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Trials Oct 2018A key step in the design of a randomised controlled trial is the estimation of the number of participants needed. The most common approach is to specify a target...
BACKGROUND
A key step in the design of a randomised controlled trial is the estimation of the number of participants needed. The most common approach is to specify a target difference in the primary outcome between the randomised groups and then estimate the corresponding sample size. The sample size is chosen to provide reassurance that the trial will have high statistical power to detect the target difference at the planned statistical significance level. Alternative approaches are also available, though most still require specification of a target difference. The sample size has many implications for the conduct of the study, as well as incurring scientific and ethical aspects. Despite the critical role of the target difference for the primary outcome in the design of a randomised controlled trial (RCT), the manner in which it is determined has received little attention. This article reports the development of the DELTA guidance on the specification and reporting of the target difference for the primary outcome in a sample size calculation for a RCT.
METHODS
The DELTA (Difference ELicitation in TriAls) project has five components comprising systematic literature reviews of recent methodological developments (stage 1) and existing funder guidance (stage 2), a Delphi study (stage 3), a 2-day consensus meeting bringing together researchers, funders and patient representatives (stage 4), and the preparation and dissemination of a guidance document (stage 5).
RESULTS
The project started in April 2016. The literature search identified 28 articles of methodological developments relevant to a method for specifying a target difference. A Delphi study involving 69 participants, along with a 2-day consensus meeting were conducted. In addition, further engagement sessions were held at two international conferences. The main guidance text was finalised on April 18, 2018, after revision informed by feedback gathered from stages 2 and 3 and from funder representatives.
DISCUSSION
The DELTA Delphi study identified a number of areas (such as practical recommendations and examples, greater coverage of different trial designs and statistical approaches) of particular interest amongst stakeholders which new guidance was desired to meet. New relevant references were identified by the review. Such findings influenced the scope, drafting and revision of the guidance. While not all suggestions could be accommodated, it is hoped that the process has led to a more useful and practical document.
Topics: Clinical Trial Protocols as Topic; Consensus; Data Interpretation, Statistical; Delphi Technique; Humans; Numbers Needed To Treat; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30305155
DOI: 10.1186/s13063-018-2887-x -
Annals of the Rheumatic Diseases Aug 2015The aim of this work was to develop a consensual recommendation under the auspices of the Assessment of SpondyloArthritis international Society (ASAS) for early referral... (Review)
Review
The aim of this work was to develop a consensual recommendation under the auspices of the Assessment of SpondyloArthritis international Society (ASAS) for early referral of patients with a suspicion of axial spondyloarthritis by non-rheumatologists. The development of a referral recommendation consisted of four phases: (1) systematic literature review, (2) the first Delphi round aiming at identification of unmet needs and development of a candidate list of referral parameters, (3) the second Delphi round aiming at identification of the most useful combination of referral parameters and (4) final discussion and formal endorsement by ASAS membership. The following consensus on a referral recommendation was achieved as a result of the Delphi processes and final voting: "Patients with chronic back pain (duration ≥3 months) and back pain onset before 45 years of age should be referred to a rheumatologist if at least one of the following parameters is present: Inflammatory back pain; human leucocyte antigen-B27; Sacroiliitis on imaging if available (X-rays or magnetic resonance imaging); Peripheral manifestations (arthritis, enthesitis, dactylitis); Extra-articular manifestations (psoriasis, inflammatory bowel disease, uveitis); Positive family history for spondyloarthritis; Good response to non-steroidal anti-inflammatory drugs; Elevated acute phase reactant." A consensual ASAS-endorsed referral recommendation for patients suspected of having axial spondyloarthritis was developed as a flexible and universal strategy to be used in clinical practice by primary care physicians or non-rheumatology specialists. The practical value of this strategy applied in different settings should be determined in future studies.
Topics: Back Pain; Chronic Disease; Delphi Technique; Humans; Program Development; Referral and Consultation; Rheumatology; Spondylarthropathies
PubMed: 25990288
DOI: 10.1136/annrheumdis-2014-207151 -
Palliative Medicine Feb 2019The goal of Palliative Day Services is to provide holistic care that contributes to the quality of life of people with life-threatening illness and their families....
BACKGROUND:
The goal of Palliative Day Services is to provide holistic care that contributes to the quality of life of people with life-threatening illness and their families. Quality indicators provide a means by which to describe, monitor and evaluate the quality of Palliative Day Services provision and act as a starting point for quality improvement. However, currently, there are no published quality indicators for Palliative Day Services.
AIM:
To develop and provide the first set of quality indicators that describe and evaluate the quality of Palliative Day Services.
DESIGN AND SETTING:
A modified Delphi technique was used to combine best available research evidence derived from a systematic scoping review with multidisciplinary expert appraisal of the appropriateness and feasibility of candidate indicators. The resulting indicators were compiled into ‘toolkit’ and tested in five UK Palliative Day Service settings.
RESULTS:
A panel of experts independently reviewed evidence summaries for 182 candidate indicators and provided ratings on appropriateness, followed by a panel discussion and further independent ratings of appropriateness, feasibility and necessity. This exercise resulted in the identification of 30 indicators which were used in practice testing. The final indicator set comprised 7 structural indicators, 21 process indicators and 2 outcome indicators.
CONCLUSION:
The indicators fulfil a previously unmet need among Palliative Day Service providers by delivering an appropriate and feasible means to assess, review, and communicate the quality of care, and to identify areas for quality improvement.
Topics: Ambulatory Care; Guidelines as Topic; Humans; Palliative Care; Quality Indicators, Health Care; Quality of Health Care
PubMed: 30451082
DOI: 10.1177/0269216318810601 -
Nutrients Jan 2023Disease-related malnutrition (DRM) affects approximately a third of hospitalized patients and is associated with an increased risk of morbimortality. However, DRM is...
Disease-related malnutrition (DRM) affects approximately a third of hospitalized patients and is associated with an increased risk of morbimortality. However, DRM is often underdiagnosed and undertreated. Our aim is to evaluate the prognostic value of morphofunctional tools and tests for nutritional assessment in clinical practice. A systematic literature review was conducted to identify studies relating to the morphofunctional assessment of nutritional status and mortality or complications. Evidence was evaluated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) method. Twelve GRADE recommendations were made and divided into seven topics: food intake and nutrient assimilation, anthropometry, biochemical analysis, hand grip strength, phase angle, muscle imaging, and functional status and quality of life. From these recommendations, 37 statements were developed and scored in a two-survey Delphi method by 183 experts. A consensus was reached on accepting 26/37 statements. Surveys had high internal consistency and high inter-rater reliability. In conclusion, evidence-based recommendations were made on the prognostic value of morphofunctional assessment tools and tests to assess malnutrition, most of which were found to be feasible in routine clinical practice, according to expert opinions.
Topics: Humans; Hand Strength; Consensus; Delphi Technique; Quality of Life; Reproducibility of Results; Malnutrition
PubMed: 36771319
DOI: 10.3390/nu15030612 -
Chest Jun 2020Chronic hypersensitivity pneumonitis (CHP) is an immune-mediated interstitial lung disease (ILD) caused by inhalational exposure to environmental antigens, resulting in...
BACKGROUND
Chronic hypersensitivity pneumonitis (CHP) is an immune-mediated interstitial lung disease (ILD) caused by inhalational exposure to environmental antigens, resulting in parenchymal fibrosis. By definition, a diagnosis of CHP assumes a history of antigen exposure, but only half of all patients eventually diagnosed with CHP will have a causative antigen identified. Individual clinician variation in eliciting a history of antigen exposure may affect the frequency and confidence of CHP diagnosis.
METHODS
A list of potential causative exposures were derived from a systematic review of the literature. A Delphi method was applied to an international panel of ILD experts to obtain consensus regarding technique for the elicitation of exposure to antigens relevant to a diagnosis of CHP. The consensus threshold was set at 80% agreement, and median ≤ 2, interquartile range = 0 on a 5-point Likert scale (1, strongly agree; 2, tend to agree; 3, neither agree nor disagree; 4, disagree; 5, strongly disagree).
RESULTS
In two rounds, 36/40 experts participated. Experts agreed on 18 exposure items to ask every patient with suspected CHP. Themes included CHP inducing exposures, features that contribute to an exposure's relevance, and quantification of a relevant exposure. Based on the results from the literature review and Delphi process, a CHP exposure assessment instrument was derived. Using cognitive interviews, the instrument was revised by patients with ILD for readability and usability.
CONCLUSIONS
This Delphi survey provides items that ILD experts agree are important to ask in all patients presenting with suspected CHP and provides basis for a systematically derived CHP exposure assessment instrument. Clinical utility of this exposure assessment instrument may be affected by different local prevalence patterns of exposures. Ongoing research is required to clinically validate these items and consider their impact in more geographically diverse settings.
Topics: Alveolitis, Extrinsic Allergic; Chronic Disease; Consensus; Humans; Lung; Tomography, X-Ray Computed
PubMed: 31958445
DOI: 10.1016/j.chest.2019.12.018 -
Digestive Diseases and Sciences Jan 2017There are guidelines for the medical management of cirrhosis and associated quality indicators (QIs), but QIs focusing on standards for palliative aspects of care are...
BACKGROUND AND AIMS
There are guidelines for the medical management of cirrhosis and associated quality indicators (QIs), but QIs focusing on standards for palliative aspects of care are needed.
METHODS
We convened a 9-member, multidisciplinary expert panel and used RAND/UCLA modified Delphi methods to develop palliative care quality indicators for patients with cirrhosis. Experts were provided with a report based on a systematic review of the literature that contained evidence concerning the proposed candidate QIs. Panelists rated QIs prior to a planned meeting using a standard 9-point RAND appropriateness scale. These ratings guided discussion during a day-long phone conference meeting, and final ratings were then provided by panel members. Final QI scores were computed and QIs with a final median score of greater than or equal to 7, and no disagreement was included in the final set.
RESULTS
Among 28 candidate QIs, the panel rated 19 as valid measures of quality care. These 19 quality indicators cover care related to information and care planning (13) and supportive care (6).
CONCLUSIONS
These QIs are evidence-based process measures of care that may be useful to improve the quality of palliative care. Research is needed to better understand the quality of palliative care provided to patients with cirrhosis.
Topics: Advance Care Planning; Delphi Technique; End Stage Liver Disease; Humans; Liver Cirrhosis; Liver Transplantation; Outcome and Process Assessment, Health Care; Palliative Care; Quality Indicators, Health Care
PubMed: 27804005
DOI: 10.1007/s10620-016-4339-3 -
Medicine Nov 2017Persistent vomiting is mentioned as a symptom of a large variety of systemic disorders. It is commonly used interchangeably with chronic, recurrent, or intractable... (Review)
Review
BACKGROUND AND AIM
Persistent vomiting is mentioned as a symptom of a large variety of systemic disorders. It is commonly used interchangeably with chronic, recurrent, or intractable vomiting and widely used as a warning sign of severe illness in dengue infection. However, it has been poorly defined in the medical literature. Therefore, we aimed to systematically review a definition of persistent vomiting in the medical literature.
METHODS
A systematic search was done through; PubMed, Google Scholar, Web of Science, Scopus, VHL, WHO-GHL, Grey Literature Report, POPLINE, and SIGLE for the last 10 years. Consensus on the definition was considered to be reached if at least 50% of studies described the same definition using the Delphi consensus technique.
RESULT
Of 2362 abstracts reviewed, 15 studies were selected based on the inclusion criteria. Three studies used the same definition. Another 2 studies defined it as vomiting of all foods and fluid in 24 hours. Three studies defined persistent vomiting in the units of days or weeks. Four studies used the number of episodes: ≥2 episodes 15 minutes apart, >3 episodes in 12 hours, and >3 episodes within 24 hours.
CONCLUSION
No consensus for the definition was found among authors. This is a point of concern that needs to be addressed by further studies.
Topics: Humans; Terminology as Topic; Time Factors; Vomiting
PubMed: 29137006
DOI: 10.1097/MD.0000000000008025 -
Medical Ultrasonography Nov 2019To define and score finger soft tissue oedema in psoriatic dactylitis by ultrasound.
AIM
To define and score finger soft tissue oedema in psoriatic dactylitis by ultrasound.
MATERIAL AND METHODS
A systematic literature review (SLR) on ultrasound-detected finger soft tissue oedema was performed. Subsequently, based on the SLR, a Delphi survey was developed and circulated among a group of 13 expert sonographers, in order to obtain agreement on detection, definition and scoring of finger oedema by B-mode and power Doppler ultrasound. Agreement was considered achieved when each statement was approved by >75% of participants.
RESULTS
At the first Delphi round, 91 % agreement was obtained for the scanning technique to adopt, including the most appropriate area to evaluate. At the second round, 76% agreement was achieved on the definition of soft tissue finger oedema. At the third round, 76% agreement was obtained for B-mode and power Doppler scores. The volar aspect of the finger and comparisons with the contralateral side were agreed to be the most appropriate in terms of scanning technique. Agreed ultrasound definition of finger soft tissue oedema was "abnormal hypoechoic/anechoic areas, diffused or localized within the subcutaneous tissue between the epidermidis and the tendon-related anatomic structures (i.e. flexor tendon sheath, peritenonium, tendon pulleys), with local thickening, with or without local abnormal Doppler signal, visualised in two perpendicular planes and not evident on the contralateral side". Semiquantitative (0-3) scores for both B-mode and power Doppler were agreed to be the most appropriate to be used.
CONCLUSION
Our work produced, for the first time, technical indications, definition and scoring for the ultrasound assessment of soft tissue oedema in psoriatic dactylitis.
Topics: Arthritis, Psoriatic; Edema; Fingers; Humans; Ultrasonography
PubMed: 31765449
DOI: 10.11152/mu-2258 -
International Journal of Cardiology Jan 2016
Review
Topics: Atrial Fibrillation; Delphi Technique; Disease Management; Humans; Treatment Outcome
PubMed: 26440460
DOI: 10.1016/j.ijcard.2015.09.086 -
Clinical Infectious Diseases : An... Mar 2020Our aim in this study was to develop quality indicators (QIs) for outpatient parenteral antimicrobial therapy (OPAT) care that can be used as metrics for quality...
BACKGROUND
Our aim in this study was to develop quality indicators (QIs) for outpatient parenteral antimicrobial therapy (OPAT) care that can be used as metrics for quality assessment and improvement.
METHODS
A RAND-modified Delphi procedure was used to develop a set of QIs. Recommendations on appropriate OPAT care in adults were retrieved from the literature using a systematic review and translated into potential QIs. These QIs were appraised and prioritized by a multidisciplinary panel of international OPAT experts in 2 questionnaire rounds combined with a meeting between rounds.
RESULTS
The procedure resulted in 33 OPAT-specific recommendations. The following QIs that describe recommended OPAT care were prioritized by the expert panel: the presence of a structured OPAT program, a formal OPAT care team, a policy on patient selection criteria, and a treatment and monitoring plan; assessment for OPAT should be performed by the OPAT team; patients and family should be informed about OPAT; there should be a mechanism in place for urgent discussion and review of emergent clinical problems, and a system in place for rapid communication; laboratory results should be delivered to physicians within 24 hours; and the OPAT team should document clinical response to antimicrobial management, document adverse events, and monitor QIs for OPAT care and make these data available.
CONCLUSIONS
We systematically developed a set of 33 QIs for optimal OPAT care, of which 12 were prioritized by the expert panel. These QIs can be used to assess and improve the quality of care provided by OPAT teams.
Topics: Adult; Anti-Bacterial Agents; Anti-Infective Agents; Delphi Technique; Humans; Outpatients; Quality Indicators, Health Care
PubMed: 31056690
DOI: 10.1093/cid/ciz362