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Researchers often analyze cancer registry data to assess for differences in survival among cancer treatments. However, the retrospective, nonrandomized design of these analyses raises questions about study validity. To examine the extent to which comparative effectiveness analyses using observational cancer registry data produce results concordant with those of randomized clinical trials. In this comparative effectiveness study, a total of 141 randomized clinical trials referenced in the National Comprehensive Cancer Network Clinical Practice Guidelines for 8 common solid tumor types were identified. Data on participants within the National Cancer Database (NCDB) diagnosed between 2004 and 2014, matching the eligibility criteria of the randomized clinical trial, were obtained. The present study was conducted from August 1, 2017, to September 10, 2019. The trials included 85 118 patients, and the corresponding NCDB analyses included 1 344 536 patients. Three Cox proportional hazards regression models were used to determine hazard ratios (HRs) for overall survival, including univariable, multivariable, and propensity score-adjusted models. Multivariable and propensity score analyses controlled for potential confounders, including demographic, comorbidity, clinical, treatment, and tumor-related variables. The main outcome was concordance between the results of randomized clinical trials and observational cancer registry data. Hazard ratios with an NCDB analysis were considered concordant if the NDCB HR fell within the 95% CI of the randomized clinical trial HR. An NCDB analysis was considered concordant if both the NCDB and clinical trial P values for survival were nonsignificant (P ≥ .05) or if they were both significant (P < .05) with survival favoring the same treatment arm in the NCDB and in the randomized clinical trial. Analyses using the NCDB-produced HRs for survival were concordant with those of 141 randomized clinical trials in 79 univariable analyses (56%), 98 multivariable analyses (70%), and 90 propensity score models (64%). The NCDB analyses produced P values concordant with randomized clinical trials in 58 univariable analyses (41%), 65 multivariable analyses (46%), and 63 propensity score models (45%). No clinical trial characteristics were associated with concordance between NCDB analyses and randomized clinical trials, including disease site, type of clinical intervention, or severity of cancer. The findings of this study suggest that comparative effectiveness research using cancer registry data often produces survival outcomes discordant with those of randomized clinical trial data. These findings may help provide context for clinicians and policy makers interpreting observational comparative effectiveness research in oncology.

The purpose of this study was to examine the psychometric properties of the Autism Program Environment Rating Scale (APERS), an instrument designed to assess quality of program environments for students with autism spectrum disorder. Data sets from two samples of public school programs that provided services to children and youth with autism spectrum disorder were utilized. Cronbach alpha analyses indicated high coefficients of internal consistency for the total APERS and moderate levels for item domains for the first data set, which was replicated with the second data set. A factor analysis of the first data set indicated that all domain scores loaded on one main factor, in alignment with the conceptual model, with this finding being replicated in the second data set. Also, the APERS was sensitive to changes resulting from a professional development program designed to promote program quality.

We compared the effects of a 16-week Cognitive-Behavioral Therapy (CBT) program and a Social Recreational (SR) program on anxiety in children with Autism Spectrum Disorders (ASD). Seventy children (9–16 years old) were randomly assigned to either of the programs ( n CBT  = 36; n SR  = 34). Measures on child’s anxiety using the Spence Child Anxiety Scale—Child (SCAS-C) and the Clinical Global Impression—Severity scale (CGI-S) were administered at pre-, post-treatment, and follow-ups (3- and 6-month). Children in both programs showed significantly lower levels of generalized anxiety and total anxiety symptoms at 6-month follow-up on SCAS-C. Clinician ratings on the CGI-S demonstrated an increase in the percentage of participants rated as “Normal” and “Borderline” for both programs. Findings from the present study suggest factors such as regular sessions in a structured setting, consistent therapists, social exposure and the use of autism-friendly strategies are important components of an effective framework in the management of anxiety in children and adolescents with ASD.

ObjectivesWe compared the effectiveness of the Gold Standard Programme (a comprehensive smoking cessation intervention commonly used in Denmark) with other face-to-face smoking cessation programmes in Denmark after implementation in real life, and we identified factors associated with successful quitting.DesignProspective cohort study.SettingA total of 423 smoking cessation clinics from different settings reported data from 2001 to 2013.ParticipantsIn total, 82 515 patients were registered. Smokers ≥15 years old and attending a programme with planned follow-up were included. Smokers who did not want further contact, who intentionally were not followed up or who lacked information about the intervention they received were excluded. A total of 46 287 smokers were included.InterventionsVarious real-life smoking cessation interventions were identified and compared: The Gold Standard Programme, Come & Quit, crash courses, health promotion counselling (brief intervention) and other interventions.Main outcomeSelf-reported continuous abstinence for 6 months.ResultsOverall, 33% (11 184) were continuously abstinent after 6 months; this value was 24% when non-respondents were considered smokers. The follow-up rate was 74%. Women were less likely to remain abstinent, OR 0.83 (CI 0.79 to 0.87). Short interventions were more effective among men. After adjusting for confounders, the Gold Standard Programme was the only intervention with significant results across sex, increasing the odds of abstinence by 69% for men and 31% for women. In particular, compliance, and to a lesser degree, mild smoking, older age and not being disadvantaged were associated with positive outcomes for both sexes. Compliance increased the odds of abstinence more than 3.5-fold.ConclusionsOver time, Danish smoking cessation interventions have been effective in real life. Compliance is the main predictor of successful quitting. Interestingly, short programmes seem to have relatively strong effects among men, but the absolute numbers are very small. Only the comprehensive Gold Standard Programme works across sexes.

Background Complex interventions such as self-management courses are difficult to evaluate due to the many interacting components. The way complex interventions are delivered can influence the effect they have for patients, and can impact the interpretation of outcomes of clinical trials. Implementation fidelity evaluates whether complex interventions are delivered according to protocol. Such assessments have been used for one-to-one psychological interventions; however, the science is still developing for group interventions. Methods We developed and tested an instrument to measure implementation fidelity of a two-day self-management course for people with epilepsy, SMILE(UK). Using audio recordings, we looked at adherence and competence of course facilitators. Adherence was assessed by checklists. Competence was measured by scoring group interaction, an overall impression score and facilitator “didacticism”. To measure “didacticism”, we developed a novel way to calculate facilitator speech using computer software. Using this new instrument, implementation fidelity of SMILE(UK) was assessed on three modules of the course, for 28% of all courses delivered. Results Using the instrument for adherence, scores from two independent raters showed substantial agreement with weighted Kappa of 0.67 and high percent agreement of 81.2%. For didacticism, the results from both raters were highly correlated with an intraclass coefficient of 0.97 ( p  < 0.0001). We found that the courses were delivered with a good level of adherence (> 50% of scored items received the maximum of 2 points) and high competence. Groups were interactive (mean score: 1.9–2.0 out of 2) and the overall impression was on average assessed as “good”. Didacticism varied from 42% to 93% of total module time and was not associated with the other competence scores. Conclusion The instrument devised to measure implementation fidelity was reproducible and easy to use. The courses for the SMILE(UK) study were delivered with a good level of adherence to protocol while not compromising facilitator competence. Trial registration ISRCTN57937389 .

BackgroundAn educational SUpport PRogramme called SUPR has been developed for hearing aid users (HAUs) and their communication partners (CPs) offering care beyond hearing aid fitting. SUPR teaches its users communication strategies, hearing aid handling skills and personal adjustment to hearing impairment.Methods/designUsing a cluster randomised controlled trial design, 70 Dutch hearing aid dispenser practices were randomised into hearing aid fitting (care as usual, 34 practices) and hearing aid fitting including SUPR (36 practices). The aim was to recruit a total of 569 older (aged 50+ years) first-time (n=258) and experienced (n=311) HAUs and their CPs. SUPR consists of a Practical Support Booklet and online material offered via email over a period of 6–7 months. The booklet provides practical information on hearing aids, advice on communication strategies and home exercises. The online material consists of educational videos on hearing aid functionality and usage, communication strategies and peer testimonials. Finally, noncommittal email contact with the dispenser is offered. Every HAU is asked to assign a CP who is advised to be involved intensively. Effect measurements for HAUs and their CPs will occur at baseline and at 6, 12 and 18 months follow-up via online questionnaires. The primary outcomes for HAUs will be the use of communication strategies as measured by the subscales of the Communication Profile for the Hearing Impaired. A process evaluation will be performed.Ethics and disseminationThe study was approved by the Dutch Institutional Review Board of the VU Medical University Center Amsterdam. This intervention could contribute to lowering the hearing impairment burden in our ageing society. The results will be disseminated through peer-reviewed publications and scientific conferences.Trial registration numberISRCTN77340339; Pre-results.

The use of faith-based organizations as sites to deliver diet and physical activity interventions is increasing. Methods to assess the messaging environment within churches are limited. Our research aimed to develop and test an objective assessment methodology to characterize health messages, particularly those related to diet and physical activity, within a sample of African American churches. Written messages (bulletins, brochures, magazines) were systematically collected over 1 year and analyzed with a coding scheme that had high interrater reliability (average κ = .77). Within all health messages (n = 1109), diet and physical activity messages were prevalent (47% and 32%, respectively). Consistent with prior qualitative research, messages related to meals and to providing food to people in need were frequently found (54% and 25% of diet messages, respectively). Contrary to past research, sports and physical activity as praise (e.g., praise dancing) were the most prevalent physical activity messages (36% and 31% of physical activity messages, respectively). Bulletins, flyers, and brochures were the media in which diet and physical activity messages were most frequently found (14%, 33%, and 24%, respectively), and the church was the most frequent source (41%). Only diet and physical activity messages focused on disease prevention were more likely to originate from national health organizations than from the church (26% vs. 16%). Churches varied in the topics, media types, and sources of health messages, an important factor to consider when planning and implementing health promotion research. Future research should determine whether the enhancement of church messaging environments can produce behavioral change.

IntroductionPhysical activity (PA) has been shown to be an important factor for health and educational outcomes in children. However, a large proportion of children's school day is spent in sedentary lesson-time. There is emerging evidence about the effectiveness of physically active lessons: integrating physical movements and educational content in the classroom. ‘Virtual Traveller’ is a novel 6-week intervention of 10-min sessions performed 3 days per week, using classroom interactive whiteboards to integrate movement into primary-school Maths and English teaching. The primary aim of this project is to evaluate the effect of the Virtual Traveller intervention on children's PA, on-task behaviour and student engagement.Methods and analysisThis study will be a cluster-randomised controlled trial with a waiting-list control group. Ten year 4 (aged 8–9 years) classes across 10 primary schools will be randomised by class to either the 6-week Virtual Traveller intervention or the waiting-list control group. Data will be collected 5 times: at baseline, at weeks 2 and 4 of the intervention, and 1 week and 3 months postintervention. At baseline, anthropometric measures, 4-day objective PA monitoring (including 2 weekend days; Actigraph accelerometer), PA and on-task behaviour observations and student engagement questionnaires will be performed. All but anthropometric measures will be repeated at all other data collection points. Changes in overall PA levels and levels during different time-periods (eg, lesson-time) will be examined. Changes in on-task behaviour and student engagement between intervention groups will also be examined. Multilevel regression modelling will be used to analyse the data. Process evaluation will be carried out during the intervention period.Ethics and disseminationThe results of this study will be disseminated through peer-review publications and conference presentations. Ethical approval was obtained through the University College London Research Ethics Committee (reference number: 3500-004).

IntroductionMetabolic syndrome (MetS) is a cluster of risk factors for cardiovascular diseases and type II diabetes. In Vietnam, more than one-quarter of its population aged 50–65 have MetS. This cluster-randomised controlled trial aims to evaluate the effectiveness of interventions to increase levels of physical activity and improve dietary behaviours among Vietnamese adults aged 50–65 years with MetS.Method and analysisThis 6-month community-based intervention includes a range of strategies to improve physical activity and nutrition for adults with MetS in Hanam, a province located in northern Vietnam. 600 participants will be recruited from 6 communes with 100 participants per commune. The 6 selected communes will be randomly allocated to either an intervention group (m=3; n=300) or a control group (m=3; n=300). The intervention comprises booklets, education sessions, resistance bands and attending local walking groups that provide information and encourage participants to improve their physical activity and healthy eating behaviours during the 6-month period. The control group participants will receive standard and 1-time advice. Social cognitive theory is the theoretical concept underpinning this study. Measurements will be taken at baseline and postintervention to evaluate programme effectiveness.Ethics and disseminationThe research protocol was approved by the Curtin University Human Research Ethics Committee (approval number: HR139/2014). The results of the study will be disseminated through publications, reports and conference presentations.Trial registration numberACTRN12614000811606.

Background Team-based interventions are effective for improving safety and quality of healthcare. However, contextual factors, such as team functioning, leadership, and organizational support, can vary significantly across teams and affect the level of implementation success. Yet, the science for measuring context is immature. The goal of this study is to validate measures from a short instrument tailored to track dynamic context and progress for a team-based quality improvement (QI) intervention. Methods Design: Secondary cross-sectional and longitudinal analysis of data from a clustered randomized controlled trial (RCT) of a team-based quality improvement intervention to reduce central line-associated bloodstream infection (CLABSI) rates in intensive care units (ICUs). Setting: Forty-six ICUs located within 35 faith-based, not-for-profit community hospitals across 12 states in the U.S. Population: Team members participating in an ICU-based QI intervention. Measures: The primary measure is the Team Check-up Tool (TCT), an original instrument that assesses context and progress of a team-based QI intervention. The TCT is administered monthly. Validation measures include CLABSI rate, Team Functioning Survey (TFS) and Practice Environment Scale (PES) from the Nursing Work Index. Analysis: Temporal stability, responsiveness and validity of the TCT. Results We found evidence supporting the temporal stability, construct validity, and responsiveness of TCT measures of intervention activities, perceived group-level behaviors, and barriers to team progress. Conclusions The TCT demonstrates good measurement reliability, validity, and responsiveness. By having more validated measures on implementation context, researchers can more readily conduct rigorous studies to identify contextual variables linked to key intervention and patient outcomes and strengthen the evidence base on successful spread of efficacious team-based interventions. QI teams participating in an intervention should also find data from a validated tool useful for identifying opportunities to improve their own implementation.