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In a randomized trial involving 8014 patients with out-of-hospital cardiac arrest, the use of epinephrine resulted in a significantly higher rate of 30-day survival than placebo but not a higher rate of survival with a favorable neurologic outcome.

SummaryThe trial compared three physiotherapy approaches: manual or exercise therapy compared with a single session of physiotherapy education (SSPT) for people with osteoporotic vertebral fracture(s). At 1 year, there were no statistically significant differences between the groups meaning there is inadequate evidence to support manual or exercise therapy.IntroductionTo evaluate the clinical and cost-effectiveness of different physiotherapy approaches for people with osteoporotic vertebral fracture(s) (OVF).Methods>Prospective, multicentre, adaptive, three-arm randomised controlled trial. Six hundred fifteen adults with back pain, osteoporosis, and at least 1 OVF participated. Interventions: 7 individual physiotherapy sessions over 12 weeks focused on either manual therapy or home exercise compared with a single session of physiotherapy education (SSPT). The co-primary outcomes were quality of life and back muscle endurance measured by the QUALEFFO-41 and timed loaded standing (TLS) test at 12 months.ResultsAt 12 months, there were no statistically significant differences between groups. Mean QUALEFFO-41: − 1.3 (exercise), − 0.15 (manual), and − 1.2 (SSPT), a mean difference of − 0.2 (95% CI, − 3.2 to 1.6) for exercise and 1.3 (95% CI, − 1.8 to 2.9) for manual therapy. Mean TLS: 9.8 s (exercise), 13.6 s (manual), and 4.2 s (SSPT), a mean increase of 5.8 s (95% CI, − 4.8 to 20.5) for exercise and 9.7 s (95% CI, 0.1 to 24.9) for manual therapy. Exercise provided more quality-adjusted life years than SSPT but was more expensive. At 4 months, significant changes above SSPT occurred in endurance and balance in manual therapy, and in endurance for those ≤ 70 years, in balance, mobility, and walking in exercise.ConclusionsAdherence was problematic. Benefits at 4 months did not persist and at 12 months, we found no significant differences between treatments. There is inadequate evidence a short physiotherapy intervention of either manual therapy or home exercise provides long-term benefits, but arguably short-term benefits are valuable.Trial registrationISRCTN 49117867.

ObjectiveEvaluating effectiveness and cost-effectiveness of ‘Families for Health V2′ (FFH) compared with usual care (UC).DesignMulticentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families.SettingThree National Health Service Primary Care Trusts in West Midlands, England.ParticipantsOverweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6–11 years and their parents/carers, recruited March 2012–February 2014.InterventionsFFH; a 10-week community-based family programme addressing parenting, lifestyle change and social and emotional development. UC; usual support for childhood obesity at each site.Main outcome measuresPrimary outcomes were 12-months change in children's BMI z-score and incremental cost per quality-adjusted life-year gained (QALY). Secondary outcomes included changes in children's physical activity, fruit and vegetable consumption and quality of life, parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style.Results115 families (128 children) were randomised to FFH (n=56) or UC (n=59). There was no significant difference in BMI z-score 12-months change (0.114, 95% CI −0.001 to 0.229, p=0.053; p=0.026 in favour of UC with missing value multiple imputation). One secondary outcome, change in children's waist z-score, was significantly different between groups in favour of UC (0.15, 95% CI 0.00 to 0.29). Economic evaluation showed that mean costs were significantly higher for FFH than UC (£998 vs £548, p<0.001). Mean incremental cost-effectiveness of FFH was estimated at £552 175 per QALY.ConclusionsFFH was neither effective nor cost-effective for the management of obesity compared with UC.Trial registration numberISRCTN45032201.

Background: The Biomarker Strategy Design has been proposed for trials assessing the value of a biomarker in guiding treatment in oncology. In such trials, patients are randomised to either receive the standard chemotherapy treatment or a biomarker-directed treatment arm, in which biomarker status is used to guide treatment. Methods: Motivated by a current trial, we consider an adaptive design in which two biomarkers are assessed. The trial is conducted in two stages. In the first stage, patients in the biomarker-guided arm are assessed using a standard and an alternative cheaper biomarker, with the standard biomarker guiding treatment. An analysis comparing biomarker results is then used to choose the biomarker to use for the remainder of the trial. The new biomarker is used if the results for the two biomarkers are sufficiently similar. Results: We show that in practical situations the first-stage results can be used to adapt the trial without type I error rate inflation. We also show that there can be considerable cost gains with only a small loss in power in the case where the alternative biomarker is highly concordant with the standard one. Conclusions: Adaptive designs have an important role in reducing the cost and increasing the clinical utility of trials evaluating biomarker-guided treatment strategies.

Background: Parenting and parent–child relationships influence children's emotional and social development and evidence exists that they may be life-course determinants of health. This study tests the hypothesis that adverse parenting in the early years predicts poor health in mid-childhood. Methods: A prospective study using data from the Avon Longitudinal Study of Parents and Children cohort. Health data on over 8000 children (60% of those recruited) were available for analysis at 6.9 and 7.7 years. Exposures: self-reported maternal hostility, resentment and hitting/shouting in early childhood. Outcomes: maternal report of child's health in general and number of health problems when the child was 6.9 and 7.7 years, adjusting for socioeconomic factors. Results: Sub-optimal parenting, as measured here, was observed among 62, 80 and 83% of families for hostility, resentment and hitting/shouting, respectively. Resentment was more common among older mothers in owner-occupied housing. Resentment and hostility predicted health at both ages independently of socioeconomic circumstances. ‘Hitting/shouting’ was weakly predictive of number of health problems. A greater proportion of variance was explained by parenting variables than by socio-economic variables. Conclusions: Parenting and parent–child relationships in the early years predict health in mid-childhood in a way consistent with a causal role. If further studies replicate this finding, policies to improve parenting could be expected to have a modest beneficial impact on health as well as emotional and social development. As some aspects of sub-optimal parenting show reverse social class distribution, initiatives targeted at those living in social deprivation may not achieve the optimum impact on health.

Background: Parent child relationships and parenting processes are emerging as potential life course determinants of health. Parenting is socially patterned and could be one of the factors responsible for the negative effects of social inequalities on health, both in childhood and adulthood. This study tests the hypothesis that some of the effect of socioeconomic risk on health in mid childhood is transmitted via early parenting. Methods: Prospective cohort study in 10 USA communities involving 1041 mother/child pairs, selected at birth at random with conditional sampling. Exposures: income, maternal education, maternal age, lone parenthood, ethnic status and objective assessments of mother child interaction in the first 4 years of life covering warmth, negativity and positive control. Outcomes: mother's report of child's health in general at 6 years. Modelling: multiple regression analyses with statistical testing of mediational processes. Results: All five indicators of socioeconomic status (SES) were correlated with all three measures of parenting, such that low SES was associated with poor parenting. Among the measures of parenting maternal warmth was independently predictive of future health, and among the socioeconomic variables maternal education, partner presence and ‘other ethnic group’ proved predictive. Measures of parenting significantly mediated the impact of measures of SES on child health. Conclusions: Parenting mediates some, but not all of the detectable effects of socioeconomic risk on health in childhood. As part of a package of measures that address other determinants, interventions to support parenting are likely to make a useful contribution to reducing childhood inequalities in health.

This cross-sectional study aimed to investigate how perceived social-emotional competencies (SECs), relationship skills, emotional regulation, and the ability to structure schoolwork at school and at home were associated with academic efficacy belief (AEB) and emotional distress among 1142 Norwegian eighth-grade students. The students answered an Internet-based questionnaire during school hours. Structural equation modeling was used to assess the paths of associations. In the structural model, AEB was treated as an intermediate variable predicted by the other SECs and as a predictor of emotional distress. Perceived relationship skills, emotional regulation, and the ability to structure schoolwork showed moderate to strong associations with AEB. AEB showed a strong association with emotional distress, whereas relationship skills and emotional regulation showed a moderately strong association with emotional distress. The results suggest that all SECs play a role in AEB, whereas high AEB, good perceived ability for emotional regulation, and relationship skills are linked to less emotional distress. Good perceived relationship skills, emotional regulation, and structuring of schoolwork were more strongly related to less emotional distress among females. Moreover, emotional regulation and structuring of schoolwork were more strongly associated with AEB for females. These findings may indicate that these SECs may be more essential to emotional well-being among female adolescent students.

Background:Adaptive seamless designs (ASDs) have been proposed to test multiple candidate compounds using an interim decision point which allows potentially effective therapies to be taken into the next design stage and to be assessed using a phase III outcome. Objective:To determine whether ASDs are feasible in secondary progressive multiple sclerosis (SPMS) and to compare them with conventional trial designs. Methods:We develop an innovative adaptive trial design for SPMS, which builds on recent developments in statistical methodology. A literature search and individual clinical datasets were used to inform a framework to run simulations to evaluate the proposed design. Results:ASDs are feasible in SPMS with MRI informing an interim decision point and Expanded Disability Status Scale (EDSS) as the final disability endpoint. Furthermore ASDs are more efficient than conventional designs with sample size savings of up to 40%. Sample sizes of 1000–1250 patients are sufficient to test up to four experimental treatments. Controlled recruitment is important to realize the full benefits of ASDs. Conclusions:Although more complex in design, ASDs have the potential to be more efficient and more powerful than conventional designs.

Background: This year has seen the emergence of two major crises, a significant increase in the frequency and severity of hurricanes and the COVID-19 pandemic. However, little is known as to how each of these two events have impacted the other. A rapid qualitative assessment was conducted to determine the impact of the pandemic on preparedness and response to natural disasters and the impact of past experiences with natural disasters in responding to the pandemic. Methods: Semi-structured interviews were conducted with 26 representatives of 24 different community-based programs in southern Louisiana. Data were analyzed using procedures embedded in the Rapid Assessment Procedure-Informed Community Ethnography methodology, using techniques of immersion and crystallization and focused thematic analysis. Results: The pandemic has impacted the form and function of disaster preparedness, making it harder to plan for evacuations in the event of a hurricane. Specific concerns included being able to see people in person, providing food and other resources to residents who shelter in place, finding volunteers to assist in food distribution and other forms of disaster response, competing for funds to support disaster-related activities, developing new support infrastructures, and focusing on equity in disaster preparedness. However, several strengths based on disaster preparedness experience and capabilities were identified, including providing a framework for how to respond and adapt to COVID and integration of COVID response with their normal disaster preparedness activities. Conclusions: Although prior experience has enabled community-based organizations to respond to the pandemic, the pandemic is also creating new challenges to preparing for and responding to natural disasters.

Objective To evaluate the effectiveness and cost utility of a universally provided early years parenting programme. Design Multicentre randomised controlled trial with cost-effectiveness analysis. Setting Early years centres in four deprived areas of South Wales. Participants Families with children aged between 2 and 4 years. 286 families were recruited and randomly allocated to the intervention or waiting list control. Intervention The Family Links Nurturing Programme (FLNP), a 10-week course with weekly 2 h facilitated group sessions. Main outcome measures Negative and supportive parenting, child and parental well-being and costs assessed before the intervention, following the course (3 months) and at 9 months using standardised measures. Results There were no significant differences in primary or secondary outcomes between trial arms at 3 or 9 months. With ‘+’ indicating improvement, difference in change in negative parenting score at 9 months was +0.90 (95%CI −1.90 to 3.69); in supportive parenting, +0.17 (95%CI −0.61 to 0.94); and 12 of the 17 secondary outcomes showed a non-significant positive effect in the FLNP arm. Based on changes in parental well-being (SF-12), the cost per quality-adjusted life year (QALY) gained was estimated to be £34 913 (range 21 485–46 578) over 5 years and £18 954 (range 11 664–25 287) over 10 years. Probability of cost per QALY gained below £30 000 was 47% at 5 years and 57% at 10 years. Attendance was low: 34% of intervention families attended no sessions (n=48); only 47% completed the course (n=68). Also, 19% of control families attended a parenting programme before 9-month follow-up. Conclusions Our trial has not found evidence of clinical or cost utility for the FLNP in a universal setting. However, low levels of exposure and contamination mean that uncertainty remains. Trial registration The trial is registered with Current Controlled Trials ISRCTN13919732.