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International Journal of Technology... Jul 2023Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare hematological disease whose clinical management includes caplacizumab along with plasma exchange and...
Effectiveness and safety of caplacizumab in acquired thrombotic thrombocytopenic purpura: health technology assessment and classification according to the methodology established in Colombia.
OBJECTIVES
Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare hematological disease whose clinical management includes caplacizumab along with plasma exchange and immunosuppression, according to international guidelines. Caplacizumab has been available in Colombia since 2022. This study seeks to determine the therapeutic classification of caplacizumab according to the methodology of the Instituto de Evaluación Tecnológica en Salud.
METHODS
The classification was carried out through a deliberative process following the modified Delphi technique, with a panel of experts, made up of four hemato-oncologists, a pharmaceutical chemist, and a patient. The results of effectiveness and safety obtained through a systematic review, therapeutic thresholds (clinical significance), and degree of acceptability (willingness to use the technology) were used for the classification.
RESULTS
Fourteen effectiveness and safety outcomes were submitted for the classification process. Caplacizumab showed clinical significance for some effectiveness outcomes, was not considered inferior in terms of safety, and displayed acceptability of use. Through consensus, the panel determined that caplacizumab plus the standard regimen is superior to the standard regimen in terms of treatment response and composite outcome, and no different for the other effectiveness and safety outcomes. Likewise, in overall terms, the panel determined that caplacizumab together with the standard regimen is superior to the standard regimen.
CONCLUSION
Treatment with caplacizumab together with the standard regimen was considered superior to the standard regimen for the treatment of patients with aTTP, as it showed clinically significant benefits in critical outcomes for decision making, and a safety profile no different to its comparator.
Topics: Humans; Purpura, Thrombotic Thrombocytopenic; Technology Assessment, Biomedical; Colombia
PubMed: 37476982
DOI: 10.1017/S0266462323000442 -
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 -
BJOG : An International Journal of... Jan 2024This study aimed to create core outcome sets (COSs) for use in research studies relating to the awareness and clinical management of reduced fetal movement (RFM).
OBJECTIVE
This study aimed to create core outcome sets (COSs) for use in research studies relating to the awareness and clinical management of reduced fetal movement (RFM).
DESIGN
Delphi survey and consensus process.
SETTING
International.
POPULATION
A total of 128 participants (40 parents, 19 researchers and 65 clinicians) from 16 countries.
METHODS
A systematic literature review was conducted to identify outcomes in studies of interventions relating to the awareness and the clinical management of RFM. Using these outcomes as a preliminary list, stakeholders rated the importance of these outcomes for inclusion in COSs for studies of: (i) awareness of RFM; and (ii) clinical management of RFM.
MAIN OUTCOME MEASURES
Preliminary lists of outcomes were discussed at consensus meetings where two COSs (one for studies of RFM awareness and one for studies of clinical management of RFM).
RESULTS
The first round of the Delphi survey was completed by 128 participants, 66% of whom (n = 84) completed all three rounds. Fifty outcomes identified by the systematic review, after multiple definitions were combined, were voted on in round one. Two outcomes were added in round one, and as such 52 outcomes were voted on in two lists in rounds two and three. The COSs for studies of RFM awareness and clinical management are comprised of eight outcomes (four maternal and four neonatal) and 10 outcomes (two maternal and eight neonatal), respectively.
CONCLUSIONS
These COSs provide researchers with the minimum set of outcomes to be measured and reported in studies relating to the awareness and the clinical management of RFM.
Topics: Infant, Newborn; Humans; Research Design; Fetal Movement; Delphi Technique; Parents; Outcome Assessment, Health Care
PubMed: 37394688
DOI: 10.1111/1471-0528.17589 -
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 -
Transfusion Aug 2023Although pediatric residents frequently order blood products, transfusion medicine (TM) education is both limited and unstandardized during postgraduate training. Using...
BACKGROUND
Although pediatric residents frequently order blood products, transfusion medicine (TM) education is both limited and unstandardized during postgraduate training. Using Delphi methodology, this study aimed to identify and prioritize which pediatric TM curricular topics are most important to inform postgraduate training in TM for general pediatricians and pediatric subspecialists.
METHODS
A national panel of experts iteratively rated potential curricular topics, on a 5-point scale, to determine their priority for inclusion within a TM curriculum. After each round, responses were analyzed. Topics receiving a mean rating <3/5 were removed from subsequent rounds and remaining topics were resent to the panel for further ratings until consensus was achieved, defined as Cronbach α ≥ 0.95. At conclusion of the Delphi process, topics rated ≥4/5 were considered core curricular topics, while topics rated ≥3 to <4 were considered extended topics.
RESULTS
Forty-five TM experts from 17 Canadian institutions and 12 subspecialties completed the first Delphi round and 31 completed the second. Fifty-seven potential curricular topics were generated from a systematic literature review and Delphi panelists. Two survey rounds were completed before consensus was achieved. Seventy-three topics in six domains reached consensus: 31 core curricular topics and 42 extended topics. There were no significant differences in ratings between TM and non-TM specialists.
DISCUSSION
A multispecialty Delphi panel reached consensus in identification of curricular topics for pediatric resident physicians. These results set the stage to develop a pediatric TM curriculum that will be foundational for pediatric trainees to enhance learning and improve transfusion safety.
Topics: Humans; Child; Delphi Technique; Transfusion Medicine; Canada; Medicine; Internship and Residency; Curriculum; Clinical Competence
PubMed: 37309566
DOI: 10.1111/trf.17453 -
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 -
European Urology Oct 2023In contrast to other cancers, the concept of oligometastatic disease (OMD) has not been investigated in bladder cancer (BC).
Definition and Diagnosis of Oligometastatic Bladder Cancer: A Delphi Consensus Study Endorsed by the European Association of Urology, European Society for Radiotherapy and Oncology, and European Society of Medical Oncology Genitourinary Faculty.
BACKGROUND
In contrast to other cancers, the concept of oligometastatic disease (OMD) has not been investigated in bladder cancer (BC).
OBJECTIVE
To develop an acceptable definition, classification, and staging recommendations for oligometastatic BC (OMBC) spanning the issues of patient selection and the roles of systemic therapy and ablative local therapy.
DESIGN, SETTING, AND PARTICIPANTS
A European consensus group of 29 experts, led by the European Association of Urology (EAU), the European Society for Radiotherapy and Oncology (ESTRO), and the European Society of Medical Oncology (ESMO), and including members from all other relevant European societies, was established.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
A modified Delphi method was used. A systematic review was used to build consensus questions. Consensus statements were extracted from two consecutive surveys. The statements were formulated during two consensus meetings. Agreement levels were measured to determine if consensus was achieved (≥75% agreement).
RESULTS AND LIMITATIONS
The first survey included 14 questions and the second survey had 12. Owing to a considerable lack of evidence, which was the major limitation, definition was limited in the context of de novo OMBC, which was further classified as synchronous OMD, oligorecurrence, and oligoprogression. A maximum of three metastatic sites, all resectable or amenable to stereotactic therapy, was proposed as the definition of OMBC. Pelvic lymph nodes represented the only "organ" not included in the definition of OMBC. For staging, no consensus on the role of F-fluorodeoxyglucose positron emission tomography/computed tomography was reached. A favourable response to systemic treatment was proposed as the criterion for selection of patients for metastasis-directed therapy.
CONCLUSIONS
A consensus statement on the definition and staging of OMBC has been formulated. This statement will help to standardise inclusion criteria in future trials, potentiate research on aspects of OMBC for which consensus was not achieved, and hopefully will lead to the development of guidelines on optimal management of OMBC.
PATIENT SUMMARY
As an intermediate state between localised cancer and disease with extensive metastasis, oligometastatic bladder cancer (OMBC) might benefit from a combination of systemic treatment and local therapy. We report the first consensus statements on OMBC drawn up by an international expert group. These statements can provide a basis for standardisation of future research, which will lead to high-quality evidence in the field.
Topics: Humans; Delphi Technique; Urology; Urinary Bladder Neoplasms; Medical Oncology; Faculty
PubMed: 37217391
DOI: 10.1016/j.eururo.2023.05.005 -
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 -
The American Journal of Medicine Aug 2023Perioperative medicine is a rapidly growing multidisciplinary field with significant advances published each year. In this review, we highlight important perioperative... (Review)
Review
Perioperative medicine is a rapidly growing multidisciplinary field with significant advances published each year. In this review, we highlight important perioperative publications in 2022. A multi-database literature search from January to December of 2022 was undertaken. Original research articles, systematic reviews, meta-analyses, and guidelines were included. Abstracts, case reports, letters, protocols, pediatric and obstetric articles, and cardiac surgery literature were excluded. Two authors reviewed each reference using the Distiller SR systematic review software (Evidence Partners Inc., Ottawa, Ont, Canada). A modified Delphi technique was used to identify 8 practice-changing articles. We identified another 10 articles for tabular summaries. We highlight why these articles have the potential to change clinical perioperative practice and areas where more information is needed.
Topics: Pregnancy; Female; Humans; Child; Perioperative Medicine; Cardiac Surgical Procedures; Canada
PubMed: 37148994
DOI: 10.1016/j.amjmed.2023.04.021