorbidity. This pragmatic, multicenter RCT will provide high-quality evidence on the benefits and harms of exercise therapy and self-management support and, if the results support it, lead to the development of a plan for implementation in clinical practice. [ABSTRACT FROM AUTHOR]

The hospitalization and the unfamiliar experiences of patients in interventional radiology procedures cause a moderate to high levels of anxiety. This study was aimed to evaluate the anxiolytic effect of Cananga odorata essential oil (COE) aromatherapy in unexperienced patients hospitalized for interventional neuroradiology (INR) procedures. Forty-four patients admitted for their first INR procedure were randomly divided into COE and placebo control groups. COE or distilled water was dropped onto 2 pieces of mulberry paper and attached to the participant's gown at the shoulder level overnight. The main outcomes were observed from the morning salivary cortisol levels and salivary alpha-amylase activity after intervention. The Thai version of Spielberger State-Trait Anxiety Inventory (STAI) and the vital signs (blood pressure and heart rate) were also assessed before and after COE intervention as the secondary outcome. The demographic and baseline data of both groups did not show any significant difference. After intervention, COE group had a significantly lower salivary alpha-amylase activity than placebo control group. The post-intervention scores of Trait (STAI-T) and State (STAI-S) anxiety were significantly less than those of baseline in both groups. Interestingly, the COE group had a greater percentage reduction on STAI-T after intervention than placebo control group. No significant difference was observed in other outcomes. In addition, the salivary alpha-amylase activity was weak but showed significant correlation with STAI anxiety scores. This study indicates that COE aromatherapy reduces the saliva alpha amylase activity and STAI-T anxiety in unexperienced patients hospitalized for INR procedures. [ABSTRACT FROM AUTHOR]

The hospitalization and the unfamiliar experiences of patients in interventional radiology procedures cause a moderate to high levels of anxiety. This study was aimed to evaluate the anxiolytic effect of Cananga odorata essential oil (COE) aromatherapy in unexperienced patients hospitalized for interventional neuroradiology (INR) procedures. Forty-four patients admitted for their first INR procedure were randomly divided into COE and placebo control groups. COE or distilled water was dropped onto 2 pieces of mulberry paper and attached to the participant's gown at the shoulder level overnight. The main outcomes were observed from the morning salivary cortisol levels and salivary alpha-amylase activity after intervention. The Thai version of Spielberger State-Trait Anxiety Inventory (STAI) and the vital signs (blood pressure and heart rate) were also assessed before and after COE intervention as the secondary outcome. The demographic and baseline data of both groups did not show any significant difference. After intervention, COE group had a significantly lower salivary alpha-amylase activity than placebo control group. The post-intervention scores of Trait (STAI-T) and State (STAI-S) anxiety were significantly less than those of baseline in both groups. Interestingly, the COE group had a greater percentage reduction on STAI-T after intervention than placebo control group. No significant difference was observed in other outcomes. In addition, the salivary alpha-amylase activity was weak but showed significant correlation with STAI anxiety scores. This study indicates that COE aromatherapy reduces the saliva alpha amylase activity and STAI-T anxiety in unexperienced patients hospitalized for INR procedures. [ABSTRACT FROM AUTHOR]

The placebo serves as an indispensable control in many randomized trials. When analyzing the benefit of a new treatment, researchers are often confronted with large placebo effects that diminish the treatment effect. Various alternative methods have been proposed for analyzing placebo and treatment effects in studies where large placebo effects are expected or have already occurred. This paper presents an overview of methodological work that has been proposed for assessing and/or controlling for placebo effects in randomized trials. Throughout this paper, two main approaches are discussed. The first approach considers designs that represent alternatives to the classical placebo-controlled randomized trial design. Separately, the second approach considers adopting new methods for the statistical analysis of placebo and treatment effects to be implemented after the data have been collected using a classical randomized trial design. [ABSTRACT FROM AUTHOR]

Biomarkers may serve as objective measures in complicated grief (CG) potentially capturing responses to stress reduction treatment. This paper reports challenges in obtaining and assessing salivary cortisol and α-amylase (sAA) for a recent randomized clinical trial. Within-session changes in salivary cortisol and sAA for 54 older adults with CG who received Accelerated Resolution Therapy were compared with perceived stress measured by Subjective Units of Distress Scale. Bivariate correlations and multiple regressions examined changes in biomarkers. Protocols, study logs, and audit reports identified challenges. Challenges included obtaining unstimulated passive drool salivary samples and their analyses. Our sample of older females on multiple medications may have resulted in a perfect storm of moderating and intervening variables which affected the stress response. This paper contributes to the discussion on designing clinical trials for older adults which must account for physiologic changes, multimorbidity, and polypharmacy common in this population and makes recommendations moving forward. [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]

We conducted a systematic review of the literature on telemedicine use in long-term care facilities (LTCFs) and assessed the quality of the published evidence. A database search identified 22 papers which met the inclusion criteria. The quality of the studies was assessed and if they contained economic data, they were rated according to standard criteria. The clinical services provided by telemedicine included allied health (n = 5), dermatology (3), general practice (4), neurology (2), geriatrics (1), psychiatry (4) and multiple specialities (3). Most studies (17) employed real-time telemedicine using videoconferencing. The remaining five used store and forward telemedicine. The papers focused on economics (3), feasibility (9), stakeholder satisfaction (12), reliability (5) and service implementation (2). Overall, the quality of evidence for telemedicine in LTCFs was low. There was only one small randomised controlled trial (RCT). Most studies were observational and qualitative, and focused on utilisation. They were mainly based on surveys and interviews of stakeholders. A few studies evaluated the cost associated with implementing telemedicine services in LTCFs. The present review shows that there is evidence for feasibility and stakeholder satisfaction in using telemedicine in LTCFs in a number of clinical specialities. [ABSTRACT FROM AUTHOR]

Dried blood spots (DBS) are widely used to test for HIV in a variety of research and service delivery settings; however, uniform guidelines regarding collection, storage and DNA extraction processes have neither been developed nor evaluated. Previously published reports suggested DBS may be stored at room temperature for up to 60 days, and intensive stability tests have shown that DBS can withstand high temperatures, humidity and freeze-thawing. During the implementation of a large randomized controlled trial (RCT) in southern Africa, with HIV acquisition as the primary endpoint, we observed 65 instances when DBS samples collected from the same day as a positive HIV antibody test yielded negative DNA polymerase chain reaction (PCR) results. The source of this discrepancy may have been due to inadequate specimen volume, filter paper or DNA extraction procedures, but were most likely due to storage conditions that have been reported as acceptable in other settings [ABSTRACT FROM AUTHOR]

The prevalence of randomized controlled trials (RCTs) performed without fully informed prospective consent from subjects is unknown. We performed this study to estimate the prevalence of high-impact RCTs performed without informed consent from all subjects and examine whether such trials are becoming more prevalent. We performed a systematic review of English-language RCTs published from 2014 through 2018 identified in Scopus and sorted to identify the top 100 most highly cited RCTs each year. Text search of title and abstract included terms randomized controlled or clinical trial and spelling variants thereof, and excluded metaanalyses and systematic reviews. We independently identified the most highly cited RCTs based on predefined criteria and negotiated to agreement, then independently performed keyword searches, read, abstracted and coded information regarding informed consent from each paper and again negotiated to agreement. No quality indicators were assessed. We planned descriptive qualitative analysis and appropriate quantitative analysis to examine the prevalence and characteristics of trials enrolling subjects with other than fully informed prospective consent. We find that 44 (8.8%, binomial exact 95% CI 6.5% to 11.6%) of 500 high-impact RCTs did not secure informed consent from at least some subjects. The prevalence of such trials did not change over the 5 years (OR=1.09, z=0.78, p=0.44). A majority (66%) of the trials involved emergency situations, and 40 of 44 (90.9%) of the trials involved emergency interventions, pragmatic designs, were cluster randomized, or a combination of these factors. A qualitative analysis explores the methods of and justifications for waiving informed consent in our sample of RCTs. [ABSTRACT FROM AUTHOR]

Introduction Assessment of the effectiveness of individual placement and support in forensic mental health settings is a relatively new field of research despite evidence demonstrating its effectiveness in generic mental health settings. Method IPS was implemented into a community forensic mental health setting within a large National Health Service trust in the United Kingdom over 6 months. Using the Consolidated Framework for Implementation Research this paper describes the lessons learned from implementing individual placement and support into such settings. Results Our findings suggest that implementation of individual placement and support in forensic mental health settings is complex and requires robust planning and collaboration with internal and external agencies. Barriers to implementation included staff attitudes, difficulty engaging employers and lack of employment related performance indicators, and facilitators included the support of service managers and outside groups. Adaptations to the IPS model were made to address challenges encountered, including difficulty starting rapid job searches, concerns about stigma, lack of confidence, uncertainty around employment opportunities, offence restrictions and lack of interest from potential employers. Conclusion This paper adds to the limited literature in the field. Findings are relevant to practitioners and service providers who wish to implement individual placement and support services for people with mental disorder and offending histories. [ABSTRACT FROM AUTHOR]

Meta-analysis of randomized controlled trials is generally considered the most reliable source of estimates of relative treatment effects. However, in the last few years, there has been interest in using non-randomized studies to complement evidence from randomized controlled trials. Several meta-analytical models have been proposed to this end. Such models mainly focussed on estimating the average relative effects of interventions. In real-life clinical practice, when deciding on how to treat a patient, it might be of great interest to have personalized predictions of absolute outcomes under several available treatment options. This paper describes a general framework for developing models that combine individual patient data from randomized controlled trials and non-randomized study when aiming to predict outcomes for a set of competing medical interventions applied in real-world clinical settings. We also discuss methods for measuring the models' performance to identify the optimal model to use in each setting. We focus on the case of continuous outcomes and illustrate our methods using a data set from rheumatoid arthritis, comprising patient-level data from three randomized controlled trials and two registries from Switzerland and Britain. [ABSTRACT FROM AUTHOR]

A need for improved empirical evidence for the effectiveness of interventions used in the management of child wasting (moderate and/or severe acute malnutrition) has recently been highlighted. There is no lack of published studies in this field, but when examined through the lens of systematic review protocols, few of these studies stand up to rigorous methodological critique. This paper summarizes the current state of knowledge, as supported by high-quality research included in multiple systematic reviews. It also elaborates on the criteria and standards used in such reviews. The paper highlights the weaknesses of many studies that could, with more care during study design and reporting, result in a larger body of evidence being available to policy makers and program implementers dealing with child wasting. [ABSTRACT FROM AUTHOR]

Experts laud the potential of educational technology (edtech) to promote reading among students with disabilities, but supporting evidence is lacking. This study evaluated the effectiveness of the Lexia® Core5® Reading edtech program (Core5) on the Measures of Academic Progress® (MAP) Growth Reading™ and easyCBM oral reading fluency performance of students with reading or language-based disabilities in Grades K to 5. Core5 systematically addresses multiple reading domains and previously was effective in general education. We hypothesized treatment students using Core5 would outperform controls on the reading assessments. This was a cluster randomized effectiveness evaluation, with condition assignment by school (three treatment and two business-as-usual control schools). Participating students in Grades K to 5 (N = 115; nTreatment = 65) were flagged by their Chicago-area district as needing reading intervention and had Individualized Education Program (IEP) designations of specific learning disability, speech or language impairment, or developmental delay. Treatment students used Core5 to supplement Tier 1 instruction for an average of 58.76 minutes weekly for 24.58 weeks. Regressions revealed treatment students outperformed controls on MAP (B = 3.85, CI = 0.57–7.13, p =.022, d =.24), but there were no differences for oral reading fluency. MAP findings confirm edtech can effectively supplement reading instruction for this population. [ABSTRACT FROM AUTHOR]

This paper presents new estimates of the effects of the City University of New York's (CUNY 's) Accelerated Study in Associate Programs (ASAP) model, evaluated using a randomized controlled trial first in New York and later through a replication in Ohio. It presents longer-term effects of CUNY ASAP in New York, showing that the program's effect on associate's degree receipt persisted through 8 years and likely represents a permanent increase in degree receipt. It also presents an analysis from the pooled study samples in New York and Ohio. The findings indicate that the program had consistent effects on degree receipt across the two states but also for somewhat different levels of service contrast, such as the number of additional advising visits. [ABSTRACT FROM AUTHOR]

Objectives: Quality of life, mental wellbeing, and physical function deteriorate among women with breast cancer. Tai Chi is a moderate form of exercise that may be effective in improving the mental and physical wellbeing, therefore, the quality of life of women with breast cancer. This protocol paper outlines a trial to determine the therapeutic effects of a Tai Chi programme on breast cancer management. Methods: The study will be an interventional, single-blind, double-armed, randomized, and controlled trial involving a 12-week Tai Chi programme for women with breast cancer. Forty participants aged 18 years and above who are diagnosed with breast cancer from the general community will be recruited. All participants will be randomized to either a Tai Chi programme or a waiting list control group. The Tai Chi programme will involve 12 weeks of group Tai Chi sessions, with 45 min per session, twice a week. The primary outcome will be potential improvements to the quality of life, and secondary outcomes will be potential improvements in mental wellbeing (anxiety and depression), and physical function (pain, flexibility, obesity, and vital signs). These outcomes will be assessed via self-administered online assessments and physical examinations pre-and post-intervention. Linear mixed modelling will be used to assess changes in outcomes. Discussion and dissemination: Tai Chi is a safe, easy to learn, inexpensive, and low-intensity exercise with increasing popularity worldwide. If the intervention improves the quality of life in women with breast cancer, this study will build research capacity and increase awareness of the potential for Tai Chi to empower patients and engage them in self-management of breast cancer symptoms. Research findings will be disseminated to the public, health professionals, researchers, and healthcare providers through conference presentations, lay summaries, and peer-reviewed publications. [ABSTRACT FROM AUTHOR]

Reviews of therapeutic drugs usually focus on the highly selected and closely monitored patient populations from randomized controlled trials. The objective of this study was to review systematically the tolerability and adherence of multiple sclerosis disease-modifying therapies, using data from both randomized controlled trials and observational settings. Relevant literature was identified using predefined search terms, and adverse event and study discontinuation data were extracted and categorized according to study type (randomized controlled trial or observational) and study duration. A total of 151 papers were selected for analysis; 33% were classified as randomized controlled trials and 62% as observational studies. Most of the papers concerned interferon preparations and glatiramer acetate; the limited available information on mitoxantrone and natalizumab precluded extensive examination of these. The most common adverse events were flu-like symptoms (interferon therapies only) and injection-site reactions. Mean discontinuation rates ranged from 16% to 27%. There were no marked differences in tolerability or adherence data from randomized controlled trials and observational studies, but the incidence of adverse events remained high in lengthy studies and discontinuations accumulated with time. The present systematic review of randomized clinical trial and observational data highlights the tolerability and adherence issues associated with commonly used first-line multiple sclerosis treatments. [ABSTRACT FROM PUBLISHER]