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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 -
BMC Psychology Oct 2023A growing body of evidence suggests that improving the mental wellness of adolescents living with HIV (ALHIV) will also result in improved adherence to antiretroviral...
A growing body of evidence suggests that improving the mental wellness of adolescents living with HIV (ALHIV) will also result in improved adherence to antiretroviral therapy (ART), as well as improving their general health and wellbeing as they age into adulthood. However, to develop effective strategies and interventions aimed at improving mental wellness, we require age and culturally appropriate instruments to build an evidence base. Currently, there is a lack of mental wellness measures developed for ALHIV, especially in the African context. To address this gap, we developed a measure of mental wellness following modified guidelines set out by DeVellis [1] and Godfred et al. as a guiding framework [2]; (1) Identifying the gap, (2) Set the theoretical foundations and identify domains and (3); Instrument development and initial validation. For the first two steps, we conducted a systematic review, photovoice study and integrative review - which we briefly describe as the findings have been published. Following this we describe the processes to develop the instrument and to establish content validity through a modified Delphi Study. Through this process we were able to refine the instrument which will be subject to further testing.Implications and Contribution: This study aims to add to the body of knowledge on promoting mental health (mental wellness) among adolescents living with HIV in South Africa through developing an appropriate and valid measure of mental wellness for this population. This study reports on the results of a Delphi Study aimed at improving the content validity of the instrument Mental Wellness Measure for Adolescents Living with HIV (MWM-ALHIV).
Topics: Humans; Adolescent; Mental Health; Delphi Technique; HIV Infections; Medication Adherence; South Africa
PubMed: 37849013
DOI: 10.1186/s40359-023-01350-9 -
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 -
Sleep Health Dec 2023To develop and present consensus findings of the National Sleep Foundation sleep timing and variability panel regarding the impact of sleep timing variability on health...
OBJECTIVE
To develop and present consensus findings of the National Sleep Foundation sleep timing and variability panel regarding the impact of sleep timing variability on health and performance.
METHODS
The National Sleep Foundation assembled a panel of sleep and circadian experts to evaluate the scientific evidence and conduct a formal consensus and voting procedure. A systematic literature review was conducted using the NIH National Library of Medicine PubMed database, and panelists voted on the appropriateness of 3 questions using a modified Delphi RAND/UCLA Appropriateness Method with 2 rounds of voting.
RESULTS
The literature search and panel review identified 63 full text publications to inform consensus voting. Panelists achieved consensus on each question: (1) is daily regularity in sleep timing important for (a) health or (b) performance? and (2) when sleep is of insufficient duration during the week (or work days), is catch-up sleep on weekends (or non-work days) important for health? Based on the evidence currently available, panelists agreed to an affirmative response to all 3 questions.
CONCLUSIONS
Consistency of sleep onset and offset timing is important for health, safety, and performance. Nonetheless, when insufficient sleep is obtained during the week/work days, weekend/non-work day catch-up sleep may be beneficial.
Topics: Humans; Sleep; Sleep Deprivation; Consensus; Delphi Technique
PubMed: 37684151
DOI: 10.1016/j.sleh.2023.07.016 -
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 -
Nursing in Critical Care Nov 2023Trauma is the most common cause of death and disability in the paediatric population. There are a huge number of variables involved in the care they receive from health... (Review)
Review
BACKGROUND
Trauma is the most common cause of death and disability in the paediatric population. There are a huge number of variables involved in the care they receive from health care professionals.
AIM
The aim of this study was to review the available evidence of initial paediatric trauma care throughout the health care process with a view to create quality indicators (QIs).
STUDY DESIGN
A systematic review was performed from Cochrane Library, Medline, Scopus and SciELO between 2010 and 2020. Studies and guidelines that examined quality or suggested QI were included. Indicators were classified by health care setting, Donabedian's model, risk of bias and the quality of the publication with the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) assessment.
RESULTS
The initial search included 686 articles, which were reduced to 22, with 15 primary and 7 secondary research articles. The snowball sampling technique was used to add a further seven guidelines and two articles. From these, 534 possible indicators were extracted, summarizing them into 39 and grouping the prehospital care indicators as structure (N = 5), process (N = 12) and outcome (N = 3) indicators and the hospital care indicators as structure (N = 4), process (N = 10) and outcome (N = 6) indicators. Most of the QIs have been extracted from US studies. They are multidisciplinary and in some cases are based on an adaptation of the QIs of adult trauma care.
CONCLUSIONS
There was a clear gap and large variability between the indicators, as well as low-quality evidence. Future studies will validate indicators using the Delphi method.
RELEVANCE TO CLINICAL PRACTICE
Design a QI framework that may be used by the health system throughout the process. Indicators framework will get nurses, to assess the quality of health care, detect deficient areas and implement improvement measures.
Topics: Adult; Humans; Child; Quality Indicators, Health Care; Delivery of Health Care; Intensive Care Units, Pediatric; Emergency Medical Services
PubMed: 37621180
DOI: 10.1111/nicc.12970 -
Inflammatory Bowel Diseases Jun 2024The concept of disease clearance has been proposed as a potential target in ulcerative colitis (UC). We conducted a systematic review to investigate the role of disease...
The concept of disease clearance has been proposed as a potential target in ulcerative colitis (UC). We conducted a systematic review to investigate the role of disease clearance, defined as a composite outcome including simultaneous clinical, endoscopic, and histologic remission of disease in the management of patients with UC. Based on the literature data, statements regarding disease clearance were developed and voted on by the members of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) according to a Delphi methodology. A definition of disease clearance was proposed to standardize its use in clinical practice and clinical trials and to provide practical recommendations for its implementation as a therapeutic target in UC.
Topics: Colitis, Ulcerative; Humans; Consensus; Remission Induction; Delphi Technique; Severity of Illness Index; Treatment Outcome
PubMed: 37549104
DOI: 10.1093/ibd/izad159 -
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 -
American Journal of Otolaryngology 2023A systematic review of the evidence on the success of Drug-Induced Sleep Endoscopy (DISE) directed surgery in children with obstructive sleep apnea (OSA) defined as cure...
OBJECTIVE
A systematic review of the evidence on the success of Drug-Induced Sleep Endoscopy (DISE) directed surgery in children with obstructive sleep apnea (OSA) defined as cure rate.
DATA SOURCES
The PRISMA guidelines were followed and three databases (PubMed, Embase and Cochrane Library) were searched for studies on DISE directed surgery in children.
ENDPOINTS
Pre- and post-surgical change in polysomnography (PSG); change in surgical target; side effects.
REVIEW METHODS
Study quality was assessed using the modified Delphi technique quality appraisal tool for case series. Risk of bias was assessed using the Cochrane Collaboration's tool for assessing risk of bias.
RESULTS
A total of 1805 studies were found. The most important reasons for exclusion were as follows: none-DISE studies, reports on adults, conflation of results on syndromic and healthy patients, no relevant outcome measurements. Five studies with a total of 376 patients (range: 26-126) were included. The surgeons changed the planned strategy in 50.4 % of patients according to the DISE findings. Comparison of pre- and post-surgical sleep monitoring revealed an average decrease in apnea-hypopnea index (AHI) of 11.1 and a treatment success (AHI < 5) and cure (AHI < 2) of 78 % and 53 %, respectively. The quality of the included studies was moderate especially due to small populations, designs without randomization or control groups, lack of analysis of drop outs, short follow-up, and considerable level of bias.
CONCLUSION
DISE directed surgery has been shown to change the surgical approach when treating children with OSA. If this can be transferred into a better outcome compared to standard surgical treatment is unknown, due to the current poor level of evidence. To decide whether or not DISE should be included in the treatment of children with OSA, we suggest further data, preferably an RCT, to increase the level of evidence.
Topics: Adult; Humans; Child; Sleep Apnea, Obstructive; Sleep; Endoscopy; Polysomnography; Tonsillectomy
PubMed: 37480683
DOI: 10.1016/j.amjoto.2023.103992