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JAMA May 2022Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and...
IMPORTANCE
Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use.
OBJECTIVE
To develop international, consensus-based, PRO-specific ethical guidelines for clinical research.
EVIDENCE REVIEW
The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.
FINDINGS
Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans.
CONCLUSIONS AND RELEVANCE
The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.
Topics: Biomedical Research; Consensus; Delphi Technique; Ethics, Clinical; Humans; Morals; Patient Reported Outcome Measures; Practice Guidelines as Topic; Research Design; Research Report
PubMed: 35579638
DOI: 10.1001/jama.2022.6421 -
International Forum of Allergy &... Mar 2023Critical review of computed tomography (CT) imaging is essential in preoperative planning for endoscopic sinus surgery. In this study, we used a systematic review and a...
Development of an optimized preoperative computed tomography imaging checklist for endoscopic sinus surgery utilizing a systematic review of the literature and the modified Delphi method.
BACKGROUND
Critical review of computed tomography (CT) imaging is essential in preoperative planning for endoscopic sinus surgery. In this study, we used a systematic review and a modified Delphi method to develop a comprehensive checklist that facilitates preoperative review of sinus CT imaging.
METHODS
We performed a systematic review of PubMed, Embase, CINAHL, Cochrane, and Web of Science databases to identify existing checklists developed to evaluate sinus CT imaging. An inclusive list of items from these checklists was compiled and a modified Delphi methodology was used to assign ranked priority. The Delphi process involved 14 rhinologists and had three phases: an initial survey with Likert priority (scale of 1-9) and two rounds of live discussions followed by survey to confirm consensus.
RESULTS
Ninety-seven possible checklist items were identified from a systematic review and panelist input. On initial survey, 63 items reached a consensus score of 7+, and 13 items had near consensus scores between 6 and 7; two of these 13 borderline items were retained after subsequent panelist discussion. The resulting items were consolidated into an 11-item disease checklist and a 24-item anatomical checklist; the anatomical checklist was further divided into six subsections: nasal cavity, maxillary, ethmoid, sphenoid, frontal, skull base, and orbit. Additionally, panelists identified six core aspects of patient history to consider prior to surgery.
CONCLUSIONS
After establishing content validity through a systematic literature review and a modified Delphi method, we developed a comprehensive checklist for preoperative sinus CT imaging review; implementation and evaluation of validity among trainees will suggest overall utility.
Topics: Humans; Checklist; Delphi Technique; Endoscopy; Tomography, X-Ray Computed; Consensus
PubMed: 35856704
DOI: 10.1002/alr.23064 -
International Journal of Environmental... Aug 2020As falls are among the most common causes of injury for the elderly, the prevention and early intervention are necessary. Fall assessment tools that include a variety of...
As falls are among the most common causes of injury for the elderly, the prevention and early intervention are necessary. Fall assessment tools that include a variety of factors are recommended for preventing falls, but there is a lack of such tools. This study developed a multifactorial fall risk assessment tool based on current guidelines and validated it from the perspective of professionals. We followed the Meta-Analysis of Observational Studies in Epidemiology's guidelines in this systematic review. We used eight international and five Korean databases to search for appropriate guidelines. Based on the review results, we conducted the Delphi survey in three rounds; one open round and two scoring rounds. About nine experts in five professional areas participated in the Delphi study. We included nine guidelines. After conducting the Delphi study, the final version of the "Multifactorial Fall Risk Assessment tool for Community-Dwelling Older People" (MFA-C) has 36 items in six factors; general characteristics, behavior factors, disease history, medication history, physical function, and environmental factors. The validity of the MFA-C tool was largely supported by various academic fields. It is expected to be beneficial to the elderly in the community when it comes to tailored interventions to prevent falls.
Topics: Accidental Falls; Activities of Daily Living; Aged; Aged, 80 and over; Delphi Technique; Fear; Female; Humans; Independent Living; Male; Risk Assessment
PubMed: 32825699
DOI: 10.3390/ijerph17176097 -
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 -
JAMA Oncology Jun 2022Pancreatic cancer is the third most common cause of cancer death; however, randomized clinical trials (RCTs) of survival in patients with resectable pancreatic cancer...
Consensus Statement on Mandatory Measurements for Pancreatic Cancer Trials for Patients With Resectable or Borderline Resectable Disease (COMM-PACT-RB): A Systematic Review and Delphi Consensus Statement.
IMPORTANCE
Pancreatic cancer is the third most common cause of cancer death; however, randomized clinical trials (RCTs) of survival in patients with resectable pancreatic cancer lack mandatory measures for reporting baseline and prognostic factors, which hampers comparisons between outcome measures.
OBJECTIVE
To develop a consensus on baseline and prognostic factors to be used as mandatory measurements in RCTs of resectable and borderline resectable pancreatic cancer.
EVIDENCE REVIEW
We performed a systematic literature search of the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and Embase for RCTs on resectable and borderline resectable pancreatic cancer with overall survival as the primary outcome. We produced a systematic summary of all baseline and prognostic factors identified in the RCTs. A Delphi panel that included 13 experts was surveyed to reach a consensus on mandatory and recommended baseline and prognostic factors.
FINDINGS
The 42 RCTs that met inclusion criteria reported a total of 60 baseline and 19 prognostic factors. After 2 Delphi rounds, agreement was reached on 50 mandatory baseline and 20 mandatory prognostic factors for future RCTs, with a distinction between studies of neoadjuvant vs adjuvant treatment.
CONCLUSION AND RELEVANCE
This findings of this systematic review and international expert consensus have produced this Consensus Statement on Mandatory Measurements in Pancreatic Cancer Trials for Resectable and Borderline Resectable Disease (COMM-PACT-RB). The baseline and prognostic factors comprising the mandatory measures will facilitate better comparison across RCTs and eventually will enable improved clinical practice among patients with resectable and borderline resectable pancreatic cancer.
Topics: Delphi Technique; Humans; Neoadjuvant Therapy; Pancreatic Neoplasms
PubMed: 35446336
DOI: 10.1001/jamaoncol.2022.0168 -
Neurourology and Urodynamics Apr 2024This is a Delphi study that aims to explore expert consensus regarding open questions in current literature evidence on lower urinary tract infections (UTIs). This... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND OBJECTIVE
This is a Delphi study that aims to explore expert consensus regarding open questions in current literature evidence on lower urinary tract infections (UTIs). This manuscript deals with adults and analyzed the most recent guidelines and meta-analysis on the topic.
METHODS
A panel of leading urologists and urogynaecologists participated in a consensus-forming project using a Delphi method to reach consensus on gray zone issues on recurrent lower UTIns (rUTIs), asymptomatic bacteriuria (AB) in pregnant women, and catheter-associated UTIs (CAUTI) in adults. All the panelists were invited to participate the four phases consensus. Consensus was defined as ≥75% agreement. An ordinal scale (0-10) was used. A systematic literature review was analyzed for diagnostic workup and prevention of rUTIs, AB, and CAUTI.
RESULTS
In total, 37 experts participated. All panelists participated in the four phases of the consensus process. Consensus was reached if ≥75% of the experts agreed on the proposed topic. Online meetings and a face-to-face consensus meeting was held in Milan in March 2023. Formal consensus was achieved for 12/13 items.
CONCLUSIONS
This manuscript is a Delphi survey of experts that showed interest on some debated points on rUTIs, AB in pregnancy, and prevention of CAUTI. There is still little data on nonantibiotic prevention of UTIs and CAUTI; quite old studies have been reported on AB in pregnancy. The emerging problem of antibiotic resistance is relevant and nonantibiotic prophylaxis may play a role in its prevention.
Topics: Adult; Humans; Female; Pregnancy; Delphi Technique; Urinary Tract Infections; Bacteriuria; Consensus
PubMed: 38213058
DOI: 10.1002/nau.25385 -
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 -
Australasian Journal on Ageing Sep 2022To map explicit screening tools to identify potentially inappropriate medication (PIMs), and the characteristics and limitations of these tools. Including... (Review)
Review
OBJECTIVE
To map explicit screening tools to identify potentially inappropriate medication (PIMs), and the characteristics and limitations of these tools. Including PIMs-interactions, therapeutic alternatives and the clinical management of PIMs.
METHODS
A systematic scoping review was conducted in PubMed and Scopus (until May 2021). The number of PIMs listed as essential drugs was identified in Model List of Essential Medicines by the World Health Organization (WHO) and National List of Essential Medicines (Brazil). In addition to reporting the therapeutic alternatives and clinical management proposed by explicit screening tools to identify PIMs, we suggested our own alternatives for the PIMs most frequently reported.
RESULTS
Fifty-eight tools reported 614 PIMs and 747 PIMs-interactions. Limited overlap between the tools was observed: 123 (69.1%) of 178 therapeutic alternatives proposed by the tools were considered inappropriate by other tools, and 222 (36.1%) of the 614 PIMs identified were named as being inappropriate only once. Only 21 tools were developed by a Delphi panel technique associated with systematic review. The PIMs listed as essential medication in Brazil and by the WHO were 30.6% and 23.3% of the total reported, respectively. For the most-cited PIMs, such as non-steroidal anti-inflammatory drugs, tricyclic antidepressants and benzodiazepines, we suggested the use of non-opioid and opioid analgesics; agomelatine, bupropion or moclobemide; and melatonin, respectively.
CONCLUSIONS
The next stages in the development of explicit screening tools to identify PIMs include achieving more consensus between them and improving their applicability across countries. Further, it is recommended that tools include PIMs risks and advice on therapeutic alternatives.
Topics: Brazil; Consensus; Humans; Inappropriate Prescribing; Potentially Inappropriate Medication List
PubMed: 35226786
DOI: 10.1111/ajag.13046 -
Current Medical Research and Opinion Jan 2023The objective of this study is to generate a core clinical dataset (CD) containing the minimum acceptable amount of information that should be collected for each patient...
OBJECTIVE
The objective of this study is to generate a core clinical dataset (CD) containing the minimum acceptable amount of information that should be collected for each patient presenting with triglyceride-induced acute pancreatitis within global treatment centres or sites.
METHOD
The Jandhyala Method, including systematic literature review and SMART interviews, was used to observe expert opinion from ten leaders in the treatment of triglyceride-induced acute pancreatitis (TG-IAP) across the US and EU.
RESULTS
Using the PRISMA Literature Review Protocol, data were extracted from 123 of the 6718 identified studies. A total of 243 items were identified from the data extracted from these studies and, combined with the unique items coded from the Awareness Round (1) survey, formed the Consensus Round (2) survey. One hundred and ninety-five of the 243 items (80%) met the consensus threshold and were included for appraisal in the SMART interview phase. A total of 109 items were agreed to form part of the current clinical diagnostic and monitoring procedure by all experts once the weights across all the stakeholder disciplines were balanced to eliminate bias. These items were further condensed to form the core dataset, comprising a total of 87 items.
CONCLUSION
Once validated and adopted, the TG-IAP CD will improve the overall management of patients with TG-IAP by speeding up diagnosis and detecting changes in disease severity and subsequent disease progression, informing personalized patient management plans, and improving patient outcomes.
Topics: Humans; Pancreatitis; Acute Disease; Triglycerides; Disease Progression; Patient Acuity; Delphi Technique
PubMed: 36384356
DOI: 10.1080/03007995.2022.2144054 -
Canadian Journal on Aging = La Revue... Mar 2022We identified quality indicators (QIs) for care during transitions of older persons (≥ 65 years of age). Through systematic literature review, we catalogued QIs...
We identified quality indicators (QIs) for care during transitions of older persons (≥ 65 years of age). Through systematic literature review, we catalogued QIs related to older persons' transitions in care among continuing care settings and between continuing care and acute care settings and back. Through two Delphi survey rounds, experts ranked relevance, feasibility, and scientific soundness of QIs. A steering committee reviewed QIs for their feasible capture in Canadian administrative databases. Our search yielded 326 QIs from 53 sources. A final set of 38 feasible indicators to measure in current practice was included. The highest proportions of indicators were for the emergency department (47%) and the Institute of Medicine (IOM) quality domain of effectiveness (39.5%). Most feasible indicators were outcome indicators. Our work highlights a lack of standardized transition QI development in practice, and the limitations of current free-text documentation systems in capturing relevant and consistent data.
Topics: Aged; Aged, 80 and over; Canada; Delphi Technique; Emergency Service, Hospital; Humans; Quality Indicators, Health Care
PubMed: 34080533
DOI: 10.1017/S0714980820000446