When piloting health services interventions, what predicts real world behaviours? A systematic concept mapping review.

BACKGROUND: Modeling studies to inform the design of complex health services interventions often involves elements that differ from the intervention's ultimate real-world use. These "hypothetical" elements include pilot participants, materials, and settings. Understanding the conditions under which studies with "hypothetical" elements can yield valid results would greatly help advance health services research. Our objectives are: 1) to conduct a systematic review of the literature to identify factors affecting the relationship between hypothetical decisions and real-world behaviours, and 2) to summarise and organize these factors into a preliminary framework. METHODS: We conducted an electronic database search using PsycINFO and Medline on November 30th, 2015, updated March 7th, 2019. We also conducted a supplemental snowball search on December 9th 2015 and a reverse citation search using Scopus and Web of Science. Studies were eligible to be included in this review if they clearly addressed the consistency between some type of hypothetical decision and a corresponding real decision or behaviour. Two reviewers extracted data using a standardized data collection form developed through an iterative consensus-based process. We extracted basic study information and data about each study's research area, design, and research question. Quotations from the articles were extracted and summarized into standardized factor statements. RESULTS: Of the 2444 articles that were screened, 68 articles were included in the review. The articles identified 27 factors that we grouped into 4 categories: decision maker factors, cognitive factors, task factors, and matching factors. CONCLUSIONS: We have summarized a large number of factors that may be relevant when considering whether hypothetical health services pilot work can be expected to yield results that are consistent with real-world behaviours. Our descriptive framework can serve as the basis for organizing future work exploring which factors are most relevant when seeking to develop complex health services interventions.

Informed Consent Documents Used in Critical Care Trials Often Do Not Implement Recommendations.

OBJECTIVE: Informed consent documents are often poorly understood by research participants. In critical care, issues such as time pressure, patient capacity, and surrogate decision making complicate the consent process further. Recommendations exist for addressing critical care-specific consent issues; we examined how well existing practice implements these recommendations. DESIGN: We conducted a systematic search of the literature for recommendations specific to critical care informed consent and rated existing informed consent documents on their implementation of 1) 18 of these critical care recommendations and 2) 36 previously developed general informed consent recommendations. Four hundred twelve registered critical care trials were identified and a request sent to the principal investigators for an example of the informed consent document associated with the trial. Each consent document was rated on both set of recommendations. SETTING: We evaluated informed consent documents for trials conducted in English or French registered with clinicaltrials.gov. PATIENTS: Not applicable. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: Independent coders rated implementation of each recommendation on a four-point scale. Of 412 requests, 137 informed consent documents were returned, for a response rate of 34.1%. Of these, 86 met inclusion criteria and were assessed. Overall agreement between raters was 90.6% (weighted κ = 0.79; 0.77-0.81). Implementation of the 18 critical care recommendations was highly variable, ranging between 2% and 96.5%. CONCLUSIONS: Critical care studies often do not provide the information recommended for those providing consent for research. These clear recommendations provide testable hypotheses about how to improve the consent process for patients and family members considering trial participation in the critical care setting.

Personalised multicomponent interventions for tobacco dependence management in low socioeconomic populations: a systematic review and meta-analysis.

BACKGROUND: There remains a disproportionally high tobacco smoking rate in low-income populations. Multicomponent tobacco dependence interventions in theory are effective. However, which intervention components are necessary to include for low socioeconomic status (SES) populations is still unknown. OBJECTIVE: To assess the effectiveness of multicomponent tobacco dependence interventions for low SES and create a checklist tool examining multicomponent interventions. METHODS: EMBASE and MEDLINE databases were searched to identify randomised controlled trials (RCTs) published with the primary outcome of tobacco smoking cessation measured at 6 months or post intervention. RCTs that evaluated tobacco dependence management interventions (for reduction or cessation) in low SES (experience of housing insecurity, poverty, low income, unemployment, mental health challenges, illicit substance use and/or food insecurity) were included. Two authors independently abstracted data. Random effects meta-analysis and post hoc sensitivity analysis were performed. RESULTS: Of the 33 included studies, the number of intervention components ranged from 1 to 6, with smoking quit rates varying between 1% and 36.6%. Meta-analysis revealed that both the 6-month and 12-month outcome timepoints, multicomponent interventions were successful in achieving higher smoking quit rates than the control (OR 1.64, 95% Cl 1.41 to 1.91; OR 1.74, 95% Cl 1.30 to 2.33). Evidence of low heterogeneity in the effect size was observed at 6-month (I2=26%) and moderate heterogeneity at 12-month (I2=56%) outcomes. CONCLUSION: Multicomponent tobacco dependence interventions should focus on inclusion of social support, frequency and duration of components. Employing community-based participatory-action research approach is essential to addressing underlying psychosocioeconomic-structural factors, in addition to the proven combination pharmacotherapies. PROSPERO REGISTRATION NUMBER: CRD42017076650.

Sociodemographic changes in emergency department visits due to alcohol during COVID-19.

INTRODUCTION: Little detailed sociodemographic information is available about how alcohol use and associated health care visits have changed during COVID-19. Therefore, we assessed how rates of emergency department (ED) visits due to alcohol have changed during COVID-19 by age and sex and for individuals living in urban and rural settings and low and high-income neighborhoods. METHODS: Our cohort included 13,660,516 unique Ontario residents between the ages of 10-105. We compared rates and characteristics of ED visits due to alcohol, identified using ICD-10 codes, from March 11-August 31 2020 to the same period in the prior 3 years. We used negative binomial regressions to examine to examine changes is visits during COVID-19 after accounting for temporal and seasonal trends. RESULTS: During COVID-19, the average monthly rate of ED visits due to alcohol decreased by 17.2 % (95 % CI -22.7, -11.3) from 50.5-40.9 visits per 100,000 individuals. In contrast, the proportion of all-cause ED visits due to alcohol increased by 11.4 % (95 % CI 7.7, 15.3) from 15.0 visits to 16.3 visits per 1000 all cause ED visits. Changes in ED visits due to alcohol were similar for men in women. Decreases in visits were larger for younger adults compared to older adults and pre-COVID-19 disparities in rates of ED visits due to alcohol between urban and rural settings and low and high-income neighborhoods widened. ED visits related to harms from acute intoxication showed the largest declines during COVID-19, particularly in younger adults and urban and high-income neighborhoods. CONCLUSION: ED visits due to alcohol decreased during the first six months of COVID-19, but to a lesser extent than decreases in all-cause ED visits. Our data suggest a widening of geographic and income-based disparities in alcohol harms in Ontario during COVID-19 which may require immediate and long-term interventions to mitigate.

A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

BACKGROUND: To date there is no established consensus of assessment criteria for evaluating research ethics review. METHODS: We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. RESULTS: Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. DISCUSSION: Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.