Group Guidelines Research Articles

Diagnosis and treatment of venous leg ulcers: S2k Guideline of the German Society of Phlebology and Lymphology (DGPL) e.V.

This S2k guideline on venous leg ulcers was created on the initiative and under the leadership of the German Society of Phlebology and Lymphology (DGPL). The guideline group also consisted of representatives from the German Society for Phlebology and Lymphology, German Dermatological Society, German Society for General Medicine, German Society for Angiology, German Society for Vascular Surgery and Vascular Medicine, German Society for Surgery, German Society for Dermatosurgery, German Society for Wound Healing and Wound Treatment, Professional Association of Phlebologists and Lymphologists and Initiative Chronische Wunden. The aim of this guideline is to combine the different approaches and levels of knowledge of the respective professional groups on the basis of consensus, so that a basic concept for the best possible treatment of patients with venous leg ulcers can be provided. A total of 70 specific recommendations were formulated and agreed upon, divided into the subject areas of diagnostics, therapy, prevention of recurrences, and everyday challenges. The guideline thus reflects the current state of scientific knowledge and is intended to be widely used as the best available document for the treatment of patients with venous leg ulcers in everyday clinical practice.

Scottish Intercollegiate Guidelines Network Guidance on Dementia: The Investigation of Suspected Dementia (SIGN 168) with Focus on Biomarkers-Executive Summary.

This is an executive summary of the recent guidance produced by the Scottish Intercollegiate Guidelines Network (SIGN) dementia guideline group with regards to the investigation of suspected dementia. This is a sub-section of the broader SIGN 168 guideline released in November 2023. The guideline group included clinicians with expertise in Old Age Psychiatry, Neurology, Radiology, and Nuclear Medicine supported by colleagues from the SIGN and Healthcare Improvement Scotland teams. There was representation from carers and support organizations with experience of dementia, to ensure the recommendations were appropriate from the perspective of the people being assessed for possible dementia and their carers. As the 2018 National Institute for Health and Clinical Excellence (NICE) dementia review included a review of the evidenced investigation of dementia, the SIGN guideline development group decided to focus on a review on the up-to-date evidence regarding the role of imaging and fluid biomarkers in the diagnosis of dementia. To give context to the consideration of more advanced diagnostic biomarker investigations, the guideline and this summary include the NICE guidance on the use of standard investigations as well as more specialist investigations. The evidence review supports consideration of the use of structural imaging, nuclear medicine imaging, and established Alzheimer's cerebrospinal fluid biomarkers (amyloid and tau) in the diagnosis of dementia. Although routine use of amyloid positron emission tomography imaging was not recommended, its potential use, under specialist direction, in patients with atypical or young-onset presentations of suspected Alzheimer's dementia was included as a clinical good practice point.

Management of unscheduled bleeding on HRT: A joint guideline on behalf of the British Menopause Society, Royal College Obstetricians and Gynaecologists, British Gynaecological Cancer Society, British Society for Gynaecological Endoscopy, Faculty of Sexual and Reproductive Health, Royal College of General Practitioners and Getting it Right First Time.

Unscheduled bleeding on hormone replacement therapy (HRT) can affect up to 40% of users. In parallel with the increase in HRT prescribing in the UK, there has been an associated increase in referrals to the urgent suspicion of cancer pathway for unscheduled bleeding. On behalf of the British Menopause Society (BMS) an expert review panel was established, including primary and secondary care clinicians with expertise in the management of menopause, with representatives from key related organisations, including the Royal College of Obstetricians & Gynaecologists, the British Gynaecological Cancer Society, British Society for Gynaecological Endoscopy, Royal College of General Practitioners and Faculty of Sexual and Reproductive Health, and service development partners from NHS England and GIRFT (Getting it Right First Time). For each topic, a focused literature review was completed to develop evidence led recommendations, where available, which were ratified by consensus review within the panel and by guideline groups.

Instructional guidelines and group discussion effects on new nurses’ competency regarding nursing care of preterm infants

BackgroundPremature birth was once one of the leading causes of infant mortality. Premature infants require improved medical and nursing skills from a highly competent nursing team. PurposeThis investigation aimed to assess the effects of instructional guidelines and group discussion on new nurses’ competency in preterm infants caring at the Neonatal Intensive Care Unit (NICU). MethodsA single-anonymized, two-group pre-test and post-test study design was accompanied in 2022. The study was accompanied for 50 newly graduated nurses concerned with competence in nursing management of preterm infants at the Neonatal Intensive Care Unit (NICU) in two hospitals: Al-Namas General Hospital, KSA, and the Pediatric Hospital of Assiut University, Egypt. Two groups were randomly selected from among the nurses to be trained on preterm infant nursing care competence either through an instructional guideline or group discussion. Nursing attitudes and practices were measured before and after training using questionnaires and checklists. ResultsThere was no significant difference between the instructional guideline group and the group discussion in the mean total score of attitudes (11.72 and 14.65, P = 0.455) and practices (14.36 and 14.80, P = 0.494) towards caring for preterm infants before intervention. While mean nurses’ attitude and practice scores increased significantly in both groups after the intervention, in the discussion group, nurses' practice scores increased significantly (p = 0.001). Still, there were no significant changes in the instructional guideline group (P = 0.202). ConclusionBoth methods were effective on the newly graduated nurses' attitude; however, the instructional guidelines did not affect their practice regard nursing care of preterm infants. However, group discussion training techniques can effectively improve the nurses’ attitude and practice toward nursing care of preterm infants. Relevance to clinical practiceThe group discussion training method should be the approved and proven method for hospitals to train new nurses to increase clinical practices, especially during nursing care for premature infants, because this method has proven its worth in increasing the skill of nurses. It enables a group to talk about a specific subject and exchange personal stories. This approach involves a group leader facilitating communication and interaction between participants.

Ultrasound assessment of the gravid cervix to assess for risk of spontaneous preterm birth: Introducing an evidence‐based clinical guideline for sonographers

AbstractThis article introduces a new evidence‐based clinical practice guideline (CPG) for sonographers; Ultrasound assessment of the gravid cervix to assess for risk of spontaneous preterm birth (sPTB). The purpose of this new CPG is to provide evidence‐based guidance for sonographers in Australia and New Zealand when making decisions on how and when they should sonographically assess the cervix in the gravid patient. Clinical questions relevant to the sonographic assessment of the gravid cervix were developed to inform the CPG. The primary sources to answer the clinical questions were relevant, existing CPGs. Recommendations in these existing CPGs were appraised for the level of evidence on which they were based and adapted for use in the new CPG. New recommendations were adapted from 19 existing CPGs rated as being based on best evidence and were applicable to three specific patient groups, each at different risk for sPTB. ‘How to Guidance’, statements about safety, acceptability, feasibility of ultrasound techniques, sonographer training and supplementary material were also developed using information from existing CPGs, relevant literature and the clinical experience of clinical guideline group members. The CPG recommendations, ‘how to guides’ and areas of future research are presented in this article. The full guideline and its supplementary materials are available at https://www.sonographers.org/resources-tools/clinical-guidance.

P002 A comparison between radiologically reported osteopenia and the FRAX score as an indication for bone densitometry

Abstract Background/Aims Osteopenia is defined as a bone mineral density score between -1 and -2.5 standard deviations compared to a young adult reference mean (T-score) based on dual energy x-ray absorptiometry (DXA). Radiologists continue to use the term in a generic and qualitative manner to mean decreased bone mineral density, but they cannot distinguish between osteopenia and osteoporosis which means patients then go on to have a DXA. We would like to see if a FRAX (fracture risk assessment tool) can safely replace osteopenia as an indication for a DXA. Methods We retrospectively identified 2276 patients to have had a DXA scan from October 2022 to March 2023 according to the departmental database. Their referral forms were obtained from the Electronic Medical Record (EMR). Out of these, 150 patients were referred with a sole indication being radiologically reported osteopenia. Out of 150 patients, 22 were excluded as they were found to have other indications not reported on their referral from and seven more were excluded as three had bilateral hip replacement, three were below 40 and one was undergoing gender reassignment and was on oestrogen. The remaining 121 patients were included in the study and their post BMD ( bone mineral density) FRAX score was obtained from patient EMR. Pre BMD FRAX was also calculated using clinical information available on patient’s EMR retrospectively. NOGG ( National Osteoporosis Guideline Group) recommendation of treatment based on the fracture risk as per the FRAX were then compared between pre and post BMD retrospectively to see if there would be any change in treatment plan. Results Of total 121 patients included, 94 were female. Mean age was 68 years. Retrospective review of the case notes revealed that using a FRAX with BMD, total 34 (28.1%) patients needed treatment for osteoporosis while 87 (71.9%) did not. Of 87 patients not requiring treatment, 55 would not have received DXA scan if FRAX assessment was done without BMD. Of the 34 who did need treatment, 32 would still be recommended for a DXA while only two patients wouldn’t. However, these two patients had other clinical indications for osteoporosis assessment and would still have required a specialist referral such that a decision can be made about DXA. Conclusion If radiologically reported osteopenia as an indication for a DXA is replaced by FRAX, DXA would not be needed in nearly half of the patients. This will have potential to save scarce DXA resource without compromising patient safety, treatment plan, and will reduce waiting times. Disclosure S. Srinivas: None. K. Hood: None. H. Sapkota: None.

New S2k guideline "Surgical techniques for gender incongruence"

Various techniques for the surgical treatment of gender incongruence (GI) have been available for years. The spectrum is broad and covers various specialties. In recent years, there has been an increase in the number of clinics offering body-modifying procedures. This has led to aconsiderable variation in methods in some cases. Although the topic has recently found its way more and more into teaching and the relevant specialist literature, there are still no evidence-based recommendations on the various techniques. Acompendium of established surgical techniques was to be compiled, containing recommendations on indication, performance and aftercare as well as complication management and subjecting them to aconsensus-based evaluation. In accordance with "Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften" (AWMF) regulations, the guideline was developed at level S2k, i.e., it is consensus based. The guideline group was founded in February 2019 in aformal constituent meeting. Atotal of 14medical societies and 2interest groups were recruited for the guideline work. In the end, two consensus meetings were held, which was due to the large number of recommendations and background texts to be adopted. The guideline focuses on the choice and applicability of surgical techniques as well as the wishes of those seeking treatment and protection of fertility. There is awide variety of methods and treatment goals for each individual. Taking into account medical standards, recommendations, and contraindications, an optimal result that minimizes individual suffering can be achieved together with the person seeking treatment. The content of the guideline represents aunique compendium of surgical methods, recommendations for the selection of procedures, and common indications in the field of body-modifying surgery for gender incongruence.

2024 guidelines for the vaccination of dogs and cats - compiled by the Vaccination Guidelines Group (VGG) of the World Small Animal Veterinary Association (WSAVA).

2024 guidelines for the vaccination of dogs and cats - compiled by the Vaccination Guidelines Group (VGG) of the World Small Animal Veterinary Association (WSAVA).

A methodological protocol for the development of a national guideline on perioperative management of gastrointestinal tumors in Germany.

The success of abdominal cancer surgery depends not only on the surgery itself but is influenced by the overall perioperative management. Given the multitude of perioperative measures and the ever-increasing number of studies on perioperative management, it is difficult to keep track and provide evidence-based perioperative management. The planned guideline on perioperative management will review the existing evidence and derive treatment recommendations. The processing of the evidence is carried out by 6 working groups according to an 8-step scheme: after drafting the guideline questions in PICO format (1), a systematic literature search is carried out (2), and the records found are screened by two independent reviewers from the coordination team. Subsequently, the full texts of the potentially relevant articles are made available to the working groups for full text screening (3). All articles to be included are reviewed for methodological quality (4) before summary of findings tables are generated (5). In line with the GRADE approach, confidence in the evidence is assessed (6) before a recommendation is derived from the evidence, using a modified GRADE Evidence to Decision Framework (7). Finally, all recommendations are compiled and agreed within the guideline group (8). Guidelines serve as foundation for therapy decisions in everyday clinical practice and should therefore be based on up-to-date research results. However, while primary studies and systematic reviews are critically reviewed for their methodological quality, the process of guideline development is often not comprehensible. A protocol with predefined methodology should therefore create transparency and strengthen confidence in the recommendations. The guideline is registered in the AWMF (Association of the Scientific Medical Societies) Guideline Register (088-010OL).

Patient and health professional views on risk-stratified monitoring of immune-suppressing treatment in adults with inflammatory diseases.

To explore the acceptability of an individualised risk-stratified approach to monitoring for target-organ toxicity in adult patients with immune-mediated inflammatory diseases established on immune-suppressing treatment(s). Adults (≥18 years) taking immune-suppressing treatment(s) for at-least six months, and healthcare professionals (HCPs) with experience of either prescribing and/or monitoring immune-suppressing drugs were invited to participate in a single, remote, one-to-one, semi-structured interview. Interviews were conducted by a trained qualitative researcher and explored their views and experiences of current monitoring and acceptability of a proposed risk-stratified monitoring plan. Interviews were transcribed verbatim and inductively analysed using thematic analysis in NVivo. Eighteen patients and 13 HCPs were interviewed. While participants found monitoring of immune-suppressing drugs with frequent blood-tests reassuring, the current frequency of these was considered burdensome by patients and HCPs alike, and to be a superfluous use of healthcare resources. Given abnormalities rarely arose during long-term treatment, most felt that monitoring blood-tests were not needed as often. Patients and HCPs found it acceptable to increase the interval between monitoring blood-tests from three-monthly to six-monthly or annually depending on the patients' risk profiles. Conditions of accepting such a change included: allowing for clinician and patient autonomy in determining an individuals' frequency of monitoring blood-tests, the flexibility to change monitoring frequency if someone's risk profile changed, and endorsement from specialist societies and healthcare providers such as the National Health Service. A risk-stratified approach to monitoring was acceptable to patients and HCPs. Guideline groups should consider these findings when recommending blood-test monitoring intervals.

Development of an opportunistic diagnostic prediction algorithm for osteoporosis and fragility fracture risk estimates from forearm radiographs (The OFFER1 Study).

Osteoporosis and associated fractures are an increasingly prevalent concern with an ageing population. This study reports testing of IBEX Bone Health (IBEX BH) software, applied following acquisition of forearm radiographs. IBEX Bone Health analyses the radiograph to measure areal bone mineral density (aBMD) at the examination site. A non-randomized cross-sectional study design was performed involving 261 (254 after exclusions) participants (112/142m/f; mean age 70.8years (SD+/-9.0); 53 with osteoporosis). They underwent posterior-anterior distal forearm radiographs; dual X-ray absorptiometry (DXA) of the wrists, hips, and lumbar spine; and questionnaires exploring clinical risk factors. IBEX Bone Health automatically identifies regions of interest (ROI) at the ultra-distal (UD) and distal third (TD) regions of the radius. Analysis investigated area under the receiver operating characteristics curve performance of IBEX BH for prediction of (i) osteoporosis (based on clinical reporting of the hip and spine DXA) and (ii) treatment recommendations by Fracture Risk Assessment Tool (FRAX) inclusive of neck of femur (NoF) areal bone mineral density (aBMD) results following National Osteoporosis Guideline Group (NOGG) guidelines. Area under the receiver operating characteristics curve for osteoporosis prediction at the UD and TD ROIs were 0.86 (99% confidence interval (CI) [0.80, 0.91]) and 0.81 (99% CI [0.75, 0.88]), respectively. Area under the receiver operating characteristics curve for treatment recommendation using FRAX inclusive of NoF aBMD at the UD and TD ROIs were 0.95 (99% CI [0.91, 1.00]) and 0.97 (99% CI [0.93,1.00]), respectively. With a matched sensitivity to FRAX (without NoF aBMD) 0.93 (99% CI [0.78, 0.99]), IBEX BH predicted at the UD and TD ROIs recommended treatment outcomes by NOGG guidelines using FRAX (with NoF aBMD) with specificity 0.89 (99% CI 0.83, 0.94]) and 0.93 (99% CI [0.87, 0.97]), respectively. This is compared with 0.60 (99% CI [0.51, 0.69]) for FRAX (without NoF aBMD). Results demonstrate the potential clinical utility of IBEX BH as an opportunistic screening tool.

Provider Perceptions of an Electronic Health Record Prostate Cancer Screening Tool.

We conducted a focus group to assess the attitudes of primary care physicians (PCPs) toward prostate-specific antigen (PSA)-screening algorithms, perceptions of using decision support tools, and features that would make such tools feasible to implement. A multidisciplinary team (primary care, urology, behavioral sciences, bioinformatics) developed the decision support tool that was presented to a focus group of 10 PCPs who also filled out a survey. Notes and audio-recorded transcripts were analyzed using Thematic Content Analysis. The survey showed that PCPs followed different guidelines. In total, 7/10 PCPs agreed that engaging in shared decision-making about PSA screening was burdensome. The majority (9/10) had never used a decision aid for PSA screening. Although 70% of PCPs felt confident about their ability to discuss PSA screening, 90% still felt a need for a provider-facing platform to assist in these discussions. Three major themes emerged: (1) confirmatory reactions regarding the importance, innovation, and unmet need for a decision support tool embedded in the electronic health record; (2) issues around implementation and application of the tool in clinic workflow and PCPs' own clinical bias; and (3) attitudes/reflections regarding discrepant recommendations from various guideline groups that cause confusion. There was overwhelmingly positive support for the need for a provider-facing decision support tool to assist with PSA-screening decisions in the primary care setting. PCPs appreciated that the tool would allow flexibility for clinical judgment and documentation of shared decision-making. Incorporation of suggestions from this focus group into a second version of the tool will be used in subsequent pilot testing.

Phenotype versus genotype to optimize cancer dosing in the clinical setting-focus on 5-fluorouracil and tyrosine kinase inhibitors.

Cancer medicines often have narrow therapeutic windows; toxicity can be severe and sometimes fatal, but inadequate dose intensity reduces efficacy and survival. Determining the optimal dose for each patient is difficult, with body-surface area used most commonly for chemotherapy and flat dosing for tyrosine kinase inhibitors, despite accumulating evidence of a wide range of exposures in individual patients with many receiving a suboptimal dose with these strategies. Therapeutic drug monitoring (measuring the drug concentration in a biological fluid, usually plasma) (TDM) is an accepted and well validated method to guide dose adjustments for individual patients to improve this. However, implementing TDM in routine care has been difficult outside a research context. The development of genotyping of various proteins involved in drug elimination and activity has gained prominence, with several but not all Guideline groups recommending dose reductions for particular variant genotypes. However, there is increasing concern that dosing recommendations are based on limited data sets and may lead to unnecessary underdosing and increased cancer mortality. This Review discusses the evidence surrounding genotyping and TDM to guide decisions around best practice.

Radiofrequency denervation of the spine and the sacroiliac joint : Asystematic literature search according to GRADE with newGerman S3 guideline

This article summarizes the results of the German guideline on radiofrequency denervation of the facet joints and the sacroiliac joint. Evidence on the indications, test blocks and technical parameters are presented. The aim is to avoid overtreatment and undertreatment, which is also of socioeconomic importance. Asystematic evaluation of the literature was carried out according to the grading of recommendations assessment, development and evaluation (GRADE) approach. Amultidisciplinary guideline group has developed recommendations and statements. Statements and recommendations were given for 20key questions. There was an 87.5% consensus for 1 recommendation and 100% consensus for all other recommendations and statements. The guideline was approved by all scientific medical societies involved. Specific questions included the value of the medical history, examination and imaging, the need for conservative treatment prior to an intervention, the importance of test blocks (medial branch block and lateral branch block), choice of imaging for denervation, choice of trajectory, the possibility to influence the size of the lesion, stimulation, the possibility of revision, sedation and decision support for patients with anticoagulants, metal implants and pacemakers and advice on how to avoid complications. Selected patients can benefit from well-performed radiofrequency denervation. The guideline recommendations are based on very low to moderate quality of evidence.

Application of the PANELVIEW instrument to evaluate the guideline development process of the German polytrauma guideline.

PANELVIEW is an instrument for evaluating the appropriateness of the process, methods, and outcome of guideline development and the satisfaction of the guideline group with these steps. To evaluate the guideline development process of the German guideline on the treatment of patients with severe/multiple injuries ('German polytrauma guideline') from the perspective of the guideline group, and to identify areas where this process may be improved in the future. We administered PANELVIEW to the participants of the 2022 update of the German polytrauma guideline. All guideline group members, including delegates of participating medical societies, steering group members, authors of guideline chapters, the chair, and methodological lead, were invited to participate. Responses were analysed using descriptive statistics. Comments received were categorised by domains/items of the tool. After the first, second, and last consensus conference, the guideline group was invited via email to participate in a web-based survey. Response rates were 36% (n/N = 13/36), 40% (12/30), and 37% (20/54), respectively. The mean scores for items ranged between 5.1 and 6.9 on a scale from 1 (fully disagree) to 7 (fully agree). Items with mean scores below 6.0 were related to (1) administration, (2) consideration of patients' views, perspectives, values, and preferences, and (3) the discussion of research gaps and needs for future research. The PANELVIEW tool showed that the guideline group was satisfied with most aspects of the guideline development process. Areas for improvement of the process were identified. Strategies to improve response rates should be explored.

Effects of breastfeeding in postoperative complication in pediatric population: a systematic review.

Surgical complications in younger patients can lead to infections, delayed healing, prolonged hospital stays, and other negative outcomes, significantly affecting their recovery. This study explores the potential impact of breastfeeding on mitigating these complications, aiming to enhance our understanding of postoperative care for paediatric and adolescent patients. The authors conducted a systematic search on databases such as PubMed, Scopus, Web of Science, and EMBASE, using relevant MESH keywords, adhering to the "Preferred Reporting Items for Systematic Reviews and Meta-analysis" methodology. Quality assessments were performed, and studies scoring above 70% were included for standardized data incorporation. Data extraction followed Cochrane Consumers and Communication Review group's guidelines. Bias and ethical criteria were considered and provided valuable evidence to answer the research question. Among 402 initially reviewed articles, six met inclusion criteria: 3 observational cohort studies, 2 systematic reviews, and 1 randomized controlled trial. The selected literature consistently demonstrates a significant reduction in postoperative infection rates and improved outcomes. Breastfeeding shortened postoperative hospital stays, accelerated recovery, and enhanced nutritional status, potentially reducing healthcare resource utilization and patient financial burden. Lower mortality and morbidity rates were also observed. This systematic review provides compelling evidence of breastfeeding's positive impact on surgical outcomes in the paediatric population. While the authors' findings support the benefits of breastfeeding in this age group, further large-scale, multicenter research is needed to provide stronger evidence for guiding clinical practices.

ESHRE guideline: number of embryos to transfer during IVF/ICSI†.

ESHRE guideline: number of embryos to transfer during IVF/ICSI†.

Commissioning and implementing a Quality Assurance program for dedicated radiation oncology MRI scanners.

ACR and AAPM task group's guidelines addressing commissioning for dedicated MR simulators were recently published. The goal of the current paper is to present the authors' 2-year experience regarding the commissioning and introduction of a QA program based on these guidelines and an associated automated workflow. All mandatory commissioning tests suggested by AAPM report 284 were performed and results are reported for two MRI scanners (MAGNETOM Sola and Aera). Visual inspection, vendor clinical or service platform, third-party software, or in-house python-based code were used. Automated QA and data analysis was performed via vendor, in-house or third-party software. QATrack+ was used for QA data logging and storage. 3D geometric distortion, B0 inhomogeneity, EPI, and parallel imaging performance were evaluated. Contrasting with AAPM report 284 recommendations, homogeneity and RF tests were performed monthly. The QA program allowed us to detect major failures over time (shimming, gradient calibration and RF interference). Automated QA, data analysis, and logging allowed fast ACR analysis daily and monthly QA to be performed in 3h. On the Sola, the average distortion is 1mm for imaging radii of 250mm or less. For radii of up to 200mm, the maximum, average (standard deviation) distortion is 1.2 and 0.4mm (0.3mm). Aera values are roughly double the Sola for radii up to 200mm. EPI geometric distortion, ghosting ratio, and long-term stability were found to be under the maximum recommended values. Parallel imaging SNR ratio was stable and close to the theoretical value (ideal g-factor). No major failures were detected during commissioning. An automated workflow and enhanced QA program allowed to automatically track machine and environmental changes over time and to detect periodic failures and errors that might otherwise have gone unnoticed. The Sola is more geometrically accurate, with a more homogenous B0 field than the Aera.

Intensive Blood Pressure Lowering and Renal Function in Ischemic Stroke Patients: Secondary Analysis of the ENCHANTED Trial

Introduction: Renal failure is a major safety concern of intensive systolic blood pressure (SBP) lowering. We aimed to determine the effect of this treatment on early change in renal function in participants of the international Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED). Methods: Post hoc analysis of the ENCHANTED BP-arm in which thrombolyzed patients with acute ischemic stroke (AIS) were randomized to intensive (target 130–140 mm Hg within 1 h) or guideline-recommended (target ∆eGFR = 24 h – baseline eGFR), analyzed using linear regression with adjustment for clinical variables. Key SBP parameters were attained (mean), variability (standard deviation), and magnitude of reduction within 24 h. Results: Of 2,151 participants (mean age 66.9 years; 38% female) included with the available baseline eGFR, there were significant differences in attained 144.3 ± 10.2 versus 149.8 ± 12.0 [Δ5.5 mm Hg]; p p p ∆eGFR (adjusted mean difference −1.10, 95% confidence interval [CI] −3.14 to −0.94; p = 0.29) between the intensive and guideline groups, respectively. The neutral effect on ∆eGFR was consistent in patients with different baseline eGFR stages and in sensitivity analysis after multiple imputations for missing follow-up eGFR. SBP variability was significantly associated with decreasing ∆eGFR (per 5 mm Hg increase by category: adjusted mean difference −1.35, 95% CI: −2.43 to −0.28; p for trend = 0.01). Conclusion: Intensive SBP lowering with a target of 130–140 mm Hg had no impact on early renal function in thrombolyzed AIS patients. Wide SBP variability was associated with a larger decline in eGFR.

Grading of recommendations, assessment, development and evaluations concept 7: issues and insights linking guideline recommendations to trustworthy essential medicine lists

ObjectivesGuidelines and essential medicine lists (EMLs) bear similarities and differences in the process that lead to decisions. Access to essential medicines is central to achieve universal health coverage. The World Health Organization (WHO) EML has guided prioritization of essential medicines globally for nearly 50 years, and national EMLs (NEMLs) exist in over 130 countries. Guideline and EML decisions, at WHO or national levels, are not always coordinated and aligned. We sought to explore challenges, and potential solutions, for decision-making to support trustworthy medicine selection for EMLs from a Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Working Group perspective. We primarily focus on the WHO EML; however, our findings may be applicable to NEML decisions as well. Study Design and SettingWe identified key challenges in connecting the EML to health guidelines by involving a broad group of stakeholders and assessing case studies including real applications to the WHO EML, South Africa NEML, and a multiple sclerosis guideline connected to a WHO EML application for multiple sclerosis treatments. To address challenges, we utilized the results of a survey and feedback from the stakeholders, and iteratively met as a project group. We drafted a conceptual framework of challenges and potential solutions. We presented a summary of the results for feedback to all attendees of the GRADE Working Group meetings in November 2022 (approximately 120 people) and in May 2023 (approximately 100 people) before finalizing the framework. ResultsWe prioritized issues and insights/solutions that addressed the connections between the EML and health guidelines. Our suggested solutions include early planning alignment of guideline groups and EMLs, considering shared participation to strengthen linkage, further clarity on price/cost considerations, and using explicit shared criteria to make guideline and EML decisions. We also provide recommendations to strengthen the connection between WHO EML and NEMLs including through contextualization methods. ConclusionThis GRADE concept article, jointly developed by key stakeholders from the guidelines and EMLs field, identified key conceptual issues and potential solutions to support the continued advancement of trustworthy EMLs. Adopting structured decision criteria that can be linked to guideline recommendations bears the potential to advance health equity and gaps in availability of essential medicines within and between countries.