Group Guidelines Research Articles

Precision in prescription: multiple micronutrient supplements in pregnancy

Precision in prescription: multiple micronutrient supplements in pregnancy

Aspirin to target arterial events in chronic kidney disease (ATTACK): study protocol for a multicentre, prospective, randomised, open-label, blinded endpoint, parallel group trial of low-dose aspirin vs. standard care for the primary prevention of cardiovascular disease in people with chronic kidney disease

BackgroundChronic kidney disease (CKD) is a very common long-term condition and powerful risk factor for cardiovascular disease (CVD).Low-dose aspirin is of proven benefit in the secondary prevention of myocardial infarction (MI) and stroke in people with pre-existing CVD. However, in people without CVD, the rates of MI and stroke are much lower, and the benefits of aspirin in the primary prevention of CVD are largely balanced by an increased risk of bleeding.People with CKD are at greatly increased risk of CVD and so the absolute benefits of aspirin are likely to be greater than in lower-risk groups, even if the relative benefits are the same. Post hoc evidence suggests the relative benefits may be greater in the CKD population but the risk of bleeding may also be higher. A definitive study of aspirin for primary prevention in this high-risk group, recommended by the National Institute for Health and Care Excellence (NICE) in 2014, has never been conducted. The question has global significance given the rising burden of CKD worldwide and the low cost of aspirin.MethodsATTACK is a pragmatic multicentre, prospective, randomised, open-label, blinded endpoint adjudication superiority trial of aspirin 75 mg daily vs. standard care for the primary prevention of CVD in 25,210 people aged 18 years and over with CKD recruited from UK Primary Care.Participants aged 18 years and over with CKD (GFR category G1-G4) will be identified in Primary Care and followed up using routinely collected data and annual questionnaires for an average of 5 years. The primary outcome is the time to first major vascular event (composite of non-fatal MI, non-fatal stroke and cardiovascular death [excluding confirmed intracranial haemorrhage and other fatal cardiovascular haemorrhage]). Deaths from other causes (including fatal bleeding) will be treated as competing events. The study will continue until 1827 major vascular events have occurred. The principal safety outcome is major intracranial and extracranial bleeding; this is hypothesised to be increased in those randomised to take aspirin. The key consideration is then whether and to what extent the benefits of aspirin from the expected reduction in CVD events exceed the risks of major bleeding.DiscussionThis will be the first definitive trial of aspirin for primary CVD prevention in CKD patients. The research will be of great interest to clinicians, guideline groups and policy-makers, in the UK and globally, particularly given the high and rising prevalence of CKD that is driven by population ageing and epidemics of obesity and diabetes. The low cost of aspirin means that a positive result would be of relevance to low- and middle-income countries and the impact in the developed world less diluted by any inequalities in health care access.Trial registrationISRCTN: ISRCTN40920200. EudraCT: 2018-000644-26. ClinicalTrials.gov: NCT03796156

UK clinical guideline for the prevention and treatment of osteoporosis

SummaryThe National Osteoporosis Guideline Group (NOGG) has revised the UK guideline for the assessment and management of osteoporosis and the prevention of fragility fractures in postmenopausal women, and men age 50 years and older. Accredited by NICE, this guideline is relevant for all healthcare professionals involved in osteoporosis management.IntroductionThe UK National Osteoporosis Guideline Group (NOGG) first produced a guideline on the prevention and treatment of osteoporosis in 2008, with updates in 2013 and 2017. This paper presents a major update of the guideline, the scope of which is to review the assessment and management of osteoporosis and the prevention of fragility fractures in postmenopausal women, and men age 50 years and older.MethodsWhere available, systematic reviews, meta-analyses and randomised controlled trials were used to provide the evidence base. Conclusions and recommendations were systematically graded according to the strength of the available evidence.ResultsReview of the evidence and recommendations are provided for the diagnosis of osteoporosis, fracture-risk assessment and intervention thresholds, management of vertebral fractures, non-pharmacological and pharmacological treatments, including duration and monitoring of anti-resorptive therapy, glucocorticoid-induced osteoporosis, and models of care for fracture prevention. Recommendations are made for training; service leads and commissioners of healthcare; and for review criteria for audit and quality improvement.ConclusionThe guideline, which has received accreditation from the National Institute of Health and Care Excellence (NICE), provides a comprehensive overview of the assessment and management of osteoporosis for all healthcare professionals involved in its management. This position paper has been endorsed by the International Osteoporosis Foundation and by the European Society for the Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases.

Compare the efficacy of recommended peripheral intravascular cannula insertion practices with a standard protocol: A randomized control trial

BackgroundMillions of patients admitted globally in health care setups require insertion of peripheral intravascular catheter for intravenous drugs or fluid administration. However, if proper precautions are not followed during insertion, it results in significant morbidity. This study was designed to study the efficacy and safety of recommended Centre for Disease Control and Prevention (CDC) guidelines for peripheral intravascular catheter insertion practice and its comparison with a standard insertion protocol being followed and their outcome. MethodsPatients were randomized and catheter was inserted as recommended by CDC guideline (Group 1, n = 100) or followed standard defined steps during insertion (Group 2, n = 100). ResultsAlmost double the patients had occurrence of thrombophlebitis in Group 1 (p = 0.02). No difference observed between catheter needle size and infection rates (p = 0.3). Infection rate increased significantly if second attempt is taken for insertion. The time required to insert catheter following CDC recommended protocol is less than as by standard surgical complete asepsis cleaning protocol (86.03 vs 109.40 s) (p = 0.001). Study also observed that insertion at wrist joint leads to higher incidence of thrombophlebitis. During 0–24 h, 6% (12) insertions turned positive followed by a dip during 25–48 h, 2% (5) insertions. 80% (159) insertions did not develop thrombophlebitis at the end of 72 h. ConclusionIt is thus amply demonstrated that meticulous adherence to insertion procedure with asepsis plays an important role in decreasing intravascular catheter associated morbidity. Other parameters like needle gauge, sites of insertion, have little bearing. The time required in following standard aseptic technique is significantly more but keeping in view the benefit to the patient it is highly recommended.

ERN GENTURIS clinical practice guidelines for the diagnosis, treatment, management and surveillance of people with schwannomatosis

A Guideline Group (GG) was convened from multiple specialties and patients to develop the first comprehensive schwannomatosis guideline. The GG undertook thorough literature review and wrote recommendations for treatment and surveillance. A modified Delphi process was used to gain approval for recommendations which were further altered for maximal consensus. Schwannomatosis is a tumour predisposition syndrome leading to development of multiple benign nerve-sheath non-intra-cutaneous schwannomas that infrequently affect the vestibulocochlear nerves. Two definitive genes (SMARCB1/LZTR1) have been identified on chromosome 22q centromeric to NF2 that cause schwannoma development by a 3-event, 4-hit mechanism leading to complete inactivation of each gene plus NF2. These genes together account for 70–85% of familial schwannomatosis and 30–40% of isolated cases in which there is considerable overlap with mosaic NF2. Craniospinal MRI is generally recommended from symptomatic diagnosis or from age 12–14 if molecularly confirmed in asymptomatic individuals whose relative has schwannomas. Whole-body MRI may also be deployed and can alternate with craniospinal MRI. Ultrasound scans are useful in limbs where typical pain is not associated with palpable lumps. Malignant-Peripheral-Nerve-Sheath-Tumour-MPNST should be suspected in anyone with rapidly growing tumours and/or functional loss especially with SMARCB1-related schwannomatosis. Pain (often intractable to medication) is the most frequent symptom. Surgical removal, the most effective treatment, must be balanced against potential loss of function of adjacent nerves. Assessment of patients’ psychosocial needs should be assessed annually as well as review of pain/pain medication. Genetic diagnosis and counselling should be guided ideally by both blood and tumour molecular testing.

New national osteoporosis guidance-implications for geriatricians.

Fragility fractures are painful, debilitating, often life-changing and accounted for an estimated 2.4% of pre-pandemic health care spending in the UK. Those who are older, frail and multimorbid have the highest fracture risk and therefore the most to gain from anti-osteoporosis treatments to reduce this risk. Currently, an unacceptable treatment gap exists between those eligible for and those who receive treatment. This commentary discusses the major changes to the new, National Institute for Health and Care Excellence accredited, UK National Osteoporosis Guideline Group (NOGG) guidance (published March 2022) most relevant to the management of older people's bone health. Changes include intervention thresholds; using fracture probabilities from FRAX; for patients too frail to undergo DXA; greater emphasis on vertebral fracture detection and the use of intravenous zoledronate as a first-line anti-osteoporosis therapy; the new concept of 'very high fracture risk' which should prompt consideration of use of parenteral anti-osteoporosis therapy; new guidance regarding anabolic treatment options; concerns regarding denosumab cessation; and the urgent need to get patients with a fragility fracture onto treatment to reduce re-fracture risk with follow-up to check tolerance and ensure adherence.

How fertility preservation guidelines have progressed worldwide: Potential implications and inspiration

Abstract To summarize fertility preservation (FP) guidelines and consensus provided by medical facilities worldwide. Five reference databases (PubMed/Embase, China BioMedical Literature Database, ClinicalKey, Wanfang Data, and China Knowledge Resource Integrated) and 7 guideline databases (Guideline International Network, National Collaborating Centre for Women's and Children's Health, National Guideline Clearinghouse, The National Institute for Health and Care Excellence, Scottish Intercollegiate Guidelines Network, New Zealand Guideline Group, and Canadian Medical Association infobase) were searched. Official websites of societies were searched to find relevant guidelines and consensus, and guidelines and published systematic reviews and consensus were reviewed from inception through May 2021. A literature search was performed regarding guidance offered in professional facilities, and 304 records (including 4 in Chinese) of existing guidelines for full-text review were found. Moreover, 55 guidelines were identified after a manual search. The literature review demonstrated that FP guidance and options were unevenly distributed worldwide for women who wanted to post-pone pregnancy or had impaired fertility after gonadal toxicity. With promising cancer survival rates and diversified family decisions, more attention should be paid to the improvement and update of accessible guidelines and regulatory infrastructure to inform patients about the available options and empower them to make informed choices. Restrictions to such services can be gradually eased due to the efficacy and safety of certain FP techniques for the right candidates to initiate pregnancy conception.

ESHRE guideline: endometriosis.

ESHRE guideline: endometriosis.

Actively implementing an evidence-based feeding guideline for critically ill patients (NEED): a multicenter, cluster-randomized, controlled trial

BackgroundPrevious cluster-randomized controlled trials evaluating the impact of implementing evidence-based guidelines for nutrition therapy in critical illness do not consistently demonstrate patient benefits. A large-scale, sufficiently powered study is therefore warranted to ascertain the effects of guideline implementation on patient-centered outcomes.MethodsWe conducted a multicenter, cluster-randomized, parallel-controlled trial in intensive care units (ICUs) across China. We developed an evidence-based feeding guideline. ICUs randomly allocated to the guideline group formed a local "intervention team", which actively implemented the guideline using standardized educational materials, a graphical feeding protocol, and live online education outreach meetings conducted by members of the study management committee. ICUs assigned to the control group remained unaware of the guideline content. All ICUs enrolled patients who were expected to stay in the ICU longer than seven days. The primary outcome was all-cause mortality within 28 days of enrollment.ResultsForty-eight ICUs were randomized to the guideline group and 49 to the control group. From March 2018 to July 2019, the guideline ICUs enrolled 1399 patients, and the control ICUs enrolled 1373 patients. Implementation of the guideline resulted in significantly earlier EN initiation (1.20 vs. 1.55 mean days to initiation of EN; difference − 0.40 [95% CI − 0.71 to − 0.09]; P = 0.01) and delayed PN initiation (1.29 vs. 0.80 mean days to start of PN; difference 1.06 [95% CI 0.44 to 1.67]; P = 0.001). There was no significant difference in 28-day mortality (14.2% vs. 15.2%; difference − 1.6% [95% CI − 4.3% to 1.2%]; P = 0.42) between groups.ConclusionsIn this large-scale, multicenter trial, active implementation of an evidence-based feeding guideline reduced the time to commencement of EN and overall PN use but did not translate to a reduction in mortality from critical illness.Trial registration: ISRCTN, ISRCTN12233792. Registered November 20th, 2017.

Commentary on the 2020 update of the KDOQI clinical practice guideline for nutrition in chronic kidney disease.

Commentary on the 2020 update of the KDOQI clinical practice guideline for nutrition in chronic kidney disease.

Health care transition from pediatric to adult care: an evidence-based guideline

For consistent quality of treatment of young people with chronic health care needs, a structured health care transition (HCT) from pediatric medicine to adult medical care is essential. Currently, most countries have no guidelines on HCT based on systematic evidence research. To close this gap, guidance to support HCT was developed in Germany. Twenty-two experts in the management of adolescents and young adults with different chronic conditions and three patient representatives were invited to take part in the guideline group. Based on a systematic literature search recommendations for HCT were drafted. Where evidence was lacking, recommendations were developed using collective expert consensus. The consensus process was independently moderated using a Delphi approach. The final draft was reviewed and endorsed by all major German medical societies. The clinical recommendations provide guidance for all chronic somatic diseases. After assessment of HCT readiness, an individualized plan for HCT should be drawn up. Key elements here are a responsible coordinator, age-adapted patient education, involvement of caregivers, web-based interventions, joint visits, and a structured summary for the receiving physician. The aim is the gradual transfer of responsibility for disease management to the young person themselves. Conclusion: As only a few randomized controlled studies on HCT are available, evidence-based statements are possible for some but not all areas of HCT. However, this guideline may help to develop globally accepted standards. These standards should be established and implemented. The aim should be a reimbursement by individual national health systems to allow appropriate support for young people.What is Known:• Health care transition from pediatric to adult care is primarily organized in local settings, partly based on disease-specific guidelines.•There have been no national guidelines in Germany until now.What is New:• Here we present the general evidence-based guidelines of the German Association of Scientific Medical Societies for health care transition.• These might serve as a blueprint for further national or international health care transition guidelines.

Deutschsprachige Übersetzung des PANELVIEW Instruments zur Evaluierung des Prozesses der Leitlinienentwicklung aus der Perspektive der Leitliniengruppe

IntroductionThe development process for clinical guidelines is influenced by factors that are relevant to the validity of a guideline but often are not captured sufficiently in the final guideline documents. PANELVIEW is an English-language tool that can be used to explore the guideline development process from the perspective of guideline group members. Our aim was to translate the PANELVIEW tool into German, taking into account national contexts and linguistic differences. MethodsThe PANELVIEW tool was initially translated by a core team, then refined and approved by a group of experts in a consensus-based Delphi process. The experts were selected on the basis of their experience in guideline development covering different fields (clinical, methodological, organisational, health professional, patient perspective) and geographical regions (Germany, Austria, Switzerland). A representative of the original PANELVIEW team was also involved. The Delphi steps included an online survey, an online consensus conference and final approval by circulating the results via email. Individual items were seen as generally agreed upon if the level of agreement in the respective steps was 75 % or more. ResultsThe expert group consisted of 12 persons. Of these, 11 (92 %) participated in the online survey and 10 (83 %) in the subsequent consensus conference. After the first Delphi step, sufficient agreement was achieved for 19 of 34 items (56 %). The remaining 15 items were discussed in the consensus conference and finally obtained 100 % agreement. The discussion focused on clarifying and adapting terms whose meaning was ambiguous or inadequate in the German context, which led to a deviation from the original wording in some instances. DiscussionThe PANELVIEW tool was translated into German by means of a Delphi process. PANELVIEW complements existing instruments for assessing the methodological quality of guidelines by capturing the perspective of the guideline group. This will enable guideline developers and organisations to identify problems in the drafting process and avoid them in future projects. User testing and validation of the German-language PANELVIEW tool are planned for the future. ConclusionThe German-language translation of PANELVIEW will enable guideline developers in German-speaking countries to continuously evaluate and, where necessary, improve the process and methods of guideline development.

EAES rapid guideline: systematic review, network meta-analysis, CINeMA and GRADE assessment, and European consensus on bariatric surgery-extension 2022.

The European Association for Endoscopic Surgery Bariatric Guidelines Group identified a gap in bariatric surgery recommendations with a structured, contextualized consideration of multiple bariatric interventions. To provide evidence-informed, transparent and trustworthy recommendations on the use of sleeve gastrectomy, Roux-en-Y gastric bypass, adjustable gastric banding, gastric plication, biliopancreatic diversion with duodenal switch, one anastomosis gastric bypass, and single anastomosis duodeno-ileal bypass with sleeve gastrectomy in patients with severe obesity and metabolic diseases. Only laparoscopic procedures in adults were considered. A European interdisciplinary panel including general surgeons, obesity physicians, anesthetists, a psychologist and a patient representative informed outcome importance and minimal important differences. We conducted a systematic review and frequentist fixed and random-effects network meta-analysis of randomized-controlled trials (RCTs) using the graph theoryapproach for each outcome. We calculated the odds ratio or the (standardized) mean differences with 95% confidence intervals for binary and continuous outcomes, respectively. We assessed the certainty of evidence using the CINeMA and GRADE methodologies. We considered the risk/benefit outcomes within a GRADE evidence to decision framework to arrive at recommendations, which were validated through an anonymous Delphi process of the panel. We identified 43 records reporting on 24 RCTs. Most network information surrounded sleeve gastrectomy and Roux-en-Y gastric bypass. Under consideration of the certainty of the evidence and evidence to decision parameters, we suggest sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass over adjustable gastric banding, biliopancreatic diversion with duodenal switch and gastric plication for the management of severe obesity and associated metabolic diseases. One anastomosis gastric bypass and single anastomosis duodeno-ileal bypass with sleeve gastrectomy are suggested as alternatives, although evidence on benefits and harms, and specific selection criteria is limited compared to sleeve gastrectomy and Roux-en-Y gastric bypass. The guideline, with recommendations, evidence summaries and decision aids in user friendly formats can also be accessed in MAGICapp: https://app.magicapp.org/#/guideline/Lpv2kE CONCLUSIONS: This rapid guideline provides evidence-informed, pertinent recommendations on the use of bariatric and metabolic surgery for the management of severe obesity and metabolic diseases. The guideline replaces relevant recommendations published in the EAES Bariatric Guidelines 2020.

Quality of life after tonsillectomy in adult patients with recurrent acute tonsillitis: a systematic review.

The aims of this systematic review were to (1) explore the evidence for improved quality of life (QOL) in adult patients undergoing tonsillectomy because of recurrent acute tonsillitis (RT) and (2) evaluate which set of guidelines for tonsillectomy in adult RT patients is preferable, using QOL as outcome measure. A systematic search was conducted in the PubMed, Embase, and Scopus databases. RCT/cohort studies exploring the effect of elective tonsillectomy in adult RT patients using any QOL assessment tool no less than 6months after surgery were included. Studies were divided into two guideline groups based on the number of tonsillitis episodes required for tonsillectomy (Group 1: ≥ 5; Group 2: ≤ 4). A total of 364 unique records were identified. Seven studies (n = 409 patients) were included in a qualitative analysis and four studies were included in a meta-analysis. Patients' QOL rose significantly, primarily because of improvements in the general and physical domains. In the meta-analysis, 96% (293/304) of patients benefitted from tonsillectomy. Patients included in guideline Group 1 studies had significantly higher QOL scores (Glasgow Benefit Inventory (GBI) 39.6) compared to patients in Group 2 studies (GBI 24.9) (p < 0.001). Adult patients undergoing tonsillectomy because of RT reported improved QOL 6-84months after surgery. The benefit of tonsillectomy was higher among patients in studies with a higher minimum number of tonsillitis episodes compared to those included in studies with less strict criteria. Whether the improved QOL outweigh the morbidity associated with surgery in both guideline groups remains unclear.

Neonatal early-onset sepsis calculator safety in an Australian tertiary perinatal centre.

To determine if any cases of culture-positive neonatal early-onset sepsis (EOS) would be missed using the neonatal EOS calculator, when compared with current guidelines and practices. Retrospective audit of all neonates born at ≥35 weeks and admitted to Royal Brisbane and Women's Hospital with EOS from January 2014 to December 2020. A missed case was defined as antibiotic therapy not being recommended within 24 h of birth. Management recommendations according to the neonatal EOS calculator were compared with current guidelines and current practices. There were significantly more missed cases using the neonatal EOS calculator compared to the current guideline and current management groups. Using the neonatal EOS calculator, 11 neonates (35%, 95% confidence interval 19.2-54.6%) would not have received antibiotics by 24 h of age. In comparison, only one neonate (3%, 95% confidence interval 0.1-16.7%) would not have received antibiotics by 24 h of age using the current guidelines. In terms of the current practice in the cohort of patients, two neonates (6%) did not receive antibiotics by 24 h of age. The significantly higher rate of missed cases using the neonatal EOS calculator compared with current guidelines and practice supports the concerns many neonatologists have regarding safety of the neonatal EOS calculator.

Effect of montelukast therapy on clinical course, pulmonary function, and mortality in patients with COVID-19.

The inflammatory/anti‐inflammatory balance has an important role in the clinical course of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) (coronavirus disease [COVID‐19]) infection, which has affected over 200 million people since it first appeared in China in December 2019. This study aimed to determine the effectiveness of montelukast, which has known anti‐inflammatory and bronchodilatory effects, in these patients. The prospective randomized controlled study included 180 patients who were hospitalized in the infectious diseases department of our hospital between May and July 2021 and were diagnosed with the delta variant of SARS‐CoV‐2 by real‐time polymerase chain reaction of nasopharyngeal swabs. The patients were divided into three groups and received only standard treatment according to national guidelines (Group 1) or standard treatment plus 10 mg/day montelukast (Group 2) or 20 mg/day montelukast (Group 3). Laboratory parameters and pulmonary function tests (PFTs) at admission and on Day 5 of treatment were compared. Comparison of laboratory parameters on Day 5 showed that Groups 2 and 3 had significantly lower levels of lactate dehydrogenase, fibrinogen, D‐dimer, C‐reactive protein, and procalcitonin compared with Group 1 (p = 0.04, 0.002, 0.05, 0.03, and 0.04, respectively). In the comparison between Groups 2 and 3, only fibrinogen was significantly lower in Group 3 (p = 0.02). PFT results did not differ between the groups at admission, while on Day 5, only Group 3 showed significant improvements in forced expiratory volume in 1 s, forced vital capacity, and peak expiratory flow 25–75 compared with admission (p = 0.001 for all). Montelukast may be beneficial in COVID‐19 patients to maintain the inflammatory/anti‐inflammatory balance, prevent respiratory failure through its bronchodilator activity, and reduce mortality.

Rhizomatic Encounters With Inter/Transmedia Art: A Pedagogy for Learning and Teaching Experiential Contemporary Art

Teaching and learning through contemporary art has gained validity as a powerful and effective pedagogy in contemporary art education practice. In this article, we highlight characteristics of contemporary art and rhizomatic learning theory, and then we propose a pedagogical model that combines them for teaching and learning through experiential contemporary art. We also explain how to implement this model by showing examples of students’ rhizomatic encounters with inter/transmedia art created by Taiwanese artist teams. As the artworks offered present moments as sites of learning or places in process, students were triggered by the intersection of sounds and visuals and recalled their memories along with relevant themes; they then re/created personal meanings and/or new knowledge. Thus, the proposed pedagogy model with the implementation guidelines (autonomy, documentation, and group discussion of collective rhizomatic learning artifacts) is effective. Strategies and challenges for implementing this model in art education are recommended and discussed.

Performance of the Fracture Risk Assessment Tool Associated with Muscle Mass Measurements and Handgrip to Screen for the Risk of Osteoporosis in Young Postmenopausal Women.

To evaluate the improvement in screening accuracy of the Fracture Risk Assessment Tool (FRAX) for the risk of developing osteoporosis among young postmenopausal women by associating with it clinical muscle mass measures. A sample of postmenopausal women was submitted to calcaneal quantitative ultrasound (QUS), application of the FRAX questionnaire, and screening for the risk of developing sarcopenia at a health fair held in the city of São Bernardo do Campo in 2019. The sample also underwent anthropometric measurements, muscle mass, walking speed and handgrip tests. A major osteoporotic fracture (MOF) risk ≥ 8.5% on the FRAX, a classification of medium risk on the clinical guideline of the National Osteoporosis Guideline Group (NOGG), and a QUS T-score ≤ -1.8 sd were considered risks of having low bone mass, and QUS T-score ≤ -2.5sd, risk of having fractures. In total, 198 women were evaluated, with a median age of 64 ± 7.7 years, median body mass index (BMI) of 27.3 ± 5.3 kg/m2 and median QUS T-score of -1.3 ± 1.3 sd. The accuracy of the FRAX with a MOF risk ≥ 8.5% to identify women with T-scores ≤ -1.8 sd was poor, with an area under the curve (AUC) of 0.604 (95% confidence interval [95%CI]: 0.509-0.694) for women under 65 years of age, and of 0.642 (95%CI: 0.571-0.709) when age was not considered. Including data on muscle mass in the statistical analysis led to a significant improvement for the group of women under 65 years of age, with an AUC of 0,705 (95%CI: 0.612-0.786). The ability of the high-risk NOGG tool to identify T-scores ≤ -1.8 sd was limited. Clinical muscle mass measurements increased the accuracy of the FRAX to screen for osteoporosis in women aged under 65 years.

Systemic therapy in metastatic renal cell carcinoma (mRCC): an evidence-based recommendation of the German interdisciplinary RCC guidelines group.

PurposeThe treatment landscape in metastatic renal cell carcinoma (mRCC) has evolved dramatically in recent years. Within the German guideline committee for RCC we evaluated current medical treatments and gave recommendations.MethodsA systematic review of published evidence for medical treatment of mRCC was performed (July 2016–August 2019) to cover the duration from last guideline update in 2016. Evidence was graded according to SIGN (http://www.sign.ac.uk/pdf/sign50.pdf). Recommendations were made on the basis of a nominal group work with consensus approach and included patient advocates and shareholder of the German RCC treatment landscape. Each recommendation was graded according to its strength as strong recommendation (A) or recommendation (B). Expert statements were given, where appropriate. ResultsStrong first-line recommendations (IA) exist for axitinib + pembrolizumab (all risk categories) and ipilimumab + nivolumab (intermediate or poor risk only). Axitinib + avelumab is a recommended first-line treatment across patients with any risk category (IB). In patients who are not candidates for immune check point inhibitor (ICI) combinations, targeted agents should be offered as an alternative treatment. Subsequent treatment after ICI-based combinations remain ill-defined and no standard of care can be formulated.ConclusionICI-based combinations are the first-line standard of care and should be considered accordingly. There is an unmet medical need for pivotal studies that define novel standards in patients with failure of ICI-based combinations.

Effect of education on physical and occupational therapists' perceptions of clinical practice guidelines and shared decision making: a randomized controlled trial.

[Purpose] This study aimed to investigate the influence of the evidence practice gap on physiotherapist and occupational therapists through shared decision making using the clinical practice guidelines. [Participants and Methods] A randomized controlled trial was used. The participants included 126 therapists from three institutions. The inclusion criteria was permanent employment in these institutions. Participants’ characteristics were masked from the allocator, evaluator, and analyzer. For the intervention group, a workshop on shared decision making was conducted using clinical practice guidelines. Two control groups were set. One group received a lecture on the knowledge of clinical practice guidelines, and the other group received a lecture on the knowledge of shared decision making. The primary outcomes were “education, attitudes and beliefs, and interest and perceived role in evidence-based practice” scale. [Results] The primary outcomes showed a significant difference between the clinical practice guidelines with shared decision making group and the clinical practice guidelines group (mean ± standard deviation, pre/post; clinical practice guidelines with shared decision making group, 2.4 ± 0.9/4.4 ± 1.7; clinical practice guidelines group, 3.0 ± 1.5/3.5 ± 2.0; shared decision making group, 2.6 ± 1.2/ 3.3 ± 1.8). [Conclusion] Shared decision making education using the clinical practice guidelines improves evidence-based practice of self-efficacy in physiotherapists and occupational therapists.