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Aims: The aim of this work was to measure the impact of P2P (i.e. peer‐to‐peer), a peer‐led smoking prevention intervention, on daily smoking prevalence of adolescents over 2 school years. Design: A cluster‐randomized controlled trial was performed over a 16‐month follow‐up (trial status: closed to follow‐up). P2P was implemented 1–3 and 13–15 months after baseline. Assessments took place at baseline and 4, 10 and 16 months after baseline. The research team, assessors and adolescents were blinded to the study‐arm assignment only at baseline. Setting: Fifteen vocational high schools in France were randomized into two clusters, using a 1:1 allocation ratio per French department (n intervention = 7, n control = 8). Participants: Participants comprised a sample of 2010 students in year 11 (i.e. 15–16 years) in vocational high schools. A total of 437 students could not be assessed at baseline (absent or left school), yielding a total sample of 1573 students (n intervention = 749, n control = 824). Intervention and comparator: The P2P programme trained voluntary students to become peer educators and design smoking prevention actions for their schoolmates in the intervention group (n = 945 students), compared with a passive control group (n = 1065 students). Measurements The primary outcome was change from baseline in the prevalence of self‐reported daily smoking (i.e. at least one cigarette per day) at 16 months. Findings The 'time × group' interaction indicated that, compared with the control group, the intervention group had statistically significantly fewer daily smokers after 16 months [odds ratio (OR) = 0.33, 95% confidence interval (CI) = 0.20, 0.53]. Similarly, compared with the control group, the intervention group had statistically significantly fewer daily smokers after 4 months (OR = 0.50, 95% CI = 0.30, 0.82) and 10 months (OR = 0.60, 95% CI = 0.37, 0.98). No adverse events of P2P2 were reported. Conclusions: A cluster‐randomized trial found evidence that the peer‐led P2P (peer‐to‐peer) smoking prevention intervention reduced the uptake of daily smoking among high school students in France over 16 months. [ABSTRACT FROM AUTHOR]

Background: Standardization of health systems often hinders client‐centered care. This study investigates whether allowing more flexibility in the planning range of the Dutch home‐based postpartum care service improves its quality of care, as innovative approach to client‐centered care. Methods: A randomized controlled trial was conducted (2017–2019), in which pregnant women who intended to breastfeed were assigned into two groups (1:1). The intervention group was allowed to receive care up to the 14th‐day postpartum, instead of the first 8–10 consecutive days ("usual care"). Primary outcome measure was the proportion of newborns still receiving exclusively breastmilk on final caring day of the service. This so‐called successful breastfeeding rate is currently used by the Dutch health sector to measure the quality of care. Secondary outcome measures were self‐care experience, overall care experience, and exclusive breastfeeding duration rate. Results: Based on data from 1275 participants, there was no difference in exclusive breastfeeding on final caring day (86,7% intervention group vs. 88,9% control group, RR: 1.03, 95% CI: 0.98–1.07). Both groups showed similar self‐care experiences. Women in the intervention group had slightly poorer overall care experience and lower exclusive breastfeeding duration rates. Conclusions: This study found no effect on the quality of care when allowing more flexibility in the planning range of home‐based postpartum care. Women can, therefore, be offered more flexibility to suit them. Given the confusion in interpreting the sector's current main quality indicator, we call for an inclusive dialogue on how to best measure the quality of home‐based postpartum care. [ABSTRACT FROM AUTHOR]

Background and aims: Offering financial incentives is effective for smoking cessation during pregnancy. We tested the effectiveness of financial incentives for maintaining postpartum cessation, comparing 12-month and 3-month incentives with each other and with usual care (UC). Design, setting and participants: This study was a pragmatic, multi-centre, three-arm randomized controlled trial involving four English, National Health Service, stop smoking services. A total of 462 postpartum women (aged ≥ 16 years) took part, who stopped smoking during pregnancy with financial incentives, validated as abstinent from smoking at end of pregnancy or early postpartum. Interventions: Interventions comprised (i) UC; (ii) UC plus up to £60 of financial voucher incentives offered to participants and £60 offered to an optional significant-other supporter, over 3 months postpartum, contingent upon validated abstinence ('3-month incentives'); or (iii) UC plus '3-month incentives' plus £180 of vouchers offered to participants over 9 months postpartum, contingent upon abstinence ('12-month incentives'). Measurements: Primary outcome: biochemically validated abstinence at 1 year postpartum. To adjust for testing all comparisons between groups with equal precision, P < 0.017 was necessary for significance. Secondary outcomes: self-reported and validated abstinence at 3 months postpartum; self-reported abstinence at 1 year postpartum. Findings: Primary outcome ascertainment: abstinence was 39.6% (63/159) 12 months incentives, 21.4% (33/154) 3 months incentives and 28.2% (42/149) UC. Adjusted odds ratios [95% confidence interval (CI)] = 12-month versus 3-month incentives OR = 2.41 (95% CI = 1.46-3.96), P = 0.001; 12 months versus UC 1.67 (1.04-2.70), P = 0.035; 3 months versus UC 0.69 (0.41-1.17), P = 0.174. Bayes factors indicated that for 12- month versus 3-month incentives and 12 months versus UC there was good evidence for the alternative hypothesis, and for 3 months versus UC there was good evidence for the null hypothesis. Conclusions: This randomized controlled trial provides weak evidence that up to £300 of voucher incentives over 12 months is effective for maintaining smoking abstinence postpartum compared with usual care. There was good evidence that 12-month incentives are superior to those over only 3 months, for which there was no evidence of effectiveness relative to usual care. [ABSTRACT FROM AUTHOR]

Resilience training has beneficial effects on the ability of undergraduate students to withstand adversity and stress. However, there are inconsistencies in the content and delivery approaches for resilience training. Given the increasing shifts towards computer‐assisted instruction, there is a need to develop and evaluate innovative approaches for resilience training. This study aimed to examine the efficacy of two versions of the Resilience Skills Enhancement (RISE) programme. A randomized controlled trial was used to evaluate the effects of blended learning (BL) and a self‐guided RISE programme on the resilience, social support, and learning outcomes of undergraduate students. One hundred and fourteen students were recruited and randomly allocated to receive either BL or the self‐guided RISE programme. The within‐group analyses indicated significant improvements in resilience scores for the BL (F = 37.74, p < 0.001) and self‐guided groups (F = 10.16, p < 0.001) with moderate (d = 0.62, 95% CI: 0.25, 1.00) to large effect sizes (d = 1.11, 95% CI: 0.71, 1.50) respectively. There were also significant differences across the three time points for social support scores for the BL (F = 4.50, p < 0.05) and self‐guided groups (F = 4.59, p < 0.05). Students in the BL group had considerable improvements in self‐efficacy of learning and performance (F = 5.42, p < 0.01) and meta‐cognitive self‐regulation scores (F = 5.91, p < 0.01). In the between‐group analyses, both BL and self‐guided RISE were comparable for resilience, social support, and learning scores (p > 0.05). The study provided preliminary evidence that both modes, BL and self‐guided RISE programme lead to positive effects on the resilience, social support, and learning scores of students. [ABSTRACT FROM AUTHOR]

Background: Rural family caregivers (FCGs) in the United States often experience high economic costs. This randomized controlled trial compared a transitional palliative care intervention (TPC) to support FCGs of seriously ill care recipients (CRs) to an attention control condition. We evaluated the TPC's effect on healthcare use and out‐of‐pocket spending for both FCGs and CRs. Methods: TPC FCGs received teaching, guidance, and counseling via video calls for 8 weeks following CR discharge from the hospital. After discharge, a research assistant called all FCGs once a month for up to 6 months or CR death to collect self‐reported healthcare utilization (e.g., outpatient, emergency department, and hospital), out‐of‐pocket healthcare spending (e.g., deductibles and coinsurance), and health‐related travel costs (e.g., transportation, lodging, food) for FCGs and CRs. Incidence rate ratios (IRRs) were estimated using negative binomial regressions. Results: The study included 282 FCG–CR dyads across three U.S. states. Follow‐up over the 6‐month period was shortened by high CR mortality rates across both arms (29%), but was similar across arms. TPC reduced nights in the hospital for CR (IRR = 0.75; 95% confidence interval [CI] = 0.56–0. 99). Total out‐of‐pocket spending was not significantly different for TPC versus control. Across both groups, mean out‐of‐pocket spending for dyads was $1401.85, with healthcare payments contributing $1048.58 and transportation expenses contributing $136.79. TPC dyads reported lower lodging costs (IRR = 0.71; 95% CI = 0.56–0.89). Conclusions: This study contributes to evidence that palliative care interventions reduce the number of nights in the hospital for seriously ill patients. Yet, overall rural FCGs and seriously ill CRs experience substantial out‐of‐pocket economic costs in the 6 months following hospitalization. Transitional care intervention design should consider impacts on patient and caregiver spending. Clinicaltrials.gov # is NCT03339271. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness of an individualized nutritional education program in promoting adequate nutrient intake in pregnant women. Methods: A stratified randomized controlled trial was conducted. Participants were stratified by factors affecting the primary outcome and randomly assigned to the intervention or control groups. Intervention group participants received an individualized 30‐min booklet‐based education program in their 2nd and 3rd trimesters; the control group received usual care. The primary outcome was protein intake after the intervention, which was compared between the intervention and control groups. Secondary outcomes included comparing the amount of increase of protein before and after the intervention. Nutrient intake was measured using a self‐administered short dietary history questionnaire, and analyses of covariance and t tests were performed. Results: Of the 130 participants, 66 were assigned to the intervention group and 64 to the control group. There was no difference in protein intake between the two groups after the intervention (p =.051, 95% CI [−0.021, 12.4]). Comparing the increase in protein intake before and after intervention, the intervention group was 7.4 g/day higher than that of the control group (p =.040; F = 4.31; effect size = 0.36). Conclusions: The primary outcome, a comparison of protein intake between the groups after the program, revealed no significant differences. However, on comparing the amount of protein increase before and after the intervention, the intervention group's increase was significantly higher than that of the control group. Results indicate the potential for individualized face‐to‐face interventions for pregnant women in Japan. [ABSTRACT FROM AUTHOR]

Background and aims: Despite the high prevalence and negative effects of hazardous substance use, few young adults enter treatment. Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, has proved efficacious in promoting treatment entry. The aim of the current trial was to compare the efficacy of CRAFT with an active control for parents of young adults (aged 18–24 years) with hazardous substance use. Design: This was a randomized controlled superiority trial comparing CRAFT (n = 58) with an active control group receiving manualized counselling (n = 55), with outcome assessments at 6, 12 and 24 weeks (primary end‐point). A sequential design with a stopping rule was added post recruitment commencement. Setting: The study took place in two outpatient clinics for young adults in Stockholm, Sweden, and subsequently via video‐conference due to COVID‐19. Participants: Between October 2018 and May 2021, 113 participants (92% female) who were parents of young adults (87% male) were recruited. Recruitment was discontinued when 70% of the planned sample had been recruited, following an interim analysis of the primary outcome showing no difference between conditions. Intervention and comparator: Participants were randomized (ratio 1 : 1) to eight manual‐based individual CRAFT sessions or five individual manual‐based counselling sessions + one voluntary psychoeducative group session, delivered over maximum 14 weeks. Measurements The primary outcome measure was the rate of young adult entry in substance use treatment during the trial period (24 weeks). Findings At the 24 weeks follow‐up, 19 (33%) of CRAFT participants and 17 (31%) of counselling participants had reported young adult treatment entry, with no difference between conditions (odds ratio CRAFT versus counselling 0.84, 95% confidence interval = 0.35; 1.99, P = 0.700). Both conditions reported clinically relevant reductions in young adult substance use, but no change in participants' levels of depression, anxiety or stress. Conclusions: This trial showed no statistically significant evidence that Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, is more efficacious than manual‐based counselling regarding treatment entry for young adults. [ABSTRACT FROM AUTHOR]

Aims: To test the effectiveness of a digital intervention to reduce cannabis use (ICan) with adherence‐focused guidance compared with educational cannabis information. Design: This was a single‐blind randomized controlled trial. Follow‐up clinical outcome measurements took place 3 and 6 months after randomization. Setting: The trial was conducted in the Netherlands. The intervention and guidance took place on‐line, with recruitment via Facebook/Instagram advertisement campaigns. Participants: Inclusion criteria were ≥ 18 years, cannabis use on ≥ 3 days/week, the desire to reduce/quit cannabis and using a smartphone. Participants were allocated to either ICan (n = 188) or control (n = 190) (69% male, mean age = 27.5 years). Intervention and comparator: ICan is a mobile (web‐)application based on motivational interviewing and cognitive behavioural therapy and includes three main components: screening, brief intervention (six modules) and referral to treatment. The control condition consisted of non‐interactive educational cannabis information. Measurements Primary outcome was the number of cannabis use days in the 7 days prior to the 6‐month follow‐up measurement. Secondary outcome measures at 3‐ and 6‐month follow‐up were the number of grams of cannabis used and attitudes towards seeking professional help for cannabis use related problems. Findings Intention‐to‐treat analysis showed that 6 months after randomization the mean number of cannabis use days in the past 7 days was reduced in both conditions (time P < 0.001), with no significant group × time interaction effect [ICan = 4.17 days, control = 4.31 days, Cohen's dbetween = 0.06, 95% confidence interval (CI) = −0.15, 0.26, P = 0.93]. Three months after randomization the mean number of grams used in the past 7 days was reduced in both conditions, with a significantly larger reduction in the ICan condition (P = 0.009, Cohen's dbetween = 0.15). At 6‐month follow‐up the significant group × time interaction effect was no longer present (P = 0.30). In both conditions, attitudes towards seeking professional help remained virtually unchanged over time. Conclusions: A digital intervention to reduce cannabis use (ICan) was more effective than non‐interactive educational cannabis information in reducing grams of cannabis used over 3 months, but not more effective at reducing cannabis use days at 6‐month follow‐up. Cannabis use reductions were maintained in both conditions between 3 and 6 months' follow‐up. [ABSTRACT FROM AUTHOR]

Introduction: The aim is to perform an economic evaluation alongside a randomized controlled trial comparing guided self‐help cognitive behavioral therapy‐enhanced (CBT‐E) for binge‐eating disorder (BED) to a waiting list control condition. Methods: BED patients (N = 212) were randomly assigned to guided self‐help CBT‐E or the 3‐month waiting list. Measurements took place at baseline and the end‐of‐treatment. The cost‐effectiveness analysis was performed using the number of binge‐eating episodes during the last 28 days as an outcome indicator according to the eating disorder examination. A cost‐utility analysis was performed using the EuroQol‐5D. Results: The difference in societal costs over the 3 months of the intervention between both conditions was €679 (confidence interval [CI] 50–1330). The incremental costs associated with one incremental binge eating episode prevented in the guided self‐help condition was approximately €18 (CI 1–41). From a societal perspective there was a 96% likelihood that guided self‐help CBT‐E led to a greater number of binge‐eating episodes prevented, but at higher costs. Each additional quality‐adjusted life year (QALY) gained was associated with incremental costs of €34,000 (CI 2494–154,530). With a 95% likelihood guided self‐help CBT‐E led to greater QALY gain at higher costs compared to waiting for treatment. Based on the National Institute for Health and Clinical Excellence willingness‐to‐pay threshold of €35,000 per QALY, guided self‐help CBT‐E can be considered cost‐effective with a likelihood of 95% from a societal perspective. Discussion: Guided self‐help CBT‐E is likely a cost‐effective treatment for BED in the short‐term (3‐month course of treatment). Comparison to treatment‐as‐usual is recommended for future research, as it enables an economic evaluation with a longer time horizon. Public Significance: Offering treatment remotely has several benefits for patients suffering from binge‐eating disorders. Guided self‐help CBT‐E is an efficacious and likely cost‐effective treatment, reducing binge eating and improving quality‐of‐life, albeit at higher societal costs. [ABSTRACT FROM AUTHOR]

Background and Aims: Most alcohol‐dependent people have a moderate level of dependence. General practitioners (GPs) hesitate to engage in this area, and need to have access to treatment they find applicable and feasible to use. The aim of this present study was to test if an open‐ended internet‐based cognitive–behavioral therapy (iCBT) program added to treatment‐as‐usual (TAU) is more effective than TAU‐only for alcohol‐dependent patients in primary care. Design, Setting and Participants: The present study was a two‐group, parallel, randomized controlled superiority trial comparing iCBT+TAU versus TAU‐only at 3‐ and 12‐month follow‐ups. TAU was delivered at 14 primary care centers in Stockholm, Sweden. A total of 264 patients (mean age 51 years, of whom 148 were female and 116 were male) with alcohol dependence and hazardous alcohol consumption were enrolled between September 2017 and November 2019. Measurements: Participants were randomized at a ratio of 1:1 to iCBT, as a self‐help intervention added to TAU (n = 132) or to TAU‐only (n = 132). The GPs gave participants in both treatment arms feedback on the assessments and biomarkers and offered TAU at the primary care center. Primary outcome was weekly alcohol consumption in g/week at 12‐month follow‐up, analyzed according to intention‐to‐treat (n = 132 + 132). The per‐protocol analysis included participants who completed at least one module of iCBT (n = 102 + 132). Findings There was no significant difference in weekly alcohol consumption between iCBT+TAU and TAU in the intention‐to‐treat (ITT) analysis at 12‐month follow‐up [iCBT+TAU = 133.56 (95% confidence interval, CI = 100.94–166.19) and TAU = 176.20 (95% CI = 144.04–208.35), P = 0.068, d = 0.23]. In the per‐protocol analysis, including only those who initiated iCBT, the iCBT+TAU group showed lower mean weekly alcohol consumption compared with TAU [iCBT+TAU = 107.46 (95% CI = 71.17–143.74), TAU = 176.00 (95% CI = 144.21–207.80), P = 0.010, d = 0.42]. Conclusions: In Sweden, an internet‐based cognitive–behavioral program added to treatment‐as‐usual to reduce alcohol consumption showed weak evidence of a benefit at 12 months in the intention‐to‐treat analysis and good evidence of a benefit in the per‐protocol analysis. [ABSTRACT FROM AUTHOR]

Purpose: We tested the feasibility of survivorship care plan (SCP) delivery with/without a lay health educator (LHE) telephone‐delivered information session among rural cancer survivors, and their effects on health‐related self‐efficacy and knowledge of cancer history. Methods: Randomized trial of cancer survivors from 3 rural oncology clinics featuring either SCP alone (control) or SCP plus LHE‐delivered information session (intervention). Participants completed a questionnaire on health‐related self‐efficacy and knowledge of cancer‐specific medical history. Responses were compared to medical records for accuracy. SCPs were then mailed to participants. Approximately 5 months later, participants completed a follow‐up questionnaire. A subset of participants took part in subsequent qualitative interviews about their study experience. Findings: Of 301 survivors approached, 72 (23.9%) were randomized (mean age 66.4 years; 3.1 years from diagnosis; 62.5% female), and 65 (90.3%) completed the study. Global mental and physical health or self‐efficacy scores did not change significantly from baseline to follow‐up for either group. In exploratory analyses, self‐efficacy increased in participants with inadequate/marginal health literacy in the intervention arm (+0.7, 95% CI = 0.1‐1.2; P =.01). Accuracy of knowledge did not improve but was high at baseline (mean 76.0±14.5%). 60.1% and 48.4% of control and intervention participants, respectively, found SCPs definitely/somewhat useful. Qualitative data (n = 20) suggested that SCPs were helpful to patients when primary and oncology care were less integrated. Conclusions: An LHE‐delivered informational session was feasible but had limited benefit to rural cancer survivors versus delivery of SCP alone but may be of benefit to patients with low health literacy or with less integrated care. [ABSTRACT FROM AUTHOR]

Rationale: Pragmatic design may facilitate the generalizability of effectiveness of randomized controlled trials (RCTs) in primary health care (PHC). Aims and Objectives: The aim of this study was to investigate whether published protocols in PHC were designed pragmatically and to explore whether specific trial characteristics may be related to a pragmatic design. Methods: Using the Pragmatic Explanatory Continuum Indicator Summary‐2 (PRECIS‐2), we assessed pragmatism for 123 published RCT protocols. For each domain, we calculated the mean score with the 95% confidence interval (95% CI). Interrater reliability was assessed by weighted κ‐coefficient with 95% CI. We examined potential associations of published protocol characteristics with overall pragmatism by performing univariate and multivariate analyses. Results: We observed the highest score for primary analysis (4.66, 95% CI: 4.51, 4.82). The eligibility score was intermediate (3.16, 95% CI: 3.01, 3.32). Domains with scores towards the explanatory side included organization (2.50, 95% CI: 2.36, 2.63), flexibility of delivery (2.74, 95% CI: 2.60, 2.88) and flexibility of adherence (3.00, 95% CI: 2.83, 3.17). Interrater agreement was good (κ = 0.61; 95% CI: 0.34, 0.80; p < 0.001). Higher sample sizes were correlated to a pragmatic design (odds ratio: 6.86, 95% CI: 1.64, 28.75; p = 0.04). Conclusion: Most RCT protocols were rated as intermediate in the pragmatic‐explanatory continuum. Future research may guide all stakeholders on how best to incorporate the level of pragmatism in the interpretation of the results so that the trials are more likely to be applicable in real‐world settings. [ABSTRACT FROM AUTHOR]

Background: 5%–10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non‐inferiority of OST compared to multi‐session CBT for treating specific phobias in CYP. Methods: ASPECT was a pragmatic, multi‐center, non‐inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university‐based CYP well‐being service. CYP aged 7–16 years with specific phobia were randomized to receive OST or CBT. Clinical non‐inferiority and a nested cost‐effectiveness evaluation was assessed 6‐months post‐randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal‐based outcome measure, and EQ‐5DY and CHU‐9D, collected blind at baseline and six‐months. Results: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention‐to‐treat (ITT) and per‐protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale‐adjusted mean difference for CBT compared to OST ‐0.123, 95% CI −0.449 to 0.202 (ITT), mean difference −0.204, 95% CI −0.579 to 0.171 (PP)). These findings were wholly below the standardized non‐inferiority limit of 0.4, suggesting that OST is non‐inferior to CBT. No between‐group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. Conclusions: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost‐saving alternative. [ABSTRACT FROM AUTHOR]

Aim: Radio‐Taiso, a traditional exercise program in Japan, may serve as a coping strategy for older adults with frailty during the COVID‐19 pandemic. This phase II trial tested program adherence and safety and explored the potential effectiveness of a home‐based Radio‐Taiso. Methods: This assessor‐blind parallel randomized controlled trial included community‐dwelling Jolder Japanese adults with frailty and pre‐frailty. Fifty‐eight eligible participants were randomly allocated to intervention and control groups. Intervention participants performed 3–5‐min sessions of Radio‐Taiso one to four times per day for 12 weeks. Feasibility criteria were set at practice and retention rates of ≥75%. Safety was monitored by assessing all adverse events reported by participants during the intervention period, irrespective of causality. Potential effectiveness was exploratorily assessed using items that allow clinical interpretation of changes: mobility and health‐related quality of life (HR‐QoL), assessed using the modified short physical performance battery (SPPB) and the SF‐36, respectively. Results: Both practice (83%) and retention rates (100%) met the predetermined feasibility criteria. Eleven adverse events were reported but were supposedly unrelated to the intervention. In the intention‐to‐treat analysis, there was no clinically significant difference in the change in SPPB score between groups (−0.4 points, 95% confidence interval [CI], −1.2, 0.3); however, the intervention group scored higher in the mental component of HR‐QoL than did the control group (3.4 points, 95% CI: −1.1, 7.8). Conclusions: The preliminary data indicate that a phase III trial is feasible, focusing on the mental aspect of HR‐QoL as the primary outcome. Geriatr Gerontol Int 2023; 23: 32–37. [ABSTRACT FROM AUTHOR]

Aim: Hiesho is a condition characterized by having a cold sensation in the hands or feet (i.e., sensitivity of the hands or feet to cold). This condition is common among Japanese women and is an important health problem. In this study, we aimed to evaluate a hiesho intervention program for nurses called "Preventing Hiesho: Intervention Program for Educating Nurses" in terms of its effectiveness in improving the knowledge and perceptions of nurses about the importance of hiesho care. Methods: A total of 130 nurses from Japanese hospitals and clinics providing prenatal care participated in our randomized controlled trial. Sixty‐eight nurses participated in the "Preventing Hiesho: Intervention Program for Educating Nurses" for 2 weeks (intervention group). Sixty‐two nurses received a pamphlet on hiesho care (control group). The responses of the participants to the questionnaire survey were collected by postal mail. An intention‐to‐treat analysis of the results was conducted. Results: One week after the implementation of the web‐based learning program, the scores of knowledge and perceptions of the importance of administering hiesho care were significantly higher in the intervention group than in the control group. Conclusions: A 2‐week web‐based learning program for educating nurses on preventing hiesho significantly improved their knowledge and perceptions of the importance of hiesho care. [ABSTRACT FROM AUTHOR]

BACKGROUND: This study evaluated the effect of the school‐based intervention Charge Your Brainzzz on adolescents' social‐cognitive determinants, sleep hygiene and sleep duration and quality. METHODS: A cluster‐randomized controlled trial was conducted with 972 students from 10 Dutch high schools. Schools were randomly allocated to the intervention (N = 5) or control condition (N = 5). Outcomes were measured with the digital Consensus Sleep Diary and via a digital questionnaire, based on valid measures. Data were collected at baseline (T0), ±1.5 weeks post‐intervention (T1) and ±3 months post‐intervention (T2). Mixed model analyses were performed to estimate the effects on social‐cognitive determinants, sleep hygiene, and sleep outcomes. RESULTS: The intervention increased sleep knowledge post‐intervention (b = 1.91; 95%CI: 1.22‐2.60) and at follow up (b = 1.40; 95%CI: 0.70‐2.10). The intervention was also effective in changing adolescents' attitudes (b = 0.10; 95%CI: 0.01‐0.19) and perceived behavioral control (b = 0.11; 95%CI: 0.01‐0.22) post‐intervention. No positive changes were found regarding subjective norms, behavioral intentions, sleep hygiene, or sleep outcomes. CONCLUSIONS: The intervention improved adolescents' sleep knowledge, attitude, and perceived behavioral control. To significantly impact sleep health, theoretically sound and systematically developed interventions are needed which take into account the interplay between sleep, sleep‐related behaviors, and adolescents' social and physical environment. CLINICAL TRIAL REGISTRATION: Trial name: Evaluation of the school‐based intervention Charge Your Brainzzz promoting sleep in adolescents; URL: https://doi.org/10.1186/ISRCTN36701918; ID: ISRCTN36701918. [ABSTRACT FROM AUTHOR]

Summary: Background: Few randomized controlled trial (RCT) interventions targeted children's early risk behaviours using telephone or short message service (SMS) support. Objective: To evaluate the effectiveness of telephone or SMS early intervention focusing on mothers' behaviours starting from late pregnancy to improve BMI, and eating and screen time behaviours of children aged 2 years in comparison with the control group. Methods: A 3‐arm RCT was conducted in Australia, 2017–2019. Two arms involved the interventions using nurse‐led telephone or SMS support, delivered in nine stages from late pregnancy to age 2 years. The third arm was control. The primary outcome was children's objectively measured BMI and BMI z‐score at 2 years. Secondary outcomes included child eating and screen time behaviours as reported by parents at 2 years. Results: At 2 years, 797 mother–child dyads (69%) completed the telephone survey with 666 (58%) completing weight and height measurements. The study found no statistically significant difference in BMI between the groups. The mean BMI for telephone support was 16.93 (95% CI: 16.73 to 17.13), for SMS 16.92 (95% CI: 16.73 to 17.11) or for control 16.95 (95% CI: 16.73 to 17.16) with a difference of −0.02 (95% CI: −0.31 to 0.27, p = 0.907) in telephone versus control, and a difference of −0.03 (95% CI: −0.30 to 0.24, p = 0.816) in SMS versus control. Telephone support was associated with higher odds of no bottle at bedtime (adjusted odds ratio [AOR]: 2.99; 95% CI: 2.01 to 4.47), family meals (AOR: 2.05; 95% CI: 1.26 to 3.33), drinking from a cup (AOR: 1.89; 95% CI: 1.24 to 2.88), less screen time (<1 h/day) (AOR: 1.56; 95% CI: 1.10 to 2.23) and not eating dinner in front of the TV (AOR: 1.50; 95% CI: 1.09 to 2.06). SMS support was also associated with higher odds of no bottle at bedtime (AOR 2.30, 95% CI: 1.58 to 3.33) than the control. Conclusion: The telephone or SMS support intervention had no significant effects on BMI, but was effective in increasing no bottle use at bedtime. Telephone support showed more effects than SMS on reducing screen time and eating behaviours. [ABSTRACT FROM AUTHOR]

Aim: The objective of this study was to assess the impact of health care–initiated visits versus patient‐controlled flexible visits on clinical and patient‐reported outcomes in people with type 1 diabetes. Methods: The DiabetesFlex trial was a randomized controlled, pragmatic non‐inferiority 15‐month follow‐up study comparing standard care (face‐to‐face visits every 4 months) with DiabetesFlex (patient‐controlled flexible visits using patient‐reported, outcome‐based telehealth follow‐up). Of 343 enrolled participants, 160 in each group completed the study. The primary outcome was mean change in HbA1c from baseline to 15‐month follow‐up. Secondary outcomes were blood pressure, lipid levels, frequency of visits, the World Health Organization score—five well‐being‐index (WHO‐5), the Problem Areas In Diabetes (PAID) scale and experience of participation in own care (participation score). Results: The adjusted mean difference in HbA1c between standard care and DiabetesFlex was similar and below the predefined non‐inferiority margin of 0.4% (−0.03% [95%CI: 0.15, 0.11]/−0.27 mmol/mol [−1.71, 1.16]). No intergroup mean changes in lipid or blood pressure were observed. Conversely, DiabetesFlex participants presented an increased mean WHO‐5 index of 4.5 (1.3, 7.3), participation score of 1.1 (0.5, 2.0), and decreased PAID score of −4.8 (−7.1, −2.6) compared with standard care. During follow‐up, DiabetesFlex participants actively changed 23% of face‐to‐face visits to telephone consultations, cancelled more visits (17% vs. 9%), and stayed away without cancellation less often (2% vs. 8%). Conclusion: Compared with standard care, flexible patient‐controlled visits combined with patient‐reported outcomes in participants with metabolic controlled type 1 diabetes and good psychological well‐being further improved diabetes‐related well‐being and decreased face‐to‐face visits while maintaining safe diabetes management. [ABSTRACT FROM AUTHOR]

Objectives: To compare a designated shared oral care intervention in a group of public nursing home residents with a standard oral care programme, focusing on levels of oral plaque and oral inflammation. Methods: A cluster randomized field trial was undertaken in 14 Danish public nursing homes. There were 145 participants included in the intervention group and 98 in the control group. We undertook a six‐month intervention based on the principle of situated interprofessional learning. The primary outcomes were plaque and inflammation levels measured with the mucosal plaque index (MPS); this was assessed at baseline, after three and six months (end of intervention), and at follow‐up (six months postintervention). The odds ratios (OR) and 95% confidence intervals (CI) were estimated with ordinal regression. Results: Socio‐demographic characteristics and oral health status at baseline were comparable between the two groups, with the exception of age: the intervention group were significantly younger than controls (median 82 vs 87 years). After three and six months, those receiving the shared oral care intervention had significantly lower plaque and inflammation than the control group. The adjusted ORs for a reduction in MPS were 11.8 (CI: 6.5‐21.3) and 11.0 (CI: 5.8‐20.9), respectively. At follow‐up, plaque levels and oral inflammation had approached the pre‐intervention level, with no remaining statistically significant group differences. Conclusions: The shared oral care intervention based on a situated learning perspective was effective in improving oral health among care home residents. However, after termination of the intervention, the effect quickly decreased. This confirms the challenges of achieving long‐term improvement in oral health in nursing home residents. An implementation strategy focusing on achieving changes at both organizational and individual levels with persistent attention to oral health care seem required for long‐term improvement. [ABSTRACT FROM AUTHOR]

Background: Retirement villages (RVs), also known as continuing care retirement communities, are an increasingly popular housing choice for older adults. The RV population has significant health needs, possibly representing a group with needs in between community‐dwelling older adults and those in long‐term residential care (LTC). Our previous work shows Gerontology Nurse Specialist (GNS)‐facilitated multidisciplinary team (MDT) interventions may reduce hospitalizations from LTC. This study tested whether a similar intervention reduced hospitalizations in RV residents. Methods: Open‐label randomized controlled trial in which 412 older residents of 33 RVs were randomized (1:1) to an MDT intervention or usual care. Setting: RVs across two District Health Boards in Auckland, New Zealand. Residents were eligible if considered high risk of health/functional decline (triggering ≥3 interRAI Clinical Assessment Protocols or needing special consideration identified by GNS). Intervention: GNS‐facilitated MDT intervention, including geriatrician/nurse practitioner and clinical pharmacist, versus usual care. Primary outcome was time from randomization to first acute hospitalization. Secondary outcomes were rate of acute hospitalizations, LTC admission, and mortality. Twelve residents died before randomization; all others (n = 400: MDT intervention = 199; usual care = 201) were included in intention‐to‐treat analyses. Results: Mean (SD) age was 82.2 (6.9) years, 302 (75.5%) were women, and 378 (94.5%) were European. Over median 1.5 years follow‐up, no difference was found in hazard of acute hospitalization between the MDT intervention (51.8%) and usual care (49.3%) groups (Hazard ratio [HR] = 1.01, 95% CI = 0.77–1.34). No difference was found in the incidence rate of acute hospitalizations between the MDT intervention (0.69 per person‐year) and usual care (0.86 per person‐year) groups (incidence rate ratio = 0.81, 95% CI = 0.59–1.10). Similar results were seen for the proportion of residents with LTC transition (HR = 1.18, 95% CI = 0.65–2.11) and mortality (HR = 0.70, 95% CI = 0.36–1.35). Conclusion: Further studies are needed to assess the effects of other patient‐centered interventions and outcomes with adequate primary care integration. [ABSTRACT FROM AUTHOR]

People with diabetes frequently have elevated diabetes distress. Although mindfulness‐based stress reduction (MBSR) therapy has been shown effective in reducing diabetes distress, it has only been delivered by psychologists or a multidisciplinary team with an attrition rate of up to 39%, which limits its dissemination to a broader audience. This study was aimed to pilot evaluate the feasibility of a nurse‐led MBSR therapy and explore its potential efficacy amongst people with type 2 diabetes mellitus. A total of 100 participants were randomly allocated either to the intervention group (nurse‐led MBSR therapy + regular diabetes education) or the control group (regular diabetes education). Data on diabetes distress, diabetes self‐efficacy, and diabetes self‐management were collected at baseline, 8 and 12 weeks. Hemoglobin A1c (HbA1c) was collected at baseline and 12 weeks. A generalized estimating equation analysis for repeated measures was used to determine intervention and time effects. As predicted, the nurse‐led MBSR therapy had a significant time‐by‐group interaction effect on diabetes distress total score (95% confidence interval [CI]: 0.58–0.77, p < 0.001), diabetes self‐efficacy (95% CI: −0.93 to −0.74, p < 0.001), diabetes self‐management (95% CI: −10.80 to −7.83, p < 0.001), and HbA1c levels (95% CI: 0.04–1.14, p = 0.03) in the intervention group compared with the control group over 12 weeks. This is the first nurse‐led MBSR therapy in a hospital setting that is feasible and has the potential to improve health outcomes. This approach may offer an innovative model to deliver MBSR therapy. A randomized controlled trial comparing the nurse‐led MBSR plus usual diabetes education with usual diabetes education along with a mechanism to equalize intervention attention between the groups is indicated. [ABSTRACT FROM AUTHOR]

Background and aims: The majority of smokers accessing the current best treatments continue to smoke. We aimed to test if e‐cigarettes (EC) compared with nicotine replacement treatment (NRT) can help such smokers to reduce smoking. Design Randomized controlled trial of EC (n = 68) versus NRT (n = 67) with 6‐month follow‐up. Setting: Stop smoking service in London, UK. Participants: A total of 135 smokers (median age = 40 years, 51% male) previously unable to stop smoking with conventional treatments. Interventions: Participants received either NRT of their choice (8‐week supply) or an EC starter pack and instructions to purchase further e‐liquids of strength and flavours of their choice themselves. Products were accompanied by minimal behavioural support. Measurements Participants who reported that they stopped smoking or reduced their daily cigarette consumption by at least 50% at 6‐month follow‐up were invited to provide a carbon monoxide (CO) reading. The primary outcome was biochemically validated reduction in smoke intake of at least 50% at 6 months and the main secondary outcome was sustained validated abstinence at 6 months. Drop‐outs were included as 'non‐reducers'. Findings Validated smoking reduction (including cessation) was achieved by 26.5 versus 6.0% of participants in the EC and NRT study arms, respectively [relative risk (RR) = 4.4, P = 0.005, 95% confidence interval (CI) = 1.6–12.4]. Sustained validated abstinence rates at 6 months were 19.1 versus 3.0% (RR = 6.4, P = 0.01, 95% CI = 1.5–27.3). Product use was high and equal in both study arms initially, but at 6 months allocated product use was 47% in the EC arm versus 10% in the NRT arm (χ2(1) = 22.0, P < 0.001), respectively. Adverse events were minor and infrequent. Conclusions: In smokers unable to quit using conventional methods, e‐cigarettes were more effective than nicotine replacement therapy in facilitating validated long‐term smoking reduction and smoking cessation when limited other support was provided. [ABSTRACT FROM AUTHOR]

Aims: To assess the effectiveness of training stop smoking services providers in Malaysia to deliver support for smoking cessation based on the UK National Centre for Smoking Cessation and Training (NCSCT) standard treatment programme compared with usual care. Design Two‐arm cluster‐randomized controlled effectiveness trial across 19 sites with follow‐up at 4‐week, 3‐month, and 6‐month. Setting: Stop smoking services operating in public hospitals in Malaysia. Participants: Five hundred and two smokers [mean ± standard deviation (SD), age 45.6 (13.4) years; 97.4% male] attending stop smoking services in hospital settings in Malaysia: 330 in 10 hospitals in the intervention condition and 172 in nine hospitals in the control condition. Intervention and comparator: The intervention consisted of training stop‐smoking practitioners to deliver support and follow‐up according to the NCSCT Standard Treatment Programme. The comparator was usual care (brief support and follow‐up). Measurements: The primary outcome was continuous tobacco smoking abstinence up to 6 months in smokers who received smoking cessation treatment, verified by expired‐air carbon monoxide (CO) concentration. Secondary outcomes were continuous CO‐verified tobacco smoking abstinence up to 4 weeks and 3 months. Results: Follow‐up rates at 4 weeks, 3 months and 6 months were 80.0, 70.6 and 53.3%, respectively, in the intervention group and 48.8, 30.8 and 23.3%, respectively, in the control group. At 6‐month follow‐up, 93 participants in the intervention group and 19 participants in the control group were abstinent from smoking, representing 28.2 versus 11.0% in an intention‐to‐treat (ITT) analysis assuming that participants with missing data had resumed smoking, and 52.8 versus 47.5% in a follow‐up‐only (FUO) analysis. Unadjusted odds ratios (accounting for clustering) were 5.04, (95% confidence interval (CI) = 1.22–20.77, P = 0.025) and 1.70, (95% CI = 0.25–11.53, P = 0.589) in the ITT and FUO analyses, respectively. Abstinence rates at 4 week and 3 month follow‐ups were significantly higher in the intervention versus control group in the ITT but not the FUO analysis. Conclusions: On an intention‐to‐treat analysis with missing‐equals‐smoking imputation, training Malaysian stop smoking service providers in the UK National Centre for Smoking Cessation and Training standard treatment programme appeared to increase 6 month continuous abstinence rates in smokers seeking help with stopping compared with usual care. However, the effect may have been due to increasing follow‐up rates. [ABSTRACT FROM AUTHOR]

Aims: The study aimed to evaluate the effectiveness of the government school‐based program #Tamojunto2.0, the third Brazilian version of the European drug prevention program, Unplugged, in preventing the use of alcohol and other drugs. Design A parallel, two‐arm cluster randomized controlled trial was conducted in 205 classes in 73 public schools (37 intervention and 36 control) with a baseline assessment and follow‐up after 9 months. Setting: Schools in the cities of São Paulo, Fortaleza and Eusebio in Brazil. Participants: A total of 5208 students in the 8th grade with a mean age of 13.2 years (standard deviation = 0.8 years) and an equal gender ratio. Intervention: In 2019, the intervention group attended 12 classes of the program #Tamojunto2.0, under the supervision of a team from the Ministry of Health. The control group did not receive any intervention to prevent alcohol and drug use. Measurements The primary outcome measured was prevalence of binge drinking (five or more doses of alcohol in an occasion) within the past month. Secondary outcomes were prevalence of initiation and use of alcohol, tobacco, inhalants, marijuana and cocaine within the past month. Findings A statistically significant difference was not found in the prevalence of binge drinking within the past month between intervention and control groups [odds ratio (OR) = 0.934; 95% confidence interval (CI) = 0.761–1.146]. However, students who were exposed to the program were less likely to initiate alcohol use than those in the control group (OR = 0.782; 95% CI = 0.636–0.961). The Bayes factor for reduction in binge drinking was 0.01, providing evidence in favor of the null hypothesis for this variable. Conclusions: The drug prevention program #Tamojunto 2.0 reduced alcohol initiation, but appeared not to reduce past‐month binge drinking among 8th grade students in Brazil. [ABSTRACT FROM AUTHOR]

Self‐reported physical activity differs from activity levels measured by device. We tested the effect of a video that visualizes the intensity levels of physical activity to increase the agreement between self‐reported and accelerometer‐based moderate‐to‐vigorous physical activity (MVPA) within a single‐blinded, randomized study. Participants (N = 378, 40‐75 years) wore an accelerometer for seven days. Prior to the collection of self‐reported data by the IPAQ‐SF, participants were randomly assigned (1:1) to a control group (CG) or a video group (VG). The outcome was the absolute difference between self‐reported and accelerometer‐based time spent in MVPA (Δ MVPAIPAQ−Accelerometry). To examine the agreement, we used Spearman correlation coefficients and Bland‐Altman analysis. To test the video effect, we used Wilcoxon signed‐rank test, Bayes factor, and simultaneous‐quantile regression. In total, 302 participants fulfilled the accelerometer wear time criteria (≥10 hours/day; ≥6 days) and completed self‐reports within three days after the wearing period. The median of Δ MVPAIPAQ−Accelerometry was −9.0 min/day (IQR: −32.0 to 66.6) for CG and −11.5 min/day (IQR: −29.9 to 14.3) for VG. Wilcoxon signed‐rank test revealed no differences in Δ MVPAIPAQ−Accelerometry between study groups whereas Bayes factor indicated insensitivity of the data. Simultaneous‐quantile regression revealed no relationship between video presentation and Δ MVPAIPAQ−Accelerometry in the 25th percentile. In the 50th (b = −12.4 [95% CI = −23.2 to −1.5] and 75th percentile (b = −45.7 [95% CI = −70.5 to −20.9]), Δ MVPAIPAQ−Accelerometry was negatively associated with video presentation. To conclude, video‐supported assessment may increase the accuracy of self‐reported MVPA among individuals who slightly underestimated and those who overestimated their MVPA. [ABSTRACT FROM AUTHOR]

Background and Aims: Many evidence‐based treatments (EBTs) for substance use disorder (SUD) exist, yet few are tailored to Indigenous patients. This trial tested the efficacy of a culturally tailored EBT that combined Motivational Interviewing and the Community Reinforcement Approach (MICRA) versus treatment as usual (TAU). Design A mixed efficacy/effectiveness randomized controlled trial of MICRA (n = 38) and TAU (n = 41) using a parallel design with follow‐up assessments at 4‐, 8‐, and 12‐ months post baseline. Setting United States, reservation‐based outpatient, addiction specialty care treatment program. Participants: 79 (68% male) American Indian and Alaska Native (AI/AN) Tribal members meeting criteria for SUD and seeking SUD treatment. Interventions: MICRA (individual therapy sessions beginning with MI for 2–3 sessions) compared with TAU (individual and group counseling sessions in a didactic style with Twelve‐Step philosophy and elements of relapse prevention). Measures: Demographics, percent days abstinent (PDA; the primary outcome at 12months assessed by Form 90D), Inventory of Drug Use Consequences, Alcohol and Drug Use Self‐Efficacy Scale, Native American Spirituality Scale, and SCID‐DSM‐IV‐TR. Findings There was no evidence for the benefit of MICRA over TAU (MICRA PDA = 72.63%, TAU = 73.62%, treatment effect: B = −4.04 (SE = 5.47); 95% CI = −14.941, 6.866; BF = 3.44) in the primary outcome. Both groups showed improvements in PDA, SUD severity, and negative consequences from baseline to the 12‐month follow‐up. Neither self‐efficacy nor spirituality were significant mediators of MICRA. Conclusions: There were no treatment group differences between culturally tailored evidence‐based treatments for substance use disorder and treatment as usual in this randomized controlled trial with American Indian and Alaska Native participants. Nonetheless, participants improved over time on several substance‐related outcomes. [ABSTRACT FROM AUTHOR]

Background and Aims: Recent meta‐analyses of motivational interviewing (MI) for reducing risky alcohol use in young people have reported modest effects. Few studies have targeted individual patient factors to increase MI effectiveness. This study determined if MI enhanced with individualised personality‐specific coping skills training (QuikFix) was more efficacious than standard MI or an assessment feedback/information (AF/I) control among young people with alcohol‐related injuries or illnesses. Design and Setting: Single‐centre, single‐blind, three‐group superiority randomized controlled trial with 1‐, 3‐, 6‐ and 12‐months follow‐ups. Telephone intervention, Brisbane, Australia. Participants: A total of 398 young people (16–25 years; M age = 20.30 years, SD = 2.12; 54% female) with alcohol‐related injuries and/or illnesses were recruited from an emergency department (ED) or rest/recovery service (RRS). Measures: The primary outcome was total standard (10 g ethanol) drinks in the past month (Timeline Follow back [TLFB]) at 12 months (primary time point). Secondary outcomes were total drinking days and standard drinks per drinking day (TLFB) in the past month and the frequency of alcohol‐related problems in the past 3 months (Rutgers Alcohol Problem Index). Interventions: Young people were randomized to two sessions of QuikFix enhanced with individualised personality‐specific coping skills training (n = 132), two sessions of MI (n = 136) or one session of AF/I (n = 130), all delivered by telehealth. Findings QuikFix resulted in greater reductions (all P < 0.0017) in the primary outcome of total standard drinks (M = 19.50, CI 99.75% = [11.31, 27.68]) than both MI (M = 32.61, CI 99.75% = [24.82, 40.40]; Cohen's D = 0.40) and AF/I (M = 34.12, CI 99.75% = [26.59, 41.65]; D = 0.45) at 12 months (retention n = 324/398, 81%). QuikFix had greater reductions on drinking days (M = 3.16, CI 99.75% = [2.37, 3.96]) than both MI (M = 4.53, CI 99.75% = [3.57, 5.48];D = 0.38) and AF/I (M = 4.69, CI 99.75% = [3.73, 5.65];D = 0.42) and fewer drinks per drinking day (M = 5.02, CI 99.75% = [3.71, 6.33]) than AF/I (M = 7.15, CI 99.75% = [5.93, 8.38;D = 0.47) at 12 months. Conclusions: Young people with alcohol‐related injuries and/or illnesses who attended ED and rest/recovery services and received an individualised personality‐specific coping skills training intervention (QuikFix) had greater reductions in the amount of alcohol consumed at 12 months compared with those who received motivational interviewing or an assessment feedback/information intervention. [ABSTRACT FROM AUTHOR]

Purpose: RobotReviewer is a machine learning system for semi‐automated assistance in risk of bias assessment. The tools's performance in randomized controlled trials (RCTs) in the field of nursing remains unknown. We aimed therefore to evaluate the agreement in risk of bias assessment between RobotReviewer and human reviewers. Design: Evaluation study using a retrospective diagnostic design. Methods: We used RobotReviewer as the index test and human reviewers' risk of bias assessment reported in Cochrane reviews as the reference test. A convenience sample of electronically available English‐language full texts of RCTs included in Cochrane reviews with nurs* in the title were eligible for inclusion. In this context, we assessed random sequence generation, allocation concealment, and blinding (personnel or participants and assessors) corresponding to Cochrane risk of bias version 2011. Two independent research teams performed and double‐checked data extraction and analysis. We calculated sensitivity, specificity, receiver operating characteristic (ROC) curve, the area under the ROC curve, predictive values, observed percentage of agreement, and Cohen's kappa (including confidence intervals, if applicable). Findings: The selection process yielded 190 RCTs published between 1958 and 2016 in 23 Cochrane reviews published between 2000 and 2018. Missing assessments of risk of bias domains in Cochrane reviews or RobotReviewer yielded varying sample sizes per risk of bias domain. Sensitivity ranged from 0.44 to 0.88 and specificity from 0.48 to 0.95. Positive predictive value was highest for allocation concealment (0.79) and lowest for blinding assessors (0.25). Cohen's kappa was moderate for randomization (0.52), allocation concealment (0.60), and for blinding of personnel/patients (0.43). Blinding of outcome assessors had only slight agreement (0.04). Conclusions: This is the first evaluation of risk of bias assessment by RobotReviewer in RCTs included in nursing‐related Cochrane reviews. It yielded a moderate degree of agreement with human reviewers for randomization and allocation concealment, and an adequate sensitivity for detecting low risk of selection bias. Clinical Relevance: Based on our results, using the RobotReviewer for risk of bias assessment in RCTs can be supportive in some risk of bias domains. However, human reviewers should supervise the semi‐automated assessment process. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to evaluate the plaque removal efficacy of a newly developed electric‐powered ionic toothbrush vs. a manual toothbrush. Materials and Methods: Manual or electric‐powered ionic toothbrushes were randomly assigned to 30 healthy volunteers divided into two groups (Phase I). After 2 min of brushing, all tooth surfaces were stained with a plaque staining solution, and blinded examiners performed scoring using the Rustogi Modification of the Navy Plaque Index. Plaque removal rate was calculated at the central incisors, first premolar and first molar, as representative teeth, in the maxilla and mandibula. One week following Phase I, the same examinations were repeated in all subjects using another toothbrush (Phase II), as a crossover design. Results: Electric ionic toothbrushes demonstrated a significantly higher plaque removal rate than manual toothbrushes in the premolar and molar areas (p <.05). However, in the central incisor area, no statistically significant difference was observed. Conclusions: Compared with manual toothbrushes, electric‐powered ionic ones were significantly efficient in removing plaque in the premolar and molar areas. [ABSTRACT FROM AUTHOR]

Complementary feeding diets in low‐ and middle‐income countries are generally inadequate to meet requirements for growth and development. Food‐based interventions may prevent nutrient inadequacies provided that they do not displace other nutrient‐rich foods. We conducted a randomized controlled trial in rural Malawi in which 660 children aged 6 to 9 months were provided an egg a day for 6 months or assigned to a control group. Dietary intake of complementary foods and drinks was assessed at baseline, 3‐month midline and 6‐month endline visits using a tablet‐based multipass 24‐h recall. Up to two repeat recalls were collected at each time point in a subsample of 100 children per treatment group. At midline and endline, usual energy intake from eggs was about 30 kcal/day higher in the egg group compared with controls (p < 0.0001). Compared with controls, children in the egg group were over nine times more likely to consume eggs at midline and endline. There was a comparable, but nonsignificant, greater total usual energy intake from complementary foods of 30 kcal/day at midline (p = 0.128) and 36 kcal/day at endline (p = 0.087). There also was a displacement of 7 kcal/day in legumes and nuts in children at endline (p = 0.059). At midline and endline, more than 80% of children in the egg group consumed a minimally diverse diet compared with 53% at midline and 60% at endline in the control group. This study illustrates that mothers in the egg group fed eggs to young children on a regular basis without substantial displacement of other complementary foods. [ABSTRACT FROM AUTHOR]

School‐based healthy living interventions are widely promoted as strategies for preventing obesity. The peer‐led Healthy Buddies™ curriculum has been shown to improve obesity‐related outcomes in school‐aged children. We examined whether these improvements existed among subgroups of children stratified by sex, income level and urban/rural geography. In a cluster‐randomized controlled trial, elementary schools in Manitoba, Canada, were randomly allocated to Healthy Buddies™ (10 schools, 340 students) or standard curriculum (10 schools, 347 students). Healthy Buddies™ participants had 21weekly lessons on healthy eating, physical activity and self‐efficacy, delivered by children age 9–12 to children age 6–8. We assessed pre‐ and post‐intervention body mass index (BMI) z‐scores, waist circumference, healthy living knowledge, dietary intake and self‐efficacy among the younger children. Compared to standard curriculum (n = 154), Healthy Buddies™ participants (n = 157) experienced a greater reduction in waist circumference (−1.7 cm; 95% confidence interval [CI][−2.8, −0.5 cm]) and improved dietary intake (4.6; 95% CI [0.9, 8.3]), healthy living knowledge (5.9; 95% CI [2.3, 9.5]) and self‐efficacy (5.3; 95% CI [1.0, 9.5]) scores. In subgroup analyses, effects for waist circumference (−2.0 cm; 95% CI [−3.6, −0.5]), healthy living knowledge (9.1; 95% CI [4.4, 13.8]) and self‐efficacy (8.3; 95% CI [3.3, 13.3]) were significant among boys. Dietary intake (10.5; 95% CI [5.5, 15.4]), healthy living knowledge (9.8; 95% CI [4.5, 15.0]) and self‐efficacy (6.7; 95% CI [0.7, 12.7]) improved among urban‐dwelling but not rural‐dwelling children. Healthy Buddies™ was effective for boys and children living in urban settings. Enhanced curricula may be needed to improve program effectiveness for select subgroups of school‐aged children. [ABSTRACT FROM AUTHOR]

Background and aim: Reducing alcohol misuse by male prisoners is an important global issue. Control of drinking behaviour could be a useful target for intervention in this population, and locus of control could be a causal factor in this. We aimed to assess the effect of a clinical psychologist‐facilitated group intervention on male prisoners' locus of control of drinking behaviour. Design A two‐arm, single‐site, open, randomized controlled trial. Setting: A category B local training prison in South Wales, housing about 770 mainly sentenced men. Participants: Prisoners serving less than 2 years who met inclusion criteria for pre‐imprisonment alcohol misuse, alone or with drug misuse. A total of 119 were allocated to the intervention arm and 119 to the control arm; 104 and 87, respectively, completed the post‐randomization baseline interview and 68 and 60 completed a second interview approximately 4 weeks later, respectively, after intervention or treatment as usual (TAU) alone. Intervention: Nine clinical psychologist‐facilitated groups in the prison over 3 weeks. Range of participants per session was one to seven, with three to five most usual. Measures: The primary outcome was locus of control of behaviour (LCB); secondary outcomes included mental state generally (comprehensive psychiatric rating scale/CPRS) and specifically (Beck Depression Inventory/BDI). An integral process evaluation was conducted. Findings LCB scores decreased during the study, but without significant intervention effect [−1.7, 95% confidence interval (CI) = –5.1 to 1.6, P = 0.329]. Change among completers in the control group was from a mean score of 37.4 [standard deviation (SD) = 10.0] to 33.7[SD = 11.7] and in the intervention group from 37.4 (SD = 11.6) to 31.9 (SD = 11.8). Secondary outcomes, including change in mental state, did not differ between arms, but 686 (64%) sessions were lost, most because of 'prison issues'. Conclusions: A clinical psychologist‐facilitated group intervention did not have a statistically significant effect on sense of control of drinking behaviour among men with pre‐imprisonment alcohol misuse serving less than 2 years in a South Wales prison. The study proved coterminous, however, with 40% prison staff cuts which seem likely to have contributed to the high loss of group sessions and possibly overwhelmed any treatment effect. Intervention completion failures, previously cited as harmful, had no effect here, so the trial should be repeated when the prison climate improves. [ABSTRACT FROM AUTHOR]

Childhood obesity has been associated with consumption of energy‐dense foods such as caloric beverages and fast foods. Many low‐ and middle‐income countries like Bangladesh are now experiencing a rising problem of noncommunicable diseases along with the long‐standing problem of stunting and undernutrition. WASH Benefits Bangladesh was a large community‐based cluster randomized controlled trial conducted in rural Bangladesh. Study clusters were randomized into seven arms: single nutrition (N); water (W); sanitation (S); hygiene (H); combined water, sanitation, and hygiene (WSH); WSH and nutrition (N + WSH); and a double sized control (C). Nutrition intervention messages included four promotional components: maternal nutrition, breastfeeding, complementary feeding, and lipid‐based nutrient supplements. The World Health Organization infant food frequency questionnaire (24‐hr recall and 7‐day recall) was administered at Year 1 and Year 2 of intervention. The likelihood of any snack food consumption was significantly lower (odds ratio 0.37: 95% confidence interval [0.28, 0.49]) in the nutrition intervention arms compared to the control arm in Year 2 follow‐up. In addition, in the water intervention arm, fewer children (about 50% less) consumed soft drinks, but not the other sugar‐sweetened beverages, compared with control in Year 2. There were no other differences between groups. Simple messages about balanced diet and feeding family foods were effective in lowering commercially produced snack food consumption of the young children in low‐income rural communities of Bangladesh. Provision of safe water apparently encouraged mothers to reduce offering unhealthy beverages to the young children. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the presence and characteristics of spin (a distorted interpretation to make research findings seem favourable) in abstracts of randomized controlled trials (RCTs) in periodontology and oral implantology, and to explore its associated factors and influence on the subsequent literature. Materials and methods: PubMed was searched to identify recent RCTs in periodontology and oral implantology, whose primary outcome was non‐significant. Spin in abstracts was assessed and categorized according to pre‐determined spin strategies. The associations between study characteristics and the presence/severity of spin were analysed using multivariable logistic regressions. Results: 196 abstracts were included, 137 (69.9%) of which had spin. 57 (29.1%) abstracts had spin in the Results section, and 126 (64.3%) had spin in the Conclusion section. The main spin strategies in the Results and Conclusion sections were focusing on secondary outcomes (16.3%) and focusing on within‐group comparisons (28.6%), respectively. The presence of spin was associated with number of centres (OR = 0.28, 95% CI: 0.11–0.73; p =.009), while its severity was associated with topic (OR = 0.24, 95% CI: 0.08–0.70; p =.009). Conclusions: The frequency of spin is relatively high among published RCT abstracts in periodontology and oral implantology. Findings reported in these abstracts need to be interpreted with caution. [ABSTRACT FROM AUTHOR]

Objective: To assess the association of the quality of allocation concealment with heterogeneity in age, the P value of the primary outcome and statistical significance of the primary outcome. Study design and setting: We extracted data from articles published in four major medical journals in 2017 and 2018 that reported the results of randomized controlled trials. The outcome measures were the quality of allocation concealment used in the trial, the P value of the primary outcome, whether the P value of the primary outcome was statistically significant and the level of heterogeneity in age between the treatment groups (measured using the I2 statistic). The association between the quality of allocation concealment and the P value of the primary outcome was assessed using a kernel density plot, while the association between the quality of allocation concealment and whether the P value was statistically significant was assessed using logistic regression. Results: Trials that used inadequate concealment methods were more likely to report statistically significant findings than trials that used good or adequate methods (OR 1.90; 95% CI: 0.91 to 3.95; P =.09). The values of I2 for trials that used good, adequate, inadequate and unclear concealment methods were 0%, 1.0%, 32.6%, and 93.8%, respectively. Conclusion: There is evidence of an association between poor allocation concealment methods and statistical significance of the primary outcome. Trials that use inadequate allocation concealment methods are more likely to have statistically significant P values compared with trials using good or adequate allocation concealment methods. [ABSTRACT FROM AUTHOR]

Aim: To test whether alerting clinicians to severe weight loss in older patients leads to higher dietitian visit rates, to higher body mass index (BMI) levels and, mainly, to lower annual death risk. Methods: The randomized controlled trial included patients aged ≥75 years, with BMI ≤23 kg/m2 that decreased ≥2 kg/m2 during the previous 2 years. All participants received usual care. Additionally, an email alert was sent only to clinicians of participants assigned to the email alert group. The follow‐up period was 12 months. Results: Among 706 participants (mean age 83 ± 6 years; mean baseline BMI 20.5 kg/m2), the BMI record was updated in 541 (77%) participants, and 123 participants died. Dietitian visits were reported for 22 patients (6%) in the email group (n = 362) and 14 patients (4%) in the control group (n = 344; OR 1.5, 95% CI 0.8–2.9; P = 0.24). Measured BMI were raised by a mean of 0.69 (95% CI 0.43–0.95) kg/m2 versus 0.79 (95% CI 0.48–1.1) kg/m2 (P = 0.63). A total of 77 patients (21%) died in the intervention group versus 47 (14%) in the control group (P = 0.008; number needed to harm = 13; 95% CI 7–43). Conclusions: In this trial, alerting clinical staff to severe weight loss in patients aged ≥75 years was not associated with higher visit rates to a dietitian or change in BMI, but was associated with a significantly higher death rate than usual clinical care. Geriatr Gerontol Int 2020; 20: 329–335. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives: The International Classification of Functioning, Disability and Health (ICF) is a landmark for physiotherapy to describe the full spectrum of human functioning, but ICF patient record completion could improve. In this study, we examine the effect of supervised teaching and personalized feedback on physiotherapists' completion and reporting of ICF in electronic patient records. Method: In this proof‐of‐concept randomized controlled trial, the intervention group (10 physiotherapists) received supervised teaching and four rounds of personalized feedback on reporting of ICF components in electronic patient records. In the intervention group, review on patient record completion (n = 670 records) was performed at baseline, after teaching, after each of four feedback rounds, and at long‐term follow‐up. In the control group (five physiotherapists), which received no supervised teaching nor personalized feedback, review (n = 140 records) was performed at baseline, after the third feedback round of the intervention group, and at follow‐up. Results: After the third round of feedback (95% vs 72% completion; β, 2.68; 95% CI, 0.62‐4.74), patient record completion was significantly higher in the intervention group. This was also true for following ICF components: "activity" (93% versus 64% completion; β, 3.03; 95% CI, 1.52‐4.54), "participation" (50% versus 14% completion; β, 3.67; 95% CI, 1.79‐5.55), and "personal factors" (35% versus 20% completion; β, 2.10; 95% CI, 0.63‐3.57). These statistically significant and clinically relevant effects persisted at long‐term follow‐up. For "environmental factors," effects after the third round of feedback (75% vs 30% completion; β, 1.88; 95% CI, 0.63‐3.13) disappeared at follow‐up. Reporting of "body functions and structures" improved similarly across groups. Conclusions: Supervised teaching and personalized feedback are active ingredients of an intervention to improve reporting of ICF components in physiotherapeutic patient records. [ABSTRACT FROM AUTHOR]

Background: We have demonstrated the efficacy of a brief behavioral intervention for sleep in children with ADHD in a previous randomized controlled trial and now aim to examine whether this intervention is effective and cost‐effective when delivered by pediatricians or psychologists in community settings. Methods: Translational, cluster‐randomized trial of a behavioral intervention versus usual care from 19th January, 2015 to 30th June, 2017. Participants (n = 361) were children aged 5–13 years with ADHD and parent report of a moderate/severe sleep problem who met criteria for American Academy of Sleep Medicine criteria for chronic insomnia disorder, delayed sleep–wake phase disorder, or were experiencing sleep‐related anxiety. Participants were randomized at the level of the pediatrician (n = 61) to intervention (n = 183) or usual care (n = 178). Families in the intervention group received two consultations with a pediatrician or a psychologist covering sleep hygiene and tailored behavioral strategies. Results: In an intention‐to‐treat analysis, at 3 and 6 months respectively, the proportion of children with moderate to severe sleep problems was lower in the intervention (28.0%, 35.8%) compared with usual care group (55.4%, 60.1%; 3 month: risk ratio (RR): 0.51, 95% CI 0.37, 0.70, p < .001; 6 month: RR: 0.58; 95% CI 0.45, 0.76, p < .001). Intervention children had improvements across multiple Children's Sleep Habits Questionnaire subscales at 3 and 6 months. No benefits of the intervention were observed in other domains. Cost‐effectiveness of the intervention was AUD 13 per percentage point reduction in child sleep problem at 3 months. Conclusions: A low‐cost brief behavioral sleep intervention is effective in improving sleep problems when delivered by community clinicians. Greater sample comorbidity, lower intervention dose or insufficient clinician supervisions may have contributed to the lack benefits seen in our previous trial. [ABSTRACT FROM AUTHOR]

Objective: The aim of the study was to determine the effectiveness of the lateral approach to subacromial injection, compared with the posterior approach, for the treatment of subacromial impingement syndrome. Method: A pragmatic randomized controlled trial was carried out in an outpatient community musculoskeletal service. The sample comprised 80 adults, aged 18 years or over, with subacromial impingement syndrome. The intervention group received a single subacromial injection, using a 21‐gauge green needle, of 40 mg/ml triamcinolone acetonide (Kenalog) and 4 ml 1% lignocaine using a lateral approach. The control group received identical treatment, with the exception that the injection was given using a posterior approach. The outcome measures were pain measured using 0–10 numerical pain scale and shoulder pain and disability index (SPADI) scores at 8 and 12 weeks' follow‐up. Result: A moderate but statistically and clinically significant difference in improvement in daytime pain (mean change in score) occurred in favour of the lateral group (mean = 4.0) compared with the posterior group (mean = 2.0) between weeks 0 and 8 (1.4 points [95% confidence interval 0.3, 2.6; p = 0.018]). However, there were no statistically significant differences between the groups in night‐time pain, shoulder function and SPADI scores. There was a statistically and clinically significant difference (p = 0.001) within the groups for all clinical outcomes between weeks 0 and 8, and between weeks 0 and 12. Conclusion: There were no significant differences in the treatments; however, both forms of treatment were associated with a significant improvement in shoulder pain, function and disability. [ABSTRACT FROM AUTHOR]

Background: Chronic abdominal pain can be due to entrapped intercostal nerves (anterior cutaneous nerve entrapment syndrome [ACNES]). If abdominal wall infiltration using an anesthetic agent is unsuccessful, a neurectomy may be considered. Pulsed radiofrequency (PRF) applies an electric field around the tip of the cannula near the affected nerve to induce pain relief. Only limited retrospective evidence suggests that PRF is effective in ACNES. Methods: A multicenter, randomized, nonblinded, controlled proof‐of‐concept trial was performed in 66 patients. All patients were scheduled for a neurectomy procedure. Thirty‐three patients were randomized to first receive a 6‐minute cycle of PRF treatment, while the other 33 were allocated to an immediate neurectomy procedure. Pain was recorded using a numeric rating scale (NRS, 0 [no pain] to 10 [worst pain possible]). Successful treatment was defined as >50% pain reduction. Patients in the PRF group were allowed to cross over to a neurectomy after 8 weeks. Results: The neurectomy group showed greater pain reduction at 8‐week follow‐up (mean change from baseline −2.8 (95% confidence interval [CI] −3.9 to −1.7) vs. −1.5 (95% CI −2.3 to −0.6); P = 0.045) than the PRF group. Treatment success was reached in 12 of 32 (38%, 95% CI 23 to 55) of the PRF group and 17 of 28 (61%, 95% CI 42 to 72) of the neurectomy group (P = 0.073). Thirteen patients were withdrawn from their scheduled surgery. Adverse events were comparable between treatments. Conclusions: PRF appears to be an effective and minimally invasive treatment option and may therefore be considered in patients who failed conservative treatment options before proceeding to a neurectomy procedure. Anterior neurectomy may possibly lead to a greater pain relief compared with PRF in patients with ACNES, but potential complications associated with surgery should be discussed. [ABSTRACT FROM AUTHOR]

Background: The measurement and interpretation of patient experience is a distinct dimension of health care quality. The Midwives @ New Group practice Options (M@NGO) randomized control trial of caseload midwifery compared with standard care among women regardless of risk reported both clinical and cost benefits. This study reports participants' perceptions of the quality of antenatal care within caseload midwifery, compared with standard care for women of any risk within that trial. Methods: A trial conducted at two Australian tertiary hospitals randomly assigned participants (1:1) to caseload midwifery or standard care regardless of risk. Women were sent an 89‐question survey at 6 weeks postpartum that included 12 questions relating to pregnancy care. Ten survey questions (including 7‐point Likert scales) were analyzed by intention to treat and illustrated by participant quotes from two free‐text open‐response items. Results: From the 1748 women recruited to the trial, 58% (n = 1017) completed the 6‐week survey. Of those allocated to caseload midwifery, 66% (n = 573) responded, compared with 51% (n = 444) of those allocated to standard care. The survey found women allocated to caseload midwifery perceived a higher level of quality care across every antenatal measure. Notably, those women with identified risk factors reported higher levels of emotional support (aOR 2.52 [95% CI 1.87‐3.39]), quality care (2.94 [2.28‐3.79]), and feeling actively involved in decision‐making (3.21 [2.35‐4.37]). Conclusions: Results from the study show that in addition to the benefits to clinical care and cost demonstrated in the M@NGO trial, caseload midwifery outperforms standard care in perceived quality of pregnancy care regardless of risk. [ABSTRACT FROM AUTHOR]

Objectives: This single‐centre, controlled, randomized, double‐blinded clinical study in parallel groups was performed to assess the efficacy of an experimental toothpaste on plaque and gingivitis. Methods: In adult subjects with gingivitis, amine fluoride/stannous chloride toothpaste (test) and monofluorophosphate toothpaste (control) were applied twice daily by regular toothbrushing at home. Evaluations of plaque index (PI), gingival index (GI), modified sulcus bleeding index (mSBI) and safety took place at baseline and after 3 and 12 weeks of study product use. After study completion, all subjects received a dental prophylaxis. A descriptive statistical analysis included means and standard deviations. Unpaired t tests compared index reductions between groups at a significance level of 0.05. Results: Intention‐to‐treat analysis included 240 out of 241 subjects. Baseline mean PI was reduced by 0.87 ± 0.35 in the test group and by 0.65 ± 0.41 in the control group. Within‐group differences and between‐group differences in index reduction were statistically significant (P < 0.001). Mean GI and mSBI were reduced significantly over time (P < 0.001) with no clinically meaningful differences between groups. Conclusions: Both toothpastes reduced plaque and gingivitis statistically significant and clinically meaningful over 12 weeks. Compared to the control toothpaste, application of the amine fluoride/stannous chloride toothpaste led to a clinically meaningful and more pronounced plaque reduction. [ABSTRACT FROM AUTHOR]

Introduction: This study examined the impact of a multicomponent physical activity (PA) intervention (MOVI‐KIDS) on improving cognition in schoolchildren. This paper also analyzed the mediator role of motor fitness between MOVI‐KIDS and cognition. Methods: Propensity score analysis of data from a cluster randomized controlled trial (MOVI‐KIDS study). This analysis including 240 5‐7 years old children from nine schools in the provinces of Cuenca and Ciudad Real, Spain. MOVI‐KIDS program consisted of: (a) three weekly after‐school sessions of recreational non‐competitive PA lasting 60 minutes during one academic year, (b) educational materials for parents and teachers, and (c) school playground modifications. Changes in cognition (logical reasoning, verbal factor, numerical factor, spatial factor, and general intelligence) were measured. A propensity score cross‐cluster matching procedure and mediation analysis (Hayes's PROCESS macro) were conducted. Results: All cognitive variables pre‐post mean changes were significantly higher (P ≤ 0.05) in children from intervention schools than those from control schools (effect size ranged from 0.33 to 1.48). The effect of the intervention on the spatial factor and general intelligence was partially mediated by motor fitness (indirect effect = 0.92, 95% CI: 0.36; 1.65; and indirect effect = 1.21, 95% CI: 0.06; 2.62, respectively). Conclusions: This study shows that a one‐school‐year multicomponent intervention consisting of a recreational non‐competitive PA program, educational materials for parents and teachers, and school playground modifications improved the cognition of first‐grade children. Further, our results suggest that the effect of the intervention on cognition was mediated by changes in motor fitness. [ABSTRACT FROM AUTHOR]

Objectives: The aim of the study was to determine whether behaviourally informed short message service (SMS) primer and reminder messages could increase the return rate of HIV self‐sampling kits ordered online. Methods: The study was a 2 × 2 factorial design randomized control trial. A total of 9585 individuals who ordered a self‐sampling kit from www.freetesting.hiv different SMS combinations: 1) standard reminders sent days 3 and 7 after dispatch (control); 2) primer sent 1 day after dispatch plus standard reminders; 3) behavioural insights (BI) reminders (no primer); or 4) primer plus BI reminders. The analysis was restricted to individuals who received all messages (n = 8999). We used logistic regression to investigate independent effects of the primer and BI reminders and their interaction. We explored the impact of sociodemographic characteristics on kit return as a secondary analysis. Results: Those who received the primer and BI reminders had a return rate 4% higher than that of those who received the standard messages. We found strong evidence of a positive effect of the BI reminders (odds ratio 1.13; 95% confidence interval 1.04–1.23; P = 0.003) but no evidence for an effect of the primer, or for an interaction between the two interventions. Odds of kit return increased with age, with those aged ≥ 65 years being almost 2.5 times more likely to return the kit than those aged 25–34 years. Men who have sex with men were 1.5–4.5 times more likely to return the kit compared with other sexual behaviour and gender identity groups. Non‐African black clients were 25% less likely to return the kit compared with other ethnicities. Conclusions: Adding BI to reminder messages was successful in improving return rates at no additional cost. [ABSTRACT FROM AUTHOR]

Aim: To assess whether periodontal treatment can lead to clinical, glycaemic control and quality of life improvements in metabolically unbalanced diabetic patients (type 1 or type 2) diagnosed with periodontitis. Methods: In this open‐labelled randomized controlled trial, diabetic subjects (n = 91) were given "immediate" or "delayed" periodontal treatment (full‐mouth non‐surgical scaling and root planing, systemic antibiotics, and oral health instructions). The main outcome was the effect on glycated haemoglobin (HbA1C) and fructosamine levels. The General Oral Health Assessment Index and the SF‐36 index were used to assess quality of life (QoL). Results: Periodontal health significantly improved after periodontal treatment (p < 0.001). Periodontal treatment seemed to be safe but had no significant effects on glycaemic control based on HbA1C (adjusted mean difference with a 95% confidence interval (aMD) of 0.04 [−0.16;0.24]) and fructosamine levels (aMD 5.0 [−10.2;20.2]). There was no obvious evidence of improvement in general QoL after periodontal treatment. However, there was significant improvement in oral health‐related QoL (aMD 7.0 [2.4;11.6], p = 0.003). Conclusion: Although periodontal treatment showed no clinical effect on glycaemic control in this trial, important data were provided to support periodontal care among diabetic patients. Periodontal treatment is safe and improves oral health‐related QoL in patients living with diabetes. ISRCTN15334496. [ABSTRACT FROM AUTHOR]

Multidisciplinary biopsychosocial rehabilitation has been recommended for chronic low back pain (LBP), including physical exercise. However, which exercise modality that is most advantageous in multidisciplinary biopsychosocial rehabilitation is unclear. In this study, we investigated whether multidisciplinary biopsychosocial rehabilitation could be more effective in reducing pain‐related disability when general physical exercise was replaced by strength training in the form of progressive resistance training using elastic resistance bands. In this single‐blinded (researchers), randomized controlled trial, 99 consenting adults with moderate‐to‐severe non‐specific LBP were randomized to three weeks of multidisciplinary biopsychosocial rehabilitation with either general physical exercise or progressive resistance band training and were then instructed to continue with their respective home‐based programs for nine additional weeks, in which three booster sessions were offered. The primary outcome was between‐group difference in change on the Oswestry Disability Index (ODI) at 12 weeks. Due to early dropouts, data from 74 participants (mean age: 45 years, 57% women, mean ODI: 30.4) were obtained at baseline, 61 participants were followed‐up at 3 weeks, and 46 at 12 weeks. There was no difference in the change in ODI score between groups at 12 weeks (mean difference 1.9, 95% CI: −3.6, 7.4, P = .49). Likewise, the change in secondary outcomes did not differ between groups, except for the patient‐specific functional scale (0‐10), which favored general physical exercise (mean difference 1.4, 95% CI: 0.1, 2.7, P = .033). In conclusion, this study does not support that progressive resistance band training compared to general physical exercise improve outcomes in multidisciplinary biopsychosocial rehabilitation for patients with non‐specific LBP. [ABSTRACT FROM AUTHOR]

Abstract: Aims: To assess the cost‐effectiveness of a two‐component intervention designed to increase attendance at the NHS Stop Smoking Services (SSSs) in England. Design: Cost‐effectiveness analysis alongside a randomized controlled trial (Start2quit). Setting: NHS SSS and general practices in England. Participants: The study comprised 4384 smokers aged 16 years or more identified from medical records in 99 participating practices, who were motivated to quit and had not attended the SSS in the previous 12 months. Intervention and comparator: Intervention was a personalized and tailored letter sent from the general practitioner (GP) and a personal invitation and appointment to attend a taster session providing information about SSS. Control was a standard generic letter from the GP advertising SSS and asking smokers to contact the service to make an appointment. Measurements: Costs measured from an NHS/personal social services perspective, estimated health gains in quality‐adjusted life‐years (QALYs) measured with EQ‐5D and incremental cost per QALY gained during both 6 months and a life‐time horizon. Findings: During the trial period, the adjusted mean difference in costs was £92 [95% confidence interval (CI) = –£32 to –£216) and the adjusted mean difference in QALY gains was 0.002 (95% CI = –0.001 to 0.004). This generates an incremental cost per QALY gained of £59 401. The probability that the tailored letter and taster session is more cost‐effective than the generic letter at 6 months is never above 50%. In contrast, the discounted life‐time health‐care cost was lower in the intervention group, while the life‐time QALY gains were significantly higher. The probability that the intervention is more cost‐effective is more than 83% using a £20 000–30 000 per QALY‐gained decision‐making threshold. Conclusions: An intervention designed to increase attendance at the NHS Stop Smoking Services (tailored letter and taster session in the services) appears less likely to be cost‐effective than a generic letter in the short term, but is likely to become more cost‐effective than the generic letter during the long term. [ABSTRACT FROM AUTHOR]

Abstract: Background: Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post‐stroke pneumonia, which causes 30% of stroke‐related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post‐stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. Aims: This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow‐strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post‐stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full‐scale trial. Methods & Procedures: Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration‐Aspiration Scale (PAS) and patient‐reported outcomes (Swallow Related Quality of Life—SWAL‐QOL). Outcomes & Results: Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual‐care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. Conclusions & Implications: The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically meaningful outcome improvements, justifying progression to a fully powered study. It also showed clinically meaningful treatment trends for the Ampcare ESP intervention. [ABSTRACT FROM AUTHOR]

Abstract: Background and Aims: Pharmacologically controlled drinking in the treatment of alcohol dependence or alcohol use disorders (AUDs) is an emerging concept. Our objective was to explore the comparative effectiveness of drugs used in this indication. Design: Systematic review with direct and network meta‐analysis of double‐blind randomized controlled trials (RCTs) assessing the efficacy of nalmefene, naltrexone, acamprosate, baclofen or topiramate in non‐abstinent adults diagnosed with alcohol dependence or AUDs. Two independent reviewers selected published and unpublished studies on Medline, the Cochrane Library, Embase, ClinicalTrials.gov, contacted pharmaceutical companies, the European Medicines Agency and the Food and Drug Administration, and extracted data. Setting: Thirty‐two RCTs. Participants: A total of 6036 patients. Measurements: The primary outcome was total alcohol consumption (TAC). Other consumption outcomes and health outcomes were considered as secondary outcomes. Findings: No study provided direct comparisons between drugs. A risk of incomplete outcome data was identified in 26 studies (81%) and risk of selective outcome reporting in 17 (53%). Nalmefene [standardized mean difference (SMD) = −0.19, 95% confidence interval (CI) = −0.29, –0.10; I2 = 0%], baclofen (SMD = −1.00, 95% CI = −1.80, −0.19; one study) and topiramate (SMD = −0.77, 95% CI = −1.12, –0.42; I2 = 0%) showed superiority over placebo on TAC. No efficacy was observed for naltrexone or acamprosate. Similar results were observed for other consumption outcomes, except for baclofen (the favourable outcome on TAC was not reproduced). The number of withdrawals for safety reasons increased under nalmefene and naltrexone. No treatment demonstrated any harm reduction (no study was powered to explore health outcomes). Indirect comparisons suggested that topiramate was superior to nalmefene, naltrexone and acamprosate on consumption outcomes, but its safety profile is known to be poor. Conclusions: There is currently no high‐grade evidence for pharmacological treatment to control drinking using nalmefene, naltrexone, acamprosate, baclofen or topiramate in patients with alcohol dependence or alcohol use disorder. Some treatments show low to medium efficacy in reducing drinking across a range of studies with a high risk of bias. None demonstrates any benefit on health outcomes. [ABSTRACT FROM AUTHOR]

Abstract: Background and aims: Methamphetamine use is increasingly prevalent and associated with HIV transmission. Early‐phase human studies suggested naltrexone reduced amphetamine use among dependent individuals. We tested if extended‐release naltrexone (XRNTX) reduces methamphetamine use and associated sexual risk behaviors among high‐risk methamphetamine‐dependent men who have sex with men (MSM). Design: Double‐blind, placebo‐controlled, randomized trial of XRTNX versus placebo over 12 weeks from 2012 to 2015. Setting: San Francisco Department of Public Health, California, USA. Participants: One hundred community‐recruited, sexually‐active, actively‐using methamphetamine‐dependent MSM. Mean age was 43.2 years; 96% were male, 3% transfemale, and 1% transmale; 55.0% were white, 19.0% African American, and 18.0% Latino. Interventions: XRNTX 380 mg (n = 50) or matched placebo (n = 50) administered by gluteal injection at 4‐week intervals. Measurements: Regression estimated average level and change in level of positive urines during the period 2–12 weeks (primary outcomes) and sexual risk behaviors (secondary outcome). Findings: Ninety per cent of visits were completed. By intent‐to‐treat, participants assigned to XRNTX had similar differences during 2–12 weeks in methamphetamine‐positive urines as participants assigned to placebo [incidence rate ratio (IRR) = 0.95, 95% confidence interval (CI) = 0.76–1.20; Bayes factor < 0.3]. Observed urine positivity declined from 78 to 70% in the XRNTX arm and 74 to 64% in the placebo arm. Adherence to injections was 96.7% in the XRNTX arm and 91.3% in the placebo arm. Sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug and no differences in frequency of adverse events by treatment arm. Conclusions: Notwithstanding very high medication adherence for this study, extended‐release naltrexone does not appear to reduce methamphetamine use or sexual risk behaviors among methamphetamine‐dependent men who have sex with men compared with placebo. [ABSTRACT FROM AUTHOR]