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The methodological quality is insufficient in clinical practice guidelines in the context of COVID-19: systematic review.
Stamm, TA, Andrews, MR, Mosor, E, Ritschl, V, Li, LC, Ma, JK, Campo-Arias, A, Baker, S, Burton, NW, Eghbali, M, et al
Journal of clinical epidemiology. 2021;:125-135
Abstract
OBJECTIVES The number of published clinical practice guidelines related to COVID-19 has rapidly increased. This study explored if basic methodological standards of guideline development have been met in the published clinical practice guidelines related to COVID-19. STUDY DESIGN AND SETTING Rapid systematic review from February 1 until April 27, 2020 using MEDLINE [PubMed], CINAHL [Ebsco], Trip and manual search, including all types of healthcare workers providing any kind of healthcare to any patient population in any setting. RESULTS There were 1342 titles screened and 188 guidelines included. The highest average AGREE II domain score was 89% for scope and purpose, the lowest for rigor of development (25%). Only eight guidelines (4%) were based on a systematic literature search and a structured consensus process by representative experts (classified as the highest methodological quality). The majority (156; 83%) was solely built on an informal expert consensus. A process for regular updates was described in 27 guidelines (14%). Patients were included in the development of only one guideline. CONCLUSION Despite clear scope, most publications fell short of basic methodological standards of guideline development. Clinicians should use guidelines that include up-to-date information, were informed by stakeholder involvement, and employed rigorous methodologies.
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Drug treatment and prevention of malaria in pregnancy: a critical review of the guidelines.
Al Khaja, KAJ, Sequeira, RP
Malaria journal. 2021;(1):62
Abstract
BACKGROUND Malaria caused by Plasmodium falciparum in pregnancy can result in adverse maternal and fetal sequelae. This review evaluated the adherence of the national guidelines drawn from World Health Organization (WHO) regions, Africa, Eastern Mediterranean, Southeast Asia, and Western Pacific, to the WHO recommendations on drug treatment and prevention of chloroquine-resistant falciparum malaria in pregnant women. METHODS Thirty-five updated national guidelines and the President's Malaria Initiative (PMI), available in English language, were reviewed. The primary outcome measures were the first-line anti-malarial treatment protocols adopted by national guidelines for uncomplicated and complicated falciparum malaria infections in early (first) and late (second and third) trimesters of pregnancy. The strategy of intermittent preventive treatment of malaria in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) was also addressed. RESULTS This review evaluated the treatment and prevention of falciparum malaria in pregnancy in 35 national guidelines/PMI-Malaria Operational Plans (MOP) reports out of 95 malaria-endemic countries. Of the 35 national guidelines, 10 (28.6%) recommend oral quinine plus clindamycin as first-line treatment for uncomplicated malaria in the first trimester. As the first-line option, artemether-lumefantrine, an artemisinin-based combination therapy, is adopted by 26 (74.3%) of the guidelines for treating uncomplicated or complicated malaria in the second and third trimesters. Intravenous artesunate is approved by 18 (51.4%) and 31 (88.6%) guidelines for treating complicated malaria during early and late pregnancy, respectively. Of the 23 national guidelines that recommend IPTp-SP strategy, 8 (34.8%) are not explicit about directly observed therapy requirements, and three-quarters, 17 (73.9%), do not specify contra-indication of SP in human immunodeficiency virus (HIV)-infected pregnant women receiving cotrimoxazole prophylaxis. Most of the guidelines (18/23; 78.3%) state the recommended folic acid dose. CONCLUSION Several national guidelines and PMI reports require update revisions to harmonize with international guidelines and emergent trends in managing falciparum malaria in pregnancy. National guidelines and those of donor agencies should comply with those of WHO guideline recommendations although local conditions and delayed guideline updates may call for deviations from WHO evidence-based guidelines.
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AGREEing on Nutritional Management of Patients with CKD-A Quality Appraisal of the Available Guidelines.
Bakaloudi, DR, Chrysoula, L, Poulia, KA, Dounousi, E, Liakopoulos, V, Chourdakis, M
Nutrients. 2021;(2)
Abstract
Chronic kidney disease (CKD) is an important public health issue with increasing prevalence worldwide. Several clinical practice guidelines have been recently published regarding the nutritional management of CKD patients. The purpose of the present study is to evaluate the quality of the published guidelines and provide recommendation for future updates. PubMed, Scopus and Google Scholar were searched for relevant guidelines and 11 clinical practice guidelines were finally included. Guidelines developed by the American Society for Parenteral and Enteral nutrition (ASPEN), the Dietitians Association of Australia (DAA), the German Society for Nutritional Medicine (DGEM), the European Best Practice Guidelines (EBPG), the European Dialysis and Transplantation Nurses Association-European Renal Care Association (EDTNA-ERCA), the European Society for Clinical Nutrition and Metabolism (ESPEN), the Andalusian Group for Nutrition Reflection and Investigation (GARIN) group, the National Kidney foundation-Kidney Disease Outcomes Quality Initiative (KDOQI), the Italian Society of Nephrology-Association of Dieticians-Italian Association of Hemodialysis, Dialysis and Transplant (SIN-ANDID-ANED), and the Renal Association were assessed using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool. Guidelines by KDOQI, ESPEN, and DAA were of moderate quality and the rest of them were low-quality guidelines. Our study demonstrates gaps related to the development of guidelines and therefore greater emphasis on methodological approaches is recommended. AGREE II tool can be useful to improve quality of guidelines.
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Central venous catheter-related infections in hematology and oncology: 2020 updated guidelines on diagnosis, management, and prevention by the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO).
Böll, B, Schalk, E, Buchheidt, D, Hasenkamp, J, Kiehl, M, Kiderlen, TR, Kochanek, M, Koldehoff, M, Kostrewa, P, Claßen, AY, et al
Annals of hematology. 2021;(1):239-259
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Abstract
Cancer patients frequently require central venous catheters for therapy and parenteral nutrition and are at high risk of central venous catheter-related infections (CRIs). Moreover, CRIs prolong hospitalization, cause an excess in resource utilization and treatment cost, often delay anti-cancer treatment, and are associated with a significant increase in mortality in cancer patients. We therefore summoned a panel of experts by the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO) and updated our previous guideline on CRIs in cancer patients. After conducting systematic literature searches on PubMed, Medline, and Cochrane databases, video- and meeting-based consensus discussions were held. In the presented guideline, we summarize recommendations on definition, diagnosis, management, and prevention of CRIs in cancer patients including the grading of strength of recommendations and the respective levels of evidence. This guideline supports clinicians and researchers alike in the evidence-based decision-making in the management of CRIs in cancer patients.
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Assessment of the Methods Used to Develop Vitamin D and Calcium Recommendations-A Systematic Review of Bone Health Guidelines.
Dai, Z, McKenzie, JE, McDonald, S, Baram, L, Page, MJ, Allman-Farinelli, M, Raubenheimer, D, Bero, LA
Nutrients. 2021;(7)
Abstract
BACKGROUND There are numerous guidelines developed for bone health. Yet, it is unclear whether the differences in guideline development methods explain the variability in the recommendations for vitamin D and calcium intake. The objective of this systematic review was to collate and compare recommendations for vitamin D and calcium across bone health guidelines, assess the methods used to form the recommendations, and explore which methodological factors were associated with these guideline recommendations. METHODS We searched MEDLINE, EMBASE, CINAHL, and other databases indexing guidelines to identify records in English between 2009 and 2019. Guidelines or policy statements on bone health or osteoporosis prevention for generally healthy adults aged ≥40 years were eligible for inclusion. Two reviewers independently extracted recommendations on daily vitamin D and calcium intake, supplement use, serum 25 hydroxyvitamin D [25(OH)D] level, and sunlight exposure; assessed guideline development methods against 25 recommended criteria in the World Health Organization (WHO) handbook for guideline development; and, identified types identified types of evidence underpinning the recommendations. RESULTS we included 47 eligible guidelines from 733 records: 74% of the guidelines provided vitamin D (200~600-4000 IU/day) and 70% provided calcium (600-1200 mg/day) recommendations, 96% and 88% recommended vitamin D and calcium supplements, respectively, and 70% recommended a specific 25(OH)D concentration. On average, each guideline met 10 (95% CI: 9-12) of the total of 25 methodological criteria for guideline development recommended by the WHO Handbook. There was uncertainty in the association between the methodological criteria and the proportion of guidelines that provided recommendations on daily vitamin D or calcium. Various types of evidence, including previous bone guidelines, nutrient reference reports, systematic reviews, observational studies, and perspectives/editorials were used to underpin the recommendations. CONCLUSIONS There is considerable variability in vitamin D and calcium recommendations and in guideline development methods in bone health guidelines. Effort is required to strengthen the methodological rigor of guideline development and utilize the best available evidence to underpin nutrition recommendations in evidence-based guidelines on bone health.
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Clinical practice guidelines for BRCA1 and BRCA2 genetic testing.
Pujol, P, Barberis, M, Beer, P, Friedman, E, Piulats, JM, Capoluongo, ED, Garcia Foncillas, J, Ray-Coquard, I, Penault-Llorca, F, Foulkes, WD, et al
European journal of cancer (Oxford, England : 1990). 2021;:30-47
Abstract
BRCA1 and BRCA2 gene pathogenic variants account for most hereditary breast cancer and are increasingly used to determine eligibility for PARP inhibitor (PARPi) therapy of BRCA-related cancer. Because issues of BRCA testing in clinical practice now overlap with both preventive and therapeutic management, updated and comprehensive practice guidelines for BRCA genotyping are needed. The integrative recommendations for BRCA testing presented here aim to (1) identify individuals who may benefit from genetic counselling and risk-reducing strategies; (2) update germline and tumour-testing indications for PARPi-approved therapies; (3) provide testing recommendations for personalised management of early and metastatic breast cancer; and (4) address the issues of rapid process and tumour analysis. An international group of experts, including geneticists, medical and surgical oncologists, pathologists, ethicists and patient representatives, was commissioned by the French Society of Predictive and Personalised Medicine (SFMPP). The group followed a methodology based on specific formal guidelines development, including (1) evaluating the likelihood of BRCAm from a combined systematic review of the literature, risk assessment models and expert quotations, and (2) therapeutic values of BRCAm status for PARPi therapy in BRCA-related cancer and for management of early and advanced breast cancer. These international guidelines may help clinicians comprehensively update and standardise BRCA testing practices.
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Non-Adherence to Antihypertensive Guidelines in Patients with Asymptomatic Carotid Stenosis.
Haley, W, Shawl, F, Charles Sternbergh, W, Turan, TN, Barrett, K, Voeks, J, Brott, T, Meschia, JF
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. 2021;(8):105918
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IMPORTANCE Hypertension and carotid stenosis are both risk factors for stroke, but the presence of carotid stenosis might dampen enthusiasm for tight control of hypertension because of concerns for hypoperfusion. OBJECTIVE To determine the extent to which there are opportunities to potentially improve pharmacotherapy for hypertension in patients known to have asymptomatic high-grade carotid stenosis. DESIGN We examined anti-hypertensive medication prescription and adherence to evidence-based hypertension treatment guidelines in a cross-sectional analysis of baseline data of patients enrolled in a clinical trial. SETTING The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) is a multicenter prospective randomized open blinded end-point clinical trial of intensive medical management with or without revascularization by endarterectomy or stenting for asymptomatic high-grade carotid stenosis. PARTICIPANTS 1479 participants (38.6% female; mean age 69.8 years) from 132 clinical centers enrolled in the CREST-2 trial as of April 6, 2020 who were taking ≥1 antihypertensive drug at baseline. EXPOSURES Pharmacotherapy for hypertension. MAIN OUTCOME Adherence to evidence-based guidelines for treating hypertension. RESULTS Of 1458 participants with complete data, 26% were on one, 31% on 2, and 43% on ≥3 antihypertensive medications at trial entry. Thirty-two percent of participants were prescribed thiazide; 74%, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB); 38%, calcium channel blocker (CCB); 56%, a beta blocker; 11%, loop diuretic; and 27%, other. Of those prescribed a single antihypertensive medication, the proportion prescribed thiazide was 5%; ACEI or ARB, 55%, and CCB, 11%. The prevalence of guideline-adherent regimens was 34% (95% CI, 31-36%). CONCLUSIONS AND RELEVANCE In a diverse cohort with severe carotid disease and hypertension, non-adherence to hypertension guidelines was common. All preferred classes of antihypertensive drug were under-prescribed. Using staged iterative guideline-based care for hypertension, CREST-2 will characterize drug tolerance and stroke rates under these conditions. TRIAL REGISTRATION ClinicalTrials.gov Number NCT02089217.
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A Primary Care Agenda for Brain Health: A Scientific Statement From the American Heart Association.
Lazar, RM, Howard, VJ, Kernan, WN, Aparicio, HJ, Levine, DA, Viera, AJ, Jordan, LC, Nyenhuis, DL, Possin, KL, Sorond, FA, et al
Stroke. 2021;(6):e295-e308
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A healthy brain is critical for living a longer and fuller life. The projected aging of the population, however, raises new challenges in maintaining quality of life. As we age, there is increasing compromise of neuronal activity that affects functions such as cognition, also making the brain vulnerable to disease. Once pathology-induced decline begins, few therapeutic options are available. Prevention is therefore paramount, and primary care can play a critical role. The purpose of this American Heart Association scientific statement is to provide an up-to-date summary for primary care providers in the assessment and modification of risk factors at the individual level that maintain brain health and prevent cognitive impairment. Building on the 2017 American Heart Association/American Stroke Association presidential advisory on defining brain health that included "Life's Simple 7," we describe here modifiable risk factors for cognitive decline, including depression, hypertension, physical inactivity, diabetes, obesity, hyperlipidemia, poor diet, smoking, social isolation, excessive alcohol use, sleep disorders, and hearing loss. These risk factors include behaviors, conditions, and lifestyles that can emerge before adulthood and can be routinely identified and managed by primary care clinicians.
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Systematic review of clinical practice guidelines for colorectal and anal cancer: the extent of recommendations for managing long-term symptoms and functional impairments.
Wiltink, LM, White, K, King, MT, Rutherford, C
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2020;(6):2523-2532
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PURPOSE Due to increasing numbers of colorectal and anal cancer survivors, more individuals are living with long-term symptoms after treatment. A systematic review was undertaken to assess the extent to which practice guidelines for colorectal and anal cancer provide recommendations for managing long-term symptoms and functioning impairments. METHODS Four electronic databases and websites of 30 international cancer societies were searched for clinical practice guidelines, consensus statements, or best practice recommendations for colorectal or anal cancer. Quality of included guidelines was evaluated with the Appraisal of Guidelines for Research & Evaluation II tool. Results were narratively summarized. RESULTS We included 51 guidelines or consensus statements. Recommendations for managing long-term symptoms or functioning impairments were reported in 13 guidelines (25.4%). All 13 recommend a healthy lifestyle, diet, body weight, and physical activity. The ASCO Colorectal Cancer Survivorship Care Guideline is the most comprehensive, including interventions targeting sexual and bowel function to pain and cognitive issues, and also highlights limited evidence for informing management strategies. Other guidelines recommend treating incontinence, chronic diarrhea, and distress, and stress the need for greater awareness for sexual dysfunction, survivorship clinics, and referrals to specific supportive care interventions. CONCLUSIONS Few clinical practice guidelines include recommendations for managing long-term symptoms and functioning impairments. It is unclear if this is due to limited evidence or absence of management strategies and interventions. Clear recommendations for managing long-term symptoms and functioning to help health professionals in supporting colorectal and anal cancer survivors are needed.
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Precision Medicine in Diabetes: A Consensus Report From the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).
Chung, WK, Erion, K, Florez, JC, Hattersley, AT, Hivert, MF, Lee, CG, McCarthy, MI, Nolan, JJ, Norris, JM, Pearson, ER, et al
Diabetes care. 2020;(7):1617-1635
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The convergence of advances in medical science, human biology, data science, and technology has enabled the generation of new insights into the phenotype known as "diabetes." Increased knowledge of this condition has emerged from populations around the world, illuminating the differences in how diabetes presents, its variable prevalence, and how best practice in treatment varies between populations. In parallel, focus has been placed on the development of tools for the application of precision medicine to numerous conditions. This Consensus Report presents the American Diabetes Association (ADA) Precision Medicine in Diabetes Initiative in partnership with the European Association for the Study of Diabetes (EASD), including its mission, the current state of the field, and prospects for the future. Expert opinions are presented on areas of precision diagnostics and precision therapeutics (including prevention and treatment), and key barriers to and opportunities for implementation of precision diabetes medicine, with better care and outcomes around the globe, are highlighted. Cases where precision diagnosis is already feasible and effective (i.e., monogenic forms of diabetes) are presented, while the major hurdles to the global implementation of precision diagnosis of complex forms of diabetes are discussed. The situation is similar for precision therapeutics, in which the appropriate therapy will often change over time owing to the manner in which diabetes evolves within individual patients. This Consensus Report describes a foundation for precision diabetes medicine, while highlighting what remains to be done to realize its potential. This, combined with a subsequent, detailed evidence-based review (due 2022), will provide a roadmap for precision medicine in diabetes that helps improve the quality of life for all those with diabetes.