| 1. |
- Begley, Cecily, 1954, et al.
(author)
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A systematic review identifying outcomes to measure the effect of oxytocin used in treating delay in labour
- 2014
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In: Optimizing childbirth across Europe - an intedisciplinary maternity care conference. 9-10 April 2014, Brussels. Part of COST Action IS0907: Childbirth Cultures, Concerns & Consequences: Creating a dynamic EU framework for Optimal maternity care..
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Conference paper (other academic/artistic)abstract
- Background: Different outcome measures have been used in studies examining the effects of oxytocin used to treat delay in labour. Comparison of study results is thus difficult, and evidence is inconsistent. Aims of review: To identify outcomes, including salutogenic, positive, health-focussed outcomes, used in systematic reviews and randomised trials designed to measure the effectiveness of oxytocin used to treat delay in labour. This review was supported by the European Commission under COST Action:IS0907. Search and review methodology: A comprehensive search strategy was employed, and eight relevant citation databases were searched up to January 2013. randomised trials, and systematic reviews of randomised trials, that measured effectiveness of oxytocin in treating delay in labour were included. Trials comparing different action lines on partograms or active management of labour were excluded. Two reviewers screened a total of 1918 citations identified and data were extracted independently. no results were to be used, therefore no quality assessment of papers was required. five systematic reviews and 26 randomised trials were included. Primary and secondary outcomes were recorded and frequency distributions calculated. Findings: Primary outcomes used most frequently were caesarean section (n=15, 46%), labour length (n=14, 42%), measurements of uterine activity (n=13, 39%) and mode of vaginal birth (n=9, 27%). maternal satisfaction was identified a priori by only one review and included by four papers as a secondary outcome. no further salutogenic or positive health-focussed outcomes were identified. Conclusions: heterogeneous outcomes were used to measure the effectiveness of oxytocin in treating delay in labour. Additional salutogenic, women-centred and health-focussed outcomes should be included in future randomised trials of oxytocin used as a treatment for delayed labour. An improved focus on salutogenesis in childbirth may result, with potential for increased resilience in women. A core outcome dataset, based on evidence and applicable for evaluating the effects of oxytocin in prolonged labour, should be generated to support future research.
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| 2. |
- Begley, Cecily, 1954, et al.
(author)
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Evaluation of an intervention to increase vaginal birth after caesarean section through enhanced women-centred care: The OptiBIRTH randomised trial (ISRCTN10612254)
- 2017
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In: 31th ICM Triennial Congress.
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Conference paper (other academic/artistic)abstract
- Background: Vaginal birth after a previous caesarean (VBAC) is a safe alternative to repeat caesarean section (CS), is the preferred option of most women and may reduce overall CS rates.1 However, VBAC rates vary; e.g., rates in Germany, Ireland and Italy are considerably lower (29-36%) than those in the Netherlands, Sweden and Finland (45-55%). Purpose/Objective: To evaluate the effectiveness of an intervention to maximise VBAC rates. The OptiBIRTH Project was funded by a European Union Grant: FP7-HEALTH-2012-INNOVATION-1-HEALTH.2012.3.2-1. Agreement No:305208 Method: A cluster randomised trial was used. A sample size of 12 maternity units was required, each recruiting 120 consenting women, to detect an absolute 15% difference in successful VBACs (increase from 25% in control to 40% in intervention groups), using an ICC of 0.05, with power of >80% and an alpha of 0.05. To allow for loss to follow-up, 15 trial units were randomised across three countries with low VBAC rates (Germany, Ireland and Italy) and the trial commenced April 2014. An evidence-based intervention was introduced in all intervention sites. Control sites had usual care. Interim analysis by an independent Data Monitoring Committee at mid-point permitted continuation. Data were analysed using intention to treat. Key Findings: Recruitment closed October 2015, with the last babies born in December 2015, and data analysis will be completed in April 2016. The primary outcome, comparison of annual VBAC rates for each hospital before and after introduction of the intervention will be presented, and selected secondary outcomes for the recruited women including: mode of birth, perineal trauma, breastfeeding, uterine rupture, wound breakdown, perinatal mortality, Apgar scores, and admission to neonatal intensive care unit. Discussion: If the OptiBIRTH intervention increases VBAC rates safely, its introduction across Europe could prevent 160,000 unnecessary CSs every year, saving maternity services >€150 million annually and contributing to the normalisation of birth for thousands of women. References: 1 Cunningham et al (2010). National Institute of Health Consensus Development Conference Statement: Vaginal birth after caesarean. Obstet & Gynecol 115(6): 1279-1295. 2 EURO-PERISTAT 2008: CD006066.EURO-PERISTAT Project (2008). European Perinatal Health Report. (www.europeristat.com).
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| 3. |
- Byrne, Molly, et al.
(author)
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Sexual counselling for sexual problems in patients with cardiovascular disease
- 2016
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In: Cochrane Database of Systematic Reviews. - : WILEY-BLACKWELL. - 1469-493X. ; :2, s. 1-39
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Research review (peer-reviewed)abstract
- BACKGROUND: Sexual problems are common among people with cardiovascular disease. Although clinical guidelines recommend sexual counselling for patients and their partners, there is little evidence on its effectiveness.OBJECTIVES: To evaluate the effectiveness of sexual counselling interventions (in comparison to usual care) on sexuality-related outcomes in patients with cardiovascular disease and their partners.SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE, and three other databases up to 2 March 2015 and two trials registers up to 3 February 2016.SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs, including individual and cluster RCTs. We included studies that compared any intervention to counsel adult cardiac patients about sexual problems with usual care.DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane.MAIN RESULTS: We included three trials with 381 participants. We were unable to pool the data from the included studies due to the differences in interventions used; therefore we synthesised the trial findings narratively.Two trials were conducted in the USA and one was undertaken in Israel. All trials included participants who were admitted to hospital with myocardial infarction (MI), and one trial also included participants who had undergone coronary artery bypass grafting. All trials followed up participants for a minimum of three months post-intervention; the longest follow-up timepoint was five months.One trial (N = 92) tested an intensive (total five hours) psychotherapeutic sexual counselling intervention delivered by a sexual therapist. One trial (N = 115) used a 15-minute educational video plus written material on resuming sexual activity following a MI. One trial (N = 174) tested the addition of a component that focused on resumption of sexual activity following a MI within a hospital cardiac rehabilitation programme.The quality of the evidence for all outcomes was very low.None of the included studies reported any outcomes from partners.Two trials reported sexual function. One trial compared intervention and control groups on 12 separate sexual function subscales and used a repeated measures analysis of variance (ANOVA) test. They reported statistically significant differences in favour of the intervention. One trial compared intervention and control groups using a repeated measures analysis of covariance (ANCOVA), and concluded: "There were no significant differences between the two groups [for sexual function] at any of the time points".Two trials reported sexual satisfaction. In one trial, the authors compared sexual satisfaction between intervention and control and used a repeated measured ANOVA; they reported "differences were reported in favour of the intervention". One trial compared intervention and control with a repeated measures ANCOVA and reported: "There were no significant differences between the two groups [for sexual satisfaction] at any of the timepoints".All three included trials reported the number of patients returning to sexual activity following MI. One trial found some evidence of an effect of sexual counselling on reported rate of return to sexual activity (yes/no) at four months after completion of the intervention (relative risk (RR) 1.71, 95% confidence interval (CI) 1.26 to 2.32; one trial, 92 participants, very low quality of evidence). Two trials found no evidence of an effect of sexual counselling on rate of return to sexual activity at 12 week (RR 1.01, 95% CI 0.94 to 1.09; one trial, 127 participants, very low quality of evidence) and three month follow-up (RR 0.98, 95% CI 0.88 to 1.10; one trial, 115 participants, very low quality of evidence).Two trials reported psychological well-being. In one trial, no scores were reported, but the trial authors stated: "No treatment effects were observed on state anxiety as measured in three points in time". In the other trial no scores were reported but, based on results of a repeated measures ANCOVA to compare intervention and control groups, the trial authors stated: "The experimental group had significantly greater anxiety at one month post MI". They also reported: "There were no significant differences between the two groups [for anxiety] at any other time points".One trial reporting relationship satisfaction and one trial reporting quality of life found no differences between intervention and control.No trial reported on satisfaction in how sexual issues were addressed in cardiac rehabilitation services.AUTHORS' CONCLUSIONS: We found no high quality evidence to support the effectiveness of sexual counselling for sexual problems in patients with cardiovascular disease. There is a clear need for robust, methodologically rigorous, adequately powered RCTs to test the effectiveness of sexual counselling interventions for people with cardiovascular disease and their partners.
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| 4. |
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| 5. |
- Clarke, Mike, et al.
(author)
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OptiBIRTH: a cluster randomised trial of acomplex intervention to increase vaginalbirth after caesarean section
- 2020
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In: BMC Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393 .- 1471-2393.
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Journal article (peer-reviewed)abstract
- Background: Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are lowin many countries.Methods: OptiBIRTH investigated the effects of a woman-centred intervention designed to increase VBAC ratesthrough an unblinded cluster randomised trial in 15 maternity units with VBAC rates < 35% in Germany, Ireland andItaly. Sites were matched in pairs or triplets based on annual birth numbers and VBAC rate, and randomised, 1:1 or 2:1, intervention versus control, following trial registration. The intervention involved evidence-based education ofclinicians and women with one previous caesarean section (CS), appointment of opinion leaders, audit/peer review,and joint discussions by women and clinicians. Control sites provided usual care. Primary outcome was annualhospital-level VBAC rates before the trial (2012) versus final year of the trial (2016). Between April 2014 and October2015, 2002 women were recruited (intervention 1195, control 807), with mode-of-birth data available for 1940women.Results: The OptiBIRTH intervention was feasible and safe across hospital settings in three countries. There was nostatistically significant difference in the change in the proportion of women having a VBAC between interventionsites (25.6% in 2012 to 25.1% in 2016) and control sites (18.3 to 22.3%) (odds ratio adjusted for differences betweenintervention and control groups (2012) and for homogeneity in VBAC rates at sites in the countries: 0.87, 95% CI:0.67, 1.14, p = 0.32 based on 5674 women (2012) and 5284 (2016) with outcome data. Among recruited womenwith birth data, 4/1147 perinatal deaths > 24 weeks gestation occurred in the intervention group (0.34%) and 4/782in the control group (0.51%), and two uterine ruptures (one per group), a rate of 1:1000.Conclusions: Changing clinical practice takes time. As elective repeat CS is the most common reason for CS inmultiparous women, interventions that are feasible and safe and that have been shown to lead to decreasingrepeat CS, should be promoted. Continued research to refine the best way of promoting VBAC is essential. Thismay best be done using an implementation science approach that can modify evidence-based interventions inresponse to changing clinical circumstances.Trial registration: The OptiBIRTH trial was registered on 3/4/2013. Trial registration number ISRCTN10612254.
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| 6. |
- Lundgren, Ingela, 1957, et al.
(author)
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Clinician-centred interventions to increase vaginal birth after caesarean section (VBAC): a systematic review
- 2015
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In: BMC Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393. ; 15:16
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Journal article (peer-reviewed)abstract
- BackgroundThe number of caesarean sections (CS) is increasing globally, and repeat CS after a previous CS is a significant contributor to the overall CS rate. Vaginal birth after caesarean (VBAC) can be seen as a real and viable option for most women with previous CS. To achieve success, however, women need the support of their clinicians (obstetricians and midwives). The aim of this study was to evaluate clinician-centred interventions designed to increase the rate of VBAC.MethodsThe bibliographic databases of The Cochrane Library, PubMed, PsychINFO and CINAHL were searched for randomised controlled trials, including cluster randomised trials that evaluated the effectiveness of any intervention targeted directly at clinicians aimed at increasing VBAC rates. Included studies were appraised independently by two reviewers. Data were extracted independently by three reviewers. The quality of the included studies was assessed using the quality assessment tool, `Effective Public Health Practice Project¿. The primary outcome measure was VBAC rates.Results238 citations were screened, 255 were excluded by title and abstract. 11 full-text papers were reviewed; eight were excluded, resulting in three included papers. One study evaluated the effectiveness of antepartum x-ray pelvimetry (XRP) in 306 women with one previous CS. One study evaluated the effects of external peer review on CS birth in 45 hospitals, and the third evaluated opinion leader education and audit and feedback in 16 hospitals. The use of external peer review, audit and feedback had no significant effect on VBAC rates. An educational strategy delivered by an opinion leader significantly increased VBAC rates. The use of XRP significantly increased CS rates.ConclusionsThis systematic review indicates that few studies have evaluated the effects of clinician-centred interventions on VBAC rates, and interventions are of varying types which limited the ability to meta-analyse data. A further limitation is that the included studies were performed during the late 1980s-1990s. An opinion leader educational strategy confers benefit for increasing VBAC rates. This strategy should be further studied in different maternity care settings and with professionals other than physicians only.
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| 7. |
- Sinclair, Marlene, et al.
(author)
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Assisting women in autonomous decision making about vaginal birth after C section (VBAC): Designing motivational Apps in OptiBIRTH cluster randomised trial (ISRCTN10612254
- 2017
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In: 31th ICM Triennial Congress 18-22 June 2017.
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Conference paper (other academic/artistic)abstract
- Background: Optibirth is a funded FP7 research programme using a cluster randomised trial in Ireland, Germany and Italy, with 15 clusters of 94 women per cluster. The aim of OptiBIRTH is to evaluate the effectiveness of a complex intervention aimed at increased VBAC rates through enhanced women-centred care1 .The intervention consisted of motivationally enhanced, evidence-based, educational information for women and clinicians for use in face to face and online modes. Purpose/Objective: This paper reports the design process associated with creating three interrelated mobile apps, as part of a complex intervention, to enable women with a previous caesarean section to decide autonomously between a repeat caesarean section and a vaginal birth. The emphasis has been on using technology creatively and effectively maximizing optimality bearing in mind the needs of the new “Z” generation. Method: Focus groups were undertaken across six European countries to illicit women’s need for information about caesarean section and VBAC. Motivational theory underpinned the development of subsequent e-learning materials to enhance woman-led-decision-making. Ethical approval was obtained from Trinity College University, Dublin. Following analysis of focus group data, consultation with experts and exploration of technological solutions, three electronic applications were designed. Following three iterations, the Apps were reviewed for content, motivational design and functionality by Irish, German and Italian midwifery experts and translated into German and Italian. Key Findings: The following interrelated Apps were designed to provide women and health professionals with rapid access to women’s perceptions of their previous birth experience and their current decision-making-in-progress: “My birth story” uses a wordle to communicate past birth experience “My birth thoughts” enables women to communicate their current decision making “My Birth plan” generates a personalised birth plan Discussion: Discussion will focus on challenges facing midwives including, embedding the Apps into a motivationally-designed portal, staff support and training, timeline, cultural differences and translation issues
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| 8. |
- Smith, Valerie, et al.
(author)
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Protocol for the development of a salutogenic intrapartum core outcome set (SIPCOS)
- 2017
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In: BMC Medical Research Methodology. - : Springer Science and Business Media LLC. - 1471-2288. ; 17:61
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Journal article (peer-reviewed)abstract
- Background: Maternity intrapartum care research and clinical care more often focus on outcomes that minimise or prevent adverse health rather than on what constitutes positive health and wellbeing (salutogenesis). This was highlighted recently in a systematic review of reviews of intrapartum reported outcomes where only 8% of 1648 individual outcomes, from 102 systematic reviews, were agreed as being salutogenically-focused. Added to this is variation in the outcomes measured in individual studies rendering it very difficult for researchers to synthesise, fully, the evidence from studies on a particular topic. One of the suggested ways to address this is to develop and apply an agreed standardised set of outcomes, known as a ‘core outcome set’ (COS). In this paper we present a protocol for the development of a salutogenic intrapartum COS (SIPCOS) for use in maternity care research and a SIPCOS for measuring in daily intrapartum clinical care. Methods: The study proposes three phases in developing the final SIPCOSs. Phase one, which is complete, involved the conduct of a systematic review of reviews to identify a preliminary list of salutogenically-focused outcomes that had previously been reported in systematic reviews of intrapartum interventions. Sixteen unique salutogenically-focused outcome categories were identified. Phase two will involve prioritising these outcomes, from the perspective of key stakeholders (users of maternity services, clinicians and researchers) by asking them to rate the importance of each outcome for inclusion in the SIPCOSs. A final consensus meeting (phase three) will be held, bringing international stakeholders together to review the preliminary SIPCOSs resulting from the survey and to agree and finalise the final SIPCOSs for use in future maternity care research and daily clinical care. Discussion: The expectation in developing the SIPCOSs is that they will be collected and reported in all future studies evaluating intrapartum interventions and measured/recorded in future intrapartum clinical care, as routine, alongside other outcomes also deemed important in the context of the study or clinical scenario. Using the SIPCOSs in this way, will promote and encourage standardised measurements of positive health outcomes in maternity care, into the future.
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| 9. |
- Smith, Valerie, et al.
(author)
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Salutogenically focused outcomes in systematic reviews of intrapartum interventions:A systematic review of systematic reviews
- 2014
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In: Midwifery. - : Elsevier BV. - 0266-6138. ; 30:4
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Research review (peer-reviewed)abstract
- Introduction: research on intrapartum interventions in maternity care has focused traditionally on the identification of risk factors' and on the reduction of adverse outcomes with less attention given to the measurement off actors that contribute to well-being and positive health outcomes.We conducted a systematic review of reviews to determine the type and number of salutogenically-focused reported outcomes in current maternity care intrapartum intervention-based research.For the conduct of this review,we interpreted salutogenic outcomes as tho se relating to optimum and/or positive maternal and neonatal health and well-being. Objectives: to identify salutogenically-focused outcomes reported in systematic reviews of randomised trials of intrapartum interventions. Review methods: we searched Issue 9(September 2011 of the Cochrane Database of Systematic Reviews for allreviews of intrapartum interventions published by the Cochrane Pregnancy and Childbirth Group using the group filter “hm-preg”. Systematic reviews of randomised trials ofi ntrapartum interventions were eligible for inclusion.We excluded protocols for systematic reviews and systematic reviews that had been withdrawn. Outcome data were extracted independently from each included review by at least two review authors.Unique lists of salutogenically and non-salutogenically focused outcomes wereestablished. Results: 16 salutogenically-focused outcome categories were identified in 102 included reviews. Maternal satisfaction and breastfeeding were reported most frequently. 49non-salutogenically-focusedoutcome categories were identified in the102 included reviews. Measures of neonatal morbidity were reported most frequently. Conclusion: there is an absence of salutogenically focused outcomes reported in intrapartum intervention- based research. We recommend the development of a core outcome dataset of salutogenically-focused outcomes for intrapartumresearch.
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| 10. |
- Smith, Valerie, et al.
(author)
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Salutogenically focused outcomes in systematic reviews of intrapartum interventions: A systematic review of systematic reviews
- 2014
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In: Optimising Childbirth Across Europe, 9-10 April 2014. Brussels, Belgium..
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Conference paper (other academic/artistic)abstract
- Introduction: Salutogenesis explores health systematically in terms of movement along the health continuum, thereby eliminating a distinct dichotomy of being in a state of health or being in a state of disease. Currently there is little understanding of what constitutes salutogenically focused outcomes in maternity care. In evaluating current maternity care intrapartum intervention-based research, a systematic review of reviews, to determine the type and number of salutogenically-focused reported outcomes, was performed. Aim: To present the findings of this systematic review of systematic reviews. Methodology: Systematic reviews of randomsied trials of intrapartum interventions were eligible for inclusion. Protocols for systematic reviews and systematic reviews that had been withdrawn were excluded. Issue 9, 2011 of the Cochrane Database of Systematic Reviews was searched for all reviews published by the Cochrane Pregnancy and Childbirth Group using the group filter “hm-preg”. At least two review authors independently reviewed each review for inclusion and extracted the data using a purposively designed data extraction form. Any disagreements were resolved through within pair discussions or deferral to the team for consensus. Unique lists of salutogenically-focused and non-salutogenically-focused outcome categories were identified. Ethical approval: Not applicable. Findings: A total of 102 reviews were included. 135 salutogenically-focused outcomes were identified and collapsed into 16 outcome categories. Examples include maternal satisfaction, spontaneous vaginal birth, maternal parenting confidence and breastfeeding. 1632 non-salutogenically-focused outcomes, collapsed into 49 outcome categories, were identified. Examples include preterm birth, instrumental birth and neonatal death. Conclusion: The findings of this review support the hypothesis that the effectiveness of intrapartum interventions is measured against adverse outcomes rather than increases in measures of health and wellbeing. Given the relative absence of salutogenically-focused reported outcomes identified in this systematic review of reviews, the development of a core dataset of salutogenic outcomes for reporting in maternity care research, is recommended.
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