Assessment of complementary health approaches use in pediatric oncology: Modification and preliminary validation of the "Which Health Approaches and Treatments Are You Using?" (WHAT) questionnaires.

OBJECTIVE: Complementary Health Approaches (CHA) are commonly used by children with cancer; however, a few health care providers (HCPs) inquire about the use of CHA. A standardized questionnaire could facilitate such clinical discussions. We aimed to adapt and determine the face and content validity of the "Which Health Approaches and Treatments are you using?" (WHAT) child and parent-report questionnaires in pediatric oncology. METHODS: An electronic Delphi survey that included children with cancer (8-18 years), parents, and HCPs and CHA researchers was conducted to reach consensus on the content of the WHAT questionnaires in pediatric oncology. Children and parents from the Hospital for Sick Children (SickKids), and HCPs and researchers from the International Society of Pediatric Oncology and Pediatric Complementary and Alternative Medicine Research and Education Network completed the survey. To determine the face and content validity of the questionnaires, two iterative cycles of individual interviews were conducted with purposive samples of children (8-18 years), parents, and HCPs from SickKids. RESULTS: Consensus was reached on all domains and items of the original WHAT questionnaires after one Delphi cycle (n = 61). For face and content validity testing, the first cycle of interviews (n = 19) revealed that the questionnaires were mostly comprehensive and relevant. However, the paper-based format of the original WHAT was not user-friendly, and generic items were vague and not aimed at facilitating clinical dialogues about CHA use. The WHAT questionnaires were then modified into electronic cancer-specific self- and proxy-report questionnaires including 13 and 15 items, respectively. The second cycle (n = 21) showed no need for further changes. CONCLUSIONS: The modified electronic cancer-specific WHAT questionnaires showed adequate face and content validity. The next step is to determine inter-rater reliability, construct validity, and feasibility of administration of the modified WHAT questionnaires in pediatric oncology.

Protocol for the development of guidance for collaborator and partner engagement in health care evidence syntheses.

BACKGROUND: Involving collaborators and partners in research may increase relevance and uptake, while reducing health and social inequities. Collaborators and partners include people and groups interested in health research: health care providers, patients and caregivers, payers of health research, payers of health services, publishers, policymakers, researchers, product makers, program managers, and the public. Evidence syntheses inform decisions about health care services, treatments, and practice, which ultimately affect health outcomes. Our objectives are to: A. Identify, map, and synthesize qualitative and quantitative findings related to engagement in evidence syntheses B. Explore how engagement in evidence synthesis promotes health equity C. Develop equity-oriented guidance on methods for conducting, evaluating, and reporting engagement in evidence syntheses METHODS: Our diverse, international team will develop guidance for engagement with collaborators and partners throughout multiple sequential steps using an integrated knowledge translation approach: 1. Reviews. We will co-produce 1 scoping review, 3 systematic reviews and 1 evidence map focusing on (a) methods, (b) barriers and facilitators, (c) conflict of interest considerations, (d) impacts, and (e) equity considerations of engagement in evidence synthesis. 2. Methods study, interviews, and survey. We will contextualise the findings of step 1 by assessing a sample of evidence syntheses reporting on engagement with collaborators and partners and through conducting interviews with collaborators and partners who have been involved in producing evidence syntheses. We will use these findings to develop draft guidance checklists and will assess agreement with each item through an international survey. 3. CONSENSUS: The guidance checklists will be co-produced and finalised at a consensus meeting with collaborators and partners. 4. DISSEMINATION: We will develop a dissemination plan with our collaborators and partners and work collaboratively to improve adoption of our guidance by key organizations. CONCLUSION: Our international team will develop guidance for collaborator and partner engagement in health care evidence syntheses. Incorporating partnership values and expectations may result in better uptake, potentially reducing health inequities.

Decisional needs assessment for patient-centred pain care in Canada: the DECIDE-PAIN study protocol.

INTRODUCTION: The 2021 Action Plan for Pain from the Canadian Pain Task Force advocates for patient-centred pain care at all levels of healthcare across provinces. Shared decision-making is the crux of patient-centred care. Implementing the action plan will require innovative shared decision-making interventions, specifically following the disruption of chronic pain care during the COVID-19 pandemic. The first step in this endeavour is to assess current decisional needs (ie, decisions most important to them) of Canadians with chronic pain across their care pathways. METHODS AND ANALYSIS: DesignGrounded in patient-oriented research approaches, we will perform an online population-based survey across the ten Canadian provinces. We will report methods and data following the CROSS reporting guidelines.SamplingThe Léger Marketing company will administer the online population-based survey to its representative panel of 500 000 Canadians to recruit 1646 adults (age ≥18 years old) with chronic pain according to the definition by the International Association for the Study of Pain (eg, pain ≥12 weeks). ContentBased on the Ottawa Decision Support Framework, the self-administered survey has been codesigned with patients and contain six core domains: (1) healthcare services, consultation and postpandemic needs, (2) difficult decisions experienced, (3) decisional conflict, (4) decisional regret, (5) decisional needs and (6) sociodemographic characteristics. We will use several strategies such as random sampling to improve survey quality. AnalysisWe will perform descriptive statistical analysis. We will identify factors associated with clinically significant decisional conflict and decision regret using multivariate analyses. ETHICS AND DISSEMINATION: Ethics was approved by the Research Ethics Board at the Research Centre of the Centre Hospitalier Universitaire de Sherbrooke (project #2022-4645). We will codesign knowledge mobilisation products with research patient partners (eg, graphical summaries and videos). Results will be disseminated via peer-reviewed journals and national and international conferences to inform the development of innovative shared decision-making interventions for Canadians with chronic pain.

Validation of the parent global assessment as a health-related quality of life measure in juvenile idiopathic arthritis: results from ReACCh-Out.

OBJECTIVES: To (i) validate the JIA parent global assessment (parent global) as a health-related quality of life (HRQoL) instrument; (ii) evaluate measurement properties of accepted HRQoL measures relative to those of the parent global; and (iii) assess causal pathways determining parent global scores. METHODS: Data from the Research in Arthritis in Canadian Children emphasizing outcomes (ReACCh-Out) cohort were used. Measurement properties were assessed in 344 patients at enrolment and 6 months later. Causal pathways were tested by structural equation modelling to understand root causes and mediators leading to parent global scores. RESULTS: Construct validity was supported by Spearman correlations of 0.53-0.70 for the parent global with the Juvenile Arthritis Quality of Life Questionnaire, Quality of My Life health scale (HRQoML), Pediatric Quality of Life Inventory (PedsQL)-Parent, and Child Health Questionnaire (CHQ)-Physical. Exceptions were PedsQL-Child (0.44) and CHQ-Psychosocial (0.31). Correlations were lower (0.14-0.49) with disease activity measures (physician global assessment of disease activity, active joint count, ESR). Responsiveness of the parent global to improvement according to parent ratings (0.51) was acceptable and within the range (0.32-0.71) of that of other measures. Reliability estimates and measurement errors for all measures were unsatisfactory, likely due to the prolonged time between assessments. Causal pathways for the parent global matched those previously reported for HRQoML. CONCLUSIONS: Our results offer support for the parent global as a valid measure of HRQoL for JIA. If confirmed, existing studies using the parent global may be re-interpreted, enhancing our knowledge of HRQoL in children with JIA.

Needs assessment of parents for a patient decision aid in pediatric interval appendectomy via the qualitative interview method.

Objectives: Appendicitis is one of the most commonly encountered pediatric surgical diagnoses, with non-operative management of perforated appendicitis leading to two treatment options: an interval appendectomy (IA) or expectant management. The primary objective of this study was to assess parents' need for a patient decision aid (PDA) among parents considering IA or expectant management. A secondary objective was to determine parent preferences for the format and distribution plan of a drafted patient decision aid. Methods: Coulter's systematic development process for PDA was used to guide the assessment interviews for parents. Participants included caregivers of a patient who experienced perforated appendicitis, and admission between 2019 and 2020. Semi-structured individual interviews were conducted to collect information about decision-making needs of parents of children who experienced perforated appendicitis. Results: A total of 12 different parents participated in the interviews. Results indicate decisional conflict associated with the lack of evidence for optimal treatment, supporting the need for the development of a patient decision aid to assist in clarifying information and parent values with practitioners. Parents clearly identified a need for evidence to support decision-making in various formats (eg, pamphlet or electronic). Timing of when to deliver the PDA varied (ie, during hospital admission, at discharge, or at follow-up appointment). Conclusion: Results indicated various factors contributing to parental decisional conflict, including the lack of evidence showing the optimal treatment, the need for more information, and guidance from practitioners. Overall, findings indicate a strong need for a patient decision aid.

Traduction franco-canadienne de l'Assessment of Systematic Reviews Revised (AMSTAR 2) : validation transculturelle et fidélité interjuges.

Objective: Produce a French-Canadian translation of AMSTAR 2, affirm its content validity, and examine interrater reliability. Methods: Based on Vallerand's methodological approach, we conducted forward and parallel inverse-translations. Subsequently, an expert panel evaluated the translations to create a preliminary experimental French-Canadian version. A second expert panel examined this version and proposed additional modifications. Twenty future health professionals then rated the second experimental version for ambiguity on a scale (from 1 to 7). The principal co-investigators then reviewed the problematic elements and proposed a pre-official version. To ascertain content validity, a final back-translation was conducted resulting in the official version. Four judges evaluated 13 systematic reviews using the official French-Canadian version of AMSTAR 2. The Kappa coefficient was used to evaluate interrater reliability. Results: This rigorous adaptation enabled the development of a Franco-Canadian version of AMSTAR 2. Its application demonstrated low ambiguity (mean 1.15; SD 0.26) as well as good overall interrater reliability (total κ > 0.64) across all items. Conclusion: The French-Canadian version of AMSTAR 2 can now support francophone clinicians, educators, and managers in Canada as they undertake evidence-based practice.

Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set.

OBJECTIVE: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions. METHODS: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set. RESULTS: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as "mandatory in specific circumstances". The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders. CONCLUSION: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials.

Assessing the reporting quality of physical activity programs in randomized controlled trials for the management of juvenile idiopathic arthritis using three standardized assessment tools.

BACKGROUND: The reporting quality of physical activity (PA) programs in randomized controlled trials (RCTs) for the management of juvenile idiopathic arthritis (JIA) remains unknown. This study aimed to assess and compare the reporting quality of PA programs in RCTs for the management of JIA using three difference standardized assessment tools, and to describe the elements that were similar and different between these tools. METHODS: A systematic search was conducted for moderate-to high-quality RCTs of PA programs in JIA, published up until January 2019. Two reviewers independently included 10 RCTs and scored the reporting quality of PA programs using the following tools: Consensus on Exercise Reporting Template (CERT) checklist, Consensus on Therapeutic Exercise Training (CONTENT) scale, and Template for Intervention Description and Replication (TIDieR) checklist. RESULTS: Results showed that reporting of PA programs in 10 moderate- to high-quality RCTs for JIA management remains incomplete. The average reporting quality (± standard deviation) for all RCTs combined was moderate for the three standardized assessment tools with 70.8 (±14.3)% for the TIDieR checklist, 53.2 (±20.2)% for the CERT checklist, and 70.0 (±18.9)% for the CONTENT scale. Despite some overlap, the three standardized assessment tools (TIDieR, CERT, CONTENT) included different elements resulting in different scores. All tools assess elements linked to PA programs (provider, location, timing, personalization and adherence), but the CERT checklist includes other essential elements (e.g., additional resources, motivational strategies, adverse events). CONCLUSIONS: The lack of complete reporting of PA programs in RCTs for the management of JIA and the variation in scores and assessed elements among standardized assessment tools show the need to improve reporting. Using the most comprehensive standardized tool (i.e., the CERT) and providing accessible supplemental information on PA programs may improve the reporting quality of PA programs in RCTs and help reproduce PA programs in research and clinical practice.

La version franco-canadienne de l'outil Assessment of Multiple Systematic Reviews (AMSTAR).

Objectives: The primary objective was to produce a French-Canadian translation of AMSTAR (a measurement tool to assess systematic reviews) and to examine the validity of the translation's contents. The secondary and tertiary objectives were to assess the inter-rater reliability and factorial construct validity of this French-Canadian version of AMSTAR. Methods: A modified approach to Vallerand's methodology (1989) for cross-cultural validation was used.1 First, a parallel back-translation of AMSTAR2 was performed, by both professionals and future professionals. Next, a first committee of experts (P1) examined the translations to create a first draft of the French-Canadian version of the AMSTAR tool. This draft was then evaluated and modified by a second committee of experts (P2). Following that, 18 future professionals (master's students in physiotherapy) rated this second draft of the instrument for clarity using a seven-point scale (1: very clear; 7: very ambiguous). Lastly, the principal co-investigators then reviewed the problematic elements and proposed final changes. Four independent raters used this French-Canadian version of AMSTAR to assess 20 systematic reviews that were published in French after the year 2000. An intraclass correlation coefficient (ICC) and kappa coefficient were calculated to measure the tool's inter-rater reliability. A Cronbach's alpha coefficient was also calculated to measure internal consistency. In addition, factor analysis was used to evaluate construct validity in order to determine the number of dimensions. Results: The statements on the final version of the AMSTAR tool received an average ambiguity rating of between 1.0 and 1.4. No statement received an average rating below 1.4, which indicates a high level of clarity. Inter-rater reliability (n=4) for the instrument's total score was moderate, with an intraclass correlation coefficient of 0.61 (95% confidence interval [CI]: 0.29, 0.97). Inter-rater reliability for 82% of the individual items was good, according to the kappa values obtained. Internal consistency was excellent, with a Cronbach's alpha coefficient of 0.91 (95% CI: 0.83, 0.99). The French-Canadian version of AMSTAR is a unidimensional tool, as confirmed by factor analysis and community values greater than 0.30. Conclusion: A valid French-Canadian version of AMSTAR was created using this rigorous five-step process. This version is unidimensional, with moderate inter-rater reliability for the elements overall, and with excellent internal consistency. This tool could be valuable to French-Canadian professionals and researchers, and could also be of interest to the international Francophone community.

Health Equity Considerations for Developing and Reporting Patient-reported Outcomes in Clinical Trials: A Report from the OMERACT Equity Special Interest Group.

OBJECTIVE: Despite advances integrating patient-centered outcomes into rheumatologic studies, concerns remain regarding their representativeness across diverse patient groups and how this affects equity. The Outcome Measures in Rheumatology (OMERACT) Equity Working Group aims to determine whether and how to address equity issues within the core outcome sets of domains and instruments. METHODS: We surveyed current and previous OMERACT meeting attendees and members of the Campbell and Cochrane Equity Group regarding whether to address equity issues within the OMERACT Filter 2.0 Core Outcome Sets and how to assess the appropriateness of domains, instruments, and measurement properties among diverse patients. At OMERACT 2016, results of the survey and a narrative review of differential psychosocial effects of rheumatoid arthritis (i.e., on men) were presented to stimulate discussion and develop a research agenda. RESULTS: We proposed 6 moments for which an equity lens could be added to the development, selection, or testing of patient-reported outcome measures (PROM): (1) recruitment, (2) domain selection, (3) feasibility in diverse settings, (4) instrument validity, (5) thresholds of meaning, and (6) consideration of statistical power of subgroup analyses for outcome reporting. CONCLUSION: There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking of importance of outcome domains or a patient's response to questionnaire items, and (2) conduct the same survey described above with patients representing groups experiencing health inequities.

Models of Care for addressing chronic musculoskeletal pain and health in children and adolescents.

Chronic musculoskeletal pain among children and adolescents is common and can negatively affect quality of life. It also represents a high burden on the health system. Effective models of care for addressing the prevention and management of pediatric musculoskeletal pain are imperative. This chapter will address the following key questions: (1) Why are pediatric-specific models of pain care needed? (2) What is the burden of chronic musculoskeletal pain among children and adolescents? (3) What are the best practice approaches for early identification and prevention of chronic musculoskeletal pain in children and adolescents? (4) What are the recommended strategies for clinical management of chronic pain, including pharmacological, physical, psychological and complementary, and alternative approaches? (5) What are the most effective strategies for implementing models of pain care across different care settings? (6) What are the research priorities to improve models of care for children and adolescents with chronic musculoskeletal pain?

Toward Ensuring Health Equity: Readability and Cultural Equivalence of OMERACT Patient-reported Outcome Measures.

OBJECTIVE: The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. METHODS: The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM. RESULTS: Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation. CONCLUSION: Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures.

The associations among economic hardship, caregiver psychological distress, disease activity, and health-related quality of life in children with juvenile idiopathic arthritis.

PURPOSE: To examine the associations among caregiver perceived economic hardship, psychological distress, children's disease activity, and health-related quality of life (HRQOL) in children with juvenile idiopathic arthritis (JIA). METHODS: Caregivers of 182 children with JIA (ages 2-18) attending the rheumatology clinics at the Montreal Children's Hospital and the British Columbia's Children Hospital completed a series of questionnaires on perceived financial hardship, caregiver psychological distress, and children's HRQOL at baseline, 6 and 12 months. Clinical information such as disease activity was obtained from medical charts. Statistical models were used to look at the significance of several factors of interest while controlling for possible confounders. RESULTS: Higher caregiver perceived economic hardship [(ß = 0.03, 95% CI = 0.005, 0.06), P = 0.02], psychological distress [(ß = 0.02, 95% CI = 0.006, 0.03), P = 0.004], and higher children's disease activity [(ß = 0.11, 95% CI = 0.07, 0.15), P < 0.0001] were associated with worse children's HRQOL. CONCLUSIONS: Findings suggest that caregiver financial hardship and psychological distress as well as children's disease activity may impact children's HRQOL. By providing psychological help to parents, offering information regarding financial resources in the community and by ensuring disease control, especially when the disease is severe, health providers may improve children's health outcomes.