Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study.

INTRODUCTION: Mild traumatic brain injury is common in children and it can be challenging to accurately identify those in need of urgent medical intervention. The Scandinavian guidelines for management of minor and moderate head trauma in children, the Scandinavian Neurotrauma Committee guideline 2016 (SNC16), were developed to aid in risk stratification and decision-making in Scandinavian emergency departments (EDs). This guideline has been validated externally with encouraging results, but internal validation in the intended healthcare system is warranted prior to broad clinical implementation. OBJECTIVE: We aim to validate the diagnostic accuracy of the SNC16 to predict clinically important intracranial injuries (CIII) in paediatric patients suffering from blunt head trauma, assessed in EDs in Sweden and Norway. METHODS AND ANALYSIS: This is a prospective, pragmatic, observational cohort study. Children (aged 0-17 years) with blunt head trauma, presenting with a Glasgow Coma Scale of 9-15 within 24 hours postinjury at an ED in 1 of the 16 participating hospitals, are eligible for inclusion. Included patients are assessed and managed according to the clinical management routines of each hospital. Data elements for risk stratification are collected in an electronic case report form by the examining doctor. The primary outcome is defined as CIII within 1 week of injury. Secondary outcomes of importance include traumatic CT findings, neurosurgery and 3-month outcome. Diagnostic accuracy of the SNC16 to predict endpoints will be assessed by point estimate and 95% CIs for sensitivity, specificity, likelihood ratio, negative predictive value and positive predictive value. ETHICS AND DISSEMINATION: The study is approved by the ethical board in both Sweden and Norway. Results from this validation will be published in scientific journals, and a tailored development and implementation process will follow if the SNC16 is found safe and effective. TRIAL REGISTRATION NUMBER: NCT05964764.

An evaluation of the quality, suitability and impact on equity of clinical practice guidelines relevant to preterm birth for use in Aotearoa New Zealand.

BACKGROUND: Preterm birth is a leading cause of perinatal morbidity and mortality and a defining event for pregnant people, infants, and whanau (extended families). Recommendations have been made for a national preterm birth prevention initiative focusing on equity in Aotearoa New Zealand, including the development of a national best practice guide. An understanding of the number and quality of guidelines, and consideration of their suitability and impact on equity is required. METHODS: Guidelines were identified through a systematic literature search, search of professional bodies websites, and invitation to regional health services in Aotearoa New Zealand. Obstetric and midwifery clinical directors were invited to report on guideline use. Identified guidelines were appraised by a 23-member trans-disciplinary Review Panel; quantitatively using the AGREE-II instrument and qualitatively using modified ADAPTE questions. The quality of guidelines available but not in use was compared against those in current use, and by health services by level of maternity and neonatal care. Major themes affecting implementation and impact on equity were identified using Braun and Clarke methodology. RESULTS: A total of 235 guidelines were included for appraisal. Guidelines available but not in use by regional health services scored higher in quality than guidelines in current use (median domain score Rigour and Development 47.5 versus 18.8, p < 0.001, median domain score Overall Assessment 62.5 versus 44.4, p < 0.001). Guidelines in use by regional health services with tertiary maternity and neonatal services had higher median AGREE II scores in several domains, than those with secondary level services (median domain score Overall Assessment 50.0 versus 37.5, p < 0.001). Groups identified by the Review Panel as experiencing the greatest constraints and limitations to guideline implementation were rural, provincial, low socioeconomic, Maori, and Pacific populations. Identified themes to improve equity included a targeted approach to groups experiencing the least advantage; a culturally considered approach; nationally consistent guidance; and improved funding to support implementation of guideline recommendations. CONCLUSIONS: We have systematically identified and assessed guidelines on preterm birth. High-quality guidelines will inform a national best practice guide for use in Taonga Tuku Iho, a knowledge translation project for equity in preterm birth care and outcomes in Aotearoa.

Use of qualitative research in World Health Organisation guidelines: a document analysis.

BACKGROUND: Guidelines depend on effect estimates, usually derived from randomised controlled trials, to inform their decisions. Qualitative research evidence may improve decisions made but where in the process and the methods to do this have not been so clearly established. We sought to describe and appraise how qualitative research has been used to inform World Heath Organization guidance since 2020. METHODS: We conducted a document analysis of WHO guidelines from 2020 to 2022. We purposely sampled guidelines on the topics of maternal and newborn health (MANH) and infectious diseases, as most of the qualitative synthesis to date has been conducted on these topics, likely representing the 'best case' scenario. We searched the in-built repository feature of the WHO website and used standardised search terms to identify qualitative reporting. Using deductive frameworks, we described how qualitative evidence was used to inform guidelines and appraised the standards of this use. RESULTS: Of the 29 guidelines, over half used qualitative research to help guide decisions (18/29). A total of 8 of these used qualitative research to inform the guideline scope, all 18 to inform recommendations, and 1 to inform implementation considerations. All guidelines drew on qualitative evidence syntheses (QES), and five further supplemented this with primary qualitative research. Qualitative findings reported in guidelines were typically descriptive, identifying people's perception of the benefits and harms of interventions or logistical barriers and facilitators to programme success. No guideline provided transparent reporting of how qualitative research was interpreted and weighed used alongside other evidence when informing decisions, and only one guideline reported the inclusion of qualitative methods experts on the panel. Only a few guidelines contextualised their recommendations by indicating which populations and settings qualitative findings could be applied. CONCLUSIONS: Qualitative research frequently informed WHO guideline decisions particularly in the field of MANH. However, the process often lacked transparency. We identified unmet potential in informing implementation considerations and contextualisation of the recommendations. Use in these areas needs further methods development.

"Going into the black box": a policy analysis of how the World Health Organization uses evidence to inform guideline recommendations.

Background: The World Health Organization (WHO) plays a crucial role in producing global guidelines. In response to previous criticism, WHO has made efforts to enhance the process of guideline development, aiming for greater systematicity and transparency. However, it remains unclear whether these changes have effectively addressed these earlier critiques. This paper examines the policy process employed by WHO to inform guideline recommendations, using the update of the WHO Consolidated HIV Testing Services (HTS) Guidelines as a case study. Methods: We observed guideline development meetings and conducted semi-structured interviews with key participants involved in the WHO guideline-making process. The interviews were recorded, transcribed, and analysed thematically. The data were deductively coded and analysed in line with the main themes from a published conceptual framework for context-based evidence-based decision making: introduction, interpretation, and application of evidence. Results: The HTS guideline update was characterized by an inclusive and transparent process, involving a wide range of stakeholders. However, it was noted that not all stakeholders could participate equally due to gaps in training and preparation, particularly regarding the complexity of the Grading Recommendations Assessment Development Evaluation (GRADE) framework. We also found that WHO does not set priorities for which or how many guidelines should be produced each year and does not systematically evaluate the implementation of their recommendations. Our interviews revealed disconnects in the evidence synthesis process, starting from the development of systematic review protocols. While GRADE prioritizes evidence from RCTs, the Guideline Development Group (GDG) heavily emphasized "other" GRADE domains for which little or no evidence was available from the systematic reviews. As a result, expert judgements and opinions played a role in making recommendations. Finally, the role of donors and their presence as observers during GDG meetings was not clearly defined. Conclusion: We found a need for a different approach to evidence synthesis due to the diverse range of global guidelines produced by WHO. Ideally, the evidence synthesis should be broad enough to capture evidence from different types of studies for all domains in the GRADE framework. Greater structure is required in formulating GDGs and clarifying the role of donors through the process.

The Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer, 2022 Edition: changes from the 2018 edition and general statements on breast cancer treatment.

The Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer, 2022 Edition was published in June 2022. The guidelines were prepared while conforming as much as possible to the "Minds Manual for Guideline Development 2020 ver. 3.0." edited by the Minds Manual Development Committee of the Japan Council for Quality Health Care in 2021. In addition, a survey of Japanese Breast Cancer Society members on the 2018 edition of the guidelines was conducted from February 19 to March 4, 2021. Based on the responses from over 600 members, original innovations were made to make the guidelines more user-friendly. The 2018 edition of the guidelines was developed to provide support tools for physicians and patients to utilize shared decision-making. The 2022 guidelines consist of two volumes: (1) an "Epidemiology and Diagnosis" section covering "Screening and Diagnosis", "Radiological diagnosis", and "Pathological diagnosis", and (2) a "Treatment" section covering "Surgical therapy", "Radiation therapy", and "Systemic therapy". We believe that this concise summary of the guidelines will be useful to physicians and researchers in Japan and overseas.

Effects of glucose-lowering drugs on cardiovascular outcomes in patients with type 2 diabetes: an update.

INTRODUCTION: Over the last few years, there has been a substantial increase in the data available about the benefits of sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in improving cardiovascular and renal outcomes in patients with type 2 diabetes (T2D). Very little new information is available for the other groups of glucose-lowering drugs. AREAS COVERED: This brief report summarizes the recent information about the respective benefits of the two newer groups of glucose-lowering drugs and the effects on cardiovascular risk factors that may be involved in these benefits. The articles reviewed were identified by a Medline search. EXPERT OPINION: Recent guidelines recommend SGLT2 inhibitors or GLP-1 RAs with proven cardiovascular disease benefits as potential first line treatment for patients with T2D and established atherosclerotic cardiovascular disease (ASCVD) or those with high risk of ASCVD or with chronic kidney disease or heart failure. Both groups of drugs have been shown to reduce major adverse cardiovascular events, but the mechanisms vary between them. SGLT2 inhibitors are preferred for the treatment and prevention of heart failure and chronic kidney disease, whereas GLP-1 RAs are more effective in reducing body weight and improving glycemic control in patients with T2D.

Evaluation of the use of a clinical practice guideline for external apical root resorption among orthodontists.

BACKGROUND: External apical root resorption (EARR) is a frequently observed adverse event in patients undergoing fixed appliance therapy. Assessing the patients' risk during treatment is important, as certain factors are assumed to be associated with an increased likelihood of occurrence. However, their predictive value remains limited, making evidence-based clinical decision-making challenging for orthodontists. To address this issue, the Dutch Association of Orthodontists (NvVO) developed a clinical practice guideline (CPG) for EARR in accordance with the AGREE II instrument (Appraisal of Guidelines for Research and Evaluation II) in 2018. The aim of this study is to get insight into the actual utilization and the practical implementation of the guideline among orthodontists. The hypothesis to be tested was that after its introduction, clinical practice for EARR has changed towards the recommendations in the CPG. OBJECTIVE: To investigate the use of the 2018 clinical practice guidelines for EARR among orthodontists 3 years after its introduction. METHODS: A questionnaire using a 7-point Likert scale was developed concerning four domains of EARR described in the guideline. The questionnaire was piloted, finalised, and then distributed digitally among Dutch orthodontists. REDCap was used for data collection, starting with an invitation email in June 2021, followed by two reminders. Effect was tested by the Mann-Whitney U test, and the influence of demographic variables was analysed. RESULTS: Questionnaires were sent out to all 275 and completed by 133 (response rate 48%); N = 59 females and N = 73 males were included; 81% had their training in the Netherlands, 89% had ≥ 6 years of work experience, and 89% worked in private orthodontic practice. One hundred thirty orthodontists (98.5%) reported changes in clinical practice. The biggest positive change in clinical behaviour regarding EARR occurred if EARR was diagnosed during treatment. Sex, clinical experience, country of specialist training, and working environment of the respondents did not affect clinical practices regarding EARR. CONCLUSIONS: This questionnaire demonstrated that, 3 years after introduction of the guideline, orthodontists improved their self-reported clinical practices to a more standardised management of root resorption. None of the demographic predictors had a significant effect on the results.

[Transition in sickle cell disease - recommendations of the transition initiative sickle cell disease]. / Transition bei der Sichelzellkrankheit ­ Empfehlungen der Transitionsinitiative Sichelzellkrankheit.

Sickle cell disease is a rare, but complex multi-systemic disorder with high need of interdisciplinary and specialized care and new structural requirements. Besides care of those chronically sick patients, transition process is a vulnerable phase which highly influences further treatment. To make matters worse, patients often have migration background with subsequent communication problems. A national guidance for a standardized transition process is lacking in Germany. In context of a structured consensus process, the "transition initiative sickle cell disease" developed specific recommendations for a structured transition of sickle cell patients on the basis of the S3 transition guideline of the DGfTM. These recommendations should improve this vulnerable process in this complex disease to ensure adequate further treatment and to avoid acute and chronic complications but also mental, social or job-related issues. Besides improvement of quality of life, medical treatment and survival, health economic aspects arise. Documents were developed to support and facilitate the transition process and are available under www.sichelzellkrankheit.info/transition/.

[Prostate cancer - from the patients' perspective]. / Prostatacancer ur patienternas perspektiv.

Prostate cancer is the most common cancer among Swedish men. To get this diagnose is not only a threat to the men's lives but also to their quality of life because the treatment often affects sexuality, bladder function and bowel function. It is therefore particularly problematic that the rehabilitation of men after treatment for prostate cancer often does not reach the standards set out in the national guidelines. Despite the past years' promotion of standardized cancer care pathways to speed up the process of investigating and treating cancer, the lead times for men who are being investigated for a suspicion of prostate cancer, or are waiting for a planned prostate cancer treatment, are the longest in Swedish cancer care. Patients' organisations are currently active in all 21 Swedish regions to support men with prostate cancer and their near ones. Their national umbrella organisation is increasingly involved in various healthcare organisations, such as the National Prostate Cancer Guidelines Group, and supports clinical prostate cancer research.

Commentary on: physical activity and exercise for mild cognitive impairment and dementia: a collaborative international guideline.

Physical inactivity is an important, but potentially reversible risk factor for dementia and mild cognitive impairment (MCI). There is literature about physical activity and exercise for the prevention and management of dementia and MCI, but this had not been previously synthesized into specific guidelines about this topic. A recent guideline on physical activity and exercise in MCI and dementia was published, authored by several international societies, including lay representatives. In this commentary, we discuss the implications of this guidance for healthcare professionals, caregivers, and lay representatives involved in the care of people with MCI and dementia.The guidelines highlight the importance of physical activity and exercise in cognitively healthy persons and for dementia and MCI, at different stages of these conditions. For primary prevention of dementia, physical activity may be suggested in cognitively healthy persons. In people with MCI, mind-body interventions, such as yoga, have the greatest evidence, whilst the role of physical activity and exercise requires more evidence from high-quality randomized controlled trials. In people living with moderately severe dementia, exercise may be useful for maintaining physical and cognitive function. There are benefits of physical activity and exercise separate from their impact on cognitive outcomes. The guidelines also proposed some questions for future research. In conclusion, there is limited evidence on the beneficial role of physical activity and exercise in preserving cognitive functions in subjects with normal cognition, MCI or dementia. The guidelines support the promotion of physical activity based on the beneficial effects on almost all facets of health.

Experimental evidence on the role of shared protocols as coordination device on clinical best practices.

Our experiment assesses the level of coordination on clinical best practice among physicians and investigates whether the release of guidelines helps in supporting coordination. Based on three clinical vignettes using current national guidelines, physicians evaluate the appropriateness of each of the proposed courses of action. Afterwards, physicians are allowed to ask which action corresponds to national guidelines and change their ratings, if desired. On average, slightly more than half of the sample coordinated on appropriateness evaluations. Empirical analysis indicates that several organizational and individual variables influence the level of coordination. Additionally, the release of national guidelines improved both the level of conformity and coordination. Our findings suggest changes in implementation practices to increase the impact of these shared protocols in the health field.

Guidelines in Practice: A Safe Environment of Care.

Creating a safe environment for performing surgical procedures is essential to achieve successful patient outcomes and protect the perioperative personnel who are providing care. Numerous factors challenge the provision of a safe environment of care and create a complex setting for perioperative nurses to manage. The updated AORN "Guideline for a safe environment of care" provides perioperative nurses with recommendations for establishing a safe environment for both patients and personnel. This article provides an overview of the guideline and discusses recommendations for implementing fire safety protocols, using warming cabinets, and creating a latex-safe environment. It also includes a scenario describing the care of a patient with an unidentified latex allergy who is undergoing a laparoscopic sleeve gastrectomy and hiatal hernia repair. Perioperative nurses should review the guideline in its entirety and implement recommendations as applicable in operative and other procedural settings.

Systematic evaluation of Merkel cell carcinoma clinical practice guidelines using the AGREE II instrument.

Merkel cell carcinoma (MCC) is a rare type of skin cancer that requires a multidisciplinary approach with a variety of specialists for management and treatment. Clinical practice guidelines (CPGs) have recently been established to standardize management algorithms. The objective of this study was to appraise such CPGs via the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Eight CPGs were identified via systematic literature search following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. Four appraisers trained in AGREE II protocols evaluated each CPG and deemed two CPGs as high quality, five as moderate quality, and one as low quality. Intraclass correlation coefficients (ICCs) were calculated to verify reviewer consistency as excellent, good, and moderate across four, one, and one domain, respectively. The majority of MCC CPGs are lacking in specifying stakeholder involvement, applicability, and rigor of development. The two high quality CPGs are from the Alberta Health Services (AHS) and the collaboration between the European Dermatology Forum, the European Association of Dermato-Oncology, and the European Organization of Research and Treatment of Cancer (EDF/EADO/EORTC). The EDF/EADO/EORTC CPG had the highest overall score with no significant deficiencies across any domain. An important limitation is that the AGREE II instrument is not designed to evaluate the validity of each CPG's recommendations; conclusions therefore can only be drawn about each CPG's developmental quality. Future MCC CPGs may benefit from garnering public perspectives, inviting external expert review, and considering available resources and implementation barriers during their developmental stages.

Frequency of Guideline-Discordant Prostate Cancer Screening Among Older Males.

This cross-sectional study examines the association of life expectancy and prostate cancer screening practices among older males using data from a national survey.