scholarly journals A core outcome set for studies of gestational diabetes mellitus prevention and treatment

Diabetologia ◽  
2020 ◽  
Vol 63 (6) ◽  
pp. 1120-1127 ◽  
Author(s):  
Aoife M. Egan ◽  
◽  
Delia Bogdanet ◽  
Tomás P. Griffin ◽  
Oratile Kgosidialwa ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Prevention And Treatment

scholarly journals A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study

2019 ◽  
Vol 221 (4) ◽  
pp. 339.e1-339.e10 ◽  
Author(s):  
Patricia Healy ◽  
Sanne J. Gordijn ◽  
Wessel Ganzevoort ◽  
Irene M. Beune ◽  
Ahmet Baschat ◽  
...  
Keyword(s):  
Fetal Growth ◽  
Fetal Growth Restriction ◽  
Core Outcome Set ◽  
Growth Restriction ◽  
Core Outcome ◽  
Outcome Set ◽  
Prevention And Treatment

Gestational Diabetes Mellitus pharmacological prevention and treatment

2021 ◽  
Vol 27 ◽  
Author(s):  
Chatzakis Christos ◽  
Cavoretto Paolo ◽  
Sotiriadis Alexandros
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Therapeutic Option ◽  
Safety Data ◽  
Long Term Effects ◽  
Pharmacological Prevention ◽  
Oral Agents ◽  
Prevention And Treatment

: Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy and is defined as glucose intolerance that first emerges or is first recognized during pregnancy. Several factors increase the risk of a pregnant woman to develop gestational diabetes mellitus and several interventions have been tested for the prevention of GDM development. The most common pharmacological interventions that have been assessed are metformin administration , probiotics administration and vitamin D administration. However, no intervention appears to be universally superior to placebo / no intervention for the prevention of GDM. Administration of insulin is the preferred medication for treating hyperglycemia in gestational diabetes mellitus. Metformin and glyburide are not regarded as first-line agents, as both cross the placenta to the fetus. Even though there are sufficient data indicating that administration of metformin is safe and effective in women with GDM there are very limited data concerning the long-term effects of metformin on offspring. Furthermore, glyburide should be used with caution, as increases the risk of neonatal hypoglycemia and some studies showed that increases also the risk of macrosomia. Overall, oral agents may be a therapeutic option in women with GDM after a discussion of the known risks and the need for more long-term safety data in offspring . The present review aims to highlight that current scientific status regarding the prevention and treatment of GDM.

scholarly journals Protocol for the development of a Core Outcome Set for trials on the prevention and treatment of Orthodontically induced enamel White Spot Lesions (COS-OWSL)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Danchen Qin ◽  
Yunlei Wang ◽  
Colin Levey ◽  
Peter Ngan ◽  
Hong He ◽  
...  
Keyword(s):  
Qualitative Interviews ◽  
Core Outcome Set ◽  
White Spot ◽  
Core Outcome ◽  
White Spot Lesions ◽  
Outcome Set ◽  
Prevention And Treatment ◽  
Dental Aesthetics ◽  
Orthodontic Patients ◽  
Dental Professionals

Abstract Background Enamel white spot lesions (WSLs), characterized by an opaque, matt, and chalky white appearance of enamel, are a sign of incipient caries. WSLs are common in orthodontic practice and can affect both the oral health and dental aesthetics of patients. Extensive studies have been conducted to evaluate the effectiveness of prevention or treatment for orthodontically induced enamel WSLs. However, substantial heterogeneity has been found in the outcomes used for the prevention and treatment of WSLs in literature, which prevents researchers from comparing and combining the results of different studies to draw more decisive conclusions. Therefore, we aim to develop a Core Outcome Set for trials on the prevention and treatment of Orthodontically induced enamel White Spot Lesions (COS-OWSL). Methods The development of COS-OWSL comprises four phases: (1) a scoping review to identify and summarize all existing outcomes that have been used in trials on the prevention or treatment of orthodontically induced WSLs; (2) qualitative interviews with orthodontic patients without (for prevention) and with WSL-affected teeth (for treatment) and relevant dental professionals to identify additional outcomes relevant to them; (3) Delphi surveys to collect opinions from key stakeholders including patients, dental professionals, and researchers and to reach a preliminary consensus; and (4) a consensus meeting to develop the final COS-OWSL. Discussion The COS-OWSL will be developed to facilitate the synthesis of evidence regarding the prevention and treatment of orthodontically induced WSLs and to promote the consistent use of relevant patient-important outcomes among future studies in this field. Trial registration Core Outcome Measures in Effectiveness Trials (COMET) initiative (the COS-WSL project) 1399

scholarly journals A Core Outcome Set for Clinical Trials of First- and Second-Segree Perineal Tears Prevention and Treatment: A Study Protocol for a Systematic Review and a Delphi Survey

2021 ◽  
Author(s):  
Lin Xiao ◽  
Lei Shi ◽  
Suting Liu ◽  
yuan yuan Luo ◽  
Jin hui Tian ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Vaginal Delivery ◽  
Core Outcome Set ◽  
Delphi Survey ◽  
Core Outcome ◽  
Perineal Tears ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Prevention And Treatment

Abstract Background Perineal tear is a common consequence of vaginal births affecting females globally. Even mild perineal tears could cause short- and long-term complications for females. Though many studies of interventions to prevent or treat perineal tears to minimize the consequences have been conducted, however, there is significant heterogeneity in the outcomes measured and reported in existing studies, which makes meaningful comparison difficult and makes the generalizability to clinical practice challenging. Developing a core outcome set (COS) could solve these methodological concerns. In this paper, we report a protocol to develop a COS for clinical trials of mild perineal tears, which shall assist in establishing the evidence base and implementation of effective measures to reduce the incidence and minimize the consequences of mild perineal tears. Methods /Design: The development of this COS will be guided by a study advisory group composed of obstetricians, midwives, nursing managers, service users and methodologists. This study will include four stages: (1) a systematic review of the literature to identify outcomes reported in prior studies; (2) a semi-structured interview with key stakeholders to collect their opinions on important outcomes; (3) a panel of experts will be invited to conduct a three-round Delphi survey to prioritize these outcomes; (4) a consensus meeting with key stakeholders to determine the list of outcomes included in the final COS. Discussion The development of this COS will provide an international standards for the outcomes to be collected and reported in all clinical trials and audits of practice, that involve prevention and treatment of first- and second-degree perineal tears for women with vaginal delivery. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved perineal care for women choosing vaginal delivery.

scholarly journals A core outcome set for clinical trials of first- and second-degree perineal tears prevention and treatment: a study protocol for a systematic review and a Delphi survey

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lin Xiao ◽  
Lei Shi ◽  
Suting Liu ◽  
Yuanyuan Luo ◽  
Jinhui Tian ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Vaginal Delivery ◽  
Core Outcome Set ◽  
Delphi Survey ◽  
Core Outcome ◽  
Perineal Tears ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Prevention And Treatment ◽  
Second Degree

Abstract Background Perineal tear is a common consequence of vaginal births affecting females globally. Even mild perineal tears could cause short- and long-term complications for females. Though many studies of interventions to prevent or treat perineal tears to minimize the consequences have been conducted, there is a significant heterogeneity in the outcomes measured and reported in existing studies, which makes meaningful comparison difficult and makes the generalizability to clinical practice challenging. Developing a core outcome set (COS) could solve these methodological concerns. In this paper, we report a protocol to develop a COS for clinical trials of mild perineal tears, which shall assist in establishing the evidence base and implementation of effective measures to reduce the incidence and minimize the consequences of mild perineal tears. Methods/design The development of this COS will be guided by a study advisory group composed of obstetricians, midwives, nursing managers, service users, and methodologists. This study will include four stages: (1) a systematic research of the literature to identify outcomes reported in prior studies, (2) a semi-structured interview with key stakeholders to collect their opinions on important outcomes, (3) a panel of experts will be invited to conduct a three-round Delphi survey to prioritize these outcomes, and (4) a consensus meeting with key stakeholders to determine the list of outcomes included in the final COS. Discussion The development of this COS will provide international standards for the outcomes to be collected and reported in all clinical trials and audits of practice, which involve prevention and treatment of first- and second-degree perineal tears for women with vaginal delivery. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved perineal care for women choosing vaginal delivery. Trial registration This study was registered in the database of Core Outcome Measures in Effectiveness Trials (COMET) on June11th, 2021 (https://comet-initiative.org/Studies/Details/1884).

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