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

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).

Download Full-text

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

10.21203/rs.3.rs-625834/v1 ◽

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.

Download Full-text

A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey

Trials ◽

10.1186/s13063-018-3082-9 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 2

Author(s):

Geng Li ◽

Li Zhou ◽

Wenwei Ouyang ◽

Meiling Xuan ◽

Liming Lu ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Chinese Medicine ◽

Study Protocol ◽

Core Outcome Set ◽

Delphi Survey ◽

Core Outcome ◽

Outcome Set

Download Full-text

Core Outcome Set for Clinical Trials of COVID-19 based on Traditional Chinese and Western Medicine

10.1101/2020.03.23.20041533 ◽

2020 ◽

Cited By ~ 2

Author(s):

Ruijin Qiu ◽

Chen Zhao ◽

Tengxiao Liang ◽

Xuezeng Hao ◽

Ya Huang ◽

...

Keyword(s):

Clinical Trials ◽

Western Medicine ◽

Core Outcome Set ◽

Delphi Survey ◽

Oxygen Intake ◽

Inflammatory Factor ◽

Core Outcome ◽

Arterial Blood ◽

Outcome Set ◽

Factor C

AbstractBackgroundDevelopment of a core outcome set (COS) for clinical trials for COVID-19 is urgent because of the pandemic wreaking havoc worldwide and the heterogeneity of outcomes in clinical trials.MethodsA preliminary list of outcomes were developed after a systematic review of protocols of clinical trials for COVID-19. Then, two rounds of the Delphi survey were conducted. Stakeholders were traditional Chinese medicine (TCM) experts, Western medicine (WM) experts, nurses and the public. Patients with confirmed COVID-19 were also invited to participate in a questionnaire written in understandable language. Frontline clinicians, as well as nurse, methodologist, evidence based-medicine researcher, and staff from the Chinese Clinical Trials Registry participated by video conference to vote.ResultsNinety-seven eligible study protocols were identified from 160 clinical trials. Seventy-six outcomes were identified from TCM clinical trials and 126 outcomes were identified from WM clinical trials. Finally, 145 outcomes were included in the first round of the Delphi survey. Then, a COS for clinical trials of TCM and WM was developed. The COS include clinical outcomes (recovery/improvement/progression/death), etiology (SARS-CoV-2 nucleic-acid tests, viral load), inflammatory factor (C-reactive protein), vital signs (temperature, respiration), blood and lymphatic-system parameters (lymphocytes, virus antibody), respiratory outcomes (Pulmonary imaging, blood oxygen saturation, PaO2/FiO2 ratio, arterial blood gas analysis, mechanical ventilation, oxygen intake, pneumonia severity index), clinical efficacy (prevalence of preventing patients with mild-to-moderate disease progressing to severe disease), symptoms (clinical symptom score). Outcomes were recommended according to different types of disease. Outcome measurement instrument/definition were also recommended.ConclusionA COS for COVID-19 may improve consistency of outcome reporting in clinical trials.

Download Full-text

Development of a core outcome set for clinical trials aimed at improving antimicrobial stewardship in care homes

Antimicrobial Resistance and Infection Control ◽

10.1186/s13756-021-00925-8 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Hoa Q. Nguyen ◽

Declan T. Bradley ◽

Michael M. Tunney ◽

Carmel M. Hughes

Keyword(s):

Clinical Trials ◽

Antimicrobial Stewardship ◽

Outcome Measurement ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Delphi Survey ◽

Care Homes ◽

Core Outcome ◽

Outcome Set ◽

Days Of Therapy

Abstract Background Diverse outcomes reported in clinical trials of antimicrobial stewardship (AMS) interventions in care homes have hindered evidence synthesis. Our main objective was to develop a core outcome set (COS) for use in trials aimed at improving AMS in care homes. Methods A refined inventory of outcomes for AMS interventions in care homes, compiled from a previous study, was rated in a three-round international Delphi survey with 82 participants, using a nine-point Likert scale (from 1, unimportant, to 9, critical). This was followed by an online consensus exercise with 12 participants from Northern Ireland to finalise the COS content. Subsequently, a suitable outcome measurement instrument (OMI) was selected for each outcome in the COS by: identifying existing OMIs through a literature search and experts’ suggestions, assessing the quality of OMIs, and selecting one OMI for each core outcome via a two-round international Delphi survey with 59 participants. Results Of 14 outcomes initially presented, consensus was reached for inclusion of five outcomes in the COS after the three-round Delphi survey and the online consensus exercise, comprising the total number of antimicrobial courses prescribed, appropriateness of antimicrobial prescribing, days of therapy per 1000 resident-days, rate of antimicrobial resistance, and mortality related to infection. Of 17 potential OMIs identified, three were selected for the two-round Delphi exercise after the quality assessment. Consensus was reached for selection of two OMIs for the COS. Conclusion This COS is recommended to be used in clinical trials aimed at improving AMS in care homes.

Download Full-text

Developing a core outcome set for children with protracted bacterial bronchitis

ERJ Open Research ◽

10.1183/23120541.00344-2019 ◽

2020 ◽

Vol 6 (1) ◽

pp. 00344-2019

Author(s):

Francis J. Gilchrist ◽

Imran Ali ◽

Malcolm Brodlie ◽

Will D. Carroll ◽

Bridget Kemball ◽

...

Keyword(s):

Clinical Trials ◽

Core Outcome Set ◽

Consensus Meeting ◽

Delphi Survey ◽

Respiratory Pathogen ◽

Core Outcome ◽

Potential Core ◽

Outcome Set ◽

Protracted Bacterial Bronchitis ◽

Wet Cough

BackgroundProtracted bacterial bronchitis (PBB) is a chronic endobrochial infection and a leading cause of chronic wet cough in children. There is an urgent need for a randomised controlled trial to investigate the optimal treatment but there is no core outcome set (COS) to inform choice of outcomes. A COS is a standardised set of outcomes representing the minimum that should be measured and reported in clinical trials of a specific condition. We have developed a COS for PBB.MethodsPotential core outcomes were collated from a systematic review, interviews with parents and a clinician survey. A two-round Delphi survey of healthcare professionals identified which outcomes had consensus for inclusion. The final COS was agreed at a consensus meeting of parent representatives and clinicians.Results20 outcomes were identified for the Delphi survey. After two rounds, 10 reached consensus. These were combined and edited at the consensus meeting into the final six: 1) Resolution of cough assessed using a cough score/diary recorded daily by parent(s) during treatment; 2) relapse of chronic wet cough and/or cumulative antibiotic treatment during ≥12 months follow-up; 3) change in child's quality of life (parent-proxy reporting for young children); 4) emergence of antibiotic resistance; 5) development of bronchiectasis diagnosed on clinically indicated computed tomography scans; and 6) microbiological clearance of identified respiratory pathogen if samples readily available.ConclusionsWe have developed a COS for PBB which will reduce the outcome heterogeneity and bias of future clinical trials, as well as promoting comparison between studies.

Download Full-text