7 research outputs found
Development of a Core outcome set for fetal Myelomeningocele (COSMiC): study protocol
BACKGROUND: Open spina bifida (OSB) is one of the most common congenital central nervous system defects and leads to long-term physical and cognitive disabilities. Open fetal surgery for OSB improves neurological outcomes and reduces the need for ventriculoperitoneal shunting, compared to postnatal surgery, but is associated with a significant risk of prematurity and maternal morbidity. Fetoscopic surgery comes with less maternal morbidity, yet the question remains whether the procedure is neuroprotective and reduces prematurity. Comparison of outcomes between different treatment options is challenging due to inconsistent outcome reporting. We aim to develop and disseminate a core outcome set (COS) for fetal OSB, to ensure that outcomes relevant to all stakeholders are collected and reported in a standardised fashion in future studies. METHODS: The COS will be developed using a validated Delphi methodology. A systematic literature review will be performed to identify outcomes previously reported for prenatally diagnosed OSB. We will assess maternal (primary and subsequent pregnancies), fetal, neonatal and childhood outcomes until adolescence. In a second phase, we will conduct semi-structured interviews with stakeholders, to ensure representation of additional relevant outcomes that may not have been reported in the literature. We will include patients and parents, as well as health professionals involved in the care of these pregnancies and children (fetal medicine specialists, fetal surgeons, neonatologists/paediatricians and allied health). Subsequently, an international group of key stakeholders will rate the importance of the identified outcomes using three sequential online rounds of a modified Delphi Survey. Final agreement on outcomes to be included in the COS, their definition and measurement will be achieved through a face-to-face consensus meeting with all stakeholder groups. Dissemination of the final COS will be ensured through different media and relevant societies. DISCUSSION: Development and implementation of a COS for fetal OSB will ensure consistent outcome reporting in future clinical trials, systematic reviews and clinical practice guidelines. This will lead to higher quality research, better evidence-based clinical practice and ultimately improved maternal, fetal and long-term childhood outcomes. TRIAL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO) CRD42018104880 . Registered on December 5, 2018. Core Outcome Measures in Effectiveness Trials (COMET): 1187
Ultrasonographic and biochemical assessments as early prediction of polycystic ovarian syndrome in obese women
Backgroud: Polycystic ovary syndrome (PCOS) is considered as a common
cause of hormonal disturbance and obesity. The diagnosis of PCOS was
done by different methods including clinical signs as anovulation,
hyperandrogenism, biochemical markers and ultrasounographic
investigation. This study investigated comparative outcomes of
ultrasonographic and biochemical markers for early prediction of PCOS
in obese women. Subjects and methods: Seventy-five patients were
clinically diagnosed with obese, PCOS and obese with PCOS and
twenty-five normal age matched subjects were enrolled as control.
Abdominal and transvaginal ultrasonographic for assessment of ovarian
properties. In addition, BMI, serum free testosterone,
dehydroepiandrosterone (DHEA), insulin, glycosylated hemoglobin (HbA1c)
and LDL-c levels were evaluated. Results: In obese patients with PCOs
(20%) ovaries revealed normal appearance in morphology while the rest
(80%) showed PCOs in the form of cysts of 2\u20138 mm in diameter
peripherally arranged around stroma. A significant elevation of free
testosterone, DHEA and insulin in obese with or without PCOS compared
with obese group (p<0.001). A positive correlation with hormonal
abnormalities of increased HA1c, LDL-c, free testosterone, DHEA and
insulin compared with obese only. Conclusion: According to our study
findings, ovarian morphology combined with biochemical markers is more
reliable for early prediction and diagnosis of PCOS for interpretation
and management
Development of a core outcome set for fetal Myelomeningocele (COSMiC): study protocol
Background: Open spina bifida (OSB) is one of the most common congenital central nervous system defects and leads to long-term physical and cognitive disabilities. Open fetal surgery for OSB improves neurological outcomes and reduces the need for ventriculoperitoneal shunting, compared to postnatal surgery, but is associated with a significant risk of prematurity and maternal morbidity. Fetoscopic surgery comes with less maternal morbidity, yet the question remains whether the procedure is neuroprotective and reduces prematurity. Comparison of outcomes between different treatment options is challenging due to inconsistent outcome reporting. We aim to develop and disseminate a core outcome set (COS) for fetal OSB, to ensure that outcomes relevant to all stakeholders are collected and reported in a standardised fashion in future studies. Methods: The COS will be developed using a validated Delphi methodology. A systematic literature review will be performed to identify outcomes previously reported for prenatally diagnosed OSB. We will assess maternal (primary and subsequent pregnancies), fetal, neonatal and childhood outcomes until adolescence. In a second phase, we will conduct semi-structured interviews with stakeholders, to ensure representation of additional relevant outcomes that may not have been reported in the literature. We will include patients and parents, as well as health professionals involved in the care of these pregnancies and children (fetal medicine specialists, fetal surgeons, neonatologists/paediatricians and allied health). Subsequently, an international group of key stakeholders will rate the importance of the identified outcomes using three sequential online rounds of a modified Delphi Survey. Final agreement on outcomes to be included in the COS, their definition and measurement will be achieved through a face-to-face consensus meeting with all stakeholder groups. Dissemination of the final COS will be ensured through different media and relevant societies. Discussion: Development and implementation of a COS for fetal OSB will ensure consistent outcome reporting in future clinical trials, systematic reviews and clinical practice guidelines. This will lead to higher quality research, better evidence-based clinical practice and ultimately improved maternal, fetal and long-term childhood outcomes.Samar Altoukhi, Clare L. Whitehead, Greg Ryan, Jan Deprest, Luc Joyeux, Katie Gallagher, James Drake, Paige Church, Daphne Horn, Yenge Diambomba, Jose C.A. Carvalho, and Tim Van Mieghe
Hemorrhagic fever in Saudi Arabia: challenge to public health, effective management and future considerations
Background: Viral hemorrhagic fevers (VHF) refers to a group of febrile
illnesses caused by different viruses that result in high mortality in
animals and humans. Many risk factors like increased human-animal
interactions, climate change, increased mobility of people and limited
diagnostic facility have contributed to the rapid spread of VHF.
Materials: The history of VHFs in the Saudi Arabian Peninsula has been
documented since the 19th century, in which many outbreaks have been
reported from the southwestern region of Saudi Arabia. Despite presence
of regional network of experts and technical organizations, which
expedite support and respond during outbreaks, there are some more
challenges that need to be addressed immediately. Gaps in funding,
exhaustive and inclusive response plans and improved surveillance
systems are some areas of concern in the region which can be dealt
productively. This review primarily focusses on the hemorrhagic fevers
that are caused by three most common viruses namely, the Alkhurma
hemorrhagic fever virus, Rift valley fever virus, and Dengue fever
virus. Conclusion: In summary, effective vector control, health
education, possible use of vaccine and concerted synchronized efforts
between different government organizations and private research
institutions will help in planning effective outbreak-prevention and
response strategies in future
03:36 PM Abstract No. 367 An ex vivo bench and perfused liver assessment and extension of the ablation zone by “EdgeBoost” with IR-Circle: a new bipolar ablation device
Impact of cytoreductive surgery and HIPEC on intraoperative gastrointestinal wall thickness and patient outcomes
Background: Cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC) is associated with significant postoperative ileus (POI). This study examined intraoperative gastrointestinal wall thickness (GWT) and its association with patient outcomes. Patients and Methods: A prospective study of patients undergoing CRS and HIPEC. Proximal and distal small intestine GWT, before and after HIPEC were recorded. Results: Thirty-four patients (mean age=56.1 years, 61.8% female) were recruited. After HIPEC, the mean proximal (4.5 vs. 3.0 mm, p=0.03) and distal (4.3 vs. 3.4 mm, p<0.01) GWT were increased. Increased GWT was associated with prolonged operative time (10 vs. 8.5 h, p=0.03) and total length of stay (35.71 vs. 21.25 days, p=0.02). Postoperative ileus occurred in 23.5% of patients but differences between GWT groups did not reach significance (28.6% vs. 20%, p=0.56). Conclusion: GWT increased significantly during CRS and HIPEC and is reflective of tissue trauma and oedema. This was associated with prolonged operative time, total length of stay and post-operative ileus
Safety and efficacy of dual versus triple antithrombotic therapy (DAT vs TAT) in patients with atrial fibrillation following a PCI: a systematic review and network meta-analysis
Objective Creating an appropriate antithrombotic therapy for patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI) remains a dilemma. Several clinical trials compared the use of a dual antithrombotic therapy (DAT) regimen with a direct oral anticoagulants including (apixaban, dabigatran, edoxaban or rivaroxaban) and a P2Y12 inhibitor versus a triple antithrombotic therapy (TAT) that includes a vitamin K antagonist plus aspirin and a P2Y12 inhibitor in patients with AF who have undergone PCI. However, there are no head-to-head trials comparing the DAT regimens to each other. We aimed to compare the efficacy and safety of DAT regimens using a network meta-analysis (NMA) approach.Design A systematic review and NMA of randomised clinical trials.Methods We conducted a systematic literature review to identify relevant randomised clinical trials and performed a Bayesian NMA for International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding, all-cause mortality, stroke, myocardial infarction (MI) and stent thrombosis outcomes. We used NetMetaXL V.1.6.1 and WinBUGS V.1.4.3 for the NMA and estimated the probability of ranking the treatments based on the surface under the cumulative ranking curve.Results The comparison between DAT regimens showed no significant difference in the safety or efficacy outcomes. Apixaban regimen was ranked first as the preferred therapy in terms of ISTH major or CRNM bleeding and stroke, with a probability of 52% and 54%, respectively. Rivaroxaban regimen was the preferred therapy in terms of MI and stent thrombosis, with a probability of 34% and 27%, respectively. Dabigatran regimen was ranked first in terms of all-cause mortality, with a probability of 28%.Conclusion The DAT regimens are as safe and effective as TAT regimens. However, ranking probabilities for the best option in the selected outcomes can be used to guide the selection among these agents based on different patients’ conditions