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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]

Abstract Question In people who have undergone surgical carpal tunnel release, do sensorimotor-based exercises performed on the touchscreen of a tablet device improve outcomes more than a conventional home exercise program prescribed on paper? Design Randomised, parallel-group trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Participants Fifty participants within 10 days of surgical carpal tunnel release. Intervention Each participant was prescribed a 4-week home exercise program. Participants in the experimental group received the ReHand tablet application, which administered and monitored exercises via the touchscreen. The control group was prescribed a home exercise program on paper, as is usual practice in the public hospital system. Outcome measures The primary outcome was functional ability of the hand, reported using the shortened form of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Secondary outcomes were grip strength, pain intensity measured on a 10-cm visual analogue scale, and dexterity measured with the Nine-Hole Peg Test. Outcomes were measured by a blinded assessor at baseline and at the end of the 4-week intervention period. Results At Week 4, functional ability improved significantly more in the experimental group than the control group (MD –21, 95% CI –33 to –9) on the QuickDASH score (0 to 100). Although the mean estimates of effect on the secondary outcome also all favoured the experimental group, none reached statistical significance: grip strength (MD 5.6 kg, 95% CI –0.5 to 11.7), pain (MD –1.4 cm, 95% CI –2.9 to 0.1), and dexterity (MD –1.3 seconds, 95% CI –3.7 to 1.1). Conclusion Use of the ReHand tablet application for early rehabilitation after carpal tunnel release is more effective in the recovery of functional ability than a conventional home exercise program. It remains unclear whether there are any benefits in grip strength, pain or dexterity. Trial registration ACTRN12618001887268. [ABSTRACT FROM AUTHOR]

Question Do people with musculoskeletal conditions better adhere to their home exercise programs when these are provided to them on an app with remote support compared to paper handouts? Design Randomised, parallel-group trial with intention-to-treat analysis. Participants Eighty participants with upper or lower limb musculoskeletal conditions were recruited to the trial. Each participant was prescribed a 4-week home exercise program by a physiotherapist at a tertiary teaching hospital in Australia. Participants were randomly assigned via a computer-generated concealed block randomisation procedure to either intervention (n = 40) or control (n = 40) groups. Intervention Participants in the intervention group received their home exercise programs on an app linked to the freely available website www.physiotherapyexercises.com . They also received supplementary phone calls and motivational text messages. Participants in the control group received their home exercise programs as a paper handout. Outcome measures Blinded assessors collected outcome measures at baseline and 4 weeks. The primary outcome was self-reported exercise adherence. There were five secondary outcomes, which captured functional performance, disability, patient satisfaction, perceptions of treatment effectiveness, and different aspects of adherence. Results Outcomes were available on 77 participants. The mean between-group difference for self-reported exercise adherence at 4 weeks was 1.3/11 points (95% CI 0.2 to 2.3), favouring the intervention group. The mean between-group difference for function was 0.9/11 points (95% CI 0.1 to 1.7) on the Patient-Specific Functional Scale, also favouring the intervention group. There were no significant between-group differences for the remaining outcomes. Conclusion People with musculoskeletal conditions adhere better to their home exercise programs when the programs are provided on an app with remote support compared to paper handouts; however, the clinical importance of this added adherence is unclear. Trial registration ACTRN12616000066482. [Lambert TE, Harvey LA, Avdalis C, Chen LW, Jeyalingam S, Pratt CA, Tatum HJ, Bowden JL, Lucas BR (2017) An app with remote support achieves better adherence to home exercise programs than paper handouts in people with musculoskeletal conditions: a randomised trial. Journal of Physiotherapy 63: 161–167] [ABSTRACT FROM AUTHOR]

Abstract: The ability to critically analyse surgical papers is an important skill that all surgeons should possess. This article describes a simple two-step approach to the appraisal of scientific literature. It relies on a rapid review based on the abstract followed by a detailed review based on simple checklists. These can be applied to systematic reviews, randomized trials and observational studies. At the end of the process, the quality of the methods, quality of the results and applicability of the work are evaluated to formulate an opinion on overall quality. The article ends with a suggested format for writing a report based on such an appraisal. [Copyright &y& Elsevier]

Objective Friction foot blisters are a common injury occurring in up to 39% of marathoners, the most common injury in adventure racing, and represent more than 70% of medical visits in multi-stage ultramarathons. The goal of the study was to determine whether paper tape could prevent foot blisters in ultramarathon runners. Methods This prospective randomized trial was undertaken during RacingThePlanet 155-mile (250-km), 7-day self-supported ultramarathons in China, Australia, Egypt, Chile, and Nepal in 2010 and 2011. Paper tape was applied prerace to one randomly selected foot, with the untreated foot acting as the own control. The study end point was development of a hot spot or blister on any location of either foot. Results One hundred thirty-six participants were enrolled with 90 (66%) having completed data for analysis. There were 36% women, with a mean age of 40 ± 9.4 years (range, 25–40 years) and pack weight of 11 ± 1.8 kg (range, 8–16 kg). All participants developed blisters, with 89% occurring by day 2 and 59% located on the toes. No protective effect was observed by the intervention (47 versus 35; 52% versus 39%; P = .22), with fewer blisters occurring around the tape on the experimental foot than under the tape (23 vs 31; 25.6% versus 34.4%), yet 84% of study participants when queried would choose paper tape for blister prevention in the future. Conclusions Although paper tape was not found to be significantly protective against blisters, the intervention was well tolerated with high user satisfaction. [ABSTRACT FROM AUTHOR]

The measurement of proglucagon-derived peptides (PGDPs) is a challenging task mainly due to major overlaps in their molecular sequence in addition to their low circulating levels. Here, we present the technical characteristics of novel ELISA assays measuring C-peptide and all six PGDPs including, for the first time, major proglucagon fragment (MPGF), and we validate them by performing a pilot in vivo cross-over randomized clinical trial on whether coffee consumption may affect levels of circulating PGDPs. The performance and technical characteristics of novel ELISA assays from Ansh measuring GLP-1, GLP-2, oxyntomodulin, glicentin, glucagon, MPGF and C-peptide were first evaluated in vitro in procured samples from a commercial vendor as well as in deidentified human samples from three previously performed clinical studies. Their performance was further evaluated in vivo in the context of a cross-over randomized controlled trial, in which 33 subjects consumed in random order and together with a standardized meal, 200 ml of either (a) instant coffee with 3 mg/kg caffeine, or (b) instant coffee with 6 mg/kg caffeine, (c) or water. All assays demonstrated high accuracy (spike and recovery and average linearity recovery ±15%), precision (inter-assay CV ≤ 6.4%), specificity (no significant cross-reactivities) and they were sensitive in low concentrations. Measurements of glicentin in archived random human samples using the Ansh assay correlated strongly with the glicentin measurements of Mercodia assay (r = 0.968) and of GLP-1 modestly with Millipore GLP-1 assay (r = 0.440). Oxyntomodulin, glicentin and glucagon concentrations were 2–5 fold higher in plasma compared to serum and serum concentrations correlated modestly (for oxyntomodulin and glicentin) or poorly (for glucagon) with the plasma concentrations. The evaluated assays detected a postprandial increase of gut-secreted PGDPs (GLP-1, GLP-2, oxyntomodulin and glicentin) and a postprandial decrease of pancreas-secreted PGDPs (glucagon, MPGF) in response to consuming coffee in comparison to consuming water with breakfast (enter here composition of breakfast). Only coffee consumption at the high dose alter levels of gut-secreted PGDPs and both at low and high dose to lower levels of pancreas-secreted PGDPs compared to water consumption during breakfast. Accurate, precise and specific measurement of six PGDPs is possible with novel assays. A randomized controlled trial demonstrated in vivo utility of those assays and supports the notion that coffee may exert part of its beneficial effects on glucose homeostasis in the short term through the regulation of PGDPs. • Sequences of PGDPs are overlapping and their low circulating levels make their measurement difficult. • Novel assays can perform an accurate, precise, and specific measurement of PGDPs. • Regulation of glucose homeostasis by coffee may occur through altering circulating levels of PGDPs. [ABSTRACT FROM AUTHOR]

Abstract: This review summarises all trauma and related papers published in the British Journal of Oral and Maxillofacial Surgery (BJOMS) from January 2010 to December 2011. In total 45 articles were published, of which 42% (19) were full-length articles. These articles primarily focused on the management of mandibular condyle and orbital fractures, with several papers discussing maxillofacial surgery by the British military. There were no articles discussing midfacial fractures or massive facial trauma. The remaining papers included short communications, technical notes, and letters; and provided discussion of interesting cases, new surgical techniques and fracture classifications. The number of trauma papers published in BJOMS appears to be less than other sub-specialties such as head and neck oncology. The number of prospective and randomised studies remains low, highlighting a need to foster further research within maxillofacial trauma. [Copyright &y& Elsevier]

Abstract: Research is an essential part of surgical training, so a surgical trainee must publish to prosper. The most important piece of advice is to seek expert help before commencing the process of research and subsequent publication. Having a piece of research worthy of communication to peers is an essential prerequisite, but there are many different types of publication, and many different avenues for publication. Starting with a simple case report is often a good beginning; publication in high-profile, high-impact-factor journals requires high-quality research such as randomized trials or systematic reviews. The more high profile the research, the more likely there are to be formal rules about its conduct and its publication (CONSORT, PRISMA etc). Writing in scientific English requires economy of style and linguistic restraint; many readers will not have English as a first language. By convention, scientific articles are written in IMRAD style – introduction, methods, results and discussion. This author has evolved a method to make writing a scientific manuscript as painless as possible. It may be tempting to relax once the writing is complete, but managing the paper through submission can also be challenging. Most journals will not accept a paper immediately, but will require corrections suggested by independent referees after formal peer review. All dealings with journal editors should be professional and courteous. [Copyright &y& Elsevier]

Abstract: This paper provides a summary of the 49 trauma and related papers published in British Journal of Oral and Maxillofacial Surgery during the period January 2008 to December 2009. 16/49 (32%) of these publications were full length articles, which covered areas such as epidemiology, service provision, materials and operative surgery. In addition there were other articles including short communications, technical notes, letters to the editor and interesting cases. Whilst fewer full length articles were published compared to the other sub-specialties, it was reassuring to see that the studies represent all aspects of trauma. More basic science and randomized control studies relating to trauma need to be encouraged. [ABSTRACT FROM AUTHOR]

Abstract: The incidence of Cholangiocellular carcinoma (CCA) is increasing, due to a sharp increase of the intra-hepatic form. Evidence-ascertained risk factors for CCA are primary sclerosing cholangitis, Opistorchis viverrini infection, Caroli disease, congenital choledocal cist, Vater ampulla adenoma, bile duct adenoma and intra-hepatic lithiasis. Obesity, diabetes, smoking, abnormal biliary-pancreatic junction, bilio-enteric surgery, and viral cirrhosis are emerging risk factors, but their role still needs to be validated. Patients with primary sclerosing cholangitis should undergo surveillance, even though a survival benefit has not been clearly demonstrated. CCA is most often diagnosed in an advanced stage, when therapeutic options are limited to palliation. Diagnosis of the tumor is often difficult and multiple imaging techniques should be used, particularly for staging. Surgery is the standard of care for resectable CCA, whilst liver transplantation should be considered only in experimental settings. Metal stenting is the standard of care in inoperable patients with an expected survival >4 months. Gemcitabine or platinum analogues are recommended in advanced CCA whilst there are no validated neo-adjuvant treatments or second-line chemotherapies. Even though promising results have been obtained in CCA with radiotherapy, further randomized controlled trials are needed. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed was done to analyze recent trends in nursing research published in the Journal of Korean Academy of Nursing by focusing on the content of nursing interventions and their level of evidence. Methods: A total of 209 studies published between 2007 and 2008 were reviewed using analysis criteria developed by the researchers. Results: The number of quantitative studies was greater than that of qualitative studies. There was a slight increase in the number of qualitative studies and studies including elderly populations, which reflects the recent population trend in Korea. More randomized controlled trials with a low risk of bias were needed to support more evidence-based nursing practice. Concerning the low rate of ethical consideration, stricter application of research ethics needs to be encouraged. Conclusion: The findings of this study suggest the recent trends in nursing research and the direction of nursing research and review in the Journal. [ABSTRACT FROM AUTHOR]

The article offers information on reduction of disease activity in axial spondyloarthritis from High intensity exercise for three months, as compared with standard care.

Background: The cost-effectiveness of using a mobile diary app as an adjunct in dialectical behavior therapy (DBT) in patients with borderline personality disorder is unknown.Objective: This study aims to perform an economic evaluation of a mobile diary app compared with paper-based diary cards in DBT treatment for patients with borderline personality disorder in a psychiatric outpatient facility.Methods: This study was conducted alongside a pragmatic, multicenter, randomized controlled trial. The participants were recruited at 5 Danish psychiatric outpatient facilities and were randomized to register the emotions, urges, and skills used in a mobile diary app or on paper-based diary cards. The participants in both groups received DBT delivered by the therapists. A cost-consequence analysis with a time horizon of 12 months was performed. Consequences included quality-adjusted life years (QALYs), depression severity, borderline severity, suicidal behavior, health care use, treatment compliance, and system usability. All relevant costs were included. Focus group interviews were conducted with patients, therapists, researchers, and industry representatives to discuss the potential advantages and disadvantages of using a mobile diary app.Results: A total of 78 participants were included in the analysis. An insignificantly higher number of participants in the paper group dropped out before the start of treatment (P=.07). Of those starting treatment, participants in the app group had an average of 37.1 (SE 27.55) more days of treatment and recorded an average of 3.16 (SE 5.10) more skills per week than participants in the paper group. Participants in both groups had a QALY gain and a decrease in depression severity, borderline severity, and suicidal behavior. Significant differences were found in favor of the paper group for both QALY gain (adjusted difference -0.054; SE 0.03) and reduction in depression severity (adjusted difference -1.11; SE 1.57). The between-group difference in total costs ranged from US $107.37 to US $322.10 per participant during the 12 months. The use of services in the health care sector was similar across both time points and groups (difference: psychiatric hospitalization <5 and <5; general practice -1.32; SE 3.68 and 2.02; SE 3.19). Overall, the patients showed high acceptability and considered the app as being easy to use. Therapists worried about potential negative influences on the therapist-patient interaction from new work tasks accompanying the introduction of the new technology but pointed at innovation potential from digital database registrations.Conclusions: This study suggests both positive and negative consequences of mobile diary apps as adjuncts to DBT compared with paper diary cards. More research is needed to draw conclusions regarding its cost-effectiveness.Trial Registration: ClinicalTrials.gov NCT03191565; http://clinicaltrials.gov/ct2/show/NCT03191565.International Registered Report Identifier (irrid): RR2-10.2196/17737. [ABSTRACT FROM AUTHOR]

Background: Electronic recording of vital sign observations (e-Obs) has become increasingly prevalent in hospital care. The evidence of clinical impact for these systems is mixed. Objective: The objective of our study was to assess the effect of e-Obs versus paper documentation (paper) on length of stay (time between trauma unit admission and "fit to discharge") for trauma patients. Methods: A single-center, randomized stepped-wedge study of e-Obs against paper was conducted in two 26-bed trauma wards at a medium-sized UK teaching hospital. Randomization of the phased intervention order to 12 study areas was computer generated. The primary outcome was length of stay. Results: A total of 1232 patient episodes were randomized (paper: 628, e-Obs: 604). There were 37 deaths in hospital: 21 in the paper arm and 16 in the e-Obs arm. For discharged patients, the median length of stay was 5.4 (range: 0.2-79.0) days on the paper arm and 5.6 (range: 0.1-236.7) days on the e-Obs arm. Competing risks regression analysis for time to discharge showed no difference between the treatment arms (subhazard ratio: 1.05; 95% CI 0.82-1.35; P=.68). A greater proportion of patient episodes contained an Early Warning Score (EWS) ≥3 using the e-Obs system than using paper (subhazard ratio: 1.63; 95% CI 1.28-2.09; P<.001). However, there was no difference in the time to the subsequent observation, "escalation time" (hazard ratio 1.05; 95% CI 0.80-1.38; P=.70). Conclusions: The phased introduction of an e-Obs documentation system was not associated with a change in length of stay. A greater proportion of patient episodes contained an EWS≥3 using the e-Obs system, but this was not associated with a change in "escalation time." Trial Registration: ISRCTN Registry ISRCTN91040762; http://www.isrctn.com/ISRCTN91040762 (Archived by WebCite at http://www.webcitation.org/72prakGTU) [ABSTRACT FROM AUTHOR]

Copyright of African Journal of Reproductive Health is the property of Women's Health & Action Research Centre and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The article presents a synopsis on comprehensive non-surgical treatment which leads to improved walking ability in people with lumbar spinal stenosis. Topics discussed include dominant symptom of people with lumbar spinal stenosis; marginal differences between treatment groups in other more traditional outcomes; and training program offered to the comprehensive training and motivated patients.

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

The article discusses the airway pressure for infants with meconium aspiration syndrome which includes mechanical ventilation and medical care .

The article focuses on a 12-week pedometer-based intervention, delivered in primary care, produces long-term gains in physical activity. It mentions study illuminate the potential of pragmatic, pedometer-based interventions to impact on activity levels over more extended time frames; and also mentions the natural overlap between rehabilitation and physical activity presents an opportunity for physiotherapists to respond to major public health issue.

The article focuses on the effectiveness of inpatient rehabilitation for improving activities and participation in patients with multiple sclerosis (MS). It mentions whilst quality of life appeared to ‘substantially' improve on all measures at discharge within the treatment group; and also mentions comprehensive description of the intervention and its context is therefore essential to reliably implement interventions shown to be useful, and replicate or build on research findings.

The article focuses on a 12-week pedometer-based intervention, delivered in primary care, produces long-term gains in physical activity. It mentions the multi-component intervention included a pedometer, keeping a step-count diary, 12 weeks of goal setting, and a handbook that included behaviour change techniques; and also mentions participants in the control group were provided with a pedometer and instructions with no further support.

This study assessed the current evidence for the use of TMJR reconstruction in skeletally immature patients. A systematic review was conducted according to PRISMA guidelines. An electronic search in PubMed and Embase was performed. Meta-analysis randomized controlled trials (RCTs), cohort studies, observational studies, case series, and case reports were eligible for inclusion. Case reports were also included due to the limited number of publications identified with the predefined terms. Exclusion criteria were: (1) studies written in a language other than English; (2) full-text unavailability (i.e., posters and conference abstracts). The selected studies were assessed for risk of bias. A meta-analysis was not performed as it necessitates a substantial between-study design homogeneity; hence, a descriptive synthesis of data was performed. There were 9 TMJR device reconstruction studies involving 14 subjects 13 years of age or younger. Follow-up ranged from 7 months to 120 months. All papers reported significant decrease in pain and improvement of diet. All prostheses were functional. No material failures of the prosthesis components were observed. The mandible continued to show limited growth following TMJR and most of the cases required no secondary or revision surgery even when the patient reached skeletal maturity. This systematic review had some limitations. The studies included had a low level of evidence and a high risk of bias. Most of the studies had a small patient sample, and no study had a control group. The literature reviewed supports the use of TMJR devices in the restoration of mandibular function and form in skeletally immature patients. There has been increased discussion about how best to manage TMJ reconstruction in skeletally immature patients; namely, whether to utilize autogenous grafts or alloplastic devices. While autogenous grafts have been classically considered the first treatment option in such cases, those grafts are not without reports of complications and failures. Therefore, surgeons have recently looked to alloplastic reconstruction as a way to deliver more stable and predictable outcomes, especially in cases of relapse and prior failure. To provide some information on this issue, a systematic review of the literature was conducted to assess the current evidence for the use of the TMJR reconstruction option in skeletally immature patients. [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.

This review summarises all orthognathic and related papers published between January 2011 and December 2012 in the British Journal of Oral and Maxillofacial Surgery (BJOMS). A total of 36 articles were published, a high proportion of which (78%) were full-length papers. The remainder consisted of short communications and technical notes. The topics included operative planning and postoperative outcomes, and there was a strong focus on distraction osteogenesis. There were fewer orthognathic articles published in BJOMS than articles on other subspecialties such as trauma or head and neck oncology. Only 8 (29%) of the full-length articles were prospective studies or randomised trials, which highlights a need for well-designed clinical studies in orthognathic research. [ABSTRACT FROM AUTHOR]

Aim. Around 2.5% of Poles will develop post-traumatic stress disorder (PTSD) during their lifetime. Recent events, i.e. the pandemic and the war in Ukraine, are the factors that will increase the number of people dealing with PTSD. Owing to that, this paper aims to review and familiarise readers with the available scientific evidence on psychotherapies of PTSD provided in Poland. Method. A review of meta-analyses of randomised controlled trials and a review of the most recent treatment guidelines concerning PTSD. Results. The best available evidence points to high efficacy of cognitive-behavioural therapy (CBT) with prolonged exposure and Eye Movement Desensitisation and Reprocessing (EMDR). Humanistic therapy also proves effective to a certain degree, but not as effective as therapies that use exposure to stimuli and memories associated with trauma. There is no evidence of the efficacy of psychodynamic therapy and methods based on polyvagal theory. Organisations preparing guidelines recommend primarily CBT and EMDR. Conclusions. Efficacious treatment of PTSD should include a protocol with a component of exposure to trauma-related memories and stimuli. It is recommended to use such therapies in the psychotherapeutic treatment of PTSD. [ABSTRACT FROM AUTHOR]

Background: There is growing interest in the use of information communication technologies to treat obesity. An intervention delivered by smartphone could be a convenient, potentially cost-effective, and wide-reaching weight management strategy. Although there have been studies of texting-based interventions and smartphone applications (apps) used as adjuncts to other treatments, there are currently no randomized controlled trials (RCT) of a stand-alone smartphone application for weight loss that focuses primarily on self-monitoring of diet and physical activity. Objective: The aim of this pilot study was to collect acceptability and feasibility outcomes of a self-monitoring weight management intervention delivered by a smartphone app, compared to a website and paper diary. Methods: A sample of 128 overweight volunteers were randomized to receive a weight management intervention delivered by smartphone app, website, or paper diary. The smartphone app intervention, My Meal Mate (MMM), was developed by the research team using an evidence-based behavioral approach. The app incorporates goal setting, self-monitoring of diet and activity, and feedback via weekly text message. The website group used an existing commercially available slimming website from a company called Weight Loss Resources who also provided the paper diaries. The comparator groups delivered a similar self-monitoring intervention to the app, but by different modes of delivery. Participants were recruited by email, intranet, newsletters, and posters from large local employers. Trial duration was 6 months. The intervention and comparator groups were self-directed with no ongoing human input from the research team. The only face-to-face components were at baseline enrollment and brief follow-up sessions at 6 weeks and 6 months to take anthropometric measures and administer questionnaires. Results: Trial retention was 40/43 (93%) in the smartphone group, 19/42 (55%) in the website group, and 20/43 (53%) in the diary group at 6 months. Adherence was statistically significantly higher in the smartphone group with a mean of 92 days (SD 67) of dietary recording compared with 35 days (SD 44) in the website group and 29 days (SD 39) in the diary group (P<.001). Self-monitoring declined over time in all groups. In an intention-to-treat analysis using baseline observation carried forward for missing data, mean weight change at 6 months was -4.6 kg (95% CI -6.2 to -3.0) in the smartphone app group, -2.9 kg (95% CI -4.7 to -1.1) in the diary group, and -1.3 kg (95% CI -2.7 to 0.1) in the website group. BMI change at 6 months was -1.6 kg/m2 (95% CI -2.2 to -1.1) in the smartphone group, -1.0 kg/m2 (95% CI -1.6 to -0.4) in the diary group, and -0.5 kg/m2 (95% CI -0.9 to 0.0) in the website group. Change in body fat was -1.3% (95% CI -1.7 to -0.8) in the smartphone group, -0.9% (95% CI -1.5 to -0.4) in the diary group, and -0.5% (95% CI -0.9 to 0.0) in the website group. Conclusions: The MMM app is an acceptable and feasible weight loss intervention and a full RCT of this approach is warranted. Trial Registration: ClinicalTrials.gov NCT01744535; http://clinicaltrials.gov/ct2/show/NCT01744535 (Archived by WebCite at http://www.webcitation.org/6FEtc3PVB) (J Med Internet Res 2013;15(4):e32) [ABSTRACT FROM AUTHOR]

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.

Background: Major international guidelines recommend mental health screening during the perinatal period. However, substantial barriers to screening have been reported by pregnant and postpartum women and perinatal care providers. E-screening offers benefits that may address implementation challenges.Objective: The primary objective of this randomized controlled trial was to evaluate the feasibility and acceptability of Web-based mental health e-screening compared with paper-based screening among pregnant women. A secondary objective was to identify factors associated with women's preferences for e-screening and disclosure of mental health concerns.Methods: Pregnant women recruited from community and hospital-based antenatal clinics and hospital-based prenatal classes were computer-randomized to a fully automated Web-based e-screening intervention group or a paper-based control group. Women were eligible if they spoke or read English, were willing to be randomized to e-screening, and were willing to participate in a follow-up diagnostic interview. The intervention group completed the Antenatal Psychosocial Health Assessment and the Edinburgh Postnatal Depression Scale on a tablet computer, while controls completed them on paper. All women completed self-report baseline questions and were telephoned 1 week after randomization by a blinded research assistant for a MINI International Neuropsychiatric Interview. Renker and Tonkin's tool of feasibility and acceptability of computerized screening was used to assess the feasibility and acceptability of e-screening compared with paper-based screening. Intention-to-treat analysis was used. To identify factors associated with preference for e-screening and disclosure, variables associated with each outcome at P<.20 were simultaneously entered into final multivariable models to estimate adjusted odds ratios (AORs) and 95% CIs.Results: Of the 675 eligible women approached, 636 agreed to participate (participation rate 94.2%) and were randomized to the intervention (n=305) or control (n=331) groups. There were no significant baseline differences between groups. More women in the e-screening group strongly or somewhat agreed that they would like to use a tablet for answering questions on emotional health (57.9%, 175/302 vs 37.2%, 121/325) and would prefer using a tablet to paper (46.0%, 139/302 vs 29.2%, 95/325), compared with women in the paper-based screening group. There were no differences between groups in women's disclosure of emotional health concerns (94.1%, 284/302 vs 90.2%, 293/325). Women in the e-screening group consistently reported the features of e-screening more favorably than controls (more private or confidential, less impersonal, less time-consuming). In the multivariable models, being in the e-screening group was significantly associated with preferring e-screening (AOR 2.29, 95% CI 1.66-3.17), while no factors were significantly associated with disclosure.Conclusions: The findings suggest that mental health e-screening is feasible and acceptable to pregnant women.Trial Registration: Clinicaltrials.gov NCT01899534; https://clinicaltrials.gov/ct2/show/NCT01899534 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb). [ABSTRACT FROM AUTHOR]

Background: The use of the Internet to administer questionnaires has many potential advantages over the use of pen-and-paper administration. Yet it is important to validate Internet administration, as most questionnaires were initially developed and validated for pen-and-paper delivery. While some have been validated for use over the Internet, these questionnaires have predominately been used amongst the healthy general population. To date, information is lacking on the validity of questionnaires administered over the Internet in patients with chronic diseases such as heart failure. Objectives: To determine the validity of three heart failure questionnaires administered over the Internet compared to pen-and-paper administration in patients with heart failure. Methods: We conducted a prospective randomized study using test-retest design comparing administration via the Internet to pen-and-paper administration for three heart failure questionnaires provided to patients recruited from a heart failure clinic in Toronto, Ontario, Canada: the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Self-Care Heart Failure Index (SCHFI). Results: Of the 58 subjects enrolled, 34 completed all three questionnaires. The mean difference and confidence intervals for the summary scores of the KCCQ, MLHFQ, and SCHFI were 1.2 (CI -1.5 to 4.0, scale from 0 to 100), 4.0 (CI -1.98 to 10.04, scale from 0 to 105), and 10.1 (CI 1.18 to 19.07, scale from 66.7 to 300), respectively. Conclusions: Internet administration of the KCCQ appears to be equivalent to pen-and-paper administration. For the MLHFQ and SCHFI, we were unable to demonstrate equivalence. Further research is necessary to determine if the administration methods are equivalent for these instruments. [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]

Background: The Institute of Medicine recommends Survivorship Care Plans (SCPs) for all cancer survivors. However, it is unclear whether certain patient groups may or may not benefit from SCPs.Objective: The aim was to assess whether the effects of an automatically generated paper SCP on patients' satisfaction with information provision and care, illness perceptions, and health care utilization were moderated by disease-related Internet use.Methods: Twelve hospitals were randomized to either SCP care or usual care in the pragmatic cluster randomized Registrationsystem Oncological GYnecology (ROGY) Care trial. Newly diagnosed endometrial cancer patients completed questionnaires after diagnosis (N=221; response: 74.7%, 221/296), 6 months (n=158), and 12 months (n=147), including patients' satisfaction with information provision and care, illness perceptions, health care utilization (how many times patients visited a medical specialist or primary care physician about their cancer in the past 6 months), and disease-related Internet use (whether patients used the Internet to look for information about cancer).Results: In total, 80 of 221 (36.2%) patients used the Internet to obtain disease-related information. Disease-related Internet use moderated the SCP care effect on the amount of information received about the disease (P=.03) and medical tests (P=.01), helpfulness of the information (P=.01), and how well patients understood their illness (P=.04). All stratified analyses were not statistically significant. However, it appeared that patients who did not seek disease-related information on the Internet in the SCP care arm reported receiving more information about their disease (mean 63.9, SD 20.1 vs mean 58.3, SD 23.7) and medical tests (mean 70.6, SD 23.5 vs mean 64.7, SD 24.9), finding the information more helpful (76.7, SD 22.9 vs mean 67.8, SD 27.2; scale 0-100), and understanding their illness better (mean 6.6, SD 3.0 vs mean 6.1, SD 3.2; scale 1-10) than patients in the usual care arm did. In addition, although all stratified analyses were not significant, patients who did seek disease-related information on the Internet in the SCP care arm appeared to receive less information about their disease (mean 65.7, SD 23.4 vs mean 67.1, SD 20.7) and medical tests (mean 72.4, SD 23.5 vs mean 75.3, SD 21.6), did not find the information more helpful (mean 78.6, SD 21.2 vs mean 76.0, SD 22.0), and reported less understanding of their illness (mean 6.3, SD 2.8 vs mean 7.1, SD 2.7) than patients in the usual care arm did.Conclusions: Paper SCPs appear to improve the amount of information received about the disease and medical tests, the helpfulness of the information, and understanding of the illness for patients who do not search for disease-related information on the Internet. In contrast, paper SCPs do not seem beneficial for patients who do seek disease-related information on the Internet.Trial Registration: ClinicalTrials.gov NCT01185626; https://clinicaltrials.gov/ct2/show/NCT01185626 (Archived by WebCite at http://www.webcitation.org/6fpaMXsDn). [ABSTRACT FROM AUTHOR]

INTRODUCTION: The development of biomarkers for Alzheimer's disease (AD) has allowed researchers to increase sample homogeneity and test candidate treatments earlier in the disease. The integration of biomarker "screening" criteria should be met with a parallel implementation of standardized methods to disclose biomarker testing results to research participants; however, the extent to which protocolized disclosure occurs in trials is unknown. METHODS: We reviewed the literature to identify prodromal AD trials published in the past 10 years. From these, we quantified the frequency of biomarker disclosure reporting and the depth of descriptions provided. RESULTS: Of 30 published trials using positron emission tomography or cerebrospinal fluid‐based amyloid positivity as an eligibility criterion, only one mentioned disclosure, with no details on methods. DISCUSSION: Possible reasons for and implications of this information gap are discussed. Recommendations are provided for trialists considering biomarker screening as part of intervention trials focused on prodromal AD. HIGHLIGHTS: Few prodromal Alzheimer's disease (AD) trial papers discuss biomarker disclosure.Disclosure has implications for participants, family members, and trial success.Disclosure must be consistently integrated and reported in prodromal AD trials.Best practice guidelines and training resources for disclosure are needed. [ABSTRACT FROM AUTHOR]

Objectives: Nausea is one of the most important symptoms of patients undergoing chemotherapy. This study aims to determine the effects of aromatherapy with sour lemon on nausea in patients undergoing chemotherapy. Methods: A total of 50 patients undergoing chemotherapy were randomly assigned to experimental and placebo (control) groups. The two groups completed the visual analogue scale for nausea before and the first to the fourth week after starting the intervention. The intervention was performed during chemotherapy. Using a dropper, a paper towel was saturated with 3 drops of sour lemon essential oil; however, for the control group, 3 mL of water as a placebo was spread on a paper towel. The intervention in the experimental and control groups was performed once a week for 4 weeks during weekly chemotherapy sessions. Results: At the beginning of the study, no significant difference was observed between the mean score of nausea in the two groups (P>0.05). The first to the fourth week after starting the intervention, significant differences were observed between the mean score of nausea in the two groups (P<0.05). The results of the repeated measures analysis of variance indicated that the mean score of nausea changed over time in the experimental group, indicating a gradual decrease in the mean score of nausea (P<0.05). Discussion: Our findings indicated that aromatherapy with sour lemon can be effective in reducing nausea in patients undergoing chemotherapy. [ABSTRACT FROM AUTHOR]

The present scoping review focused upon the functional benefits of hard martial arts training for older adults. The AXIS Critical Appraisal Tool was used to appraise all studies included in the review. A systematic literature search identified 265 papers via electronic database and ten papers from additional sources. Of these, six studies featuring 240 participants were included in the final scoping review. Of the included studies, three were randomized control trials and three were comparative studies with concurrent controls. The available studies outlined improvements in functional fitness parameters for older adults participating in hard martial arts training (strength 9.3-34%; mobility 9.5-13.6%; aerobic endurance 13.4%; flexibility 11.1-316.7%; balance 20.5%). However, inconsistencies in training stimulus and a limited number of studies highlight the need for further research before hard martial arts can be recommended for older adults. Based upon the limited available literature, to improve functional fitness, hard martial arts training should be conducted for 60 to 90 minutes, at least twice a week for a minimum of eleven weeks. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures (PROMs) are increasingly used to measure patient's perspective of functional well-being, disease burden, treatment effectiveness, and clinical decision making. Electronic versions are increasingly feasible because of smartphone and tablet usage. However, validation of these electronic PROMs (ePROMs) is warranted for justified implementation. The International Index of Erectile Function (IIEF) 5 and 15 are widely used PROMs in urology to measure erectile dysfunction. Measurement reliability and validity testing of the IIEF ePROMs are essential before clinical application.Objective: The aim of this study was to assess reliability and validity of an ePROM version of both IIEF-5 and 15.Methods: This study included 179 patients from our urology outpatient clinic. It also had a randomized crossover design-participants completed either a paper and electronic IIEF-5 or 15 or twice completed an electronic version-with a 5-day delay. Internal consistency was assessed using Cronbach alpha and Spearman-Brown coefficient, test-retest reliability using the intraclass correlation coefficient (ICC), and convergent validity using the Pearson and Spearman correlation coefficient.Results: A total of 122 participants completed the study. Internal consistency was excellent for the electronic IIEF-5 (ICC 0.902) and good to excellent for the domains of the IIEF-15 (ICC 0.962-0.834). Test-retest reliability was excellent for the IIEF-5 (ICC 0.924) and good to excellent for the domains of the IIEF-15 (ICC 0.950-0.778). Convergent validity was excellent for the IIEF-5 and IIEF-15, with a correlation of r=0.923 and r=0.951, respectively.Conclusions: We successfully introduced patient-acceptable ePROM versions of the IIEF-5 and IIEF-15. This study's results demonstrate that the ePROM versions of the IIEF-5 and IIEF-15 can be reliably implemented, as outcomes are reliable and in accordance with findings of the paper version.Trial Registration: ClinicalTrials.gov NCT03222388; https://clinicaltrials.gov/ct2/show/NCT03222388. [ABSTRACT FROM AUTHOR]

Copyright of International Annals of Criminology is the property of Cambridge University Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The use of information from real world to assess the effectiveness of medical products is becoming increasingly popular and more acceptable by regulatory agencies. According to a strategic real-world evidence framework published by U.S. Food and Drug Administration, a hybrid randomized controlled trial that augments internal control arm with real-world data is a pragmatic approach worth more attention. In this paper, we aim to improve on existing matching designs for such a hybrid randomized controlled trial. In particular, we propose to match the entire concurrent randomized clinical trial (RCT) such that (1) the matched external control subjects used to augment the internal control arm are as comparable as possible to the RCT population, (2) every active treatment arm in an RCT with multiple treatments is compared with the same control group, and (3) matching can be conducted and the matched set locked before treatment unblinding to better maintain the data integrity and increase the credibility of the analysis. Besides a weighted estimator, we also introduce a bootstrap method to obtain its variance estimation. The finite sample performance of the proposed method is evaluated by simulations based on data from a real clinical trial. [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Health History is the property of University of Toronto Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The aim of this review was to compare mandibular angle fracture fixation methods that were evaluated through randomized clinical trials considering postoperative complications. Additionally, different treatment methods were ranked based on their performance. A systematic review was performed based on the Cochrane and PRISMA guidelines. The quality of evidence and network meta-analysis were conducted using the GRADE tool and R software, respectively. Four databases were searched, and the papers were selected based on the PICOS strategy. A total of 3584 papers were found. After screening 15 papers were included. One plate placed on lateral border (tension zone) presented lower risk than one plate placed on superior border (tension zone) for infection [risk ratio (RR): 0.48, 95% confidence interval (CI): 0.33 to 0.71] and plate removal necessity (RR: 0.44, 95% CI: 0.28 to 0.69), with moderate quality of evidence. There were no significant differences among the mandibular angle fracture treatments for malocclusion and paraesthesia outcomes. In conclusion, one plate placed on the lateral border in the tension zone is the best choice regarding postoperative infection and plate removal necessity when fixing mandibular angle fractures. None of the tested fixation methods were associated with a significant risk of malocclusion and paraesthesia events. [ABSTRACT FROM AUTHOR]

Scaling up clean cooking is a priority to address the substantial health burden from exposure to household air pollution resulting from burning of polluting fuels. The costs of cooking equipment and fuel, as well as cooking behaviors, may present barriers to adoption and sustained use of clean cooking. This paper reports novel qualitative findings from a Randomized Controlled Trial (RCT) evaluating the effects of innovative energy-efficient cooking pots on sustained use of LPG for the first time in a low and middle-income setting. Semi-structured interviews (SSIs) were conducted with 22 of 200 cooks (LPG primary users) from an informal settlement in Nairobi, participating in the RCT. Data were analysed through thematic analysis. Reported benefits of the enhanced pots (compared to standard pots), included perceived fuel and time savings and prestige. Findings also indicate participants' willingness to pay for the pots and ways to support their scale. This study highlights the potential for energy-efficient pots in facilitating sustained/exclusive clean cooking with LPG and their ability to meet all cooking needs. This is relevant to informing commercial scalability of energy-efficient cookware in the local Kenyan market. • Adoption of clean cooking fuels such as LPG is a priority for sustainable development. • Cooking speed and heat retention were valued aspects of the tested innovative cookware • Innovative cookware can support greater uptake of LPG among low-income households. • Affordability is key for innovative cookware to be promoted in the Kenyan market. [ABSTRACT FROM AUTHOR]

Probation has been in existence in Singapore for more than 70 years. Given its long existence and vested interest in community-based sentencing, this paper calls for an effective measurement of probation officers training and supervision of the offenders measured against recidivism. First the paper focuses on the genesis and evolution of probation coupled with a brief description of programs conducted by probation officers since its introduction till its present iteration, along with its merits. The emphasis lies in the shift from a supervisory program to one which proactively seeks to transform behaviour, hence reaffirming remodelling character of probation. Second, it is recommended that effectiveness of training, supervision of offenders by Probation Officers be measured against the rate of recidivism. To this end, it is proposed that effectiveness of probation can only be measured against recidivism given that probation targets criminogenic needs of offenders. An evaluation of data presented on recidivism suggests that while the recidivism rate is decreasing, it does not maximize the potential role of Probation Officers. Third, training along the lines of Strategic Training Initiative in Community Supervision (STICs) program can be considered to enhance lower recidivism rates. Lastly, it is recommended that Randomized Controlled Trials (RCTs) be conducted for evidence-based policy making in criminal justice system, since RCTs can be useful in assessing the efficacy of probation as a community-based sentencing tool, particularly whether the policy orientation of probation meets the goal of reducing crime. [ABSTRACT FROM AUTHOR]

Introduction. The primary aim of this study was to provide a comparison of the effects of 2 commonly used pedagogical approaches (paper-based case studies vs authentic patient experiences) on clinical reasoning and critical thinking of secondyear entry-level physical therapy students. Current literature reveals a lack of consistency in how clinical reasoning is taught and assessed in physical therapist education. There is a need for evidence-based approaches to develop clinical reasoning in entry-level physical therapy students in the United States. Subjects. Twenty-three students in their second year of a Doctor of Physical therapy (DPT) degree program participated in this study. Methods. Participants were randomly assigned to a control group or to receive 1 of 2 supplemental learning activities (paper-based case studies or authentic patient experiences). Outcomes measured preintervention and postintervention included the Health Science Reasoning Test with Numeracy (HSRT-N) and the Self- Assessment of Clinical Reasoning and Re- flection (SACRR). Data analysis included a comparison of effect sizes of change scores between groups and correlational analysis of pretest scores and student factors. Results. Authentic patient experiences demonstrated a moderate to large effect size for improved HSRT-N scores on 5 of 8 subscales, compared with paper-based case studies. Authentic patient experiences demonstrated a moderate effect size for improved SACRR scores compared with the control group. Discussion and Conclusion. The use of authentic patient experiences may be more effective than paper-based case studies for improving critical thinking and clinical reasoning in an entry-level DPT curriculum. [ABSTRACT FROM AUTHOR]

A letter to the editor about the clarification provided by M. Kucera et al. on aspects of the treatment intervention used in the randomised controlled trial (RCT) of a study is presented.

Objective: To determine whether a musculoskeletal curriculum involving gamification via Kahoot! (an online classroom response system) was acceptable and more effective at teaching pediatric residents musculoskeletal knowledge and skills than a nongamified curriculum. Methods: A prospective, randomized controlled trial was conducted at an urban, academic pediatric clinic. All participants received a curriculum that included brief didactics and knowledge questions. The knowledge questions were delivered via Kahoot! to the intervention group and administered via paper to the control group. The primary outcome was knowledge and skill acquisition following curriculum participation. Results: A total of 73 of 85 (86%) residents completed the study (intervention group: 46; control group: 27). Following participation in the curriculum, intervention and control residents demonstrated an improvement in musculoskeletal knowledge (P < .05) measured via questionnaire, as well as an improvement in physical exam skills during a standardized patient encounter (P < .05). There was no difference in knowledge or skill improvement between groups. Intervention participants indicated positive attitudes toward Kahoot!. Conclusions: Our musculoskeletal curriculum demonstrated improvements in knowledge and skills among residents, though inclusion of Kahoot! did not enhance the experimental effect. Further research is needed to identify strategies to optimize gamification for learning. [ABSTRACT FROM AUTHOR]

Review of: Rosenstock J, Perkovic V, Johansen, OE, et al. Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial. JAMA. 2019;321:69-79. McGuire DK, Alexander JH, Johansen OE, et al. Linagliptin effects on heart failure and related outcomes in individuals with type 2 diabetes mellitus at high cardiovascular and renal risk in CARMELINA. Circulation. 2019;139:351-361. These two papers describe the findings from the CARMELINA trial (Cardiovascular and Renal Microvascular Outcome Study with Linagliptin): the first paper reported results for the primary cardiovascular composite outcome (cardiovascular [CV] death, nonfatal myocardial infarction [MI], or nonfatal stroke; 3-point major adverse cardiovascular event [3P-MACE]) and the key secondary renal composite outcome (renal death, end-stage kidney disease, or sustained ≥40% decrease in eGFR from baseline); the second paper reported secondary analyses of heart failure (HF) and related outcomes. The CARMELINA trial was a randomized, placebo-controlled, multicenter non-inferiority trial of adults with type 2 diabetes mellitus (T2DM) and elevated CV and renal risk. After a median 2.2-year follow-up of 6979 participants, patients allocated to linagliptin demonstrated no increase in the risk of 3P-MACE versus placebo: hazard ratio (HR) 1.02 [95% confidence interval (CI) 0.89-1.17]; P < 0.001 for non-inferiority. There was also no increase in the risk of hospitalization for HF for linagliptin versus placebo (HR 0.90 [0.74-1.08]). There was no increased risk of progression to end-stage kidney disease or death due to kidney disease (HR 0.87 [0.69-1.10]). Additionally, progression of albuminuria occurred less frequently in patients who received linagliptin versus placebo (HR 0.86 [0.78-0.95]). Overall, no new safety findings were identified for linagliptin, and no increased risk of hypoglycemia was observed for linagliptin versus placebo. Together, these findings from the CARMELINA trial reaffirm treatment guidelines for choosing additional therapies for patients with T2DM at elevated CV and/or renal risk, and provide new information on the role of linagliptin in the management of T2DM. [ABSTRACT FROM AUTHOR]

Background: In view of the complexity of dietary and nutritional education for most patients with type 2 diabetes mellitus (T2DM), a simplified approach called the "restricted diet with a plate" or "plate model" is recommended.Purpose: To evaluate whether the plate model can effectively improve glycemic control and cardiovascular risk markers in type 2 diabetes mellitus (T2DM), while reducing the time devoted to education and avoiding weight gain.Methods: The study was a randomized, multicenter, controlled study, conducted between October 2018 and October 2019, among patients with T2DM living in Nanjing. The study included 419 participants who were randomly divided into a plate group and a counting group. The plate model included three components: a low-literacy, color leaflet containing the explanation and composition of the plate model, health education, and medical visits. Patients in the counting group received health education, group medical visits, and a paper booklet containing traditional carbohydrate counting education. Primary outcomes were glycemic control and weight.Results: Participants in the plate model reduced HbA1c by 0.7% in the first three months, and reduced to a greater extent at six months (1.44%), but this was not sustained, and HbA1c increased slightly over the following six months. Fasting plasma glucose (FPG) and 2-h postprandial glucose (2hPG) values were significantly reduced at the endpoint in the plate model (9.25 ± 1.72% vs. 7.44 ± 0.88%, P = 0.008; 12.07 ± 2.94 vs. 8.35 ± 1.99%; P = 0.004); however, the 2hPG values decreased most significantly. Total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels decreased significantly in the plate group, which occurred at six months and lasted for 12 months. In the first three months, the average weight loss in the plate group was 1.2 kg/month (95% CI 0.92-1.48), and in the fourth to twelfth months, the average weight gain was 0.21 kg/month (95% CI 0.08-0.34). There was significant difference in education time between the groups (17.3 ± 4.42 vs. 38.6 ± 12.63; P < 0.001).Conclusions: The plate model is at least as effective as the counting model over the short term for glycemic control and perhaps even better for weight and lipid control. Plate model has the potential to improve education of those with low health literacy by reducing reading demands. [ABSTRACT FROM AUTHOR]

• The role of tranexamic acid in the management of traumatic brain injury remains controversial. • There is some evidence for efficacy however there are significant time constraints for administration of the drug. • There are circumstances where administration of the drug may cause harm. • This paper suggests that more research is required regarding use of a tranexamic acid. Evidence from recent trials evaluating efficacy of antifibrinolytic agents in the context of traumatic brain injury may lead to changes in the management of patients with traumatic brain injury. Tranexamic acid (TXA) reduces the proteolytic action of plasmin on fibrin clots, resulting in an inhibition of fibrinolysis and stabilisation of established blood clots. There has been significant interest in use of the drug as a therapeutic agent in the context of severe haemorrhage; however, considerable controversies regarding its efficacy remain. A number of trials have demonstrated a small but significant decrease in mortality following its administration, but the results have been somewhat inconsistent and may not be generalisable. The results of the CRASH-3 trial were that there was no statistical difference in the number of traumatic brain injury related deaths (18.5% with TXA and 19.8% with placebo; relative risk [RR] 0·94; 95% confidence interval [CI] 0·86–1·02). Nonetheless, there was a subgroup of patients for whom TXA appeared to provide benefit, and this was in patients with mild and moderate injury (with a Glasgow Coma Score > 8). This is potentially a very important finding that may have huge potential implications; however, we believe it does not currently provide indisputable evidence to support the administration of TXA to all patients with TBI. Further work is required to better define the subset of patients who may benefit as well as to evaluate the long-term functional benefit in order to determine which types of severe traumatic brain injury patients would derive more benefits than harms from TXA. [ABSTRACT FROM AUTHOR]

Safety evaluation is a continual and iterative process throughout the drug development life cycle and requires long time horizons and large amounts of data to fully understand the safety profile of a medical product. Although randomized clinical trials (RCT) provide high-quality data for an initial assessment of safety signals, the safety signals may not all have been known at the time of approval because safety data collected from RCT only involve a relatively small number of subjects during a relatively short follow-up period. The increased accumulation of post-marketing real-world data (RWD) presents an opportunity to utilize them for safety decision-making; these include identifying new safety signals, further characterization of safety concerns that are raised in pre-marketing RCT, and further generalization of RCT findings to the broader patient populations not previously studied in RCT. In this paper, we use cardiovascular safety outcome trial for antidiabetic therapies as an illustrative example and discuss how integrative analysis of RCT and observational study data can answer regulatory concerns about cardiovascular risk in a post-marketing setting. A novel statistical analysis strategy is proposed to combine both sources of safety data in a data fusion approach. The proposed approach includes three stages: (1) feasibility analysis that uses an RCT to validate an observational study, applying estimand framework and emulating RCT with RWD; (2) integrative analysis that combines evidence from the RCT and observational study data cooperatively; and (3) sensitivity analysis that examines the consistency of the previous analyses. Two potential utilities of the proposed integrative analysis for the cardiovascular safety outcome trial are discussed. [ABSTRACT FROM AUTHOR]