Letter to the Editor, BJOG Title: ESMiE confidential enquiry: Broader view besides focus on errors by birth-attendants.Re: Rowe R, Draper ES, Kenyon S, Bevan C, Dickens J, Forrester M, Scanlan R, Tuffnell D, Kurinczuk JJ. Intrapartum-related perinatal deaths in births planned in midwifery-led settings in Great Britain: findings and recommendations from the ESMiE confidential enquiry. BJOG 2020;127:1665–1675.Author: Mr. Shashikant L SHOLAPURKARMD, DNB, MRCOGDept of Obstetrics & Gynaecology,Royal United Hospital, Bath, BA1 3NG, UKShort running title: ESMiE enquiry: broader viewEmail: email@example.com Tel: 07906620662Word count: 500Corresponding Author: Mr. Shashikant L SHOLAPURKARMD, DNB, MRCOGDept of Obstetrics & Gynaecology,Royal United Hospital, Bath, BA1 3NG, UKStatement of interest: The author has no conflict of interest or funding to declare.
Re: Training in the use of intrapartum electronic fetal monitoring with cardiotocography: systematic review and meta‐analysis. Cardiotocography training is a complex intervention and requires complex evaluations: a letter to editor.Lightly K, Weeks AD, Scott HCorrespondence to Dr Kate Lightly – firstname.lastname@example.orgClinical Research Fellow, Sanyu Research Unit, University of Liverpool and Liverpool Women’s NHS Foundation Trust, members of Liverpool Health Partners, Crown Street, Liverpool, L8 7SS.Professor Andrew D WeeksProfessor of International Maternal Health, Sanyu Research Unit, University of Liverpool and Liverpool Women’s NHS Foundation Trust, members of Liverpool Health Partners, Crown Street, Liverpool, L8 7SS.Professor Hazel ScottDean of School of Medicine, School of Medicine, University of Liverpool, Cedar House, Liverpool, L69 3GE.Running title - CTG training requires complex evaluationsWe congratulate Kelly et al on their review on the effects of training in cardiotocography (CTG).i It is a critical step towards understanding how to correctly implement CTG training. However, we query the relevance of some of the included studies and whether using Kirkpatrick’s model adequately captures all of the relevant complexities. We believe that further work is needed to understand how such training will impact on practice.Some of the CTG research projects reviewed were poorly representative of the needs of clinicians tasked with improving fetal monitoring in their hospitals. For clinicians, their population of interest is practising clinicians who work on labour wards (sometimes infrequently); studies involving undergraduates alone may not be generalisable. Training in intermittent auscultation is also relevant. Considerable detail on the training intervention is required, including not only the format of teaching, but the duration, curriculum and proportion of relevant staff trained. Detail is also required of supporting interventions and context, as training alone is unlikely to impact change. Many would consider ‘no training’ unethical and therefore not a relevant comparator . In the UK, CTG training and competency is now required for all maternity staff.ii The ultimate aim of CTG (and therefore CTG training) is to detect the hypoxic fetus, so that timely intervention can be undertaken to avoid perinatal harm, without unnecessary intervention. Therefore, the outcomes of interest have to include intrapartum stillbirths, hypoxic ischaemic encephalopathy and mode of delivery.Kirkpatrick’s model was used in this review to evaluate training at four levels (reaction, knowledge, behaviour change and organisational performance). However, it does not attempt to understand why interventions work, or the context, or the causal pathways between training and change in practice.iii Whether participants like training (‘reaction’) is of little relevance, and knowledge acquisition (‘knowledge’) is a proxy which does not equate with improved on the job performance and outcomes. Maternal and perinatal outcomes (‘performance’) were only collected in a small number of studies.CTG training is a complex intervention which aims to create change, not simply knowledge acquisition. We therefore believe that a formal Realist Evaluation is needed. This emerging methodology has been used successfully to understand healthcare change processes and supplement traditional Cochrane style reviews. It aims to understand why complex interventions work, how, for whom, in what context and to what extentiv. Collaboration with the relevant authors to gain detailed intervention descriptions, with a realist approach, may add some much needed explanatory power to this critical subject.Training alone is unlikely to impact change. Even the best educational package will fail without the necessary support - it needs an educational and working culture which supports learning and change, aligned and clear policies, and motivated, well supported drivers and leaders.How doctors learn and what supports them to put new knowledge into practice are key research questions. High quality, methodologically appropriate, properly funded studies are needed to address these questions. Not answering them means many research findings are redundant, as they simply will not be implemented.ReferencesI Kelly S, Redmond P, King S, Oliver‐Williams C, Lamé G, Liberati E et al. Training in the use of intrapartum electronic fetal monitoring with cardiotocography: systematic review and meta‐analysis. BJOG. 2021; 00: 1–12. https://doi.org/10.1111/1471-0528.16619ii NHS England. Saving Babies’ Lives Version Two. A care bundle for reducing perinatal mortality. London: NHS England 2019. [cited 2021 Feb 3]. Available from: www.england.nhs.ukiii Moreau KA. Has the new Kirkpatrick generation built a better hammer for our evaluation toolbox? Med Teach. 2017 Sep; 39(9): 999-1001. https://doi.org/10.1080/0142159X.2017.1337874iv Wong G, Westhorp G, Greenhalgh J, Manzano A, Jagosh J, Greenhalgh T. Quality and reporting standards, resources, training materials and information for realist evaluation: the RAMESES II project. Health Services and Delivery Research. 2017 5 (28): 1–108. https://doi.org/10.3310/hsdr05280.Acknowledgements – NilDisclosure of interests - NilContribution to authorshipKL wrote the first draft of this letter and then it was revised by AW and HS.Details of ethics approval – N/AFunding – Dr Lightly’s PhD entitled “Improving intrapartum fetal monitoring in India: A mixed methods approach” is funded by MRC/DfID/Wellcome Trust Joint Global Health Trials Fund. MR/R006/1801
Risk stratification of HPV positive women in routine cervical screeningHigh risk HPV primary screening is replacing organised cytology-based screening based on increased sensitivity to detect high grade intra-epithelial neoplasia and the very high negative predictive value which will allow extended screening intervals. The benefit of increased CIN detection and cancer prevention needs to balance against the disbenefits to screen positive women in over investigation not east the psychological impact. For colposcopy services, the English cervical screening programme reported a 80% increase in colposcopy referrals in the first round of screening, creating huge pressures on service capacity (Rebolj M et al BMJ 2019;364:l240). The lower positive predictive value also impacts on colposcopy performance with a different referral population wit proportionately less high grade CIN present. In this issue of BJOG, Gori M et al provide observational data from a large longitudinal study of routine primary HPV screening in an organised quality assured cervical screening programme in 3 regions of Italy. Whilst routinely collected data from real-world programmes will have limitations, they do provide an insight into disease detection and importantly impact on colposcopy provision. In a comparison of triage strategies, combined HPV genotyping for HPV16 and high-grade cytology offered an acceptable balance of risk of CIN3+ with number of colposcopies needed to detect one lesion. These results differ from the English pilot (Rebolj M et al 2019 BJC;121(6):455-463) where HPV16/18 genotyping detected only 1.2% more cases of CIN2+ with 5.9% additional colposcopies. Gori M et al did not combine HPV16/18 but they did report that HPV18 on genotyping was not as clinically useful at baseline or 12-month follow-up. Furthermore, 90% of women screened were aged over 35 years when HPV screening is more clinically effective whereas the English pilot started screening at age 25 years when HPV infection is more prevalent and less likely to be clinically significant. Longer follow-up, importantly at the next screening round, is not yet available when the relevance of non-HPV 16 types may be more apparent.The impact of the Covid 19 pandemic on health services and in particular screening, has sharpened the argument of risk stratification following primary screen positive testing both for service providers and those in the target population. Ciavattini A et al (2020 Int J Cancer 30(8):1097-1100) reported on suspension or postponement of cervical screening programmes across Europe relevant to both routine screening and onward referral to colposcopy. As services have needed to adapt to Covid infection rates and health service capacity, the ability to triage effectively and avoid unnecessary hospital visits is critical. Clinicians and women need information on their risk to inform clinical practice and provide reassurance. In the current second wave, the suspension of screening implemented in the first wave is no longer acceptable. Whilst data, such as these from Gori et al, continue to emerge from national and regional screening programmes, Covid has highlighted the need to be responsive and adaptive to allow cancer prevention to continue.
Objective To compare the effectiveness, safety and acceptability of medical abortion before and after the introduction of no-test telemedicine Design Cohort study Setting The three main abortion providers in England Population All patients having an early medical abortion (comprising 85% of all medical abortions performed nationally) Methods Comparison of no-test telemedicine hybrid model vs. traditional model (blanket in-person provision including ultrasound), adjusted for baseline differences Main outcome measures Access: waiting time, gestation Effectiveness: successful medical abortion Safety: significant adverse events; ectopic pregnancy and late gestation Acceptability: Patient-reported outcomes Results 52,142 medical abortions were conducted, 29,984 in the telemedicine-hybrid cohort and 22,158 in the traditional cohort. Mean waiting times were 4.2 days shorter in the telemedicine-hybrid cohort and 40% were ≤6 weeks’ gestation vs. 25% in the traditional cohort (p<0.001). There was no difference in success rates (98.8% vs. 98.2%, p=1.0), nor in prevalence of serious adverse events (0.02% vs. 0.04%, p=0.557). Incidence of ectopic pregnancy was equivalent in both cohorts (0.2%, p=0.796); 0.04% of abortions appeared to have been provided after 10 weeks’ gestation with all completed safely at home. In the telemedicine-hybrid cohort, effectiveness was higher in the telemedicine group vs. the in-person group (99.2% vs. 98.1%, p<0.001). Acceptability was high (96% satisfied), 80% reported a future preference for telemedicine, and none reported that they were unable to consult in private using teleconsultation. Conclusions Medical abortion provided through a hybrid model that includes no-test telemedicine without ultrasound is effective, safe, acceptable, and improves access to care. Funding None