One size doesn't fit all: methodological reflections in conducting community-based behavioural science research to tailor COVID-19 vaccination initiatives for public health priority populations.

BACKGROUND: Promoting the uptake of vaccination for infectious diseases such as COVID-19 remains a global challenge, necessitating collaborative efforts between public health units (PHUs) and communities. Applied behavioural science can play a crucial role in supporting PHUs' response by providing insights into human behaviour and informing tailored strategies to enhance vaccination uptake. Community engagement can help broaden the reach of behavioural science research by involving a more diverse range of populations and ensuring that strategies better represent the needs of specific communities. We developed and applied an approach to conducting community-based behavioural science research with ethnically and socioeconomically diverse populations to guide PHUs in tailoring their strategies to promote COVID-19 vaccination. This paper presents the community engagement methodology and the lessons learned in applying the methodology. METHODS: The community engagement methodology was developed based on integrated knowledge translation (iKT) and community-based participatory research (CBPR) principles. The study involved collaboration with PHUs and local communities in Ontario, Canada to identify priority groups for COVID-19 vaccination, understand factors influencing vaccine uptake and co-design strategies tailored to each community to promote vaccination. Community engagement was conducted across three large urban regions with individuals from Eastern European communities, African, Black, and Caribbean communities and low socioeconomic neighbourhoods. RESULTS: We developed and applied a seven-step methodology for conducting community-based behavioural science research: (1) aligning goals with system-level partners; (2) engaging with PHUs to understand priorities; (3) understanding community strengths and dynamics; (4) building relationships with each community; (5) establishing partnerships (community advisory groups); (6) involving community members in the research process; and (7) feeding back and interpreting research findings. Research partnerships were successfully established with members of prioritized communities, enabling recruitment of participants for theory-informed behavioural science interviews, interpretation of findings, and co-design of targeted recommendations for each PHU to improve COVID-19 vaccination uptake. Lessons learned include the importance of cultural sensitivity and awareness of sociopolitical context in tailoring community engagement, being agile to address the diverse and evolving priorities of PHUs, and building trust to achieve effective community engagement. CONCLUSION: Effective community engagement in behavioural science research can lead to more inclusive and representative research. The community engagement approach developed and applied in this study acknowledges the diversity of communities, recognizes the central role of PHUs, and can help in addressing complex public health challenges.

Choosing which in-hospital laboratory tests to target for intervention: a scoping review.

INTRODUCTION: Some laboratory testing practices may be of low value, leading to wasted resources and potential patient harm. Our scoping review investigated factors and processes that developers report using to inform decisions about what tests to target for practice improvement. METHODS: We searched Medline on May 30th, 2019 and June 28th, 2021 and included guidelines, recommendation statements, or empirical studies related to test ordering practices. Studies were included if they were conducted in a tertiary care setting, reported making a choice about a specific test requiring intervention, and reported at least one factor informing that choice. We extracted descriptive details, tests chosen, processes used to make the choice, and factors guiding test choice. RESULTS: From 114 eligible studies, we identified 30 factors related to test choice including clinical value, cost, prevalence of test, quality of test, and actionability of test results. We identified nine different processes used to inform decisions regarding where to spend intervention resources. CONCLUSIONS: Intervention developers face difficult choices when deciding where to put scarce resources intended to improve test utilization. Factors and processes identified here can be used to inform a framework to help intervention developers make choices relevant to improving testing practices.

AGREE-S: AGREE II extension for surgical interventions: appraisal instrument.

BACKGROUND: The Appraisal of Guidelines Research and Evaluation (AGREE) II instrument was developed to evaluate the quality of clinical practice guidelines. Evidence suggests that development, reporting, and appraisal of guidelines on surgical interventions may be better informed by modification of the instrument. OBJECTIVE: We aimed to develop an AGREE II extension specifically designed for appraisal of guidelines of surgical interventions. METHODS: In a three-part project funded by the United European Gastroenterology and the European Association for Endoscopic Surgery, (i) we identified factors that were associated with higher quality of surgical guidelines, (ii) we statistically calibrated the AGREE II instrument in the context of surgical guidelines using correlation, reliability, and factor analysis, and (iii) we undertook a Delphi consensus process of stakeholders to inform the development of an AGREE II extension instrument for surgical interventions. RESULTS: Several features were prioritized by stakeholders as of particular importance for guidelines of surgical interventions, including development of a guideline protocol, consideration of practice variability and surgical expertise in different settings, and specification of infrastructures required to implement the recommendations. The AGREE-S-AGREE II extension instrument for surgical interventions has 25 items, compared to the 23 items of the original AGREE II instrument, organized into the following 6 domains: Scope and purpose, Stakeholders, Evidence synthesis, Development of recommendations, Editorial independence, and Implementation and update. As the original instrument, it concludes with an overall appraisal of the quality of the guideline and a judgement on whether the guideline is recommended for use. Several items were amended and rearranged among domains, and an item was deleted. The Rigor of Development domain of the original AGREE II was divided into Evidence Synthesis and Development of Recommendations. Items of the AGREE II domain Clarity of Presentation were incorporated in the new domain Development of Recommendations. Three new items were introduced, addressing the development of a guideline protocol, support by a guideline methodologist, and consideration of surgical experience/expertise. CONCLUSION: The AGREE-S appraisal instrument has been developed to be used for assessment of the methodological and reporting quality of guidelines on surgical interventions.

Mixed-Methods Evaluation of a Patient Behaviour Risk Screening, Communication and Care Planning Intervention for Hospital Settings.

Workplace violence is a common safety concern for hospital staff. The Behaviour Safety Risk Communication and Care Planning program identifies, manages and cares for patients at risk of exhibiting unsafe behaviours. This paper reports on a mixed-methods evaluation consisting of staff surveys, focus groups and open forums, screening audits, patient interviews and assessment of effectiveness measures at five hospital sites. Staff perceptions about safety risk imposed by a patient's behaviour significantly improved after this program was implemented. Opportunities exist to improve staff adherence to screening processes and communication with patients. This study provides insight for teams implementing similar interventions.

Guideline Assessment Project II: statistical calibration informed the development of an AGREE II extension for surgical guidelines.

OBJECTIVE: To inform the development of an AGREE II extension specifically tailored for surgical guidelines. AGREE II was designed to inform the development, reporting, and appraisal of clinical practice guidelines. Previous research has suggested substantial room for improvement of the quality of surgical guidelines. METHODS: A previously published search in MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017, resulted in a total of 67 guidelines. The quality of these guidelines was assessed using AGREE II. We performed a series of statistical analyses (reliability, correlation and Factor Analysis, Item Response Theory) with the objective to calibrate AGREE II for use specifically in surgical guidelines. RESULTS: Reliability/correlation/factor analysis and Item Response Theory produced similar results and suggested that a structure of 5 domains, instead of 6 domains of the original instrument, might be more appropriate. Furthermore, exclusion and re-arrangement of items to other domains was found to increase the reliability of AGREE II when applied in surgical guidelines. CONCLUSIONS: The findings of this study suggest that statistical calibration of AGREE II might improve the development, reporting, and appraisal of surgical guidelines.

Development and validation of a prediction model of poor performance status and severe symptoms over time in cancer patients (PROVIEW+).

BACKGROUND: Predictive cancer tools focus on survival; none predict severe symptoms. AIM: To develop and validate a model that predicts the risk for having low performance status and severe symptoms in cancer patients. DESIGN: Retrospective, population-based, predictive study. SETTING/PARTICIPANTS: We linked administrative data from cancer patients from 2008 to 2015 in Ontario, Canada. Patients were randomly selected for model derivation (60%) and validation (40%). Using the derivation cohort, we developed a multivariable logistic regression model to predict the risk of an outcome at 6 months following diagnosis and recalculated after each of four annual survivor marks. Model performance was assessed using discrimination and calibration plots. Outcomes included low performance status (i.e. 10-30 on Palliative Performance Scale), severe pain, dyspnea, well-being, and depression (i.e. 7-10 on Edmonton Symptom Assessment System). RESULTS: We identified 255,494 cancer patients (57% female; median age of 64; common cancers were breast (24%); and lung (13%)). At diagnosis, the predicted risk of having low performance status, severe pain, well-being, dyspnea, and depression in 6-months is 1%, 3%, 6%, 13%, and 4%, respectively for the reference case (i.e. male, lung cancer, stage I, no symptoms); the corresponding discrimination for each outcome model had high AUCs of 0.807, 0.713, 0.709, 0.790, and 0.723, respectively. Generally these covariates increased the outcome risk by >10% across all models: lung disease, dementia, diabetes; radiation treatment; hospital admission; pain; depression; transitional performance status; issues with appetite; or homecare. CONCLUSIONS: The model accurately predicted changing cancer risk for low performance status and severe symptoms over time.

Physical distancing messages targeting youth on the social media accounts of Canadian public health entities and the use of behavioral change techniques.

INTRODUCTION: Physical distancing (PD) is an important public health strategy to reduce the transmission of COVID-19 and has been promoted by public health authorities through social media. Although youth have a tendency to engage in high-risk behaviors that could facilitate COVID-19 transmission, there is limited research on the characteristics of PD messaging targeting this population on social media platforms with which youth frequently engage. This study examined social media posts created by Canadian public health entities (PHEs) with PD messaging aimed at youth and young adults aged 16-29 years and reported behavioral change techniques (BCTs) used in these posts. METHODS: A content analysis of all social media posts of Canadian PHEs from Facebook, Twitter, Instagram and YouTube were conducted from April 1st to May 31st, 2020. Posts were classified as either implicitly or explicitly targeting youth and young adults. BCTs in social media posts were identified and classified based on Behavior Change Technique Taxonomy version 1 (BCTTv1). Frequency counts and proportions were used to describe the data. RESULTS: In total, 319 youth-targeted PD posts were identified. Over 43% of the posts originated from Ontario Regional public health units, and 36.4 and 32.6% of them were extracted from Twitter and Facebook, respectively. Only 5.3% of the total posts explicitly targeted youth. Explicit posts were most frequent from federal PHEs and posted on YouTube. Implicit posts elicited more interactions than explicit posts regardless of jurisdiction level or social media format. Three-quarters of the posts contained at least one BCT, with a greater portion of BCTs found within implicit posts (75%) than explicit posts (52.9%). The most common BCTs from explicit posts were instructions on how to perform a behavior (25.0%) and restructuring the social environment (18.8%). CONCLUSIONS: There is a need for more PD messaging that explicitly targets youth. BCTs should be used when designing posts to deliver public health messages and social media platforms should be selected depending on the target population.

Developing and Implementing a Patient Behaviour Risk Screening, Communication and Care Planning Intervention for Hospital Settings.

Workplace violence prevention of patient behaviours is a primary safety focus in hospital settings. In response to provincial mandates, a multi-site tertiary care hospital system developed the Behaviour Safety Risk Communication and Care Planning Program. Components include patient risk screening, communication tools and care plans that outline mitigation strategies. The program has been implemented at six sites using the following strategies: educational and planning meetings, formation of steering committees, identification of champions, educational materials/training, facilitation and consultation, and audit and feedback. Our paper can guide program development and implementation in similar contexts.

Research Collaboration in Pediatric Critical Care Randomized Controlled Trials: A Social Network Analysis of Coauthorship.

OBJECTIVES: Clinical research is a collaborative enterprise; researchers benefit from the expertise, experience, and resources of their collaborators. We sought to describe the extent and patterns of collaboration among pediatric critical care trialists, and to identify the most influential individuals, centers, and countries. DESIGN: Social network analysis of coauthorship. DATA SOURCES: Publications of pediatric critical care randomized controlled trials (1986-2018). DATA EXTRACTION: We manually extracted the names of all authors and their affiliations. We used productivity (number of randomized controlled trials), influence (number of citations), and four measures of prominence in the social network (degree, betweenness, closeness, and eigenvector centrality) to identify the most influential individuals. MEASUREMENTS AND MAIN RESULTS: From 415 randomized controlled trials in pediatric critical care, we identified 2,176 trialists from 377 centers in 43 countries. The coauthorship network is highly disconnected and dominated by a single large cluster of trialists publishing 142 (34%) of the randomized controlled trials. However, 119 (29%) of the randomized controlled trials were published by 28 smaller clusters-a median (interquartile range) of 3 (2-4) randomized controlled trials each. The remaining 154 (37%) randomized controlled trials were coauthored by researchers publishing a single randomized controlled trial each. This overall structure has remained constant with the publication of new randomized controlled trials over 33 years. The most influential trialists and centers varied according to the metric we used; only one trialist and three centers ranked in the top 10 for all measures of influence. Thirty-five of the 40 trialists (88%) ranking in the top 10 of any of the measures were from the United States, the United Kingdom, and Canada. CONCLUSIONS: Pediatric critical care has made considerable progress in the number of trialists and randomized controlled trials, but the research enterprise remains highly clustered and fragmented, particularly geographically. Efforts to further increase the quantity and quality of research in the field should include steps to increase the level and range of collaboration.

A method to audit and score implementation of knowledge translation (KT) interventions in large health regions - an observational pilot study using rectal cancer surgery in Ontario.

BACKGROUND: Across Ontario, since the year 2006 various knowledge translation (KT) interventions designed to improve the quality of rectal cancer surgery have been implemented by the provincial cancer agency or by individual researchers. Ontario is divided administratively into 14 health regions. We piloted a method to audit and score for each region of the province the KT interventions implemented to improve the quality of rectal cancer surgery. METHODS: We interviewed stakeholders to audit KT interventions used in respective regions over years 2006 to 2014. Results were summarized into narrative and visual forms. Using a modified Delphi approach, KT experts reviewed these data and then, for each region, scored implementation of KT interventions using a 20-item KT Signature Assessment Tool. Scores could range from 20 to 100 with higher scores commensurate with greater KT intervention implementation. RESULTS: There were thirty interviews. KT experts produced scores for each region that were bimodally distributed, with an average score for 2 regions of 78 (range 73-83) and for 12 regions of 30.5 (range 22-38). CONCLUSION: Our methods efficiently identified two groups with similar KT Signature scores. Two regions had relatively high scores reflecting numerous KT interventions and the use of sustained iterative approaches in addition to those encouraged by the provincial cancer agency, while 12 regions had relatively low scores reflecting minimal activities outside of those encouraged by the provincial cancer agency. These groupings will be used for future comparative quantitative analyses to help determine if higher KT signature scores correlate with improved measures for quality of rectal cancer surgery.

Guideline Assessment Project: Filling the GAP in Surgical Guidelines: Quality Improvement Initiative by an International Working Group.

OBJECTIVE: The aim of the study was to identify clinical practice guidelines published by surgical scientific organizations, assess their quality, and investigate the association between defined factors and quality. The ultimate objective was to develop a framework to improve the quality of surgical guidelines. SUMMARY BACKGROUND DATA: Evidence on the quality of surgical guidelines is lacking. METHODS: We searched MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017. We investigated the association between the following factors and guideline quality, as assessed using the AGREE II instrument: number of guidelines published within the study period by a scientific organization, the presence of a guidelines committee, applying the GRADE methodology, consensus project design, and the presence of intersociety collaboration. RESULTS: Ten surgical scientific organizations developed 67 guidelines over the study period. The median overall score using AGREE II tool was 4 out of a maximum of 7, whereas 27 (40%) guidelines were not considered suitable for use. Guidelines produced by a scientific organization with an output of ≥9 guidelines over the study period [odds ratio (OR) 3.79, 95% confidence interval (CI), 1.01-12.66, P = 0.048], the presence of a guidelines committee (OR 4.15, 95% CI, 1.47-11.77, P = 0.007), and applying the GRADE methodology (OR 8.17, 95% CI, 2.54-26.29, P < 0.0001) were associated with higher odds of being recommended for use. CONCLUSIONS: Development by a guidelines committee, routine guideline output, and adhering to the GRADE methodology were found to be associated with higher guideline quality in the field of surgery.

Developing evidence briefs for policy: a qualitative case study comparing the process of using a guidance-contextualization workbook in Peru and Uganda.

BACKGROUND: Translating research evidence from global guidance into policy can help strengthen health systems. A workbook was developed to support the contextualization of the WHO's 'Optimizing health worker roles to improve maternal and newborn health' (OptimizeMNH) guidance. This study evaluated the use of the workbook for the development of evidence briefs in two countries - Peru and Uganda. Findings surrounding contextual factors, steps in the process and evaluation of the workbook are presented. METHODS: A qualitative embedded case study was used. The case was the process of using the workbook to support the contextualization of global health systems guidance, with local evidence, to develop evidence briefs. Criterion sampling was used to select the countries, participants for interviews and documents included in the study. A template-organizing style and constant comparison were used for data analysis. RESULTS: A total of 19 participant-observation sessions and 8 interviews were conducted, and 50 documents were reviewed. Contextual factors, including the cadres, or groups, of health workers available in each country, the way the problem and its causes were framed, potential policy options to address the problem, and implementation considerations for these policy options, varied substantially between Peru and Uganda. However, many similarities were found in the process of using the workbook. Overall, the workbook was viewed positively and participants in both countries would use it again for other topics. CONCLUSIONS: Organizations that produce global guidance, such as WHO, need to consider institutionalizing the application of the workbook into their guidance development processes to help users at the national/subnational level create actionable and context-relevant policies. Feedback mechanisms also need to be established so that the evidence briefs and health policies arising from global guidance are tracked and the findings coming out of such guideline contextualization processes can be taken into consideration during future guidance development and research priority-setting.

Uncertain times: A survey of Canadian women's perspectives toward mammography screening.

Evolving scientific evidence about mammography has raised new questions about the net benefits of organized screening, yet gaps remain about women's current screening practices, knowledge, attitudes and values toward screening to support informed decision making in this area. We addressed this gap through an online survey of 2000 screen-eligible women from Ontario, Canada in January 2016. Likert-scaled and categorical questions were used to collect information about screening practices, knowledge of benefits and risks of screening and underlying attitudes and values toward screening. Results for all responses were summarized using descriptive statistics. Comparison of results between ever screened versus never screened respondents was performed using chi-squared tests. Most women felt informed about screening yet had doubts about how informed their decisions were. They were more confident in their knowledge of the benefits than the risks which aligned with the emphasis given to benefits in discussions with health care providers. The benefits of screening were linked with lowered anxiety about breast cancer. The never screened were less likely to overstate the benefits of screening, more likely to give weight to the risks, and less likely to report anxiety or worry about breast cancer. Findings highlight the need for improved communication strategies and decision supports that emphasize the provision of current, balanced information about the benefits and risks of screening, both at the population-level (through mass media) and within patient-provider interactions. Sensitivity to the psychosocial factors that shape women's attitudes toward mammography screening should be central to any strategy.

Variable participation of knowledge users in cancer health services research: results of a multiple case study.

BACKGROUND: Integrated knowledge translation (IKT) is a research approach in which knowledge users (KUs) co-produce research. The rationale for IKT is that it leads to research that is more relevant and useful to KUs, thereby accelerating uptake of findings. The aim of the current study was to evaluate IKT activities within a cancer health services research network in Ontario, Canada. METHODS: An embedded multiple case study design was used. The cases were 5 individual studies within an overarching cancer health services research network. These studies focused on one of the following topics: case costing of cancer treatment, lung cancer surgery policy analysis, patient and provider-reported outcomes, colorectal cancer screening, and a team approach to women's survivorship. We conducted document reviews and held semi-structured interviews with researchers, KUs, and other stakeholders within a cancer system organization. The analysis examined patterns across and within cases. RESULTS: Researchers and their respective knowledge users from 4 of the 5 cases agreed to participate. Eighteen individuals from 4 cases were interviewed. In 3 of 4 cases, there were mismatched expectations between researchers and KUs regarding KU role; participants recommended that expectations be made explicit from the beginning of the collaboration. KUs perceived that frequent KU turnover may have affected both KU engagement and the uptake of study results within the organization. Researchers and KUs found that sharing research results was challenging because the organization lacked a framework for knowledge translation. Uptake of research findings appeared to be related to the researcher having an embedded role in the cancer system organization and/or close alignment of the study with organizational priorities. Document reviews found evidence of planned IKT strategies in 3 of 4 cases; however, actual KU role/engagement on research teams was variable. CONCLUSIONS: Barriers to KU co-production of cancer health services research include mismatched expectations of KU role and frequent KU turnover. When a research study directly aligns with organizational priorities, it appears more likely that results will be considered in programming. Research teams that take an IKT approach should consider specific strategies to address barriers to KU engagement.

Advancing Randomized Controlled Trials in Pediatric Critical Care: The Perspectives of Trialists.

OBJECTIVES: Clinical research is a complex scientific and social enterprise. Our objective was to identify strategies that pediatric critical care trialists consider acceptable, feasible, and effective to improve the design and conduct randomized controlled trials in pediatric critical care. DESIGN: Qualitative descriptive study using semistructured individual interviews. SUBJECTS: We interviewed 26 pediatric critical care researchers from seven countries who have published a randomized controlled trial (2005-2015). We used purposive sampling to achieve diversity regarding researcher characteristics and randomized controlled trial characteristics. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Most participants (24 [92%]) were from high-income countries, eight (31%) had published more than one randomized controlled trial, 17 (65%) had published a multicenter randomized controlled trial, and eight (31%) had published a multinational randomized controlled trial. An important theme was "building communities"-groups of individuals with similar interests, shared experiences, and common values, bound by professional and personal relationships. Participants described a sense of community as a source of motivation and encouragement and as a means to larger, more rigorous trials, increasing researcher and clinician engagement and maintaining enthusiasm. Strategies to build communities stressed in-person interactions (both professional and social), capable leadership, and trust. Another important theme was "getting started." Participants highlighted the importance of formal research training and high-quality experiential learning through collaboration on other's projects, guided by effective mentorship. Also important was "working within the system"-ensuring academic credit for a range of contributions, not only for the principal investigator role. The longitudinal notion of "building on success" was also underscored as a cross-cutting theme. CONCLUSIONS: Coordinated, deliberate actions to build community and ensure key training and practical experiences for new investigators may strengthen the research enterprise in pediatric critical care. These strategies, potentially in combination with other novel approaches, may vitalize clinical research in this field.

Developing a workbook to support the contextualisation of global health systems guidance: a case study identifying steps and critical factors for success in this process at WHO.

BACKGROUND: Global guidance can help countries strengthen their health systems to deliver effective interventions to their populations. However, to have an impact, guidance needs to be contextualised or adapted to local settings; this process includes consideration of health system arrangements and political system factors. To date, methods to support contextualisation do not exist. In response, a workbook was designed to provide specific methods and strategies to enable the contextualisation of WHO's 'Optimizing health worker roles to improve maternal and newborn health' (OptimizeMNH) guidance at the national or subnational level. The objective of this study was to describe the process of developing the workbook and identify key steps of the development process, barriers that arose and facilitators that helped overcome some of these barriers. METHODS: A qualitative single case study design was carried out. Interviews, documents and a reflexive journal were used. Constant comparison and an edit-style of organisation were used during data analysis to develop concepts, themes, subthemes and relationships among them. RESULTS: Thirteen interviews were conducted and 52 documents were reviewed. Three main steps were identified in the process of developing the workbook for health systems guidance contextualisation, namely (1) determining the need for and gaining approval to develop the workbook, (2) developing the workbook (taking on the task, creating the structure of the workbook, operationalising its components, undergoing approval processes and editing it), and (3) implementing the workbook both at the WHO level and at the national/subnational level. Five barriers and/or facilitators emerged relevant to each step, namely (1) having well-placed and credible champions, (2) creating and capitalising on opportunities, (3) finding the right language to engage various actors and obtain buy-in, (4) obtaining and maintaining meaningful buy-in, and (5) ensuring access to resources. CONCLUSIONS: Understanding the key steps and the critical factors involved in the process of developing the workbook could help in the planning of similar and other tools aimed to support the implementation of WHO guidance. A plan for dissemination and implementation needs to be addressed during the preparation of these tools.

Validity and usability testing of a health systems guidance appraisal tool, the AGREE-HS.

BACKGROUND: Health systems guidance (HSG) provides recommendations to address health systems challenges. No tools exist to inform HSG developers and users about the components of high quality HSG and to differentiate between HSG of varying quality. In response, we developed a tool to assist with the development, reporting and appraisal of HSG - the Appraisal of Guidelines for Research and Evaluation-Health Systems (AGREE-HS). This paper reports on the validity, usability and initial measurement properties of the AGREE-HS. METHODS: To establish face validity (Study 1), stakeholders completed a survey about the AGREE-HS and provided feedback on its content and structure. Revisions to the tool were made in response. To establish usability (Study 2), the revised tool was applied to 85 HSG documents and the appraisers provided feedback about their experiences via an online survey. An initial test of the revised tool's measurement properties, including internal consistency, inter-rater reliability and criterion validity, was conducted. Additional revisions to the tool were made in response. RESULTS: In Study 1, the AGREE-HS Overview, User Manual, quality item content and structure, and overall assessment questions were rated favourably. Participants indicated that the AGREE-HS would be useful, feasible to use, and that they would apply it in their context. In Study 2, participants indicated that the quality items were easy to understand and apply, and the User Manual, usefulness and usability of the tool were rated favourably. Study 2 participants also indicated intentions to use the AGREE-HS. CONCLUSIONS: The AGREE-HS comprises a User Manual, five quality items and two overall assessment questions. It is available at agreetrust.org.

"There is always a better way": Managing uncertainty in decision making about new cancer drugs in Canada.

Policy decisions about the approval and funding of new cancer drugs must often be made in an environment of complex uncertainty about clinical and cost-effectiveness data. The focus of this article is on the results from qualitative interviews with senior officials (n = 16) who make decisions about or influence cancer drug policy in various organizations in the Canadian cancer control system. Most participants identified the use of a limited number of informal approaches to address uncertainty, such as grounding decisions in evidence and advice from expert groups. People tended to focus on evidence informed decisions including price negotiations, the ability to implement policy changes, and stakeholder values. Lessons from the Canadian context related to continuing efforts to build a public culture of understanding into how policy decisions like cancer drug funding are made may result in greater acceptance and increased confidence in health policy decision-making processes across multiple sectors internationally.

Reporting Items for Updated Clinical Guidelines: Checklist for the Reporting of Updated Guidelines (CheckUp).

BACKGROUND: Scientific knowledge is in constant development. Consequently, regular review to assure the trustworthiness of clinical guidelines is required. However, there is still a lack of preferred reporting items of the updating process in updated clinical guidelines. The present article describes the development process of the Checklist for the Reporting of Updated Guidelines (CheckUp). METHODS AND FINDINGS: We developed an initial list of items based on an overview of research evidence on clinical guideline updating, the Appraisal of Guidelines for Research and Evaluation (AGREE) II Instrument, and the advice of the CheckUp panel (n = 33 professionals). A multistep process was used to refine this list, including an assessment of ten existing updated clinical guidelines, interviews with key informants (response rate: 54.2%; 13/24), a three-round Delphi consensus survey with the CheckUp panel (33 participants), and an external review with clinical guideline methodologists (response rate: 90%; 53/59) and users (response rate: 55.6%; 10/18). CheckUp includes 16 items that address (1) the presentation of an updated guideline, (2) editorial independence, and (3) the methodology of the updating process. In this article, we present the methodology to develop CheckUp and include as a supplementary file an explanation and elaboration document. CONCLUSIONS: CheckUp can be used to evaluate the completeness of reporting in updated guidelines and as a tool to inform guideline developers about reporting requirements. Editors may request its completion from guideline authors when submitting updated guidelines for publication. Adherence to CheckUp will likely enhance the comprehensiveness and transparency of clinical guideline updating for the benefit of patients and the public, health care professionals, and other relevant stakeholders.