How a Canadian federal organization integrated synoptic reporting and quality improvement tools to drive a national learning health system in cancer surgery.

Accurate and complete surgical and pathology reports are the cornerstone of treatment decisions and cancer care excellence. Synoptic reporting is a process for reporting specific data elements in a specific format in surgical and pathology reports. Since 2007, The Canadian Partnership Against Cancer has led the implementation of synoptic reporting mechanisms across multiple cancer disease sites and jurisdictions across Canada. While the implementation of synoptic reporting has been successful, its use to drive improvements in the quality of cancer care delivery has been lacking. Here we describe the Partnership's 4-year, national multi-jurisdictional quality improvement initiative to catalyse the use synoptic data to drive cancer system improvements. Resources provided to the jurisdictions included operational funding, training in quality improvement methodology, national forums, expert coaches, and ad hoc monitoring and support. The program emphasized foundational concepts including data literacy, audit and feedback reports, communities of practice, and positive deviance methodology.

Analyzing interprofessional teamwork in the operating room: An exploratory observational study using conventional and alternative approaches.

Intraoperative teamwork is vital for patient safety. Conventional tools for studying intraoperative teamwork typically rely on behaviorally anchored rating scales applied at the individual or team level, while others capture narrative information across several units of analysis. This prospective observational study characterizes teamwork using two conventional tools (Operating Theatre Team Non-Technical Skills Assessment Tool [NOTECHS]; Team Emergency Assessment Measure [TEAM]), and one alternative approach (modified-Systems Engineering Initiative for Patient Safety [SEIPS] model). We aimed to explore the advantages and disadvantages of each for providing feedback to improve teamwork practice. Fifty consecutive surgical cases at a Canadian academic hospital were recorded with the OR Black Box®, analyzed by trained raters, and summarized descriptively. Teamwork performance was consistently high within and across cases rated with NOTECHS and TEAMS. For cases analyzed with the modified-SEIPS tool, both optimal and suboptimal teamwork behaviors were identified, and team resilience was frequently observed. NOTECHS and TEAM provided summative assessments and overall pattern descriptions, while SEIPS facilitated a deeper understanding of teamwork processes. As healthcare organizations continue to prioritize teamwork improvement, SEIPS may provide valuable insights regarding teamwork behavior and the broader context influencing performance. This may ultimately enhance the development and effectiveness of multi-level teamwork interventions.

Review of pragmatic trials found that multiple primary outcomes are common but so too are discrepancies between protocols and final reports.

OBJECTIVES: To describe prevalence of multiple primary outcomes, changes in primary outcomes and target sample sizes between protocols and final reports, and how issues of multiplicity are addressed in pragmatic trials. STUDY DESIGN AND SETTING: Individually randomized trials labeled as pragmatic, published 2014-2019 in MEDLINE and registered with ClinicalTrials.gov. RESULTS: We identified 262 final reports and located protocols for 159 (61%); primary outcomes were clearly reported in 145 (91%) protocols and 256 (98%) final reports. Thirty (19%) protocols and 38 (15%) final reports had multiple primary outcomes. Primary outcomes were present and identical in 128 (81%) matched protocol-final reports. Among 140 pairs with target sample sizes reported, 28 (20.0%) reduced their target sample size (mean 543 fewer participants per trial) and 16 (11.4%) increased it (mean 192 more participants per trial). Thirteen (29.5%) provided an explanation. Only 2 of 30 (7%) protocols and 4 of 38 (11%) final reports with co-primary outcomes explained how results would be interpreted in light of multiplicity; 21 of 30 (70%) protocols and 20 of 38 (53%) final reports accounted for co-primary outcomes in power calculations. CONCLUSION: Co-primary outcomes are common in pragmatic trials; improved transparency around design and analysis decisions involving co-primary outcomes is required.

The longitudinal impact of division-wide implementation of an enhanced recovery after thoracic surgery programme.

OBJECTIVES: Data regarding enhanced recovery after thoracic surgery (ERATS) are sparse and inconsistent. This study aims to evaluate the effects of implementing an enhanced ERATS programme on postoperative outcomes, patient experience and quality of life (QOL). METHODS: We conducted a prospective, longitudinal study evaluating 9 months before (pre-ERATS) and 9 months after (post-ERATS) a 3-month implementation of an ERATS programme in a single academic tertiary care centre. All patients undergoing major thoracic surgeries were included. The primary outcomes included length of stay (LOS), adverse events (AEs), 6-min walk test scores at 4 weeks, 30-day emergency room visits (without admission) and 30-day readmissions. The process-of-care outcomes included time to 'out-of-bed', independent ambulation, successful fluid intake, last chest tube removal and removal of urinary catheter. Perioperative anaesthesia-related outcomes were examined as well as patient experience and QOL scores. RESULTS: The pre-ERATS group (n = 352 patients) and post-ERATS group (n = 352) demonstrated no differences in demographics. Post-ERATS patients had improved LOS (4.7 vs 6.2 days, P < 0.02), 6-min walk test scores (402 vs 371 m, P < 0.05) and 30-day emergency room visits (13.7% vs 21.6%, P = 0.03) with no differences in AEs and 30-day readmissions. Patients experienced shorter mean time to 'out-of-bed', independent ambulation, successful fluid intake, last chest tube removal and urinary catheter removal. There were no differences in postoperative analgesia administration, patient satisfaction and QOL scores. CONCLUSIONS: ERATS implementation was associated with improved LOS, expedited feeding, ambulation and chest tube removal, without increasing AEs or readmissions, while maintaining a high level of patient satisfaction and QOL.

Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them.

BACKGROUND: Ensuring adequate, informed, and timely participation in clinical trials is a multifactorial problem. We have previously developed a systematic, tailorable survey development approach that is informed by theory, can identify barriers and enablers to participation, and can suggest recruitment strategies to address these issues. In this study, we surveyed subscribers to the Canadian Breast Cancer Network (CBCN) in order to identify a comprehensive list of theory-informed barriers and enablers relevant to participation in a hypothetical breast cancer trial. METHODS: We developed and conducted an online survey of breast cancer patients informed by the Theoretical Domains Framework and designed to determine previous experience with clinical trials, knowledge about clinical trials, and importance of a comprehensive list of barriers and enablers to trial participation. Participants were contacted by email or through social media. RESULTS: From 2451 subscribers of the CBCN, we received 244 responses and 210 completed surveys (244/2451 or 9.9% participation, 210/244 or 86.1% completion). A total of 38% of respondents indicated experience in trial participation, but 83% indicated confidence in their knowledge about clinical trials. Those who had previously participated in clinical trials were more confident in their knowledge (χ2= 6.77, p = 0.009) and answered more knowledge questions (t = -3.90 p = 0.000). Endorsed barriers and enablers to participation included 39 factors across 12 of 14 domains relevant to behaviour change. Our approach identifies barriers that might be meaningfully addressed by careful knowledge provision ('If I would learn more about my condition'; 'If I find the trial documents hard to understand'), those that may require other theory-informed approaches to address ('my feelings about the quality of my drug plan'; 'my worry over unknown side effects'), and those that may require tailored approaches depending on participant differences such as previous experience in trials ('If there were patient-friendly decision-making tools to help you make your participation decision'). DISCUSSION: This work demonstrates that a comprehensive, theory-guided survey of barriers and enablers to participation in breast cancer clinical trials is feasible, can lead to detailed knowledge about the issues related to participation in specific trials, and most importantly, can lead to insights about evidence-based ways to better support patient participation.

A patient-focused, theory-guided approach to survey design identified barriers to and drivers of clinical trial participation.

OBJECTIVES: Despite clear evidence showing that many clinical trials fail or are delayed because of poor patient recruitment, there is surprisingly little empirically supported guidance for trialists seeking to optimize their trial recruitment strategies. We propose that the challenges of recruitment can be better understood and addressed by thinking of research participation as one or more behaviors, subject to the same forces as other human behaviors. In this article, we describe an adaptable, behavioral theory-driven approach for designing pretrial surveys of the barriers and drivers relevant to trial participation. Instead of proposing a single survey instrument intended to be used uniformly across many situations, we propose that tailored surveys be informed by a common comprehensive, theory-guided development approach that ensures all domains potentially guiding participation are considered. STUDY DESIGN AND SETTING: We used the Theoretical Domains Framework (TDF), which organizes over 100 constructs known to be associated with behavior and behavior change into 14 domains that describe determinants of professional and patient health behaviors, to inform the development of tailored surveys about barriers to and drivers of clinical trial participation. After searching the literature for barriers and drivers to trial recruitment relevant to each of the TDF domains, we developed separate surveys for members of two national health charities (Canadian Breast Cancer Network, Huntington Society of Canada) to exemplify how the approach can be adapted across settings. We conducted think-aloud interviews with members of each group to maximize the clarity and usability of the surveys, elicited opinions about which barriers/drivers were relevant for each patient group, and identified additional barriers/drivers. Interviews proceeded iteratively with changes incorporated into subsequent interviews. Here, we describe our two target patient groups, as well as our process of modifying, adding, and deleting barrier/driver items for each group and across theoretical domains. RESULTS: We interviewed 8 women with a history of breast cancer from the Canadian Breast Cancer Network (48-65 year old) and 11 Huntington Disease community members (9 women) from the Huntington Society of Canada (26-70 year old). After the iterative development interviews, the breast cancer group had identified 38 barriers/drivers thought relevant to their participation in clinical trials across 12 TDF domains. The Huntington group identified 47 items across 13 TDF domains. CONCLUSION: Our patient-focused and theory-guided approach was able to identify a more comprehensive range of barriers to and drivers of trial participation than existing published tools. Our approach is also more broadly adaptable than such tools, in that it uses a theoretical framework and in-depth piloting to generate a set of items tailored to each specific clinical area, rather than a single set of items intended to be applicable to all situations. This theory-guided approach also enables more specific recruitment strategies to be developed once domain-specific barriers are known, potentially optimizing participation for a given trial and helping build a cumulative evidence of barriers/drivers and strategies for addressing them.

Effect of audit and feedback on physicians' intraoperative temperature management and patient outcomes: a three-arm cluster randomized-controlled trial comparing benchmarked and ranked feedback.

PURPOSE: Audit and feedback can improve physicians' practice; however, the most effective type of feedback is unknown. Inadvertent perioperative hypothermia is associated with postoperative complications and remains common despite the use of effective and safe warming devices. This study aimed to measure the impact of targeted audit and feedback on anesthesiologists' intraoperative temperature management and subsequent patient outcomes. METHODS: This study was a three-arm cluster randomized-controlled trial. Anesthesiologists' intraoperative temperature management performance was analyzed in two phases. The first was a baseline phase with audit but no feedback for eight months, followed by an intervention phase over the next seven-month period after participants had received interventions according to their randomized group allocation of no feedback (control), benchmarked feedback, or ranked feedback. Anesthesiologists' percentage of hypothermic patients at the end of surgery (primary endpoint) and use of a warming device were compared among the groups. RESULTS: Forty-five attending anesthesiologists who took care of 7,846 patients over 15 months were included. The odds of hypothermia (temperature < 36°C at the end of surgery) increased significantly from pre- to post-intervention in the control and ranked groups (control odds ratio [OR], 1.27; 95% confidence interval [CI], 1.03 to 1.56; P = 0.02; ranked OR, 1.26; 95% CI, 1.01 to 1.56; P = 0.04) but not in the benchmarked group (OR, 1.05; 95% CI, 0.87 to 1.28; P = 0.58). Between-arm differences in pre- to post-intervention changes were not significant (benchmark vs control OR, 0.83; 95% CI, 0.62 to 1.10; P = 0.19; ranked vs control OR, 0.99; 95% CI, 0.73 to 1.33, P = 0.94). No significant overall effect on intraoperative warmer use change was detected. CONCLUSION: We found no evidence to suggest that audit and feedback, using benchmarked or ranked feedback, is more effective than no feedback at all to change anesthesiologists' intraoperative temperature management performance. Feedback may need to be included in a bundle to produce its effect. TRIALS REGISTRATION: www.clinicaltrials.gov (NCT02414191). Registered 19 March 2015.

Educating children and adolescents about vaccines: a review of current literature.

INTRODUCTION: Until recently, research on vaccine hesitancy has focused primarily on parent populations. Although adolescent knowledge and views are gaining momentum within the literature, particularly with regards to the human papillomavirus and influenza, children remain a virtually unstudied population with regards to vaccine hesitancy. AREAS COVERED: This review focuses on the lack of literature in this area and argues for more vaccine hesitancy research involving child and adolescent populations. It also outlines special issues to consider when framing health promotion messages for children and adolescents. Finally, we explore the use of new and existing technologies as delivery mechanisms for education on vaccines and immunizations in populations of children and adolescents. EXPERT COMMENTARY: Children undergo cognitive development and experiences with vaccines (e.g. pain or education) have the potential to create future attitudes toward vaccines. This can influence future vaccine behaviour, including their participation in decision-making around adolescent vaccines, their decisions to vaccinate themselves when they are adults, and their decisions to vaccinate their own children. Interventions aimed at children, such as education, can create positive attitudes toward vaccines. These can also potentially influence parental attitudes toward vaccines as children convey this knowledge to them. Both of these impacts require further study.

Decision aids for people considering taking part in clinical trials.

BACKGROUND: Several interventions have been developed to promote informed consent for participants in clinical trials. However, many of these interventions focus on the content and structure of information (e.g. enhanced information or changes to the presentation format) rather than the process of decision making. Patient decision aids support a decision making process about medical options. Decision aids support the decision process by providing information about available options and their associated outcomes, alongside information that enables patients to consider what value they place on particular outcomes, and provide structured guidance on steps of decision making. They have been shown to be effective for treatment and screening decisions but evidence on their effectiveness in the context of informed consent for clinical trials has not been synthesised. OBJECTIVES: To assess the effectiveness of decision aids for clinical trial informed consent compared to no intervention, standard information (i.e. usual practice) or an alternative intervention on the decision making process. SEARCH METHODS: We searched the following databases and to March 2015: Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library; MEDLINE (OvidSP) (from 1950); EMBASE (OvidSP) (from 1980); PsycINFO (OvidSP) (from 1806); ASSIA (ProQuest) (from 1987); WHO International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/); ClinicalTrials.gov; ISRCTN Register (http://www.controlled-trials.com/isrctn/). We also searched reference lists of included studies and relevant reviews. We contacted study authors and other experts. There were no language restrictions. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials comparing decision aids in the informed consent process for clinical trials alone, or in conjunction with standard information (such as written or verbal) or alongside alternative interventions (e.g. paper-based versus web-based decision aids). Included trials involved potential trial participants, or their guardians, being asked to consider participating in a real or hypothetical clinical trial. DATA COLLECTION AND ANALYSIS: At least two authors independently assessed studies for inclusion, extracted reported data and assessed risk of bias. Findings were pooled where appropriate. We used GRADE to assess the quality of the evidence for each outcome. MAIN RESULTS: We identified one study (290 randomised participants) that investigated the effectiveness of decision aids compared to standard information in the informed consent process for clinical trials. This study reported two separate decision aid randomised controlled trials (RCTs). The decision aid trials were nested within two different parent trials focusing on breast cancer in postmenopausal women. One trial focused on informed consent for treatment in women who had previously had surgery for ductal carcinoma in situ (DCIS), the other on informed consent for prevention in women at high risk for breast cancer. Two different decision aids were used in these RCTs, and were compared with standard information.The pooled findings highlight the uncertainty surrounding most reported outcomes, including knowledge, decisional conflict, anxiety, trial participation and attrition. There was very low quality evidence that decision aids lower levels of decisional regret to a small degree (MD -5.53, 95% CI -10.29 to -0.76). No data were identified on several prespecified primary outcomes, including accurate risk perception, values-based decision, or whether potential participants recognised that a decision needed to be made, were able to identify features of options that matter most to individuals, or were involved in the decision. AUTHORS' CONCLUSIONS: There was insufficient evidence to determine whether decision aids to support the informed consent process for clinical trials are more effective than standard information. Additional well designed, adequately powered clinical trials in more diverse clinical and social populations are needed to strengthen the results of this review. More generally, future research on which outcomes are most relevant for assessment in this context would be helpful.

Understanding the Canadian adult CT head rule trial: use of the theoretical domains framework for process evaluation.

BACKGROUND: The Canadian CT Head Rule was prospectively derived and validated to assist clinicians with diagnostic decision-making regarding the use of computed tomography (CT) in adult patients with minor head injury. A recent intervention trial failed to demonstrate a decrease in the rate of head CTs following implementation of the rule in Canadian emergency departments. Yet, the same intervention, which included a one-hour educational session and reminders at the point of requisition, was successful in reducing cervical spine imaging rates in the same emergency departments. The reason for the varied effect of the intervention across these two behaviours is unclear. There is an increasing appreciation for the use of theory to conduct process evaluations to better understand how strategies are linked with outcomes in implementation trials. The Theoretical Domains Framework (TDF) has been used to explore health professional behaviour and to design behaviour change interventions but, to date, has not been used to guide a theory-based process evaluation. In this proof of concept study, we explored whether the TDF could be used to guide a retrospective process evaluation to better understand emergency physicians' responses to the interventions employed in the Canadian CT Head Rule trial. METHODS: A semi-structured interview guide, based on the 12 domains from the TDF, was used to conduct telephone interviews with project leads and physician participants from the intervention sites in the Canadian CT Head Rule trial. Two reviewers independently coded the anonymised interview transcripts using the TDF as a coding framework. Relevant domains were identified by: the presence of conflicting beliefs within a domain; the frequency of beliefs; and the likely strength of the impact of a belief on the behaviour. RESULTS: Eight physicians from four of the intervention sites in the Canadian CT Head Rule trial participated in the interviews. Barriers likely to assist with understanding physicians' responses to the intervention in the trial were identified in six of the theoretical domains: beliefs about consequences; beliefs about capabilities; behavioural regulation; memory, attention and decision processes; environmental context and resources; and social influences. Despite knowledge that the Canadian CT Head Rule was highly sensitive and reliable for identifying clinically important brain injuries and strong beliefs about the benefits for using the rule, a number of barriers were identified that may have prevented physicians from consistently applying the rule. CONCLUSION: This proof of concept study demonstrates the use of the TDF as a guiding framework to design a retrospective theory-based process evaluation. There is a need for further development and testing of methods for using the TDF to guide theory-based process evaluations running alongside behaviour change intervention trials.

Health among caregivers of children with health problems: findings from a Canadian population-based study.

OBJECTIVES: We used population-based data to evaluate whether caring for a child with health problems had implications for caregiver health after we controlled for relevant covariates. METHODS: We used data on 9401 children and their caregivers from a population-based Canadian study. We performed analyses to compare 3633 healthy children with 2485 children with health problems. Caregiver health outcomes included chronic conditions, activity limitations, self-reported general health, depressive symptoms, social support, family functioning, and marital satisfaction. Covariates included family (single-parent status, number of children, income adequacy), caregiver (gender, age, education, smoking status, biological relationship to child), and child (age, gender) characteristics. RESULTS: Logistic regression showed that caregivers of children with health problems had more than twice the odds of reporting chronic conditions, activity limitations, and elevated depressive symptoms, and had greater odds of reporting poorer general health than did caregivers of healthy children. CONCLUSIONS: Caregivers of children with health problems had substantially greater odds of health problems than did caregivers of healthy children. The findings are consistent with the movement toward family-centered services recognizing the link between caregivers' health and health of the children for whom they care.