The Institute of Medicine defines ‘quality’ as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes, consistent with current professional knowledge .
PEARLS-QI assessed the effectiveness of implementation of an evidence-based standardized multiprofessional training package, using a matched-pair cluster RCT, on women’s health outcomes and the content of clinical practice. The gap between the availability of evidence and its implementation in relation to the management of perineal trauma following childbirth was highlighted in a national survey of midwives conducted by our team prior to designing the PEARLS-QI intervention . This gap was also found in phase 1 of the study, in which prior to delivery of the QI intervention in any units, only 35.8% and 56.5% of women had perineal repairs carried out using the recommended technique in the group A and B clusters respectively. Interestingly, there was a significant improvement in the use of the continuous suturing technique for perineal repair in the group A clusters (from 35.8% to 72.5%) after delivery of the training intervention. The use of evidence-based techniques also significantly improved after delivery of the intervention in the group B clusters in phase 3 of the study. However, the improvements in the group A clusters were not sustained to the level achieved in phase 2, although this was still better than the baseline level in phase 1 (Table 2, Table 3, Table 6). Despite low rates of use of the continuous suturing technique prior to the PEARLS-QI intervention, most clinicians used the recommended more rapidly absorbed polyglactin suture material . This is probably due to the fact that purchase and use of suture material tends to be decided at an organizational rather than individual clinician level. However, the potential benefits to maternal health, which may accrue from the use of appropriate suturing material, are likely to be dissipated by using less effective perineal suturing techniques. Current evidence supports the use of a continuous non-locking technique rather than interrupted suturing for perineal repair, particularly in relation to perineal pain at 10 to 12 days post-natal . In spite of an improvement in the use of the recommended suturing technique, we were unable to show a reduction in women’s reported pain outcomes. This may be due to the fact that a high percentage of women in both groups (A and B) had subcutaneous sutures inserted to close the perineal skin even before delivery of the the QI intervention. Indeed, this technique of skin closure appears to be associated with a reduction in reported perineal pain . Nevertheless, there was a significant reduction in rates of perineal wound infection in the group A compared with the group B clusters at the end of phase 2. Wound infection was the outcome of most importance for women in the Delphi survey we conducted during the initial project development. Genital tract sepsis was the commonest cause of direct maternal death in the UK during 2006 to 2008 . Sepsis is a complex and poorly understood cause of maternal morbidity and mortality, and highlights the importance of effective care to minimize infection and the need to increase awareness of sepsis among women and clinicians.
To our knowledge, PEARLS is the first RCT to test a QI intervention specifically developed to improve use of evidence-based assessment and management of birth-related perineal trauma to reduce maternal morbidity. It is the largest study to date to evaluate the effect on women’s post-natal health of using evidence-based perineal repair methods. A major strength of the study design was the inclusion of a long-term assessment phase to measure the sustainability of the intervention. It seems that implementation of the intervention changed clinical practice, in that use of evidence-based techniques for perineal repair were better utilized several months after ‘actively’ delivering the PEARLS-QI intervention, albeit to a lesser extent compared with phase 2. We can only speculate on possible reasons for the inability to sustain the same level of improvement. It could be related to a dissipation in the effect of the training in changing attitudes, or more likely, could be related to staff service and training rotations between clinical areas causing a dilution in the number of those receiving the QI intervention and still being involved in intra-partum care. Whatever the reason, it reinforces the need for regular, ongoing updates in perineal training for those clinicians involved in intra-partum care.
There are numerous examples of delay in implementing evidence into clinical practice being associated with poor patient outcomes [23–26]. Several barriers are reported as underlying reasons for this, including lack of resources and organizational support, increased workload, and individuals’ resistance to change. In 1998, Burry and Mead suggested that to facilitate local implementation of evidence-based practice, change should be managed locally, there should be clarity about the expected benefits, and the involvement of all interested parties should be ensured . PEARLS was designed as a pragmatic trial, hence in addition to testing the intervention, we wanted to ensure we used a pragmatic approach for its delivery. Therefore, the findings of our national midwifery survey helped us to understand some of the barriers and facilitators to implementation of evidence to enhance management and outcomes of perineal trauma. We believe that use of a local trained PEARLS facilitator in each cluster increased the sense of local ownership of the project and the generalizability of the study findings. Indeed, knowledge translation for healthcare professionals and consumers is more likely to be successful if the choice of translation strategy is informed by an assessment of the likely barriers and facilitators .
There are some limitations to our study. We did not ask facilitators to document how many of the clinicians received PEARLS training, as we considered that this would have been an additional burden and anticipated that some staff would require on-going training. As the sample size calculation was based on the primary outcome measure, there was low power for some secondary outcomes, which occurred infrequently. Over half of the women who met the study inclusion criteria were not recruited, an issue that reflects the pragmatic nature of the study, which acknowledged that service demands can compete with recruitment. This discrepancy could also be a reflection of participants’ choice because we were able to include women within a cluster only if they consented to participate. Thirdly, of the women for whom a completed entry details form was available, the percentages returning the 10 to 12 day questionnaires were 62%, 49% ,and 57% for phases 1, 2 and 3 respectively, and for the 3-month questionnaire were 49%, 40% and 53% respectively. The data analysis assumed that questionnaires are missing completely at random; bias might result if this was not the case. However, we note that response rates were comparable in the three phases and between both sets of clusters (for example, for phase 2, the 10 to 12 day questionnaire had a response rate of 54% for group A and 55% for group B, and the 3 month questionnaire had a response rate of 38% for group A and 44% for group B). Finally, the ratio of the number of women in group A clusters relative to women in group B clusters was 1.37 for phase 1, 1.75 for phase 2, and 1.36 for phase 3. The reasons for, and implications of, the ratio being greater than 1, and being greater in phase 2 compared with phases 1 and 3 are unknown, and could reflect wider individual organizational issues not addressed within the study.
There are also several strengths to our study. The risk of contamination was minimized by the use of a cluster design with matched paired maternity centers as the unit of intervention allocation. The pragmatic nature of the trial, cascading the intervention by means of local trained facilitators, and the inclusion of a range of maternity units and birth centers, increases the external validity of the study and make the findings generalizable to the UK. Additionally, publication of the trial protocol, pre-specification of the primary outcome, large sample size, and extended follow-up period were important further strengths of the study design.
In England, the Clinical Negligence Scheme for Trusts (CNST) handles all clinical negligence claims against member NHS bodies. Membership contributions are influenced by several factors, including the achievement of certain risk-management and clinical standards. In line with CNST standards, most member NHS hospitals are currently addressing clinical training provision in perineal assessment and repair to comply with CNST recommendations. Nevertheless, there is currently no standardized tested package to deliver this training or audit its effects. Similar to the implementation of the evidence-based continuous suturing technique, the improvement in women’s reported outcomes was not sustained to the same level of original improvement when assessed in phase 3. This highlights that although the PEARLS-QI intervention was effective in improving the implementation of evidence into practice, which had a positive effect on some aspects of women’s health, it is important to ensure training is actively embedded within routine clinical care to ensure that its effect is sustained. Undoubtedly, this fits in with the current model proposed by CNST, which expects that clinicians involved in intra-partum care will receive regular perineal repair and management updates. The extent to which this is currently happening is not known.