Fostering Shared Decision-Making Between Patients and Health Care Professionals in Clinical Practice Guidelines: Protocol for a Project to Develop and Test a Tool for Guideline Developers.

BACKGROUND: Clinical practice guidelines (CPGs) are designed to assist health care professionals in medical decision-making, but they often lack effective integration of shared decision-making (SDM) principles to reflect patient values and preferences, particularly in the context of preference-sensitive CPG recommendations. To address this shortcoming and foster SDM through CPGs, the integration of patient decision aids (PDAs) into CPGs has been proposed as an important strategy. However, methods for systematically identifying and prioritizing CPG recommendations relevant to SDM and related decision support tools are currently lacking. OBJECTIVE: The aim of the project is to develop (1) a tool for systematically identifying and prioritizing CPG recommendations for which SDM is considered particularly relevant and (2) a platform for PDAs to support practical SDM implementation. METHODS: The project consists of 6 work packages (WPs). It is embedded in the German health care context but has an international focus. In WP 1, we will conduct a scoping review in bibliographic databases and gray literature sources to identify methods used to foster SDM via PDAs in the context of CPGs. In WP 2, we will conduct semistructured interviews with CPG experts to better understand the concepts of preference sensitivity and identify strategies for fostering SDM through CPGs. WP 3, a modified Delphi study including surveys and focus groups with SDM experts, aims to define and operationalize preference sensitivity. Based on the results of the Delphi study, we will develop a methodology for prioritizing key questions in CPGs. In WP 4, the tool will be developed. A list of relevant items to identify CPG recommendations for which SDM is most relevant will be created, tested, and iteratively refined, accompanied by the development of a user manual. In WP 5, a platform for creating and digitizing German-language PDAs will be developed to support the practical application of SDM during clinical encounters. WP 6 will conclude the project by testing the tool with newly developed and revised CPGs. RESULTS: The Brandenburg Medical School Ethics Committee approved the project (165122023-ANF). An international multidisciplinary advisory board is involved to guide the tool development on CPGs and SDM. Patient partners are involved throughout the project, considering the essential role of the patient perspective in SDM. As of February 20, 2024, we are currently assessing literature references to determine eligibility for inclusion in the scoping review (WP 1). We expect the project to be completed by December 31, 2026. CONCLUSIONS: The tool will enable CPG developers to systematically incorporate aspects of SDM into CPG development, thereby providing guideline-based support for the patient-practitioner interaction. Together, the tool for CPGs and the platform for PDAs will create a systematic link between CPGs, SDM, and PDAs, which may facilitate SDM in clinical practice. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57611.

National Trends in PSA Cancer Screening With Parallel Investigation of Colorectal Cancer Screening: An Analysis of the CDC Behavioral Risk Factor Surveillance System From 2012 to 2022.

INTRODUCTION/BACKGROUND: From 2012 to 2022 there have been numerous revisions in the United States Preventative Task Force guidelines for prostate cancer screening, including advising against PSA testing to allowing shared-decision making for men aged 55 to 69. We sought to observe trends in PSA testing rates in relation to the changing guidelines. Conversely, colorectal cancer screening recommendations remained consistent for patients aged 50-75 and we sought to use this as a comparison to observe the effect of differing guidelines. METHODS: The Centers for Disease Control Behavioral Risk Factor Surveillance System is a national database of surveys on health-related behaviors and preventive medical services. We extracted responses from 2012 to 2022 regarding both prostate and colorectal cancer screening. Our primary variable of interest was prostate cancer screening while colorectal cancer screening served as a positive control. RESULTS: Prostate cancer screening decreased among respondents from 70.1% in 2012 to 59.7% in 2022. However, there was a significant rebound in prostate cancer screening prevalence in 2022. In contrast, colorectal cancer screening rates steadily increased from 70.7% in 2012 to 78% in 2022. The annual percentage of men who had received prostate cancer screening was statistically different year to year. CONCLUSIONS: Trends in the rate of screening for prostate and colorectal cancer appeared to adapt to the updated recommendations. However, further investigation regarding lower income levels, minority groups, and uninsured men are essential to address the social and racial disparities seen in prostate cancer screening. Efforts to promote shared-decision making may improve effective cancer screening.

Stimulating implementation of clinical practice guidelines in hospital care from a central guideline organization perspective: A systematic review.

BACKGROUND: The uptake of guidelines in care is inconsistent. This review focuses on guideline implementation strategies used by guideline organizations (governmental agencies, scientific/professional societies and other umbrella organizations), experienced implementation barriers and facilitators and impact of their implementation efforts. METHODS: We searched PUBMED, EMBASE and CINAHL and conducted snowballing. Eligibility criteria included guidelines focused on hospital care and OECD countries. Study quality was assessed using the Mixed Methods Appraisal Tool. We used framework analysis, narrative synthesis and summary statistics. RESULTS: Twenty-six articles were included. Sixty-two implementation strategies were reported, used in different combinations and ranged between 1 and 16 strategies per initiative. Most frequently reported strategies were educational session(s) and implementation supporting materials. The most commonly reported barrier and facilitator were respectively insufficient healthcare professionals' time and resources; and guideline's credibility, evidence base and relevance. Eighty-five percent of initiatives that measured impact achieved improvements in adoption, knowledge, behavior and/or clinical outcomes. No clear optimal approach for improving guideline uptake and impact was found. However, we found indications that employing multiple active implementation strategies and involving external organizations and hospital staff were associated with improvements. CONCLUSION: Guideline organizations employ diverse implementation strategies and encounter multiple barriers and facilitators. Our study uncovered potential effective implementation practices. However, further research is needed on effective tailoring of implementation approaches to increase uptake and impact of guidelines.

Incorporating postmenopausal women's perspectives into osteoporosis clinical guidelines: a systematic review.

OBJECTIVES: To assess the inclusion of individuals' perspectives in the development of osteoporosis Clinical Practice Guidelines (CPGs) for primary fracture prevention in postmenopausal women. STUDY DESIGN AND SETTING: We performed a comprehensive systematic search across guideline databases and (CPGs) developing organizations websites. Using the AGREE II tool, we assessed the quality of the guidelines, with particular emphasis on the inclusion of patients, or representatives in the development process. We also examined if women's perspectives were considered at the recommendations level and explored the potential association between the inclusion of patients' values and preferences with the quality of the CPGs. RESULTS: We retrieved a total of 491 eligible CPGs, of which 33 were finally included. The majority of the CPGs were developed by scientific societies (63.6%), primarily from Europe (39.4%) and North America (30.3%). One in every four (24.2%) guidelines explicitly included individuals' perspectives in their development, and one in ten (12.1%) included research evidence about this aspect to support their recommendations. The domains with the lowest mean scores in the quality assessment were applicability (42.4%), rigor of development (44.7%), and stakeholder involvement (45.7%), and 61% were recommended for use according to our assessment. Guidelines of higher quality were more likely to include women's perspective in their development (mean difference 39.31, P = .003). CONCLUSION: The incorporation of women's perspectives into the process of developing guidelines for primary fracture prevention in osteoporosis remains inadequate. Our findings serve as a call for guideline developers to improve this situation, and for users, and policymakers to be aware of these limitations, when using or implementing guidelines in this field.

Methodological quality and clinical recommendations of guidelines on the management of dyslipidaemias for cardiovascular disease risk reduction: a systematic review and an appraisal through AGREE II and AGREE REX tools.

BACKGROUND: Clinical practice guidelines (CPGs) are statements to assist practitioners and stakeholders in decisions about healthcare. Low methodological quality guidelines may prejudice decision-making and negatively affect clinical outcomes in non-communicable diseases, such as cardiovascular diseases worsted by poor lipid management. We appraised the quality of CPGs on dyslipidemia management and synthesized the most updated pharmacological recommendations. METHODS: A systematic review following international recommendations was performed. Searches to retrieve CPG on pharmacological treatments in adults with dyslipidaemia were conducted in PubMed, Scopus, and Trip databases. Eligible articles were assessed using AGREE II (methodological quality) and AGREE-REX (recommendation excellence) tools. Descriptive statistics were used to summarize data. The most updated guidelines (published after 2019) had their recommendations qualitatively synthesized in an exploratory analysis. RESULTS: Overall, 66 guidelines authored by professional societies (75%) and targeting clinicians as primary users were selected. The AGREE II domains Scope and Purpose (89%) and Clarity of Presentation (97%), and the AGREE-REX item Clinical Applicability (77.0%) obtained the highest values. Conversely, guidelines were methodologically poorly performed/documented (46%) and scarcely provided data on the implementability of practical recommendations (38%). Recommendations on pharmacological treatments are overall similar, with slight differences concerning the use of supplements and the availability of drugs. CONCLUSION: High-quality dyslipidaemia CPG, especially outside North America and Europe, and strictly addressing evidence synthesis, appraisal, and recommendations are needed, especially to guide primary care decisions. CPG developers should consider stakeholders' values and preferences and adapt existing statements to individual populations and healthcare systems to ensure successful implementation interventions.

Dementia Ideal Care: Ecosystem Map of Best Practices and Care Pathways Enhanced by Technology and Community.

Background: Globally, much work has been done by nonprofit, private, and academic groups to develop best practices for the care of people living with dementia (PLWD), including Alzheimer's disease. However, these best practices reside in disparate repositories and tend to focus on one phase of the patient journey or one relevant group. Objective: To fill this gap, we developed a Dementia Ideal Care Map that everyone in the dementia ecosystem can use as an actionable tool for awareness, policy development, funding, research, training, service delivery, and technology design. The intended audience includes (and not limited to) policymakers, academia, industry, technology developers, health system leaders, clinicians, social service providers, patient advocates, PLWD, their families, and communities at large. Methods: A search was conducted for published dementia care best practices and quality measures, which were then summarized in a visual diagram. The draft diagram was analyzed to identify barriers to ideal care. Then, additional processes, services, technologies, and quality measures to overcome those challenges were brainstormed. Feedback was then obtained from experts. Results: The Dementia Ideal Care Map summarizes the ecosystem of over 200 best practices, nearly 100 technology enablers, other infrastructure, and enhanced care pathways in one comprehensive diagram. It includes psychosocial interventions, care partner support, community-based organizations; awareness, risk reduction; initial detection, diagnosis, ongoing medical care; governments, payers, health systems, businesses, data, research, and training. Conclusions: Dementia Ideal Care Map is a practical tool for planning and coordinating dementia care. This visualized ecosystem approach can be applied to other conditions.

Evaluación de la calidad de guías de práctica clínica para el tratamiento de adultos con COVID-19 leve o moderada, utilizando la herramienta AGREE II / Assessment of the quality of clinical practice guidelines on the treatment of adults with mild or moderate COVID-19, using the AGREE II tool

INTRODUCCIÓN: Varias guías de práctica clínica para el tratamiento de la COVID-19 se han desarrollado durante los dos últimos años de pandemia, sin embargo, su calidad metodológica es poco clara. OBJETIVO: Realizar una evaluación sistemática de la calidad de las guías de práctica clínica publicadas entre 2021 y octubre de 2022 para el tratamiento de la COVID-19, utilizando la herramienta AGREE II, e identificar las recomendaciones formuladas en dichas guías. JUSTIFICACIÓN: Durante la pandemia, surgieron múltiples guías, pero la claridad so-bre su calidad metodológica fue limitada. MÉTODOS: Se realizó una búsqueda sistemática de guías de práctica clínica sobre el tratamiento para la COVID-19 leve o moderada utilizando metabuscadores como Epistemonikos y Trip Database, y sitios web de organizaciones de sa-lud. Las guías seleccionadas fueron evaluadas con el instrumento AGREE II. RESULTADOS: Se evaluaron 11 GPC, presentando altas puntuaciones en los dominios de alcance y propósito (98,74 %), participación de los implicados (97,22 %), rigor en la elaboración (92 %), claridad de presentación (100 %), aplicabilidad (85,61 %), e independencia editorial (100 %). Aunque la ca-lidad general de las guías fue alta, se identificó la necesidad de mejorar en los aspectos de rigor en la elaboración y aplicabilidad de las recomendaciones. CONCLUSIONES: Encontramos que la calidad de las guías de práctica clínica evaluadas, en su mayoría es alta y, por lo tanto, son recomendables, aunque reconocemos la necesidad de mejorar la descripción de los dominios de rigor en la elaboración y aplicabilidad de las recomendaciones.

INTRODUCTION: Several clinical practice guidelines for the management of COVID-19 have been developed during the last two years of the pandemic, but their methodological quality is unclear. OBJECTIVE: To systematically assess the quality of clinical practice guidelines for the treatment of COVID-19 published between 2021 and October 2022 using the AGREE II tool, and to identify the recommendations made in these guidelines. JUSTIFICATION: During the pandemic, many guidelines were published, but clarity about their methodological quality was limited. METHODS: A systematic search for clinical practice guidelines on the management of mild-to-moderate COVID-19 was performed using meta-search engines such as Epistemoni-kos and Trip Database, as well as health organization websites. The selected guidelines were appraised using the AGREE II instrument. RESULTS: Eleven clinical practice guidelines (CPGs) were evaluated, showing high scores in the domains of scope and purpose (98.74%), stakehol-der involvement (97.22%), rigor of development (92%), clarity of presentation (100%), applica-bility (85.61%), and editorial independence (100%). Although the overall quality of the guidelines was high, there was identified a need for improvement in the areas of rigor of development and applicability of the recommendations. CONCLUSIONS: We found that the quality of the evalua-ted clinical practice guidelines is predominantly high, and therefore, they are recommendable. However, we recognize the need to improve the descriptions of the domains of rigor of develop-ment and applicability of the recommendations,

Opening the black box of registration practice for self-harm and suicide attempts in emergency departments: a qualitative study.

BACKGROUND: The World Health Organization has called for improved surveillance of self-harm and suicide attempts worldwide to benefit suicide prevention programs. International comparisons of registrations are lacking, however, and there is a need for systematically collected, high-quality data across countries. The current study investigated healthcare professionals' perceptions of registration practices and their suggestions for ensuring high-quality registration of self-harm and suicide attempts. METHODS: Qualitative interviews (N = 20) were conducted among medical secretaries, medical doctors, nurses, and registration advisers from psychiatric and somatic emergency departments in all regions of Denmark between September 2022 and March 2023. Content analysis was performed using NVivo. RESULTS: Despite great efforts to standardize and assure the quality of registration in Denmark, almost all the healthcare professionals perceived registration practice as inconsistent and unreliable. Codes are often misclassified or unused due to insufficient time, non-standardized training, or insufficient information. The interview informants suggested that coding guidelines should be simplified and made more visible, alongside technical solutions in the electronic health record system. CONCLUSION: The study findings resulted in eight overall recommendations for clinical practice that aim at improving the registration of patients presenting with self-harm or suicide attempts. This would be expected to help improve surveillance and prevention programs.

Development and prioritisation of policy recommendations for medication safety improvement for intensive care units: a European Association of Hospital Pharmacists Special Interest Group Delphi Study.

OBJECTIVES: Medication errors (MEs) are a leading cause of morbidity and mortality in the healthcare system. Patients admitted to intensive care units (ICUs) are potentially more susceptible to MEs due to severity of illness, the complexity of treatments they receive and the challenging nature of the ICU setting. The European Association of Hospital Pharmacists established a Special Interest Group (SIG) to undertake a programme of work to develop and prioritise recommendations to support medication safety improvement in ICUs across Europe. METHODS: Initial policy recommendations for medication safety within the ICU environment were developed following reviews of the literature and engagement with relevant stakeholders. A Delphi panel of 21 members of the SIG, that comprised healthcare professionals (HCPs) with expertise in ICU and/or medication safety, was convened in 2022. We conducted two rounds using a modified Delphi technique whereby participants anonymously ranked on a 9-point Likert Scale the policy recommendations according to their priority for implementation. RESULTS: In total, 32 policy recommendations were developed. In Delphi Round 1, 19 HCPs participated; consensus was achieved on most recommendations and partial consensus on six. In Delphi Round 2, 18 HCPs participated. After two Delphi rounds, consensus was achieved on all 32 recommendations. All recommendations were considered 'high priority' except one that was considered 'medium priority'. CONCLUSIONS: Through this study it was possible to develop and prioritise evidence-based policy recommendations to enhance medication safety, which may contribute to reducing MEs in ICUs across Europe. All recommendations were considered 'high priority' for implementation except one, indicating the perceived value of these recommendations in improving medication safety through preventing MEs in ICUs.

Critical appraisal of the Colombian clinical practice guide for the prevention, diagnosis and treatment of suicidal ideation and/or behaviour (adoption).

INTRODUCTION: Suicide is a complex, global public health problem. The Colombian clinical practice guideline provides relevant input for its prevention, diagnosis and treatment. The objective was to evaluate the methodological quality, credibility and applicability of the Colombian clinical practice guideline for suicidal behaviour. METHODS: An academic group of 12 evaluators was established to assess the guide and its recommendations in a standardised way, using the AGREE-II and AGREE-REX instruments. The evaluations were given in the range of 0.0-1.0 with 0.7 as a cut-off point for appropriate quality. RESULTS: The global assessment of the AGREE-II was greater than 0.7 in the dimensions: "scope and objective" (0.86), "clarity of presentation" (0.89), "applicability" (0.73) and "editorial independence" (0.89). The lowest scores were for "participation of those involved" (0.67) and "rigour in preparation" (0.69). With the AGREE-REX, the results in all dimensions were below 0.70, which indicates lower quality and suitability for use. CONCLUSIONS: The adoption process of the Colombian guideline for suicidal behaviour was a rigorous methodological process, while the practice recommendations were valued as of low applicability due to low support in local evidence. It is necessary to strengthen the generation and synthesis of evidence at the national level to give greater support and applicability to the practice recommendations.

Clinical practice guidelines on the management of status epilepticus in adults: A systematic review.

OBJECTIVE: Status epilepticus (SE) is the second most common neurological emergency in adults. Despite improvements in the management of acute neurological conditions over the last decade, mortality is still durably high. Because a gap has emerged between SE management based on clinical practice guidelines (CPGs) and actual clinical practice, we conducted a systematic review of CPGs, assessing their quality, outlining commonalities and discrepancies in recommendations, and highlighting research gaps. METHODS: We searched the PubMed and EMBASE databases and other gray literature sources (nine among guideline registries, evidence-based medicine databases, point-of-care tools; seven websites of governmental organizations and international neurologic societies) in December 2021 (updated in November 2023). The units of analysis were CPGs that included recommendations on the diagnostic and/or therapeutic management of SE in adults. The quality of the CPGs was assessed using the AGREE II tool. RESULTS: Fifteen CPGs were included. The "Applicability" domain was assigned the lowest median score of 10%. The domains "Stakeholder Involvement", "Rigor of Development," and "Editorial Independence" were as well generally underrated. Recommendations on general and diagnostic management and on organizational interventions were fragmented and scattered. Recommendations on pre-hospital and hospital treatment of early-onset and refractory SE were broadly agreed, whereas there was less agreement on the treatment model and medications for established SE and super-refractory SE. SIGNIFICANCE: The CPGs for the management of SE developed in recent years are flawed by several methodological issues and discrepancies in the coverage of important topics. The gap between CPG-based management of SE and actual clinical practice may be due in part to the inherent limitations of the CPGs produced so far.

Valoración crítica de la guía de práctica clínica colombiana para la prevención, el diagnóstico y el tratamiento de la ideación y/o la conducta suicida (adopción) / Critical Appraisal of the Colombian Clinical Practice Guide for the Prevention, Diagnosis and Treatment of Suicidal Ideation and/or Behaviour (Adoption)

RESUMEN Introducción: El suicidio es un complejo problema de salud pública global. La guía colombiana de práctica clínica es un insumo relevante para su prevención, diagnóstico y tratamiento. El objetivo es evaluar la calidad metodológica, la credibilidad y la aplicabilidad de la guía de práctica clínica colombiana sobre la conducta suicida. Métodos: Un grupo académico de 12 evaluadores se estandarizó para la valoración de la guía y sus recomendaciones mediante los instrumentos AGREE-II y AGREE-REX. Las valoraciones se dieron en el intervalo de 0,0-1,0, con 0,7 como punto de corte para apropiada calidad. Resultados: La valoración global del AGREE-II fue >0,7 en las dimensiones «alcance y objetivo¼ (0,86), «claridad de la presentación¼ (0,89), «aplicabilidad¼ (0,73) e «independencia editorial¼ (0,89). Los menores puntajes fueron para «participación de los implicados¼ (0,67) y «rigor en la elaboración¼ (0,69). Con el AGREE-REX los resultados en todas las dimensiones estuvieron por debajo de 0,70, lo cual indica menores calidad e idoneidad de uso. Conclusiones: El proceso de adopción de la guía colombiana sobre conducta suicida fue un proceso riguroso en lo metodológico, en tanto que las recomendaciones de práctica se valoraron como de baja aplicabilidad por el escaso sustento en evidencia local. Se requiere fortalecer la generación y la síntesis de evidencia en el país para dar más soporte y aplicabilidad a las recomendaciones de práctica.

ABSTRACT Introduction: Suicide is a complex, global public health problem. The Colombian clinical practice guideline provides relevant input for its prevention, diagnosis and treatment. The objective was to evaluate the methodological quality, credibility and applicability of the Colombian clinical practice guideline for suicidal behaviour. Methods: An academic group of 12 evaluators was established to assess the guide and its recommendations in a standardised way, using the AGREE-II and AGREE-REX instruments. The evaluations were given in the range of 0.0-1.0 with 0.7 as a cut-off point for appropriate quality. Results: The global assessment of the AGREE-II was greater than 0.7 in the dimensions: "scope and objective" (0.86), "clarity of presentation" (0.89), "applicability" (0.73) and "editorial independence" (0.89). The lowest scores were for "participation of those involved" (0.67) and "rigour in preparation" (0.69). With the AGREE-REX, the results in all dimensions were below 0.70, which indicates lower quality and suitability for use. Conclusions: The adoption process of the Colombian guideline for suicidal behaviour was a rigorous methodological process, while the practice recommendations were valued as of low applicability due to low support in local evidence. It is necessary to strengthen the genera-tion and synthesis of evidence at the national level to give greater support and applicability to the practice recommendations.

Evidence-based Medication knowledge Brokers in Residential Aged CarE (EMBRACE): protocol for a helix-counterbalanced randomised controlled trial.

INTRODUCTION: Clinical practice guidelines recommend against the routine use of psychotropic medications in residential aged care facilities (RACFs). Knowledge brokers are individuals or groups who facilitate the transfer of knowledge into practice. The objective of this trial is to evaluate the effectiveness and cost-effectiveness of using knowledge brokers to translate Australia's new Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care. METHODS AND ANALYSIS: The Evidence-based Medication knowledge Brokers in Residential Aged CarE (EMBRACE) trial is a helix-counterbalanced randomised controlled trial. The 12-month trial will be conducted in up to 19 RACFs operated by four Australian aged care provider organisations in Victoria, New South Wales, Western Australia and Queensland. RACFs will be randomised to receive three levels of implementation strategies (knowledge broker service, pharmacist-led quality use of medications education activities and distribution of the Guidelines and supporting materials) across three medication contexts (antipsychotics, benzodiazepines and antidepressants). Implementation strategies will be delivered by an embedded on-site aged care pharmacist working at a system level across each participating RACF. All RACFs will receive all implementation strategies simultaneously but for different medication contexts. The primary outcome will be a composite dichotomous measure of 6-month RACF-level concordance with Guideline recommendations and good practice statements among people using antipsychotics, benzodiazepines and antidepressants for changed behaviours. Secondary outcomes will include proportion of residents with Guideline concordant use of antipsychotics, benzodiazepines and antidepressants measured at the RACF-level and proportion of residents with psychotropic medication use, hospitalisation, falls, falls with injury, polypharmacy, quality of life, activities of daily living, medication incidents and behavioural incidents measured at the RACF-level. DISCUSSION: The EMBRACE trial investigates a novel guideline implementation strategy to improve the safe and effective use of psychotropic medications in RACFs. We anticipate that the findings will provide new information on the potential role of knowledge brokers for successful and cost-effective guideline implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623001141639. Registered 6 November 2023 - retrospectively registered, https://www.anzctr.org.au/TrialSearch.aspx .

Real-world treatment of metastatic hormone-sensitive prostate cancer in the USA, Europe and Asia.

Aim: To characterize real-world patients with metastatic hormone-sensitive prostate cancer (mHSPC) and treating physicians and evaluate treatment trends and baseline concordance versus guidelines internationally. Materials & methods: Retrospective, cross-sectional data from the Ipsos Global Oncology Monitor database 2018-2020 were used for descriptive analysis of mHSPC patients, treating physicians and treatment utilization. Results: Among the 6198 mHSPC patients from five countries, the most common treatment was either androgen deprivation therapy (ADT) monotherapy or first-generation androgen receptor inhibitor + ADT. Second-generation androgen receptor inhibitor use was only initiating but increasing over the study period. Conclusion: Despite contemporaneous guidelines recommending treatment intensification of ADT in combination with novel antihormonals or docetaxel, 76.1% of reported mHSPC patients received non-guideline-concordant care.

Prostate cancer is the second most common cancer among men worldwide and a leading cause of cancer-related death globally. Metastatic hormone-sensitive prostate cancer (mHSPC) refers to the stage of prostate cancer where it has spread to other parts of the body ('metastatic') but still responds to hormonal therapy ('hormone-sensitive'), such as androgen deprivation therapy (ADT). Treatment guidelines around the world for men with mHSPC have changed over time, but there remains a lack of understanding of how well guidelines are followed in real-world practice. Consequently, this study analyzes real-world data from five countries between 2018 and 2020 to understand treatment patterns, baseline concordance versus guidelines and potential drivers of treatment trends. The study found prevalent use of ADT monotherapy and older antihormonal agents, and only marginal but increasing use of novel antihormonals in real-world practice. These practices deviate from guidelines from the study period, which generally recommended ADT combination with either newer antihormonal agents or docetaxel for patients with mHSPC. Overall, the proportion of the 6198 patients treated with non­guideline-concordant therapies was 76.1%. Since guideline-recommended care is associated with better outcomes, this baselining finding highlights the need for appropriate treatment selection and intensification for mHSPC patients.

Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme.

Background: Randomised controlled trials ('trials') are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted. Objectives: PROMoting THE Use of Studies Within A Trial aimed to facilitate at least 25 Studies Within A Trial evaluating recruitment or retention strategies. We share our experience of delivering the PROMoting THE Use of Studies Within A Trial programme, and the lessons learnt for undertaking randomised Studies Within A Trial. Design: A network of 10 Clinical Trials Units and 1 primary care research centre committed to conducting randomised controlled Studies Within A Trial of recruitment and/or retention strategies was established. Promising recruitment and retention strategies were identified from various sources including Cochrane systematic reviews, the Study Within A Trial Repository, and existing prioritisation exercises, which were reviewed by patient and public members to create an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding and receive support from the PROMoting THE Use of Studies Within A Trial team to undertake Studies Within A Trial. We also tested the feasibility of undertaking co-ordinated Studies Within A Trial, across multiple host trials simultaneously. Setting: Clinical trials unit-based trials recruiting or following up participants in any setting in the United Kingdom were eligible. Participants: Clinical trials unit-based teams undertaking trials in any clinical context in the United Kingdom. Interventions: Funding of up to £5000 and support from the PROMoting THE Use of Studies Within A Trial team to design, implement and report Studies Within A Trial. Main outcome measures: Number of host trials funded. Results: Forty-two Studies Within A Trial were funded (31 host trials), across 12 Clinical Trials Units. The mean cost of a Study Within A Trial was £3535. Twelve Studies Within A Trial tested the same strategy across multiple host trials using a co-ordinated Study Within A Trial design, and four used a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. PROMoting THE Use of Studies Within A Trial will add 18% more Studies Within A Trial to the Cochrane systematic review of recruitment strategies, and 79% more Studies Within A Trial to the Cochrane review of retention strategies. For retention, we found that pre-notifying participants by card, letter or e-mail before sending questionnaires was effective, as was the use of pens, and sending personalised text messages to improve questionnaire response. We highlight key lessons learnt to guide others planning Studies Within A Trial, including involving patient and public involvement partners; prioritising and selecting strategies to evaluate and elements to consider when designing a Study Within A Trial; obtaining governance approvals; implementing Studies Within A Trial, including individual and co-ordinated Studies Within A Trials; and reporting Study Within A Trials. Limitations: The COVID-19 pandemic negatively impacted five Studies Within A Trial, being either delayed (n = 2) or prematurely terminated (n = 3). Conclusions: PROMoting THE Use of Studies Within A Trial significantly increased the evidence base for recruitment and retention strategies. When provided with both funding and practical support, host trial teams successfully implemented Studies Within A Trial. Future work: Future research should identify and target gaps in the evidence base, including widening Study Within A Trial uptake, undertaking more complex Studies Within A Trial and translating Study Within A Trial evidence into practice. Study registration: All Studies Within A Trial in the PROMoting THE Use of Studies Within A Trial programme had to be registered with the Northern Ireland Network for Trials Methodology Research Study Within A Trial Repository. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in Health Technology Assessment; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information.

A Study Within A Trial is a research study nested inside a larger 'host trial', promoting the use of Studies Within A Trial aimed to do Study Within A Trial routine practice in clinical trial units by funding and supporting at least 25 Studies Within A Trial. The best way to test health and social care treatments is to do a randomised controlled trial ('trial'), where some patients get the treatment being tested and some do not. The results of different groups are compared to see if the treatment improves care. Recruiting patients and keeping them involved in trials is often very difficult. Research teams often do not know how best to recruit and keep patients engaged as the methods have not been tested to see if they work. The best way to test these methods is by doing a Study Within A Trial. We test a programme of Studies Within A Trial for recruiting and keeping patients engaged in trials. Trial teams were able to apply for funding of up to £5000 and receive support from Promoting the use of Study Within A Trial team to do Studies Within A Trial. We used our experience of doing Studies Within A Trial to outline lessons learnt for doing Studies Within A Trial. We funded 42 Studies Within A Trial and gave teams necessary advice to do them. We significantly increased the knowledge for both recruitment and retention strategies, and found 'pre-notifying' before sending questionnaires, sending pens and personalised text messages were all effective for increasing responses by participants. We tested Studies Within A Trial across several different trials at the same time to find out more quickly whether their methods worked. We highlight key lessons learnt to guide others doing Studies Within A Trial, including involving patient partners; picking the right strategy to test; getting ethical approvals; how to do and report Studies Within A Trial. Promoting the use of studies within a trial was successful and supported more Studies Within A Trial than planned. We hope our experience will support those doing Studies Within A Trial in the future.

Designing tailored maintenance strategies for systematic reviews and clinical practice guidelines using the Portfolio Maintenance by Test-Treatment (POMBYTT) framework.

BACKGROUND: Organizations face diverse contexts and requirements when updating and maintaining their portfolio, or pool, of systematic reviews or clinical practice guidelines they need to manage. We aimed to develop a comprehensive, theoretical framework that might enable the design and tailoring of maintenance strategies for portfolios containing systematic reviews and guidelines. METHODS: We employed a conceptual approach combined with a literature review. Components of the diagnostic test-treatment pathway used in clinical healthcare were transferred to develop a framework specifically for systematic review and guideline portfolio maintenance strategies. RESULTS: We developed the Portfolio Maintenance by Test-Treatment (POMBYTT) framework comprising diagnosis, staging, management, and monitoring components. To illustrate the framework's components and their elements, we provided examples from both a clinical healthcare test-treatment pathway and a clinical practice guideline maintenance scenario. Additionally, our literature review provided possible examples for the elements in the framework, such as detection variables, detection tests, and detection thresholds. We furthermore provide three example strategies using the framework, of which one was based on living recommendations strategies. CONCLUSIONS: The developed framework might support the design of maintenance strategies that could contain multiple options besides updating to manage a portfolio (e.g. withdrawing and archiving), even in the absence of the target condition. By making different choices for variables, tests, test protocols, indications, management options, and monitoring, organizations might tailor their maintenance strategy to suit specific contexts and needs. The framework's elements could potentially aid in the design by being explicit about the operational aspects of maintenance strategies. This might also be helpful for end-users and other stakeholders of systematic reviews and clinical practice guidelines.

Knowledge about the best practice guidelines in the nursing degree: A non-randomized post-test design.

AIM: To compare knowledge of Nursing Degree students about Best Practice Guidelines when there are included as teaching content in a subject vs knowledge through having the usual internship experience without teaching specific guidelines contents. DESIGN: Non-randomized post-test-only design with a comparison group. METHODS: 143 students of the nursing degree at the Autonomous University of Barcelona were recruited. The intervention group received a classroom training in three Best Practice Guidelines with Problem-Based Learning methodology. The comparison group only attended internship, without specific guidelines contents. Knowledge was evaluated with an ad hoc post intervention questionnaire. The information was collected between 2016 and 2018. RESULTS: The average score of knowledge was low, 5.1 out of 10, and differs between guides. The best results were obtained by the students with internships and that had consulted the guides on some occasions. Synchronized effort and leadership in Academia and Healthcare are needed to favour evidence-based practice. The combination of the consultation of the Best Practice Guidelines in theoretical learning combined with the practice, increases the knowledge of the Best Practice Guidelines and will favour the implementation of evidence-based practice. Some students were involved in questionnaire design.

Ten-Year Follow-Up of Women at High Risk for Familial Breast and Ovarian Cancer in Otago and Southland, New Zealand.

BACKGROUND: Care for families affected by Familial Breast and Ovarian Cancer (FBOC) is challenging as a broad range of professions and specialties are involved. The aim was to review management and outcomes for a cohort of women at high risk for familial breast and ovarian cancer. METHODS: Ten-year retrospective follow-up study of individuals in Southern New Zealand  assessed by Genetic Health Service New Zealand to be high risk for FBOC and without a personal cancer diagnosis at time of consultation. RESULTS: Twenty women were identified; twelve underwent genetic testing, and a pathogenic BRCA variant was identified in eleven. Eight women had no testing, as no index case was available. Guidelines had been fully adhered to in 55% of women, regardless of BRCA status. Six did not undergo appropriate breast surveillance. To date, seven of the 11 patients who tested positive for a pathogenic BRCA variant (64%) had risk-reducing surgeries. Two women were diagnosed with breast cancer on surveillance imaging; none were diagnosed with ovarian cancer. Four women were lost to follow-up, one of whom subsequently presented with a symptomatic breast cancer. CONCLUSIONS: To our knowledge, this is the first study providing long-term data for FBOC in New Zealand. Overall, guidelines were followed satisfactorily, but some women did not receive appropriate surveillance or referrals. An integrated interdisciplinary long-term care provision model in New Zealand might help to address gaps in FBOC surveillance and management.

Controversies in terminology associated with management of BCG-unresponsive NMIBC in Asia-Pacific.

OBJECTIVES: Examine the understanding of terminologies and management patterns of bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC) in six territories in Asia-Pacific. METHODS: This study involved two phases: (1) a survey with 32 urologists and 7 medical oncologists (MOs) and (2) a factorial experiment and in-depth interviews with 23 urologists and 2 MOs. All clinicians had ≥8 years' experience managing NMIBC patients in Australia, Hong Kong, Japan, South Korea, Singapore, and Taiwan. Data from Phase 1 were summarized using descriptive statistics; content and thematic analyses applied in Phase 2. RESULTS: In phase 1, 35% of clinicians defined BCG-unresponsive as BCG-refractory, -relapse and -resistant, 6% defined it as BCG-refractory and -relapse; 22% classified BCG-failure as BCG-refractory, -relapse, -resistant, and when muscle-invasive bladder cancer is detected. If eligible and willing, 50% (interquartile range [IQR], 50%-80%) of BCG-unresponsive patients would undergo radical cystectomy (RC), and 50% (IQR 20%-50%) of RC-eligible patients would receive bladder-sparing treatment or surveillance. In phase 2, we found that 32%, 88%, and 48% of clinicians, respectively, used "BCG-unresponsive," "BCG-refractory," and "BCG-relapse" in clinical practice but with no consistent interpretation of the terms. Compared with EAU definitions, 8%-60% of clinicians appropriately classified 9 tumor types that are persistent or recurrent after adequate BCG. Fifty percent of clinicians mentioned a lack of bladder-preserving treatment that outperforms RC in quality of life as a reason to retreat BCG-unresponsive patients with BCG. CONCLUSIONS: Our study revealed varied understanding and application of BCG-unresponsive terminologies in practice. There is a need for a uniform and simple definition of BCG-unresponsive disease in Asia-Pacific.