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Clinical & Translational Oncology :... May 2024This study aimed to develop a set of criteria and indicators to evaluate the quality of care of patients with head and neck cancer (HNC).
PURPOSE
This study aimed to develop a set of criteria and indicators to evaluate the quality of care of patients with head and neck cancer (HNC).
METHODS
A systematic literature review was conducted to identify valuable criteria/indicators for the assessment of the quality of care in HNC. With the aid of a technical group, a scientific committee of oncologists specialised in HNC used selected criteria to propose indicators that were evaluated with a two-round Delphi method. Indicators on which consensus was achieved were then prioritised by the scientific committee to develop a final set of indicators.
RESULTS
We proposed a list of 50 indicators used in the literature or developed by us to be evaluated with a Delphi method. There was consensus on the appropriateness of 47 indicators in the first round; the remaining 3 achieved consensus in the second round. The 50 indicators were scored to prioritise them, leading to a final selection of 29 indicators related to structure (3), process (22), or outcome (4) and covering diagnosis, treatment, follow-up, and health outcomes in patients with HNC. Easy-to-use index cards were developed for each indicator, with their criterion, definition, formula for use in real-world clinical practice, rationale, and acceptable level of attainment.
CONCLUSIONS
We have developed a set of 29 evidence-based and expert-supported indicators for evaluating the quality of care in HNC, covering diagnosis, treatment, follow-up, and health outcomes.
Topics: Humans; Spain; Quality Indicators, Health Care; Head and Neck Neoplasms; Consensus; Delphi Technique
PubMed: 37848694
DOI: 10.1007/s12094-023-03298-z -
International Journal of Clinical... Feb 2024Over the past 40 years, the tasks of pharmacists have shifted from logistic services to pharmaceutical care (PhC). Despite the increasing importance of measuring...
BACKGROUND
Over the past 40 years, the tasks of pharmacists have shifted from logistic services to pharmaceutical care (PhC). Despite the increasing importance of measuring quality of care, there is no general definition of Quality Indicators (QIs) to measure PhC. Recognising this, a working group in a European association of PhC researchers, the Pharmaceutical Care Network Europe (PCNE), was established in 2020.
AIM
This research aimed to review existing definitions of QIs and develop a definition of QIs for PhC.
METHOD
A two-step procedure was applied. Firstly, a systematic literature review was conducted to identify existing QI definitions that were summarised. Secondly, an expert panel, comprised of 17 international experts from 14 countries, participated in two surveys and a discussion using a modified Delphi technique to develop the definition of QIs for PhC.
RESULTS
A total of 182 QI definitions were identified from 174 articles. Of these, 63 QI definitions (35%) cited one of five references as the source. Sixteen aspects that construct QI definitions were derived from the identified definitions. As a result of the Delphi study, the panel reached an agreement on a one-sentence definition of QIs for PhC: "quality indicators for pharmaceutical care are validated measurement tools to monitor structures, processes or outcomes in the context of care provided by pharmacists".
CONCLUSION
Building upon existing definition of QIs, an international expert panel developed the PCNE definition of QIs for PhC. This definition is intended for universal use amongst researchers and healthcare providers in PhC.
Topics: Humans; Quality Indicators, Health Care; Consensus; Europe; Pharmaceutical Services; Delphi Technique
PubMed: 37646963
DOI: 10.1007/s11096-023-01631-8 -
Journal of Orthopaedic Surgery and... Aug 2023Lower limb swelling after total knee arthroplasty (TKA) hinders surgical effectiveness. The poor results of studies on swelling interventions are due to the lack of a...
BACKGROUND
Lower limb swelling after total knee arthroplasty (TKA) hinders surgical effectiveness. The poor results of studies on swelling interventions are due to the lack of a classification of swelling causes through appropriate medical tests. A gold standard is missing. This study aimed to clarify the causes of TKA postoperative swelling and how to identify them through indicators and medical tests by consulting a wide range of experts from multiple disciplines.
METHOD
The Delphi method was used. A first draft of the index was prepared based on a systematic search of the literature. A total of 11 experts from several disciplines were invited to evaluate the rationality of the indicators and suggest modifications. After two rounds of consultation, the experts reached a consensus, and the consultation was stopped.
RESULTS
The response rate of the 11 experts was 100%, and the authoritative Cr was 0.896. Kendall's W values for opinion coordination of the two rounds of consultation were 0.262 and 0.226, respectively (P < 0.001). Among the final indicators, there were 4 primary indicators for swelling cause classification (inflammatory response, poor venous return, joint hematoma, muscle damage, and healing), 19 secondary and 19 tertiary indicators.
CONCLUSION
The indications obtained by systematic literature review and multidisciplinary expert consultation are reliable and scientific. Multiple causes of lower extremity swelling after TKA were identified. Blood test indicators can reflect an inflammatory response, suggest poor venous return, and reflect muscle damage and healing progress. Ultrasound scans are needed to identify underlying thrombotic or valvular problems, joint hematomas, and muscle damage. These tests help clinicians and researchers determine the cause of swelling after TKA and take appropriate management.
Topics: Humans; Arthroplasty, Replacement, Knee; Delphi Technique; Edema; Consensus; Lower Extremity
PubMed: 37543607
DOI: 10.1186/s13018-023-03980-6 -
Journal of Pain and Symptom Management Oct 2023Ensuring patient-centered palliative care requires a comprehensive assessment of needs beginning in the initial encounter. However, there is no generally accepted guide...
CONTEXT
Ensuring patient-centered palliative care requires a comprehensive assessment of needs beginning in the initial encounter. However, there is no generally accepted guide for carrying out this multidimensional needs assessment as a first step in palliative intervention.
OBJECTIVES
To develop an expert panel-endorsed interview guide that would enable proactive and systematic Multidimensional needs Assessment in the Palliative care initial encounter (MAP).
METHODS
A preliminary version of the MAP guide was drafted based on a published literature review, published semistructured interviews with 20 patients, 20 family carers, and 20 palliative care professionals, and a nominal group process with palliative care professionals and a representative of the national patient's association. Consensus regarding its content was obtained through a modified Delphi process involving a panel of palliative care physicians from across Spain.
RESULTS
The published systematic literature review and qualitative study resulted in the identification of 55 needs, which were sorted and grouped by the nominal group. Following the Delphi process, the list of needs was reduced to 47, linked to six domains: Clinical history and medical conditions (n = 8), Physical symptoms (n = 17), Functional and cognitive status (n = 4), Psycho-emotional symptoms (n = 5), Social issues (n = 8), and Spiritual and existential concerns (n = 5).
CONCLUSION
MAP is an expert panel-endorsed semi-structured clinical interview guide for the comprehensive, systematic, and proactive initial assessment to efficiently assess multiple domains while adjusting to the needs of each patient. A future study will assess the feasibility of using the MAP guide within the timeframe of the palliative care initial encounter.
Topics: Humans; Palliative Care; Needs Assessment; Hospice and Palliative Care Nursing; Caregivers; Qualitative Research
PubMed: 37468050
DOI: 10.1016/j.jpainsymman.2023.07.011 -
Journal of Pain and Symptom Management Oct 2023Delirium is a serious neurocognitive syndrome which is highly prevalent in people approaching the end of life. Existing trials of interventions to prevent or treat...
CONTEXT
Delirium is a serious neurocognitive syndrome which is highly prevalent in people approaching the end of life. Existing trials of interventions to prevent or treat delirium in adults receiving palliative care report heterogeneous outcomes.
OBJECTIVES
To undertake an international consensus process to develop a core outcome set for trials of interventions, designed to prevent and/or treat delirium, for adults receiving palliative care.
METHODS
The core outcome set development process included a systematic review, qualitative interviews, modified Delphi method and virtual consensus meetings using nominal group technique (Registration http://www.comet-initiative.org/studies/details/796). Participants included family members, clinicians, and researchers with experience of delirium in palliative care.
RESULTS
Forty outcomes were generated from the systematic review and interviews informing the Delphi Round one survey. The international Delphi panel comprised 92 participants including clinicians (n = 71, 77%), researchers (n = 13, 14%), and family members (n = 8, 9%). Delphi Round two was completed by 77 (84%) participants from Round one. Following the consensus meetings, four outcomes were selected for the core outcome set: 1) delirium occurrence (incidence and prevalence); 2) duration of delirium until resolution defined as either no further delirium in this episode of care or death; 3) overall delirium symptom profile (agitation, delusions or hallucinations, delirium symptoms and delirium severity); 4) distress due to delirium (person with delirium, and/or family and/or carers [including healthcare professionals]).
CONCLUSION
Using a rigorous consensus process, we developed a core outcome set comprising four delirium-specific outcomes for inclusion in future trials of interventions to prevent and/or treat delirium in palliative care.
Topics: Adult; Humans; Research Design; Palliative Care; Delphi Technique; Outcome Assessment, Health Care; Delirium; Treatment Outcome
PubMed: 37311495
DOI: 10.1016/j.jpainsymman.2023.05.013 -
BMC Health Services Research Jun 2023Internationally, the need for appropriately structured, high-quality care in psycho-oncology is more and more recognized and quality-oriented care is to be established....
BACKGROUND
Internationally, the need for appropriately structured, high-quality care in psycho-oncology is more and more recognized and quality-oriented care is to be established. Quality indicators are becoming increasingly important for a systematic development and improvement of the quality of care. The aim of this study was to develop a set of quality indicators for a new form of care, a cross-sectoral psycho-oncological care program in the German health care system.
METHODS
The widely established RAND/UCLA Appropriateness Method was combined with a modified Delphi technique. A systematic literature review was conducted to identify existing indicators. All identified indicators were evaluated and rated in a two-round Delphi process. Expert panels embedded in the Delphi process assessed the indicators in terms of relevance, data availability and feasibility. An indicator was accepted by consensus if at least 75% of the ratings corresponded to category 4 or 5 on a five-point Likert scale.
RESULTS
Of the 88 potential indicators derived from a systematic literature review and other sources, 29 were deemed relevant in the first Delphi round. After the first expert panel, 28 of the dissented indicators were re-rated and added. Of these 57 indicators, 45 were found to be feasible in terms of data availability by the second round of expert panel. In total, 22 indicators were transferred into a quality report, implemented and tested within the care networks for participatory quality improvement. In the second Delphi round, the embedded indicators were tested for their practicability. The final set includes 16 indicators that were operationalized in care practice and rated by the expert panel as relevant, comprehensible, and suitable for care practice.
CONCLUSION
The developed set of quality indicators has proven in practical testing to be a valid quality assurance tool for internal and external quality management. The study findings could contribute to traceable high quality in cross-sectoral psycho-oncology by providing a valid and comprehensive set of quality indicators.
TRIAL REGISTRATION
"Entwicklung eines Qualitätsmanagementsystems in der integrierten, sektorenübergreifenden Psychoonkologie-AP "Qualitätsmanagement und Versorgungsmanagement" zur Studie "integrierte, sektorenübergreifende Psychoonkologie (isPO)" a sub-project of the "integrierte, sektorenübergreifende Psychoonkologie (isPO)", was registered in the German Clinical Trials Register (DRKS) (DRKS-ID: DRKS00021515) on 3rd September 2020. The main project was registered on 30th October 2018 (DRKS-ID: DRKS00015326).
Topics: Humans; Quality Indicators, Health Care; Psycho-Oncology; Delphi Technique; Germany; Consensus
PubMed: 37291536
DOI: 10.1186/s12913-023-09604-3 -
Oral Surgery, Oral Medicine, Oral... Jun 2023A core outcome set (COS) is the minimum agreed-on data set required to be measured in interventional trials. To date, there is no COS for oral lichen planus (OLP). This...
OBJECTIVE
A core outcome set (COS) is the minimum agreed-on data set required to be measured in interventional trials. To date, there is no COS for oral lichen planus (OLP). This study describes the final consensus project that brought together the results of the previous stages of the project to develop the COS for OLP.
STUDY DESIGN
The consensus process followed the Core Outcome Measures in Effectiveness Trials guidelines and involved the agreement of relevant stakeholders, including patients with OLP. Delphi-style clicker sessions were conducted at the World Workshop on Oral Medicine VIII and the 2022 American Academy of Oral Medicine Annual Conference. Attendees were asked to rate the importance of 15 outcome domains previously identified from a systematic review of interventional studies of OLP and a qualitative study of OLP patients. In a subsequent step, a group of OLP patients rated the domains. A further round of interactive consensus led to the final COS.
RESULTS
The consensus processes led to a COS of 11 outcome domains to be measured in future trials on OLP.
CONCLUSION
The COS developed by consensus will help reduce the heterogeneity of outcomes measured in interventional trials. This will allow future pooling of outcomes and data for meta-analyses. This project showed the effectiveness of a methodology that could be used for future COS development.
Topics: Humans; Lichen Planus, Oral; Delphi Technique; Outcome Assessment, Health Care; Research Design; Consensus; Treatment Outcome
PubMed: 37244864
DOI: 10.1016/j.oooo.2023.01.013 -
Brazilian Journal of Otorhinolaryngology 2023To evaluate the effectiveness of maxillomandibular advancement surgery in the treatment of Obstructive Sleep Apnea by comparing the pre- and postoperative Apnea and... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To evaluate the effectiveness of maxillomandibular advancement surgery in the treatment of Obstructive Sleep Apnea by comparing the pre- and postoperative Apnea and Hypopnea Index, in addition to classifying the degree of evidence and risk of intervention bias.
METHODS
A systematic review of the literature was carried out in the PUBMED, LILACS, EMBASE, SCOPUS, WEB OF SCIENCE and COCHRANE platforms, including cohort studies with polysomnographic follow-up, without other associated pharyngeal or nasal surgical procedures. The risk of study bias was assessed using the Modified Delphi technique. Pre- and postoperative Apnea and Hypopnea Index data were plotted for meta-analysis, and the quality of evidence was assessed using the GRADE system.
RESULTS
Of 1882 references, 32 articles were selected for full-text reading, of which four studies were included, totaling 83 adults with obstructive sleep apnea who underwent maxillomandibular advancement. The meta-analysis was in favor of the intervention (DM = -33.36, 95% CI -41.43 to -25.29, p < 0.00001), with a mean percentage reduction in the Apnea and Hypopnea Index of 79.5% after surgery, even though the level of evidence was classified as very low quality by the GRADE system.
CONCLUSION
The meta-analysis was in favor of the intervention, characterizing maxillomandibular advancement surgery as an effective treatment for obstructive sleep apnea in adults.
Topics: Adult; Humans; Mandibular Advancement; Maxilla; Polysomnography; Sleep Apnea, Obstructive; Treatment Outcome
PubMed: 37167845
DOI: 10.1016/j.bjorl.2023.02.007 -
Global Heart 2023Hypertensive disorders in pregnancy (HDP) and cardiometabolic and kidney diseases are rising in low- and middle-income countries (LMICs). While HDP are risk factors for... (Review)
Review
Hypertensive disorders in pregnancy (HDP) and cardiometabolic and kidney diseases are rising in low- and middle-income countries (LMICs). While HDP are risk factors for cardiometabolic and kidney diseases, cost-effective, scalable strategies for screening and prevention in women with a history of HDP are lacking. Existing guidelines and recommendations require adaptation to LMIC settings. This article aims to generate consensus-based recommendations for the prevention and screening of cardiometabolic and kidney diseases tailored for implementation in LMICs. We conducted a systematic review of guidelines and recommendations for prevention and screening strategies for cardiometabolic and chronic kidney diseases following HDP. We searched PubMed/Medline, Embase and Cochrane Library for relevant articles and guidelines published from 2010 to 2021 from both high-income countries (HICs) and LMICs. No other filters were applied. References of included articles were also assessed for eligibility. Findings were synthesized narratively. The summary of guiding recommendations was subjected to two rounds of Delphi consensus surveys with experts experienced in LMIC settings. Fifty-four articles and 9 guidelines were identified, of which 25 were included. Thirty-five clinical recommendations were synthesized from these and classified into six domains: identification of women with HDP (4 recommendations), timing of first counseling and provision of health education (2 recommendations), structure and care setting (12 recommendations), information and communication needs (5 recommendations), cardiometabolic biomarkers (8 recommendations) and biomarkers thresholds (4 recommendations). The Delphi panel reached consensus on 33 final recommendations. These recommendations for health workers in LMICs provide practical and scalable approaches for effective screening and prevention of cardiometabolic disease following HDP. Monitoring and evaluation of implementation of these recommendations provide opportunities for reducing the escalating burden of noncommunicable diseases in LMICs.
Topics: Pregnancy; Female; Humans; Hypertension, Pregnancy-Induced; Delphi Technique; Risk Factors; Health Education; Biomarkers
PubMed: 37125389
DOI: 10.5334/gh.1195 -
Health Technology Assessment... Mar 2023Second-stage caesarean sections, of which there are around 34,000 per year in the UK, have greater maternal and perinatal morbidity than those in the first stage. The...
BACKGROUND
Second-stage caesarean sections, of which there are around 34,000 per year in the UK, have greater maternal and perinatal morbidity than those in the first stage. The fetal head is often deeply impacted in the maternal pelvis, and extraction can be difficult. Numerous techniques are reported, but the superiority of one over another is contentious and there is no national guidance.
OBJECTIVE
To determine the feasibility of a randomised trial of different techniques for managing an impacted fetal head during emergency caesarean.
DESIGN
A scoping study with five work packages: (1) national surveys to determine current practice and acceptability of research in this area, and a qualitative study to determine acceptability to women who have experienced a second-stage caesarean; (2) a national prospective observational study to determine incidence and rate of complications; (3) a Delphi survey and consensus meeting on choice of techniques and outcomes for a trial; (4) the design of a trial; and (5) a national survey and qualitative study to determine acceptability of the proposed trial.
SETTING
Secondary care.
PARTICIPANTS
Health-care professionals, pregnant women, women who have had a second-stage caesarean, and parents.
RESULTS
Most (244/279, 87%) health-care professionals believe that a trial in this area would help guide their practice, and 90% (252/279) would be willing to participate in such a trial. Thirty-eight per cent (98/259) of parents reported that they would take part. Women varied in which technique they thought was most acceptable. Our observational study found that impacted head is common (occurring in 16% of second-stage caesareans) and leads to both maternal (41%) and neonatal (3.5%) complications. It is most often treated by an assistant pushing the head up vaginally. We designed a randomised clinical trial comparing the fetal pillow with the vaginal push technique. The vast majority of health-care professionals, 83% of midwives and 88% of obstetricians, would be willing to participate in the trial proposed, and 37% of parents reported that they would take part. Our qualitative study found that most participants thought the trial would be feasible and acceptable.
LIMITATIONS
Our survey is subject to the limitation that, although responses refer to contemporaneous real cases, they are self-reported by the surgeon and collected after the event. Willingness to participate in a hypothetical trial may not translate into recruitment to a real trial.
CONCLUSIONS
We proposed a trial to compare a new device, the fetal pillow, with a long-established procedure, the vaginal push technique. Such a trial would be widely supported by health-care professionals. We recommend that it be powered to test an effect on important short term maternal and baby outcomes which would require 754 participants per group. Despite the well-known difference between intent and action, this would be feasible within the UK.
FUTURE WORK
We recommend a randomised controlled trial of two techniques for managing an impacted fetal head with an in-built internal pilot phase and alongside economic and qualitative substudies.
STUDY REGISTRATION
This study is registered as Research Registry 4942.
FUNDING
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 27, No. 6. See the NIHR Journals Library website for further project information.
Topics: Infant; Infant, Newborn; Humans; Pregnancy; Female; Cesarean Section; Feasibility Studies; Fetus; Qualitative Research; Prenatal Care; Randomized Controlled Trials as Topic; Observational Studies as Topic
PubMed: 37022927
DOI: 10.3310/KUYP6832