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British Journal of Anaesthesia Nov 2019Patient-centred outcomes are increasingly used in perioperative clinical trials. The Standardised Endpoints in Perioperative Medicine (StEP) initiative aims to define...
BACKGROUND
Patient-centred outcomes are increasingly used in perioperative clinical trials. The Standardised Endpoints in Perioperative Medicine (StEP) initiative aims to define which measures should be used in future research to facilitate comparison between studies and to enable robust evidence synthesis.
METHODS
A systematic review was conducted to create a longlist of patient satisfaction, health-related quality of life, functional status, patient well-being, and life-impact measures for consideration. A three-stage Delphi consensus process involving 89 international experts was then conducted in order to refine this list into a set of recommendations.
RESULTS
The literature review yielded six patient-satisfaction measures, seven generic health-related quality-of-life measures, eight patient well-being measures, five functional-status measures, and five life-impact measures for consideration. The Delphi response rates were 92%, 87%, and 100% for Rounds 1, 2, and 3, respectively. Three additional measures were added during the Delphi process as a result of contributions from the StEP group members. Firm recommendations have been made about one health-related quality-of-life measure (EuroQol 5 Dimension, five-level version with visual analogue scale), one functional-status measure (WHO Disability Assessment Schedule version 2.0, 12-question version), and one life-impact measure (days alive and out of hospital at 30 days after surgery). Recommendations with caveats have been made about the Bauer patient-satisfaction measure and two life-impact measures (days alive and out of hospital at 1 yr after surgery, and discharge destination).
CONCLUSIONS
Several patient-centred outcome measures have been recommended for use in future perioperative studies. We suggest that every clinical study should consider using at least one patient-centred outcome within a suite of endpoints.
Topics: Activities of Daily Living; Delphi Technique; Endpoint Determination; Humans; Patient Outcome Assessment; Patient Satisfaction; Perioperative Care; Psychometrics; Quality of Life; Surgical Procedures, Operative
PubMed: 31493848
DOI: 10.1016/j.bja.2019.07.020 -
The American Journal of Medicine Nov 2022Recent literature published in a variety of multidisciplinary journals has significantly influenced perioperative patient care. Distilling and synthesizing the... (Review)
Review
Recent literature published in a variety of multidisciplinary journals has significantly influenced perioperative patient care. Distilling and synthesizing the clinically important literature can be challenging. This review summarizes practice-changing articles in perioperative medicine from the years 2020 and 2021. Embase, Ovid, and EBM reviews databases were queried from January 2020 to December 2021. Inclusion criteria were original research, systematic review, meta-analysis, and important guidelines. Exclusion criteria were conference abstracts, case reports, letters, protocols, pediatric and obstetric articles, and cardiac surgery literature. 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 9 practice-changing articles. We identified another 13 articles for tabular summaries, as they were relevant to an internist's perioperative evaluation of a patient. Articles were selected to highlight the clinical implications of new evidence in each field. We have also pointed out limitations of each study and clinical populations where they are not applicable.
Topics: Child; Female; Humans; Pregnancy; Canada; Cardiac Surgical Procedures; Perioperative Care; Perioperative Medicine
PubMed: 35820457
DOI: 10.1016/j.amjmed.2022.06.003 -
Pediatric Research Mar 2022The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice...
BACKGROUND
The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents.
METHODS
A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the included studies, the described outcomes were extracted in accordance with the provisions of the Core Outcome Measures in Effectiveness Trials (COMET) handbook and registered.
RESULTS
Among 884 abstracts identified, 90 randomised controlled trials (RCTs) were included in this review. Only 30 manuscripts explicitly stated the primary and/or secondary outcomes. A total of 88 distinct outcomes were recorded across all 90 studies included. These were then assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The most frequently reported outcome was survival with 74% (n = 67) of the studies reporting an outcome within this domain.
CONCLUSIONS
This systematic review constitutes one of the initial phases in the protocol for developing a COS in neonatal sepsis. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation.
IMPACT
This systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis. The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely. The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders.
Topics: Delphi Technique; Humans; Infant, Newborn; Neonatal Sepsis; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome
PubMed: 34997225
DOI: 10.1038/s41390-021-01883-y -
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 -
Ultrasound in Obstetrics & Gynecology :... Apr 2023To determine, by expert consensus through a modified Delphi process, the role of standardized and new ultrasound signs in the prenatal evaluation of patients at high...
OBJECTIVE
To determine, by expert consensus through a modified Delphi process, the role of standardized and new ultrasound signs in the prenatal evaluation of patients at high risk of placenta accreta spectrum (PAS).
METHODS
A systematic review of articles providing information on ultrasound imaging signs or markers associated with PAS was performed before the development of questionnaires for the first round of the Delphi process. Only peer-reviewed original research studies in the English language describing one or more new ultrasound sign(s) for the prenatal evaluation of PAS were included. A three-round consensus-building Delphi method was then conducted under the guidance of a steering group, which included nine experts who invited an international panel of experts in obstetric ultrasound imaging in the evaluation of patients at high risk for PAS. Consensus was defined as agreement of ≥ 70% between participants.
RESULTS
The systematic review identified 15 articles describing eight new ultrasound signs for the prenatal evaluation of PAS. A total of 35 external experts were approached, of whom 31 agreed and participated in the first round. Thirty external experts (97%) and seven experts from the steering group completed all three Delphi rounds. A consensus was reached that a prior history of at least one Cesarean delivery, myomectomy or PAS should be an indication for detailed PAS ultrasound assessment. The panelists also reached a consensus that seven of the 11 conventional signs of PAS should be included in the examination of high-risk patients and the routine mid-gestation scan report: (1) loss of the 'clear zone', (2) myometrial thinning, (3) bladder-wall interruption, (4) placental bulge, (5) uterovesical hypervascularity, (6) placental lacunae and (7) bridging vessels. A consensus was not reached for any of the eight new signs identified by the systematic review. With respect to other ultrasound features that are not specific to PAS but increase the probability of PAS at birth, the panelists reached a consensus for the finding of anterior placenta previa or placenta previa with cervical involvement. The experts were also asked to determine which PAS signs should be quantified and consensus was reached only for the quantification of placental lacunae using an existing score. For predicting surgical outcome in patients with a high probability of PAS at delivery, a consensus was obtained for loss of the clear zone, bladder-wall interruption, presence of placental lacunae and presence of placenta previa involving the cervix.
CONCLUSIONS
We have confirmed the continued importance of seven established standardized ultrasound signs of PAS, highlighted the role of transvaginal ultrasound in evaluating the placental position and anatomy of the cervix, and identified new ultrasound signs that may become useful in the future prenatal evaluation and management of patients at high risk for PAS at birth. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Placenta Accreta; Placenta; Placenta Previa; Delphi Technique; Ultrasonography; Ultrasonography, Prenatal; Retrospective Studies
PubMed: 36609827
DOI: 10.1002/uog.26155 -
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 -
Nursing Open Jul 2022To develop an assessment tool to assess the severity and healing of skin impairment with the central venous access device.
AIM
To develop an assessment tool to assess the severity and healing of skin impairment with the central venous access device.
DESIGN
Delphi technique.
METHODS
The instrument domain list was developed through a systematic literature review and semi-structured interviews. Experts from China evaluated the relevance and significance of these items in assessing the degree of skin impairment surrounding central venous access device sites through two Delphi rounds. The APA Style JARS checklist for this article was used.
RESULTS
For the systematic literature review, 28 articles were included to develop the wound assessment instrument. From the articles and interview contents, 15 criteria were selected based on reporting frequency. After further screening via in-depth discussion, the central venous access devices associated with the skin impairment assessment tool were refined to include 14 major domains. Through a two-phase Delphi process, 71 items in 12 domains were ultimately retained.
Topics: Checklist; Mass Screening; Physical Examination; Skin Care; Wound Healing
PubMed: 35502576
DOI: 10.1002/nop2.1220 -
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 -
The Journal of Maternal-fetal &... Feb 2022Neonatal abstinence syndrome (NAS) is a combination of symptoms in infants exposed to any variety of substances in utero. Information systems and registries help to...
OBJECTIVES
Neonatal abstinence syndrome (NAS) is a combination of symptoms in infants exposed to any variety of substances in utero. Information systems and registries help to collect information about these patients; however, there is always a deep gap between complete and accurate information to be collected, understood, and applied in the health care system; thus, defining a minimum data sets (MDS) as one of the primarily steps of designing a registry system is essential. The aim of this study was to develop an MDS of the registry for infants with NAS in Iran.
METHODS
This research is a descriptive cross-sectional study. In this study, three steps were carried out to develop the MDS including systematic review, Delphi technique, and focus group discussion. A systematic review was conducted in relevant databases to identify appropriate related data. In the second phase, a focus group discussion was used to classify the extracted data elements by contributing neonatologists. Finally, data elements were chosen through the decision Delphi technique in two distinct rounds. Collected data were analyzed using SPSS 22 (SPSS Inc., Chicago, IL).
RESULTS
By reviewing related papers and available NAS registries in other countries, 145 essential data elements were identified. They were classified into two main categories based on the eight experts' opinions including maternal with two sections and infant with two sections. After applying two rounds of Delphi technique, the final data elements for maternal and infant categories were 42 and 31, respectively. Thus, on completion of the survey, 73 data elements were approved.
CONCLUSION
The proposed MDS for NAS can help to store an accurate and comprehensive data, document medical records, integrate them with other information systems and registries, and communicate with other healthcare providers and healthcare centers. This MDS can contribute to the provision of high-quality care and better clinical decisions.
Topics: Cross-Sectional Studies; Delphi Technique; Focus Groups; Humans; Infant; Infant, Newborn; Neonatal Abstinence Syndrome; Plant Extracts; Surveys and Questionnaires
PubMed: 33047642
DOI: 10.1080/14767058.2020.1730319 -
Journal of Affective Disorders Apr 2020Currently, no specific, systematic assessment tool for the monitoring and reporting of ketamine-related side effects exists. Our aim was to develop a comprehensive...
BACKGROUND
Currently, no specific, systematic assessment tool for the monitoring and reporting of ketamine-related side effects exists. Our aim was to develop a comprehensive Ketamine Side Effect Tool (KSET) to capture acute and longer-term side effects associated with repeated ketamine treatments.
METHODS
Informed by systematic review data and clinical research, we drafted a list of the most commonly reported side effects. Face and content validation were obtained via feedback from collaborators with expertise in psychiatry and anaesthetics, clinical trial piloting and a modified Delphi Technique involving ten international experts.
RESULTS
The final version consisted of four forms that collect information at time points: screening, baseline, immediately after a single treatment, and longer-term follow-up. Instructions were developed to guide users and promote consistent utilisation.
LIMITATIONS
Further evaluation of feasibility, construct validity and reliability is required, and is planned across multiple international sites.
CONCLUSIONS
The structured Ketamine Side Effect Tool (KSET) was developed, with confirmation of content and face validity via a Delphi consensus process. This tool is timely, given the paucity of data regarding ketamine's safety, tolerability and abuse potential over the longer term, and its recent adoption internationally as a clinical treatment for depression. Although based on data from depression studies, the KSET has potential applicability for ketamine (or derivatives) used in other medical disorders, including chronic pain. We recommend its utilisation for both research and clinical scenarios, including data registries.
Topics: Chronic Pain; Drug-Related Side Effects and Adverse Reactions; Humans; Ketamine; Reproducibility of Results
PubMed: 32056935
DOI: 10.1016/j.jad.2020.01.120