Background: Biomedical funders are increasingly introducing requirements for research data management (RDM) and data sharing to promote transparency and reproducibility. However, expectations for Data Management and Sharing Plans (DMSPs) and data sharing are heterogeneous and may create uncertainty and an administrative burden for researchers. Objective: In this study, we aimed to: (1) identify DMSP and data sharing requirements from biomedical funders; (2) identify how these requirements are evaluated, monitored, and supported; (3) identify existing DMSP templates used by funders; and (4) compare and assess the existing required elements for the DMSPs and how they were developed. Design: We conducted a scoping review using the Joanna Briggs Institute approach. We searched websites of 287 biomedical funders (private, philanthropic, and hybrid funders) listed on www.healthresearchfunders.org (March-August 2024) for policies, guidelines, templates, or general guidance related to RDM and data sharing. Screening and data extraction were conducted in duplicate, and data were analyzed descriptively and thematically. Results: Of 287 funders screened, 264 were eligible, and 196 documents from 84 funders were included. Sixty-five funders (25%) have explicit DMSP expectations, 76 (29%) expect data sharing, and 31 (12%) cover RDM costs. Expectations were more common among public funders (63% DMSP; 66% data sharing) than philanthropic funders (10% and 15% respectively). Regionally, requirements were most frequent in Asia (40%) and North America (32%). Nearly half of funders with DMSP policies described evaluation (49%) or monitoring (43%) processes, but approaches varied. Where expected, templates or guidance were common (86%), but the level of detail and the number of required elements differed widely. Conclusions: Our results show that biomedical funders’ expectations for DMSPs and data sharing by researchers are expanding but remain inconsistent, with considerable variation in evaluation, monitoring, and guidance. While our analysis relied on publicly available documents and did not include commercial funders, the findings highlight the need for greater harmonization, participatory template development, and clearer monitoring processes to reduce the burden on researchers and improve the impact of the policies on open and reproducible science.

Introduction Fewer than half of patients receive evidence-based upper limb rehabilitation after stroke. Implementation science interventions may improve use of guidelines by clinicians; however, it is not yet known whether they lead to evidence-based stroke rehabilitation practice. We aim to determine the effect and cost-effectiveness of a champion-led implementation package (PROMOTE) to increase adherence to best practice guidelines for upper limb rehabilitation after stroke.Methods and analysis A multistate, multicentre, cluster-randomised, implementation phase IV trial with concealed allocation, blinded measurement and intention-to-treat analysis will be conducted. The PROMOTE package includes appointing an internal champion, local audit and feedback, interactive education tailored to gaps in knowledge and skill, and a decision-aid to support intervention selection. To be eligible, centres delivered rehabilitation to at least 20 stroke patients in the preceding year. Assuming 35% baseline adherence to guidelines, 14 centres (n=238) will be recruited to provide 80% power to detect a 30% absolute difference with a two-sided α=0.05. An embedded process evaluation and economic analysis will assess implementation and costs. The primary outcome is the proportion of people with stroke who are documented to receive guideline-recommended upper limb rehabilitation interventions by 6 months. Secondary outcomes include self-reported clinician behaviour change, upper limb therapy outcomes at the end of intervention, costs and cost effectiveness (eg, incremental cost per quality adjusted life year). Process evaluation outcomes include reach, adoption, implementation and maintenance (sustainability).Ethics and dissemination Ethical approval was obtained from the Alfred Hospital Human Research Ethics Committee (approval number 89725 (NMA), 26 April 2023) with each participating site providing ethical clearance prior to the commencement of the trial. Findings will be reported in accordance with the Consolidated Standards of Reporting Trials extended for cluster-randomised trials and in peer-reviewed journals, and communicated to stakeholders and the public. Understanding and characterising the active ingredients of effective implementation will inform scalable strategies to improve stroke rehabilitation practice, health outcomes and the equitable delivery of evidence-based care.Trial registration number The trial is currently recruiting and is registered at https://www.anzctr.org.au/.ID: ANZCTR 12623000608662 (UTN U1111-1292-8705), 2 June 2023.

BACKGROUND AND OBJECTIVES:Linking patient decision aids (PtDAs) to clinical practice guidelines (CPGs) can improve the integration of patient preferences into health care decisions. However, due to the extensive number of recommendations in many CPGs and the limited resources available to CPG development groups, developing a PtDA for each recommendation may be impractical. This study aimed to develop and rank criteria to prioritize CPG recommendations for which the development of a PtDA is relevant. METHODS:A modified three-round Delphi study was conducted between July and December 2024, following the Research and Development (RAND)/University of California at Los Angeles (UCLA) Appropriateness Method (RAM). Potential criteria were derived from selected evidence sources. Criteria reaching at least 75% agreement on the importance threshold in round 1 were retained for ranking in rounds two and three and finalized into a list. Each round comprised a pilot-tested online survey, and responses were analyzed descriptively. Following each survey round, experts discussed the respective results in a recorded videoconference, which was transcribed and analyzed through qualitative content analysis. RESULTS:Twenty-five experts in shared decision-making (SDM) and CPG development from eight countries participated. From an initial set of twelve proposed criteria, two were excluded after round 1 due to insufficient agreement, and two others were merged with related criteria. The remaining eight were ranked during rounds two and three, resulting in a consensus-based final list of criteria. Multiple options with different benefit-harm profiles was ranked as most important, with a mean rank of 1.6 (SD 1.4) on a scale from 1 (most important) to 8 (least important). Decision with impact and potential discrepancy in preferences were ranked second and third, with mean ranks of 2.8 (1.8) and 4.0 (2.1), respectively. The others, in order of importance, were treatment burden (4.1; (1.2)), uncertainty of evidence (5.3; (2.1)), life values (5.8; (1.7)), adherence (6.2; (1.3), and financial aspects (6.3; (1.6)). CONCLUSION:This study provides a consensus-based list of criteria to assist CPG developers in prioritizing recommendations for PtDA development, emphasizing decisions where PtDAs are most needed. Future research will focus on refining these criteria into a practical tool for CPG developers.

Objectives To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery.Design Mixed-methods study describing the development of a patient decision aid.Setting A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids.Participants Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group’s research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis.Results We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid’s acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional).Conclusion Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.

BACKGROUND:Shared decision making (SDM) has benefits for patients, healthcare professionals and the healthcare system. Involving patients in decisions about their healthcare is a healthcare right. OBJECTIVE:The aim of this article is to explore when and how to use SDM in consultations, and to increase awareness of the role of simple tools to support SDM, particularly in consultations where uncertainty and low-value care options exist. DISCUSSION:Implementing SDM into primary care consultations with general practitioners, practice nurses and other team members does not need specific tools, although there are many that can be helpful to assist clinicians and do not increase the length of consultations. Encouraging patients to ask questions in consultations, particularly about options; discussing the benefits and harms of options including waiting and watching; and exploring patients' values and preferences are important steps in the process.

BACKGROUND:Femoroacetabular Impingement Syndrome (FAIS) is a prominent source of non-arthritic hip pain and is highly prevalent in young active populations. Decisions to undergo surgery are significant in nature and require proper understanding of potential benefits and risks. OBJECTIVE:To develop and user-test a patient decision aid comparing non-surgical management and hip arthroscopy for FAIS with an additional military-related section. DESIGN:Mixed-methods. METHOD:The initial draft of the decision aid was developed by a multidisciplinary steering group. An iterative process of semi-structured interviews, re-drafting and further interviews provided feedback on the decision aid. The interviews were analysed reflexively using thematic analysis for qualitative findings. Acceptability questionnaires were analysed using descriptive statistics for quantitative findings. RESULTS:We interviewed 27-participants; 13 clinicians (6 physiotherapists, 3 orthopaedic surgeons, 2 general practitioners, 1 sports medicine doctor, 1 anaesthesia pain physician) and 14 patients. Most participants rated the decision aid's acceptability as good-to-excellent. Participants agreed on most aspects of the decision aid including the introduction, treatment options, comparison of outcomes and questions to consider asking a health professional. Participants agreed on including more information on the treatment options and provide more long-term outcomes comparing the options. Our decision aid met all 6 of the International Patient Decision Aid Standards qualifying criteria. CONCLUSION:Our decision aid was considered a useful tool that may help patients choose an appropriate treatment option for the management of FAIS. A clinical trial evaluating the impact of the decision aid on decision making for patients considering surgery for FAIS is needed.

Background In-vitro fertilisation (IVF) add-ons are adjuncts to IVF that are usually used with the hope of increasing the chance of IVF success. Prominent information sources for patients, including IVF clinic websites and social media, often contain misleading information about add-ons, overstating potential benefits and omitting information about risks and cost. The aim of this study was to codesign an evidence-based resource about IVF add-ons, and to evaluate its acceptability and effect on patients’ understanding of the evidence through an online randomised trial. Methods In a parallel-group, single-blinded, randomised trial, Australian patients undergoing IVF were recruited via social media between March 19 and April 6, 2025, and randomly assigned them to view the new resource or control content generated from synthesising information from high-ranking Google search results. Participants were randomly assigned centrally (1:1:1:1:1:1) using the randomisation function within Qualtrics software, to receive study or control information regarding one of three add-ons (EmbryoGlue, intralipid infusion, or endometrial receptivity testing). Three add-ons were selected to represent different evidence scenarios: evidence of benefit (EmbryoGlue); unclear evidence (intralipid infusion); and evidence of no benefit (endometrial receptivity testing). The primary outcome was gist comprehension measured using a five-item questionnaire that assessed participants’ understanding of the effect of these IVF add-ons on the chance of pregnancy, miscarriage, and live birth, the quality of the evidence, and possible side-effects (range 0–10). The analysis was conducted using pooled data from the three add-on groups. Analyses were performed following the intention-to-treat principle, including all randomly assigned participants, with multiple imputation for missing data. The trial was prospectively registered on ClinicalTrials.gov (NCT06885151). Findings 1217 eligible participants were randomly assigned (606 to the evidence-based website group and 611 to the control group, with 899 (74%) providing outcome data. Most participants were women (1202 [99%]), aged 31–40 years (869 [71%]), had undergone IVF previously (1076 [88%]) and were planning future IVF treatment (1156 [95%]). Mean gist comprehension was substantially higher in the evidence-based website group (6·1 [SD 3·0] vs the control group of 2·2 [2·4]; mean difference 3·8 [95% CI 3·5–4·2]; standardised mean difference 1·42 [95% CI 1·27–1·57]; p<0·0001). Interpretation The evidence-based IVF website improved patients’ understanding of the benefits, risks, and evidence quality of IVF add-ons, compared with typical online information about these add-ons. This resource should be used by patients and clinicians to support informed decision making about add-on use. Funding The Australian National Health and Medical Research Council and the University of Melbourne, Australia.

Patient decision aids (PDAs) are evidence informed tools designed to support patients in the process of making decisions about their health. The International Patient Decision Aid Standards (IPDAS) Collaboration last updated the standards in 2013 and the evidence about patient decision aids has expanded substantially. In this article, we report on an update to IPDAS that used a modified Delphi process with two rounds of voting to reach consensus on evidence informed changes to the criteria. The 202 participants were from 26 countries, and included patients/consumers, policy makers, researchers, and clinician researchers. IPDAS 5.0 includes seven qualifying criteria (necessary to be a patient decision aid), 10 essential criteria (necessary to reduce biased decisions), and 54 enhancing criteria (additional criteria that might improve the quality of a patient decision aid). The updated standards reflect the IPDAS Collaboration's founding goal of providing high quality patient decision aids for patients that minimise potential biases in the decisions made about potential healthcare options.

Abstract Background Translating research into clinical practice is challenging. One implementation intervention that supports translation is employment of a change champion. It is important to understand how individuals are prepared for the change champion role. This rapid systematic review aimed to identify the education, training, and support provided to individuals in change champion roles within implementation trials. Method Rapid review approach. We searched the Scopus database to identify systematic reviews on champions, knowledge brokers, facilitators, and implementation support practitioners. The most recent reviews on each topic were screened to find eligible studies. To identify studies published after these reviews, we searched Medline, PsycINFO, OVID, CINAHL, ProQuest, SCOPUS, and EBSCO. We included randomised and cluster randomised controlled trials that reported on implementation interventions in healthcare settings involving a local change champion. Results Fifteen cluster randomised controlled trials were included. Specific champion training was provided in 12 studies (80%), but none reported incorporating adult learning principles into their education program. Some form of post-training support was reported in 11 studies (73%). Only two studies included content on behaviour or organizational change in the champion preparation program. Most programs were not individualized, and details of training and support were poorly reported. Conclusions Training needs and educational outcomes of change champions are poorly reported in implementation trials. Training tends not to align with adult learning. More rigorous development and reporting of programs to prepare change champions to support implementation of evidence in healthcare is recommended. Registration PROSPERO registration number CRD42022368276.

The protocol of a randomized trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Herein, we systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (harms, outcomes, nonpharmacological treatment) and other reporting guidelines (Template for Intervention Description and Replication [TIDieR]). The potential modifications were rated in a 3-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of 2 new protocol items, revision to 5 items, deletion/merger of 5 items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open-science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policy makers, regulators, and other reviewers.

OBJECTIVE:To analyse the scope and characteristics of freely available online patient decision aids. METHODS:An international environmental scan of online decision aids, with no language restriction, was conducted by searching aids in the recent Cochrane review and 35 online sources. Aid characteristics were extracted and analysed. RESULTS:Of 1555 decision aids identified, there were 1222 unique aids after removing duplicates. Of these, 785 met eligibility criteria. The aids were from 17 countries (30 % from the Netherlands, 20 % from the US) and 44 % in English. Nearly all had a downloadable PDF or were printable and 32 % were interactive web-based. Many aids (72 %) were about a treatment decision. Most common diseases addressed were cancer (23 %), especially breast cancer, musculoskeletal diseases (11 %), and genitourinary system diseases (10 %). CONCLUSIONS:There are many freely available decision aids, with most addressing treatment decisions and particular health conditions. Many (21 %) of the aids identified were duplicates, some topics are covered by multiple versions of decision aids, and other topics have few decision aids. PRACTICE IMPLICATIONS:While many decision aids exist online, initiatives are needed to minimise aid duplication, achieve better distribution of aids across health decisions/topics, encourage greater collaboration between developers, and adaption of existing aids.

Importance In Australia, few people with acute anterior cruciate ligament (ACL) rupture are managed with rehabilitation alone despite clinical trials demonstrating similar outcomes to ACL reconstruction (ACLR). The reasons for the low uptake of rehabilitation alone for the treatment of acute ACL rupture in Australia are unclear. Objectives The objectives of this study were to evaluate physical therapists’ beliefs and the information they provide to patients about treatment options for ACL rupture, and to explore ACL rupture treatment decision-making from the perspective of physical therapists. Design The design was a mixed-methods convergent parallel design comprising an Australia-wide survey (n = 246) and semi-structured interviews (n = 10). Participants Participants included physical therapists who manage people with ACL rupture in Australia. Main outcomes The survey contained 41 items that assessed demographics, treatment of ACL rupture, referral pathways, treatment beliefs, and the information provided to patients with ACL rupture. Results Physical therapists’ beliefs about treatment options varied and did not always reflect the information they provided to patients. Although 60% agreed that ACLR and rehabilitation-alone result in similar outcomes on average, only 37% reported regularly informing patients about this. To return to pivoting/contact sport, 23% believed that ACLR was required and 79% informed patients that ACLR was the best treatment to do so. Physical therapists felt that rehabilitation-alone is underutilized as a treatment for ACL rupture. Physical therapists encountered barriers to offering and providing rehabilitation-alone for ACL rupture, reflected in 7 qualitative themes: preference for surgery reflecting societal beliefs; more weight given to surgeon’s opinion; unbalanced information from surgeon; referral pathways; uncertain recovery timeline; beliefs about treatment suitability; and knowledge and experience. Conclusions Physical therapists had mixed beliefs about treatment options and the information provided to patients was not always evidence based. Physical therapists felt that nonsurgical management was underutilized, and experienced barriers to offering and providing non-surgical management of ACL rupture in clinical practice. Relevance Informed decision-making can only occur if accurate, evidence-based information about ACL rupture treatment options is provided to patients. These findings may be used to guide professional development for physical therapists and inform strategies to improve evidence uptake by physical therapists.

Objectives To develop and user-test a patient decision aid providing evidence-based information for people with chronic low back pain (LBP) and degenerative disc disease considering lumbar fusion. Design Convergent parallel mixed methods study. Setting A prototype patient decision aid was developed, guided by the International Patient Decision Aid Standards (IPDAS) criteria, a multidisciplinary steering committee, and insights from previous studies. Participants were recruited via social media and the authors’ collaborative networks to refine and evaluate the decision aid. Participants Individuals who underwent lumbar fusion for chronic LBP and health professionals who manage these patients were purposively sampled. Primary and secondary outcomes Semi-structured interviews and questionnaires were used to gather feedback and assess the decision aid’s acceptability, usability, and preparedness for decision-making. Framework analysis was used for interview data and descriptive analysis for questionnaires. Results Sixteen clinicians (5 physiotherapists, 2 rheumatologists, 2 surgeons, 7 general practitioners) and seven patients participated, most rating the prototype’s acceptability as ‘excellent’ or ‘good’. Usability (mean [SD], health professionals: 78 [16], patients: 72 [8]) and preparedness for decision-making (health professionals: 73 [14], patients: 72 [10]) also scored highly. However, some viewed the prototype as biased against lumbar fusion, and suggestions to include more personalised information were made. Conclusions This study showed that our prototype patient decision aid is acceptable, useful, and prepares patients to make informed decisions about spinal fusion for chronic LBP and degenerative disc disease. Future studies will assess the clinical impact of our decision aid and its optimal distribution timing.

OBJECTIVES:In patients with anterior cruciate ligament injury, i) describe beliefs about treatment options and the information received from clinicians in different disciplines and ii) explore treatment decision-making experiences, including factors that influenced their treatment decisions. DESIGN:Mixed-methods convergent parallel design, using an Australia-wide survey of 734 adults with anterior cruciate ligament injury, and 12 semi-structured interviews. METHODS:Survey responses were reported descriptively. A phenomenological approach and inductive thematic analysis were used for qualitative analysis. Quantitative and qualitative data were analysed concurrently. An integration stage involved comparison and collation of findings. RESULTS:Of 734 participants (70 % women), 540 (74 %) had anterior cruciate ligament reconstruction and 119 (16 %) were managed with rehabilitation alone. Participants consulted surgeons (94 %), physiotherapists (91 %), general practitioners (65 %), emergency department clinicians (22 %) and sports physicians (19 %). Most clinicians presented anterior cruciate ligament reconstruction as the best treatment [surgeons (85 %), physiotherapists (61 %)], and the best treatment to enable return to sport [surgeons (84 %), physiotherapists (62 %)]. Few clinicians informed patients that outcomes were similar on average between treatment strategies [surgeons (10 %), physiotherapists (29 %)]. Qualitative themes describe decision-making experiences: i) surgeons promoted surgery as the best/only option; ii) surgeon consults were rushed and patients felt poorly informed; iii) clinicians downplayed surgery risks and impacts; iv) general practitioners were utilised for referrals, not management advice; and v) mixed advice from physiotherapists. Quantitative and qualitative findings were closely aligned, with qualitative findings providing deeper insights into patients' treatment decision-making experience. CONCLUSIONS:Australians with anterior cruciate ligament rupture received mixed treatment advice from clinicians, who often portrayed surgery as the best treatment option. Some patients received an unbalanced overview of treatment options that did not reflect the best-available research evidence, inhibiting an informed treatment decision.

OBJECTIVE: To estimate the prevalence of rotator cuff (RC) imaging abnormalities (tendinopathy, partial-thickness tear, full-thickness tear, or calcification) on radiograph, ultrasound, computed tomography, or magnetic resonance imaging (MRI) in asymptomatic adult shoulders. STUDY DESIGN: Systematic review. LITERATURE SEARCH: Ovid MEDLINE, Embase, CINAHL, and Web of Science (searched September 1, 2024), with forward and backward citation searches. STUDY SELECTION CRITERIA: We included studies reporting the prevalence of RC abnormalities on imaging of asymptomatic shoulders. DATA SYNTHESIS: Due to heterogeneity, data were synthesized without meta-analysis. Risk of bias was assessed using a tool for prevalence studies. Certainty of evidence was determined using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: After screening 3801 records and 188 studies in full text, we included 53 studies (29 ultrasound, 24 MRI) across population-based, miscellaneous, and athlete populations. The certainty of evidence was low to very low. For full-thickness tears, prevalence on ultrasound was 11% to 17% in 2 population-based samples (1631 shoulders), 0% to 35% across 14 studies of miscellaneous populations (3390 shoulders), and 0% to 22% across 4 studies of athlete populations (346 shoulders). On MRI, the prevalence was 20% in 1 population-based study (20 shoulders), 0% to 14% across 10 studies of miscellaneous populations (490 shoulders), and 0% to 11% across 12 studies of athlete populations (326 shoulders). For tendinopathy and/or partial-thickness tears, the prevalence on ultrasound was 34% in 1 population-based sample (539 shoulders), 0% to 47% across 11 studies of miscellaneous populations (1971 shoulders), and 7% to 70% across 4 studies of athlete populations (346 shoulders). On MRI, the prevalence was 65% in 1 population-based sample (20 shoulders), 0% to 100% across 10 studies of miscellaneous populations (490 shoulders), and 6% to 96% across 13 studies of athlete populations (426 shoulders). CONCLUSION: Across studies with low- to very low-certainty of evidence, the prevalence of RC imaging abnormalities in asymptomatic shoulders ranged from 0% to 100%. J Orthop Sports Phys Ther 2025;55(12):1-16. Epub 5 November 2025. doi:10.2519/jospt.2025.13611.

BACKGROUND:The primary aim of this study was to evaluate the effectiveness of a codesigned patient-facing decision aid compared to standard care alone for patients making a high-quality, informed decision regarding the decision to undergo total knee arthroplasty (TKA). METHODS:A double-blind, randomized controlled trial was undertaken in a multisurgeon public hospital arthroplasty clinic and private clinics of orthopaedic surgeons in Australia. A total of 216 patients were randomized before seeing an orthopaedic surgeon to either receive standard care or a printed decision aid in addition to standard care. The primary outcome was whether patients made a high-quality decision (defined as patients being knowledgeable of TKA outcomes and choosing a goal-concordant treatment) 2 weeks post-consultation. Secondary outcomes included how much the decision aid helped make a decision, satisfaction with the decision, and decisional conflict. RESULTS:At the 2-week follow-up, the primary outcome was provided by 173 (80.1%) participants. Participants receiving the aid were more likely to make a high-quality decision (odds ratio: 3.72, 95% confidence interval [CI]: 1.77 to 7.83, P < 0.001) and had lower associated decisional conflict using the Decisional Conflict Scale (mean difference: -5.7, 95% CI: -10.9 to -0.5, P = 0.033). Participants receiving the decision aid were more likely to report that they felt informed (mean difference: 2.2, 95% CI: 1.3 to 3.1, P < 0.001). There was no difference in the rate of surgery election or short-term satisfaction with the decision-making process. CONCLUSIONS:The decision aid markedly improved the likelihood of a patient making a high-quality decision and had less decisional conflict. Use of the aid in practice was feasible.

Shared decision-making is a widely promoted approach, yet clinicians, typically supportive in principle, find it difficult to implement because of concerns and barriers they commonly encounter in practice. To generate a primer that describes shared decision-making from the perspective of clinicians. We collaborated with clinicians, patient representatives, and health service researchers. We invited members of the International Society of Shared Decision Making to co-produce a primer for clinicians using a series of jointly edited online documents. We shared drafts with other clinicians and patients. Finally, we integrated the contributions until we had arrived at a consensus. Twenty-five people from 13 countries contributed; 9 had medical qualifications, 4 had nursing qualifications, and 12 others had a range of backgrounds. A total of 30 patients and clinicians provided further comments. The description differs from previous versions because it addresses the barriers that clinicians frequently mention. It describes how to overcome common challenges by emphasizing the importance of a clear invitation at initiation; it suggests how to manage patients’ resistance to shouldering decisional responsibility; reinforces the need to allow time for deliberation, especially with other stakeholders; and reassures clinicians that consensus, albeit welcome, need not be the goal of shared decision-making. This primer portrays a reflective clinician who is aware of power asymmetry, patient vulnerability, risk communication, health literacy, agenda setting, and goal clarification. It envisages a clinician who is curious about personal perspectives and who can offer collaborative, iterative, and deliberative steps.

Pediatric randomized controlled trials (RCTs) inform decisions concerning the choice of interventions in children and adolescents. To enable the implementation of effective interventions, RCT reports need to provide adequate details on the elements, infrastructure, and delivery of these interventions. Using the 12-item Template for the Intervention Description and Replication (TIDieR) framework, an international team developed guidance for comprehensive reporting of trial interventions in pediatric RCT protocols and reports. We (1) identified initial pediatric considerations (PCs) and examples of good reporting using 50 recent pediatric RCT reports, (2) held an expert panel meeting, (3) conducted a Family Caregiver Workshop to discuss and get input on PCs, (4) compiled PCs and examples of good reporting, and (5) achieved consensus on final PCs and examples. Thirteen PCs reached consensus; they address how trial intervention materials were appropriate for the age and developmental stage of trial participants, which adjustments to enhance palatability of medications and acceptability of interventions were implemented, and how pediatric-specific dosing was determined. Consensus was also reached on accompanying good reporting exemplars. Presenting a minimum set of considerations pertinent to pediatric trial interventions, the TIDieR-Child & Adolescent Health (TIDieR-C) checklist can help trial authors and evidence end users comprehensively report and appraise tested interventions. It can be used with the pediatric-specific extensions of the Standard Protocol Items for Randomized Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT): SPIRIT-Children & Adolescents and CONSORT-Children & Adolescents. Uptake of this guidance may lead to improved understanding, replicability, and implementation fidelity of effective trial interventions.

Consensus statements can be very influential in medicine and public health. Some of these statements use systematic evidence synthesis but others fail on this front. Many consensus statements use panels of experts to deduce perceived consensus through Delphi processes. We argue that stacking of panel members toward one particular position or narrative is a major threat, especially in absence of systematic evidence review. Stacking may involve financial conflicts of interest, but nonfinancial conflicts of strong advocacy can also cause major bias. Given their emerging importance, we describe here how such consensus statements may be misleading, by analyzing in depth a recent high-impact Delphi consensus statement on COVID-19 recommendations as a case example. We demonstrate that many of the selected panel members and at least 35% of the core panel members had advocated toward COVID-19 elimination (Zero-COVID) during the pandemic and were leading members of aggressive advocacy groups. These advocacy conflicts were not declared in the Delphi consensus publication, with rare exceptions. Therefore, we propose that consensus statements should always require rigorous evidence synthesis and maximal transparency on potential biases toward advocacy or lobbyist groups to be valid. While advocacy can have many important functions, its biased impact on consensus panels should be carefully avoided.

Background: Knowledge of stroke is essential to empower people to reduce their risk of events. However, valid tools are required for accurate and reliable measurement of stroke knowledge. We aimed to systematically review contemporary stroke knowledge assessment tools and appraise their content validity, feasibility, and measurement properties. Methods: The protocol was registered in PROSPERO (CRD42023403566). Electronic databases (MEDLINE, PsycInfo, CINAHL, Embase, Scopus, Web of Science) were searched to identify published articles (01/Jan/2015-01/Mar/2023), in which stroke knowledge was assessed using a validated tool. Two reviewers independently screened titles and abstracts prior to undertaking full-text review. COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methods guided the appraisal of content validity (relevance, comprehensiveness, comprehensibility), feasibility, and measurement properties. Results: After removing duplicates, the titles and abstracts of 718 articles were screened; 323 reviewed in full; with 42 included (N=23 unique stroke knowledge tools). For content validity, all tools were relevant, two were comprehensive, and six were comprehensible. Validation metrics were reported for internal consistency (n=20 tools), construct validity (n=17 tools), cross-cultural validity (n=15 tools), responsiveness (n=9 tools), reliability (n=7 tools), structural validity (n=3 tools), and measurement error (n=1 tool). The Stroke Knowledge Test met all content validity criteria, with validation data for six measurement properties (n=3 rated 'Sufficient'). Conclusion: Assessment of stroke knowledge is not standardised and many tools lacked validated content or measurement properties. The Stroke Knowledge Test was the most comprehensive, but requires updating and further validation for endorsement as a gold standard.