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Arthritis Care & Research Jul 2021To develop updated guidelines for the pharmacologic management of rheumatoid arthritis.
OBJECTIVE
To develop updated guidelines for the pharmacologic management of rheumatoid arthritis.
METHODS
We developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. After conducting a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the certainty of evidence. A voting panel comprising clinicians and patients achieved consensus on the direction (for or against) and strength (strong or conditional) of recommendations.
RESULTS
The guideline addresses treatment with disease-modifying antirheumatic drugs (DMARDs), including conventional synthetic DMARDs, biologic DMARDs, and targeted synthetic DMARDs, use of glucocorticoids, and use of DMARDs in certain high-risk populations (i.e., those with liver disease, heart failure, lymphoproliferative disorders, previous serious infections, and nontuberculous mycobacterial lung disease). The guideline includes 44 recommendations (7 strong and 37 conditional).
CONCLUSION
This clinical practice guideline is intended to serve as a tool to support clinician and patient decision-making. Recommendations are not prescriptive, and individual treatment decisions should be made through a shared decision-making process based on patients' values, goals, preferences, and comorbidities.
Topics: Antirheumatic Agents; Arthritis, Rheumatoid; Clinical Decision-Making; Consensus; Decision Support Techniques; Humans; Remission Induction; Rheumatology; Treatment Outcome
PubMed: 34101387
DOI: 10.1002/acr.24596 -
Thyroid : Official Journal of the... Mar 2021Anaplastic thyroid cancer (ATC) is a rare but highly lethal form of thyroid cancer. Since the guidelines for the management of ATC by the American Thyroid Association...
Anaplastic thyroid cancer (ATC) is a rare but highly lethal form of thyroid cancer. Since the guidelines for the management of ATC by the American Thyroid Association were first published in 2012, significant clinical and scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, and researchers on published evidence relating to the diagnosis and management of ATC. The specific clinical questions and topics addressed in these guidelines were based on prior versions of the guidelines, stakeholder input, and input of the Task Force members (authors of the guideline). Relevant literature was reviewed, including serial PubMed searches supplemented with additional articles. The American College of Physicians Guideline Grading System was used for critical appraisal of evidence and grading strength of recommendations. The guidelines include the diagnosis, initial evaluation, establishment of treatment goals, approaches to locoregional disease (surgery, radiotherapy, targeted/systemic therapy, supportive care during active therapy), approaches to advanced/metastatic disease, palliative care options, surveillance and long-term monitoring, and ethical issues, including end of life. The guidelines include 31 recommendations and 16 good practice statements. We have developed evidence-based recommendations to inform clinical decision-making in the management of ATC. While all care must be individualized, such recommendations provide, in our opinion, optimal care paradigms for patients with ATC.
Topics: Consensus; Evidence-Based Medicine; Humans; Medical Oncology; Prognosis; Thyroid Carcinoma, Anaplastic; Thyroid Neoplasms
PubMed: 33728999
DOI: 10.1089/thy.2020.0944 -
Journal of Vascular Surgery Jan 2022Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The... (Meta-Analysis)
Meta-Analysis
Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The proper treatment of patients with carotid bifurcation disease is of major interest to vascular surgeons and other vascular specialists. In 2011, the Society for Vascular Surgery published guidelines for the treatment of carotid artery disease. At the time, several randomized trials, comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS), were reported. Since the 2011 guidelines, several studies and a few systematic reviews comparing CEA and CAS have been reported, and the role of medical management has been reemphasized. In the present publication, we have updated and expanded on the 2011 guidelines with specific emphasis on five areas: (1) is CEA recommended over maximal medical therapy for low-risk patients; (2) is CEA recommended over transfemoral CAS for low surgical risk patients with symptomatic carotid artery stenosis of >50%; (3) the timing of carotid intervention for patients presenting with acute stroke; (4) screening for carotid artery stenosis in asymptomatic patients; and (5) the optimal sequence of intervention for patients with combined carotid and coronary artery disease. A separate implementation document will address other important clinical issues in extracranial cerebrovascular disease. Recommendations are made using the GRADE (grades of recommendation assessment, development, and evaluation) approach, as was used for other Society for Vascular Surgery guidelines. The committee recommends CEA as the first-line treatment for symptomatic low-risk surgical patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 70% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be <3% to ensure benefit for the patient. In patients with recent stable stroke (modified Rankin scale score, 0-2), carotid revascularization is considered appropriate for symptomatic patients with >50% stenosis and should be performed as soon as the patient is neurologically stable after 48 hours but definitely <14 days after symptom onset. In the general population, screening for clinically asymptomatic carotid artery stenosis in patients without cerebrovascular symptoms or significant risk factors for carotid artery disease is not recommended. In selected asymptomatic patients with an increased risk of carotid stenosis, we suggest screening for clinically asymptomatic carotid artery stenosis as long as the patients would potentially be fit for and willing to consider carotid intervention if significant stenosis is discovered. For patients with symptomatic carotid stenosis of 50% to 99%, who require both CEA and coronary artery bypass grafting, we suggest CEA before, or concomitant with, coronary artery bypass grafting to potentially reduce the risk of stroke and stroke/death. The sequencing of the intervention depends on the clinical presentation and institutional experience.
Topics: Cardiovascular Agents; Carotid Stenosis; Clinical Decision-Making; Consensus; Endarterectomy, Carotid; Endovascular Procedures; Evidence-Based Medicine; Humans; Risk Assessment; Risk Factors; Treatment Outcome
PubMed: 34153348
DOI: 10.1016/j.jvs.2021.04.073 -
BMJ Open Dec 2019To (1) provide an up-to-date overview of shared decision making (SDM)-models, (2) give insight in the prominence of components present in SDM-models, (3) describe who is...
OBJECTIVES
To (1) provide an up-to-date overview of shared decision making (SDM)-models, (2) give insight in the prominence of components present in SDM-models, (3) describe who is identified as responsible within the components (patient, healthcare professional, both, none), (4) show the occurrence of SDM-components over time, and (5) present an SDM-map to identify SDM-components seen as key, per healthcare setting.
DESIGN
Systematic review.
ELIGIBILITY CRITERIA
Peer-reviewed articles in English presenting a new or adapted model of SDM.
INFORMATION SOURCES
Academic Search Premier, Cochrane, Embase, Emcare, PsycINFO, PubMed, and Web of Science were systematically searched for articles published up to and including September 2, 2019.
RESULTS
Forty articles were included, each describing a unique SDM-model. Twelve models were generic, the others were specific to a healthcare setting. Fourteen were based on empirical data, 26 primarily on analytical thinking. Fifty-three different elements were identified and clustered into 24 components. Overall was the most prominent component across models. Components present in >50% of models were: ), ), ), ), and (53%). In the majority of the models (27/40), both healthcare professional and patient were identified as actors. Over time, and are the two components which are present in most models in any time period. stood out for being present in a markedly larger proportion of models over time.
CONCLUSIONS
This review provides an up-to-date overview of SDM-models, showing that SDM-models quite consistently share some components but that a unified view on what SDM is, is still lacking. Clarity about what SDM constitutes is essential though for implementation, assessment, and research purposes. A map is offered to identify SDM-components seen as key.
TRIAL REGISTRATION
PROSPERO registration CRD42015019740.
Topics: Clinical Decision-Making; Decision Making; Humans; Models, Theoretical; Patient Preference
PubMed: 31852700
DOI: 10.1136/bmjopen-2019-031763 -
Annals of the Rheumatic Diseases Oct 2023Haemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) are life-threatening systemic hyperinflammatory syndromes that can develop in most...
The 2022 EULAR/ACR points to consider at the early stages of diagnosis and management of suspected haemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
OBJECTIVE
Haemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) are life-threatening systemic hyperinflammatory syndromes that can develop in most inflammatory contexts. They can progress rapidly, and early identification and management are critical for preventing organ failure and mortality. This effort aimed to develop evidence-based and consensus-based points to consider to assist clinicians in optimising decision-making in the of diagnosis, treatment and monitoring of HLH/MAS.
METHODS
A multinational, multidisciplinary task force of physician experts, including adult and paediatric rheumatologists, haematologist/oncologists, immunologists, infectious disease specialists, intensivists, allied healthcare professionals and patients/parents, formulated relevant research questions and conducted a systematic literature review (SLR). Delphi methodology, informed by SLR results and questionnaires of experts, was used to generate statements aimed at assisting early decision-making and optimising the initial care of patients with HLH/MAS.
RESULTS
The task force developed 6 overarching statements and 24 specific points to consider relevant to early recognition of HLH/MAS, diagnostic approaches, initial management and monitoring of HLH/MAS. Major themes included the simultaneous need for prompt syndrome recognition, systematic evaluation of underlying contributors, early intervention targeting both hyperinflammation and likely contributors, careful monitoring for progression/complications and expert multidisciplinary assistance.
CONCLUSION
These 2022 EULAR/American College of Rheumatology points to consider provide up-to-date guidance, based on the best available published data and expert opinion. They are meant to help guide the initial evaluation, management and monitoring of patients with HLH/MAS in order to halt disease progression and prevent life-threatening immunopathology.
Topics: Child; Adult; Humans; United States; Lymphohistiocytosis, Hemophagocytic; Macrophage Activation Syndrome; Rheumatology; Consensus
PubMed: 37487610
DOI: 10.1136/ard-2023-224123 -
Radiotherapy and Oncology : Journal of... Jul 2020Recognizing the rapidly increasing interest and evidence in using metastasis-directed radiotherapy (MDRT) for oligometastatic disease (OMD), ESTRO and ASTRO convened a...
BACKGROUND
Recognizing the rapidly increasing interest and evidence in using metastasis-directed radiotherapy (MDRT) for oligometastatic disease (OMD), ESTRO and ASTRO convened a committee to establish consensus regarding definitions of OMD and define gaps in current evidence.
METHODS
A systematic literature review focused on curative intent MDRT was performed in Medline, Embase and Cochrane. Subsequent consensus opinion, using a Delphi process, highlighted the current state of evidence and the limitations in the available literature.
RESULTS
Available evidence regarding the use of MDRT for OMD mostly derives from retrospective, single-centre series, with significant heterogeneity in patient inclusion criteria, definition of OMD, and outcomes reported. Consensus was reached that OMD is largely independent of primary tumour, metastatic location and the presence or length of a disease-free interval, supporting both synchronous and metachronous OMD. In the absence of clinical data supporting a maximum number of metastases and organs to define OMD, and of validated molecular biomarkers, consensus supported the ability to deliver safe and clinically meaningful radiotherapy with curative intent to all metastatic sites as a minimum requirement for defining OMD in the context of radiotherapy. Systemic therapy induced OMD was identified as a distinct state of OMD. High-resolution imaging to assess and confirm OMD is crucial, including brain imaging when indicated. Minimum common endpoints such as progression-free and overall survival, local control, toxicity and quality-of-life should be reported; uncommon endpoints as deferral of systemic therapy and cost were endorsed.
CONCLUSION
While significant heterogeneity exists in the current OMD definitions in the literature, consensus was reached on multiple key questions. Based on available data, OMD can to date be defined as 1-5 metastatic lesions, a controlled primary tumor being optional, but where all metastatic sites must be safely treatable. Consistent definitions and reporting are warranted and encouraged in ongoing trials and reports generating further evidence to optimize patient benefits.
Topics: Consensus; Diagnostic Imaging; Humans; Neoplasm Metastasis; Neoplasms; Radiation Oncology; Retrospective Studies
PubMed: 32388150
DOI: 10.1016/j.radonc.2020.04.003 -
Arthritis & Rheumatology (Hoboken, N.J.) Oct 2023Haemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) are life-threatening systemic hyperinflammatory syndromes that can develop in most...
The 2022 EULAR/ACR Points to Consider at the Early Stages of Diagnosis and Management of Suspected Haemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS).
OBJECTIVE
Haemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) are life-threatening systemic hyperinflammatory syndromes that can develop in most inflammatory contexts. They can progress rapidly, and early identification and management are critical for preventing organ failure and mortality. This effort aimed to develop evidence-based and consensus-based points to consider to assist clinicians in optimising decision-making in the early stages of diagnosis, treatment and monitoring of HLH/MAS.
METHODS
A multinational, multidisciplinary task force of physician experts, including adult and paediatric rheumatologists, haematologist/oncologists, immunologists, infectious disease specialists, intensivists, allied healthcare professionals and patients/parents, formulated relevant research questions and conducted a systematic literature review (SLR). Delphi methodology, informed by SLR results and questionnaires of experts, was used to generate statements aimed at assisting early decision-making and optimising the initial care of patients with HLH/MAS.
RESULTS
The task force developed 6 overarching statements and 24 specific points to consider relevant to early recognition of HLH/MAS, diagnostic approaches, initial management and monitoring of HLH/MAS. Major themes included the simultaneous need for prompt syndrome recognition, systematic evaluation of underlying contributors, early intervention targeting both hyperinflammation and likely contributors, careful monitoring for progression/complications and expert multidisciplinary assistance.
CONCLUSION
These 2022 EULAR/American College of Rheumatology points to consider provide up-to-date guidance, based on the best available published data and expert opinion. They are meant to help guide the initial evaluation, management and monitoring of patients with HLH/MAS in order to halt disease progression and prevent life-threatening immunopathology.
Topics: Adult; Child; Humans; Lymphohistiocytosis, Hemophagocytic; Macrophage Activation Syndrome; Consensus; Physicians; Advisory Committees
PubMed: 37486733
DOI: 10.1002/art.42636 -
Zeitschrift Fur Evidenz, Fortbildung... Aug 2022Delphi techniques are conducted across different subfields in the health sciences. The reporting practices of studies using Delphi techniques vary, and current reporting... (Review)
Review
BACKGROUND
Delphi techniques are conducted across different subfields in the health sciences. The reporting practices of studies using Delphi techniques vary, and current reporting guidelines for Delphi techniques focus on individual subfields of the health sciences or on different aspects of research and are therefore of limited applicability. The aim of this article was to identify similarities, differences, and possible shortcomings of existing Delphi reporting guidelines and to draft an initial proposal for a comprehensively applicable reporting guideline.
METHODS
A systematic literature search for reporting guidelines on Delphi studies was performed in existing data resources based on databases in the health sciences (Scopus, MEDLINE, CINAHL, Epistemonikos) including publications from 2016 to 2021. In June 2021, we conducted an additional search in PubMed and included further studies by contacting experts of the scientific Delphi expert network (DeWiss). Title and abstract screening of articles was performed, followed by a full-text screening of the articles included. We qualitatively and quantitatively evaluated, compared and contrasted the reporting guidelines identified using content analysis and discussed the results among the members of the Delphi expert network.
RESULTS
We retrieved ten health science articles with reporting guidelines for Delphi studies. In analyzing them, we identified nine main categories (Justification, Expert panel, Questionnaire, Survey design, Process regulation, Analyses, Results, Discussion, Methods reflection & Ethics). The current reporting guidelines vary significantly, with only the aspect of consensus appearing in all of them. Frequency distributions show that most of the subcategories are only addressed in individual articles (e.g., meeting of participants, proceeding with the survey method, transfer of the results, validation, prevention of bias) and that epistemological foundations of the Delphi technique are rarely mentioned or reflected on. We drafted an initial proposal for Delphi reporting guidelines for the health science sector.
DISCUSSION
A well-justified position concerning epistemological foundations of Delphi studies is necessary to make the quality of the process assessable and, along with the reporting of the process, to classify and compare study results. This will increase the acceptance of both the method in the health science sector and the results in medical practice. A Delphi reporting guideline must, above all, take into account the diversity of variants, subfield-related objectives and application areas, and their modifications of the Delphi technique in order to be comprehensively applicable in the health sciences.
CONCLUSION
The results of our methodological review do not provide a final reporting guideline. The newly developed proposal is intended to encourage discussion and agreement in further analyses.
Topics: Consensus; Delphi Technique; Germany; Humans; Research Design; Research Report
PubMed: 35718726
DOI: 10.1016/j.zefq.2022.04.025 -
Lancet (London, England) Mar 2021Preterm birth is a global health priority. Using a progestogen during high-risk pregnancy could reduce preterm birth and adverse neonatal outcomes. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Preterm birth is a global health priority. Using a progestogen during high-risk pregnancy could reduce preterm birth and adverse neonatal outcomes.
METHODS
We did a systematic review of randomised trials comparing vaginal progesterone, intramuscular 17-hydroxyprogesterone caproate (17-OHPC), or oral progesterone with control, or with each other, in asymptomatic women at risk of preterm birth. We identified published and unpublished trials that completed primary data collection before July 30, 2016, (12 months before data collection began), by searching MEDLINE, Embase, CINAHL, the Maternity and Infant Care Database, and relevant trial registers between inception and July 30, 2019. Trials of progestogen to prevent early miscarriage or immediately-threatened preterm birth were excluded. Individual participant data were requested from investigators of eligible trials. Outcomes included preterm birth, early preterm birth, and mid-trimester birth. Adverse neonatal sequelae associated with early births were assessed using a composite of serious neonatal complications, and individually. Adverse maternal outcomes were investigated as a composite and individually. Individual participant data were checked and risk of bias assessed independently by two researchers. Primary meta-analyses used one-stage generalised linear mixed models that incorporated random effects to allow for heterogeneity across trials. This meta-analysis is registered with PROSPERO, CRD42017068299.
FINDINGS
Initial searches identified 47 eligible trials. Individual participant data were available for 30 of these trials. An additional trial was later included in a targeted update. Data were therefore available from a total of 31 trials (11 644 women and 16185 offspring). Trials in singleton pregnancies included mostly women with previous spontaneous preterm birth or short cervix. Preterm birth before 34 weeks was reduced in such women who received vaginal progesterone (nine trials, 3769 women; relative risk [RR] 0·78, 95% CI 0·68-0·90), 17-OHPC (five trials, 3053 women; 0·83, 0·68-1·01), and oral progesterone (two trials, 181 women; 0·60, 0·40-0·90). Results for other birth and neonatal outcomes were consistently favourable, but less certain. A possible increase in maternal complications was suggested, but this was uncertain. We identified no consistent evidence of treatment interaction with any participant characteristics examined, although analyses within subpopulations questioned efficacy in women who did not have a short cervix. Trials in multifetal pregnancies mostly included women without additional risk factors. For twins, vaginal progesterone did not reduce preterm birth before 34 weeks (eight trials, 2046 women: RR 1·01, 95% CI 0·84-1·20) nor did 17-OHPC for twins or triplets (eight trials, 2253 women: 1·04, 0·92-1·18). Preterm premature rupture of membranes was increased with 17-OHPC exposure in multifetal gestations (rupture <34 weeks RR 1·59, 95% CI 1·15-2·22), but we found no consistent evidence of benefit or harm for other outcomes with either vaginal progesterone or 17-OHPC.
INTERPRETATION
Vaginal progesterone and 17-OHPC both reduced birth before 34 weeks' gestation in high-risk singleton pregnancies. Given increased underlying risk, absolute risk reduction is greater for women with a short cervix, hence treatment might be most useful for these women. Evidence for oral progesterone is insufficient to support its use. Shared decision making with woman with high-risk singleton pregnancies should discuss an individual's risk, potential benefits, harms and practicalities of intervention. Treatment of unselected multifetal pregnancies with a progestogen is not supported by the evidence.
FUNDING
Patient-Centered Outcomes Research Institute.
Topics: 17-alpha-Hydroxyprogesterone; Administration, Intravaginal; Decision Making, Shared; Female; Humans; Infant, Newborn; Injections, Intramuscular; Pregnancy; Pregnancy Outcome; Pregnancy, High-Risk; Premature Birth; Progesterone; Randomized Controlled Trials as Topic; Risk Assessment
PubMed: 33773630
DOI: 10.1016/S0140-6736(21)00217-8 -
Medicine Aug 2020Shared decision making (SDM) is a process within the physician-patient relationship applicable to any clinical action, whether diagnostic, therapeutic, or preventive in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Shared decision making (SDM) is a process within the physician-patient relationship applicable to any clinical action, whether diagnostic, therapeutic, or preventive in nature. It has been defined as a process of mutual respect and participation between the doctor and the patient. The aim of this study is to determine the effectiveness of decision aids (DA) in primary care based on changes in adherence to treatments, knowledge, and awareness of the disease, conflict with decisions, and patients' and health professionals' satisfaction with the intervention.
METHODS
A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was conducted in Medline, CINAHL, Embase, the Cochrane Central Register of Controlled Trials, and the NHS Economic Evaluation Database. The inclusion criteria were randomized clinical trials as study design; use of SDM with DA as an intervention; primary care as clinical context; written in English, Spanish, and Portuguese; and published between January 2007 and January 2019. The risk of bias of the included studies in this review was assessed according to the Cochrane Collaboration's tool.
RESULTS
Twenty four studies were selected out of the 201 references initially identified. With the use of DA, the use of antibiotics was reduced in cases of acute respiratory infection and decisional conflict was decreased when dealing with the treatment choice for atrial fibrillation and osteoporosis. The rate of determination of prostate-specific antigen (PSA) in the prostate cancer screening decreased and colorectal cancer screening increased. Both professionals and patients increased their knowledge about depression, type 2 diabetes, and the perception of risk of acute myocardial infarction at 10 years without statins and with statins. The satisfaction was greater with the use of DA in choosing the treatment for depression, in cardiovascular risk management, in the treatment of low back pain, and in the use of statin therapy in diabetes. Blinding of outcomes assessment was the most common bias.
CONCLUSIONS
DA used in primary care are effective to reduce decisional conflict and improve knowledge on the disease and treatment options, awareness of risk, and satisfaction with the decisions made. More studies are needed to assess the impact of shared decision making in primary care.
Topics: Decision Making, Shared; Decision Support Techniques; Humans; Primary Health Care
PubMed: 32769870
DOI: 10.1097/MD.0000000000021389