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Journal of Perinatology : Official... Feb 2016This article reports the recommendations for managing neonatal tuberculosis (TB) drawn up by a group of Italian scientific societies. The Consensus Conference method was... (Review)
Review
This article reports the recommendations for managing neonatal tuberculosis (TB) drawn up by a group of Italian scientific societies. The Consensus Conference method was used, and relevant publications in English were identified through a systematic review of MEDLINE and the Cochrane Database of Systematic Reviews from their inception until 31 December 2014. Group experts concluded that if suspicion is aroused, it is necessary to undertake promptly all of the investigations useful for identifying the disease not only in the newborn, but also in the mother and family contacts because a diagnosis of TB in the family nucleus can guide its diagnosis and treatment in the newborn. If the suspicion is confirmed, empirical treatment should be started. Breast-fed newborns being treated with isoniazid should be given pyridoxine supplementation at a dose of 1 mg kg(-1) day(-1). Mothers with active-phase TB can breast-feed once they have become smear negative after having received appropriate treatment.
Topics: Antitubercular Agents; Breast Feeding; Delphi Technique; Disease Management; Humans; Infant, Newborn; Practice Guidelines as Topic; Tuberculosis
PubMed: 26270256
DOI: 10.1038/jp.2015.99 -
Otolaryngology--head and Neck Surgery :... Mar 2015A systematic review and meta-analysis of the evidence on balloon Eustachian tuboplasty (BET) as a treatment modality for Eustachian tube dysfunction (ETD). We followed... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
A systematic review and meta-analysis of the evidence on balloon Eustachian tuboplasty (BET) as a treatment modality for Eustachian tube dysfunction (ETD). We followed the PRISMA guideline and registered with PROSPERO No. CRD42014009461.
DATA SOURCES
We searched 12 databases including PubMed and Embase from January 1, 2010, to April 7, 2014, for studies of BET.
ENDPOINTS
change in symptoms, middle ear pathology, eardrum status, Eustachian tube function tests, hearing, adverse events, complications, and health-related quality of life.
REVIEW METHODS
Study quality was assessed using the modified Delphi technique quality appraisal tool for case series studies. Risk of bias was assessed using the Cochrane Collaboration's tool for assessing risk of bias.
RESULTS
Nine case series studies with 443 patients (642 tubes) were included. Population size n=4 (7 tubes) to n=210 (320 tubes). All studies were of poor quality and featured a high risk of bias. We found reduction of patient symptoms in ETD questionnaire (P<.001), postoperative normalization of the tympanic membrane, conversion of type B or type C into type A tympanograms, reduced mucosal inflammation, increased number of positive Valsalva test and Swallowing tests, improvement in Eustachian tube score, reduction in Sino-Nasal Outcome Test (SNOT)-22 score (P=.001), and increased quality of life (P=.001). No serious adverse events were found.
CONCLUSION
The evidence of BET is poor and biased. No firm conclusions can be made to identify patients who will benefit from the procedure or to accurately predict surgical results. Randomized controlled trials or case-control trials are needed.
Topics: Ear Diseases; Eustachian Tube; Humans; Middle Ear Ventilation
PubMed: 25605694
DOI: 10.1177/0194599814567105 -
Epilepsia Nov 2016Quality and safety in epilepsy monitoring units (EMUs) are of great importance because patients' seizures are induced rather than prevented in this hospital setting.... (Review)
Review
OBJECTIVE
Quality and safety in epilepsy monitoring units (EMUs) are of great importance because patients' seizures are induced rather than prevented in this hospital setting. However, the measurement and evaluation of quality and safety in EMUs are heterogeneous, as are practices and processes of care. To improve the measurement of quality and safety in EMUs, we sought to develop evidence-based and consensus-driven quality indicators, adhering to previously described methodologic standards.
METHODS
Candidate quality indicators were identified using a recent systematic review on quality and safety indicators in EMUs. These were supplemented by expert opinion to identify other indicators that had not been reported previously. The candidate quality indicators were then evaluated using a modified Delphi technique among a multidisciplinary EMU quality improvement team. Candidate indicators identified as important and feasible through the Delphi technique were then developed into quality metrics.
RESULTS
Thirty-four candidate indicators were abstracted from 135 studies included in the earlier systematic review, and two additional candidate indicators were suggested through consensus from experts. Consensus was reached after two modified Delphi rounds for 25 quality indicators identified as important. These 25 indicators were then developed into quality metrics using a standardized data collection form and were deployed in an online database for systematic data capture and further analyses.
SIGNIFICANCE
These quality indicators have the potential to improve the reporting of quality and safety in EMUs through standardized measurement and evaluation of the quality and safety of care. The ultimate goal is improved patient care and clinical outcomes through safer and better care for people with epilepsy in the EMU.
Topics: Adult; Aged; Aged, 80 and over; Consensus; Delphi Technique; Electroencephalography; Epilepsy; Humans; Middle Aged; Monitoring, Physiologic
PubMed: 27723937
DOI: 10.1111/epi.13563 -
Medicina Clinica Dec 2017To develop recommendations on the use of immunodepressors in patients with non-infectious, non-neoplastic anterior uveitis (AU) based on best evidence and experience.
BACKGROUND AND OBJECTIVE
To develop recommendations on the use of immunodepressors in patients with non-infectious, non-neoplastic anterior uveitis (AU) based on best evidence and experience.
MATERIAL AND METHODS
A multidisciplinary panel of five experts was established, who, in the first nominal group meeting defined the scope, users, and chapters of the document. A systematic literature review was performed to assess the efficacy and safety of immunosuppressors in patients with non-infectious, non-neoplastic AU. All the above was discussed in a second nominal group meeting and 33 recommendations were generated. Through the Delphi methodology, the degree of agreement with the recommendations was tested also by 25 more experts. Recommendations were voted on from one (total disagreement) to 10 (total agreement). We defined agreement if at least 70% voted ≥7. The level of evidence and degree of recommendation was assessed using the Oxford Centre for Evidence-based Medicine's Levels of Evidence.
RESULTS
The 33 recommendations were accepted. They include specific recommendations on patients with non-infectious, non-neoplastic AU, as well as different treatment lines.
CONCLUSIONS
In patients with non-infectious, non-neoplastic AU, these recommendations on the use of immunosuppressors might be a guide in order to help in the treatment decision making, due to the lack of robust evidence or other globally accepted algorithms.
Topics: Clinical Decision-Making; Delphi Technique; Drug Administration Schedule; Humans; Immunosuppressive Agents; Uveitis, Anterior
PubMed: 28911893
DOI: 10.1016/j.medcli.2017.06.059 -
BMJ (Clinical Research Ed.) Mar 2017Implementation studies are often poorly reported and indexed, reducing their potential to inform initiatives to improve healthcare services. The Standards for Reporting...
Implementation studies are often poorly reported and indexed, reducing their potential to inform initiatives to improve healthcare services. The Standards for Reporting Implementation Studies (StaRI) initiative aimed to develop guidelines for transparent and accurate reporting of implementation studies. Informed by the findings of a systematic review and a consensus-building e-Delphi exercise, an international working group of implementation science experts discussed and agreed the StaRI Checklist comprising 27 items. It prompts researchers to describe both the implementation strategy (techniques used to promote implementation of an underused evidence-based intervention) and the effectiveness of the intervention that was being implemented. An accompanying Explanation and Elaboration document (published in , doi:10.1136/bmjopen-2016-013318) details each of the items, explains the rationale, and provides examples of good reporting practice. Adoption of StaRI will improve the reporting of implementation studies, potentially facilitating translation of research into practice and improving the health of individuals and populations.
Topics: Biomedical Research; Delphi Technique; Health Plan Implementation; Humans
PubMed: 28264797
DOI: 10.1136/bmj.i6795 -
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 -
Addiction (Abingdon, England) May 2023Substance use disorders (SUD) are associated with cognitive deficits that are not always addressed in current treatments, and this hampers recovery. Cognitive training...
AIMS
Substance use disorders (SUD) are associated with cognitive deficits that are not always addressed in current treatments, and this hampers recovery. Cognitive training and remediation interventions are well suited to fill the gap for managing cognitive deficits in SUD. We aimed to reach consensus on recommendations for developing and applying these interventions.
DESIGN, SETTING AND PARTICIPANTS
We used a Delphi approach with two sequential phases: survey development and iterative surveying of experts. This was an on-line study. During survey development, we engaged a group of 15 experts from a working group of the International Society of Addiction Medicine (Steering Committee). During the surveying process, we engaged a larger pool of experts (n = 54) identified via recommendations from the Steering Committee and a systematic review.
MEASUREMENTS
Survey with 67 items covering four key areas of intervention development: targets, intervention approaches, active ingredients and modes of delivery.
FINDINGS
Across two iterative rounds (98% retention rate), the experts reached a consensus on 50 items including: (i) implicit biases, positive affect, arousal, executive functions and social processing as key targets of interventions; (ii) cognitive bias modification, contingency management, emotion regulation training and cognitive remediation as preferred approaches; (iii) practice, feedback, difficulty-titration, bias modification, goal-setting, strategy learning and meta-awareness as active ingredients; and (iv) both addiction treatment work-force and specialized neuropsychologists facilitating delivery, together with novel digital-based delivery modalities.
CONCLUSIONS
Expert recommendations on cognitive training and remediation for substance use disorders highlight the relevance of targeting implicit biases, reward, emotion regulation and higher-order cognitive skills via well-validated intervention approaches qualified with mechanistic techniques and flexible delivery options.
Topics: Humans; Delphi Technique; Cognitive Training; Substance-Related Disorders; Behavior, Addictive; Consensus
PubMed: 36508168
DOI: 10.1111/add.16109 -
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 -
British Journal of Anaesthesia Apr 2023Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome...
BACKGROUND
Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome domains. Definitions of these measures are highly variable, and validity is often unclear. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid measures of mortality, morbidity, and organ failure for use in perioperative clinical trials.
METHODS
Three domains of endpoints (mortality, morbidity, and organ failure) were explored through systematic literature review and a three-stage Delphi consensus process using methods consistently applied across the StEP initiative. Reliability, feasibility, and patient-centredness were assessed in round 3 of the consensus process.
RESULTS
A high level of consensus was achieved for two mortality time points, 30-day and 1-yr mortality, and these two measures are recommended. No organ failure endpoints achieved threshold criteria for consensus recommendation. The Clavien-Dindo classification of complications achieved threshold criteria for consensus in round 2 of the Delphi process but did not achieve the threshold criteria in round 3 where it scored equivalently to the Post Operative Morbidity Survey. Clavien-Dindo therefore received conditional endorsement as the most widely used measure. No composite measures of organ failure achieved an acceptable level of consensus.
CONCLUSIONS
Both 30-day and 1-yr mortality measures are recommended. No measure is recommended for organ failure. One measure (Clavien-Dindo) is conditionally endorsed for postoperative morbidity, but our findings suggest that no single endpoint offers a reliable and valid measure to describe perioperative morbidity that is not dependent on the quality of deli-vered care. Further refinement of current measures, or development of novel measures, of postoperative morbidity might improve consensus in this area.
Topics: Humans; Perioperative Care; Consensus; Reproducibility of Results; Perioperative Medicine; Morbidity; Delphi Technique
PubMed: 36697275
DOI: 10.1016/j.bja.2022.12.012 -
RMD Open Mar 2023To develop evidence-based points to consider for cost-effective use of biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in the... (Review)
Review
Points to consider for cost-effective use of biological and targeted synthetic DMARDs in inflammatory rheumatic diseases: results from an umbrella review and international Delphi study.
OBJECTIVES
To develop evidence-based points to consider for cost-effective use of biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in the treatment of inflammatory rheumatic diseases, specifically rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis.
METHODS
Following EULAR procedures, an international task force was formed, consisting of 13 experts in rheumatology, epidemiology and pharmacology from seven European countries. Twelve strategies for cost-effective use of b/tsDMARDs were identified through individual and group discussion. For each strategy, PubMed and Embase were systematically searched for relevant English-language systematic reviews and, for six strategies, additionally for randomised controlled trials (RCTs). Thirty systematic reviews and 21 RCTs were included. Based on the evidence, a set of overarching principles and points to consider was formulated by the task force using a Delphi procedure. Level of evidence (1a-5) and grade (A-D) were determined for each point to consider. Individual voting on the level of agreement (LoA; between 0 (completely disagree) and 10 (completely agree)) was performed anonymously.
RESULTS
The task force agreed on five overarching principles. For 10 of 12 strategies, the evidence was sufficient to formulate one or more points to consider, leading to 20 in total, regarding response prediction, drug formulary use, biosimilars, loading doses, low-dose initial therapy, concomitant conventional synthetic DMARD use, route of administration, medication adherence, disease activity-guided dose optimisation and non-medical drug switching. Ten points to consider (50%) were supported by level 1 or 2 evidence. The mean LoA (SD) varied between 7.9 (1.2) and 9.8 (0.4).
CONCLUSION
These points to consider can be used in rheumatology practices and complement inflammatory rheumatic disease treatment guidelines to incorporate cost-effectiveness in b/tsDMARD treatment.
Topics: Humans; Advisory Committees; Antirheumatic Agents; Arthritis, Rheumatoid; Cost-Benefit Analysis; Delphi Technique
PubMed: 36863753
DOI: 10.1136/rmdopen-2022-002898