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Trials Jul 2018The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently....
BACKGROUND
The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently.
METHODS
Following a systematic review of existing reporting guidelines, we conducted an online Delphi process to prioritise the list of potential items for the CONSORT-SPI 2018 checklist identified from the systematic review. Of 384 international participants, 321 (84%) participated in both rating rounds. We then held a consensus meeting of 31 scientists, journal editors, and research funders (March 2014) to finalise the content of the CONSORT-SPI 2018 checklist and flow diagram.
RESULTS
CONSORT-SPI 2018 extends 9 items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with 3 sub-items) related to stakeholder involvement in trials, and modifies the CONSORT 2010 flow diagram. This Explanation and Elaboration (E&E) document is a user manual to enhance understanding of CONSORT-SPI 2018. It discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting.
CONCLUSIONS
The CONSORT-SPI 2018 Extension, this E&E document, and the CONSORT website ( www.consort-statement.org ) are helpful resources for improving the reporting of social and psychological intervention RCTs.
Topics: Behavior Therapy; Checklist; Consensus; Data Accuracy; Delphi Technique; Endpoint Determination; Humans; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Research Design; Social Environment; Treatment Outcome
PubMed: 30060763
DOI: 10.1186/s13063-018-2735-z -
BMJ Open Nov 2020A core outcome set (COS) describes a minimum set of outcomes to be reported by all clinical trials of one healthcare condition. Delphi surveys are frequently used to...
OBJECTIVES
A core outcome set (COS) describes a minimum set of outcomes to be reported by all clinical trials of one healthcare condition. Delphi surveys are frequently used to achieve consensus on core outcomes. International input is important to achieve global COS uptake. We aimed to investigate participant representation in international Delphi surveys, with reference to the inclusion of patients and participants from low and middle income countries as stakeholders (LMICs).
DESIGN
Systematic review.
DATA SOURCES
EMBASE, Medline, Web of Science, COMET database and hand-searching.
ELIGIBILITY CRITERIA
Protocols and studies describing Delphi surveys used to develop an international COS for trial reporting, published between 1 January 2017 and 6 June 2019.
DATA EXTRACTION AND SYNTHESIS
Delphi participants were grouped as patients or healthcare professionals (HCPs). Participants were considered international if their country of origin was different to that of the first or senior author. Data extraction included participant numbers, country of origin, country income group and whether Delphi surveys were translated. We analysed the impact these factors had on outcome prioritisation.
RESULTS
Of 90 included studies, 69% (n=62) were completed and 31% (n=28) were protocols. Studies recruited more HCPs than patients (median 60 (IQR 30-113) vs 30 (IQR 14-66) participants, respectively). A higher percentage of HCPs was international compared with patients (57% (IQR 37-78) vs 20% (IQR 0-68)). Only 31% (n=28) studies recruited participants from LMICs. Regarding recruitment from LMICs, patients were under-represented (16% studies; n=8) compared with HCPs (22%; n=28). Few (7%; n=6) studies translated Delphi surveys. Only 3% studies (n=3) analysed Delphi responses by geographical location; all found differences in outcome prioritisation.
CONCLUSIONS
There is a disproportionately lower inclusion of international patients, compared with HCPs, in COS-development Delphi surveys, particularly within LMICs. Future international Delphi surveys should consider exploring for geographical and income-based differences in outcome prioritisation.
PROSPERO REGISTRATION NUMBER
CRD42019138519.
Topics: Clinical Trials as Topic; Consensus; Databases, Factual; Delphi Technique; Health Personnel; Humans; Surveys and Questionnaires; Treatment Outcome
PubMed: 33234639
DOI: 10.1136/bmjopen-2020-040223 -
Trials Mar 2018Over the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and...
Outcome Measures in Rheumatology - Interventions for medication Adherence (OMERACT-Adherence) Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology: 5 Phase Study Protocol.
BACKGROUND
Over the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA), which have led to a reduction in disease flares and the risk of re-fracture in osteoporosis, and the slowing of disease progression in RA. However, medication adherence remains suboptimal, as treatment regimens can be complex and difficult to continue long term. Many trials have been conducted to improve adherence to medication. Core domains, which are the outcomes of most relevance to patients and clinicians, are a pivotal component of any trial. These core domains should be measured consistently, so that all relevant trials can be combined in systematic reviews and meta-analyses to reach conclusions that are more valid. Failure to do this severely limits the potential for trial-based evidence to inform decisions on how to support medication adherence. The Outcome Measures in Rheumatology (OMERACT) - Interventions for Medication Adherence study by the OMERACT-Adherence Group aims to develop a core domain set for interventions that aim to support medication adherence in rheumatology.
METHODS/DESIGN
This OMERACT-Adherence study has five phases: (1) a systematic review to identify outcome domains that have been reported in interventions focused on supporting medication adherence in rheumatology; (2) semi-structured stakeholder interviews with patients and caregivers to determine their views on the core domains; (3) focus groups using the nominal group technique with patients and caregivers to identify and rank domains that are relevant to them, including the reasons for their choices; (4) an international three-round modified Delphi survey involving patients with diverse rheumatic conditions, caregivers, health professionals, researchers and other stakeholders to develop a preliminary core domain set; and (5) a stakeholder workshop with OMERACT members to review, vote on and reach a consensus on the core domain set for interventions to support medication adherence in rheumatology.
DISCUSSION
Establishing a core domain set to be reported in all intervention studies undertaken to support patients with medication adherence will enhance the relevance and the impact of these results and improve the lives of people with rheumatic conditions.
Topics: Antirheumatic Agents; Caregivers; Clinical Trials as Topic; Consensus; Delphi Technique; Health Knowledge, Attitudes, Practice; Humans; Interviews as Topic; Medication Adherence; Outcome Assessment, Health Care; Patients; Research Design; Rheumatic Diseases; Stakeholder Participation; Treatment Outcome
PubMed: 29587864
DOI: 10.1186/s13063-018-2565-z -
Exploratory Research in Clinical and... Jun 2024Key performance indicators (KPIs) are a set of indicators that improve the quality of services provided by pharmacists. They enable the monitoring and evaluation of... (Review)
Review
BACKGROUND
Key performance indicators (KPIs) are a set of indicators that improve the quality of services provided by pharmacists. They enable the monitoring and evaluation of result progress and optimize decision-making for stakeholders. Currently, there is no systematic review regarding KPIs for pharmaceutical services.
OBJECTIVES
To identify and assess the quality of KPIs developed for pharmaceutical services.
METHODS
A systematic review was conducted in PubMed, Scopus, EMBASE, and LILACS from the inception of the database until February 5th, 2024. Studies that developed a set of KPIs for pharmaceutical services were included. The indicators were evaluated using the Appraisal of Indicators through Research and Evaluation (AIRE) instrument. Two independent reviewers performed the study selection, data extraction, and quality assessment.
RESULTS
Fifteen studies were included. The studies were conducted in different regions, most of which were developed for clinical services in hospitals or ambulatory settings, and used similar domains for the development of KPIs such as medication review, patient safety, and patient counseling. Literature review combined with the Delphi technique was the method most used by the studies, with content validity by inter-rater agreement. Regarding methodological quality, most studies described information on the purpose, definition, and stakeholders' involvement in the set of KPIs. However, little information was observed on the strategy for risk adjustment, instructions for presenting and interpreting the indicator results, the detailed description of the numerator and denominator, evidence scientific, and the feasibility of the set of KPIs. Only one study achieved a high methodological quality in all domains of the AIRE tool.
CONCLUSION
Our findings showed the potential of KPIs to monitor and assess pharmacy practice quality. Future studies should expand KPIs for other settings, explore validity evidence of the existing KPIs, provide detailed descriptions of evidence, formulation, and usage, and test their feasibility in daily practice.
PubMed: 38665264
DOI: 10.1016/j.rcsop.2024.100441 -
Rheumatology (Oxford, England) Oct 2015To produce consensus-based definitions of the US elementary lesions in gout and to test their reliability in a web-based exercise. (Comparative Study)
Comparative Study
OBJECTIVE
To produce consensus-based definitions of the US elementary lesions in gout and to test their reliability in a web-based exercise.
METHODS
The process consisted of two steps. In the first step a written Delphi questionnaire was developed from a systematic literature review and expert international consensus. This collated information resulted in four statements defining US elementary lesions: double contour (DC), tophus, aggregates and erosion. The Delphi questionnaire was sent to 35 rheumatology experts in US, asking them to rate their level of agreement or disagreement with each statement. The second step tested the reliability by a web-exercise. US images of both normal and gouty elementary lesions were collected by the participants. A facilitator then constructed an electronic database of 110 images. The database was sent to the participants, who evaluated the presence/absence of US elementary lesions. A group of 20 images was displayed twice to evaluate intra-reader reliability.
RESULTS
A total of 32 participants responded to the questionnaires. Good agreement (>80%) was obtained for US definitions on DC, tophus, aggregates and erosion in the Delphi exercise after three rounds. The reliability on images showed inter-reader κ values for DC, tophus, aggregates, erosion findings of 0.98, 0.71, 0.54 and 0.85, respectively. The mean intra-reader κ values were also acceptable: 0.93, 0.78, 0.65 and 0.78, respectively.
CONCLUSION
This, the first consensus-based US definition of elementary lesions in gout, demonstrated good reliability overall. It constitutes an essential step in developing a core outcome measurement that permits a higher degree of homogeneity and comparability between multicentre studies.
Topics: Delphi Technique; Diagnostic Imaging; Gout; Humans; Internet; Observer Variation; Reproducibility of Results; Surveys and Questionnaires; Terminology as Topic; Ultrasonography
PubMed: 25972391
DOI: 10.1093/rheumatology/kev112 -
BMC Medical Education May 2017Evidence-Based Medicine (EBM) skills have been included in general practice curricula and competency frameworks. However, GPs experience numerous barriers to developing... (Review)
Review
BACKGROUND
Evidence-Based Medicine (EBM) skills have been included in general practice curricula and competency frameworks. However, GPs experience numerous barriers to developing and maintaining EBM skills, and some GPs feel the EBM movement misunderstands, and threatens their traditional role. We therefore need a new approach that acknowledges the constraints encountered in real-world general practice. The aim of this study was to synthesise from empirical research a real-world EBM competency framework for general practice, which could be applied in training, in the individual pursuit of continuing professional development, and in routine care. We sought to integrate evidence from the literature with evidence derived from the opinions of experts in the fields of general practice and EBM.
METHODS
We synthesised two sets of themes describing the meaning of EBM in general practice. One set of themes was derived from a mixed-methods systematic review of the literature; the other set was derived from the further development of those themes using a Delphi process among a panel of EBM and general practice experts. From these two sets of themes we constructed a real-world EBM competency framework for general practice.
RESULTS
A simple competency framework was constructed, that acknowledges the constraints of real-world general practice: (1) mindfulness - in one's approach towards EBM itself, and to the influences on decision-making; (2) pragmatism - in one's approach to finding and evaluating evidence; and (3) knowledge of the patient - as the most useful resource in effective communication of evidence. We present a clinical scenario to illustrate how a GP might demonstrate these competencies in their routine daily work.
CONCLUSION
We have proposed a real-world EBM competency framework for general practice, derived from empirical research, which acknowledges the constraints encountered in modern general practice. Further validation of these competencies is required, both as an educational resource and as a strategy for actual practice.
Topics: Adult; Clinical Competence; Delphi Technique; Evidence-Based Medicine; Female; General Practice; Humans; Male; Middle Aged; Problem-Based Learning
PubMed: 28468646
DOI: 10.1186/s12909-017-0916-1 -
Arthritis Care & Research Dec 2014To identify in a Delphi exercise of international systemic lupus erythematosus (SLE) experts and a systematic literature review the most relevant concepts that impact on... (Review)
Review
OBJECTIVE
To identify in a Delphi exercise of international systemic lupus erythematosus (SLE) experts and a systematic literature review the most relevant concepts that impact on the functioning of SLE patients.
METHODS
Sixty SLE experts participated in all rounds of a 3-round e-mail-based Delphi exercise; for the literature review, 573 manuscripts out of 4 decades were analyzed. Concepts in the first Delphi round and from the literature were linked to categories of the International Classification of Functioning, Disability and Health (ICF). Categories were voted on individually in a feedback-driven Delphi process, and ranked by frequency in the literature, respectively.
RESULTS
In the Delphi exercise, at least 80% of the participants found 30 categories of the domain body functions and structures, and 3 categories in the domain activities and participation and environmental factors important. In general, the categories identified in the literature review overlapped with those in the Delphi exercise with regard to body functions and structures, while showing some differences in other domains. The highest agreement concerned the ICF categories "joints," "skin and related structures," "fatiguability," "immunological system functions," and "handling stress and other psychological demands." Agreement with an earlier patient Delphi exercise was considerable.
CONCLUSION
A 3-step Delphi exercise of 60 SLE experts and a literature review identified a wide spectrum of relevant ICF categories with impact on functioning of SLE patients. The categories derived from these approaches overlap with each other and with those of a patient Delphi exercise.
Topics: Activities of Daily Living; Delphi Technique; Disability Evaluation; Disabled Persons; Health Status Indicators; Humans; Lupus Erythematosus, Systemic
PubMed: 24839085
DOI: 10.1002/acr.22372 -
Pain Nov 2015For genetic research to contribute more fully to furthering our knowledge of neuropathic pain, we require an agreed, valid, and feasible approach to phenotyping, to... (Review)
Review
For genetic research to contribute more fully to furthering our knowledge of neuropathic pain, we require an agreed, valid, and feasible approach to phenotyping, to allow collaboration and replication in samples of sufficient size. Results from genetic studies on neuropathic pain have been inconsistent and have met with replication difficulties, in part because of differences in phenotypes used for case ascertainment. Because there is no consensus on the nature of these phenotypes, nor on the methods of collecting them, this study aimed to provide guidelines on collecting and reporting phenotypes in cases and controls for genetic studies. Consensus was achieved through a staged approach: (1) systematic literature review to identify all neuropathic pain phenotypes used in previous genetic studies; (2) Delphi survey to identify the most useful neuropathic pain phenotypes and their validity and feasibility; and (3) meeting of experts to reach consensus on the optimal phenotype(s) to be collected from patients with neuropathic pain for genetic studies. A basic "entry level" set of phenotypes was identified for any genetic study of neuropathic pain. This set identifies cases of "possible" neuropathic pain, and controls, and includes: (1) a validated symptom-based questionnaire to determine whether any pain is likely to be neuropathic; (2) body chart or checklist to identify whether the area of pain distribution is neuroanatomically logical; and (3) details of pain history (intensity, duration, any formal diagnosis). This NeuroPPIC "entry level" set of phenotypes can be expanded by more extensive and specific measures, as determined by scientific requirements and resource availability.
Topics: Consensus; Databases, Bibliographic; Delphi Technique; Expert Testimony; Humans; International Cooperation; Neuralgia; Pain Measurement; Phenotype
PubMed: 26469320
DOI: 10.1097/j.pain.0000000000000335 -
Rheumatology (Oxford, England) Jan 2015SSc is clinically and aetiopathogenically heterogeneous. Consensus standards for more uniform trial design and selection of outcome measures are needed. The objective of... (Review)
Review
OBJECTIVE
SSc is clinically and aetiopathogenically heterogeneous. Consensus standards for more uniform trial design and selection of outcome measures are needed. The objective of this study was to develop evidence-based points to consider (PTCs) for future clinical trials in SSc.
METHODS
Thirteen international SSc experts experienced in SSc clinical trial design were invited to participate. One researcher with experience in systematic literature review and three trainees were also included. A systematic review using PubMed and the Cochrane Central Register of Controlled Trials was conducted and PTCs when designing clinical trials in SSc were developed. As part of that development we conducted an Internet-based Delphi exercise regarding the main points to be made in the consensus statement. Consensus was defined as achieving a median score of ≥7 of 9.
RESULTS
By consensus, the experts decided to develop PTCs for each individual organ system. The current document provides a unifying outline on PTCs regarding general trial design, inclusion/exclusion criteria and analysis. Consensus was achieved regarding all the main points of the PTCs.
CONCLUSION
Using European League Against Rheumatism suggestions for PTCs, a general outline for PTCs for controlled clinical trials in SSc was developed. Specific outlines for individual organ systems are to be published separately. This general outline should lead to more uniform and higher-quality trials and clearly delineate areas where further research is needed.
Topics: Clinical Trials as Topic; Delphi Technique; Europe; Evidence-Based Medicine; Humans; Outcome Assessment, Health Care; Patient Selection; Scleroderma, Systemic; Time Factors
PubMed: 25125594
DOI: 10.1093/rheumatology/keu288 -
Journal of the American College of... Jan 2023In the US, disparities in surgical care impede the delivery of uniformly high-quality care to all patients. There is a lack of disparity-sensitive measures related to...
BACKGROUND
In the US, disparities in surgical care impede the delivery of uniformly high-quality care to all patients. There is a lack of disparity-sensitive measures related to surgical care. The American College of Surgeons Metrics for Equitable Access and Care in Surgery group, through research and expert consensus, aimed to identify disparity-sensitive measures in surgical care.
STUDY DESIGN
An environmental scan, systematic literature review, and subspecialty society surveys were conducted to identify potential disparity-sensitive surgical measures. A modified Delphi process was conducted where panelists rated measures on both importance and validity. In addition, a novel literature-based disparity-sensitive scoring process was used.
RESULTS
We identified 841 potential disparity-sensitive surgical measures. From these, our Delphi and literature-based approaches yielded a consensus list of 125 candidate disparity-sensitive measures. These measures were rated as both valid and important and were supported by the existing literature.
CONCLUSION
There are profound disparities in surgical care within the US healthcare system. A multidisciplinary Delphi panel identified 125 potential disparity-sensitive surgical measures that could be used to track health disparities, evaluate the impact of focused interventions, and reduce healthcare inequity.
Topics: Humans; Consensus; Delphi Technique; Quality of Health Care
PubMed: 36111798
DOI: 10.1097/XCS.0000000000000420