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Health Technology Assessment... Mar 2023Second-stage caesarean sections, of which there are around 34,000 per year in the UK, have greater maternal and perinatal morbidity than those in the first stage. The...
BACKGROUND
Second-stage caesarean sections, of which there are around 34,000 per year in the UK, have greater maternal and perinatal morbidity than those in the first stage. The fetal head is often deeply impacted in the maternal pelvis, and extraction can be difficult. Numerous techniques are reported, but the superiority of one over another is contentious and there is no national guidance.
OBJECTIVE
To determine the feasibility of a randomised trial of different techniques for managing an impacted fetal head during emergency caesarean.
DESIGN
A scoping study with five work packages: (1) national surveys to determine current practice and acceptability of research in this area, and a qualitative study to determine acceptability to women who have experienced a second-stage caesarean; (2) a national prospective observational study to determine incidence and rate of complications; (3) a Delphi survey and consensus meeting on choice of techniques and outcomes for a trial; (4) the design of a trial; and (5) a national survey and qualitative study to determine acceptability of the proposed trial.
SETTING
Secondary care.
PARTICIPANTS
Health-care professionals, pregnant women, women who have had a second-stage caesarean, and parents.
RESULTS
Most (244/279, 87%) health-care professionals believe that a trial in this area would help guide their practice, and 90% (252/279) would be willing to participate in such a trial. Thirty-eight per cent (98/259) of parents reported that they would take part. Women varied in which technique they thought was most acceptable. Our observational study found that impacted head is common (occurring in 16% of second-stage caesareans) and leads to both maternal (41%) and neonatal (3.5%) complications. It is most often treated by an assistant pushing the head up vaginally. We designed a randomised clinical trial comparing the fetal pillow with the vaginal push technique. The vast majority of health-care professionals, 83% of midwives and 88% of obstetricians, would be willing to participate in the trial proposed, and 37% of parents reported that they would take part. Our qualitative study found that most participants thought the trial would be feasible and acceptable.
LIMITATIONS
Our survey is subject to the limitation that, although responses refer to contemporaneous real cases, they are self-reported by the surgeon and collected after the event. Willingness to participate in a hypothetical trial may not translate into recruitment to a real trial.
CONCLUSIONS
We proposed a trial to compare a new device, the fetal pillow, with a long-established procedure, the vaginal push technique. Such a trial would be widely supported by health-care professionals. We recommend that it be powered to test an effect on important short term maternal and baby outcomes which would require 754 participants per group. Despite the well-known difference between intent and action, this would be feasible within the UK.
FUTURE WORK
We recommend a randomised controlled trial of two techniques for managing an impacted fetal head with an in-built internal pilot phase and alongside economic and qualitative substudies.
STUDY REGISTRATION
This study is registered as Research Registry 4942.
FUNDING
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 27, No. 6. See the NIHR Journals Library website for further project information.
Topics: Infant; Infant, Newborn; Humans; Pregnancy; Female; Cesarean Section; Feasibility Studies; Fetus; Qualitative Research; Prenatal Care; Randomized Controlled Trials as Topic; Observational Studies as Topic
PubMed: 37022927
DOI: 10.3310/KUYP6832 -
BJOG : An International Journal of... Sep 2023To develop a core outcome set for pregnancy nutrition.
OBJECTIVE
To develop a core outcome set for pregnancy nutrition.
DESIGN
Mixed-methods core outcome set development study.
SETTING
Online.
POPULATION
Healthcare professionals, researchers and women with experience of pregnancy.
METHODS
Candidate outcomes were identified from a systematic review of intervention and observational studies. One-to-one semi-structured interviews with women with experience of pregnancy (n = 26) were transcribed and analysed using inductive thematic analysis. Outcomes were consolidated, organised into domains and categorised using the Core Outcome Measures in Effectiveness Trials taxonomy. A two-round, modified Delphi survey (May-August 2021) was conducted. Participants voted on how critical each outcome was to include using a nine-point Likert scale. All outcomes that did not reach consensus were discussed at a consensus meeting.
MAIN OUTCOME MEASURES
Critical outcomes to include in the core outcome set.
RESULTS
A total of 53 091 articles were identified. Outcomes were extracted from 427 articles. The qualitative data yielded 45 outcomes. An additional 24 outcomes came from the literature. In round one, 82 participants ranked 30 outcomes. One new outcome was included in round two, during which participants (n = 60) voted 12/31 outcomes as critical to include. The remaining 20 outcomes were discussed at the consensus meeting and two outcomes were included. Maternal outcomes included: pregnancy complications; delivery complications; maternal wellbeing; gestational weight change; maternal vitamin and mineral status; mental health; diet quality; nutritional intakes; need for treatments, interventions, medications and supplements; pregnancy loss or perinatal death; birth defects or congenital anomalies; neonatal complications; and newborn anthropometry and body composition.
CONCLUSIONS
The use of the Pregnancy Nutrition Core Outcome Set (PRENCOS) will ensure researchers measure what matters most from the perspective of key stakeholders.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Prenatal Nutritional Physiological Phenomena; Pregnancy Outcome; Outcome Assessment, Health Care; Pregnancy Complications; Perinatal Death; Research Design; Delphi Technique; Treatment Outcome
PubMed: 37017148
DOI: 10.1111/1471-0528.17470 -
Dental Traumatology : Official... Jul 2023Variability in the outcome measures used to assess the success of tooth autotransplantation presents challenges for combining data to examine the success of the...
BACKGROUND/AIM
Variability in the outcome measures used to assess the success of tooth autotransplantation presents challenges for combining data to examine the success of the technique. Reaching agreement on the most important outcomes will enable routine procedural and follow-up data to be collected in a standardised way. In turn this will promote greater data synthesis to evaluate outcomes and examine which procedural techniques influence outcome. The aim of this study was to identify which prognostic factors and outcomes are most important to clinicians with experience in autotransplantation of developing teeth.
METHODS
The Delphi method was used to build consensus on the most important prognostic factors and outcomes. Item identification involved a systematic literature review and review of current clinical datasets in use. A two-round Delphi questionnaire was undertaken with clinicians providing tooth autotransplantation, followed by a consensus meeting to finalise the most important items.
RESULTS
Outcomes and prognostic factors were identified from the systematic review (82 studies and eight reviews), one guideline and three existing clinical datasets. Patient interviews and a clinician survey added a number of items that would not have been identified from the literature only. A total of 56 outcomes and 93 prognostic factors were included for rating in the Delphi questionnaire. The Delphi questionnaire was completed by 15 respondents in round one and 13 respondents in round two. The consensus meeting was attended by nine participants. The final items that were judged to be most important included 29 outcomes (25 clinical, three patient-reported and one service delivery) and 49 prognostic factors (18 patient characteristics, four presurgical, 17 surgical and 10 postsurgical). Clinical outcomes were consistently rated higher than patient-reported outcomes.
CONCLUSIONS
The clinical outcomes rated as the most important were transplant survival and reason for failure, outcomes relating to pulp health, different types of resorption and evidence of infection (suppuration). Important patient-reported outcomes were satisfaction with overall treatment experience, and outcome and quality of life related to function of the transplanted tooth. Procedural information rated as being the most important related to the donor tooth: stage of root development, method for surgical removal and storage and condition of the donor tooth root surface following removal.
Topics: Humans; Prognosis; Transplantation, Autologous; Quality of Life; Tooth; Tooth Root
PubMed: 36965034
DOI: 10.1111/edt.12843 -
European Journal of Cancer (Oxford,... May 2023Local treatment improves the outcomes for oligometastatic disease (OMD, i.e. an intermediate state between locoregional and widespread disseminated disease). However,...
BACKGROUND
Local treatment improves the outcomes for oligometastatic disease (OMD, i.e. an intermediate state between locoregional and widespread disseminated disease). However, consensus about the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer is lacking. The aim of this study was to develop a multidisciplinary European consensus statement on the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer.
METHODS
In total, 65 specialists in the multidisciplinary treatment for oesophagogastric cancer from 49 expert centres across 16 European countries were requested to participate in this Delphi study. The consensus finding process consisted of a starting meeting, 2 online Delphi questionnaire rounds and an online consensus meeting. Input for Delphi questionnaires consisted of (1) a systematic review on definitions of oligometastatic oesophagogastric cancer and (2) a discussion of real-life clinical cases by multidisciplinary teams. Experts were asked to score each statement on a 5-point Likert scale. The agreement was scored to be either absent/poor (<50%), fair (50%-75%) or consensus (≥75%).
RESULTS
A total of 48 experts participated in the starting meeting, both Delphi rounds, and the consensus meeting (overall response rate: 71%). OMD was considered in patients with metastatic oesophagogastric cancer limited to 1 organ with ≤3 metastases or 1 extra-regional lymph node station (consensus). In addition, OMD was considered in patients without progression at restaging after systemic therapy (consensus). For patients with synchronous or metachronous OMD with a disease-free interval ≤2 years, systemic therapy followed by restaging to consider local treatment was considered as treatment (consensus). For metachronous OMD with a disease-free interval >2 years, either upfront local treatment or systemic treatment followed by restaging was considered as treatment (fair agreement).
CONCLUSION
The OMEC project has resulted in a multidisciplinary European consensus statement for the definition, diagnosis and treatment of oligometastatic oesophagogastric adenocarcinoma and squamous cell cancer. This can be used to standardise inclusion criteria for future clinical trials.
Topics: Humans; Delphi Technique; Neoplasms; Europe
PubMed: 36947929
DOI: 10.1016/j.ejca.2023.02.015 -
Chest Aug 2023Respiratory failure is a significant concern in neuromuscular diseases (NMDs). This CHEST guideline examines the literature on the respiratory management of patients...
BACKGROUND
Respiratory failure is a significant concern in neuromuscular diseases (NMDs). This CHEST guideline examines the literature on the respiratory management of patients with NMD to provide evidence-based recommendations.
STUDY DESIGN AND METHODS
An expert panel conducted a systematic review addressing the respiratory management of NMD and applied the Grading of Recommendations, Assessment, Development, and Evaluations approach for assessing the certainty of the evidence and formulating and grading recommendations. A modified Delphi technique was used to reach a consensus on the recommendations.
RESULTS
Based on 128 studies, the panel generated 15 graded recommendations, one good practice statement, and one consensus-based statement.
INTERPRETATION
Evidence of best practices for respiratory management in NMD is limited and is based primarily on observational data in amyotrophic lateral sclerosis. The panel found that pulmonary function testing every 6 months may be beneficial and may be used to initiate noninvasive ventilation (NIV) when clinically indicated. An individualized approach to NIV settings may benefit patients with chronic respiratory failure and sleep-disordered breathing related to NMD. When resources allow, polysomnography or overnight oximetry can help to guide the initiation of NIV. The panel provided guidelines for mouthpiece ventilation, transition to home mechanical ventilation, salivary secretion management, and airway clearance therapies. The guideline panel emphasizes that NMD pathologic characteristics represent a diverse group of disorders with differing rates of decline in lung function. The clinician's role is to add evaluation at the bedside to shared decision-making with patients and families, including respect for patient preferences and treatment goals, considerations of quality of life, and appropriate use of available resources in decision-making.
Topics: Humans; Quality of Life; Respiration, Artificial; Noninvasive Ventilation; Respiratory Insufficiency; Physicians
PubMed: 36921894
DOI: 10.1016/j.chest.2023.03.011 -
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 -
Journal of Cancer Education : the... Aug 2023Reproductive-aged breast cancer (BC) survivors are concerned about their fertility potential after BC treatment. No specific and comprehensive educational and clinical...
Reproductive-aged breast cancer (BC) survivors are concerned about their fertility potential after BC treatment. No specific and comprehensive educational and clinical package examines pregnancy health in BC survivors. This study aimed to develop and validate a pregnancy health educational package for BC survivors who intend to experience pregnancy after completing cancer treatment. The present study is a mixed methods study conducted in three phases. The researchers, in phase 1, performed a qualitative content analysis study to explore the perceived needs and experiences of pregnancy among Iranian BC survivors. Then in the second phase, the authors conducted a systematic literature review to search all available packages, guidelines, documents, and published papers on pregnancy or fertility status among BC survivors worldwide. In the third phase, the intervention type was selected according to the opinions of the expert's team during two sessions of online meetings using the Delphi technique. The package quality was assessed by an expert team using the Appraisal of Guidelines for Research and Evaluation Instrument II (AGREE II) tool. The pregnancy health package for BC survivors was developed in seven separate chapters based on the qualitative study and literature review findings. The results of the validity or quality assessment of the package according to the six domains of the AGREE II tool were reported as follows: the score for the scope and purpose domain was 95.55%, the stakeholder involvement domain was 89.16%, the score for the rigor of development domain was 92.97%, clarity of presentation domain was 94.44%, the score of applicability domain was 87.06%, and the score of editorial independence domain was calculated 93.75%. The pregnancy health package was designed with high quality and validity and, as an excellent cost-effective resource, is proposed to BC survivors to increase their awareness regarding their fertility issues before attempting to conceive.
Topics: Female; Pregnancy; Humans; Adult; Breast Neoplasms; Iran; Cancer Survivors; Qualitative Research; Research Design
PubMed: 36856948
DOI: 10.1007/s13187-023-02275-y -
Consensus views on an advanced breast cancer education curriculum for cancer nurses: A Delphi study.Nurse Education Today May 2023Specialist nursing care is a core indicator of quality care for people living with advanced breast cancer. However, access to and quality of nurse education programmes...
BACKGROUND
Specialist nursing care is a core indicator of quality care for people living with advanced breast cancer. However, access to and quality of nurse education programmes in advanced breast cancer is variable.
OBJECTIVES
This study aims to define the topics for inclusion in an international curriculum for an advanced breast cancer education programme.
METHODS
A modified four-round Delphi study was undertaken with experts by profession and experience in advanced breast cancer. Thirty-four topics related to advanced breast cancer and six online teaching and learning methods were pre-selected following a systematic review. Between September 2021 and March 2022, the expert panel determined the importance of topics for inclusion in the education programme. Consensus was defined by at least 80 % agreement on the highest three points on a 9-point Likert scale.
RESULTS
A total of 31 experts participated in rounds 1-3 of this study, and 156 experts by profession and experience participated in an additional fourth round, including people living with advanced breast cancer (n = 72, 46 %), healthcare professionals (n = 46, 29 %), family members or caregivers of a person diagnosed with advanced breast cancer (n = 30, 19 %) and advocacy professionals working in the area of advanced breast cancer (n = 8, 5 %). In round 4, 36 topics and five of six learning methods reached consensus.
CONCLUSIONS
The results of this study provide a framework to develop education programmes in advanced breast cancer, defining the essential elements of curriculum content for such programmes. The results highlight the need for advanced breast cancer education programmes to use multiple teaching and learning methods to promote nurses' understanding of person-centred supportive care and the physical, psychosocial and spiritual issues experienced by people living with advanced breast cancer.
Topics: Humans; Female; Breast Neoplasms; Consensus; Delphi Technique; Clinical Competence; Curriculum; Nurses
PubMed: 36827744
DOI: 10.1016/j.nedt.2023.105757 -
Journal of Obstetrics and Gynaecology :... Dec 2023Two-round Delphi study carried out in Spain. Three theme-based blocks were set out: 1) Patient profiles: therapeutic goal and parameters to be analysed according to...
Two-round Delphi study carried out in Spain. Three theme-based blocks were set out: 1) Patient profiles: therapeutic goal and parameters to be analysed according to POSEIDON patient profiles; 2) Ovarian stimulation protocols with antagonists: monotherapy (FSH) vs combined therapy (FSH + LH/HMG); 3) Safety and effectiveness of the devices. The antral follicle count and the anti-Müllerian hormone level were considered indicators that can be used to predict ovarian response. More than 80% of the participants agreed that FSH monotherapy is the recommended regimen in normal/hyper-responsive patients of < 35 years of age; that 150-300 IU is the dose to be used in ovarian stimulation in monotherapy depending on clinical parameters; and that FSH monotherapy improves patients' comfort compared to two combined drugs. It was unanimously considered that the type of device used by the patient influences the comfort of the treatment.IMPACT STATEMENT There is currently no consensus on the optimal treatment for controlled ovarian stimulation for patients undergoing IVF which leads to highly variable clinical practices. This study's strong point is that, since it is a consensus, it has been possible to include more topics than would normally be dealt with in a systematic review or guidelines, which are generally based on a strict method that restricts the scope of the research. Experts have reached a consensus on most of the statements and based on these they have issued consensus statements that will enable the optimal use of gonadotropins in IVF. This Delphi consensus provides a real-life clinical perspective on gonadotropin usage in IVF.
Topics: Pregnancy; Female; Humans; Follicle Stimulating Hormone; Delphi Technique; Fertilization in Vitro; Pregnancy Rate; Spain; Gonadotropins; Ovulation Induction
PubMed: 36772946
DOI: 10.1080/01443615.2023.2174692 -
Nutrients Jan 2023Disease-related malnutrition (DRM) affects approximately a third of hospitalized patients and is associated with an increased risk of morbimortality. However, DRM is...
Disease-related malnutrition (DRM) affects approximately a third of hospitalized patients and is associated with an increased risk of morbimortality. However, DRM is often underdiagnosed and undertreated. Our aim is to evaluate the prognostic value of morphofunctional tools and tests for nutritional assessment in clinical practice. A systematic literature review was conducted to identify studies relating to the morphofunctional assessment of nutritional status and mortality or complications. Evidence was evaluated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) method. Twelve GRADE recommendations were made and divided into seven topics: food intake and nutrient assimilation, anthropometry, biochemical analysis, hand grip strength, phase angle, muscle imaging, and functional status and quality of life. From these recommendations, 37 statements were developed and scored in a two-survey Delphi method by 183 experts. A consensus was reached on accepting 26/37 statements. Surveys had high internal consistency and high inter-rater reliability. In conclusion, evidence-based recommendations were made on the prognostic value of morphofunctional assessment tools and tests to assess malnutrition, most of which were found to be feasible in routine clinical practice, according to expert opinions.
Topics: Humans; Hand Strength; Consensus; Delphi Technique; Quality of Life; Reproducibility of Results; Malnutrition
PubMed: 36771319
DOI: 10.3390/nu15030612