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In people with bone and soft tissue injuries of the wrist, hand and/or fingers, do feedback-guided exercises performed on a tablet touchscreen hasten return to work, reduce healthcare usage and improve clinical recovery more than a home exercise program prescribed on paper? Randomised, parallel-group trial with concealed allocation, assessor blinding and intention-to-treat analysis. Seventy-four workers with limited functional ability due to bone and soft tissue injuries of the wrist, hand and/or fingers. Participants in the experimental and control groups received the same in-patient physiotherapy and occupational therapy. Participants in the experimental group received a home exercise program using the ReHand tablet application, which guides exercises performed on a tablet touchscreen with feedback, monitoring and progression. Participants in the control group were prescribed an evidence-based home exercise program on paper. The primary outcome was the time taken to return to work. Secondary outcomes included: healthcare usage (number of clinical appointments); and functional ability, pain intensity, and grip and pinch strength 2 and 4 weeks after randomisation. Compared with the control group, the experimental group: returned to work sooner (MD –18 days, 95% CI –33 to –3); required fewer physiotherapy sessions (MD –7.4, 95% CI –13.1 to –1.6), rehabilitation consultations (MD –1.9, 95% CI –3.6 to 0.3) and plastic surgery consultations (MD –3.6, 95% CI –6.3 to –0.9); and had better short-term recovery of functional ability and pinch strength. In people with bone and soft-tissue injuries of the wrist, hand and/or fingers, prescribing a feedback-guided home exercise program using a tablet-based application instead of a conventional program on paper hastened return to work and improved the short-term recovery of functional ability and pinch strength, while reducing the number of required healthcare appointments. ACTRN12619000344190 [ABSTRACT FROM AUTHOR]

Treatment adherence is one of the milestones in the care of hypertensive patients, with new information and communication technologies as potential educational tools. This study aimed to evaluate the add-on effect of a digital cartoon educative video on the therapeutic observance of patients followed up in the General Hospital Yaoundé compared to standard of care. We conducted a randomized simple blind clinical trial at the cardiology unit of the Yaoundé General Hospital over a 6-month period from 1st March to 30th August 2022. We enrolled 110 patients and randomized them in blocs of 4 creating two groups of 57 and 53, respectively, without (group 1) and with (group 2) intervention. Preintervention treatment adherence was assessed using the Morisky Medication Adherence Scale (MMAS). In the standard group (G1), we provided standard paper-based clinical counselling, including oral advice, and in the intervention group (G2), we did the same and added a digital cartoon video containing exactly the same message as images and audio. The primary outcome was medication adherence after three months. The mean age was 56.65 ± 10.98 years in group 1 (paper) and 56.42 ± 10.46 years in group 2 (paper + video), without any significant difference. The two groups were similar regarding the proportion of females (36.8% in G1 and 49.3% in G2) and educational levels. According to the Morisky medication adherence scale, before the intervention, the proportions of patients with good, medium and low treatment adherence in groups 1 and 2 were 7%, 25.6%, 67.4%, and 5.1%, 43.6%, 51.3%, respectively, without any significant difference. After interventions, the proportion of patients presenting a good observance moved from 7 to 11% in group 1 (paper) and 5.1 to 20% in group 2 (paper + video). The intragroup variation in treatment adherence in the intervention group (before-after) tended to be significant, with a p-value = 0.0572, while this p-value was 0.712 in the standard group. Our results provide insight into how digital cartoon videos can help to have an add-on effect on the treatment adherence of hypertensive patients, with clinical significance. [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: The internet can provide evidence-based patient education to overcome time constraints of busy ambulatory practices. Health informationprescriptions (HIPs) can be effectivelyintegrated into clinic workflow, but compliance to visit health information sites such as Medline Plus is limited.Objective: Compare the efficacy of paper (pHIP)and email (eHIP) links to deliver HIPs; evaluate patient satisfaction with the HIP process and MedlinePlus information; assess reasons for noncompliance to HIPs.Method: Of 948 patients approached at two internal medicine clinics affiliated with an academic medical centre, 592 gave informed consent after meeting the inclusion criteria. In this randomised controlled trial, subjects were randomised to receive pHIP or eHIP for accessing an intermediate website that provided up to five MedlinePlus links for physician-selected HIP conditions. Patients accessing the intermediate website were surveyed by email to assess satisfaction with the health information.Survey non-responders were contacted by telephone to determine the reasons for no response.Results: One hundred and eighty-one patients accessed the website, with significantly more 'filling' eHIP than pHIP (38% vs 23%; P < 0.001). Most(82%) survey respondents found the website information useful, with 77% favouring email for future HIPs delivery. Lack of time, forgot, lost instructions or changed mind were reasons given for not accessing the websites.Conclusions: Delivery of MedlinePlus-based HIPs in clinic is more effective using email prescriptions than paper. Satisfaction with the HIP information was high, but overall response was low and deserves further investigation to improve compliance and related outcomes. [ABSTRACT FROM AUTHOR]

The article discusses the approaches for gluteal tendinopathy which includes education plus exercise and corticosteroid injection.

Purpose: To evaluate the therapeutic effects of TNF-α blockers on ulcerative colitis (UC) and their safety. Methods: Randomized controlled trials (RCTs) of TNF-α blockers for treatment of UC were retrieved from databases. Heterogeneity test was performed on all data to select effects models. Finally, sensitivity analysis was carried out, and a funnel plot was drawn to evaluate publication bias. Results: A total of nine RCTs conformed to the inclusion criteria. Of 1,226 patients with UC, 806 were given a TNF-α blocker, and 420 were given placebo or other drugs as control. Infliximab was used in eight papers and adalimumab in one paper. Placebo was used in seven papers and hormones in two papers. Short-term response, short-term relief, long-term response, and long-term relief were better in the TNF-α blocker group than in the control group ( P < 0.05). TNF-α blockers decreased the colectomy rate ( P < 0.05). There were no significant differences in mucosal healing and quality of life between the two groups ( P > 0.05). The rates of adverse reactions were similar in the two groups ( P > 0.05), but the rate of severe adverse reactions was significantly lower in the TNF-α blocker group than in the control group ( P < 0.05). The funnel plot of each parameter was symmetrical with the lower part broader than the upper. Conclusions: TNF-α blockers have better therapeutic effects on moderate or severe UC, which shows little response to conventional therapy. TNF-α blockers can induce short-term response, maintain long-term clinical response and clinical relief, and decrease the colectomy rate and the severe adverse reaction rate, but they fail to improve quality of life and mucosal healing. [ABSTRACT FROM AUTHOR]

Objectives:(1) To evaluate the effects of a platelet-rich fibrin (PRF) membrane in the repair of traumatic tympanic membrane (TM) perforations; and (2) to compare the use of a PRF membrane with the paper patch technique with regard to recovery rates, healing time, and correction of the mean air–bone gap. Methods:A randomized, prospective analysis was performed for 60 patients who were treated for traumatic TM perforations using one of the two methods. Closure rate, speed of healing, and hearing gain were compared between the PRF (Group 1) and paper patch (Group 2) groups. Results:Closure was obtained in 28 (93%) perforations in Group 1 and 25 (83%) perforations in Group 2 (p > 0.05). On day 10, full closure of the TM was observed in 24 (80%) patients in Group 1 and 16 (53%) patients in Group 2 (p < 0.05). The improvement in the mean air–bone gap was 14.1 dB in Group 1 and 12.4 dB in Group 2 on post-operative day 45 (p < 0.05). Conclusions:In comparison with the paper patch method, PRF, a new method, provided more rapid healing with more successful audiological results, and with no requirement for a second procedure. [ABSTRACT FROM PUBLISHER]

Aim: This study aimed to compare the effects of breastfeeding, breast milk odour and mother's heartbeat sounds on perceived pain during heel lance procedures in term newborns. Design: This was a randomized three‐group experimental study. Methods: The sample of the study consisted of 90 newborns. The data were collected using pulse oximeter, fetal hand doppler, voice recorder, loudspeaker, a data collection form and the ALPS‐Neo Pain and Stress Assessment Scale for Newborn Infants. Results: During the procedure, newborns in the breast milk odour group had high levels of pain and stress, those in the mother's heartbeat sounds group had mild pain and stress, and those in the breastfeeding group had no pain and stress. Additionally, a statistically significant difference was found between their crying times. This difference was the highest for newborns in the breast milk odour group, followed by the mother's heartbeat sounds and breastfeeding groups, respectively. Conclusion: Breastfeeding and mother's heartbeat sounds, which are non‐pharmacological pain relief methods, are effective in neonatal pain management. However, breast milk odour is not effective for pain control in newborns. Further studies should examine the efficacy combinations of these methods. Summary statement: What is already known about this topic? The presence of pain is a major stress factor for newborns.The American Academy of Pediatrics (AAP) recommends the use of non‐pharmacological pain control methods to relieve the pain caused by routine medical procedures in newborns. What this paper adds? This randomized controlled experimental study showed breastfeeding is a very effective method for pain control in newborns during heel lance procedures.The sound of the mother's heartbeat was found to be moderately effective.Breast milk odour was not effective for pain control in newborns. The implications of this paper: The use of non‐pharmacological pain management methods such as maternal heart sounds in combination with methods with high evidence level (breast milk, breastfeeding, etc.) may increase the effectiveness of pain management in newborns.In order to determine the effect of sense of smell on pain management in newborns, new studies should be planned comparing newborns of different postnatal ages. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effects of computerized cognitive training on the cognitive functions of stroke patients. Background: With increased publications on computerized cognitive training, a meta‐analysis is essential to determine the effects of computerized cognitive training among stroke patients. Design A systematic review and meta‐analysis of randomized controlled studies. Data Sources: Cochrane Library, Pubmed, EBSCO, Scopus, China National Knowledge Infrastructure, China Biology Medicine disc and Wanfang Database were explored to search for research studies from inception to January 2020. Review Methods: Six outcomes indicators were considered to determine the effects of computerized cognitive training. Two reviewers were selected to search and independently appraise the available articles from various databases. Meta‐analysis was performed using the RevMan 5.3 software. Results: A total of 622 patients with 17 studies were included. Computerized cognitive training significantly improves global cognition, working memory, attention and executive function of stroke patients. However, there was inadequate evidence to demonstrate any effects of computerized cognitive training on activities of daily living and depression. Conclusion: Computerized cognitive training improves the cognitive functions of stroke patients. However, further research studies are needed to confirm its efficacy in activities of daily living as well as on alleviating depression. Summary statement: What is already known about this topic? Stroke commonly results in health impairments, particularly on cognitive functions, activities of daily living and depression, which may have a negative impact on a patient's quality of life.Previous studies indicated that computerized cognitive training is a safe and efficacious intervention for improving the cognition of older patients with dementia.Little is known about the efficacy of computerized cognitive training on improving cognitive functions, activities of daily living and depression among stroke patients. What this paper adds? Computerized cognitive training significantly improves global cognition, working memory, attention and executive function among stroke patients compared with control groups.No statistically significant effects were found on activities of daily living and depression.Subgroup analysis indicated that 4 and 12 weeks of medium‐high intensity computerized cognitive training showed significant improvement on global cognition for stroke patients. The implications of this paper: Healthcare providers should recognize the efficacy of computerized cognitive training on the cognitive rehabilitation of stroke patients.Cognitive outcome measurements vary between studies and further appraisal of reliability and validity is essential to avoid reporting bias and to validate research trials with uniform neuropsychological measurements.Further clinical trials are required with large samples and long‐term follow‐up of interventions and reporting adverse events. [ABSTRACT FROM AUTHOR]

Objective: To examine sex differences in the effectiveness of a Stories intervention for teaching affect recognition in people with a traumatic brain injury (TBI). Setting: Post-acute rehabilitation facilities. Participants: 203 participants (53 women and 150 men) with moderate to severe TBI were screened. 71 were eligible and randomized to one of three treatment conditions: two affect recognition conditions and an active control (cognition). This paper examines sex differences between the Stories intervention (n = 23, 5 women and 18 men) and the cognitive treatment control (n = 24, 8 women and 16 men). Design: Randomized controlled trial with immediate, 3- and 6-month follow-up post-tests. Interventions were 9 hours of computer-based training with a therapist. Measures: Facial Affect Recognition (DANVA2-AF); Emotional Inference from Stories Test (EIST). Results: A significant treatment effect was observed for the Stories intervention for women, who demonstrated and maintained improved facial affect recognition. In contrast, males in our sample did not benefit from the Stories intervention. Conclusion: This positive finding for the Stories intervention for females contrasts with our conclusions in a previous paper, where an analysis collapsed across sex did not reveal an overall effectiveness of the Stories intervention. This intervention warrants further research and development. [ABSTRACT FROM AUTHOR]

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Background: SARS-CoV-2 infection is associated with a significant risk of hospitalisation, death, and prolonged impact on quality of life. Evaluation of new treatment options and optimising therapeutic management of people hospitalised with SARS-CoV-2 infection remains essential, but rapid changes in pandemic conditions and potential therapies have limited the utility of traditional approaches to randomised controlled trials. Methods: ASCOT ADAPT is an international, investigator-initiated, adaptive platform, randomised controlled trial of therapeutics for non-critically ill patients hospitalised with COVID-19. The study design is open label and pragmatic. Potential participants are hospitalised adults with PCR confirmed, symptomatic, SARS-CoV-2 infection, within 14 days of symptom onset. Domains include antiviral, antibody and anticoagulant interventions, with a composite primary outcome of 28-day mortality or progression to intensive-care level respiratory or haemodynamic support. Initial interventions include intravenous nafamostat and variable dose anticoagulation. A range of secondary endpoints, and substudies for specific domains and interventions are outlined. Discussion: This paper presents the trial protocol and management structure, including international governance, remote site monitoring and biobanking activities and provides commentary on ethical and pragmatic considerations in establishing the ASCOT ADAPT trial under pandemic conditions. Trial registration: Australian and New Zealand Clinical Trials Registry (ACTRN12620000445976) and ClinicalTrials.gov (NCT04483960). [ABSTRACT FROM AUTHOR]

Martial arts routines originated in China and are a traditional sport of the Chinese nation. They are one of the outstanding sports culture representatives in China since ancient times. Excessively difficult movements in some martial arts routines during competitions or training can cause athlete injuries. The purpose of this article is to study the effect of proprioceptive training of ankle joints on preventing ankle injuries in martial arts athletes. Can ankle strength training and ankle proprioceptive training combined with strength training improve the dynamic and static balance of football players? This article analyzes the mechanism and causes of martial arts athletes' injuries and proposes treatment methods for ankle injuries. In the experimental part of this article, 16 martial arts athletes (8 males and 8 females) were selected as research objects, and they were randomly divided into 4 male and female experimental groups and 4 control groups. The experimental group received ankle muscle strength training for 6 weeks, and the control group received ankle muscle strength training and ankle proprioception training. The experimental results prove that ankle proprioceptive training can improve the dynamic and static balance of martial arts athletes and can effectively prevent the occurrence of ankle injury. In this paper, the dynamic balance ability in the biped standing state with eyes closed was tested, and the reductions of the stability index in the front and back directions of the control group and the experimental group were 0.03 and 0.2, respectively. It can be seen that the stability training effect of the experimental group was obvious. [ABSTRACT FROM AUTHOR]

Introduction: The South African National Department of Health sought to improve syndromic management of sexually transmitted infections (STIs). Continuing medical education on STIs was delivered at primary healthcare (PHC) clinics using one of three training methods: (1) lecture, (2) computer and (3) paper-based. Clinics with training were compared with control clinics.Methods: Ten PHC clinics were randomly assigned to control and 10 to each training method arm. Clinicians participated in on-site training on six modules; two per week for three weeks. Each clinic was visited by three or four unannounced standardised patient (SP) actors pre-training and post-training. Male SPs reported symptoms of male urethritis syndrome and female SPs reported symptoms of vaginal discharge syndrome. Quality of healthcare was measured by whether or not clinicians completed five tasks: HIV test, genital exam, correct medications, condoms and partner notification.Results: An average of 31% of clinicians from each PHC attended each module. Quality of STI care was low. Pre-training (n=128) clinicians completed an average of 1.63 tasks. Post-training (n=114) they completed 1.73. There was no change in the number of STI tasks completed in the control arm and an 11% increase overall in the training arms relative to the control (ratio of relative risk (RRR)=1.11, 95% CI 0.67 to 1.84). Across training arms, there was a 26% increase (RRR=1.26, 95% CI 0.77 to 2.06) associated with lecture, 17% increase (RRR=1.17, 95% CI 0.59 to 2.28) with paper-based and 13% decrease (RRR=0.87, 95% CI 0.40 to 1.90) with computer arm relative to the control.Conclusions: Future interventions should address increasing training attendance and computer-based training effectiveness.Trial Registration Number: AEARCTR-0000668. [ABSTRACT FROM AUTHOR]

Exercise training represents a health behavior for the treatment and management of the multi-faceted manifestations of multiple sclerosis (MS). This paper provides a comprehensive overview of evidence from randomized controlled trials (RCTs) regarding benefits, safety, participation, and guidelines for exercise training in MS, based on systematic reviews and meta-analyses. The paper then provides our opinions based on extensive experience regarding challenges for improving and expanding future RCTs that will advance our understanding of exercise training in MS. The comprehensive review of evidence from RCTs indicates that exercise training yields substantial improvements in aerobic and muscle fitness, mobility, fatigue and depression, quality of life, and participation outcomes. There is a non-significant increase in the risk of adverse events or serious adverse events with exercise training compared with control conditions or healthy populations. Rates of adherence and compliance with exercise training (i.e., participation) approximate 80% and 70%, respectively. The current prescriptive guidelines suggest 2–3 days per week of aerobic and resistance exercise training as the minimal dose for safely benefiting from exercise training in MS. We propose 10 important topics as avenues for expanding the body of research and improving its scope for evidence-based practice in MS. Overall, the research on exercise training in MS is strong, but it can get stronger. The expansion and advancement of evidence are critical for moving exercise training into the clinical armamentarium of MS disease treatment and management. [ABSTRACT FROM AUTHOR]

Background: The duration of anti-tuberculous therapy in tuberculous meningitis is controversial. There is variation in recommendations by different societies and expert groups on this issue. Objective: To determine the strength of evidence for short-term therapy in tuberculous meningitis through review of literature and critical appraisal. Materials and Methods: Cochrane CENTRAL (Issue 4, 2010), TRIP database, and PubMed (from 1966 to present) were searched for relevant papers with keywords 'meningeal tuberculosis' and tuberculous meningitis' combined with 'chemotherapy'. A critical appraisal of a systematic review was done using standard criteria. Results: A total of 10 relevant papers were identified. All papers were included in a systematic review. The systematic review did not specify study design of studies to be included, had only case series but no randomised controlled trial, and unclear definition of endpoints. Conclusions: The evidence base for short-term therapy for tuberculous meningitis is weak. There is a need to conduct a randomised controlled trial with non-inferiority hypothesis of adequate sample size with well-defined end points and adequate follow-up. This is a challenge as well as opportunity for Indian neurologists. [ABSTRACT FROM AUTHOR]

Background: This paper examines the methodological quality of aphasia therapy research using the Psychological database for Brain Impairment Treatment Efficacy (www.psycbite.com). PsycBITETM includes five designs: Systematic Reviews (SR), Randomised Controlled Trials (RCT), non-RCTs (NRCT), Case Series (CS), and Single Subject Designs (SSD). Aim: To provide an overview of the types of research designs and levels of compliance used in aphasia treatment research studies, and assess the methodological quality of aphasia research. Methods & Procedures: A search was completed on 27 September 2007 of all papers in the target area Communication/Language/Speech on the PsycBITETM database. Papers were listed according to the methodology used and a mean methodological quality rating (MQR) score was determined for RCTs, and NRCTs based on the PEDro scale. Finally, the rate of compliance of RCTs and NRCTs for each of the criteria on the PEDro scale was analysed. Outcomes & Results: Of 339 studies indexed for aphasia: SR = 9 (3%); RCT = 23 (7%); NRCT = 18 (5%); CS = 51 (15%); and SSD = 238 (70%). Methodological quality ratings (MQR) using the PEDro scale (scored out of 10) were available for 21 RCTs (mean MQR = 4.4, SD = 1.7, range = 2-8), and 14 NRCTs (mean MQR = 2.6, SD = 1.0, range = 1-4). Conclusions: Methodological quality of current aphasia treatment studies is modest. The current examination of a small sample of RCTs and non-RCTs indicates that sources of bias are not sufficiently well controlled. These results have implications for aphasia therapy researchers in the design and report of their work. It is hoped that access to databases such as PsycBITETM and rating scales such as PEDro will facilitate this process. [ABSTRACT FROM AUTHOR]

Background. Observational studies from China suggest that Kangbingdu oral liquid (KBD) may be effective in treating the common cold. Objective. Reevaluation of efficacy and safety of Kangbingdu oral liquid after marketing and expanding population. Design. Prospective, Pragmatic randomized controlled trial (Chictr.org.cn registration number: chiCTR-TRC-12002399). Setting. Eleven hospitals from 3 provinces in China. Patients were recruited through 11 centers, including 7 teaching hospitals, 2 University health services, one military clinic, and one community hospital. Patients. 2647 persons aged 18 to 75 years with Common cold. Intervention. Patients were randomly allocated to 2 groups: the treatment group Kangbingdu oral liquid (composed of 9 Chinese herbal medicines and honey) and the placebo group were divided into a standard-dose group of 10 ml every time, a middle dose group of 20 ml every time, high dose group of 30 ml every time, 3 times daily. Interventions and control were given for 5 days. Measurements. The primary outcome is the mean amount of total scores measured by the 11-primary symptoms: to observe the change of main symptoms from severe to disappear and to calculate and compare the mean amount of total scores after the periods of observation. Secondary outcomes are the disappearance rate of each symptom and the median time of body temperature returned to normal. Results. On day 5, the Kangbingdu liquid group had significant reductions in the mean amount of total scores measured by the 11-primary symptoms (7.39 [95% CI 7.26 to 7.51] compared to the placebo group (6.43 [95%: CI 6.24 to 6.62]). The Kangbingdu liquid can improve the remission rate of accompanying symptoms on day 5 including aversion to wind, aversion to cold, fever, cough, stuffy, runny nose, sore throat, muscular aches, headache, fatigue, and sweat (P < 0.0001). Significant reductions in time of body temperature to return to normal in the Kangbingdu liquid group (P50, 48.33 [95% CI 46.00 to 52.50] compared with the control group (P50, 64.59 [95% CI 51.08 to 70.50] (P = 0.0022). 13 (0.7%) participants in the Kangbingdu liquid group and 1(0.2%) participants in the placebo group (P > 0.05) had treatment-related AEs, which mainly include diarrhea and dyspepsia in the Kangbingdu liquid group and constipation in the placebo group. Conclusion. The study's conclusion in this paper was based on the placebo, Kangbingdu oral liquid two groups which clinically diagnosed the common cold and flu. (1) Kangbingdu oral liquid can effectively improve the comprehensive clinical symptoms of common adult cold, also improved main symptoms, including sore throat, muscle aches, headache, and so on. (2) Kangbingdu oral liquid effectively shortens the time of body temperature to return to normal. [ABSTRACT FROM AUTHOR]

Atomoxetine was first licensed to treat attention-deficit/hyperactivity disorder (ADHD) in children and adolescents in the US in 2002. The aim of this paper is to comprehensively review subsequent publications addressing the efficacy of atomoxetine in 6- to 18-year-olds with ADHD. We identified 125 eligible papers using a predefined search strategy. Overall, these papers demonstrate that atomoxetine is an effective treatment for the core ADHD symptoms (effect sizes 0.6-1.3, vs. placebo, at 6-18 weeks), and improves functional outcomes and quality of life, in various pediatric populations with ADHD (i.e., males/females, patients with co-morbidities, children/adolescents, and with/without prior exposure to other ADHD medications). Initial responses to atomoxetine may be apparent within 1 week of treatment, but can take longer (median 23 days in a 6-week study; n = 72). Responses often build gradually over time, and may not be robust until after 3 months. A pooled analysis of six randomized placebo-controlled trials ( n = 618) indicated that responses at 4 weeks may predict response at 6-9 weeks, although another pooled analysis of open-label data ( n = 338) suggests that the probability of a robust response to atomoxetine [≥40 % decrease in ADHD-Rating Scale (ADHD-RS) scores] may continue to increase beyond 6-9 weeks. Atomoxetine may demonstrate similar efficacy to methylphenidate, particularly immediate-release methylphenidate, although randomized controlled trials are generally limited by short durations (3-12 weeks). In conclusion, notwithstanding these positive findings, before initiating treatment with atomoxetine, it is important that the clinician sets appropriate expectations for the patient and their family with regard to the likelihood of a gradual response, which often builds over time. [ABSTRACT FROM AUTHOR]

Ulipristal acetate (UPA) is a medical treatment for uterine fibroids and was authorized for surgical pre-treatment in 2012 after the conduct of the PEARL I and II randomized controlled trials and for intermittent treatment after the observational PEARL III and IV trials. However, UPA came into disrepute due to its temporary suspension in 2017 and 2020 because of an apparent association with liver injury. This clinical opinion paper aims to review the process of marketing authorization and implementation of UPA, in order to provide all involved stakeholders with recommendations for the introduction of future drugs. Before marketing authorization, the European Medicines Agency (EMA) states that Phase III registration trials should evaluate relevant outcomes in a representative population, while comparing to gold-standard treatment. This review shows that the representativeness of the study populations in all PEARL trials was limited, surgical outcomes were not evaluated and intermittent treatment was assessed without comparative groups. Implementation into clinical practice was extensive, with 900 000 prescribed treatment cycles in 5 years in Europe and Canada combined. Extremely high costs are involved in developing and evaluating pre-marketing studies in new drugs, influencing trial design and relevance of chosen outcomes, thereby impeding clinical applicability. It is vitally important that the marketing implementation after authorization is regulated in such way that necessary evidence is generated before widespread prescription of a new drug. All stakeholders, from pharmaceutical companies to authorizing bodies, governmental funding bodies and medical professionals should be aware of their role and take responsibility for their part in this process. [ABSTRACT FROM AUTHOR]

Background: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.Methods: We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.Results: The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.Conclusions: The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area. [ABSTRACT FROM AUTHOR]

Background: Globally, the rate of emergency hospital admissions is increasing. However, little evidence exists to inform the development of interventions to reduce unplanned Emergency Department (ED) attendances and hospital admissions. The objective of this evidence synthesis was to review the evidence for interventions, conducted during the patient's journey through the ED or acute care setting, to manage people with an exacerbation of a medical condition to reduce unplanned emergency hospital attendance and admissions.Methods: A rapid evidence synthesis, using a systematic literature search, was undertaken in the electronic data bases of MEDLINE, EMBASE, CINAHL, the Cochrane Library and Web of Science, for the years 2000-2014. Evidence included in this review was restricted to Randomised Controlled Trials (RCTs) and observational studies (with a control arm) reported in peer-reviewed journals. Studies evaluating interventions for patients with an acute exacerbation of a medical condition in the ED or acute care setting which reported at least one outcome related to ED attendance or unplanned admission were included.Results: Thirty papers met our inclusion criteria: 19 intervention studies (14 RCTs) and 11 controlled observational studies. Sixteen studies were set in the ED and 14 were conducted in an acute setting. Two studies (one RCT), set in the ED were effective in reducing ED attendance and hospital admission. Both of these interventions were initiated in the ED and included a post-discharge community component. Paradoxically 3 ED initiated interventions showed an increase in ED re-attendance. Six studies (1 RCT) set in acute care settings were effective in reducing: hospital admission, ED re-attendance or re-admission (two in an observation ward, one in an ED assessment unit and three in which the intervention was conducted within 72 h of admission).Conclusions: There is no clear evidence that specific interventions along the patient journey from ED arrival to 72 h after admission benefit ED re-attendance or readmission. Interventions targeted at high-risk patients, particularly the elderly, may reduce ED utilization and warrant future research. Some interventions showing effectiveness in reducing unplanned ED attendances and admissions are delivered by appropriately trained personnel in an environment that allows sufficient time to assess and manage patients. [ABSTRACT FROM AUTHOR]

Objectives: The objectives of this study were to identify the amikacin dosage regimens and drug concentrations consistent with good outcomes and to determine the drug exposures related to nephrotoxicity and ototoxicity.Methods: A literature review was conducted in Medline, EMBASE and the Cochrane Central Register of Controlled Trials. Full journal articles reporting randomized controlled trials, controlled clinical trials, interrupted time series trials, and controlled before and after studies involving amikacin therapeutic drug monitoring (TDM) and dose adjustment were considered for inclusion.Results: Seventeen studies for inclusion were identified, comprising 1677 participants. Amikacin doses ranged from 11 to 15 mg/kg/day with 13 studies using 15 mg/kg/day. Studies were generally designed to compare different aminoglycosides rather than to assess concentration-effect relationships. Only 11 papers presented data on target concentrations, rate of clinical cure and toxicity. Target peak concentrations ranged from 15 to 40 mg/L and target troughs were typically <10 or <5 mg/L. It was not clear whether these targets were achieved. Measured peaks averaged 28 mg/L for twice-daily dosing and 40-45 mg/L for once-daily dosing; troughs averaged 5 and 1-2 mg/L, respectively. Fifteen of the included studies reported rates of nephrotoxicity; auditory and vestibular toxicities were reported in 12 and 8 studies.Conclusions: This systematic review found little published evidence to support an optimal dosage regimen or TDM targets for amikacin therapy. The use of alternative approaches, such as consensus opinion and a review of current practice, will be required to develop guidelines to maximize therapeutic outcomes and minimize toxicity with amikacin. [ABSTRACT FROM AUTHOR]

The randomized controlled trial (RCT) is the gold standard for evaluating the causal effects of medications. Limitations of RCTs have led to increasing interest in using real‐world evidence (RWE) to augment RCT evidence and inform decision making on medications. Although RWE can be either randomized or nonrandomized, nonrandomized RWE can capitalize on the recent proliferation of large healthcare databases and can often answer questions that cannot be answered in randomized studies due to resource constraints. However, the results of nonrandomized studies are much more likely to be impacted by confounding bias, and the existence of unmeasured confounders can never be completely ruled out. Furthermore, nonrandomized studies require more complex design considerations which can sometimes result in design‐related biases. We discuss questions that can help investigators or evidence consumers evaluate the potential impact of confounding or other biases on their findings: Does the design emulate a hypothetical randomized trial design? Is the comparator or control condition appropriate? Does the primary analysis adjust for measured confounders? Do sensitivity analyses quantify the potential impact of residual confounding? Are methods open to inspection and (if possible) replication? Designing a high‐quality nonrandomized study of medications remains challenging and requires broad expertise across a range of disciplines, including relevant clinical areas, epidemiology, and biostatistics. The questions posed in this paper provide a guiding framework for assessing the credibility of nonrandomized RWE and could be applied across many clinical questions. [ABSTRACT FROM AUTHOR]

Background: The standard of care in management of hypothyroidism is treatment with levothyroxine (L-T4). Sometimes patients are dissatisfied with L-T4 and the combination of levo-triiodothyronine (L-T3) with L-T4 is considered. Methods: We performed a systematic review and meta-analysis of blinded randomized controlled trials (RCTs), reporting how often hypothyroid patients prefer combination L-T3/L-T4 treatment to L-T4 alone. We also explored for explanatory factors for combination therapy preference in sensitivity analyses examining trial, patient, and disease characteristics. Potential dose-response relationships were explored using meta-regression analyses. We searched 9 electronic databases (from inception until February, 2019), supplemented with a hand-search. Two reviewers independently screened abstracts and citations and reviewed full-text papers, with consensus achieved on the included studies. Two reviewers independently critically appraised the quality of included studies and abstracted the data. Random effects meta-analyses were reported for the percentage of patients preferring combination L-T3/T-T4 therapy over L-T4 alone. A binomial distribution of choices (i.e., preference of combination therapy or no preference for combination therapy) was assumed. Results: We included 7 blinded RCTs including 348 hypothyroid individuals in the primary meta-analysis. The pooled prevalence rate for preference of combination therapy over L-T4 was 46.2% (95% confidence interval 40.2%, 52.4%) (p = 0.231 for the difference from chance). There was no significant statistical heterogeneity among study results (Q = 7.32, degrees of freedom = 6, p = 0.293, I 2 = 18.0%). In sensitivity analyses, combination treatment preference was explained in part by treatment effects on TSH concentration, mood and symptoms, but not quality of life nor body weight. In a secondary dose-response meta-regression analyses, a statistically significant association of treatment preference was identified for total daily L-T3 dose, but not L-T3:L-T4 dose ratio. Conclusions: In conclusion, in RCTs in which patients and investigators were blinded to treatment allocation, approximately half of participants reported preferring combination L-T3 and L-T4 therapy compared to L-T4 alone; this finding was not distinguishable from chance. An observed potential positive L-T3 dose effect on treatment preference deserves further study, with careful consideration of thyroid biochemical indices and patient reported outcomes. [ABSTRACT FROM AUTHOR]

Background: Many people with aphasia have word‐finding difficulties, with some showing particular difficulties with verbs. Picture‐naming therapy is often used to improve naming, but gains are usually limited to therapy items and do not transfer to conversation. Therapy where words are produced in sentences and in real‐life activities may be more effective. Aims: The current pilot study investigated whether an activity‐oriented therapy approach would be accepted and viable if implemented in a community setting, and whether communicating whilst cooking was more beneficial than using paper‐based activities. If successful, it would be expected that verb production would improve in structured and unstructured tasks in both naming and narrative tasks. Methods & Procedures: The study employed a case‐series repeated‐measures design, with testing of treated and control items. Seven adults with anomia participated, although only five completed the full programme. Participants were divided into two groups and each group completed both treatments, but in different orders. Each treatment was employed for six 2‐h sessions over a 3‐week period. Outcomes & Results: Naming of both treated and untreated verbs showed a statistically significant improvement following both treatments and this continued into the maintenance phase. There was a numerical but not statistically significant gain in the variety of verbs used in spoken narratives. Participants predominantly chose positive terms to describe their experience of the programme, but did not prefer one therapy over the other. Conclusions & Implications: Preliminary findings suggest that an activity‐oriented therapy approach, whether it involves carrying out tasks or paper‐based activities, can result in clinically meaningful improvements for people with chronic aphasia. Further research using a randomized control trial is required to determine whether cooking therapy alone is effective. [ABSTRACT FROM AUTHOR]

Background/Objectives: The aim of present study was to examine the effect of orofacial muscle exercise programs on swallowing function with smartphone video as well as satisfaction with outcome in sub-acute stroke patients with dysphagia. Method/Statistical Analysis: We enrolledsub-acute phase of sixteen stroke patients with dysphagia. The participants were randomly assigned to the study group (orofacial muscle exercise program using smartphone video) orcontrol (paper-based orofacial muscles exercise program). All subjects completed their prescribed orofacial muscle exercise programs 20 min/day, 3 times per week, for 4 weeks. The outcome measures were the FDS(Functional Dysphagia Scale), PAS (Penetration-Aspiration Scale) and VASS(Visual Analog Satisfaction Scale).Main analysis was Mann-Whitney U test for comparison between groups. Findings: After intervention, there were no significant differences in swallowing function between the two groups. Nevertheless, in study group satisfactionwas significantly higher than that of the control group. Improvements/Applications: Authors suggest that orofacial muscle exercise programs using smartphone can have a more positive impact on satisfaction than can paper-based orofacial muscle exercise programs in sub-acute stroke patients with dysphagia. [ABSTRACT FROM AUTHOR]

Background: Impaired physical function due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms may lead to diminished quality of life. However, even with the knowledge of the effects of CIPN on physical function, clinicians infrequently assess and manage CIPN. Interventions that prioritize the early identification of CIPN to provide prompt treatment may reduce the impact of CIPN on physical function. The purpose of this paper is to compare self-reported physical function in individuals receiving neurotoxic chemotherapy between Electronic Symptom Assessment-Cancer (ESRA-C) intervention group (e.g., opportunity for symptom screening, self-care recommendations, communication coaching, and symptom tracking) and control group participants (i.e., electronic assessment alone). Secondary outcomes include pain intensity, sensory/motor CIPN, depression, fatigue, and insomnia.Methods: The data used in this paper are a subset of a randomized controlled trial that examined the impact of the ESRA-C intervention on symptom distress in individuals receiving cancer treatment. Since the interest in this analysis is on the effects of neurotoxic chemotherapy on physical function, subjects were included if they received platinum and/or taxane-based chemotherapy and completed the baseline and end-of-treatment measures. Participants completed standardized questionnaires of physical function, CIPN, fatigue, depression, pain intensity, and insomnia prior to treatment, 3-6 weeks after treatment initiation, and after the completion of treatment. Changes in mean scores are compared between groups using linear mixed models adjusting for age.Results: Intervention group participants reported significantly less reduction in physical functioning (baseline: 87.4/100; end-of-treatment: 84.5/100) relative to the control (baseline: 90.2/100; end-of-treatment: 81.8/100) (p = 0.011). For secondary measures, significantly less depression (p = 0.005) was observed in the intervention group as compared to the control, but otherwise, there were no between-group differences. Among participants who received high cumulative doses of neurotoxic chemotherapy, the intervention group reported significantly less severe sensory (p = 0.007) and motor CIPN (p = 0.039) relative to the control.Conclusion: Use of the ESRA-C intervention led to less reduction in physical function in comparison to the control in individuals receiving neurotoxic chemotherapy. Further research is needed to confirm our findings and to identify how electronic symptom assessment technology may mediate physical function preservation.Trial Registration: ClinicalTrials.Gov NCT00852852 . Registered 27 February 2009. [ABSTRACT FROM AUTHOR]

Background: A large number of randomized controlled studies have clearly demonstrated that psychological interventions are effective in the treatment of depression. The number of studies in this area is increasing rapidly. In this paper, we present a database of controlled and comparative outcome studies on psychological treatments of depression, based on a series of meta-analyses published by our group. The database can be accessed freely through the Internet. Description: We conducted a comprehensive literature search of the major bibliographical databases (Pubmed; Psycinfo; Embase; Cochrane Central Register of Controlled Trials) and we examined the references of 22 earlier meta-analyses of psychological treatment of depression. We included randomized studies in which the effects of a psychological therapy on adults with depression were compared to a control condition, another psychological intervention, or a combined treatment (psychological plus pharmacological). We conducted nine meta-analyses of subgroups of studies taken from this dataset. The 149 studies included in these 9 meta-analyses are included in the current database. In the 149 included studies, a total of 11,369 patients participated. In the database, we present selected characteristics of each study, including characteristics of the patients (the study population, recruitment method, definition of depression); characteristics of the experimental conditions and interventions (the experimental conditions, N per condition, format, number of sessions); and study characteristics (measurement times, measures used, attrition, type of analysis and country). Conclusion: The data on the 149 included studies are presented in order to give other researchers access to the studies we collected, and to give background information about the meta-analyses we have published using this dataset. The number of studies examining the effects of psychological treatments of depression has increased considerably in the past decades, and this will continue in the future. The database we have presented in this paper can help to integrate the results of these studies in future meta-analyses and systematic reviews on psychological treatments for depression. [ABSTRACT FROM AUTHOR]

Background: Weifuchun (WFC), a Chinese herbal prescription consisting of Red Ginseng, Isodon amethystoides and Fructus Aurantii, is commonly used in China to treat a variety of chronic stomach disorders. The aim of the paper was to determine the effect of WFC on intestinal microbiota changes in precancerous lesions of gastric cancer (PLGC) patients. Methods: PLGC patients of H. pylori negative were randomly divided into two groups and received either WFC tablets for a dose of 1.44 g three times a day or vitacoenzyme (Vit) tablets for a dose of 0.8 g three times a day. All patients were treated for 6 months consecutively. Gastroscopy and histopathology were used to assess the histopathological changes in gastric tissues before and after treatment. 16S rRNA gene sequencing was carried out to assess the effects WFC on intestinal microbiota changes in PLGC patients. Receiver Operating Characteristics (ROC) analysis was used to assess the sensitivity and specificity of different intestinal microbiota in distinguishing between PLGC patients and healthy control group. Results: Gastroscopy and histopathological results indicated that WFC could improve the pathological condition of PLGC patients, especially in the case of atrophy or intestinal metaplasia. The results of 16S rRNA gene sequencing indicated that WFC could regulate microbial diversity, microbial composition, and abundance of the intestinal microbiota of PLGC patients. Following WFC treatment, the relative abundance of Parabacteroides decreased in WFC group when compared with the Vit group. ROC analysis found that the Parabacteroides could effectively distinguish PLGC patients from healthy individuals with sensitivity of 0.79 and specificity of 0.8. Conclusions: WFC could slow down the progression of PLGC by regulating intestinal microbiota abundance. Trial registration NCT03814629. Name of registry: Randomized Clinical Trial: Weifuchun Treatment on Precancerous Lesions of Gastric Cancer. Registered 3 August 2018-Retrospectively registered, https://register.clinicaltrials.gov/ NCT03814629. [ABSTRACT FROM AUTHOR]

Objective: The beneficial effects of antiseptics in the treatment of periodontitis are still controversial. The goal of this randomized split-mouth study was to evaluate the clinical and microbiologic results of a unique subgingival irrigation of 10% povidone-iodine in addition to a full-mouth scaling and root planing for the treatment of chronic periodontitis. Method and Materials: Twenty patients with chronic periodontitis took part in this investigation. In each patient, four initially untreated pockets > 4 mm were randomly selected for one subgingival irrigation. After a one-session full-mouth treatment with scaling and root planing (SRP), two pockets of a split mouth received one unique irrigation with 10 mL 0.9% NaCl solution (control group, CG). Two pockets on the other side received 10 mL of povidone-iodine 10% (test group, PIG). Full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), Plaque Index (PI), Gingival Index (GI), probing pocket depth (PPD), and clinical attachment level (CAL) parameters were assessed at baseline and after 1, 3, and 6 months (M). Bacterial samplings with sterile paper points were taken at M0 and after M1, M3, and M6. These samplings were separately cultured under aerobic and anaerobic conditions before CFU evaluation. Results: Pl, GI, PPD, and CAL were significantly improved in both groups after 6 months. The major difference was seen between M0 and M3 (P<.001). No significant differences were seen between the groups, except for deep pockets (> 6 mm) where a statistical difference was observed in favor of PIG after 6 months; in these subgroups the mean probing reduction was 2.68 ± 0.37 mm for CG versus 3.93 ±0.23 mm in PIG (P<.001). No significant differences were seen between CG and PIG regarding the microbiologic results after 6 months. Conclusion: One single irrigation of 10% povidone-iodine associated with full-mouth SRP would bring a small additional benefit in deep pockets. More studies are needed to yield additional results. [ABSTRACT FROM AUTHOR]

The review focuses on the last decade of research regarding the use of various oral appliances ( OAs) in the management of sleep bruxism ( SB) in adults. Sixteen ( n = 16) papers of 641 identified citations involving 398 participants were included in the review. Of them, seven were randomised controlled trials ( RCTs), seven were uncontrolled before-after studies and two were crossover trials. Analysis of the included articles revealed a high variability of study designs and findings. Generally, the risk of bias was low-to-unclear for RCTs and high for crossover studies, whilst the before-after studies exhibited several structural limitations. Nine studies used polysomnography/polygraphy/electromyography for SB diagnosis, whilst others were based on history taking and clinical examination. Most of them featured small samples and were short term. Of the studies using objective SB evaluations, eight showed positive results for almost every type of OA in reducing SB activity, with a higher decrease for devices that are designed to provide a certain extent of mandibular advancement. Among the studies using a subjective SB evaluation, one demonstrated a significant reduction in SB activity, and additional two showed a myorelaxant effect of OA in SB patients. Although many positive studies support the efficiency of OA treatment for SB, accepted evidence is insufficient to support its role in the long-term reduction of SB activity. Further studies with larger samples and sufficient treatment periods are needed to obtain more acknowledgements for clinical application. [ABSTRACT FROM AUTHOR]

Background Little information is available as to the safety of midazolam when used as an oral sedative. Aim To evaluate the side effects and other adverse outcomes following use of oral midazolam for behaviour management in paediatric dentistry. Design A review of published literature relating to the safety and side effects of oral midazolam for use in paediatric dental procedures was conducted. Both randomised controlled trials and non-randomised studies were assessed. Reported side effects were recorded and classified as either significant or minor. The percentage prevalence of significant or minor side effects per episode of treatment was calculated. Results Sixteen papers of randomised controlled trials met the inclusion criteria. None of the side effects recorded were considered as significant. Minor side effects were reported ( n = 68, 14%), with nausea and vomiting being the most frequently recorded ( n = 30, 6%). Eleven papers of non-randomised studies were included. No significant side effects were recorded. Minor side effects were recorded ( n = 157, 8%), with paradoxical reaction being the most common at 3.8%. Conclusion Significant side effects associated with oral midazolam usage for behaviour management in children and adolescents requiring dental treatment appear to be rare. Minor side effects are more common but determining precise figures is complicated by poor reporting. [ABSTRACT FROM AUTHOR]

Objective: Arginine-containing toothpastes are a promising new treatment for dentin hypersensitivity (DH), which afflicts a considerable number of patients. However, there have to date been only individual studies. We aim to present an overview of the clinical evidence in order to determine trends and establish firmer conclusions regarding the use of arginine-containing toothpastes for management of DH. Method and Materials: A protocol was developed based on the Cochrane Handbook for Systematic Reviews of Interventions (version 5.1.0), including: search strategy, selection criteria, data extraction, and risk of bias assessment. We searched electronic databases (up to October 2012) without language limitation, and reference lists of relevant papers for randomized controlled trials that assessed the efficacy of arginine-containing toothpastes for DH treatment. Data extraction and domain-based risk of bias assessment were independently performed by two reviewers. The meta-analysis was performed in STATA (version 12.0). The GRADE analysis was conducted in GRADE profiler (version 3.6). Results: Fourteen randomized controlled studies with different risk of bias were included in the meta-analysis, all evaluated by tactile and air blast assessment. The mean differences and standard deviations for each treatment group were pooled for analysis using a random-effect model. We found that arginine-containing toothpastes had better overall effects in comparison with placebo toothpastes (P < .05), potassium salt-containing toothpastes (P < .05), and strontium-containing toothpastes (P < .05). The GRADE analysis showed that quality of the evidence was moderate when arginine-containing toothpastes were compared to placebo and potassium salt-containing toothpastes, and quality of the evidence was low with comparison to strontium-containing toothpastes. Conclusion: Current available clinical evidence suggests that arginine-containing toothpastes are associated with the reduction of DH compared to both placebo and positive control toothpastes. However, there are limitations to the current studies, and more well-designed trials are needed to confirm the efficacy. [ABSTRACT FROM AUTHOR]

Background: Though home-based human immunodeficiency virus (HIV) counseling and testing (HBHCT) is implemented in many sub-Saharan African countries as part of their HIV programs, linkage to HIV care remains a challenge. The purpose of this study is to test an intervention to enhance linkage to HIV care and improve HIV viral suppression among individuals testing HIV positive during HBHCT in rural Uganda.Methods: The PATH (Providing Access To HIV Care)/Ekkubo Study is a cluster-randomized controlled trial which compares the efficacy of an enhanced linkage to HIV care intervention vs. standard-of-care (paper-based referrals) at achieving individual and population-level HIV viral suppression, and intermediate outcomes of linkage to care, receipt of opportunistic infection prophylaxis, and antiretroviral therapy initiation following HBHCT. Approximately 600 men and women aged 18-59 who test HIV positive during district-wide HBHCT in rural Uganda will be enrolled in this study. Villages (clusters) are pair matched by population size and then randomly assigned to the intervention or standard-of-care arm. Study teams visit households and participants complete a baseline questionnaire, receive HIV counseling and testing, and have blood drawn for HIV viral load and CD4 testing. At baseline, standard-of-care arm participants receive referrals to HIV care including a paper-based referral and then receive their CD4 results via home visit 2 weeks later. Intervention arm participants receive an intervention counseling session at baseline, up to three follow-up counseling sessions at home, and a booster session at the HIV clinic if they present for care. These sessions each last approximately 30 min and consist of counseling to help clients: identify and reduce barriers to HIV care engagement, disclose their HIV status, identify a treatment supporter, and overcome HIV-related stigma through links to social support resources in the community. Participants in both arms complete interviewer-administered questionnaires at six and 12 months follow-up, HIV viral load and CD4 testing at 12 months follow-up, and allow access to their medical records.Discussion: The findings of this study can inform the integration of a potentially cost-effective approach to improving rates of linkage to care and HIV viral suppression in HBHCT. If effective, this intervention can improve treatment outcomes, reduce mortality, and through its effect on individual and population-level HIV viral load, and decrease HIV incidence.Trial Registration: NCT02545673. [ABSTRACT FROM AUTHOR]

Background: The Internet offers several new ways of developing, implementing, and disseminating evidence-based interventions for depression.Methods: In this paper, we narratively synthesized the evidence showing that Internet-based therapies are effective in treating depression.Results: In the past decade, a considerable number of psychological treatments have been developed for the treatment of depression and several hundreds of randomized controlled trials have been conducted, showing that these interventions are effective and that there are no major differences in effects between therapies. Several meta-analyses show that Internet-based treatments are also effective in depression. Direct comparisons with face-to-face treatments do not indicate that there are relevant differences between Internet-based and face-to-face treatment formats. The challenge for the near future is to examine how these treatments can be integrated in mental health care. Major opportunities are in preventive services, primary care, specialized mental health care, and in patients with comorbid general medical disorders. New technological innovations through the smartphone, serious gaming, avatars, augmented reality, and virtual reality will give further possibilities to simplify and perhaps increase the effects of treatments.Conclusions: The Internet offers many possibilities to increase access to evidence-based psychological treatments of depression. New technological may further improve access and, perhaps, the effects of treatments. [ABSTRACT FROM AUTHOR]

Background: Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment.Methods and Design: This paper describes an innovative multidisciplinary trial design (n = 280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants' experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup.Discussion: OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the "culture" of the trial as well as potential mechanisms of OLP and ethical implications.Trial Registration: ClinicalTrials.gov, identifier: NCT02802241 . Registered on 14 June 2016. [ABSTRACT FROM AUTHOR]

Background: Health anxiety (HA), or hypochondriasis, is a psychological problem characterized by a preoccupation with the belief that one is physically unwell. A 2007 Cochrane review (Thomson and Page, 2007) found cognitive behavioural therapy (CBT) to be an effective intervention for individuals with HA. Similar findings were reported in a recent meta-analysis (Olatunji et al., 2014), which did not employ a systematic search strategy. The current review aimed to investigate the efficacy of CBT for HA, and to update the existing reviews. Method: A systematic search was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance, including randomized controlled trials that compared CBT with a control condition for people with HA. Five hundred and sixty-seven studies were found in the original search, of which 14 were included in the meta-analysis. Results: Meta-analysis was conducted on 21 comparisons and a large effect size for CBT compared with a control condition was found at post therapy d = 1.01 (95% confidence interval 0.77–1.25), as well as at 6- and 12-month follow-up. Conclusions: This systematic review and meta-analysis provides support for the hypothesis that CBT is an effective intervention for HA when compared with a variety of control conditions, e.g. treatment-as-usual, waiting list, medication, and other psychological therapies. [ABSTRACT FROM PUBLISHER]

Background: Two to 4% of emergency hospital admissions are caused by preventable adverse drug events. The estimated costs of such avoidable admissions in England were £530 million in 2015. The data-driven quality improvement in primary care (DQIP) intervention was designed to prompt review of patients vulnerable from currently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) and anti-platelets and was found to be effective at reducing this prescribing. A process evaluation was conducted parallel to the trial, and this paper reports the analysis which aimed to explore response to the intervention delivered to clusters in relation to participants' perceptions about which intervention elements were active in changing their practice.Methods: Data generation was by in-depth interview with key staff exploring participant's perceptions of the intervention components. Analysis was iterative using the framework technique and drawing on normalisation process theory.Results: All the primary components of the intervention were perceived as active, but at different stages of implementation: financial incentives primarily supported recruitment; education motivated the GPs to initiate implementation; the informatics tool facilitated sustained implementation. Participants perceived the primary components as interdependent. Intervention subcomponents also varied in whether and when they were active. For example, run charts providing feedback of change in prescribing over time were ignored in the informatics tool, but were motivating in some practices in the regular e-mailed newsletter. The high-risk NSAID and anti-platelet prescribing targeted was accepted as important by all interviewees, and this shared understanding was a key wider context underlying intervention effectiveness.Conclusions: This was a novel use of process evaluation data which examined whether and how the individual intervention components were effective from the perspective of the professionals delivering changed care to patients. These findings are important for reproducibility and roll-out of the intervention.Trial Registration: ClinicalTrials.gov, NCT01425502 . [ABSTRACT FROM AUTHOR]

Background. We systematically reviewed the evidence for an association between male circumcision and Human Papillomavirus (HPV) infection and genital warts in men. Methods. PubMed and Embase were searched to 15 September 2010. The measure of effect was the adjusted odds ratio (OR) or rate ratio (RR) when present and the crude estimate otherwise. Random effects meta-analyses were used to calculate summary measures of effect. Results. We identified 23 papers about the association between circumcision and HPV DNA. Circumcised men were less likely to have prevalent genital HPV infection than uncircumcised men (summary OR, 0.57, 95% confidence interval [CI], 0.45-0.71) with between-study heterogeneity (P-heterogeneity = 0.006; I22 = 50.5%; 19 studies). Similar summary associations were seen in clinical and methodological subgroups. The effect of circumcision was stronger at the glans/corona (OR, 0.47; 95% CI, 0.37-0.60) and urethra (OR, 0.35; 95% CI, 0.12- 1.05) compared with sites more distal to the foreskin. There was weak evidence that circumcision was associated with decreased HPV incidence (summary RR, 0.75, 95% CI, 0.57-0.99; 3 studies) and increased HPV clearance (summary RR, 1.33; 95% CI, 0.89-1.98; 3 studies) but no evidence of an association with prevalent genital warts (OR, 0.93, 95% CI, 0.65-1.33; 15 studies). Conclusions. Several countries are expanding access to voluntary medical male circumcision to reduce HIV prevalence. This could provide additional benefit in reducing HPV prevalence. [ABSTRACT FROM AUTHOR]

The evidence is strong that bariatric surgery is superior to medical treatment in terms of weight loss and comorbidities in patients with severe obesity. However, a considerable part of patients presents with unsatisfactory response in the long term. It remains unclear whether postoperative administration of glucagon-like peptide-1 analogues can promote additional benefits. Therefore, a systematic review of the current literature on the management of postoperative GLP-1 analogue usage after metabolic surgery was performed. From 4663 identified articles, 6 met the inclusion criteria, but only one was a randomized controlled trial. The papers reviewed revealed that GLP-1 analogues may have beneficial effects on additional weight loss and T2D remission postoperatively. Thus, the use of GLP-1 analogues in addition to surgery promises good results concerning weight loss and improvements of comorbidities and can be used in patients with unsatisfactory results after bariatric surgery. [ABSTRACT FROM AUTHOR]

Extraintestinal manifestations (EIM) have become an important source of morbidity and disability as well as an identified risk factor for an unfavorably course of disease in inflammatory bowel diseases (IBD). Therefore, efforts have been put into a more global and interdisciplinary management of IBD patients in collaboration with rheumatologists, dermatologists, and ophthalmologists. A real therapeutic success has also been obtained with a more "systemic" IBD treatment associated with the development of monoclonal antibodies against TNF alpha and biological agents derived from the treatment of rheumatological disease (also called biological Disease-Modifying Antirheumatic Drugs). The prevalence of these EIM remains too low to undergo randomized controlled trials with this specific focus and therefore the evidence relies on case series and experts' opinions, which lowers the level of evidence. After a careful review of the most recent literature, this paper aims to update the reader on the latest therapeutic management of IBD patients with EIM. [ABSTRACT FROM AUTHOR]

Background: The purpose of this paper is to discuss the development of two novel technology-based interventions for depression in older adults while comparing older adults' preferences for audio-based and computer-based cognitive behavioral therapy for depressive symptoms. The audio program consisted of eight compact discs and a workbook while the computer program consisted of 11 modules of similar duration provided on a tablet PC. Both interventions consisted of the following topics: 1) introduction, 2) identifying and changing unhelpful thoughts, 3) addressing feelings, 4) relaxation, 5) engaging in pleasant events, 6) assertiveness, and 7) problem-solving. Methods: Fifty-one older adults were recruited from medical settings and rural communities and randomly assigned to an immediate treatment group (computer or audio) with minimal contact or a four-week minimal contact delayed treatment control condition. Results: Participants rated computer-based and audio-based cognitive behavioral therapy fairly equally, with 75% of those who received audio treatment and 85% of those who received computer-based treatment indicating benefits to their mood. Discussion: Computer-based or audio-based cognitive behavioral treatments may be valuable, low-cost modalities to deliver psychotherapy to older adults with depressive symptoms within a health care setting. Both modalities seem to be accepted by older adults. [ABSTRACT FROM AUTHOR]

Background: The lack of evidence for the effective management of carious lesions in children's primary teeth has caused uncertainty for the dental profession and patients. Possible approaches include conventional and biological management alongside best practice prevention, and best practice prevention alone. The FiCTION trial assessed the effectiveness of these options, and included a qualitative study exploring dental professionals' (DPs) experiences of delivering the different treatment arms. This paper reports on how DPs managed children with carious lesions within FiCTION and how this related to their everyday experiences of doing dentistry. Methods: Overall, 31 DPs from FiCTION-trained dental surgeries in four regions of the UK participated in semi-structured interviews about their experiences of the three treatment arms (conventional management of carious lesions and prevention (C + P), biological management of carious lesions and prevention (B + P) or prevention alone (PA)). A theoretical framework, drawing on social practice theory (SPT), was developed for analysis. Results: Participants discussed perceived effectiveness of, and familiarity with, the three techniques. The C + P arm was familiar, but some participants questioned the effectiveness of conventional restorations. Attitudes towards the B + P arm varied in terms of familiarity, but once DPs were introduced to the techniques, this was seen as effective. While prevention was familiar, PA was described as ineffective. DPs manage children with carious lesions day-to-day, drawing on previous experience and knowledge of the child to provide what they view as the most appropriate treatment in the best interests of each child. Randomisation undermined these normal choices. Several DPs reported deviating from the trial arms in order to treat a patient in a particular way. Participants valued evidence-based dentistry, and expect to use the results of FiCTION to inform future practice. They anticipate continuing to use the full range of treatment options, and to personally select appropriate strategies for individual children. Conclusions: RCTs take place in the context of day-to-day practices of doing dentistry. DPs employ experiential and interpersonal knowledge to act in the best interests of their patients. Randomisation within a clinical trial can present a source of tension for DPs, which has implications for assuring individual equipoise in future trials. [ABSTRACT FROM AUTHOR]

Background: The efficacy of many cognitive behavioral component interventions has not been examined, with worry outcome monitoring among them.Methods: To address this issue, 51 participants with clinical levels of generalized anxiety disorder were randomly assigned to a treatment or control condition for 10 days. The treatment condition consisted of a brief ecological momentary intervention termed the Worry Outcome Journal (WOJ). WOJ participants recorded worries and tracked their outcomes, rating worry distress, interference, and expected outcome probabilities. Thought log (TL) control participants completed a record of their everyday thoughts and rated associated distress. All participants made four entries on paper each day when randomly prompted by text message. They then entered their paper contents online each night. After 30 days they reviewed their contents electronically and completed follow-up measures.Results: Primary results revealed significant reductions in worry for WOJ users compared to TL users at postintervention. A marginally significant difference was found at 20-day follow-up and treatment gains were maintained. Secondary analyses showed no harmful increases in worry beliefs for WOJ users, as well as preliminary evidence for decreases in beliefs about the uncontrollability of thoughts in both groups.Conclusion: The WOJ may be a viable therapist-independent treatment for reducing worry, even after only 10 days of use. [ABSTRACT FROM AUTHOR]

SHIFT has been one of the largest RCTs in the field of systemic family therapy in the UK. The study took place over five years, including three major centres with fifteen Trusts and twenty‐five family therapists who worked with a manualized treatment in CAMHS with adolescents who self‐harmed. While the results are not available at the time of this publication, this paper will briefly describe the pre‐ existing factors which were helpful in developing a successful bid, clinical and managerial elements of ‘real world research’ of complex psychological processes and the construction of the manualized systemic family therapy. It also offers examples of some of the unanticipated events in the life of such a large trial. Practitioner Points: Large trials develop from small studies and clinicians are urged to look for opportunities for research partnershipsInvestment in time for consideration of difficult issues as they arise is essential for effective trial managementThe balance between research rigour and ‘real life’ practice is an inevitable area of tension and requires consideration of both immediate and outcome consequences 尝试和痛苦 – 一种随机对照试验对比下的把干预当作惯常和在实施过程中出现的重要事件上的反思的家庭治疗 人工家庭治疗 摘要: SHIFT目前是英国家庭治疗领域最大的随机对照试验之一。本研究历时5年, 囊括了三个主要的中心在内的15个信托, 25位曾在CAMHS对自残青少年进行人工治疗的家庭治疗师。因为在发表这篇文章的时候, 结果还没有出来, 本文将简短地描述1）有助发展成功bid的已经存在的因素, 2）临床以及管理方面的复杂心理过程的”真实情况研究”元素, 3）以及人工系统家庭治理的建构。本文还提供了生活在这样一种大的的尝试下的一些意想不到事件的例子。 对实践者有用的几点建议: 大的尝试发展自小的研究, 临床工作者急需寻找研究合作者的机会困难事件需要及时解决, 不然就会对有效尝试管理产生重要影响研究活力和”真实生活”实践的平衡是一种不可避免的引起紧张的领域, 这需要对当下和结果的同时考虑 关键词：实证实践, 研究, 儿童和青少年精神健康, 培训 [ABSTRACT FROM AUTHOR]

Accessible summary What is known on the subject? There is evidence suggesting that exercise may be effective at reducing depression in adults and young people; however, there is no research exploring how adolescents with depression experience exercise interventions., What the paper adds to existing knowledge? This study presents the experiences of 26 adolescents with depression who undertook an innovative preferred intensity exercise programme. Important insights relating to benefits and aspects of the preferred intensity exercise emerged. Specifically, the adolescents experienced feelings of improved mood, achievement and enjoyment, alongside numerous benefits., What are the implications for practice? Given that mental health nurses are in key positions to promote physical exercise for this target group, this paper suggests that when promoting exercise they should consider that preferred intensity exercise may provide a series of valuable mental health benefits without the need for fixed intensity training., Abstract Introduction Despite systematic reviews demonstrating an association between exercise participation and reduced depressive symptoms in young people, there is no qualitative research exploring the experience of depressed adolescents who have engaged in an exercise intervention. Aims To explore the experience of depressed adolescents who had recently engaged in a preferred intensity exercise intervention. Method The participants ( n = 26) were recruited through health and social care services, were all in treatment for depression, and were purposefully sampled for interview following engagement in a preferred intensity exercise intervention, which was being evaluated via a pragmatic randomized controlled trial. A thematic approach was undertaken to analyse and organize the data. Results Numerous beneficial changes were reported by participants alongside specific aspects of the intervention that were valued. Discussion and implications The findings suggest that preferred intensity exercise can lead to feelings of improved mood, enjoyment and achievement, alongside benefits that transcend depressive symptom reduction. Considering mental health nurses are in key positions to promote exercise in this population, the current findings provide vital information for this purpose. [ABSTRACT FROM AUTHOR]

Background and purpose —There is solid evidence from animal experiments that parathyroid hormone (PTH) improves fracture healing. So far, only 3 papers on PTH and fracture repair in humans have been published. They suggest that PTH may enhance fracture healing, but the results do not appear to justify specific clinical recommendations. This study was carried out to determine whether teriparatide enhances fracture healing of proximal humerus fractures. Patients and methods —40 post-menopausal women with a proximal humerus fracture were randomized to either daily injections with 20 µg teriparatide (PTH 1-34 (Forteo)) for 4 weeks or control treatment. At randomization, the patients were asked to assess how their pain at rest and during activity (visual analog scale (VAS)) and also function (DASH score) had been prior to the fracture. At 7 weeks and again at 3 months, their current state was assessed and the tests were repeated, including radiographs. 2 radiologists performed a blind qualitative scoring of the callus at 7 weeks. Callus formation was arbitrarily classified as ”normal” or “better”. Results —39 patients completed the follow-up. The radiographic assessment showed a correct correlation, “better” in the teriparatide group and “normal” in the control group, in 21 of the 39 cases. There were no statistically significant differences in pain, in use of strong analgesics, or in function between the groups at the follow-up examinations. Interpretation —There were no radiographic signs of enhanced healing or improved clinical results in the group treated with teriparatide [ABSTRACT FROM AUTHOR]

Background: This study aimed to summarize the current status of research on ultrasound-guided acupuncture and dry-needling treatment and the specific treatment methods applied to patients. Methods: A scoping review was conducted, surveying three English databases (PubMed, Embase, and the Cochrane Library) for studies published up to May 2024. All studies related to ultrasound-guided acupuncture and dry-needling treatment were considered. Literature was selected using selection and exclusion criteria, and extracted and organized using EndNote. Results: A total of 107 eligible studies were included. Among the 107 studies, non-comparative studies accounted for the largest proportion (n = 47, 43.9%), followed by randomized controlled trials (RCTs; n = 41, 38.3%). Diseases of the musculoskeletal system or connective tissue (15 diseases of the musculoskeletal system or connective tissue) accounted for most (n = 48, 55.8%) of the 86 diseases studied, followed by symptoms, signs, or clinical conditions not otherwise classified (n = 17, 19.8%). Conclusions: Ultrasound-guided acupuncture and dry-needling have been actively studied and applied for the treatment of various diseases. However, higher-quality studies are needed for further applications in research and clinical practice. [ABSTRACT FROM AUTHOR]

Objective: The fragility index (FI), which is the minimum number of changes in status from "event" to "non-event" resulting in a loss of statistical significance, serves as a significant supplementary indicator for clinical physicians in interpreting clinical trial results and aids in understanding the outcomes of randomized controlled trials (RCTs). In this systematic literature survey, we evaluated the FI for RCTs evaluating Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS), and explored potential associations between study characteristics and the robustness of RCTs. Methods: A comprehensive search was conducted in four databases in Chinese and four databases in English from their inception to January 1, 2023. RCTs encompassed 1:1 ratio into two parallel arms and reported at least one binary outcome that demonstrated statistical significance were included. FI was calculated by the iterative reduction of a target outcome event in the treatment group and concomitant subtraction of a non-target event from that group, until positive significance (defined as P < 0.05 by Fisher's exact test) is lost. The lower the FI (minimum 1) of a trial outcome, the more fragile the positive result of the outcome was. Linear regression models were adopted to explore influence factors of the value of FI. Results: A total of 30 trials from 2 4118 potentially relevant citations were finally included. The median FI of total trials included was 1.5 (interquartile range [IQR], 1–5), and half of the trials (n = 15) had a FI equal to 1. In 12 trials (40%), the total number of participants lost to follow-up surpassed the respective FI. The study also identified that increased FI was significantly associated with no TCM syndrome differentiation for inclusion criteria of the patients, larger total sample size, low risk of bias, and larger numbers of events. Conclusions: The majority of CHM IBS RCTs with positive results were found to be fragile. Ensuring adequate sample size, scientifically rigorous study design, proper control of confounding factors, and a quality control calibration for consistency of TCM diagnostic results among clinicians should be addressed to increase the robustness of the RCTs. We recommend reporting the FI as one of the components of sensitivity analysis in future RCTs to facilitate the assessment of the fragility of trials. [ABSTRACT FROM AUTHOR]