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Clinical & Translational Oncology :... Jul 2024Genitourinary (GU) multidisciplinary tumour boards (GUMTBs) are key components of patient care, as they might lead to changes in treatment plan, improved survival, and...
PURPOSE
Genitourinary (GU) multidisciplinary tumour boards (GUMTBs) are key components of patient care, as they might lead to changes in treatment plan, improved survival, and increased adherence to guidelines. However, there are no guidelines on how GUMTBs should operate or how to assess their quality of performance.
METHODS
A systematic literature review was conducted to identify criteria and indicators to evaluate quality in GUMTBs. A scientific committee-comprising 12 GU cancer specialists from seven disciplines-proposed a list of criteria and developed indicators, evaluated in two rounds of Delphi method. Appropriateness and utility of indicators were scored using a 9-point Likert scale. Consensus was defined as at least two-thirds of Delphi respondents selecting a score sub-category that encompassed the median score of the group.
RESULTS
Forty-five criteria were selected to evaluate the quality of GUMTBs covering five dimensions: organisation, personnel, protocol and documentation, resources, and interaction with patients. Then, 33 indicators were developed and evaluated in the first round of Delphi, leading to a selection of 26 indicators in two dimensions: function, governance and resources, and GUMTB sessions. In the second round, consensus was reached on the appropriateness of all 26 indicators and on the utility of 24 of them. Index cards for criteria and indicators were developed to be used in clinical practice.
CONCLUSIONS
Criteria and indicators were developed to evaluate the quality of GUMTBs, aiming to serve as a guide to improve quality of care and health outcomes in patients with GU cancer.
Topics: Humans; Delphi Technique; Urogenital Neoplasms; Quality Indicators, Health Care; Quality of Health Care; Patient Care Team; Consensus; Medical Oncology
PubMed: 38341809
DOI: 10.1007/s12094-024-03381-z -
Zeitschrift Fur Rheumatologie Mar 2024Rheumatoid arthritis-associated interstitial lung disease (RA-ILD) is a major driver of premature mortality in patients with rheumatoid arthritis (RA). Detection of... (Review)
Review
OBJECTIVE
Rheumatoid arthritis-associated interstitial lung disease (RA-ILD) is a major driver of premature mortality in patients with rheumatoid arthritis (RA). Detection of RA-ILD is crucial but requires awareness among the treating physicians. To date, however, there is no international recommendation concerning screening for ILD in RA patients.
METHODS
After a systematic literature review, the modified Delphi technique in combination with the nominal group technique was used to provide a Delphi consensus statement elaborated by an expert panel of pneumonologists, rheumatologists, and a radiologist. Based on the available evidence, several clusters of questions were defined and discussed until consent was reached.
RESULTS
A screening algorithm for ILD in patients with RA based on clinical signs, respiratory symptoms, and risk factors has been developed. Further, the recommendations address diagnostic tools for RA-ILD and the follow-up of RA patients qualifying for ILD screening.
Topics: Humans; Arthritis, Rheumatoid; Lung Diseases, Interstitial; Risk Factors
PubMed: 38240817
DOI: 10.1007/s00393-023-01464-w -
Diabetic Medicine : a Journal of the... Apr 2024People with severe mental illness (SMI), such as schizophrenia, have higher rates of type 2 diabetes and worse outcomes, compared to those without SMI and it is not...
BACKGROUND
People with severe mental illness (SMI), such as schizophrenia, have higher rates of type 2 diabetes and worse outcomes, compared to those without SMI and it is not known whether diabetes self-management interventions are effective for people who have both conditions. Research in this area has been impeded by a lack of consensus on which outcomes to prioritise in people with co-existing SMI and diabetes.
AIMS
To develop a core outcome set (COS) for use in effectiveness trials of diabetes self-management interventions in adults with both type 2 diabetes and SMI.
METHODS
The COS was developed in three stages: (i) identification of outcomes from systematic literature review of intervention studies, followed by multi-stakeholder and service user workshops; (ii) rating of outcomes in a two-round online Delphi survey; (iii) agreement of final 'core' outcomes through a stakeholder consensus workshop.
RESULTS
Seven outcomes were selected: glucose control, blood pressure, body composition (body weight, BMI, body fat), health-related quality of life, diabetes self-management, diabetes-related distress and medication adherence.
CONCLUSIONS
This COS is recommended for future trials of effectiveness of diabetes self-management interventions for people with SMI and type 2 diabetes. Its use will ensure trials capture important outcomes and reduce heterogeneity so findings can be readily synthesised to inform practice and policy.
Topics: Adult; Humans; Diabetes Mellitus, Type 2; Self-Management; Quality of Life; Research Design; Delphi Technique; Mental Disorders; Outcome Assessment, Health Care
PubMed: 38239101
DOI: 10.1111/dme.15288 -
Journal of Evidence-based Medicine Mar 2024Clinical trials of traditional Chinese medicine (TCM) and Western medicine showed there was heterogeneity of outcome reporting in myocardial infarction (MI). Developing...
BACKGROUND
Clinical trials of traditional Chinese medicine (TCM) and Western medicine showed there was heterogeneity of outcome reporting in myocardial infarction (MI). Developing a core outcome set (COS) might improve the consistency of outcome reporting in future clinical trials.
METHODS
A list of outcomes was developed based on a systematic review of randomized controlled trials (RCTs) of MI and semistructured interviews with MI patients. Two rounds of Delphi survey for clinicians, researchers, journal editors, and methodologists were conducted. An online questionnaire sent to nurses. After an online consensus meeting, a COS for MI RCTs was developed.
RESULTS
After extracted data from clinical trials and discussed, 216 outcomes were included in round 1 of the Delphi survey. Seventy-four participants completed round 1 of the Delphi survey. Sixty-five participants completed round 2 of the Delphi survey. Twenty-two nurses completed the online questionnaire. Fifteen participants attended the online consensus meeting, and 14 of them voted and determined the final COS. For all types of MI, it was recommended that left ventricular ejection fraction and quality of life be measured and reported. For acute MI, the participants in the consensus meeting recommended the following core outcomes: death from cardio-cerebrovascular disease, cardiogenic shock, heart failure, troponin I, troponin T, creatine kinase isoenzyme, Killip class, target vessel revascularization, and emergency CABG. For previous MI, recurrent MI, recurrent angina pectoris, and heart failure readmission were recommended.
CONCLUSIONS
The COS for MI in RCTs provides recommendations for clinical trials that seek to improve outcomes for patients with MI.
Topics: Humans; Medicine, Chinese Traditional; Research Design; Delphi Technique; Myocardial Infarction; Heart Failure; Outcome Assessment, Health Care; Treatment Outcome
PubMed: 38214702
DOI: 10.1111/jebm.12579 -
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 -
BMC Palliative Care Dec 2023Neonatal death is the leading category of death in children under the age of 5 in the UK. Many babies die following decisions between parents and the neonatal team; when...
BACKGROUND
Neonatal death is the leading category of death in children under the age of 5 in the UK. Many babies die following decisions between parents and the neonatal team; when a baby is critically unwell, with the support of healthcare professionals, parents may make the decision to stop active treatment and focus on ensuring their baby has a 'good' death. There is very little evidence to support the clinical application of neonatal palliative care and/or end-of-life care, resulting in variation in clinical provision between neonatal units. Developing core outcomes for neonatal palliative care would enable the development of measures of good practice and enhance our care of families. The aim of this study is to develop a core outcome set with associated tools for measuring neonatal palliative care.
METHOD
This study has four phases: (1) identification of potential outcomes through systematic review and qualitative interviews with key stakeholders, including parents and healthcare professionals (2) an online Delphi process with key stakeholders to determine core outcomes (3) identification of outcome measures to support clinical application of outcome use (4) dissemination of the core outcome set for use across neonatal units in the UK. Key stakeholders include parents, healthcare professionals, and researchers with a background in neonatal palliative care.
DISCUSSION
Developing a core outcome set will standardise minimum reported outcomes for future research and quality improvement projects designed to determine the effectiveness of interventions and clinical care during neonatal palliative and/or end-of-life care. The core outcome set will provide healthcare professionals working in neonatal palliative and/or end-of-life support with an increased and consistent evidence base to enhance practice in this area.
TRIAL REGISTRATION
The study has been registered with the COMET initiative ( https://www.comet-initiative.org/Studies/Details/1470 ) and the systematic review is registered with the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42023451068).
Topics: Child; Humans; Infant, Newborn; Delphi Technique; Outcome Assessment, Health Care; Palliative Care; Research Design; Treatment Outcome
PubMed: 38114987
DOI: 10.1186/s12904-023-01326-x -
The Lancet. Respiratory Medicine Jan 2024Improving the treatment of non-cystic fibrosis bronchiectasis in children and adolescents requires high-quality research with outcomes that meet study objectives and are... (Review)
Review
Improving the treatment of non-cystic fibrosis bronchiectasis in children and adolescents requires high-quality research with outcomes that meet study objectives and are meaningful for patients and their parents and caregivers. In the absence of systematic reviews or agreement on the health outcomes that should be measured in paediatric bronchiectasis, we established an international, multidisciplinary panel of experts to develop a core outcome set (COS) that incorporates patient and parent perspectives. We undertook a systematic review from which a list of 21 outcomes was constructed; these outcomes were used to inform the development of separate surveys for ranking by parents and patients and by health-care professionals. 562 participants (201 parents and patients from 17 countries, 361 health-care professionals from 58 countries) completed the surveys. Following two consensus meetings, agreement was reached on a ten-item COS with five outcomes that were deemed to be essential: quality of life, symptoms, exacerbation frequency, non-scheduled health-care visits, and hospitalisations. Use of this international consensus-based COS will ensure that studies have consistent, patient-focused outcomes, facilitating research worldwide and, in turn, the development of evidence-based guidelines for improved clinical care and outcomes. Further research is needed to develop validated, accessible measurement instruments for several of the outcomes in this COS.
Topics: Adolescent; Child; Humans; Bronchiectasis; Delphi Technique; Outcome Assessment, Health Care; Quality of Life; Research Design; Systematic Reviews as Topic; Treatment Outcome; Consensus
PubMed: 38070531
DOI: 10.1016/S2213-2600(23)00233-3 -
European Journal of Surgical Oncology :... Jan 2024Measuring and benchmarking quality of care in surgical oncology has been gaining popularity. In autologous breast reconstruction (ABR), a standardized set of indicators...
Measuring and benchmarking quality of care in surgical oncology has been gaining popularity. In autologous breast reconstruction (ABR), a standardized set of indicators to assess quality of care is lacking. In this study, we defined a set of evidence-based quality indicators for autologous breast reconstruction. First, we performed a systematic review to identify factors related to quality of care in ABR. Variables were categorized depending on their function: indicators related to outcome, indicators related to process and case-mix variables. The review was followed by a 3-round Delphi Consensus to determine which indicators and case-mix-variables were considered relevant and feasible for inclusion in an ABR standard set of indicators. 932 unique articles were identified, of which 110 papers were included in the study. Indicators were categorized by function: outcome, process and case-mix variables. In total, 8 process indicators and 41 outcome indicators were extracted. 30 case-mix-variables were included. Following 3 rounds of questioning in the Delphi Consensus, all respondents agreed on type of ABR, oncological outcomes and patient satisfaction for the standard set. Indicators related to complications were consistently ranked highly. Most process indicators were not chosen after 3 rounds of questioning. 11 case-mix-variables were included in the final set. Following the Delphi Consensus, it was possible to identify 33 process and outcome indicators and 11 case-mix-variables for inclusion for a standard set of quality indicators. With the inclusion of both objective and patient-reported outcome measures, this set of indicators provides a multidimensional measurement tool for quality assessment for ABR.
Topics: Humans; Quality Indicators, Health Care; Delphi Technique; Consensus; Patient Reported Outcome Measures
PubMed: 38056020
DOI: 10.1016/j.ejso.2023.107254 -
Trauma, Violence & Abuse Jul 2024There is no consensus on the outcomes needed for the recovery and reintegration of survivors of modern slavery and human trafficking. We developed the Modern Slavery... (Review)
Review
There is no consensus on the outcomes needed for the recovery and reintegration of survivors of modern slavery and human trafficking. We developed the Modern Slavery Core Outcome Set (MSCOS) to address this gap. We conducted three English-language reviews on the intervention outcomes sought or experienced by adult survivors: a qualitative systematic review (4 databases, 18 eligible papers, thematic analysis), a rapid review of quantitative intervention studies (four databases, eight eligible papers, content analysis) and a gray literature review (2 databases, 21 websites, a call for evidence, 13 eligible papers, content analysis). We further extracted outcomes from 36 pre-existing interview transcripts with survivors, and seven interviews with survivors from underrepresented groups. We narrowed down outcomes via a consensus process involving: a three-stage E-Delphi survey (191 respondents); and a final consensus workshop (46 participants). We generated 398 outcomes from our 3 reviews, and 843 outcomes from interviews. By removing conceptual and literal duplicates, we reduced this to a longlist of 72 outcomes spanning 10 different domains. The E-Delphi produced a 14-outcome shortlist for the consensus workshop, where 7 final outcomes were chosen. Final outcomes were: "long-term consistent support," "secure and suitable housing," "safety from any trafficker or other abuser," "access to medical treatment," "finding purpose in life and self-actualisation," "access to education," and "compassionate, trauma-informed services." The MSCOS provides outcomes that are accepted by a wide range of stakeholders and that should be measured in intervention evaluation.
Topics: Humans; Survivors; Enslavement; Human Trafficking; Consensus; Adult; Female; Male; Delphi Technique
PubMed: 37991003
DOI: 10.1177/15248380231211955 -
The British Journal of Dermatology Jan 2024Cutaneous neurofibromas (cNF) are considered one of the highest burdens of neurofibromatosis type 1 (NF1). To date, no medical treatment can cure cNF or prevent their...
BACKGROUND
Cutaneous neurofibromas (cNF) are considered one of the highest burdens of neurofibromatosis type 1 (NF1). To date, no medical treatment can cure cNF or prevent their development. In that context, there is an urgent need to prepare and standardize the methodology of future trials targeting cNF.
OBJECTIVES
The objective was to develop a core outcome domain set suitable for all clinical trials targeting NF1-associated cNF.
METHODS
The validated approach of this work consisted of a three-phase methodology: (i) generating the domains [systematic literature review (SLR) and qualitative studies]; (ii) agreeing (three-round international e-Delphi consensus process and working groups); and (iii) voting.
RESULTS
(i) The SLR and the qualitative studies (three types of focus groups and a French e-survey with 234 participants) resulted in a preliminary list of 31 candidate items and their corresponding definitions. (ii) A total of 229 individuals from 29 countries participated in the first round of the e-Delphi process: 71 patients, relatives or representatives (31.0%), 130 healthcare professionals (HCPs, 56.8%) and 28 researchers, representatives of a drug regulatory authority, industry or pharmaceutical company representatives or journal editors (12.2%). The overall participation rate was 74%. After round 2, five candidate items were excluded. Between rounds 2 and 3, international workshops were held to better understand the disagreements among stakeholders. This phase led to the identification of 19 items as outcome subdomains. (iii) The items were fused to create four outcome domains ('clinical assessment', 'daily life impact', 'patient satisfaction' and 'perception of health') and prioritized. The seven items that did not reach consensus were marked for the research agenda. The final core outcome domain set reached 100% of the votes of the steering committee members.
CONCLUSIONS
Although numerous outcomes can be explored in studies related to cNF in NF1, the present study offers four outcome domains that should be reported in all trial studies, agreed on by international patients, relatives and representatives of patients; HCPs; researchers, representatives of drug regulatory authorities or pharmaceutical companies and journal editors. The next step will include the development of a set of core outcome measurement instruments to further standardize how these outcomes should be assessed.
Topics: Humans; Delphi Technique; Neurofibroma; Neurofibromatosis 1; Research Design; Skin Neoplasms
PubMed: 37877514
DOI: 10.1093/bjd/ljad397