Guideline Recommendations Research Articles

Corrigendum: A global analysis of portion size recommendations in food-based dietary guidelines

Corrigendum: A global analysis of portion size recommendations in food-based dietary guidelines

Evidence-based recommendations for comprehensive regulatory guidelines in medical devices: the imperative for global harmonization.

The medical device industry has experienced a significant upsurge in the number, diversity, and complexity of devices over the last two decades. As the global demand for medical devices grows, regulatory frameworks across major economies, including the USA, Europe, India, China, and Australia, have evolved to ensure safety, quality, and efficacy. This review critically examines the regulatory guidelines for medical devices across these regions, emphasizing the need for harmonization to streamline approval processes and reduce regulatory barriers. While countries like the USA and Europe have well-established regulatory systems-such as the Food and Drug Authority (FDA) and European Medicines Agency (EMA)-other nations, including India, are rapidly advancing their frameworks, as seen with the introduction of the Indian Medical Device Rules, 2017, and subsequent amendments. Global initiatives, such as the Global Harmonization Task Force (GHTF), Central Drug Standard Control Organisation (CDSCO), EU Medical Device Regulations (MDR), In Vitro Diagnostic Regulation (IVDR), and the International Medical Device Regulators Forum (IMDRF), have made strides in fostering collaboration, yet disparities remain. Harmonized regulations would mitigate challenges related to device registration, manufacturing, and post-market surveillance, expediting access to high-quality, safe medical devices. The review also highlights the growing prevalence of drug-device combination products, their regulatory complexities, and the importance of aligning regulatory practices globally. A harmonized regulatory framework is essential to promote innovation, reduce duplication of work, and ensure the timely availability of medical devices to patients in need. This review explores the evolution of medical devices from ancient practices to modern technologies, emphasizing projected market growth and the need for regulatory harmonization to facilitate innovation and access. It also assesses how emerging technologies are shaping future regulatory frameworks.

Contextualizing guidelines for the health system of Cyprus: Experiences and lessons learnt

AbstractBackgroundCyprus is undergoing a major health reform with the recent establishment of the General Healthcare System (GHS). The GHS offers equal healthcare access through one primary insurer (Health Insurance Organization [HIO]) and benefits from a wide collaborative network of public and private healthcare providers. However, unwanted variation in practice makes this transition challenging. Healthcare guidelines could decrease these variations in practice, but Cyprus lacks the capacity to develop them de novo. Through a collaboration with the National Institute for Health and Care Excellence (NICE) in the United Kingdom, the contextualization of NICE guidelines and the derivation of local quality indicators are carried out. This study presents the methodology and experience of contextualizing the first three NICE guidelines and deriving associated quality indicators in Cyprus.MethodsHIO managed the guideline contextualization with the support of a Guidelines Secretariat. For each guideline, a local topic expert committee (TEC) was recruited. Through a series of meetings, followed by public consultation, each TEC made contextual changes to the guideline and derived relevant quality indicators. During this process, NICE assured quality by overseeing several elements of the contextualization procedure such as TEC membership, proposed changes and justification and derived quality indicators.ResultsBetween 2022 and 2024, three NICE guidelines, NG196 on Atrial fibrillation (AF), NG230 on Thyroid cancer (TC) and NG203 on Chronic kidney disease (CKD), were contextualized through the modification of several individual guideline recommendations (21/79 [26.6%] in AF, 37/67 [55.2%] in TC and 62/217 [28.6%] in CKD). In parallel, NICE quality indicators were screened for applicability and feasibility in Cyprus while additional indicators were developed if required.ConclusionIn a country with limited experience in guideline development, a supervised and systematic process supported by an established organization ensures quality, is less resource intensive and builds capability for the sustainability of the process.

Multi-societal endorsement of the 2024 European guideline recommendations on coronary revascularization.

Multi-societal endorsement of the 2024 European guideline recommendations on coronary revascularization.

Things We Do for No Reason: Routine use of antibiotics for acute uncomplicated diverticulitis.

The treatment of acute uncomplicated diverticulitis (UD) with antibiotics remains common despite substantial evidence supporting the non-inferiority of nonantibiotic outpatient management. In the past 15 years, there have been two landmark randomized-controlled clinical trials, follow-up studies, and numerous retrospective studies that have supported the non-inferiority of nonantibiotic management of UD. Multiple medical societies including the American Gastroenterological Association and the American College of Physicians recommend using antibiotics selectively rather than routinely in UD. We aim to raise physician awareness of the latest guideline recommendations through our article, potentially improving antibiotic stewardship and reducing related healthcare costs.

Outcome prediction, quality of life, and life expectancy in metastatic spine tumors: WFNS spine committee recommendation.

This review aimed to formulate the most current, evidence-based recommendations for the prediction of outcome, life expectancy, and quality of life in patients with metastatic vertebral tumors. A systematic literature search on PubMed and Google Scholar from 2012-2022 was done, using the keywords "metastatic vertebral tumors + outcome prediction + prognoses," "quality of life + spine metastases," and "spine metastases + life expectancy." Our PubMed search yielded 402 articles for outcome prediction, whereas 40 articles were identified for life expectancy in spine metastases. These were carefully screened by the co-authors, resulting in 61 and 11 final articles analyzed for this study. Our PubMed search for quality of life yielded 137 articles, of which 63 were carefully analyzed for this study. This up-to-date information was reviewed at two separate Spine Committee meetings of the World Federation of Neurosurgical Societies (WFNS). Two rounds of the Delphi method were used to vote and arrive at a positive or negative consensus. The WFNS Spine Committee finalized seven recommendation guidelines on the prediction of outcome, life expectancy, and quality of life in metastatic vertebral tumors. Irrespective of the primary tumor, surgical decompression in appropriately selected patients potentially improves the quality of life. Pre-operative ambulatory status, overall performance, and age are independent predictors of outcome and overall survival. Prognostic scoring systems have evolved to principle-based algorithms, amongst which NOMS is the most widely used.The best tools to measure the quality of life are EUQOL5-D and SOSGOQ in patients with metastatic spine disease.

Obstacles to meeting nutritional recommendations in a tertiary pediatric intensive care unit.

Optimal nutrition is associated with positive outcomes in critically ill children. In 2017, the Society of Critical Care Medicine (SCCM) and the American Society of Parenteral and Enteral Nutrition (ASPEN) updated guidelines for nutritional support for this population. However, implementation of these guidelines may be delayed due to clinical barriers. We aimed to assess our practice against the recommendations of the ASPEN guidelines, hypothesizing that caregiver bias and clinical factors may hinder their implementation in our pediatric intensive care unit (PICU). We focused on two ASPEN recommendations: (1) feeding within 48 h (48H) of admission and (2) meeting two thirds of estimated caloric requirements after seven calendar days. All children aged 1 month to 16 years admitted to our PICU from July 2017 to January 2020 were eligible. Using a retrospective chart review, nutritional and clinical data were collected at the time of admission, at 48H, and 7 calendar days after admission. A total of 533 patients were included. After 48H of admission to the PICU, 402 out of 533 (75.4%) patients received feeding. The following factors were associated with not reaching nutritional goals at 48H: invasive ventilation support, inotropic and vasoactive support, and extracorporeal life support. After 7 days, 95 out of 118 (80.5%) received two thirds of caloric needs. At 7 days, the main obstacle to meeting caloric goals was invasive ventilation. In a representative tertiary PICU, barriers to meeting ASPEN nutritional recommendations included hemodynamic instability or invasive ventilator support, especially within the first 48H of admission.

Are Trends in Economic Modeling of Pediatric Diabetes Mellitus up to Date with the Clinical Practice Guidelines and the Latest Scientific Findings?

Background: Modeling techniques in the field of pediatrics present unique challenges beyond traditional model limitations, and sometimes difficulties in faithfully simulating the condition's evolution over time. Objective: This study aimed to identify whether economic modeling approaches in diabetes in pediatric patients align with the recommendations of clinical practice guidelines and the latest scientific evidence. Methods: A literature review was performed in March 2023 to identify modeling-based economic evaluations in diabetes in pediatric patients. Data were extracted and synthesized from eligible studies. Clinical practice guidelines for diabetes were gathered to compare their alignment with modeling strategies. Two endocrinology specialists provided insights on the latest findings in diabetes that are not yet included in the guidelines. A multidisciplinary group of experts agreed on the relevant themes to conduct the comparative analysis: parameter informing on glycemic control, diabetic ketoacidosis/hypoglycemia, C-peptide as prognostic biomarker, metabolic memory, age at diagnosis, socioeconomic status, pediatric-specific sources of risk equations, and pediatric-specific sources of utilities/disutilities. Results: Nineteen modeling-based studies (7 de novo, 12 predesigned models) and 34 guidelines were selected. Hemoglobin A1c was the main parameter to model the glycemic control; however, guidelines recommend the usage of complementary measures (eg, time in range) which are not included in economic models. Eight models included diabetic ketoacidosis (42.1%), 16 included hypoglycemia (84.2%), 2 included C-peptide (1 of those as prognostic factor) (10.5%) and 1 included legacy effect (5.3%). Neither guidelines nor models included recent findings, such as age at diagnosis or socioeconomic status, as prognostic factors. The lack of pediatric-specific sources for risk equations and utility/disutility values were additional limitations. Discussion: Economic models designed for assessing interventions in diabetes in pediatric patients should be based on pediatric-specific data and include novel adjuvant glucose-monitoring metrics and latest evidence on prognostic factors (C-peptide, legacy effect, age at diagnosis, socioeconomic status) to provide a more faithful reflection of the disease. Conclusions: Economic models represent useful tools to inform decision making. However, further research assessing the gaps is needed to enhance evidence-based health economic modeling that best represents reality.

Inpatient Metformin Utilization and Post-hospitalization Clinical Outcomes: An Observational Cohort Study.

Metformin is the first-line treatment for diabetes, with multiple long-term benefits. However, there is limited evidence for its use in the inpatient setting, and clinical guidelines have historically recommended holding oral diabetes medications during acute hospitalization. While studies have not found evidence of harm from continuing metformin during hospitalization, withholding may lead to unnecessary insulin prescriptions, which in turn may lead to hypoglycemia events after discharge and other associated complications. To investigate the association between metformin use during hospitalization and post-hospitalization outcomes. Observational cohort study from January 2016 to January 2022, emulating a target trial. Adults with type 2 diabetes admitted to a Veterans Health Administration hospital for common medical conditions. Continuation of an outpatient metformin prescription during hospitalization. Hypoglycemia within 90 days of discharge. Secondary outcomes included insulin prescriptions at discharge, 90-day readmissions, and 90-day mortality. The propensity-matched cohort included 67,162 hospitalizations, equally split between those who did and did not have metformin continued during hospitalization. Within 90 days of hospital discharge, those that received metformin had lower risk of hypoglycemia (1.5% vs 1.8%; OR 0.83, 95% CI 0.73-0.93; p = 0.003), readmissions (29.4% vs 30.6%; OR 0.96, 95% CI 0.92-1.00; p= 0.03), and mortality (6.4% vs 7.4%; OR 0.86, 95% CI 0.80-0.92; p <0.001). Patients receiving metformin also had lower risk of insulin prescriptions at discharge (18.5% vs 20.3%; OR 0.89, 95% CI 0.84-0.95; p<0.001). Continuation of metformin during hospitalization for patients with type 2 diabetes was associated with decreased risk of post-hospitalization insulin prescriptions and 90-day hypoglycemia, readmissions, and mortality. These findings question clinical guideline recommendations to hold metformin during hospitalization.

Local clinical practice patterns in urolithiasis guidelines: a critical evaluation from Turkey

PurposeThis study aimed to evaluate the current clinical practice patterns regarding the utilization of “Urolithiasis Guidelines” in Turkey and to identify critical factors influencing their application by urologists.MethodsThe study targeted practicing urologists in Turkey, primarily those involved in the management of urolithiasis, to assess their perspectives and experiences regarding the clinical application of established guidelines. A total of 415 urology specialists were invited to participate in a survey-based study conducted via Google Forms. Participation was voluntary, and 65.08% of the invited urologists completed the survey.ResultsAmong the respondents, 84.7% reported utilizing the available guidelines in their routine clinical practice, with varying frequencies of reference. The primary motivations for guideline use were the prevention of potential complications and the avoidance of legal risks, as indicated by 90.5% of respondents. While 56.9% of participants adhered to the guidelines as a clinically standardized practice, 41.6% reported applying the recommendations on a case-by-case basis. Notably, 41.0% of respondents emphasized the need for locally adapted versions of guideline texts. Additionally, nearly half of the participants reported receiving no formal education or training on the significance, content, and practical application of these guidelines. Furthermore, 12.7% expressed skepticism about the evidence-based foundation of the guidelines, questioning whether the recommendations were derived from rigorously conducted studies.ConclusionThe available urolithiasis guidelines are recognized as valuable resources offering key recommendations for the effective and safe management of urolithiasis. However, findings from this survey highlight significant variability in clinical practice patterns due to local conditions and the individual experience and attitudes of practicing urologists. The application of guideline recommendations is further influenced by perceptions regarding their development, content, and practicality. Insights gathered from this study may contribute to improving the preparation, dissemination, and implementation of urolithiasis guidelines, particularly in adapting them to local clinical settings.

Relationship Between Preoperative Fasting Duration and Anxiety Levels With Postoperative Pain, Nausea-Vomiting, and Sleep Quality in Orthopedic Surgical Patients: A Cross-Sectional Study.

This study is a cross-sectional study aimed to determine the association between preoperative fasting time and anxiety level and early postoperative pain intensity, nausea-vomiting severity, and sleep quality in patients undergoing orthopedic surgery. The study was conducted between March and June 2024 and completed with 188 patients. In the study, patient information form, Amsterdam Preoperative Anxiety and Information Scale, and Richards-Campbell Sleep Questionnaire were used. Correlation analysis indicated a significant negative correlation between postoperative sleep quality and pain intensity. There was a significant positive correlation between preoperative anxiety level and preoperative solid food fasting and fluid fasting times. According to the multiple linear regression model, preoperative anxiety level was found to have a significant effect on pain severity, and pain severity at the postoperative 24th hour significantly affected postoperative sleep quality. Adjusting patients' fasting durations prior to surgical interventions according to evidence-based guideline recommendations and monitoring anxiety closely are simple, practical, and safe measures that could alleviate postoperative pain and nausea-vomiting and improve sleep quality, potentially enhancing outcomes, comfort, and the quality of care.

Higher cardiorespiratory fitness levels attenuate but do not negate the heightened risk of sudden cardiac death due to obesity: A prospective cohort study.

Higher levels of CRF have been demonstrated to attenuate or negate the adverse cardiovascular impacts of other risk factors. We aimed to assess the interplay between body mass index (BMI), CRF and sudden cardiac death (SCD) risk. Body mass index was calculated based on guideline recommendations and CRF assessed using a respiratory gas exchange analyzer during clinical exercise testing at baseline in 2308 men aged 42-61years of age. Cox regression analysis was used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) for SCD. During a median follow-up of 28.1years, 264 SCDs occurred. Comparing obese vs normal weight category, the multivariable-adjusted HR (95% CI) for SCD was 1.86 (1.28-2.71). Comparing low vs high CRF levels, the corresponding adjusted HR (95% CI) for SCD was 1.99 (1.38-2.87). The HRs persisted on mutual adjustment for each exposure. Compared with non-obese and medium-high CRF, obese individuals with low CRF levels had the greatest risk of SCD (HR=2.90, 95% CI, 1.98-4.25), which was attenuated but persisted in obese individuals with medium-high CRF levels (HR=2.02, 95% CI, 1.08-3.78). There is an interplay between BMI, CRF and SCD risk. Higher CRF levels may attenuate the risk associated with obesity.

Scoping review indicates heterogeneous methods for developing and integrating patient decision aids in the context of clinical practice guidelines.

To review the methods used to develop and integrate patient decision aids (PDAs) based on the recommendations of clinical practice guidelines (CPGs). We conducted a scoping review covering bibliographic databases (PubMed, Embase; searched until December 2023), grey literature, references, and expert consultations to identify eligible documents. Documents published from 2000 onwards and describing methods related to guideline-based PDA development or linking CPGs and PDAs were included. Two reviewers independently selected and analyzed the documents. Results were synthesized and presented narratively. Based on 24 included documents, we categorized their methods into four topics. For topic (1), the selection of CPG recommendations for which PDAs are (most) needed, we found a total of 14 selection factors across n=11 documents, with uncertainty/variability in patient preferences and trade-offs between options being the most frequently mentioned. Topic (2) (n=24) covers methods for developing and/or updating guideline-based PDAs, such as forming a multidisciplinary development group, using CPGs and their evidence summaries along with other sources as the evidence base, and using digital solutions for semi-automated development and updating. Topic (3) (n=12) covers methods for PDA quality assessment and/or user testing, such as finalizing and approving the PDAs after a review and feedback process from the CPG group and an iterative user testing process. Topic (4) (n=20) covers methods for linking CPGs and PDAs, often through digital strategies. We identified heterogeneous methods for developing and integrating PDAs based on CPG recommendations. Empirical testing is required to determine the most useful and practically feasible (combination of) methods. CPG organizations should focus on establishing adequate methods for linking CPG and PDA development to foster shared decision making.

Low agreement among guidelines for primary prevention ICD recommendations in hypertrophic cardiomyopathy: Short title: Differing ICD recommendations in HCM

Sudden cardiac death (SCD) risk stratification and primary prevention implantable cardioverter-defibrillator (ICD) recommendations are based on differing strategies for hypertrophic cardiomyopathy (HCM). This study aimed to evaluate the impact of the 2023 European Society of Cardiology (ESC) guidelines on the 2014 ESC and the 2024 American Heart Association (AHA)/American College of Cardiology (ACC) systems in terms of primary prevention ICD recommendations for HCM. A cohort of 200 patients with HCM in Brazil was assessed for SCD risk profile according to current guidelines. The agreement for primary prevention ICD recommendations was evaluated among different strategies. SCD and appropriate shock were defined as the end points. Among the 200 patients, 63 (31%) received a primary prevention ICD, with 10 (15.8%) receiving appropriate shocks. Low agreement was found among the guidelines (Fleiss' kappa 0.340, 95% confidence interval [CI] 0.286 to 0.395, p <0.001). The European systems showed moderate agreement. The 2024 AHA/ACC algorithm placed 58% of patients in class IIa, whereas only 29% achieved this recommendation with the 2023 ESC model. The end points occurred in 8% of patients over 9.4 ± 6.5 years. The 2014 ESC guidelines had the highest accuracy (77%, 95% CI 71 to 83) and negative predictive value (96%, 95% CI 90 to 98) in detecting patients in class IIa with primary end points. However, all guidelines showed a low positive predictive value. The 2024 AHA/ACC guidelines classified the largest proportion of patients (81%) with the primary end point as class IIa. Low agreement was found among guidelines regarding primary prevention ICD recommendations in HCM, particularly between the 2023 ESC and 2024 AHA/ACC systems.

Development and cultural adaptation of text messages for promoting healthy eating among Amazonian schoolchildren.

To develop text messages for a mHealth intervention promoting healthy eating among Amazonian schoolchildren. Two rounds of expert panel analysis and formative research interviews. Western Brazilian Amazon, Cruzeiro do Sul, Acre, Brazil. Included 17 healthcare professionals and 40 caregivers of school-aged children enrolled in the Maternal and Child Health and Nutrition in Acre birth cohort study. Evaluation focused on messages' cultural appropriateness, comprehensibility, and relevance, along with caregivers' understanding and intention to adhere to the recommendations. Quantitative analysis employed the modified Cohen Kappa, the Scale-Content Validity Index Average (S-CVI-Ave), frequency calculations, and a ranking system. Fifty-five text messages were drafted. In the initial stage, eight messages did not achieve a sufficient score and were subsequently revised and reevaluated, ultimately gaining approval. The S-CVI-Ave for each domain was as follows: cultural appropriateness=0.97, comprehensibility=0.96, and relevance=0.97. Formative research indicated a 92% understanding rate and a 70% intention rate to adhere to the proposed suggestions. The final set of messages was successfully culturally adapted and will contribute to the translation and dissemination of Dietary Guidelines for Brazilian Population recommendations to Western Amazon families.

Correlation between Obesity and Left Atrial Enlargement in Patients Using Cardiac Magnetic Resonance

Objective: The correlation between left atrial (LA) enlargement and obesity has been previously reported. However, most studies primarily evaluated LA diameter using echocardiography, which is less accurate and reliable than assessing LA volume with cardiac magnetic resonance (CMR). This study aimed to explore the correlation between obesity and LA volume by using CMR imaging. Materials and Methods: We prospectively enrolled consecutive eligible patients aged 18 years or older who underwent CMR at a tertiary academic hospital. Clinical variables, including body mass index (BMI), were collected from the medical records. LA volume classification was based on the current guideline recommendations. Results: A total of 140 patients (41% men), with a mean age of 66.5 ± 10.5 years, were studied. The mean BMI was 25.7 ± 4.2 kg/m2. CMR parameters revealed an LA volume of 75.7 ± 22.5 mL, a left ventricular (LV) ejection fraction of 71.1 ± 9.5%, and an LV mass index of 46.1 ± 27.4 g/m2. Univariable analysis indicated that the factors affecting LA volume included BMI (r = 0.3, p &lt; 0.001), LV mass index (r = 0.3, p = 0.001), waist circumference (r = 0.3, p &lt; 0.001), male sex (p = 0.01), and hypertension (p = 0.01). In stepwise multivariable analysis, BMI (p &lt; 0.001), LV mass index (p = 0.02), and male sex (p = 0.03) were independently associated with LA volume. Conclusion: Obesity, as represented by BMI, was independently associated with LA enlargement. Other independent factors correlated with LA volume included the LV mass index and male sex.

Abstract 35: Impact of Artificial Intelligence Imaging Decision Support Software on Treatment of Acute Ischemic Stroke in England

Introduction: AI imaging decision support software is recommended by UK and USA stroke guidelines to facilitate identification and transfer of stroke patients eligible for endovascular therapy (EVT) but the impact on thrombectomy delivery is unclear. This prospective observational study evaluated the impact of Brainomix 360 Stroke software in four stroke networks (28 hospitals) in England’s National Health Service (NHS). The primary outcome was percentage of acute stroke patients receiving EVT (the EVT rate); door-in door-out (DIDO) times were assessed as a secondary outcome. Methods: Data were collected prospectively from the Sentinel Stroke National Audit Programme. The impact of Brainomix 360 Stroke software was assessed in two ways: comparison of EVT rates at the 28 evaluation sites and non-evaluation NHS sites before and after implementation (pre-implementation: Jan 2019-Feb 2020; post- : Jan 2022-Feb 2023); comparison of EVT rates and DIDO times at evaluation sites after implementation in patients for whom AI software was used and in those it was not. Multivariate regressions were used to evaluate whether AI use was a predictor of EVT or DIDO time, accounting for other clinical variables (e.g., age, NIHSS, day of week, time of day, time since onset). Results: The dataset included 71,327 patients from 28 evaluation hospitals. Figure 1 shows the change in EVT rates over time in evaluation (blue) and non-evaluation sites (yellow). EVT rate at evaluation sites increased from 2.3% pre-implementation to 4.6% post-implementation (p&lt;.0001). By contrast, EVT rate at non-evaluation sites changed from 1.6% to 2.6% (p&lt;.0001). After implementation, cases that were reviewed with AI software support were more likely to receive EVT (5.9% vs 3.6%; OR=1.6 [95% CI:1.3-1.9, p&lt;.0001). When limiting the analysis to cases admitted to primary stroke centres, the EVT rate was twice as high in cases reviewed with AI software (4.7% vs 2.2%; OR=2.3 [1.8-3.1], p&lt;.0001). DIDO times were shorter for cases reviewed with AI software (median 127 vs. 192 minutes; p&lt;.0001). Conclusions: This prospective study showed that use of AI imaging software was associated with a higher rate of EVT, both by comparing pre- vs. post-implementation data, as well as by comparing cases for whom AI software was versus was not used. Use of AI software was also associated with faster time to transfer. The results support guideline recommendations for AI software to be used in clinical practice.

Attitudes Towards the Management of Congenital Hypothyroidism in Türkiye: National Survey Study.

This study was conducted to assess the perspectives of pediatric endocrinologists in Türkiye on the management of congenital hypothyroidism (CH) and to analyze the potential impact of work environment and professional experience on different attitudes. The members of the Turkish Society for Pediatric Endocrinology and Diabetes were invited to participate in an online survey. An evaluation was made by obtaining survey responses from 95 (19%) of 502 members. Participants' mean age was 42.0±9.6 years, 46.3% of them were working in a university hospital, and 48.6% had >7 years of work experience. When the participants were asked about their approach to a 1-3-week-old neonate whose serum TSH concentration was 6-20 mU/L with a serum-free T4 (FT4) concentration within the age-specific reference interval, 97.7% of the participants preferred to monitor without medication. Only 24% of physicians consider starting treatment immediately if the serum TSH concentration is 20-40 mU/l with a normal FT4 level. While 5.3% of participants preferred dual imaging (ultrasound and scintigraphy), 90.5% requested only thyroid ultrasound for etiological investigation. When considering the discontinuation of levothyroxine in patients with a normal thyroid gland and a low LT4 dose, 28.4% of the participants stated that treatment should be stopped at the earliest at the age of 3 years, 16.8% at 2 years, 5.3% at 1 year, 16.8% at 6 months, and 32.6% at any time if the TSH levels remain low despite the low dosage. Physicians with over 7 years of experience can discontinue medication if TSH is low, even with a lower dose, more frequently than those with less experience (p=0.011). There were no significant differences in the approach of the physicians between employees at university hospitals and other health institutions. Although the attitudes of pediatric endocrinologists working in Türkiye towards the management of CH are generally consistent with the recommendations of international guidelines, their approaches to the treatment for isolated neonatal TSH elevation, thyroid imaging preferences and time to discontinue treatment differ significantly. These different attitudes, which are almost similar among all subgroups by experience and work setting, reflect the differences in local conditions in Türkiye and underline the need for a national consensus on the management of CH.

Guideline summary review: An evidence-based clinical guideline for the diagnosis and treatment of adults with osteoporotic vertebral compression fractures.

The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Adults with Osteoporotic Vertebral Compression Fractures features evidence-based recommendations for diagnosing and treating adult patients with osteoporotic vertebral compression fractures. The guideline is intended to reflect contemporary treatment concepts for osteoporotic vertebral compression fractures as reflected in the highest quality clinical literature available on this subject as of September 2020. The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with osteoporotic vertebral compression fractures. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. This is a guideline summary review. This guideline is the product of NASS' Clinical Practice Guidelines Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with a medical librarian. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guideline was submitted to an internal and external peer review process and ultimately approved by the NASS Board of Directors. Twenty-nine clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature. The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with osteoporotic vertebral compression fractures. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at http://www.spine.org/guidelines.

2644 Falls and physical function in older patients with benign paroxysmal positional Vertigo (BPPV)

Abstract Introduction Benign Paroxysmal Positional Vertigo (BPPV) is the most common cause of vertigo in older adults. Due to the high incidence of BPPV in older adults presenting with falls, vestibular assessment, and diagnosis of BPPV and other vestibular disorders has become a recommendation in the World Guidelines for Falls Prevention. There has been a paucity of evidence in well conducted randomised controlled trials (RCTs) to evaluate vitamin D for prevention of BPPV recurrence and its relation to falls and function. Method This is a Phase IIa single centre, placebo controlled, double blind RCT to evaluate vitamin D supplementation together with diet and Canalith Repositioning Procedure [Group A] or diet alone combined with CRP [Gorup B] can reduce recurrence rates of BPPV. Post hoc analyses were performed evaluating BPPV recurrence, falls and function. 53 participants were recruited. 14 were vitamin D replete at baseline [Group C- diet alone], the remaining 39 were randomised into Groups A and B. Group A was associated with 0.75 fewer clinical BPPV recurrences per one person year (IRD -0.75, 95% CI -1.18 to −0.32, P = 0.035). Findings Older adults in the study who suffered a fall during the 12 month follow up had lower Activities of Daily Living scores. They also had poorer Short Physical Performance Battery scores at baseline. Participants in Group A had better 5x sit to stand time compared to Group B even accounting for underlying frailty scores. 25% of participants who fell in the 12 month follow up reported fear of falling compared to 43% in those with no falls in the 12 month follow up. Vitamin D supplementation improved physical performance in 5xchair stand test. Conclusion In this study population, more participants without an incident fall during follow up experience fear of falling, prompting further consideration into the complex concept that is fear of falling.