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Gastroenterology Apr 2021The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of Inflammatory Bowel Diseases...
STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD.
BACKGROUND
The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) has proposed treatment targets in 2015 for adult patients with inflammatory bowel disease (IBD). We aimed to update the original STRIDE statements for incorporating treatment targets in both adult and pediatric IBD.
METHODS
Based on a systematic review of the literature and iterative surveys of 89 IOIBD members, recommendations were drafted and modified in 2 surveys and 2 voting rounds. Consensus was reached if ≥75% of participants scored the recommendation as 7 to 10 on a 10-point rating scale.
RESULTS
In the systematic review, 11,278 manuscripts were screened, of which 435 were included. The first IOIBD survey identified the following targets as most important: clinical response and remission, endoscopic healing, and normalization of C-reactive protein/erythrocyte sedimentation rate and calprotectin. Fifteen recommendations were identified, of which 13 were endorsed. STRIDE-II confirmed STRIDE-I long-term targets of clinical remission and endoscopic healing and added absence of disability, restoration of quality of life, and normal growth in children. Symptomatic relief and normalization of serum and fecal markers have been determined as short-term targets. Transmural healing in Crohn's disease and histological healing in ulcerative colitis are not formal targets but should be assessed as measures of the remission depth.
CONCLUSIONS
STRIDE-II encompasses evidence- and consensus-based recommendations for treat-to-target strategies in adults and children with IBD. This frameworkshould be adapted to individual patients and local resources to improve outcomes.
Topics: Adolescent; Adolescent Development; Adult; Age Factors; Biomarkers; Child; Child Development; Colitis, Ulcerative; Consensus; Crohn Disease; Delphi Technique; Endpoint Determination; Humans; Quality of Life; Remission Induction; Research Design; Treatment Outcome; Wound Healing
PubMed: 33359090
DOI: 10.1053/j.gastro.2020.12.031 -
Palliative Medicine Sep 2017The Delphi technique is widely used for the development of guidance in palliative care, having impact on decisions with relevance for patient care. (Review)
Review
BACKGROUND
The Delphi technique is widely used for the development of guidance in palliative care, having impact on decisions with relevance for patient care.
AIM
To systematically examine the application of the Delphi technique for the development of best practice guidelines in palliative care.
DESIGN
A methodological systematic review was undertaken using the databases PubMed, CINAHL, Web of Science, Academic Search Complete and EMBASE.
DATA SOURCES
Original articles (English language) were included when reporting on empirical studies that had used the Delphi technique to develop guidance for good clinical practice in palliative care. Data extraction included a quality appraisal on the rigour in conduct of the studies and the quality of reporting.
RESULTS
A total of 30 empirical studies (1997-2015) were considered for full-text analysis. Considerable differences were identified regarding the rigour of the design and the reporting of essential process and outcome parameters. Furthermore, discrepancies regarding the use of terms for describing the method were observed, for example, concerning the understanding of a 'round' or a 'modified Delphi study'.
CONCLUSION
Substantial variation was found concerning the quality of the study conduct and the transparency of reporting of Delphi studies used for the development of best practice guidance in palliative care. Since credibility of the resulting recommendations depends on the rigorous use of the Delphi technique, there is a need for consistency and quality both in the conduct and reporting of studies. To allow a critical appraisal of the methodology and the resulting guidance, a reporting standard for Conducting and REporting of DElphi Studies (CREDES) is proposed.
Topics: Decision Making; Delphi Technique; Evidence-Based Practice; Humans; Palliative Care
PubMed: 28190381
DOI: 10.1177/0269216317690685 -
Annals of the Rheumatic Diseases Aug 2017The aim was to update the 2009 European League against Rheumatism (EULAR) recommendations for the treatment of systemic sclerosis (SSc), with attention to new...
The aim was to update the 2009 European League against Rheumatism (EULAR) recommendations for the treatment of systemic sclerosis (SSc), with attention to new therapeutic questions. Update of the previous treatment recommendations was performed according to EULAR standard operating procedures. The task force consisted of 32 SSc clinical experts from Europe and the USA, 2 patients nominated by the pan-European patient association for SSc (Federation of European Scleroderma Associations (FESCA)), a clinical epidemiologist and 2 research fellows. All centres from the EULAR Scleroderma Trials and Research group were invited to submit and select clinical questions concerning SSc treatment using a Delphi approach. Accordingly, 46 clinical questions addressing 26 different interventions were selected for systematic literature review. The new recommendations were based on the available evidence and developed in a consensus meeting with clinical experts and patients. The procedure resulted in 16 recommendations being developed (instead of 14 in 2009) that address treatment of several SSc-related organ complications: Raynaud's phenomenon (RP), digital ulcers (DUs), pulmonary arterial hypertension (PAH), skin and lung disease, scleroderma renal crisis and gastrointestinal involvement. Compared with the 2009 recommendations, the 2016 recommendations include phosphodiesterase type 5 (PDE-5) inhibitors for the treatment of SSc-related RP and DUs, riociguat, new aspects for endothelin receptor antagonists, prostacyclin analogues and PDE-5 inhibitors for SSc-related PAH. New recommendations regarding the use of fluoxetine for SSc-related RP and haematopoietic stem cell transplantation for selected patients with rapidly progressive SSc were also added. In addition, several comments regarding other treatments addressed in clinical questions and suggestions for the SSc research agenda were formulated. These updated data-derived and consensus-derived recommendations will help rheumatologists to manage patients with SSc in an evidence-based way. These recommendations also give directions for future clinical research in SSc.
Topics: Angiotensin-Converting Enzyme Inhibitors; Delphi Technique; Endothelin Receptor Antagonists; Europe; Fingers; Fluoxetine; Gastrointestinal Diseases; Glucocorticoids; Hematopoietic Stem Cell Transplantation; Humans; Hypertension, Pulmonary; Kidney Diseases; Lung Diseases; Phosphodiesterase 5 Inhibitors; Prostaglandins I; Pyrazoles; Pyrimidines; Raynaud Disease; Rheumatology; Scleroderma, Systemic; Selective Serotonin Reuptake Inhibitors; Ulcer
PubMed: 27941129
DOI: 10.1136/annrheumdis-2016-209909 -
Annals of the Rheumatic Diseases Jan 2017New drugs and new evidence concerning the use of established treatments have become available since the publication of the first European League Against Rheumatism... (Review)
Review
BACKGROUND
New drugs and new evidence concerning the use of established treatments have become available since the publication of the first European League Against Rheumatism (EULAR) recommendations for the management of gout, in 2006. This situation has prompted a systematic review and update of the 2006 recommendations.
METHODS
The EULAR task force consisted of 15 rheumatologists, 1 radiologist, 2 general practitioners, 1 research fellow, 2 patients and 3 experts in epidemiology/methodology from 12 European countries. A systematic review of the literature concerning all aspects of gout treatments was performed. Subsequently, recommendations were formulated by use of a Delphi consensus approach.
RESULTS
Three overarching principles and 11 key recommendations were generated. For the treatment of flare, colchicine, non-steroidal anti-inflammatory drugs (NSAIDs), oral or intra-articular steroids or a combination are recommended. In patients with frequent flare and contraindications to colchicine, NSAIDs and corticosteroids, an interleukin-1 blocker should be considered. In addition to education and a non-pharmacological management approach, urate-lowering therapy (ULT) should be considered from the first presentation of the disease, and serum uric acid (SUA) levels should be maintained at<6 mg/dL (360 µmol/L) and <5 mg/dL (300 µmol/L) in those with severe gout. Allopurinol is recommended as first-line ULT and its dosage should be adjusted according to renal function. If the SUA target cannot be achieved with allopurinol, then febuxostat, a uricosuric or combining a xanthine oxidase inhibitor with a uricosuric should be considered. For patients with refractory gout, pegloticase is recommended.
CONCLUSIONS
These recommendations aim to inform physicians and patients about the non-pharmacological and pharmacological treatments for gout and to provide the best strategies to achieve the predefined urate target to cure the disease.
Topics: Adrenal Cortex Hormones; Anti-Inflammatory Agents, Non-Steroidal; Delphi Technique; Directive Counseling; Evidence-Based Medicine; Gout; Gout Suppressants; Humans; Interleukin-1; Life Style; Patient Education as Topic; Symptom Flare Up; Uric Acid
PubMed: 27457514
DOI: 10.1136/annrheumdis-2016-209707 -
JAMA Feb 2016Septic shock currently refers to a state of acute circulatory failure associated with infection. Emerging biological insights and reported variation in epidemiology... (Meta-Analysis)
Meta-Analysis Review
Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
IMPORTANCE
Septic shock currently refers to a state of acute circulatory failure associated with infection. Emerging biological insights and reported variation in epidemiology challenge the validity of this definition.
OBJECTIVE
To develop a new definition and clinical criteria for identifying septic shock in adults.
DESIGN, SETTING, AND PARTICIPANTS
The Society of Critical Care Medicine and the European Society of Intensive Care Medicine convened a task force (19 participants) to revise current sepsis/septic shock definitions. Three sets of studies were conducted: (1) a systematic review and meta-analysis of observational studies in adults published between January 1, 1992, and December 25, 2015, to determine clinical criteria currently reported to identify septic shock and inform the Delphi process; (2) a Delphi study among the task force comprising 3 surveys and discussions of results from the systematic review, surveys, and cohort studies to achieve consensus on a new septic shock definition and clinical criteria; and (3) cohort studies to test variables identified by the Delphi process using Surviving Sepsis Campaign (SSC) (2005-2010; n = 28,150), University of Pittsburgh Medical Center (UPMC) (2010-2012; n = 1,309,025), and Kaiser Permanente Northern California (KPNC) (2009-2013; n = 1,847,165) electronic health record (EHR) data sets.
MAIN OUTCOMES AND MEASURES
Evidence for and agreement on septic shock definitions and criteria.
RESULTS
The systematic review identified 44 studies reporting septic shock outcomes (total of 166,479 patients) from a total of 92 sepsis epidemiology studies reporting different cutoffs and combinations for blood pressure (BP), fluid resuscitation, vasopressors, serum lactate level, and base deficit to identify septic shock. The septic shock-associated crude mortality was 46.5% (95% CI, 42.7%-50.3%), with significant between-study statistical heterogeneity (I2 = 99.5%; τ2 = 182.5; P < .001). The Delphi process identified hypotension, serum lactate level, and vasopressor therapy as variables to test using cohort studies. Based on these 3 variables alone or in combination, 6 patient groups were generated. Examination of the SSC database demonstrated that the patient group requiring vasopressors to maintain mean BP 65 mm Hg or greater and having a serum lactate level greater than 2 mmol/L (18 mg/dL) after fluid resuscitation had a significantly higher mortality (42.3% [95% CI, 41.2%-43.3%]) in risk-adjusted comparisons with the other 5 groups derived using either serum lactate level greater than 2 mmol/L alone or combinations of hypotension, vasopressors, and serum lactate level 2 mmol/L or lower. These findings were validated in the UPMC and KPNC data sets.
CONCLUSIONS AND RELEVANCE
Based on a consensus process using results from a systematic review, surveys, and cohort studies, septic shock is defined as a subset of sepsis in which underlying circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than sepsis alone. Adult patients with septic shock can be identified using the clinical criteria of hypotension requiring vasopressor therapy to maintain mean BP 65 mm Hg or greater and having a serum lactate level greater than 2 mmol/L after adequate fluid resuscitation.
Topics: Adult; Advisory Committees; Biomarkers; Blood Pressure Determination; Cohort Studies; Consensus; Delphi Technique; Fluid Therapy; Humans; Hypotension; Lactates; Observational Studies as Topic; Resuscitation; Review Literature as Topic; Shock, Septic; Vasoconstrictor Agents
PubMed: 26903336
DOI: 10.1001/jama.2016.0289 -
Annals of the Rheumatic Diseases Mar 2017Develop recommendations for women's health issues and family planning in systemic lupus erythematosus (SLE) and/or antiphospholipid syndrome (APS).
EULAR recommendations for women's health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome.
OBJECTIVES
Develop recommendations for women's health issues and family planning in systemic lupus erythematosus (SLE) and/or antiphospholipid syndrome (APS).
METHODS
Systematic review of evidence followed by modified Delphi method to compile questions, elicit expert opinions and reach consensus.
RESULTS
Family planning should be discussed as early as possible after diagnosis. Most women can have successful pregnancies and measures can be taken to reduce the risks of adverse maternal or fetal outcomes. Risk stratification includes disease activity, autoantibody profile, previous vascular and pregnancy morbidity, hypertension and the use of drugs (emphasis on benefits from hydroxychloroquine and antiplatelets/anticoagulants). Hormonal contraception and menopause replacement therapy can be used in patients with stable/inactive disease and low risk of thrombosis. Fertility preservation with gonadotropin-releasing hormone analogues should be considered prior to the use of alkylating agents. Assisted reproduction techniques can be safely used in patients with stable/inactive disease; patients with positive antiphospholipid antibodies/APS should receive anticoagulation and/or low-dose aspirin. Assessment of disease activity, renal function and serological markers is important for diagnosing disease flares and monitoring for obstetrical adverse outcomes. Fetal monitoring includes Doppler ultrasonography and fetal biometry, particularly in the third trimester, to screen for placental insufficiency and small for gestational age fetuses. Screening for gynaecological malignancies is similar to the general population, with increased vigilance for cervical premalignant lesions if exposed to immunosuppressive drugs. Human papillomavirus immunisation can be used in women with stable/inactive disease.
CONCLUSIONS
Recommendations for women's health issues in SLE and/or APS were developed using an evidence-based approach followed by expert consensus.
Topics: Antiphospholipid Syndrome; Contraceptives, Oral, Hormonal; Delphi Technique; Early Detection of Cancer; Estrogen Replacement Therapy; Family Planning Services; Female; Fertility Preservation; Fetal Monitoring; Genital Neoplasms, Female; Humans; Lupus Erythematosus, Systemic; Menopause; Preconception Care; Pregnancy; Pregnancy Complications; Reproductive Techniques, Assisted; Risk Assessment
PubMed: 27457513
DOI: 10.1136/annrheumdis-2016-209770 -
Seminars in Arthritis and Rheumatism Feb 2016Despite Level 1b evidence and international consensus that exercise is beneficial in ankylosing spondylitis (AS), there is a paucity of detailed information to guide... (Review)
Review
OBJECTIVE
Despite Level 1b evidence and international consensus that exercise is beneficial in ankylosing spondylitis (AS), there is a paucity of detailed information to guide exercise prescription, including the type and dosage of exercise required for the most benefit. This collaborative project, combining evidence with clinical expertise, was established to develop practical recommendations to guide sustainable exercise prescription for individuals with AS.
METHODS
Using a modified Delphi technique, 10 clinical questions were generated and a systematic literature review was conducted for each. Draft recommendations were developed at a 2-day meeting, based on the integration of evidence summaries and expert opinion. Feedback was obtained from patient and health professional groups prior to finalisation.
RESULTS
Recommendations and practice points were developed for the following areas: assessment; monitoring; safety; disease management; AS-specific exercise; physical activity; dosage, adherence and setting. A framework was developed that could also be adapted for exercise in other chronic musculoskeletal conditions. Feedback suggests that the final consensus statement provides useful information for those seeking to provide best practice exercise prescription for people with AS.
CONCLUSION
The recommendations provide an up-to-date, evidence-based approach to the full range of issues related to the use of exercise in AS, as well as identifying evidence gaps for further research. Most importantly, this includes investigation of aspects of exercise programme design required to produce the largest effect, long-term adherence with exercise programs and the specific exercise requirements of sub-groups of people with AS. Widespread dissemination and implementation of the guidelines will be required to optimise exercise outcomes.
Topics: Consensus; Evidence-Based Medicine; Exercise Therapy; Humans; Spondylitis, Ankylosing
PubMed: 26493464
DOI: 10.1016/j.semarthrit.2015.08.003 -
Neurology Jan 2018To update the 2001 American Academy of Neurology (AAN) guideline on mild cognitive impairment (MCI).
Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.
OBJECTIVE
To update the 2001 American Academy of Neurology (AAN) guideline on mild cognitive impairment (MCI).
METHODS
The guideline panel systematically reviewed MCI prevalence, prognosis, and treatment articles according to AAN evidence classification criteria, and based recommendations on evidence and modified Delphi consensus.
RESULTS
MCI prevalence was 6.7% for ages 60-64, 8.4% for 65-69, 10.1% for 70-74, 14.8% for 75-79, and 25.2% for 80-84. Cumulative dementia incidence was 14.9% in individuals with MCI older than age 65 years followed for 2 years. No high-quality evidence exists to support pharmacologic treatments for MCI. In patients with MCI, exercise training (6 months) is likely to improve cognitive measures and cognitive training may improve cognitive measures.
MAJOR RECOMMENDATIONS
Clinicians should assess for MCI with validated tools in appropriate scenarios (Level B). Clinicians should evaluate patients with MCI for modifiable risk factors, assess for functional impairment, and assess for and treat behavioral/neuropsychiatric symptoms (Level B). Clinicians should monitor cognitive status of patients with MCI over time (Level B). Cognitively impairing medications should be discontinued where possible and behavioral symptoms treated (Level B). Clinicians may choose not to offer cholinesterase inhibitors (Level B); if offering, they must first discuss lack of evidence (Level A). Clinicians should recommend regular exercise (Level B). Clinicians may recommend cognitive training (Level C). Clinicians should discuss diagnosis, prognosis, long-term planning, and the lack of effective medicine options (Level B), and may discuss biomarker research with patients with MCI and families (Level C).
Topics: Cognitive Dysfunction; Delphi Technique; Humans
PubMed: 29282327
DOI: 10.1212/WNL.0000000000004826 -
Journal of Pediatric Gastroenterology... Jun 2017Because of the changing epidemiology of Helicobacter pylori infection and low efficacy of currently recommended therapies, an update of the European Society for...
BACKGROUND
Because of the changing epidemiology of Helicobacter pylori infection and low efficacy of currently recommended therapies, an update of the European Society for Paediatric Gastroenterology Hepatology and Nutrition/North American Society for Pediatric Gastroenterology, Hepatology and Nutrition recommendations for the diagnosis and management of H pylori infection in children and adolescents is required.
METHODS
A systematic review of the literature (time period: 2009-2014) was performed. Representatives of both societies evaluated the quality of evidence using GRADE (Grading of Recommendation Assessment, Development, and Evaluation) to formulate recommendations, which were voted upon and finalized using a Delphi process and face-to-face meeting.
RESULTS
The consensus group recommended that invasive diagnostic testing for H pylori be performed only when treatment will be offered if tests are positive. To reach the aim of a 90% eradication rate with initial therapy, antibiotics should be tailored according to susceptibility testing. Therapy should be administered for 14 days, emphasizing strict adherence. Clarithromycin-containing regimens should be restricted to children infected with susceptible strains. When antibiotic susceptibility profiles are not known, high-dose triple therapy with proton pump inhibitor, amoxicillin, and metronidazole for 14 days or bismuth-based quadruple therapy is recommended. Success of therapy should be monitored after 4 to 8 weeks by reliable noninvasive tests.
CONCLUSIONS
The primary goal of clinical investigation is to identify the cause of upper gastrointestinal symptoms rather than H pylori infection. Therefore, we recommend against a test and treat strategy. Decreasing eradication rates with previously recommended treatments call for changes to first-line therapies and broader availability of culture or molecular-based testing to tailor treatment to the individual child.
Topics: Adolescent; Antacids; Anti-Bacterial Agents; Child; Delphi Technique; Drug Administration Schedule; Drug Resistance, Bacterial; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans; Proton Pump Inhibitors
PubMed: 28541262
DOI: 10.1097/MPG.0000000000001594 -
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