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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 -
Sustainability of Biosimilars in Europe: A Delphi Panel Consensus with Systematic Literature Review.Pharmaceuticals (Basel, Switzerland) Nov 2020Biosimilars have the potential to enhance the sustainability of evolving health care systems. A sustainable biosimilars market requires all stakeholders to balance... (Review)
Review
INTRODUCTION
Biosimilars have the potential to enhance the sustainability of evolving health care systems. A sustainable biosimilars market requires all stakeholders to balance competition and supply chain security. However, there is significant variation in the policies for pricing, procurement, and use of biosimilars in the European Union. A modified Delphi process was conducted to achieve expert consensus on biosimilar market sustainability in Europe.
METHODS
The priorities of 11 stakeholders were explored in three stages: a brainstorming stage supported by a systematic literature review (SLR) and key materials identified by the participants; development and review of statements derived during brainstorming; and a facilitated roundtable discussion.
RESULTS
Participants argued that a sustainable biosimilar market must deliver tangible and transparent benefits to the health care system, while meeting the needs of all stakeholders. Key drivers of biosimilar market sustainability included: (i) competition is more effective than regulation; (ii) there should be incentives to ensure industry investment in biosimilar development and innovation; (iii) procurement processes must avoid monopolies and minimize market disruption; and (iv) principles for procurement should be defined by all stakeholders. However, findings from the SLR were limited, with significant gaps on the impact of different tender models on supply risks, savings, and sustainability.
CONCLUSIONS
A sustainable biosimilar market means that all stakeholders benefit from appropriate and reliable access to biological therapies. Failure to care for biosimilar market sustainability may impoverish biosimilar development and offerings, eventually leading to increased cost for health care systems and patients, with fewer resources for innovation.
PubMed: 33213079
DOI: 10.3390/ph13110400 -
JAMA Dermatology Mar 2020Although various treatments have been found in clinical trials to be effective in treating actinic keratosis (AK), researchers often report different outcomes....
IMPORTANCE
Although various treatments have been found in clinical trials to be effective in treating actinic keratosis (AK), researchers often report different outcomes. Heterogeneous outcome reporting precludes the comparison of results across studies and impedes the synthesis of treatment effectiveness in systematic reviews.
OBJECTIVE
To establish an international core outcome set for all clinical studies on AK treatment using systematic literature review and a Delphi consensus process.
EVIDENCE REVIEW
Survey study with a formal consensus process. The keywords actinic keratosis and treatment were searched in PubMed, Embase, CINAHL, and the Cochrane Library to identify English-language studies investigating AK treatments published between January 1, 1980, and July 13, 2015. Physician and patient stakeholders were nominated to participate in Delphi surveys by the Measurement of Priority Outcome Variables in Dermatologic Surgery Steering Committee members. All participants from the first round were invited to participate in the second round. Outcomes reported in randomized controlled clinical trials on AK treatment were rated via web-based e-Delphi consensus surveys. Stakeholders were asked to assess the relative importance of each outcome in 2 Delphi survey rounds. Outcomes were provisionally included, pending the final consensus conference, if at least 70% of patient or physician stakeholders rated the outcome as critically important in 1 or both Delphi rounds and the outcome received a mean score of 7.5 from either stakeholder group. Data analysis was performed from November 5, 2018, to February 27, 2019.
FINDINGS
A total of 516 outcomes were identified by reviewing the literature and surveying key stakeholder groups. After deduplication and combination of similar outcomes, 137 of the 516 outcomes were included in the Delphi surveys. Twenty-one physicians and 12 patients participated in round 1 of the eDelphi survey, with 17 physicians (81%) retained and 12 patients (100%) retained in round 2. Of the 137 candidate outcomes, 9 met a priori Delphi consensus criteria, and 6 were included in the final outcomes set after a consensus meeting: complete clearance of AKs, percentage of AKs cleared, severity of adverse events, patient perspective on effectiveness, patient-reported future treatment preference, and recurrence rate. It was recommended that treatment response be assessed at 2 to 4 months and recurrence at 6 to 12 months, with the AK rate of progression to cutaneous squamous cell carcinoma reported whenever long-term follow-up was possible.
CONCLUSIONS AND RELEVANCE
Consensus was reached regarding a core outcome set for AK trials. Further research may help determine the specific outcome measures used to assess each of these outcomes.
Topics: Aged; Carcinoma, Squamous Cell; Consensus; Delphi Technique; Disease Progression; Female; Humans; Keratosis, Actinic; Male; Middle Aged; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Recurrence; Skin Neoplasms; Surveys and Questionnaires; Time Factors
PubMed: 31939999
DOI: 10.1001/jamadermatol.2019.4212 -
Research in Social & Administrative... Oct 2021Global reforms in the education of health workers has culminated in the implementation of competency-based education and training (CBET). In line with the CBET model,... (Review)
Review
BACKGROUND
Global reforms in the education of health workers has culminated in the implementation of competency-based education and training (CBET). In line with the CBET model, competency frameworks are now commonplace in the health professions. In pharmacy, these frameworks are used to regulate career entry, benchmark standards of practice and facilitate expertise development.
OBJECTIVE
This systematic review assessed the development, validity and applicability to practice of pharmacy-related competency frameworks.
METHOD
PubMed/Medline, CINAHL, Embase, ERIC, Scopus, ProQuest and PsycINFO electronic databases were searched to identify relevant literature. Additional searching included Google Scholar, electronic sources of grey literature, and the Member Organisation websites of the International Pharmaceutical Federation (FIP). The findings of this review were synthesised and reported narratively. The review protocol is registered on PROSPERO with reference number CRD42018096580.
RESULTS
In total, 53 pharmacy-related frameworks were identified. The majority (n = 38, 72%) were from high income countries in Europe and the Western Pacific region, with only three each from countries in South East Asia (SEA) and Africa. The identified frameworks were developed through a variety of methods that included expert group consultation used alone, or in combination with a literature review, job/role evaluation, or needs assessment. Profession wide surveys and consensus via a nominal group, Delphi, or modified Delphi technique were the primary methods used in framework validation. The competencies in the respective frameworks were generally ranked relevant to practice, thereby confirming validity and applicability. However, variations in competency-related terminologies and descriptors were observed. Disparities on perception of relevance also existed in relation to area of practice, length of experience, and level of competence. For example, pharmaceutical care competencies were typically ranked high in relevance in the frameworks, compared to others such as the research-related competencies.
CONCLUSION
The validity and applicability to practice of pharmacy-related frameworks highlights their importance in competency-based education and training (CBET). However, the observed disparities in framework terminologies and development methods suggest the need for harmonisation.
Topics: Health Occupations; Health Personnel; Humans; Pharmaceutical Services; Pharmacies; Pharmacy
PubMed: 33640334
DOI: 10.1016/j.sapharm.2021.02.014 -
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 -
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 -
PLoS Neglected Tropical Diseases Sep 2021Leprosy is a chronic infectious disease caused by Mycobacterium leprae, the annual new case detection in 2019 was 202,189 globally. Measuring endemicity levels and...
BACKGROUND
Leprosy is a chronic infectious disease caused by Mycobacterium leprae, the annual new case detection in 2019 was 202,189 globally. Measuring endemicity levels and burden in leprosy lacks a uniform approach. As a result, the assessment of leprosy endemicity or burden are not comparable over time and across countries and regions. This can make program planning and evaluation difficult. This study aims to identify relevant metrics and methods for measuring and classifying leprosy endemicity and burden at (sub)national level.
METHODS
We used a mixed-method approach combining findings from a systematic literature review and a Delphi survey. The literature search was conducted in seven databases, searching for endemicity, burden and leprosy. We reviewed the available evidence on the usage of indicators, classification levels, and scoring methods to measure and classify endemicity and burden. A two round Delphi survey was conducted to ask experts to rank and weigh indicators, classification levels, and scoring methods.
RESULTS
The literature review showed variation of indicators, levels, and cut-off values to measure leprosy endemicity and/or burden. The most used indicators for endemicity include new case detection rate (NCDR), new cases among children and new cases with grade 2 disability. For burden these include NCDR, MB cases, and prevalence. The classification levels 'high' and 'low' were most important. It was considered most relevant to use separate scoring methods for endemicity and burden. The scores would be derived by use of multiple indicators.
CONCLUSION
There is great variation in the existing method for measuring endemicity and burden across countries and regions. Our findings contribute to establishing a standardized uniform approach to measure and classify leprosy endemicity and burden at (sub)national level, which would allow effective communication and planning of intervention strategies.
Topics: Cost of Illness; Delphi Technique; Endemic Diseases; Global Health; Humans; Leprosy
PubMed: 34543282
DOI: 10.1371/journal.pntd.0009769 -
Journal of Dentistry Mar 2022Oral health is an important component of a person's general health. Studies focusing on this issue need valid and reliable tools to assess oral health. Aim was to...
OBJECTIVES
Oral health is an important component of a person's general health. Studies focusing on this issue need valid and reliable tools to assess oral health. Aim was to develop a comprehensive measure for physical oral health and to establish its measurement properties.
METHODS
The construct physical oral health was defined based on a systematic literature review and a modified Delphi technique in an expert panel (n = 31). The preliminary tool was applied in a multicenter study (n = 609) to gain empirical data on acceptance, item characteristics, reliability, and responsiveness. Validity was assessed as correlation of sores with patients' and experts' global oral health ratings and Oral Health Impact Profile (OHIP) summary score. Based on findings of field testing, the tool was modified to derive the final version of the Physical Oral Health Index (PhOX). Finally, measurement properties of the PhOX were determined.
RESULTS
The PhOX consists of 14 items covering all relevant oral health structures and conditions. For repeated measures, reliability of the summary score was high (ICC = 0.87). The summary score was correlated in the expected direction to patients' (r = 0.43) and examiners' (r = 0.55) global oral health ratings and to OHIP summary scores (r = -0.41). Among patients receiving dental treatments between two assessments, PhOX summary scores increased from baseline to follow-up statistically significantly (p = 0.002).
CONCLUSIONS
The newly developed PhOX is a methodologically sound and easy to apply tool for the comprehensive assessment of physical oral health.
Topics: Humans; Multicenter Studies as Topic; Oral Health; Physical Examination; Quality of Life; Reproducibility of Results; Surveys and Questionnaires
PubMed: 35017019
DOI: 10.1016/j.jdent.2022.103946 -
Journal of the American Academy of... Sep 2022There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical...
BACKGROUND
There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions.
OBJECTIVE
To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials.
METHODS
Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group.
RESULTS
Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome.
LIMITATIONS
English-speaking patients and professionals rated outcomes extracted from English language studies.
CONCLUSION
A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.
Topics: Carcinoma, Basal Cell; Delphi Technique; Humans; Quality of Life; Research Design; Skin Neoplasms; Treatment Outcome
PubMed: 35551965
DOI: 10.1016/j.jaad.2022.04.059 -
JAMA Dermatology Jun 2024Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for...
IMPORTANCE
Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea.
OBJECTIVE
To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice.
EVIDENCE REVIEW
A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set.
FINDINGS
The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting.
CONCLUSIONS AND RELEVANCE
This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.
Topics: Rosacea; Humans; Clinical Trials as Topic; Consensus; Delphi Technique; Outcome Assessment, Health Care; Treatment Outcome
PubMed: 38656294
DOI: 10.1001/jamadermatol.2024.0636