Routinely collected data for randomized trials: promises, barriers, and implications

This work was supported by Stiftung Institut für klinische Epidemiologie. The Meta-Research Innovation Center at Stanford University is funded by a grant from the Laura and John Arnold Foundation. The funders had no role in design and conduct of the study; the collection, management, analysis, or interpretation of the data; or the preparation, review, or approval of the manuscript or its submission for publication.Peer reviewedPublisher PD

Advancing a Conceptual Model of Evidence-Based Practice Implementation in Public Service Sectors

Implementation science is a quickly growing discipline. Lessons learned from business and medical settings are being applied but it is unclear how well they translate to settings with different historical origins and customs (e.g., public mental health, social service, alcohol/drug sectors). The purpose of this paper is to propose a multi-level, four phase model of the implementation process (i.e., Exploration, Adoption/Preparation, Implementation, Sustainment), derived from extant literature, and apply it to public sector services. We highlight features of the model likely to be particularly important in each phase, while considering the outer and inner contexts (i.e., levels) of public sector service systems

The impact of surgical delay on resectability of colorectal cancer: An international prospective cohort study

AIM: The SARS-CoV-2 pandemic has provided a unique opportunity to explore the impact of surgical delays on cancer resectability. This study aimed to compare resectability for colorectal cancer patients undergoing delayed versus non-delayed surgery. METHODS: This was an international prospective cohort study of consecutive colorectal cancer patients with a decision for curative surgery (January-April 2020). Surgical delay was defined as an operation taking place more than 4 weeks after treatment decision, in a patient who did not receive neoadjuvant therapy. A subgroup analysis explored the effects of delay in elective patients only. The impact of longer delays was explored in a sensitivity analysis. The primary outcome was complete resection, defined as curative resection with an R0 margin. RESULTS: Overall, 5453 patients from 304 hospitals in 47 countries were included, of whom 6.6% (358/5453) did not receive their planned operation. Of the 4304 operated patients without neoadjuvant therapy, 40.5% (1744/4304) were delayed beyond 4 weeks. Delayed patients were more likely to be older, men, more comorbid, have higher body mass index and have rectal cancer and early stage disease. Delayed patients had higher unadjusted rates of complete resection (93.7% vs. 91.9%, P = 0.032) and lower rates of emergency surgery (4.5% vs. 22.5%, P < 0.001). After adjustment, delay was not associated with a lower rate of complete resection (OR 1.18, 95% CI 0.90-1.55, P = 0.224), which was consistent in elective patients only (OR 0.94, 95% CI 0.69-1.27, P = 0.672). Longer delays were not associated with poorer outcomes. CONCLUSION: One in 15 colorectal cancer patients did not receive their planned operation during the first wave of COVID-19. Surgical delay did not appear to compromise resectability, raising the hypothesis that any reduction in long-term survival attributable to delays is likely to be due to micro-metastatic disease

Supported self-management for patients with COPD who have recently been discharged from hospital: a systematic review and meta-analysis

Saimma Majothi,1 Kate Jolly,1 Nicola R Heneghan,2 Malcolm J Price,1 Richard D Riley,3 Alice M Turner,4 Susan E Bayliss,1 David J Moore,1 Sally J Singh,5 Peyman&eacute; Adab,1 David A Fitzmaurice,6 Rachel E Jordan1 1Public Health, Epidemiology and Biostatistics, School of Health and Population Sciences, University of Birmingham, Birmingham, UK; 2School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK; 3Research Institute of Primary Care and Health Sciences, Keele University, Staffordshire, UK; 4Queen Elizabeth Hospital Research Laboratories, Birmingham, UK; 5Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK; 6Primary Care Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Birmingham, UK Purpose: Although many hospitals promote self-management to chronic obstructive pulmonary disease (COPD) patients post discharge from hospital, the clinical effectiveness of this is unknown. We undertook a systematic review of the evidence as part of a Health Technology Assessment review.Methods: A comprehensive search strategy with no language restrictions was conducted across relevant databases from inception to May 2012. Randomized controlled trials of patients with COPD, recently discharged from hospital after an acute exacerbation and comparing a self-management intervention with control, usual care or other intervention were included. Study selection, data extraction, and risk of bias assessment were undertaken by two reviewers independently. Results: Of 13,559 citations, 836 full texts were reviewed with nine randomized controlled trials finally included in quantitative syntheses. Interventions were heterogeneous. Five trials assessed highly supported multi-component interventions and four trials were less supported with fewer contacts with health care professionals and mainly home-based interventions. Total sample size was 1,466 (range 33&ndash;464 per trial) with length of follow-up 2&ndash;12 months. Trials varied in quality; poor patient follow-up and poor reporting was common. No evidence of effect in favor of self-management support was observed for all-cause mortality (pooled hazard ratio =1.07; 95% confidence interval [0.74 to 1.55]; I2=0.0%, [n=5 trials]). No clear evidence of effect on all-cause hospital admissions was observed (hazard ratio 0.88 [0.61, 1.27] I2=66.0%). Improvements in St George&rsquo;s Respiratory Questionnaire score were seen in favor of self-management interventions (mean difference =3.84 [1.29 to 6.40]; I2=14.6%), although patient follow-up rates were low.Conclusion: There is insufficient evidence to support self-management interventions post-discharge. There is a need for good quality primary research to identify effective approaches. Keywords: chronic obstructive pulmonary disease, self-management support, post-discharge, systematic revie

School mental health services: signpost for out-of-school service utilization in adolescents with mental disorders? : a nationally representative United States cohort

Background: School mental health services are important contact points for children and adolescents with mental disorders, but their ability to provide comprehensive treatment is limited. The main objective was to estimate in mentally disordered adolescents of a nationally representative United States cohort the role of school mental health services as guide to mental health care in different out-of-school service sectors. Methods: Analyses are based on weighted data (N = 6483) from the United States National Comorbidity Survey Replication Adolescent Supplement (participants' age: 13–18 years). Lifetime DSM-IV mental disorders were assessed using the fully structured WHO CIDI interview, complemented by parent report. Adolescents and parents provided information on mental health service use across multiple sectors, based on the Service Assessment for Children and Adolescents. Results: School mental health service use predicted subsequent out-of-school service utilization for mental disorders i) in the medical specialty sector, in adolescents with affective (hazard ratio (HR) = 3.01, confidence interval (CI) = 1.77–5.12), anxiety (HR = 3.87, CI = 1.97–7.64), behavior (HR = 2.49, CI = 1.62–3.82), substance use (HR = 4.12, CI = 1.87–9.04), and eating (HR = 10.72, CI = 2.31–49.70) disorders, and any mental disorder (HR = 2.97, CI = 1.94–4.54), and ii) in other service sectors, in adolescents with anxiety (HR = 3.15, CI = 2.17–4.56), behavior (HR = 1.99, CI = 1.29–3.06), and substance use (HR = 2.48, CI = 1.57–3.94) disorders, and any mental disorder (HR = 2.33, CI = 1.54–3.53), but iii) not in the mental health specialty sector. Conclusions: Our findings indicate that in the United States, school mental health services may serve as guide to out-of-school service utilization for mental disorders especially in the medical specialty sector across various mental disorders, thereby highlighting the relevance of school mental health services in the trajectory of mental care. In light of the missing link between school mental health services and mental health specialty services, the promotion of a stronger collaboration between these sectors should be considered regarding the potential to improve and guarantee adequate mental care at early life stages

Self-management of health care behaviors for COPD: a systematic review and meta-analysis

Kate Jolly,1 Saimma Majothi,1 Alice J Sitch,1 Nicola R Heneghan,2 Richard D Riley,3 David J Moore,1 Elizabeth J Bates,1 Alice M Turner,4 Susan E Bayliss,1 Malcolm J Price,1 Sally J Singh,5 Peymane Adab,1 David A Fitzmaurice,1 Rachel E Jordan11Institute of Applied Health Research, 2School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, Birmingham, 3Research Institute of Primary Care and Health Sciences, Keele University, Keele, Staffordshire, 4Institute of Inflammation and Ageing, University of Birmingham, Birmingham, 5Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UKPurpose: This systematic review aimed to identify the most effective components of interventions to facilitate self-management of health care behaviors for patients with COPD. PROSPERO registration number CRD42011001588.Methods: We used standard review methods with a systematic search to May 2012 for randomized controlled trials of self-management interventions reporting hospital admissions or health-related quality of life (HRQoL). Mean differences (MD), hazard ratios, and 95% confidence intervals (CIs) were calculated and pooled using random-effects meta-analyses. Effects among different subgroups of interventions were explored including single/multiple components and multicomponent interventions with/without exercise.Results: One hundred and seventy-three randomized controlled trials were identified. Self-management interventions had a minimal effect on hospital admission rates. Multicomponent interventions improved HRQoL (studies with follow-up &gt;6 months St George&rsquo;s Respiratory Questionnaire (MD 2.40, 95% CI 0.75&ndash;4.04, I2 57.9). Exercise was an effective individual component (St George&rsquo;s Respiratory Questionnaire at 3 months MD 4.87, 95% CI 3.96&ndash;5.79,&nbsp;I2&nbsp;&nbsp;0%).Conclusion: While many self-management interventions increased HRQoL, little effect was seen on hospital admissions. More trials should report admissions and follow-up participants beyond the end of the intervention. Keywords: COPD, self-management, systematic review, meta-analysi