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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 -
Inflammatory Bowel Diseases Jun 2024The concept of disease clearance has been proposed as a potential target in ulcerative colitis (UC). We conducted a systematic review to investigate the role of disease...
The concept of disease clearance has been proposed as a potential target in ulcerative colitis (UC). We conducted a systematic review to investigate the role of disease clearance, defined as a composite outcome including simultaneous clinical, endoscopic, and histologic remission of disease in the management of patients with UC. Based on the literature data, statements regarding disease clearance were developed and voted on by the members of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) according to a Delphi methodology. A definition of disease clearance was proposed to standardize its use in clinical practice and clinical trials and to provide practical recommendations for its implementation as a therapeutic target in UC.
Topics: Colitis, Ulcerative; Humans; Consensus; Remission Induction; Delphi Technique; Severity of Illness Index; Treatment Outcome
PubMed: 37549104
DOI: 10.1093/ibd/izad159 -
The British Journal of Surgery Jul 2022The aim of this study was to develop a symptom severity instrument (ParaOesophageal hernia SympTom (POST) tool) specific to para-oesophageal hernia (POH).
BACKGROUND
The aim of this study was to develop a symptom severity instrument (ParaOesophageal hernia SympTom (POST) tool) specific to para-oesophageal hernia (POH).
METHODS
The POST tool was developed in four stages. The first was establishment of a Steering Committee. In the second stage, items were generated through a systematic review and online scoping survey of international experts. In the third stage, a three-round modified Delphi consensus process was conducted with a group of international experts who were asked to rate the importance of candidate items. An a priori threshold for inclusion was set at 80 per cent. The modified Delphi process culminated in a consensus meeting to develop the first iteration of the tool. In the final stage, two international patient workshops were held to assess the content validity and acceptability of the POST tool.
RESULTS
The systematic review and scoping survey generated 64 symptoms, refined to 20 for inclusion in the modified Delphi consensus process. Twenty-six global experts participated in the Delphi consensus process. Five symptoms reached consensus across two rounds: difficulty getting solid foods down, chest pain after meals, difficulty getting liquids down, shortness of breath only after meals, and an early feeling of fullness after eating. The subsequent patient workshops deemed these five symptoms to be relevant and suggested that reflux should be included; these were taken forward to create the final POST tool.
CONCLUSION
The POST tool is the first instrument designed to capture POH-specific symptoms. It will allow clinicians to standardize reporting of symptoms of POH and evaluate the response to surgical intervention.
Topics: Consensus; Delphi Technique; Hernia, Hiatal; Humans; Surveys and Questionnaires
PubMed: 35640625
DOI: 10.1093/bjs/znac139 -
International Emergency Nursing May 2021To examine the application and methodological quality of the Delphi method used in developing guidance for emergency nursing practice. (Review)
Review
AIM
To examine the application and methodological quality of the Delphi method used in developing guidance for emergency nursing practice.
BACKGROUND
Emergency nursing scope of practice has rapidly expanded in response to increasing patient acuity, complexity and technological innovation. Determining best practice is crucial for delivering high quality, safe and effective emergency nursing care. The Delphi method has been used to identify, prioritise complex issues and develop evidence-driven guidance in emergency nursing practice. The use and quality of the Delphi method in emergency nursing practice has not been examined.
DESIGN
Systematic literature review.
DATABASES AND DATA TREATMENT
A systematic literature search was conducted using the following databases: SCOPUS, EMBASE, Medline and ProQuest from date of inception to August 2019. The database search was limited to scholarly articles or peer-reviewed journals. No language restrictions were applied. The Cochrane Collaboration method and PRISMA checks were utilized to conduct the review.
RESULTS
Of 246 records identified 22 (8.9%) studies met the inclusion criteria. A modified Delphi method was commonly used (n = 15; 68.2%) and often conducted online (n = 11; 50.0%). Eight practice guidance themes were identified. Overall study quality was high (score 12/14; range 4-13), transparency of reporting varied.
CONCLUSION
Based on this review, the Delphi method is an appropriate method for exploring emergency nursing practice. The studies reviewed demonstrated that knowledge, skills and clinical expertise has progressively expanded in the specialty of emergency nursing. Variation in the application, conduct and transparency of reporting in Delphi studies developing guidance for emergency nursing practice is discussed.
Topics: Delphi Technique; Emergency Nursing; Humans
PubMed: 32238322
DOI: 10.1016/j.ienj.2020.100867 -
BMJ Open Sep 2021To describe the design and conduct of core outcome set (COS) studies that have included patients as participants, exploring how study characteristics might impact their...
OBJECTIVES
To describe the design and conduct of core outcome set (COS) studies that have included patients as participants, exploring how study characteristics might impact their response rates.
DESIGN
Systematic review of COS studies published between 2015 and 2019 that included more than one patient, carer or representative as participants (hereafter referred to as patients for brevity) in scoring outcomes in a Delphi.
RESULTS
There were variations in the design and conduct of COS studies that included patients in the Delphi process, including differing: scoring and feedback systems, approaches to recruiting patients, length of time between rounds, use of reminders, incentives, patient and public involvement, and piloting. Minimal reporting of participant characteristics and a lack of translation of Delphi surveys into local languages were found. Additionally, there were indications that studies that recruited patients through treatment centres had higher round two response rates than studies recruiting through patient organisations.
CONCLUSIONS
Variability was striking in how COS Delphi surveys were designed and conducted to include patient participants and other stakeholders. Future research is needed to explore what motivates patients to take part in COS studies and what factors influence COS developer recruitment strategies. Improved reporting would increase knowledge of how methods affect patient participation in COS Delphi studies.
Topics: Consensus; Delphi Technique; Humans; Outcome Assessment, Health Care; Patient Participation; Research Design; Treatment Outcome
PubMed: 34475183
DOI: 10.1136/bmjopen-2021-051066 -
International Journal of Law and... 2020This research presents a series of linked studies exploring the association between psychopathy and trauma. It comprises a systematic review (n = 58), followed by an...
This research presents a series of linked studies exploring the association between psychopathy and trauma. It comprises a systematic review (n = 58), followed by an expert Delphi (n = 19), and patient file trawl using a male forensic psychiatric patient sample (n = 66). An association between psychopathy and developmental trauma was predicted. It was further predicted that different types of trauma would be associated with different subtypes of psychopathy and that the severity of trauma would be important. The systematic review identified the following core themes: presence of Post-Traumatic Stress Disorder and/or symptoms; trauma type; trauma/abuse variables; and sex differences. The ensuing Delphi study indicated the specific variant of psychopathy to be important, with secondary psychopathy particularly relevant. The final study found that the severity of developmental trauma related differentially to primary and secondary psychopathy. Implications and directions for future research are discussed, most notably with regards to the conceptualisation of psychopathy.
Topics: Antisocial Personality Disorder; Delphi Technique; Female; Humans; Male; Prisoners; Psychological Trauma; Psychopathology; Stress Disorders, Post-Traumatic
PubMed: 32241459
DOI: 10.1016/j.ijlp.2020.101543 -
Dental Traumatology : Official... Jul 2023Variability in the outcome measures used to assess the success of tooth autotransplantation presents challenges for combining data to examine the success of the...
BACKGROUND/AIM
Variability in the outcome measures used to assess the success of tooth autotransplantation presents challenges for combining data to examine the success of the technique. Reaching agreement on the most important outcomes will enable routine procedural and follow-up data to be collected in a standardised way. In turn this will promote greater data synthesis to evaluate outcomes and examine which procedural techniques influence outcome. The aim of this study was to identify which prognostic factors and outcomes are most important to clinicians with experience in autotransplantation of developing teeth.
METHODS
The Delphi method was used to build consensus on the most important prognostic factors and outcomes. Item identification involved a systematic literature review and review of current clinical datasets in use. A two-round Delphi questionnaire was undertaken with clinicians providing tooth autotransplantation, followed by a consensus meeting to finalise the most important items.
RESULTS
Outcomes and prognostic factors were identified from the systematic review (82 studies and eight reviews), one guideline and three existing clinical datasets. Patient interviews and a clinician survey added a number of items that would not have been identified from the literature only. A total of 56 outcomes and 93 prognostic factors were included for rating in the Delphi questionnaire. The Delphi questionnaire was completed by 15 respondents in round one and 13 respondents in round two. The consensus meeting was attended by nine participants. The final items that were judged to be most important included 29 outcomes (25 clinical, three patient-reported and one service delivery) and 49 prognostic factors (18 patient characteristics, four presurgical, 17 surgical and 10 postsurgical). Clinical outcomes were consistently rated higher than patient-reported outcomes.
CONCLUSIONS
The clinical outcomes rated as the most important were transplant survival and reason for failure, outcomes relating to pulp health, different types of resorption and evidence of infection (suppuration). Important patient-reported outcomes were satisfaction with overall treatment experience, and outcome and quality of life related to function of the transplanted tooth. Procedural information rated as being the most important related to the donor tooth: stage of root development, method for surgical removal and storage and condition of the donor tooth root surface following removal.
Topics: Humans; Prognosis; Transplantation, Autologous; Quality of Life; Tooth; Tooth Root
PubMed: 36965034
DOI: 10.1111/edt.12843 -
Annals of Surgery Dec 2022To develop an international core outcome set (COS), a minimal collection of outcomes that should be measured and reported in all future clinical trials evaluating...
OBJECTIVE
To develop an international core outcome set (COS), a minimal collection of outcomes that should be measured and reported in all future clinical trials evaluating treatments of acute simple appendicitis in children.
SUMMARY OF BACKGROUND DATA
A previous systematic review identified 115 outcomes in 60 trials and systematic reviews evaluating treatments for children with appendicitis, suggesting the need for a COS.
METHODS
The development process consisted of 4 phases: (1) an updated systematic review identifying all previously reported outcomes, (2) a 2-stage international Delphi study in which parents with their children and surgeons rated these outcomes for inclusion in the COS, (3) focus groups with young people to identify missing outcomes, and (4) international expert meetings to ratify the final COS.
RESULTS
The systematic review identified 129 outcomes which were mapped to 43 unique outcome terms for the Delphi survey. The first-round included 137 parents (8 countries) and 245 surgeons (10 countries), the second-round response rates were 61% and 85% respectively, with 10 outcomes emerging with consensus. After 2 young peoples' focus groups, 2 additional outcomes were added to the final COS (12): mortality, bowel obstruction, intraabdominal abscess, recurrent appendicitis, complicated appendicitis, return to baseline health, readmission, reoperation, unplanned appendectomy, adverse events related to treatment, major and minor complications.
CONCLUSION
An evidence-informed COS based on international consensus, including patients and parents has been developed. This COS is recommended for all future studies evaluating treatment ofsimple appendicitis in children, to reduce heterogeneity between studies and facilitate data synthesis and evidence-based decision-making.
Topics: Child; Humans; Adolescent; Delphi Technique; Appendicitis; Research Design; Consensus; Acute Disease; Outcome Assessment, Health Care; Treatment Outcome
PubMed: 33630468
DOI: 10.1097/SLA.0000000000004707 -
European Urology Oct 2020There has been increasing interest in en bloc resection of bladder tumour (ERBT) as an oncologically noninferior alternative to transurethral resection of bladder tumour...
An International Collaborative Consensus Statement on En Bloc Resection of Bladder Tumour Incorporating Two Systematic Reviews, a Two-round Delphi Survey, and a Consensus Meeting.
BACKGROUND
There has been increasing interest in en bloc resection of bladder tumour (ERBT) as an oncologically noninferior alternative to transurethral resection of bladder tumour (TURBT) with fewer complications and better histology specimens. However, there is a lack of robust randomised controlled trial (RCT) data for making recommendations.
OBJECTIVE
We aimed to develop a consensus statement to standardise various aspects of ERBT for clinical practice and to guide future research.
DESIGN, SETTING, AND PARTICIPANTS
We developed the consensus statement on ERBT using a modified Delphi method. First, two systematic reviews were performed to investigate the clinical effectiveness of ERBT versus TURBT (effectiveness review) and to identify areas of uncertainty in ERBT (uncertainties review). Next, 200 health care professionals (urologists, oncologists, and pathologists) with experience in ERBT were invited to complete a two-round Delphi survey. Finally, a 16-member consensus panel meeting was held to review, discuss, and re-vote on the statements as appropriate.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Meta-analyses were performed for RCT data in the effectiveness review. Consensus statements were developed from the uncertainties review. Consensus was defined as follows: (1) ≥70% scoring a statement 7-9 and ≤15% scoring the statement 1-3 (consensus agree), or (2) ≥70% scoring a statement 1-3 and ≤15% scoring the statement 7-9 (consensus disagree).
RESULTS AND LIMITATIONS
A total of 10 RCTs were identified upon systematic review. ERBT had a shorter irrigation time (mean difference -7.24 h, 95% confidence interval [CI] -9.29 to -5.20, I = 85%, p < 0.001) and a lower rate of bladder perforation (risk ratio 0.30, 95% CI 0.11-0.83, I = 1%, p = 0.02) than TURBT, both with moderate certainty of evidence. There were no significant differences in recurrences at 0-12, 13-24, or 25-36 mo (all very low certainty of evidence). A total of 103 statements were developed, of which 99 reached a consensus. A summary of statements is as follows: ERBT should always be considered for treating non-muscle-invasive bladder cancer; ERBT should be considered feasible even for bladder tumours larger than 3 cm; number and location of bladder tumours are not major limitations in performing ERBT; the planned circumferential margin should be at least 5 mm from any visible bladder tumour; after ERBT, additional biopsy of the tumour edge or tumour base should not be performed routinely; for the ERBT specimen, T1 substage, and circumferential and deep resection margins must be assessed; it is safe to give a single dose of immediate intravesical chemotherapy, perform second-look transurethral resection, and give intravesical bacillus Calmette-Guérin (BCG) therapy after ERBT; and in studies of ERBT, both per-patient and -tumour analysis should be performed for different outcomes as appropriate. Important outcomes for future ERBT studies were also identified. A limitation is that as consensus statements are brief, concise and binary in nature, areas of uncertainty that are complex in nature may not be addressed adequately.
CONCLUSIONS
We have provided the most comprehensive review of the evidence base to date using a meta-analysis where appropriate and applying the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, and mobilised the international urology community to develop a consensus statement on ERBT using transparent and robust methods. The consensus statement will provide interim guidance for health care professionals who practice ERBT and inform researchers regarding ERBT-related studies in the future.
PATIENT SUMMARY
En bloc resection of bladder tumour (ERBT) is a surgical technique aiming to resect a bladder tumour in one piece. We included an international panel of experts to agree on the best practice of ERBT, and this will provide guidance to clinicians and researchers in the future.
Topics: Cystectomy; Delphi Technique; Humans; Practice Guidelines as Topic; Urinary Bladder Neoplasms
PubMed: 32389447
DOI: 10.1016/j.eururo.2020.04.059