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Actas Dermo-sifiliograficas May 2015A great amount of information on systemic and biologic therapies for moderate to severe psoriasis is now available. However, applying the evidence in numerous clinical... (Review)
Review
INTRODUCTION AND OBJECTIVES
A great amount of information on systemic and biologic therapies for moderate to severe psoriasis is now available. However, applying the evidence in numerous clinical scenarios has engendered debate; under these circumstances, the consensus of experts is useful.
MATERIAL AND METHODS
A scientific committee systematically reviewed the literature relevant to 5 clinical scenarios. An online Delphi survey of dermatologists with experience treating moderate to severe psoriasis was then carried out in order to shed light on questions that remained unresolved by the available evidence.
RESULTS
Twenty-three dermatologists responded to the survey and consensus was reached on 37 (56%) of the 66 statements proposed. These results led to consensus on various clinical situations even though firm evidence was lacking. Thus, intermittent therapeutic regimens and strategies for reducing the intensity of treatment are considered appropriate for optimizing biologic treatment and reducing costs. The measurement of drug and antidrug antibody levels should be included routinely when following patients on biologics to treat psoriasis. Concomitant psoriatic arthritis or a history of cardiovascular conditions will influence the choice of biologic; in these situations, an agent with anti-tumor necrosis factor properties will be preferred. Tailored management is important when the patient is pregnant or intends to conceive; drug half-life and disease severity are important factors to take into consideration in these scenarios.
CONCLUSIONS
A combination of systematic review of the literature and structured discussion of expert opinion facilitates decision-making in specific clinical scenarios.
Topics: Age Factors; Aged; Antibodies, Monoclonal; Antirheumatic Agents; Arthritis, Psoriatic; Biological Therapy; Clinical Decision-Making; Clinical Trials as Topic; Delphi Technique; Dermatology; Drug Substitution; Etanercept; Female; Humans; Immunosuppressive Agents; Male; Multicenter Studies as Topic; Practice Guidelines as Topic; Pregnancy; Pregnancy Complications; Psoriasis
PubMed: 25595327
DOI: 10.1016/j.ad.2014.11.005 -
Clinical Toxicology (Philadelphia, Pa.) Dec 2014The Extracorporeal Treatments in Poisoning (EXTRIP) workgroup was created to provide evidence and consensus-based recommendations on the use of extracorporeal treatments... (Review)
Review
CONTEXT
The Extracorporeal Treatments in Poisoning (EXTRIP) workgroup was created to provide evidence and consensus-based recommendations on the use of extracorporeal treatments (ECTRs) in poisoning.
OBJECTIVES
To perform a systematic review and provide clinical recommendations for ECTR in carbamazepine poisoning.
METHODS
After a systematic literature search, the subgroup extracted the data and summarized the findings following a pre-determined format. The entire workgroup voted via a two-round modified Delphi method to reach a consensus on voting statements, using a RAND/UCLA Appropriateness Method to quantify disagreement. Anonymous votes were compiled, returned, and discussed in person. A second vote determined the final recommendations.
RESULTS
Seventy-four articles met inclusion criteria. Articles included case reports, case series, descriptive cohorts, pharmacokinetic studies, and in-vitro studies; two poor-quality observational studies were identified, yielding a very low quality of evidence for all recommendations. Data on 173 patients, including 6 fatalities, were reviewed. The workgroup concluded that carbamazepine is moderately dialyzable and made the following recommendations: ECTR is suggested in severe carbamazepine poisoning (2D). ECTR is recommended if multiple seizures occur and are refractory to treatment (1D), or if life-threatening dysrhythmias occur (1D). ECTR is suggested if prolonged coma or respiratory depression requiring mechanical ventilation are present (2D) or if significant toxicity persists, particularly when carbamazepine concentrations rise or remain elevated, despite using multiple-dose activated charcoal (MDAC) and supportive measures (2D). ECTR should be continued until clinical improvement is apparent (1D) or the serum carbamazepine concentration is below 10 mg/L (42 the μ in μmol/L looks weird.) (2D). Intermittent hemodialysis is the preferred ECTR (1D), but both intermittent hemoperfusion (1D) or continuous renal replacement therapies (3D) are alternatives if hemodialysis is not available. MDAC therapy should be continued during ECTR (1D).
CONCLUSION
Despite the low quality of the available clinical evidence and the high protein binding capacity of carbamazepine, the workgroup suggested extracorporeal removal in cases of severe carbamazepine poisoning.
Topics: Adolescent; Adult; Anticonvulsants; Carbamazepine; Child; Child, Preschool; Consensus; Delphi Technique; Drug Overdose; Evidence-Based Medicine; Female; Hemoperfusion; Humans; Infant; Male; Middle Aged; Renal Dialysis; Severity of Illness Index; Treatment Outcome; Young Adult
PubMed: 25355482
DOI: 10.3109/15563650.2014.973572 -
Trials Jul 2018Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and...
BACKGROUND
Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018.
METHODS
We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010.
RESULTS
The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention.
CONCLUSIONS
Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.
Topics: Behavior Therapy; Checklist; Consensus; Consensus Development Conferences as Topic; Data Accuracy; Delphi Technique; Endpoint Determination; Humans; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Research Design; Social Environment; Treatment Outcome
PubMed: 30060754
DOI: 10.1186/s13063-018-2733-1 -
PLoS Neglected Tropical Diseases Sep 2021Leprosy is a chronic infectious disease caused by Mycobacterium leprae, the annual new case detection in 2019 was 202,189 globally. Measuring endemicity levels and...
BACKGROUND
Leprosy is a chronic infectious disease caused by Mycobacterium leprae, the annual new case detection in 2019 was 202,189 globally. Measuring endemicity levels and burden in leprosy lacks a uniform approach. As a result, the assessment of leprosy endemicity or burden are not comparable over time and across countries and regions. This can make program planning and evaluation difficult. This study aims to identify relevant metrics and methods for measuring and classifying leprosy endemicity and burden at (sub)national level.
METHODS
We used a mixed-method approach combining findings from a systematic literature review and a Delphi survey. The literature search was conducted in seven databases, searching for endemicity, burden and leprosy. We reviewed the available evidence on the usage of indicators, classification levels, and scoring methods to measure and classify endemicity and burden. A two round Delphi survey was conducted to ask experts to rank and weigh indicators, classification levels, and scoring methods.
RESULTS
The literature review showed variation of indicators, levels, and cut-off values to measure leprosy endemicity and/or burden. The most used indicators for endemicity include new case detection rate (NCDR), new cases among children and new cases with grade 2 disability. For burden these include NCDR, MB cases, and prevalence. The classification levels 'high' and 'low' were most important. It was considered most relevant to use separate scoring methods for endemicity and burden. The scores would be derived by use of multiple indicators.
CONCLUSION
There is great variation in the existing method for measuring endemicity and burden across countries and regions. Our findings contribute to establishing a standardized uniform approach to measure and classify leprosy endemicity and burden at (sub)national level, which would allow effective communication and planning of intervention strategies.
Topics: Cost of Illness; Delphi Technique; Endemic Diseases; Global Health; Humans; Leprosy
PubMed: 34543282
DOI: 10.1371/journal.pntd.0009769 -
Journal of the American Academy of... Sep 2022There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical...
BACKGROUND
There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions.
OBJECTIVE
To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials.
METHODS
Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group.
RESULTS
Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome.
LIMITATIONS
English-speaking patients and professionals rated outcomes extracted from English language studies.
CONCLUSION
A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.
Topics: Carcinoma, Basal Cell; Delphi Technique; Humans; Quality of Life; Research Design; Skin Neoplasms; Treatment Outcome
PubMed: 35551965
DOI: 10.1016/j.jaad.2022.04.059 -
Annals of the Rheumatic Diseases Jun 2023Application of 'treat-to-target' (T2T) in childhood-onset systemic lupus erythematosus (cSLE) may improve care and health outcomes. This initiative aimed to harmonise...
Towards development of treat to target (T2T) in childhood-onset systemic lupus erythematosus: PReS-endorsed overarching principles and points-to-consider from an international task force.
OBJECTIVES
Application of 'treat-to-target' (T2T) in childhood-onset systemic lupus erythematosus (cSLE) may improve care and health outcomes. This initiative aimed to harmonise existing evidence and expert opinion regarding T2T for cSLE.
METHODS
An international T2T Task Force was formed of specialists in paediatric rheumatology, paediatric nephrology, adult rheumatology, patient and parent representatives. A steering committee formulated a set of draft overarching principles and points-to-consider, based on evidence from systematic literature review. Two on-line preconsensus meeting Delphi surveys explored healthcare professionals' views on these provisional overarching principles and points-to-consider. A virtual consensus meeting employed a modified nominal group technique to discuss, modify and vote on each overarching principle/point-to-consider. Agreement of >80% of Task Force members was considered consensus.
RESULTS
The Task Force agreed on four overarching principles and fourteen points-to-consider. It was agreed that both treatment targets and therapeutic strategies should be subject to shared decision making with the patient/caregivers, with full remission the preferred target, and low disease activity acceptable where remission cannot be achieved. Important elements of the points-to-consider included: aiming for prevention of flare and organ damage; glucocorticoid sparing; proactively addressing factors that impact health-related quality of life (fatigue, pain, mental health, educational challenges, medication side effects); and aiming for maintenance of the target over the long-term. An extensive research agenda was also formulated.
CONCLUSIONS
These international, consensus agreed overarching principles and points-to-consider for T2T in cSLE lay the foundation for future T2T approaches in cSLE, endorsed by the Paediatric Rheumatology European Society.
Topics: Adult; Child; Humans; Quality of Life; Surveys and Questionnaires; Remission Induction; Lupus Erythematosus, Systemic; Advisory Committees
PubMed: 36627168
DOI: 10.1136/ard-2022-223328 -
Journal of Manipulative and... May 2017The purpose of this study was to update evidence-based recommendations on the best practices for chiropractic care of older adults. (Review)
Review
OBJECTIVE
The purpose of this study was to update evidence-based recommendations on the best practices for chiropractic care of older adults.
METHODS
The project consisted of a systematic literature review and a consensus process. The following were searched from October 2009 through January 2016: MEDLINE, Index to Chiropractic Literature, CINAHL (Cumulative Index to Nursing and Allied Health Literature), AMED (Allied and Complementary Medicine Database), Alt HealthWatch, Cochrane Database of Systematic Reviews, and Cochrane Registry of Controlled Trials. Search terms were: (manipulation, spinal OR manipulation, chiropractic OR chiropract*) AND (geriatric OR "older adult*"). Two reviewers independently screened articles and abstracts using inclusion and exclusion criteria. The systematic review informed the project steering committee, which revised the previous recommendations. A multidisciplinary panel of experts representing expertise in practice, research, and teaching in a variety of health professions serving older adults rated the revised recommendations. The RAND Corporation/University of California, Los Angeles methodology for a modified Delphi consensus process was used.
RESULTS
A total of 199 articles were found; after exclusion criteria were applied, 6 articles about effectiveness or efficacy and 6 on safety were added. The Delphi process was conducted from April to June 2016. Of the 37 Delphi panelists, 31 were DCs and 6 were other health care professionals. Three Delphi rounds were conducted to reach consensus on all 45 statements. As a result, statements regarding the safety of manipulation were strengthened and additional statements were added recommending that DCs advise patients on exercise and that manipulation and mobilization contribute to general positive outcomes beyond pain reduction only.
CONCLUSIONS
This document provides a summary of evidence-informed best practices for doctors of chiropractic for the evaluation, management, and manual treatment of older adult patients.
Topics: Aged; Consensus; Delphi Technique; Evidence-Based Medicine; Female; Geriatric Assessment; Humans; Male; Manipulation, Chiropractic; Manipulation, Spinal; Musculoskeletal Diseases; Musculoskeletal Pain; Pain Measurement; Practice Guidelines as Topic; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 28302309
DOI: 10.1016/j.jmpt.2017.02.001 -
BMJ Open Mar 2022The objective of this study was to develop a core outcome set (COS) for use in future clinical trials in bronchiolitis. We wanted to find out which outcomes are...
Which outcomes should be used in future bronchiolitis trials? Developing a bronchiolitis core outcome set using a systematic review, Delphi survey and a consensus workshop.
OBJECTIVES
The objective of this study was to develop a core outcome set (COS) for use in future clinical trials in bronchiolitis. We wanted to find out which outcomes are important to healthcare professionals (HCPs) and to parents and which outcomes should be prioritised for use in future clinical trials.
DESIGN AND SETTING
The study used a systematic review, workshops and interviews, a Delphi survey and a final consensus workshop.
RESULTS
Thirteen parents and 45 HCPs took part in 5 workshops; 15 other parents were also separately interviewed. Fifty-six items were identified from the systematic review, workshops and interviews. Rounds one and two of the Delphi survey involved 299 and 194 participants, respectively. Sixteen outcomes met the criteria for inclusion within the COS. The consensus meeting was attended by 10 participants, with representation from all three stakeholder groups. Nine outcomes were added, totalling 25 outcomes to be included in the COS.
CONCLUSION
We have developed the first parent and HCP consensus on a COS for bronchiolitis in a hospital setting. The use of this COS will ensure outcomes in future bronchiolitis trials are important and relevant, and will enable the trial results to be compared and combined.
TRIAL REGISTRATION NUMBER
ISRCTN75766048.
Topics: Bronchiolitis; Consensus; Delphi Technique; Humans; Outcome Assessment, Health Care; Research Design; Treatment Outcome
PubMed: 35264343
DOI: 10.1136/bmjopen-2021-052943 -
BMJ Open Jan 2023A clear development process and scientifically validated clinical practice competencies in standard critical care nursing (SCCN) have not yet been developed in Japan....
OBJECTIVES
A clear development process and scientifically validated clinical practice competencies in standard critical care nursing (SCCN) have not yet been developed in Japan. Thus, this study aimed to develop a consensus-based set of SCCN competencies to provide a framework for critical care nursing education, training and evaluation.
DESIGN
Multistep, modified Delphi study (a systematic review, focus group interviews, a three-round web-based Delphi survey and an external validation process).
PARTICIPANTS
A systematic review of 23 studies, focus group interviews by 12 experts, a Delphi survey by 239 critical care experts (physicians, nurses and physical therapists) and an external validation by 5 experts (physicians and nurses).
RESULTS
A systematic review identified 685 unique competencies. The focus group interviews resulted in the addition of 3 performance indicator items, a synthesis of 2 subdomains and 10 elements. Of the 239 participants, 218 (91.2%), 209 (98.9%) and 201 (96.2%) responded in rounds 1, 2 and 3 of the Delphi survey, respectively. After round 3, 57 items were below the consensus level and were removed in the final round. External validation process feedback was received from experts after two revisions to ensure that the final competencies were valid, applicable, useful and clear. The final set of competencies was classified into 6 domains, 26 subdomains, 99 elements and 525 performance indicators.
CONCLUSIONS
This study found a set of SCCN competencies after a multistep, modified Delphi study. The results of this study are robust, and the competency framework can be used in multiple areas to improve clinical practice, including the assessment, training and certification of standard critical care nurses.
Topics: Humans; Critical Care Nursing; Delphi Technique; Clinical Competence; Physicians; Consensus
PubMed: 36697042
DOI: 10.1136/bmjopen-2022-068734 -
Implementation Science : IS Mar 2015Dissemination and implementation of health care interventions are currently hampered by the variable quality of reporting of implementation research. Reporting of other... (Review)
Review
BACKGROUND
Dissemination and implementation of health care interventions are currently hampered by the variable quality of reporting of implementation research. Reporting of other study types has been improved by the introduction of reporting standards (e.g. CONSORT). We are therefore developing guidelines for reporting implementation studies (StaRI).
METHODS
Using established methodology for developing health research reporting guidelines, we systematically reviewed the literature to generate items for a checklist of reporting standards. We then recruited an international, multidisciplinary panel for an e-Delphi consensus-building exercise which comprised an initial open round to revise/suggest a list of potential items for scoring in the subsequent two scoring rounds (scale 1 to 9). Consensus was defined a priori as 80% agreement with the priority scores of 7, 8, or 9.
RESULTS
We identified eight papers from the literature review from which we derived 36 potential items. We recruited 23 experts to the e-Delphi panel. Open round comments resulted in revisions, and 47 items went forward to the scoring rounds. Thirty-five items achieved consensus: 19 achieved 100% agreement. Prioritised items addressed the need to: provide an evidence-based justification for implementation; describe the setting, professional/service requirements, eligible population and intervention in detail; measure process and clinical outcomes at population level (using routine data); report impact on health care resources; describe local adaptations to the implementation strategy and describe barriers/facilitators. Over-arching themes from the free-text comments included balancing the need for detailed descriptions of interventions with publishing constraints, addressing the dual aims of reporting on the process of implementation and effectiveness of the intervention and monitoring fidelity to an intervention whilst encouraging adaptation to suit diverse local contexts.
CONCLUSIONS
We have identified priority items for reporting implementation studies and key issues for further discussion. An international, multidisciplinary workshop, where participants will debate the issues raised, clarify specific items and develop StaRI standards that fit within the suite of EQUATOR reporting guidelines, is planned.
REGISTRATION
The protocol is registered with Equator: http://www.equator-network.org/library/reporting-guidelines-under-development/#17 .
Topics: Delphi Technique; Diffusion of Innovation; Health Services Research; Humans; Program Development; Translational Research, Biomedical
PubMed: 25888928
DOI: 10.1186/s13012-015-0235-z