The evidence for Episcissors-60 is limited in quality and quantity and relates only to the reusable Episcissors-60
3.1 The clinical evidence for reusable Episcissors‑60 comprises 8 published studies and 3 unpublished studies:
1 systematic review and meta-analysis (Divakova et al. 2019; included studies are van Roon et al. 2015, Sawant et al. 2015, Lou et al. 2016 and Mohiudin et al. 2018)
1 systematic review (Cole et al. 2019; included studies are Freeman et al. 2014, Patel et al. 2014, van Roon et al. 2015, Sawant et al. 2015 and Mohiudin et al. 2018)
1 proof of concept study (Freeman et al. 2014)
1 case series (Patel et al. 2014)
1 cohort study (Sawant et al. 2015)
3 before and after studies (van Roon et al. 2015, Mohiudin et al. 2018, Ayuk et al. 2019)
2 abstracts (Farnworth et al. 2019, Condell et al. 2017)
1 observational study (Lou et al. 2016).
The evidence includes patients who had a mediolateral episiotomy with reusable Episcissors-60 or standard episiotomy scissors. Two studies introduced reusable Episcissors‑60 with other care measures (see sections 4.3 and 4.4), which makes it difficult to ascertain the impact of reusable Episcissors‑60 alone on the rate of obstetric anal sphincter injuries (OASI). All of the studies used only the reusable version of Episcissors‑60, so there is no evidence evaluating the single-use disposable version of Episcissors‑60. For full details of the clinical evidence, see section 3 of the external assessment centre's (EAC) assessment report in the supporting documents – committee papers.
The evidence base is limited to a small number of non-comparative studies and before and after studies with a high risk of bias
3.2 The EAC assessed the quality of the evidence base as very low. This is primarily because there are no randomised trials, only observational studies, 3 of which had no comparator group or information on the comparator. There is a high risk of bias because outcomes were measured differently across the studies, and most studies did not report the 'before' data for accurate comparison. In addition, not all studies reported who carried out the episiotomies and suturing after delivery.
The studies suggest that using reusable Episcissors-60 results in reliable post-delivery suture angles
3.3 Four studies reported a median or mean post-delivery suture angle within a 40 to 60 degree range with reusable Episcissors‑60. In one before and after study (van Roon et al. 2015) it was reported that 100% of midwives and 86% of doctors achieved a post-delivery suture angle between 40 and 60 degrees when using reusable Episcissors‑60. However, this is based on only 76 episiotomies, limiting its reliability. Furthermore, no comparable data were reported for the 'before' period so no comment can be made on whether this outcome represented a significant change from previous practice with standard scissors.
3.4 Pooled analysis suggests no significant reduction in OASI rates in women who had an episiotomy with reusable Episcissors‑60 compared with standard episiotomy scissors. However, pooled results of 2 studies that included using reusable Episcissors‑60 with a care bundle showed a significant reduction in OASI rates in women with an episiotomy.
3.5 Pooled analysis suggests that rates of episiotomies could increase by between 1% and 4% (absolute increase) with using Episcissors‑60. However the result was not statistically significant.
3.6 One study (Sawant et al. 2015) reported that the episiotomy incision was longer with reusable Episcissors‑60 than with standard scissors. One study (Ayuk et al. 2019) reported an increase in the estimated mean delivery blood loss by approximately 50 ml after reusable Episcissors‑60 were introduced. For full details of the adverse events, see section 3.7 of the EAC's assessment report in the supporting documents – committee papers.
3.7 Most studies were done in the UK, providing directly applicable evidence for using reusable Episcissors‑60 in the NHS. Two studies, a comparative cohort study and a non-comparative case series study, were in Indian hospitals. The EAC stated that women of Asian family origin may be at higher risk of OASI because of a shorter perineal body length, so those studies may also be applicable to the UK.
The company's cost model shows that using Episcissors-60 is cost saving on a cost per birth basis in an all-births population
3.8 The company created a de novo cost analysis using a simple decision tree model. The model had a single decision node: using Episcissors‑60 or standard scissors, leading to 2 outcomes: an OASI repair or no OASI repair. The time horizon was 1 year. The company's model showed that using Episcissors‑60 saves £20.67 per birth based on all births. Costs were based on the cost of single-use disposable standard episiotomy scissors and a cost per use of reusable Episcissors‑60. For full details of the cost evidence, see section 4 of the EAC's assessment report in the supporting documents – committee papers).
3.9 The EAC agreed with the company's model structure, but did not agree with all the model inputs. The EAC suggested that the population should be confined to those having an episiotomy as opposed to all births, and the incidence of OASI should be for episiotomy births and not all births. The EAC's revised model shows that using Episcissors‑60 saves £30.70 per patient.
Sensitivity analyses suggest that any cost savings with Episcissors-60 are driven by the baseline OASI rate
3.10 Assuming reduced OASI rates with Episcissors‑60 compared with standard scissors, the EAC's sensitivity analysis showed that the cost analysis was most sensitive to the rate of OASI in the comparator (standard scissors) arm. The lower the baseline OASI rate, the less effect Episcissors‑60 have on OASI rates and the lower the expected cost savings. The EAC base case comparator OASI rate was 5.1%. If the OASI rate in the comparator group is reduced in the model to 4%, then Episcissors‑60 are cost incurring by £1.81 per patient per birth by episiotomy. If the OASI rate in the comparator group is increased in the model to 7%, Episcissors‑60 are cost saving by £63.21.
3.11 It was uncertain whether or not additional length of stay attributed to OASI should be included in the cost model. Additional analysis assessed the impact of including length of stay or not on the difference in total costs. Excluding the cost of an excess length of stay attributable to OASI from the cost model results in reduced cost savings associated with Episcissors‑60.