Search

The commentary on the paper entitled "The effects of ketogenic diet on systolic and diastolic blood pressure: A Systematic Review and Meta‐Regression Analysis of Randomized Controlled Trials," provides a critical appraisal of the evidence presented and identifies key areas for further inquiry. The original paper, which compiles results from 34 high-quality studies, concludes that ketogenic diets significantly reduce systolic and diastolic blood pressures. While acknowledging these findings, the commentary highlights several issues, such as the lack of uniformity in intervention durations and the observed heterogeneity in systolic blood pressure results, suggesting that the impact of the ketogenic diet may vary significantly based on these factors. It also points out the need for clarity in discussing the term "ketogenic diets" due to the diverse protocols that exist. Moreover, the commentary enriches the discussion by proposing that future research should explore the underlying physiological mechanisms in greater depth and consider the impact of dietary composition on metabolic health and blood pressure regulation. This reflection aims to refine the conclusions drawn from the meta-analysis and suggests a more nuanced approach to studying and implementing ketogenic diets in hypertension management. [ABSTRACT FROM AUTHOR]

Background: Takayasu arteritis (TAK) is a large vessel vasculitis affecting relatively younger population. Since literature on bibliometric analysis of TAK is scarce, we analyzed top-cited articles in TAK to address this knowledge gap. Methods: We analyzed the top hundred cited articles in TAK on Web of Science and Scopus for time of publication, article type, country of origin, source journal, and authors. Furthermore, we conducted univariable- and multivariable-adjusted linear regression analyses to explore associations of rank of cited articles, mean number of annual citations, and total citations with traditional (journal impact factor, CiteScore) and alternative (PlumX) metrics. Results: Concordance between databases was 76%. Most top-cited articles were from the USA, Japan, or the UK, and published in Annals of the Rheumatic Diseases, Arthritis and Rheumatism, and Circulation and Rheumatology (Oxford). Original articles comprised a majority of these top-cited articles. Articles describing criteria or disease management recommendations received the highest mean number of citations. Performing multivariable-adjusted linear regression analyses, years of publication associated with mean annual citations on Web of Science as well as total citations across databases (p < 0.01). The 2-year JIF significantly associated with mean annual citations on Web of Science (p = 0.047). On Scopus, the number of captures denoted under PlumX metrics consistently associated with citations (p < 0.001). Conclusion: Both traditional and alternative metrics associate with higher citations in TAK. Development of disease assessment and clinical practice guidelines and conduct and reporting of randomized controlled trials to guide TAK management are important research areas. The key points themselves are all right. Key Points • A majority of top-cited papers in TAK are original articles. • Both traditional and alternative metrics associate with number of citations for these papers. • Recommendations for disease assessment or clinical practice and clinical trials are important research agenda in TAK. [ABSTRACT FROM AUTHOR]

Treatment adherence is one of the milestones in the care of hypertensive patients, with new information and communication technologies as potential educational tools. This study aimed to evaluate the add-on effect of a digital cartoon educative video on the therapeutic observance of patients followed up in the General Hospital Yaoundé compared to standard of care. We conducted a randomized simple blind clinical trial at the cardiology unit of the Yaoundé General Hospital over a 6-month period from 1st March to 30th August 2022. We enrolled 110 patients and randomized them in blocs of 4 creating two groups of 57 and 53, respectively, without (group 1) and with (group 2) intervention. Preintervention treatment adherence was assessed using the Morisky Medication Adherence Scale (MMAS). In the standard group (G1), we provided standard paper-based clinical counselling, including oral advice, and in the intervention group (G2), we did the same and added a digital cartoon video containing exactly the same message as images and audio. The primary outcome was medication adherence after three months. The mean age was 56.65 ± 10.98 years in group 1 (paper) and 56.42 ± 10.46 years in group 2 (paper + video), without any significant difference. The two groups were similar regarding the proportion of females (36.8% in G1 and 49.3% in G2) and educational levels. According to the Morisky medication adherence scale, before the intervention, the proportions of patients with good, medium and low treatment adherence in groups 1 and 2 were 7%, 25.6%, 67.4%, and 5.1%, 43.6%, 51.3%, respectively, without any significant difference. After interventions, the proportion of patients presenting a good observance moved from 7 to 11% in group 1 (paper) and 5.1 to 20% in group 2 (paper + video). The intragroup variation in treatment adherence in the intervention group (before-after) tended to be significant, with a p-value = 0.0572, while this p-value was 0.712 in the standard group. Our results provide insight into how digital cartoon videos can help to have an add-on effect on the treatment adherence of hypertensive patients, with clinical significance. [ABSTRACT FROM AUTHOR]

Background and objective: The number of people suffering from dementia is increasing worldwide and so is the need for reliable and economical diagnostic instruments. Therefore, the aim of this study was to compare the processing times of the neuropsychological tests Trail Making Tests A and B (TMT-A/B) and Color-Word Interference Test (CWIT), which were performed in both digital and paper versions. Methods: The pilot study was conducted among 50 healthy participants (age 65–83 years) using a randomized crossover design. The correlations and differences in the individual processing times of the two test versions were statistically analyzed. Further research questions concerned the influence of the individual usage of technology and the technology commitment of participants as well as the influence of the assessed usability on participants' performance. Results: Between the two versions (paper-based vs. digital) statistically significant correlations were found in all tests, e.g., TMT-A r(48) = 0.63, p < 0.01; TMT-B rs(48) = 0.77, p < 0.001). The mean value comparison showed statistically significant differences, e.g., interference table (CWIT) t(49) = 11.24, p < 0.01). Correlations with medium effect were found between the differences in processing times and the individual usage of computer (e.g., rs(48) = − 0.31) and smartphone (rs(48) = − 0.29) and between the processing times of the TMT-B and the usability (rs(48) = 0.29). Conclusions: The high correlations between the test procedures appear promising. However, the differences found in the processing times of the two test versions require validation and standardization of digitized test procedures before they can be used in practice. [ABSTRACT FROM AUTHOR]

Although many patients suffer from taste disorder, methods to improve taste sensitivity are limited. To develop a taste recall training method to improve the perception of taste, 42 healthy individuals were randomly assigned to either the training or the control group. Using the filter paper disc method, participants in the training group were asked to match the four tastes (sweetness, saltiness, sourness, and bitterness) between those of taste recognition thresholds and those of a one-step higher concentration until they get them right. Then, they were asked to match the four tastes between those of one-step lower and one-step higher in concentration from their taste recognition thresholds until they get them right. Finally, they were asked to match the four tastes between those of one-step lower concentration and those of their taste recognition thresholds until they get them right. This training was repeated until perfectly matched. The taste recall training program led to a lowered taste recognition threshold in healthy adults for each taste quality, suggesting the improvement of taste sensitivity. This lowered threshold for each taste was observed with each additional training session. We conclude that this taste recall training method might be a therapeutic approach for treating taste disorder. [ABSTRACT FROM AUTHOR]

Purpose: Surrogate outcomes are clinical endpoints that are used as substitutes for direct measures of how a patient feels, functions, or survives. The present study aims to analyze the impact of surrogate outcomes on the results of randomized controlled trials on shoulder rotator cuff tears disorders. Methods: Randomized controlled trials (RCTs) related to rotator cuff tear conditions published up until 2021 were retrieved from the PubMed and ACCESSSS databases. The primary outcome of the article was considered a surrogate outcome when the authors used radiological, physiologic, or functional variables. The result of the article was considered positive when results supported the intervention based on the trial's primary outcome. We recorded the sample size, the mean follow-up, and the type of funding. Statistical significance was set at p < 0.05. Results: A total of 112 papers were included in the analysis. The mean sample size was 87.6 patients; mean follow-up period was 25.97 months. Thirty-six out of 112 RCTs used a surrogate outcome as a primary endpoint. More than half of papers using surrogate outcomes reported a positive finding (20 out of 36), while 10 out of 71 RCTs using patient-centered outcomes favored the intervention (14.08%, p < 0.001) [RR = 3.94 (95% CI 2.07–7.51)]. The mean sample size was smaller in trials using surrogate endpoints (75.11 vs 92.35 patients, respectively, p = 0.049), while the follow-up was shorter (14.12 m vs. 31.9 m, p < 0.001). Approximately 25% of the papers that reported surrogate endpoints (22.58%) were industry-funded projects. Conclusions: The substitution of surrogate endpoints for patient-important outcomes in shoulder rotator cuff trials quadruplicates the chances of obtaining a favorable result that favors the analyzed intervention. [ABSTRACT FROM AUTHOR]

Purpose: This study compared a tablet PC questionnaire with a paper method for reliability and patient preferences in the acquisition of patient-reported outcomes (PROs) for patients treated with radiotherapy. By comparing the two modes of PRO administration, we aimed to evaluate the adequacy of using tablet PC questionnaires in future clinical use.Methods: Patients were randomized in a crossover study design using two different methods for PRO entry. A group of 89 patients answered a paper questionnaire followed by the tablet PC version, whereas 89 patients in another group completed the tablet PC questionnaire followed by the paper version. Surveys were performed four times per patient throughout the course of the radiotherapy. The Korean versions of the M.D. Anderson Symptom Inventory (MDASI-K) and the Brief Fatigue Inventory (BFI-K) were used. The primary endpoint of our current study was an assessment of patient preference for the survey method. The proportions of patients preferring each mode of questionnaire were evaluated.Results: The proportion of patients who preferred the tablet PC version, paper form, or who had no preference was 52.2, 22.1, and 25.7 %, respectively. More than half of the patients preferred the tablet PC to the paper version in all four surveys. Age, gender, educational status, prior experience of using a tablet PC, and the order of paper to tablet PC administration did not impact patient preferences. Inter-class correlation coefficients (ICCs) between the modes were 0.92 for MDASI-K and 0.94 for BFI-K and ranged from 0.91 to 0.96 on both instruments during the four surveys.Conclusions: A tablet PC-based PRO is an acceptable and reliable method compared with paper-based data collection for Korean patients receiving radiotherapy. [ABSTRACT FROM AUTHOR]

Purpose: The Social Difficulties Inventory (SDI-21) assesses everyday problems experienced by cancer patients, including difficulties with self-care, work and relationships. Early development and psychometric evaluation studies have validated the SDI-21 for computer administration. However, several recent studies have administered the SDI-21 on paper. We sought to test the score equivalence of electronic and paper versions of the SDI-21. Methods: A randomised two-arm crossover trial in a sample of cancer patients with varied diagnoses. Patients completed electronic (via the internet) and paper versions of the SDI-21, with half randomly assigned to complete the electronic version first ( n = 51) and half the paper version first ( n = 60). Patients were asked to complete both versions at home, within 2 weeks. Analyses were performed for the SDI-21 summary score and three subscales. Results: Score distributions and internal reliabilities for the paper and electronic versions were highly similar. There were no significant differences between mean summary or subscale scores for the two administration modes. All mean score differences (all <0.25 of a scale point) were well below the SDI-21's established minimally important differences, and all 95 % confidence intervals were narrow and included zero. Intraclass correlations between paper and electronic scores were uniformly high and significant (all ≥0.85) and above the standard acceptable level of reliability. Conclusions: Paper and electronic versions of the SDI-21 can be considered equivalent and used interchangeably. This is important because, despite the growth of electronic formats, paper versions are currently still necessary to ensure inclusive use of the SDI-21 with representative samples. [ABSTRACT FROM AUTHOR]

Introduction: More than 20 years have passed since we reported our results of treating patients with the acute respiratory distress syndrome (ARDS) with inhaled nitric oxide (iNO). The main finding was that iNO alleviated pulmonary hypertension (PH) by selective vasodilation of pulmonary vessels in ventilated lung areas. This, in turn, improved arterial oxygenation. Methods: We now set out to review the time span between the discovery of NO in 1987 and today in order to identify and describe interesting areas of research and clinical practice surrounding the application of iNO. Major Findings: Enhancement of ventilation-perfusion matching and alleviation of PH in ARDS, treatment of PH of the newborn, and treatment of perioperative PH in congenital heart disease serve as just a few exciting examples for the successful use of iNO. Breathing NO prevents PH induced by stored blood transfusions or sickle cell disease. Exploiting the anti-inflammatory properties of NO helps to treat malaria. Discussion: Regarding the use of iNO in ARDS, there remains the unresolved question of whether important outcome parameters can be positively influenced. At first glance, several randomized controlled trials and meta-analyses seem to send the clear message: 'There is none!' Careful analyses, however, leave sufficient room for doubt that the ideal study to produce the unequivocal proof for the inability of iNO to positively impact on important outcome parameters has, as yet, not been conducted. Conclusion: In summary, the discovery of and research on the many positive effects of iNO has improved care of critically ill patients worldwide. It is a noble effort to continue on this path. [ABSTRACT FROM AUTHOR]

Based on current data and experience, the joint working group of the European Society of Minimally Invasive Neurological Therapy (ESMINT) and the European Society of Neuroradiology (ESNR) make suggestions on trial design and conduct aimed to investigate therapeutic effects of mechanical thrombectomy (MT). We anticipate that this roadmap will facilitate the setting up and conduct of successful trials in close collaboration with our neighbouring disciplines. [ABSTRACT FROM AUTHOR]

Purpose: Randomised controlled trials (RCTs) are considered the gold standard for evaluating the efficacy of an intervention. However, previous research has shown that RCTs in several surgical specialities are poorly reported, making it difficult to ascertain if various biases have been appropriately minimised. This systematic review assesses the reporting quality of surgical head and neck cancer RCTs. Methods: A literature search of PubMed and Embase was performed. Papers were included if they reported RCTs which assessed a surgical technique used to treat or diagnose head and neck cancer published during or after 2011. The CONSORT 2010 checklist was used to evaluate the reporting quality of these trials. Results: 41 papers were included. The mean CONSORT score was 16.5/25 (66% adherence) and the scores ranged from 7.5 (30%) to 25. The most common omissions were full trial protocol (found in 14.6%), participant recruitment method (22%) and effect size with a precision estimate for all outcome measures (29.3%). The full design and implementation of the randomisation methods were reported in 6 (14.6%). Papers published in journals which endorsed CONSORT had significantly higher scores (p = 0.02) and the journal impact factor was significantly correlated with CONSORT score (p = 0.01). Conclusion: We have identified several pieces of information that are underreported in surgical head and neck cancer RCTs. These omissions make understanding and comparing the methodologies and conclusions of RCTs more difficult. The endorsement of CONSORT by journals improved adherence, suggesting that wider adoption of the checklist may improve reporting. [ABSTRACT FROM AUTHOR]

The use of simulation in surgical training is ever growing. Evidence suggests such training may have beneficial clinically relevant effects. The objective of this research is to investigate the effects of surgical simulation training on clinically relevant patient outcomes by evaluating randomized controlled trials (RCT). PubMed was searched using PRISMA guidelines: "surgery" [All Fields] AND "simulation" [All Fields] AND "patient outcome" [All Fields]. Of 119 papers identified, 100 were excluded for various reasons. Meta-analyses were conducted using the inverse-variance random-effects method. Nineteen papers were reviewed using the CASP RCT Checklist. Sixteen studies looked at surgical training, two studies assessed patient-specific simulator practice, and one paper focused on warming-up on a simulator before performing surgery. Median study population size was 22 (range 3–73). Most articles reported outcome measures such as post-intervention Global Rating Scale (GRS) score and/or operative time. On average, the intervention group scored 0.42 (95% confidence interval 0.12 to 0.71, P = 0.005) points higher on a standardized GRS scale of 1–10. On average, the intervention group was 44% (1% to 87%, P = 0.04) faster than the control group. Four papers assessed the impact of simulation training on patient outcomes, with only one finding a significant effect. We found a significant effect of simulation training on operative performance as assessed by GRS, albeit a small one, as well as a significant reduction to operative time. However, there is to date scant evidence from RCTs to suggest a significant effect of surgical simulation training on patient outcomes. [ABSTRACT FROM AUTHOR]

Soluble guanylate cyclase (sGC) modulation has been scrutinized in several disease states including heart failure (HF). Recently, it was shown that an sGC modulator improved HF-related hospitalization significantly, though, there was no benefit related to mortality. Herein, a comprehensive meta-analysis of randomized controlled trials (RCTs) for sGC modulation in HF patients was provided in agreement with the PRISMA statement. A total of 10 RCTs yielding 12 papers were included. There were 7526 patients with heart failure of each phenotype, 4253 in the sGC modulator group and 3273 in the placebo group. Use of sGC modulators in HF patients yielded no significant difference in the risk of all-cause mortality compared to placebo (RR = 0.97, 95% CI 0.88–1.08, p = 0.62). The use of sGC modulators was associated with a trend toward a considerable but non-significant increase in the incidence of SAEs (RR = 1.10, 95% CI 0.99–1.22, p = 0.07), as well as an increased incidence of hypotension and anemia. There was an overall neutral effect of sGC modulation on NT-proBNP levels, 6MWD and mortality, at a cost of slight increase in hypotension and anemia. Of note, the improvement in EQ-5D-based quality of life was significant. Hence, the benefit seems to be driven by distinctive domains of quality of life. [ABSTRACT FROM AUTHOR]

Objectives: The paper studies the impact of predictive policing on crime in a developing country. It also assesses the impact of different police trainings. Method: We analyze a randomized controlled trial conducted in Montevideo, Uruguay to assess the implementation of a predictive policing software developed in the United States. Half of the precincts were randomly assigned to the software and half to the local crime analysts (status quo). The second experiment allocated randomly a specially trained police force to targeted patrol areas per shift and day. Results: No statistically significant differences were found in crime outcomes between the precincts assigned to the foreign predictive software and those assigned to local crime analysts. On the second experiment, given determined targeted places, the specially trained task force showed more compliance with the assigned patrol sites (20% more patrol time) and a greater potential for reducing crime (reduction of 30% in robberies only during high crime shifts in comparison to the control group (no special training). There is also evidence of a diffusion of benefits to adjacent areas. Conclusions: The implementation of an international predictive policing software did not outperform local crime analysts in terms of crime reduction. Local crime analysts are more cost-effective. Given determined targeted places, a modest increase in police dosage of a specially trained police force could reduce crime in high-crime times. In developing countries new policing technologies and training require a deep understanding of the context to channel limited resources in the most efficient way. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature 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.)

While loneliness has been linked to various mental and physical health problems, the sense in which loneliness is a cause of these conditions has so far attracted little philosophical attention. This paper aims to fill this gap by analyzing research on health effects of loneliness and therapeutic interventions through current approaches to causality. To deal with the problem of causality between psychological, social, and biological variables, the paper endorses a biopsychosocial model of health and disease. I will investigate how three main approaches to causality used in psychiatry and public health apply to loneliness: interventionism, mechanisms, and dispositional theories. Interventionism can specify whether loneliness causes specific effects, or whether a treatment works, incorporating results from randomized controlled trials. Mechanisms help explain how loneliness brings about negative health effects, spelling out psychological processes involved in lonely social cognition. Dispositional approaches help stress particular features of loneliness connected to negative social interactions, such as defensiveness. I will conclude by showing that previous research alongside emerging approaches to health effects of loneliness lend themselves to analysis in terms of the causal models under discussion. [ABSTRACT FROM AUTHOR]

Purpose: Laparoscopic herniorrhaphy (LH) has become the treatment of choice in many centers for patients with inguinal hernia (IH). Our aim was to compare the morbidity outcomes of bilateral vs unilateral IH repair using the laparoscopic total extra-peritoneal (TEP) technique, to determine whether undertaking bilateral IH repair places patients at additional risk. Methods: Manuscripts published up to the end of 2021 on PubMed/MEDLINE, EMBASE, Cochrane Library, Scopus, and Web of Science were searched. Patients (> 16 years) undergoing a primary elective unilateral or bilateral TEP operation, using the standard 3-port laparoscopic technique, were identified. Quality of evidence was assessed using the GRADE criteria. Meta-analysis was conducted where possible. Where this was not possible, vote counting was conducted using effect direction plots. Results: Eight observational studies, with a total of 18,153 patients were included. Operative time was significantly longer for bilateral operations. There was no significant difference in conversion to open, post-operative seroma, urinary retention, haematoma, and length of hospital stay. There was an increased rate of hernia recurrence in patients undergoing bilateral IH repair. Conclusion: Although limited by the observational nature of the included studies, there is no conclusive evidence to suggest a differential burden of morbidity between unilateral and bilateral TEP IH repair. As all included papers are from observational studies only, evidence from all outcomes is at best very low quality. This manuscript thereby highlights a need for randomized controlled trials to be conducted in this area. [ABSTRACT FROM AUTHOR]

Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone. [ABSTRACT FROM AUTHOR]

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

Background: Teen drivers with a traffic violation are at increased risk for crashes and crash-related injuries; however, most parent-focused interventions target teen drivers with supervised learner's permits. Very few interventions are implemented at the probationary driver's license stage or target high-risk teen drivers, such as those with traffic violations. This paper describes the protocol of ProjectDRIVE, A Randomized Controlled Trial to Improve Driving Practices of High-Risk Teen Drivers with a Traffic Violation, which targets improving parent-teen communication about safe driving practices to reduce unsafe driving behaviors and traffic violation recidivism of teen drivers cited for traffic violation. Methods: Teen drivers (ages 16 or 17) cited for a moving violation and the parent/legal guardian most involved with the teen's driving are recruited from juvenile traffic courts following their required court hearing. After completing informed consent/assent, enrolled dyads are randomized into one of three groups using stratified block randomization: control, device feedback only, or device feedback plus parent communication training. Participating dyads are followed for 6 months with 3 months of active intervention. Using in-vehicle device and smartphone application technology, the study provides real-time and cumulative driving feedback to intervention teens and collects continually recorded, objectively measured driving outcome data throughout the teen's study participation. Primary outcomes include rates of risky driving events and unsafe driving behaviors per 1000 miles driven. Secondary outcomes include traffic violation recidivism up to 12 months following study completion and frequency and quality of parent-teen communication about safe driving practices. Discussion: Through partnership with the local juvenile traffic courts, this study integrates recruitment and randomization into existing court practices. Successfully completing this study will significantly impact juvenile traffic court's practices and policies by informing judges' decisions regarding the driving safety programs they refer to teens to prevent motor vehicle crashes and crash-related injuries and deaths. Trial registration The study was registered on ClinicalTrials.gov Registry (NCT04317664) on March 19, 2020, https://clinicaltrials.gov/study/NCT04317664 and updated on April 27, 2021. This protocol was developed per the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Checklist. [ABSTRACT FROM AUTHOR]

Background: Goals generated by Goal Attainment Scaling (GAS) can be used as an outcome measure to promote person-centred research and care. There are no training packages which support its use outside of the rehabilitation discipline. This paper describes the development and evaluation of a training package to support the implementation of GAS as an outcome measure in healthcare research. The training package consisted of classroom teaching, a training manual for self-directed learning, one-on-one simulation and hot reviews. It was developed for the GOAL Trial, a randomised controlled trial assessing a Comprehensive Geriatric Assessment's effectiveness in enabling frail older people living with chronic kidney disease to attain their goals. Training participants were invited to complete pre- and post-training online evaluation surveys. Results: Forty-two healthcare professionals attended an initial online classroom teaching, with 27 proceeding to administer GAS to GOAL Trial patients. Response rates for the online pre- and post-training surveys were 95% and 72%, respectively. Prior to training, only 15% of participants reported being able to appropriately scale and troubleshoot GAS goals. Post-training this was 92%. There was 100% participant satisfaction for the training manual, one-on-one simulation, and hot reviews. Conclusions: This training package helps ensure healthcare professionals administering GAS have adequate knowledge and skills. It has the potential for adoption as a guide to support the implementation of GAS by other researchers seeking to embrace persont-centred principles in their work. [ABSTRACT FROM AUTHOR]

Background: Decisions regarding maintenance therapy in patients with multiple myeloma should be based on both treatment efficacy and health-related quality of life (HRQL) consequences. In the CARFI trial, patients with first relapse of multiple myeloma underwent salvage autologous stem cell transplantation (salvage ASCT) before randomization to carfilzomib-dexamethasone maintenance therapy (Kd) or observation. The primary clinical endpoint was time to progression, which was extended by 8 months by Kd. The aim of this paper is to present the all HRQL endpoints of the CARFI trial including the HRQL effect of Kd maintenance therapy relative to observation. The primary HRQL endpoint was assessed by EORTC QLQ-C30 Summary score (QLQ-C30-sum) at 8 months follow-up. A key secondary HRQL endpoint was quality-adjusted progression-free-survival (QAPFS). Methods: HRQL was assessed with EORTC QLQ-C30, EORTC QLQ-MY20 and FACT/GOG-Ntx at randomization and every second month during follow-up. HRQL data were analyzed with linear mixed effect models until 8 months follow-up. QAPFS per individual was calculated by multiplying progression-free survival (PFS) by two quality-adjustment metrics, the QLQ-C30-sum and EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The QAPFS per treatment group was estimated with the Kaplan-Meier method. P < 0.05 was used for statistical significance, and a between-group minimal important difference of 10 points was interpreted as clinically relevant for the QLQ-C30-sum. Results: 168 patients were randomized. HRQL questionnaire compliance was 93%. For the QLQ-C30-sum, the difference of 4.62 points (95% confidence interval (CI) -8.9: -0.4, p = 0.032) was not clinically relevant. PFS was 19.3 months for the Kd maintenance group and 16.8 months for the observation group; difference = 2.5 months (95% CI 0.5; 4.5). QAPFS based on the QLQ-C30-sum for the Kd maintenance group was 18.0 months (95% CI 16.4; 19.6) and for the observation group 15.0 months (95% CI 13.5; 16.5); difference = 3.0 months (95% CI 0.8–5.3). QAPFS based on the QLU-C10D for the Kd maintenance group was 17.5 months (95% CI 15.9; 19.2) and 14.0 months (95% CI 12.4; 15.5) for the observation group; difference = 3.5 months (95% CI 1.1–5.9). Conclusions: Kd maintenance therapy after salvage ASCT did not adversely affect overall HRQL, but adjustment for HRQL reduced the PFS compared to unadjusted PFS. PFS of maintenance therapy should be quality-adjusted to balance the benefits and HRQL impact. [ABSTRACT FROM AUTHOR]

Patient-reported outcomes (PRO) represent a cornerstone in the management of patients with rheumatoid arthritis (RA). However, PRO are currently recorded mainly on paper and only during on-site appointments. Electronic PRO (ePRO) enable continuous remote monitoring and could improve shared decision-making (SDM) and implementation of a treat-to-target (T2T) approach. This study aims to investigate patient and physician experiences, perceived drawbacks and benefits of using an ePRO web-app (ABATON RA) to digitally support SDM and T2T. A qualitative study embedded in a multicenter randomized controlled trial (RCT) consisting of interviews with RA patients and physicians that were subsequently analyzed using deductive-inductive qualitative content analysis. Between August 2021 and May 2022, interviews with ten RA patients and five physicians were completed. Three key themes emerged in the analysis: (i) App user experiences; (ii) perceived drawbacks of app-supported rheumatology care; and (iii) perceived benefits of app-supported rheumatology care. Continuous ePRO collection and a high level of standardization strained some RA patients. Certain ePRO seemed outdated and were hard to understand. Patients and physicians appreciated having an improved overview of disease activity, capturing disease flares and continuous remote monitoring. Paper- and time-saving were associated with using ePRO. Physicians feared to become too focused on ePRO data, stressed the lack of ePRO monitoring reimbursement and app interoperability. For RA patients and physicians, benefits seemed to outweigh observed drawbacks of the digitally supported SDM using ePRO. The software was easy to use and could lead to a better understanding of the individual disease course, resource allocation and treatment of rheumatoid arthritis. [ABSTRACT FROM AUTHOR]

Factors related to the research context, such as inquiry mode, setting, and experimenter contact, may affect participants' comfort with and willingness to disclose certain sexual attitudes or admit to engaging in sensitive sexual behaviors. In this study, 255 female undergraduates (42.7 % non-White) completed a survey containing measures of sexual behavior and attitudes. The level of experimenter contact (high vs. low contact), setting (in lab vs. out of lab), and inquiry mode (pencil-and-paper vs. computer) were manipulated and participants were randomly assigned to conditions. We hypothesized that low-contact, out-of-lab, computer conditions would be associated with more liberal sexual attitudes and higher rates of reported sexual behaviors than high-contact, in-lab, and paper-and-pencil conditions, respectively. Further, we hypothesized that effects would be moderated by race, such that differences would be greater for non-White participants because of concerns that reporting socially undesirable behavior might fuel racial stereotypes. For attitudinal measures, White participants endorsed more liberal attitudes toward sex in high-contact conditions and non-White participants endorsed more liberal attitudes in low-contact conditions. For behavioral measures, non-White participants reported more behaviors on pencil-and-paper surveys than on computers. White participants demonstrated no significant mode-related differences or reported more sexual behaviors in computer conditions than paper-and-pencil conditions. Overall, results suggest that experimenter contact and mode significantly impact sexual self-report and this impact is often moderated by race. [ABSTRACT FROM AUTHOR]

Teen dating violence (TDV) affects millions of young people in the USA each year (Basile et al. 2020) and is associated with a myriad of negative consequences across the lifespan, including placing individuals at greater risk for experiencing intimate partner violence (IPV) in their more permanent relationships in adulthood (Exner-Cortens et al. Pediatrics 131(1):71-78 Exner-Cortens et al. 2013; Exner-Cortens et al. Journal of Adolescent Health 60(2):176-183 Exner-Cortens et al. 2017). The CDC developed the Dating Matters®: Strategies to Promote Healthy Teen Relationships comprehensive prevention model to prevent TDV and its consequences among young people, and it was found to be effective at reducing TDV perpetration and victimization compared with another evidence-based program (Niolon et al. American Journal of Preventive Medicine 57(1):13-23 Niolon et al. 2019). Dating Matters addresses multiple risk and protective factors for TDV through its multiple components, many of which are shared risk and protective factors for other forms of violence and risk behaviors among adolescents. This article introduces this special section, which includes three papers examining these secondary outcomes of the Dating Matters comparative effectiveness, multi-site, longitudinal cluster randomized controlled trial and concludes with an invited commentary by Debnam and Temple (2020). This introduction briefly discusses the Dating Matters comprehensive prevention model, the comparative effectiveness trial used to evaluate effectiveness, the outcomes examined by the three papers included in this special section and the commentary from external reviewers. This special section makes an important contribution to the field of violence prevention, highlighting a preventive intervention for TDV that addresses a constellation of risk and protective factors and demonstrating its effects on multiple adolescent risk and violence outcomes. [ABSTRACT FROM AUTHOR]

Background: Underreporting is the major limitation of a voluntary adverse drug reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to reduce underreporting. Objective: We aimed to conduct a critical review of papers that assessed the effectiveness of different strategies to increase ADR reporting, regardless of the health professionals or patients included. Data Sources: Scientific papers were selected after a search of the MEDLINE-PubMed and EMBASE scientific databases up to 7 December 2010. Study Selection: We included papers in English, French or Spanish that analysed an intervention aimed at increasing the number of reported ADRs, and quantify the results of the intervention in terms of number of reports. Data Extraction: The abstracts retrieved in both computerized searches were reviewed independently by two of the authors. Initially selected papers were thoroughly read to evaluate if they met inclusion and exclusion criteria. Data in finally selected papers were independently extracted by both authors and set in pre-designed tables. A third author took the final decision in case of disagreement. For each study, we analysed study design, type of intervention, assessment period, and results of the intervention. Results: Of the 4,221 papers located that fulfilled the search criteria, 43 met the selection criteria. With the exception of one study, the interventions assessed were deemed to be effective. The vast majority of papers displayed methodological and formal limitations that lowered the grade of evidence. Multiple interventions seem to have had more impact than did single interventions. There were very few cases in which interventions were designed on the basis of inappropriate attitudes and mistaken beliefs about ADRs. Conclusions: In general, there is a need for studies of better methodological quality in this topic, so that more evidence of the effectiveness of the respective strategies can be collected for the purpose of improving ADR reporting by health professionals. It is probable that multiple interventions cause greater increases in the ADR reporting rates than single. [ABSTRACT FROM AUTHOR]

Background: This paper presents the baseline characteristics and their moderators in the Healthy Learning Mind (HLM)– school-based cluster-randomized controlled trial. Objectives: The paper evaluates the state of various measures of well-being, their moderators and how these results compare to national and global norms/population studies. Methods: Data were collected from all participants prior to the intervention and further analyzed by gender, grade and perceived socioeconomic status, including standardized measures for resilience, depressive symptoms and socioemotional functioning; health-related quality of life, dispositional mindfulness, satisfaction with life, compassion/self-kindness, self-rated health and morning tiredness. Results: Participating 2793 students (1425 girls, 1368 boys), ages 12 to 15 years, filled in the questionnaires. The outcomes were in line with previous research, demonstrating gender differentiation and lower wellbeing among older children and adolescents. Conclusions: All outcomes were associated with perceived socioeconomic status, suggesting that perceived low socioeconomic status should be addressed as a serious risk factor and included as a moderator in similar trials. [ABSTRACT FROM AUTHOR]

This paper presents findings of a second trial evaluating telephone-based motivational enhancement therapy (MET) to motivate untreated and unadjudicated men who abuse their intimate partners to explore treatment options. Participants' perceptions of how their abuse is negatively affecting them personally are a highlight of the paper. One hundred forty-one adult men were recruited through social marketing and randomly assigned to the intervention (MET) or comparison (Mail) group. The MET condition consisted of two feedback sessions guided by a personalized feedback report on participants' intimate partner violence (IPV) and substance use. The Mail condition included a mailed educational brochure on IPV and substance use. Results supported the likely effectiveness of MET in short-term reduction of IPV behavior, marijuana use, and increasing motivation for treatment seeking particularly for participants who reported more adverse consequences of IPV to themselves. Findings emphasize the importance of including a focus in interventions on IPV's impact on the abusers themselves. The study's virtual participation and success in reaching and retaining a diverse population of male abusers can contribute to transformative justice and communities looking for alternative early interventions for men of color prior to encountering the criminal justice system. [ABSTRACT FROM AUTHOR]

Background:Literature reviews of cancer trials have highlighted the need for better understanding of phase II statistical designs. Understanding the key elements associated with phase II design and knowledge of available statistical designs is necessary to enable appropriate phase II trial design.Methods:A systematic literature review was performed to identify phase II trial designs applicable to oncology trials. The results of the review were used to create a library of currently available designs, and to develop a structured approach to phase II trial design outlining key points for consideration.Results:A total of 122 papers describing new or adapted phase II trial designs were obtained. These were categorised into nine levels, reflecting the practicalities of implementation, and form a library of phase II designs. Key design elements were identified by data extraction. Along with detailed description of the key elements and the library of designs, a structured thought process was developed to form a guidance document for choice of phase II oncology trial design.Conclusion:The guidance offers researchers a structured and systematic approach to identifying phase II trial designs, highlighting key issues to be considered by both clinicians and statisticians and encouraging an interactive approach to more informed trial design. [ABSTRACT FROM AUTHOR]

Background: Missing data in costs and/or health outcomes and in confounding variables can create bias in the inference of health economics and outcomes research studies, which in turn can lead to inappropriate policies. Most of the literature focuses on handling missing data in randomized controlled trials, which are not necessarily always the data used in health economics and outcomes research. Objectives: We aimed to provide an overview on missing data issues and how to address incomplete data and report the findings of a systematic literature review of methods used to deal with missing data in health economics and outcomes research studies that focused on cost, utility, and patient-reported outcomes. Methods: A systematic search of papers published in English language until the end of the year 2020 was carried out in PubMed. Studies using statistical methods to handle missing data for analyses of cost, utility, or patient-reported outcome data were included, as were reviews and guidance papers on handling missing data for those outcomes. The data extraction was conducted with a focus on the context of the study, the type of missing data, and the methods used to tackle missing data. Results: From 1433 identified records, 40 papers were included. Thirteen studies were economic evaluations. Thirty studies used multiple imputation with 17 studies using multiple imputation by chained equation, while 15 studies used a complete-case analysis. Seventeen studies addressed missing cost data and 23 studies dealt with missing outcome data. Eleven studies reported a single method while 20 studies used multiple methods to address missing data. Conclusions: Several health economics and outcomes research studies did not offer a justification of their approach of handling missing data and some used only a single method without a sensitivity analysis. This systematic literature review highlights the importance of considering the missingness mechanism and including sensitivity analyses when planning, analyzing, and reporting health economics and outcomes research studies. [ABSTRACT FROM AUTHOR]

Acute lung injury (ALI) is a life-threatening clinical syndrome with high morbidity and mortality. The main pathological features of ALI are increased alveolar-capillary membrane permeability, edema, uncontrolled migration of neutrophils to the lungs, and diffuse alveolar damage, resulting in acute hypoxemic respiratory failure. We performed a systematic review and meta-analysis to elucidate the antioxidant activities of flavanols in a rat model of acute lung injury (ALI). PubMed, EMBASE, Scopus, ProQuest, Web of Science, and Google Scholar databases were searched to obtain the relevant papers. Nine studies with 343 rat models of ALI were included in this study. We investigated oxidative stress with the corresponding 95% CI. Estimating the correlation and 95% CIs for the inflammatory agents and oxidative stress in the intervention group, compared with that in the control group (ALI), respectively (correlation: 0.635; 95% CI, 0.560–0.699, P value = 0.000, Z value= 12.648) and (correlation: 0.317; 95% CI, 0.189–0.434, P value = 0.00, Z value= 4.7). In conclusion, investigating the effects of different flavanols on oxidative stress in lung injury may provide a useful therapeutic strategy in ALI mouse models. However, the final conclusion on treatment efficacy should be sufficient for prospective controlled randomized trials. [ABSTRACT FROM AUTHOR]

While integrative data analysis (IDA) presents great opportunity, it also necessitates a myriad of methodological decisions related to harmonizing disparate measures collected across multiple studies. There is a lack of step-by-step methodological guidance for harmonizing disparate measures of latent constructs differently conceptualized or operationalized across studies, such as social, emotional, and behavioral constructs often utilized in prevention science. The current paper addressed this gap by providing methodological guidance and a case illustration focused on harmonizing measures of disparately conceptualized and operationalized constructs. We do so by outlining a five-phased harmonization approach paired with an illustrative example of the approach as applied to harmonization of broadband latent emotional and behavioral health constructs assessed with different measures across studies. This approach builds on and expands upon procedures currently recommended in the IDA literature with parallels to best practices in test development procedures. The illustrative example of our phased approach is drawn from an IDA study of 11 randomized controlled trials of Coping Power (Lochman & Wells, 2004), an evidence-based preventive intervention. We demonstrate the harmonization of two constructs, internalizing and externalizing problems, as harmonized across the teacher-reported scales of the Achenbach System of Empirically Based Assessment (Achenbach, 1991a) and the Behavior Assessment System for Children (Reynolds & Kamphaus, 2004). Finally, we consider the potential strengths and limitations of this phased approach, underscoring areas for future methodological research and conclude with some recommendations. [ABSTRACT FROM AUTHOR]

This article presents the MOBIS dataset and underlying survey methods used in its collection. The MOBIS study was a nation-wide randomised controlled trial (RCT) of transport pricing in Switzerland, utilising a combination of postal recruitment, online surveys, and GPS tracking. 21,571 persons completed the first online survey, and 3680 persons completed 8 weeks of GPS tracking. Many continued tracking for over a year after the study was completed. In the field experiment, participants participated through the use of a GPS tracking app, Catch-my-Day, which logged their daily travel on different transport modes and imputed the trip segments and modes. The experiment lasted 8 weeks, bookended by two online surveys. After the first 4-week control phase, participants were split into two different treatment groups and a continued control group. An analysis of the survey participation shows that the technology is capable of supporting such an experiment on both Android and iOS, the two main mobile platforms. Significant differences in the engagement and attrition were observed between iOS and Android participants over the 8-week period. Finally, the attrition rate did not vary between treatment groups. This paper also reports on the wealth of data that are being made available for further research, which includes over 3 million trip stages and activities, labelled with transport mode and purpose respectively. [ABSTRACT FROM AUTHOR]

Failure to meet international targets set for the human immunodeficiency virus HIV pandemic suggests that more effective public health strategies are needed. New strategies informed by behavioural economics are now increasingly being tested, with promising results. However, the evidence base is diverse and challenging for policymakers to interpret. This paper aims to synthesise existing evidence by reporting results from a systematic review of behavioural economics-based interventions for addressing HIV prevention, testing and treatment. The reported study was a systematic review of randomized controlled trials. The search was conducted in four electronic medical literature databases, six trial registries, four grey literature sources and was not restricted to any country or region. Bias was assessed using criteria outlined in the Cochrane Handbook for Systematic Reviews; quality of evidence was assessed using GRADE methodology. Fifteen full text articles were included in the final analysis. The synthesis of these studies revealed that strategies involving opt-out defaults, active-choice defaults, and lottery incentives can potentially increase uptake of HIV testing. Lottery incentives also showed signs of effectiveness in improving HIV prevention, ART adherence and initiation. Despite the promising findings, the overall evidence was judged to be of moderate to very low quality. Behavioural economics-based interventions are promising behavioural change strategies, although more well-designed studies are needed to strengthen the evidence base. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this systematic review is to assess the clinical implications of employing various Extended Reality (XR) tools for image guidance in urological surgery. Methods: In June 2023, a systematic electronic literature search was conducted using the Medline database (via PubMed), Embase (via Ovid), Scopus, and Web of Science. The search strategy was designed based on the PICO (Patients, Intervention, Comparison, Outcome) criteria. Study protocol was registered on PROSPERO (registry number CRD42023449025). We incorporated retrospective and prospective comparative studies, along with single-arm studies, which provided information on the use of XR, Mixed Reality (MR), Augmented Reality (AR), and Virtual Reality (VR) in urological surgical procedures. Studies that were not written in English, non-original investigations, and those involving experimental research on animals or cadavers were excluded from our analysis. The quality assessment of comparative and cohort studies was conducted utilizing the Newcastle-Ottawa scale, whilst for randomized controlled trials (RCTs), the Jadad scale was adopted. The level of evidence for each study was determined based on the guidelines provided by the Oxford Centre for Evidence-Based Medicine. Results: The initial electronic search yielded 1,803 papers after removing duplicates. Among these, 58 publications underwent a comprehensive review, leading to the inclusion of 40 studies that met the specified criteria for analysis. 11, 20 and 9 studies tested XR on prostate cancer, kidney cancer and miscellaneous, including bladder cancer and lithiasis surgeries, respectively. Focusing on the different technologies 20, 15 and 5 explored the potential of VR, AR and MR. The majority of the included studies (i.e., 22) were prospective non-randomized, whilst 7 and 11 were RCT and retrospective studies respectively. The included studies that revealed how these new tools can be useful both in preoperative and intraoperative setting for a tailored surgical approach. Conclusions: AR, VR and MR techniques have emerged as highly effective new tools for image-guided surgery, especially for urologic oncology. Nevertheless, the complete clinical advantages of these innovations are still in the process of evaluation. [ABSTRACT FROM AUTHOR]

This paper considers an important recent (May 2018) contribution by Miguel Hernán to the ongoing debate about causal inference in epidemiology. Hernán rejects the idea that there is an in-principle epistemic distinction between the results of randomized controlled trials and observational studies: both produce associations which we may be more or less confident interpreting as causal. However, Hernán maintains that trials have a semantic advantage. Observational studies that seek to estimate causal effect risk issuing meaningless statements instead. The POA proposes a solution to this problem: improved restrictions on the meaningful use of causal language, in particular "causal effect". This paper argues that new restrictions in fact fail their own standards of meaningfulness. The paper portrays the desire for a restrictive definition of causal language as positivistic, and argues that contemporary epidemiology should be more realistic in its approach to causation. In a realist context, restrictions on meaningfulness based on precision of definition are neither helpful nor necessary. Hernán's favoured approach to causal language is saved from meaninglessness, along with the approaches he rejects. [ABSTRACT FROM AUTHOR]

Only one paper, "Artificial Intelligence Algorithm Improves Radiologist Performance in Skeletal Age Assessment: A Prospective Multicenter Randomized Controlled Trial", published in I Radiology i , was a randomized controlled trial. Keywords: Artificial intelligence; Randomized controlled trial; Radiology EN Artificial intelligence Randomized controlled trial Radiology 4223 4225 3 05/17/23 20230601 NES 230601 A rapid growth in artificial intelligence (AI) applications in radiology has encompassed many aspects, from medical imaging interpretation to workflow management and decision-making. [[5]] As AI becomes an integral part of radiology workflow, critical evaluation of AI through methodologically strong tools is crucial. [Extracted from the article]

Given the longevity of investments in energy-consuming products (such as household appliances, vehicles, and properties), underinvestment in energy efficiency can have long-lasting negative economic and environmental consequences. Previous research has indicated that underinvestment may be due to imperfect information in relation to the long-term benefits of investing in energy efficiency. This paper presents the results of a cluster randomised controlled trial examining an intervention which aims to overcome this information deficit by providing long-term energy cost information on appliances in an electrical retail chain in Ireland. Two treatments are considered: a label showing 10-year energy cost information based on typical usage for four appliance categories (fridge freezers, dishwashers, washing machines, and tumble dryers); and a second treatment which supplements this label with a QR code where consumers can gain personalised cost estimates based on their expected appliance usage. Results indicate that neither of the treatments resulted in an increase in the average energy efficiency of appliances sold. Also, engagement of customers with the QR code was extremely low. Given that the newly designed EU energy labels incorporate QR codes for personalisation, this low usage suggests that this element of the new labels may be ineffective in increasing the uptake of energy efficiency. Finally, a customer survey suggests that while the treatment increased the stated importance of energy efficiency in decision-making, this did not translate into an increase in efficiency of products purchased, i.e., stated preferences for energy efficiency did not translate into revealed purchasing preferences. [ABSTRACT FROM AUTHOR]

Introduction: The phase 2 MANTA and MANTA-RAy studies were developed in consultation with global regulatory authorities to investigate potential impacts of filgotinib, a Janus kinase 1 preferential inhibitor, on semen parameters in men with active inflammatory diseases. Here we describe the methods and rationale for these studies. Methods and Rationale: The MANTA and MANTA-RAy studies included men (aged 21–65 years) with active inflammatory bowel disease (IBD) and rheumatic diseases, respectively. Participants had no history of reproductive health issues, and the following semen parameter values (≥ 5th percentile of World Health Organization reference values) at baseline: semen volume ≥ 1.5 mL, total sperm/ejaculate ≥ 39 million, sperm concentration ≥ 15 million/mL, sperm total motility ≥ 40% and normal sperm morphology ≥ 30%. Each trial included a 13-week, randomized, double-blind, placebo-controlled period (filgotinib 200 mg vs placebo, up to N = 125 per arm), for pooled analysis of the week-13 primary endpoint (proportion of participants with ≥ 50% decrease from baseline in sperm concentration). All semen assessments were based on two samples (≤ 14 days apart) to minimize effects of physiological variation; stringent standardization processes were applied across assessment sites. From week 13, MANTA and MANTA-RAy study designs deviated owing to disease-specific considerations. All subjects with a ≥ 50% decrease in sperm parameters continued the study in the monitoring phase until reversibility, or up to a maximum of 52 weeks, with standard of care as treatment. Overall conclusions from MANTA and MANTA-RAy will be based on the totality of the data, including secondary/exploratory measures (e.g. sperm motility/morphology, sex hormones, reversibility of any effects on semen parameters). Conclusions: Despite the complexities, the MANTA and MANTA-RAy studies form a robust trial programme that is the first large-scale, placebo-controlled evaluation of potential impacts of an advanced IBD and rheumatic disease therapy on semen parameters. Trial Registration: EudraCT numbers 2017-000402-38 and 2018-003933-14; ClinicalTrials.gov identifiers NCT03201445 and NCT03926195. Plain Language Summary: Filgotinib is a treatment for patients with ulcerative colitis and rheumatoid arthritis, and is being studied in other inflammatory diseases. Filgotinib works by blocking Janus kinase 1, an intracellular protein involved in inflammatory signalling processes. We designed the MANTA and MANTA-RAy trials with global health agencies to find out if filgotinib decreases the quality of semen in men with active inflammatory bowel disease (ulcerative colitis or Crohn's disease) (MANTA) or rheumatic disease (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondylitis) (MANTA-RAy). This paper describes the design of the two trials. Patients had normal sperm measurements and could not have had previous reproductive health issues. Nearly 250 patients were included in each trial. In both MANTA and MANTA-RAy, half of the patients were treated with 200 mg of filgotinib once a day for 13 weeks, and the other half with placebo. We determined if any patients had a decrease in number of sperm cells per millilitre (sperm concentration) by at least half after 13 weeks of treatment. We then monitored any patients who had such a decrease in sperm concentration for up to 52 weeks (while they received standard of care treatment) or until the decrease was reversed. The conclusions from the trials will be in a different paper and will be based on all the final data, including changes in sex hormones. This is the first large-scale clinical trial programme to measure the effect of a treatment on sperm in men with inflammatory bowel disease or rheumatic diseases. [ABSTRACT FROM AUTHOR]

The need for developing effective telehealth tools for dysphagia management is high not only for people who live in rural areas, but also for individuals with mobility/access limitations. We aimed to develop an electronic case History Tool/form (thereafter, e-HiT) for dysphagia, and compare its effectiveness with its paper-based version (PBV) on completion time, completeness, independence, and patient perceptions/satisfaction. Secondarily, we examined associations between the aforementioned variables and predictor variables, such as age, cognition, and computer/internet use. Forty adults who expressed concerns with eating/swallowing participated. To compare both versions, a randomized, controlled two-period crossover design was used. In Visit 1, Group A completed the e-HiT and Group B completed the PBV. In Visit 2, Group A completed the PBV and Group B completed the e-HiT. A satisfaction survey was completed post visits. There were no statistically significant differences for completion time (p = 0.743), completeness (p = 0.486), and independence (p = 0.738). Patient perception/satisfaction was significantly higher with the e-HiT (p = 0.004). In addition, a significant association was found between completion time and age (p = 0.0063). Our results indicate that completing the e-HiT is as time efficient as completing the PBV and that both forms elicit the same amount of information with no or minimal support. Also, completion of the e-HiT yielded significantly higher satisfaction responses. This is the first study documenting the effectiveness of the e-HiT for outpatients with dysphagia, providing evidence that the first step of a swallowing assessment-case history completion-can be effectively completed via telehealth by individuals with reliable internet connection and basic computer literacy skills. [ABSTRACT FROM AUTHOR]

Background: Stoma formation is a commonly performed procedure both during and following colorectal surgery. When designed correctly, stomas can dramatically improve patients' quality of life, but the reverse may occur when complications arise. Given the significant negative impact of complications following stoma formation, understanding risk factors that may be mitigated pre-operatively is important. Method: A systematic search of publications using MEDLINE, CINAHL, and Cochrane databases was conducted in May 2022. Data was extracted and a narrative synthesis undertaken. The evidence-based librarianship (EBL) checklist assessed the methodological quality of the included studies. The systematic review includes various research designs such as randomised controlled trials (RCT), case–control studies, and observational cohort studies written in English. Reviews, conference papers, opinion papers, and those including participants < 18 years old were excluded. No restrictions on the date of publication and study setting were applied. Results: This review included 17 studies, conducted between 2001 and 2020. The study designs were prospective audit, prospective analysis, retrospective analysis, longitudinal analysis and multivariate analysis of self-reported questionaires/surveys. Twenty-two possible risk factors for the development of stoma complications following stoma formation were identified. These include demographical risk factors, underlying medical condition, type of surgery, elective vs emergency surgery, stoma factors, surgical factors, indications for surgery and factors which may impact healing. Furthermore, high BMI, emergency surgery, and stoma type were identified as the most frequently occurring risk factors. Conclusion: Given the large number of risk factors identified, the implementation of a risk stratification tool may decrease the incidence and prevalence of stoma complication development. This, in turn, would decrease the associated healthcare-related costs, and negative impact on mortality, length of stay and quality of life. [ABSTRACT FROM AUTHOR]

To analyze the efficacy of using honey to treat acute cough in children. Systematic review, synthesis without meta-analysis. We searched PubMed, Scopus, CENTRAL, CINAHL, and Web of Science databases on August 15, 2022, for words honey and cough. Randomized controlled trials conducted in children were included. Risk-of-bias and evidence quality were assessed. Studies were not pooled due to lack of key information. Instead, we provided the range of observed effects for the main outcomes. Three hundred ninety-six papers were screened, and 10 studies were included. Two studies had high risk-of-bias and six had some concerns. Honey seemed to decrease cough frequency more than placebo/no treatment (range of observed effect 0.0–1.1 points) and cough medication (0.2–0.9 points). Sleep improved more often in the honey group (range of effect was 0.0–1.1) compared to placebo/no treatment and (− 0.2–1.1 points) compared to cough medication. Quality of the evidence was low to very low. Conclusion: We found low quality evidence that honey may be more effective than cough medication or placebo/no treatment in relieving symptoms and improving sleep in children with acute cough. Better quality randomized, placebo-controlled blinded trials are needed to confirm the effectiveness of honey in treating acute cough in children. Trial registration: CRD42022369577. What is Known: • Honey has been suggested to be effective as a symptomatic treatment in acute cough. • Prior randomized trials have had conflicting results and thus an overview of the literature was warranted. What is New: • Based on low quality evidence honey may be more effective than placebo or over-the-counter medications for acute symptom reliwef in cough. • Future studies with better reporting are needed to confirm the results. [ABSTRACT FROM AUTHOR]

Background: Therapeutic strategies such as improvement muscle activation are fundamental for clinical practice, especially for the quadriceps muscle. It is not yet clear in the literature whether Kinesio Taping (KT) can modify muscle activation. This study sought to evaluate the effect of Kinesio Taping™ (KT) with different directions and tensions on the muscle activity of the rectus femoris in young adults with a muscle imbalance promoted by mechanical vibration. Thirty-two subjects were allocated into two groups: group A, used taping origin to insertion and group B, used taping insertion to origin. In both groups the dominant limb received the taping while the non-dominant limb was used as a control. A continuous vibration (60 Hz) was conducted on the patella tendon for 20 min before the electromyography (EMG) evaluation. Mean and maximum EMG values of the rectus femoris were collected during three maximal isometric voluntary contractions performed in 5 s. Muscle activity was evaluated three times: prior to KT application, immediately after KT placement, and 24 h later. These evaluations were done with 0% (no tension), with 10% (paper off), and with 75–100% (total tension) on both groups. Significance level of p < 0.05 was used. Results: Compared with no intervention, on group A, there were differences for mean and maximum EMG values 24-h post-application with 0%, 10%, and 75% of tension (p < 0.05). On group B, there were differences for maximum EMG values immediately and 24 h post-application with 0% and 75% of tension (p < 0.05). There were no differences between both groups (p > 0.05). Conclusions: Kinesio Taping applied with different directions and tensions increased the muscle activity immediately and 24 h post-application of the rectus femoris of healthy individuals. The inhibition technique cannot decrease the muscle activity. [ABSTRACT FROM AUTHOR]

Purpose: Vulvar lichen sclerosus (LS) is a chronic debilitating inflammatory skin disease. Today, the gold standard is a life-long topical steroid treatment. Alternative options are highly desired. We present a study protocol of a prospective, randomized, active-controlled, investigator-initiated clinical trial comparing a novel non-invasive dual Nd:YAG/Er:YAG laser therapy with the gold standard for the management of LS. Methods: We recruited 66 patients, 44 in the laser arm and 22 in the steroid arm. Patients with a physician-administered clinical LS score ≥ 4 were included. Participants received either four laser treatments 1–2 months apart, or 6 months of topical steroid application. Follow-ups were planned at 6, 12, and 24 months. The primary outcome looks at the efficacy of the laser treatment at the 6-month follow-up. Secondary outcomes look at comparisons between baseline and follow-ups within the laser or the steroid arm, and comparisons between laser vs. steroid arm. Objective (LS score, histopathology, photo documentation) and subjective (Vulvovaginal Symptoms Questionnaire, symptom VAS score, patient satisfaction) measurements, tolerability, and adverse events are evaluated. Conclusion: The findings of this trial have the potential to offer a novel treatment option for LS. The standardized Nd:YAG/Er:YAG laser settings and the treatment regime are presented in this paper. Clinical trial identification number: NCT03926299. [ABSTRACT FROM AUTHOR]

Background: Limited data regarding the effects of school-based obesity prevention programs focusing on the changes in obesity-related knowledge and behaviors in China are available. The objective of this paper was to evaluate the effects of a school-based comprehensive lifestyle intervention among Chinese kids against obesity (CLICK-Obesity) in primary schools in Nanjing. Methods: We designed a cluster randomized controlled trial in eight randomly selected urban primary schools among 4th graders between May 2011 to April 2012 in Jianye, an urban district of Nanjing. Each school was randomly assigned to either the intervention or control group (four schools in each group). Mixed regression models and generalized estimating equations (GEE) were used to adjust for individual-level covariates under cluster randomization. Results: In this study, 1178 students (96.2%; 665 boys and 513 girls, 544 in control and 634 in intervention) participated in the baseline survey with mean age 10.2 ± 0.5 years. At the end of one-year intervention, 1125 students (91.8%; 628 boys and 497 girls, 513 in control and 612 in intervention) were reassessed. Notably, we found that the intervention group improved the knowledge and awareness of obesity-related risk factors, presented a lower increase of consumption of red/white meat (with a mean difference of −180.9 g/week, 95% CI: −350.6 to −11.2, p = 0.040), a larger increase in the time spent playing ball (with a mean difference of 24.2 min/week, 95% CI: −5.3 to 53.7, p = 0.090), and a significant reduction in screen time (with a mean difference of −71.0 min/week, 95% CI: −125.3 to −16.6, p = 0.020) compared to the control group after cluster (school) adjustment. Conclusion: The school-based integrated intervention was successful to modify unhealthy lifestyle behaviors and had a potential effect on childhood obesity prevention in urban China. However, the long-term effects and cost-effectiveness need to be evaluated in through further study. [ABSTRACT FROM AUTHOR]

Purpose: In a randomised controlled trial, patients were offered financial incentives to improve their adherence to anti-psychotic maintenance medication. Compared to a control group without the incentives, they had an improved adherence and also better subjective quality of life (SQOL) after 1 year. This paper explores the question as to whether this improvement in SQOL was associated with the amount of money received or with the improved adherence itself.Method: A secondary analysis was performed using data of the experimental group in the trial. Adherence was assessed as the percentage of all prescribed long-acting anti-psychotic injections that were taken by the patient. In regression models, we tested whether changes in medication adherence and/or the amount of incentives received over the 12-month period was associated with SQOL, as rated on the DIALOG scale.Results: Adherence changed from 68.49 % at baseline to 88.23 % (mean difference in adherence = 19.59 %, SD = 17.52 %). The total amount of incentives received within the 1-year study period varied between £75 and £735, depending on the treatment cycle and the number of long-acting injections taken. Improvement in adherence was found to be a significant predictor of better subjective quality of life (β = 0.014, 95 % CI 0.003-0.025, p = 0.014), whilst the amount of incentives received was not (β = 0.0002, 95 % CI -0.002 to 0.002, p = 0.818).Conclusion: Improved medication adherence is associated with a more favourable SQOL. This underlines the clinical relevance of improved adherence in response to financial incentives in this patient group. [ABSTRACT FROM AUTHOR]

Neuropathic pain represents a broad category of pain syndromes that include a wide variety of peripheral and central disorders. The overall prevalence of neuropathic pain in the general population is reported to be between 7 and 10%. Management of neuropathic pain presents an unmet clinical need, with less than 50% of patients achieving substantial pain relief with medications currently recommended such as pregabalin, gabapentin, duloxetine and various tricyclic antidepressants. It has been suggested that cannabis-based medicines (CbMs) and medical cannabis (MC) may be a treatment option for those with chronic neuropathic pain. CbMs/MC are available in different forms: licensed medications or medical products (plant-derived and/or synthetic products such as tetrahydrocannabinol or cannabidiol); magistral preparations of cannabis plant derivatives with defined molecular content such as dronabinol (tetrahydrocannabinol); and herbal cannabis with a defined content of tetrahydrocannabinol and/or cannabidiol, together with other active ingredients (phytocannabinoids other than cannabidiol/tetrahydrocannabinol, terpenes and flavonoids). The availability of different types of CbMs/MC varies between countries worldwide. Systematic reviews of available randomised controlled trials have stated low-quality evidence for CbMs and MC for chronic neuropathic pain. Depending on the studies included in the various quantitative syntheses, authors have reached divergent conclusions on the efficacy of CbMs/MC for chronic neuropathic pain (from not effective to a clinically meaningful benefit). Clinically relevant side effects of CbMs/MC, especially for central nervous system and psychiatric disorders, have been reported by some systematic reviews. Recommendations for the use of CbMs/MC for chronic neuropathic pain by various medical associations also differ, from negative recommendations, no recommendation possible, recommended as third-line therapy, or recommended as an alternative in selected cases failing standard therapies within a multimodal concept. After reading this paper, readers are invited to formulate their own conclusions regarding the potential benefits and harms of CbMs/MC for the treatment of chronic neuropathic pain. [ABSTRACT FROM AUTHOR]

Background: Many countries are experiencing an increased demand for health care and a shortage of health professionals in rural areas, impacting an individual's ability to receive timely treatment. The management of uncomplicated urinary tract infections by community pharmacists is usual practice in some regions of the United Kingdom and Canada, and Queensland, Australia. Aim: To systematically gather, assess, and synthesize the available peer-reviewed published literature on the management of uncomplicated UTIs by community pharmacists in women aged 16–65 years, provide an understanding of the clinical and economic evidence, while also identifying the essential components of interventions employed. Method: A systematic review was conducted to identify primary studies detailing interventions for the management of uncomplicated UTIs by community pharmacists. PubMed, PsycINFO, Scopus, Cochrane, CINAHL, EMBASE, and Web of Science were searched to February 2023. Non-primary and qualitative studies were excluded. Study details were recorded in a tailored data extraction form. The quality of studies was assessed using the Joanna Briggs Institute tools. Results: Ten publications were included following review of 2129 records. High self-reported cure rates between 84 and 89% and referral rates of about 7% were reported. A single study found pharmacist management was cost effective compared to general practitioner management. No randomized controlled trials were found and papers were of variable quality. Conclusion: Preliminary evidence suggests pharmacist-led management of uncomplicated UTIs is safe and effective, however no firm conclusion can be provided since the methodologies reported in included studies have significant limitations. [ABSTRACT FROM AUTHOR]

Purpose: The use of natural and herbal products as alternative therapies, in conjunction with blood glucose-lowering medications, is on the rise for patients with diabetes. Our objective was to conduct a systematic review and comprehensive meta-analysis of both human and animal models to investigate the impact of chamomile consumption on glycemic control. Methods: A systematic search was conducted on all published papers from January 1990 up to January 2022 via Scopus, PubMed/Medline, Google Scholar, and ISI Web of Science. Human and animal articles evaluating the effect of chamomile on serum glycemic markers were included. We used the random-effects model to establish the pooled effect size. The dose-dependent effect was also assessed. Results: Overall, 4 clinical trials on human and 8 studies on animals met the inclusion criteria. With regard to RCTs, a favorable effect of chamomile consumption on serum fasting blood glucose (Standardized Mean Differences (SMD): -0.65, 95% CI: -1.00, -0.29, P < 0.001; I2 = 0%) and hemoglobin A1C (HbA1C) levels (SMD: -0.90, 95% CI: -1.39, -0.40, P < 0.001; I2 = 45.4%) was observed. Considering animal studies, consumption of chamomile extracts significantly reduced serum blood glucose (SMD: -4.37, 95% CI: -5.76, -2.98, P < 0.001; I2 = 61.2%). Moreover, each 100 mg/d increase in chamomile extract intervention resulted in a significantly declined blood glucose concentrations (MD: -54.35; 95% CI: -79.77, -28.93, P < 0.001; I2 = 94.8). Conclusion: The current meta-analysis revealed that chamomile consumption could exert favorable effects on serum blood glucose and HbA1C. However, additional randomized controlled trials are needed to further confirm these findings. [ABSTRACT FROM AUTHOR]