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Exploring standardisation, monitoring and training of medical devices in assisted vaginal birth studies: protocol for a systematic review.

ABSTRACT: INTRODUCTION:Assisted vaginal birth (AVB) can markedly improve maternal and neonatal outcomes arising from complications in the second stage of labour. Historically, both forceps and ventouse devices have been used to assist birth; however, they are not without risk and are associated with complications, such as cephalohaematoma, retinal haemorrhage and perineal trauma. As new devices are developed to overcome the limitations of existing techniques, it is necessary to establish their efficacy and effectiveness within randomised controlled trials (RCTs). A major challenge of evaluating complex interventions (ie, invasive procedures/devices used to assist vaginal birth) is ensuring they are delivered as intended. It can be difficult to standardise intervention delivery and monitor fidelity, and account for the varying expertise of clinicians (accoucher expertise). This paper describes the protocol for a systematic review aiming to investigate the reporting of device standardisation, monitoring and training in trials evaluating complex interventions, using AVB as a case study. METHODS AND ANALYSIS:Relevant keywords and subject headings will be used to conduct a comprehensive search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and ClinicalTrials.gov, for RCTs and pilot/feasibility studies evaluating AVB. Abstracts will be screened and full-text articles of eligible studies reviewed for inclusion. Information relating to the following categories will be extracted: standardisation of device use (ie, descriptions of operative steps, including mandatory/flexible parameters), monitoring of intervention delivery (ie, intervention fidelity, confirming that an intervention is delivered as intended) and accoucher expertise (ie, entry criteria for participation, training programmes and previous experience with the device). Risk of bias of included studies will be assessed. ETHICS AND DISSEMINATION:Ethical approval is not required because primary data will not be collected. Findings will be disseminated by publishing in a peer-reviewed journal and presentations at relevant conferences.

SUBMITTER: Hotton EJ

PROVIDER: S-EPMC6500334 | biostudies-other | 2019 Apr

REPOSITORIES: biostudies-other

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Exploring standardisation, monitoring and training of medical devices in assisted vaginal birth studies: protocol for a systematic review.

Hotton Emily J EJ Renwick Sophie S Barnard Katie K Lenguerrand Erik E Wade Julia J Draycott Tim T Crofts Joanna F JF Blencowe Natalie S NS

BMJ open 20190414 4

<h4>Introduction</h4>Assisted vaginal birth (AVB) can markedly improve maternal and neonatal outcomes arising from complications in the second stage of labour. Historically, both forceps and ventouse devices have been used to assist birth; however, they are not without risk and are associated with complications, such as cephalohaematoma, retinal haemorrhage and perineal trauma. As new devices are developed to overcome the limitations of existing techniques, it is necessary to establish their eff ...[more]

PMID: 30987994

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Project description:ObjectiveAssisted vaginal birth (AVB) is a complex intervention involving medical devices, comprising multiple components. This complexity creates difficulties when designing and conducting randomised controlled trials (RCTs), in terms of describing, standardising and monitoring the intervention, and accounting for differing clinician expertise. This review examines the reporting standards of complex interventions involving a medical device, in the context of AVB RCTs.Study designSearches were undertaken from the start of indexing to March 2021, and limited to RCTs, feasibility and pilot studies including at least one device for AVB. RCTs were selected if they included participants having an AVB with any device, with or without a comparator group. Reporting details were assessed according to the Consolidating Standards of Reporting Trials extension for non-pharmacological treatments (CONSORT-NPT), focusing on intervention descriptions, standardization, adherence and clinician expertise. Screening of abstracts, full-text articles and data extraction was performed by two independent reviewers.ResultsOf 4098 abstracts and 83 full-text articles, 39 papers were included, investigating 80 interventions. Twenty-seven different named devices were identified. Intervention descriptions were provided in 20 (55%) papers with varying levels of detail and with only one covering the entire procedure. Standardization of interventions was mentioned in 25 papers (64%). Only eight (21%) papers reported any form of adherence to the intended procedure. Some data regarding expertise were reported in 25 (64%) papers.ConclusionsDespite some compliance with reporting standards, there is a lack of detail regarding intervention description, standardization, adherence and expertise in RCTs of AVB. This creates difficulties in understanding how intervention delivery was intended and what actually occurred. Clearer guidelines for the reporting of invasive procedures and devices are required.

Project description:BackgroundOperative vaginal birth is a common procedure used to expedite birth after full cervical dilatation where there is a clinical need to do so (15% of births in the UK in 2016). The acquisition of skills for operative vaginal birth is dependent on the exposure of junior obstetricians to situations in which they can undertake directly supervised learning from senior accouchers. The Royal College of Obstetricians and Gynaecologists has recently introduced the first structured course in operative vaginal birth. To date, there have been no attempts to determine the clinical impact of a structured training package for operative vaginal birth.MethodsThe STROBE study is a quasi-experimental before-after interrupted time-series study of the effect of simulation training in operative vaginal birth for obstetricians on clinical outcomes of women and babies following operative vaginal birth. Similar to a stepped-wedge design, the intervention will be gradually implemented in all participating units but at different time periods. The primary outcome is failed operative vaginal birth with the first intended instrument. Secondary maternal outcomes are; use of second instrument to achieve operative vaginal birth, caesarean section, episiotomy, perineal trauma (1st, 2nd, 3rd, 4th degree tear), cervical tear requiring suturing, general anaesthesia and estimated blood loss. Secondary neonatal outcomes are; Apgar score at one, five, and ten minutes, Umbilical artery pH, shoulder dystocia, admission to Neonatal Intensive Care Unit and death within 28 days of birth. The analysis will be intention-to-treat (per unit) on the primary and secondary outcomes. The STROBE study received approval from the Health Research Authority and is sponsored by North Bristol NHS Trust. Results will be published in an open-access peer-reviewed medical journal within one year of completion of data gathering.DiscussionThe STROBE study will help establish our understanding of the effectiveness of locally-delivered simulation training for operative vaginal birth. Robust evidence supporting the effectiveness of such an approach would add weight to the argument supporting regular, local training for junior obstetricians in operative vaginal birth.Trial registrationISRCTN11760611 05/03/2018 (retrospectively registered).

Project description:BackgroundMonitoring resistance training has a range of unique difficulties due to differences in physical characteristics and capacity between athletes, and the indoor environment in which it often occurs. Traditionally, methods such as volume load have been used, but these have inherent flaws. In recent times, numerous portable and affordable devices have been made available that purport to accurately and reliably measure kinetic and kinematic outputs, potentially offering practitioners a means of measuring resistance training loads with confidence. However, a thorough and systematic review of the literature describing the reliability and validity of these devices has yet to be undertaken, which may lead to uncertainty from practitioners on the utility of these devices.ObjectiveA systematic review of studies that investigate the validity and/or reliability of commercially available devices that quantify kinetic and kinematic outputs during resistance training.MethodsFollowing PRISMA guidelines, a systematic search of SPORTDiscus, Web of Science, and Medline was performed; studies included were (1) original research investigations; (2) full-text articles written in English; (3) published in a peer-reviewed academic journal; and (4) assessed the validity and/or reliability of commercially available portable devices that quantify resistance training exercises.ResultsA total of 129 studies were retrieved, of which 47 were duplicates. The titles and abstracts of 82 studies were screened and the full text of 40 manuscripts were assessed. A total of 31 studies met the inclusion criteria. Additional 13 studies, identified via reference list assessment, were included. Therefore, a total of 44 studies were included in this review.ConclusionMost of the studies within this review did not utilise a gold-standard criterion measure when assessing validity. This has likely led to under or overreporting of error for certain devices. Furthermore, studies that have quantified intra-device reliability have often failed to distinguish between technological and biological variability which has likely altered the true precision of each device. However, it appears linear transducers which have greater accuracy and reliability compared to other forms of device. Future research should endeavour to utilise gold-standard criterion measures across a broader range of exercises (including weightlifting movements) and relative loads.

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Exploring standardisation, monitoring and training of medical devices in assisted vaginal birth studies: protocol for a systematic review.

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Exploring standardisation, monitoring and training of medical devices in assisted vaginal birth studies: protocol for a systematic review.

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