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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]

Primary paper mill sludge (PPMS) is the major waste expelled from the pulp and paper industries contributing soil and water pollution through the recalcitrant organic and inorganic constituents. These pollutants can, however, be transformed into a high-value soil ameliorating material with nominal investment and time. Current study therefore evaluated the potential of rotary drum composting PPMS for 20 days to delineate an environmentally sustainable option. Five trials with proportions of PPMS, cow dung and saw dust: Trial 1 (10:0:0), Trial 2 (8:1:1), Trial 3 (7:2:1), Trial 4 (6:3:1) and Trial 5 (5:4:1) were performed for evaluation of degrading and nutritive ability along with the fate of pollutants for total mass of 150 kg. Trial 4 exhibited highest metabolic activity contributing higher temperature evolution and longer thermophilic phase (10 days) owing to optimum addition of innoculum and nitrogen through the cattle manure. Moreover, degradation of 16.8% organic matter was also best achieved in Trial 4 following up first-order kinetics. Furthermore, BOD, COD and C/N ratio also explains degradation to be maximum in trial 4 (6:3:1) with reduction of 59.3%, 60.1% and C/N ratio from 55.1 to 18 respectively, proving to be the essential determining factors. Phosphorus availability increased by around 67% in trial 4. PPMS can be thus transformed into a potential valued added product and safe for subsequent land application. [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]

• The use of the ProFibro app for six weeks was not more effective than the use of a traditional paper book with similar content for health-related quality of life, symptoms, or self-care agency in individuals with fibromyalgia. • Improvements on severity of symptoms in both groups suggest that the self-care program using a mobile app or a paper book may be beneficial in individuals with fibromyalgia. • The Sleep Strategies was the most used function of the ProFibro app, followed by the Exercise Program, and the diary for the practice of gratitude. The ProFibro application (app) was developed as a Mobile Health resource to promote self-care in fibromyalgia management. This study aimed to assess the effects of the use of the ProFibro app for six weeks compared to the use of a traditional paper book of similar content to improve health-related quality of life, symptoms, and self-care agency in individuals with fibromyalgia. Forty individuals with fibromyalgia were included in this randomized, single-blind, parallel trial. One group received intervention content using the ProFibro app on a smartphone while the other received similar information using a paper book. Participants were assessed at baseline and after six weeks. The primary outcome was the Revised Fibromyalgia Impact Questionnaire. Secondary outcomes were Widespread Pain Index, Pain Visual Analog Scale, Symptom Severity Scale, and Appraisal of Self-Care Agency Scale – Revised. No differences in changes were found between groups at the end of the treatment for any outcome. Both groups showed improvements in symptom severity. The use of the ProFibro app for six weeks was not more effective than the use of a traditional paper book with similar content for health-related quality of life, symptoms, or self-care agency in individuals with fibromyalgia. Both groups showed improvements from baseline on severity of symptoms, suggesting that the self-care program using a mobile app or a paper book may be beneficial for individuals with fibromyalgia. [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]

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]

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]

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]

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]

Highlights • Caregivers who became physically active significantly lengthened in average telomere lengths compared to those in waitlist. • Caregivers who became physically active also improved in their cardiorespiratory fitness, BMI, and perceived chronic stress. • However, caregivers in either group didn't change in their telomerase activity levels. Abstract Study design Family members caring for chronically ill relatives are typically sedentary, chronically stressed, and at high risk of disease. Observational reports suggest caregivers have accelerated cellular aging as indicated by shorter leukocyte telomere lengths. We performed a randomized controlled trial to examine the effect of aerobic exercise on changes in telomerase levels (primary outcome) and telomere lengths (secondary outcome) in inactive caregivers. Methods 68 female and male community dwelling dementia caregivers who reported high stress and physical inactivity were randomly assigned to a highly supervised aerobic exercise intervention vs. waitlist control group for 24 weeks. Average leukocyte telomere lengths and peripheral blood mononuclear cells' telomerase activity were measured pre- and post-intervention. All staff completing blood draws, fitness testing and bioassays were blinded to group assignment. Results The intervention group completed approximately 40 min of aerobic exercise 3–5 times per week, verified by actigraphy. There was high (81%) adherence to 120 min/week of aerobic exercise. Groups did not significantly differ in telomerase activity changes across time, but had significant different telomere length changes across time (67.3 base pairs, 95%CI 3.1, 131.5). There were also significant reductions in body mass index and perceived stress and an increase in cardiorespiratory fitness (i.e., VO 2peak) in the exercising caregivers versus controls. Conclusion In the context of a highly controlled intervention, exercise can induce apparent telomere lengthening, though the mechanisms remain elusive. Our study underscores the importance of increasing participation in aerobic exercise to improve markers of health and attenuate cellular aging in high-risk samples. [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]

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

Objectives: To evaluate the robustness of the intervention modeling experiment (IME) methodology as a way of developing and testing behavioral change interventions before a full-scale trial by replicating an earlier paper-based IME. Study Design and Setting: Web-based questionnaire and clinical scenario study. General practitioners across Scotland were invited to complete the questionnaire and scenarios, which were then used to identify predictors of antibiotic-prescribing behavior. These predictors were compared with the predictors identified in an earlier paper-based IME and used to develop a new intervention. Results: Two hundred seventy general practitioners completed the questionnaires and scenarios. The constructs that predicted simulated behavior and intention were attitude, perceived behavioral control, risk perception/anticipated consequences, and self-efficacy, which match the targets identified in the earlier paper-based IME. The choice of persuasive communication as an intervention in the earlier IME was also confirmed. Additionally, a new intervention, an action plan, was developed. Conclusion: A web-based IME replicated the findings of an earlier paper-based IME, which provides confidence in the IME methodology. The interventions will now be evaluated in the next stage of the IME, a web-based randomized controlled trial. [ABSTRACT FROM AUTHOR]

Abstract: Self-monitoring has traditionally been done using a paper record, which can be tedious and burdensome. A personal digital assistant (PDA) with dietary software can provide an alternative to a paper record. The study aimed to describe the differences in dietary changes at 6 months between participants randomly assigned to use a paper record or PDA for self-monitoring in a clinical trial of weight-loss treatment. Self-monitoring adherence and changes in weight and diet were assessed between 2006 and 2009. The sample (n=192) was 84% female and 78% white, with a mean age of 49 years and body mass index (calculated as kg/m2) of 34.1. At baseline, the groups did not differ in energy intake, percent calories from fat, and number of servings of the examined food groups. At 6 months, both groups had significant reductions in weight, energy intake, and percent calories from total fat and saturated fatty acids (P<0.001); no between-group differences were found. Compared to the paper record group, the PDA group significantly increased consumption of fruit (P=0.02) and vegetables (P=0.04) and decreased consumption of refined grains (P=0.02). Interactions among self-monitoring and the two groups were found in relation to changes in percent calories from total fat (P=0.02), monounsaturated fatty acids (P=0.002), and trans-fatty acids (P=0.04). Frequent self-monitoring was significantly associated with total sugar (P=0.02) and added sugar (P=0.01) intake in both groups. Our findings suggest that use of a PDA for self-monitoring might improve self-awareness of behavior and dietary changes. [Copyright &y& Elsevier]

Background: In 2019, a randomized controlled trial (RCT) authored by Dr. Ismail was retracted due to concerns about data integrity. Since there are no policies in place to investigate other publications of authors of retracted studies, we investigated Dr. Ismail's other trials.Methods: We searched for RCTs authored by Dr. Ismail. We made pairwise comparisons of values in baseline and outcome tables between trials. We assessed whether the distributions of baseline characteristics were compatible with properly conducted randomization, using Monte Carlo simulations and the Kolmogorov-Smirnov test. We read the publications carefully for unusual features.Results: Dr. Ismail was author in eight published and one unpublished trial. In three of his first author studies we found multiple identical values in the baseline and/or outcome tables from different trials. At least some of the trials were unlikely to have followed a proper randomization process. There were a number of other unusual features in the papers we reviewed.Conclusions: It is probable that other trials published by Dr. Ismail contain questionable data. We call for a thorough investigation of the original trial data and related official documents. Our exercise suggests that the practice to assess research integrity should include all publications of authors with retracted fabricated articles. [ABSTRACT FROM AUTHOR]

Nearly half of the individuals who release from state prisons each year are under the age of 35; 89% are men. These young men are highly likely to be re-incarcerated. Research suggests untreated trauma symptoms contribute to high rates of incarceration and re-incarceration. As trauma symptomatology can increase during reentry, implementing trauma treatment during this time is critical. The current study fills an important gap by implementing an evidence-driven trauma intervention with young, incarcerated men and extending treatment post-release in the community. This study evaluates the impact of the Resiliency in Stressful Experiences (RISE) program for 18–35-year-old incarcerated males releasing to participating counties. RISE is a multi-phased comprehensive trauma-based reentry program designed according to the transitional nature of reentry. The researchers will assess the influence of RISE on post-release housing and employment stability and recidivism and identify key mechanisms of change. Participants (n = 400) are randomly assigned 1:1 to RISE or a Treatment as Usual control group. This study will provide critical information about how trauma-informed reentry programming impacts traditional reentry outcomes (e.g., recidivism, housing, employment) and identify key mechanisms of action (e.g., reduced impulsivity and aggression). Coping with trauma symptomatology is a largely untapped area of scientific inquiry for criminal justice-involved populations, despite the significant role trauma plays in individuals' lives. Results advance identification of critical components of trauma-informed reentry interventions for moderate- to high-risk young men. This study provides critical data to support policymakers and corrections professionals eager for innovative approaches to improve post-release outcomes. [ABSTRACT FROM AUTHOR]

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 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.

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.

Abstract: Background: Longitudinal mood instability is the essential feature of bipolar disorder, however most rating scales are cross sectional in nature, and focus on acute symptoms. By contrast, the NIMH Life Chart Methodology (LCM) characterizes in detail the severity, duration, and frequency of mood episodes. Adherence to daily rating, however, tends to be low. In this study an online version of the LCM, designed to enhance adherence, was compared to the standard paper version. Methods: Patients from a mood disorders specialty clinic were randomized to the standard LCM or an online, open-source adaptation. The online version used hypertext links embedded in a daily email as the primary rating interface. Participants rated for 90days. The total number of days rated and the number of days with complete data were compared for the two groups. Results: Forty-eight patients participated in the study. The online group rated approximately twice as many days compared to the standard group (44.3 versus 20.4, p =.029). The online group also entered complete data for a larger portion of days (55.2% versus 27.7%, p =.039). Limitations: This was a small, short-term study. The implications for longer-term rating are unclear. Conclusions: Despite the advantages of documenting mood fluctuation on a daily basis, the LCM is not commonly used, in part because ensuring adequate adherence can be resource intensive. An easily accessible online adaptation that utilizes email checking behavior can make this tool available to a wider range of patients. [Copyright &y& Elsevier]

Abstract: Comparative effectiveness reviews (CERs) are systematic reviews that evaluate evidence on alternative interventions to help clinicians, policy makers, and patients make informed treatment choices. Reviews should assess harms and benefits to provide balanced assessments of alternative interventions. Identifying important harms of treatment and quantifying the magnitude of any risks require CER authors to consider a broad range of data sources, including randomized controlled trials (RCTs) and observational studies. This may require evaluation of unpublished data in addition to published reports. Appropriate synthesis of harms data must also consider issues related to evaluation of rare or uncommon events, assessments of equivalence or noninferiority, and use of indirect comparisons. This article presents guidance for evaluating harms when conducting and reporting CERs. We include suggestions for prioritizing harms to be evaluated, use of terminology related to reporting of harms, selection of sources of evidence on harms, assessment of risk of bias (quality) of harms reporting, synthesis of evidence on harms, and reporting of evidence on harms. [Copyright &y& Elsevier]

Background There is increasing evidence that opioids interfere with the oral bioavailability of P2Y 12 inhibitors leading to delayed onset of antiplatelet effects. Several strategies have been proposed to mitigate this interaction including utilizing alternative analgesic agents in the management of ischemic chest pain. Methods The lidocAine Versus Opioids In MyocarDial Infarction (AVOID-2) study is a phase II, pre-hospital, open-label, non-inferiority, randomized controlled trial conducted by Ambulance Victoria and Monash University in metropolitan Melbourne, Victoria, Australia. The purpose of the study is to compare the analgesic effect (reduction in pain by arrival to hospital) and safety (e.g. adverse drug reactions) (co-primary endpoints) of intravenous lidocaine versus intravenous fentanyl in 300 adult patients attended by ambulance with suspected ST-elevation myocardial infarction (STEMI). Secondary endpoints and a cardiac magnetic resonance imaging (MRI) sub-study will also compare infarct size between these two groups. Conclusions The evaluation of alternative analgesic agents in the management of acute coronary syndromes is urgently needed to manage the opioid-P2Y 12 inhibitor interaction. The results of this trial will have significant implications on the emergency management of acute coronary syndromes internationally. [ABSTRACT FROM AUTHOR]

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]

Objectives: The aim of this study was to assess the measurement equivalence of individual response scale types by using a patient reported outcome measure (PROM) collected on paper and migrated into electronic format for use on the subject's own mobile device (BYOD) and on a provisioned device (site device).Methods: Subjects suffering from chronic health conditions causing daily pain or discomfort were invited to participate in this single-site, single visit, three-way crossover study. Association between individual item and instrument subscale scores was assessed by using the intraclass correlation coefficient (ICC) and its CI. Participant attitudes toward the use of BYOD in a clinical trial were assessed through use of a questionnaire.Results: In this study, 155 subjects (females 83 [54%]; males 72 [46%]) ages 19 to 69 years (mean ± SD: 48.6 ± 13.1) were recruited. High association between the modes of administration (paper, BYOD, site device) was shown with analysis of ICCs (0.79-0.98) for each response scale type, including visual analogue scale, numeric rating scale, verbal response scale, and Likert scale. Of the subjects, 94% (146 of 155) stated that they would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Forty-five percent of subjects felt BYOD would be more convenient compared with 15% preferring a provisioned device (40% had no preference).Conclusions: This study provides strong evidence supporting the use of BYOD for PROM collection in terms of the conservation of instrument measurement equivalence across the most widely used response scale types, and high patient acceptance of the approach. [ABSTRACT FROM AUTHOR]

Objective: Bleeding data in contraceptive trials are often collected using daily diaries, but data quality may vary due to compliance and recall bias. Text messaging is a widespread and promising modality for data collection.Study Design: This trial randomized participants 1:1 to use text messages or paper diaries to report on bleeding experienced during the 90 days after intrauterine device (IUD) insertion. Participants chose either the copper T380A or the 52-mg levonorgestrel IUD. Our primary outcome was number of days of reported bleeding data. We hypothesized that data gathered with daily text messages would have fewer missing values than paper diaries. Intention to treat analyses used the rank-sum test to compare medians.Results: Two hundred thirty women enrolled, and randomization yielded groups similar in baseline characteristics. Twenty percent of participants provided no bleeding data; of these, 77% were assigned to paper diaries. With 90 days of reporting, approximately 20% in each group provided complete bleeding data. The text group reported a median of 82 days [interquartile range (IQR) 40-89] and the paper group reported a median of 36 days (IQR 0-88) (p≤.001). The number of responses received decreased gradually over the 90-day period but was always higher in the text group. Women who had attained higher levels of education did well regardless of data collection modality, while response rates of text messages were greater among those with a high school education or less (p<.01).Conclusions: Participants reporting bleeding via text messages provided more complete data than women using paper diaries.Implications: Depending on resources and population of interest, text messages may be a useful modality to improve data collection for patient-reported outcomes. [ABSTRACT FROM AUTHOR]

Background: Fermentation is a widely used method of natural food preservation that has consequences on the nutritional value of the transformed food. Fermented dairy products are increasingly investigated in view of their ability to exert health benefits beyond their nutritional qualities.Objective: To explore the mechanisms underpinning the health benefits of fermented dairy intake, the present study followed the effects of milk fermentation, from changes in the product metabolome to consequences on the human serum metabolome after its ingestion.Methods: A randomized crossover study design was conducted in 14 healthy men [mean age: 24.6 y; mean body mass index (in kg/m2): 21.8]. At the beginning of each test phase, serum samples were taken 6 h postprandially after the ingestion of 800 g of a nonfermented milk or a probiotic yogurt. During the 2-wk test phases, subjects consumed 400 g of the assigned test product daily (200 g, 2 times/d). Serum samples were taken from fasting participants at the end of each test phase. The serum metabolome was assessed through the use of LC-MS-based untargeted metabolomics.Results: Postprandial serum metabolomes after milk or yogurt intake could be differentiated [orthogonal projections to latent structures discriminant analysis (OPLS-DA) Q2 = 0.74]. Yogurt intake was characterized by higher concentrations of 7 free amino acids (including proline, P = 0.03), reduced concentrations of 5 bile acids (including glycocholic acid, P = 0.04), and modulation of 4 indole derivative compounds (including indole lactic acid, P = 0.01). Fasting serum samples after 2 wk of daily intake of milk or yogurt could also be differentiated based on their metabolic profiles (OPLS-DA Q2 = 0.56) and were discussed in light of the postprandial results.Conclusion: Metabolic pathways related to amino acids, indole derivatives, and bile acids were modulated in healthy men by the intake of yogurt. Further investigation to explore novel health effects of fermented dairy products is warranted.This trial was registered at clinicaltrials.gov as NCT02230345. [ABSTRACT FROM AUTHOR]

An introduction for the articles published in the periodical on several topics including research paper writing, non-randomized studies and noninferiority (NI) trials.

Objective: To investigate the effect of font size and paper thickness on the response to, and completion of, a self-completion postal questionnaire among older people with joint pain.Study Design and Setting: Randomized trial. People aged 50 years and older with joint pain who consulted a general practitioner at one of five general practices in Central Cheshire were sent a postal questionnaire. Questionnaire format (large or small font size, thick or thin paper) was randomly allocated using a 2 x 2 factorial design.Results: Questionnaires were received from 502 out of 650 participants (crude response 77%). Response was significantly higher for participants receiving questionnaires with a larger font size (79.3% vs. 75.2%; hazard ratio 1.26, 95% confidence interval: 1.02, 1.56). Paper thickness had no significant effect on response. Completion (measure by assessing double-page turnover error) was increased in participants receiving questionnaires printed on thicker paper (3.2% vs. 7.1%; P=0.049) but was not affected by font size.Conclusion: This study demonstrates that questionnaires in larger font and on thicker paper may produce higher and more complete responses than surveys using standard size font and standard thickness paper, and should therefore be considered in studies among older people. [ABSTRACT FROM AUTHOR]

Early adverse parenting predicts various negative outcomes, including psychopathology and altered development. Animal work suggests that adverse parenting might change amygdala–prefrontal cortex (PFC) circuitry, but work in humans remains correlational. The present study leveraged data from a randomized controlled trial examining the efficacy of an early parenting intervention targeting parental nurturance and sensitivity (Attachment and Biobehavioral Catch-up [ABC]) to test whether early parenting quality causally affects amygdala-PFC connectivity later in life. Participants (N = 60, mean age = 10.0 years) included 41 high-risk children whose parents were referred by Child Protective Services and randomly assigned to receive either ABC (n = 21) or a control intervention (n = 20) during the children's infancy and a comparison sample of low-risk children (n = 19). Amygdala-PFC connectivity was assessed via functional magnetic resonance imaging while children viewed fearful and neutral faces. Across facial expressions, ABC produced different changes than the control intervention in amygdala-PFC connectivity in response to faces. The ABC group also exhibited greater responses than the control intervention group to faces in areas classically associated with emotion regulation, including the orbitofrontal cortex and right insula. Mediation analysis suggested that the effect of ABC on PFC activation was mediated by the intervention's effect on amygdala-PFC connectivity. Results provide preliminary causal evidence for the effect of early parenting intervention on amygdala-PFC connectivity and on PFC responses to face viewing. Findings also highlight amygdala-PFC connectivity as a potential mediator of the effects of early parenting intervention on children's emotion regulation development. Intervening Early With Neglected Children; https://clinicaltrials.gov/ ; NCT02093052. We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. One or more of the authors of this paper received support from a program designed to increase minority representation in science. While citing references scientifically relevant for this work, we also actively worked to promote sex and gender balance in our reference list. [ABSTRACT FROM AUTHOR]

Depression, frequently associated with cancer, significantly impacts health outcomes, necessitating effective treatments. This systematic review and meta-analysis aim to synthesize and critically evaluate the evidence from randomized controlled trials (RCTs) for the efficacy of nurse-led psychological interventions in managing depression among adult cancer patients. It focuses on the unique contribution of these interventions to improving depression management in oncology care, an underrepresented area in the existing literature. We conducted a comprehensive search in databases including Scopus, Medline, CINAHL, and PsycINFO, applying strict criteria to select RCTs assessing nurse-led psychological interventions for depression in cancer patients. We used the Cochrane Risk of Bias 2 tool to assess study quality. Out of 425 screened abstracts, nine papers describing seven distinct interventions involving 1463 participants were selected. The overall effect size estimate of −0.75 (95% confidence interval: −1.23 to −0.27) indicates significant effectiveness of these interventions in reducing depression compared to treatment as usual. Additionally, the calculated prediction interval highlights the variability in effectiveness across different settings, suggesting that contextual factors play a crucial role in the success of these interventions. The findings advocate for the integration of nurse-led psychological interventions into standard cancer care, highlighting their efficacy in improving depressive symptoms in adult cancer patients. These interventions show promise but require further refinement and research to optimize their effectiveness across diverse patient groups and healthcare settings. This review underscores the potential of nurse-led psychological interventions in enriching oncology care and addresses a critical gap in the existing body of research. [ABSTRACT FROM AUTHOR]

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]

Data collection by mailing questionnaires to the study population is one of the main research methods in epidemiologic studies. As participation rates are decreasing, easy-to-implement and cost-effective strategies to increase survey participation are needed. In this study, we tested the effect of a pragmatic combination of evidence-based interventions. We conducted a two-armed randomized controlled trial, nested in a cohort of breast cancer survivors (n = 1000) in the setting of a health outcomes survey. The intervention arm received a postal pre-notification, a non-monetary incentive (ballpoint with the study logo) and an alternative invitation letter in which several lay-out and textual adjustments were implemented according to behavioural science techniques. The alternative invitation letter also contained a QR-code through which an information video about the study could be accessed. The control arm was invited according to standard practice. Participants had the option to fill-out a questionnaire either on paper or online. A questionnaire with more than 50% of the questions answered classified as participation. Overall participation rate was 62.9%. No significant difference in participation rate was observed between intervention and control arm (64.5% vs 61.3%, Risk Ratio (RR) 1.05, 95% CI [0.96 – 1.16]). Older age at study (>65 vs <51 years), and high socio-economic status (highest vs lowest quartile) were associated with higher participation rates (RR 1.30, 95% CI [1.07 – 1.57] and 1.24, 95% CI [1.09 – 1.42] respectively). In-situ carcinoma compared to invasive cancer and longer interval since treatment were associated with lower participation (RR 0.86, 95% CI [0.74 – 0.99] and RR 0.92, 95% CI [0.87 – 0.99] per 5 year increase, respectively). Overall, the combination of four interventions tested in this study did not improve survey participation among breast cancer survivors. The overall participation rate was relatively high, possibly due to the study population of cancer survivors. [ABSTRACT FROM AUTHOR]

Over the past 16 years, we have developed a 'Meta-analytic Research Domain' (MARD) of all randomized trials of psychological treatments of depression. A MARD is a living systematic review of a research field, that cannot be otherwise covered by one (network) meta-analysis and includes multiple PICOs. In this paper we give an overview of the findings of this MARD. A narrative review of the results of the 118 meta-analyses on psychotherapies for depression that were published within our MARD. Most research has been conducted on cognitive-behavioral therapy (CBT), but several other psychotherapies are also effective, with few differences between therapies. They can be effectively delivered in individual, group, telephone and guided self-help format and are effective in many different target groups and across different age groups, although the effects are significantly smaller in children and adolescents. Psychotherapies have comparable effects as pharmacotherapy at the short term but are probably more effective at the longer term. Combined treatment is more effective than either psychotherapy or pharmacotherapy alone at the short, but also at the longer term. We did not summarize all published meta-analyses (protocols, methodological studies) and have not compared our results to those found in other meta-analyses on comparable subjects. Psychotherapies can contribute considerably to a reduction of the disease burden of depression. MARDs are an important next step in the aggregation of knowledge from randomized controlled trials in psychological treatments of depression as well as in other healthcare sectors. • The paper gives a complete overview of what is known about therapies for depression. • Several different types of therapy are effective. • Therapy can be effectively be delivered in different formats. • Therapy is as effective as drugs at the short, but more effective at the long term. • Combined treatment is better than drugs or psychotherapy alone. [ABSTRACT FROM AUTHOR]

• Prenatal testing induces elevated anxiety levels among high-risk pregnant women. • The utilization of virtual reality and music during non-stress tests alleviates anxiety and enhances satisfaction among high-risk pregnant women undergoing the procedure. • Virtual reality intervention resulted in a reduction in the duration of reactive non-stress tests. Prenatal tests cause high-risk pregnant women to experience high anxiety levels. This paper investigated the effect of Virtual Reality (VR) and music on anxiety, non-stress test parameters, and satisfaction of high-risk pregnant women undergoing non-stress tests (NSTs). This was a randomized controlled trial. The sample consisted of 102 participants randomized into three groups (VR = 34, music = 34, and control = 34). Maternal anxiety was assessed using the Spielberger State-Trait Anxiety Inventory-S (STAI-S) before and after NSTs. Satisfaction was evaluated using the Visual Analogue Scale (VAS) after NSTs. NST parameters were evaluated after NSTs. The findings were reported based on the Consolidated Standards of Reporting Trials (CONSORT). The VR and music groups had significantly lower mean posttest STAI-S scores than the control group (p <.05). There was no significant difference in NST findings (reactive/nonreactive) between the groups (p >.05). The VR group had a significantly shorter reactive NST duration than the control group (p <.05). The VR and music groups had significantly higher mean VAS-satisfaction scores than the control group (p <.05) Virtual reality and music during NSTs help high-risk pregnant women experience less anxiety and satisfy them more with the procedure. We recommend that obstetric midwives and nurses use these low-cost, simple, and noninvasive methods to reduce anxiety in high-risk pregnant women during prenatal testing. [ABSTRACT FROM AUTHOR]

Abstract When treating older adults, a main factor to consider is physical frailty. Because specific assessments in clinical trials are frequently lacking, critical appraisal of treatment evidence with respect to functional status is challenging. Our aim was to identify and categorize assessments for functional status given in clinical trials in older adults to allow for a retrospective characterization and indirect comparison of treatment evidence from these cohorts. We conducted 4 separate systematic reviews of randomized and nonrandomized controlled clinical trials in older people with hypertension, diabetes, depression, and dementia. All assessments identified that reflected functional status were analyzed. Assessments were categorized across 4 different functional status levels. These levels span from functionally not impaired, slightly impaired, significantly impaired, to severely impaired/disabled. If available from the literature, cut-offs for these 4 functioning levels were extracted. If not, or if the existing cut-offs did not match the predefined functional levels, cut-off points were defined by an expert group composed of geriatricians, pharmacists, pharmacologists, neurologists, psychiatrists, and epidemiologists using a patient-centered approach. We identified 51 instruments that included measures of functional status. Although some of the assessments had clearly defined cut-offs across our predefined categories, many others did not. In most cases, no cut-offs existed for slightly impaired or severely impaired older adults. Missing cut-offs or values to adjust were determined by the expert group and are presented as described. The functional status assessments that were identified and operationalized across 4 functional levels could now be used for a retrospective characterization of functional status in randomized controlled trials and observational studies. Allocated categories only serve as approximations and should be validated head-to-head in future studies. Moreover, as general standard, upcoming studies involving older adults should include and explicitly report functional impairment as a baseline characteristic of all participants enrolled. [ABSTRACT FROM AUTHOR]

Cerebral palsy (CP) is a group of neuromotor diseases that develops as a result of damage to the developing central nervous system during the perinatal period. The condition is usually accompanied by musculoskeletal problems resulting in movement disorders. Gait improvement therefore, is an important part of its treatment. Roboticassisted gait training (RAGT) is a new potential rehabilitation tool for CP patients, however there is no clear evidence for the effectiveness of this method. Can robotic-assisted gait training improve walking function in children with CP? A systematic search was performed in five databases: MEDLINE (via PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Embase, Scopus, and Web of Science. Eligible studies were randomized controlled trials (RCT) with CP patients under the age of 18. Gross motor function and kinematic gait parameters of patients were the main outcomes. Two authors determined the risk of bias of the RCTs independently using the revised Risk of Bias 2 (ROB 2) tool. Mean Differences (MDs) along with their 95% Confidence Interval (CI) were calculated when at least three studies were present for an outcome, subgroup analysis was performed based on the treatment of the control group. Of the 7363 screened articles, 13 papers met our inclusion criteria and among them, 7 studies could be used in our meta-analyses. The results related to RAGT suggest nonsignificant improvement in standing and walking function (Gross Motor Function Measure D, E), moreover changes in gait speed, step length, and in cadence were also only comparable to controls. The results indicate that there is a trend in some gait parameters where the improvement was higher in the intervention group than in control group. The therapeutic effect of RAGT was probably not superior to physiotherapy combined with treadmill training. • Robotic-assisted gait training is a promising new treatment in cerebral palsy. • Effects and significance are not proven yet. • This review found a tendency for gait improvement after robotic training. • Straightforward evidence for effectiveness is still missing. [ABSTRACT FROM AUTHOR]

[Display omitted] Notre étude avait pour objectif la revue systématique des données sur les effets de l'alimentation ou des compléments alimentaires sur l'activité de la maladie dans la spondyloarthrite (SpA). Une revue systématique de la littérature (RSL) a été menée dans les bases de données MEDLINE, Embase, Cochrane et Scopus, conformément au format « PEO » (population, exposition, critère d'évaluation). La population était constituée de patients atteints de SpA (axiale [SpAax] ou périphérique [SpAp] et rhumatisme psoriasique [RPso]), l'intervention était tout type de régime/complément alimentaire et le critère d'évaluation était l'activité de la maladie. Les critères d'inclusion étaient les suivants : patients adultes, essais comparatifs randomisés (ECR) et études longitudinales (permettant de disposer d'une évaluation pré- et post-intervention), articles en anglais. Le risque de biais (RoB) a été évalué avec différents instruments selon la conception des études. La recherche de la littérature a identifié 1390 publications dont 15 ont finalement été incluses : 12 études interventionnelles et trois études observationnelles. Parmi les publications ayant un faible RoB : a) deux ECR, RoB indéterminé pour l'un et faible pour l'autre, n'ont pas montré de bénéfice des probiotiques dans la SpA ; b) deux ECR ayant un RoB indéterminé ont démontré que la perte de poids, mais pas l'adoption d'un régime hypocalorique, était associée à l'obtention d'une activité modérée de la maladie (AMM) dans le RPso. Le RoB était élevé dans les autres études interventionnelles. Une étude observationnelle sur le régime méditerranéen a démontré l'existence d'une association entre l'observance du régime alimentaire et une diminution ≥ 20 % du score ASDAS dans la SpAax. La qualité des deux autres études observationnelles a été jugée médiocre. Il semble que la perte de poids a un effet sur l'activité de la maladie dans le RPso et que les probiotiques sont inutiles dans la SpA ; les données concernant les comportements alimentaires sont peu nombreuses et hétérogènes. Our study aimed to systematically review the evidence about the effect of diet or dietary supplements on spondyloarthritis (SpA) disease activity. A systematic literature review (SLR) was conducted in MEDLINE, EMBASE, Cochrane and SCOPUS according to the "PEO" format (Population, Exposure, Outcome). The population was SpA (axial or peripheral, axSpA/pSpA, including Psoriatic Arthritis-PsA); the intervention any kind of diet/dietary supplement; the outcome disease activity. Inclusion criteria were: adult patients, Randomized Controlled Trials (RCTs) and longitudinal studies (so that a pre- and post-intervention assessment were available), papers in English. Risk of bias (RoB) was conducted with different tools according to the design of the study. Literature search yielded 1,390 publications, of which 15 were finally inlcuded: 12 interventional and 3 observational studies. Among those with the lower RoB: a) 2 RCTs, one at unclear and one at low RoB, failed to show benefit of probiotics in SpA; b) Two RCT at unclear RoB provided evidence that weight loss, but not hypocaloric diet, was associated to MDA achievement in PsA. The remaining interventional studies were at high RoB. Among the observational studies, one study on Mediterranean diet demonstrated an association between diet adherence and a ≥ 20 % decrease of ASDAS in axSpA. The other two observational studies were judged of poor quality. Weight loss seem to be able to impact disease activity in PsA, while probiotics do not seem useful in SpA; evidence for dietary behaviors is scarce and heterogeneous. [ABSTRACT FROM AUTHOR]

To answer the PICO(S) question: Is there a difference in clinical longevity between direct and indirect resin composite restorations placed on permanent posterior teeth? Randomized controlled clinical trials (RCTs) investigating direct and indirect resin composite restorations in posterior permanent teeth were considered. Several electronic databases were searched, with no language or date restrictions. The revised Cochrane Collaboration's tool for assessing risk of bias (RoB-2) was used to analyze the studies; meta-analyses were run and the certainty of evidence was assessed by the GRADE tool. A subgroup meta-analysis was performed for resin composite restorations placed on posterior worn dentition. Twenty-three articles were included in qualitative synthesis, while 8 studies were used for meta-analyses. According to the RoB-2 tool, 5 studies were ranked as "low risk", 7 had "some concerns", while 11 papers were rated as "high risk" of bias. There were no statistically significant differences in short-term (p = 0.27; RR=1.54, 95% CI [0.72, 3.33]), medium-term (p = 0.27; RR=1.87, 95% CI [0.61, 5.72]) and long-term longevity (p = 0.86; RR=0.95, 95% CI [0.57, 1.59]). The choice of restorative technique had no influence on short-term survival of resin composite restorations placed on worn dentition (p = 0.13; RR=0.46, 95% CI [0.17, 1.25]). The certainty of evidence was rated as "very low". Direct and indirect resin composite restorations may show similar clinical longevity in posterior region, regardless of the observation period or substrate (wear-affected and non-affected dentition). The very low quality of evidence suggests that more long-term RCTs are needed to confirm our results. [Display omitted] [ABSTRACT FROM AUTHOR]

Missing outcome data is common in trials, and robust methods to address this are needed. Most trial reports currently use methods applicable under a missing completely at random assumption (MCAR), although this strong assumption can often be inappropriate. To identify and summarise current literature on the analytical methods for handling missing outcome data in randomised controlled trials (RCTs), emphasising methods appropriate for data missing at random (MAR) or missing not at random (MNAR). We conducted a methodological scoping review and identified papers through searching four databases (MEDLINE, Embase, CENTRAL, and CINAHL) from January 2015 to March 2023. We also performed forward and backward citation searching. Eligible papers discussed methods or frameworks for handling missing outcome data in RCTs or simulation studies with an RCT design. From 1878 records screened, our search identified 101 eligible papers. 90 (89%) papers described specific methods for addressing missing outcome data and 11 (11%) described frameworks for overall methodological approach. Of the 90 methods papers, 30 (33%) described methods under the MAR assumption, 48 (53%) explored methods under the MNAR assumption and 11 (12%) discussed methods under a hybrid of MAR and MNAR assumptions. Control-based methods under the MNAR assumption were the most common method explored, followed by multiple imputation under the MAR assumption. This review provides guidance on available analytic approaches for handling missing outcome data, particularly under the MNAR assumption. These findings may support trialists in using appropriate methods to address missing outcome data. [ABSTRACT FROM AUTHOR]