Clinical guidelines—the challenges and opportunities: What we have learned from the case of misoprostol for postpartum hemorrhage

Abstract Objective To establish whether national guidelines for postpartum hemorrhage (PPH) reflect new scientific evidence on misoprostol, and determine the challenges faced in their implementation. Methods A web‐based survey was sent by email to 130 national societies of obstetrics and gynecology (FIGO Member Associations) in 2016. The survey, composed of 18 questions, covered national guidelines on PPH with particular reference to misoprostol, the creation of national guidelines, and challenges to implementation. Results Completed surveys were received from 69 societies, for a 53% response rate. The key findings were that many countries lacked comprehensive, up‐to‐date, evidence‐based national guidelines providing guidance on misoprostol use; recommended regimens were very different in the national guidelines as well as between international and regional guidelines that are most often used as referencing documents; and there are a variety of challenges to implementation of guidelines. Conclusion There is a need, especially in countries with high maternal mortality, to establish mechanisms that ensure the existence of up‐to‐date, comprehensive, evidence‐based guidelines on PPH. This can be difficult given conflicting guidance at the international level. Regional and international societies should prioritize clinical updates and ensure their dissemination and implementation.

cases. Administration of uterotonics is an important component in the prevention and treatment of PPH once the cause has been established as uterine atony. The gold-standard uterotonic for management of PPH due to uterine atony is oxytocin delivered by intravenous or intramuscular injection. Where oxytocin is not available, storage conditions are inadequate, or staff are not trained to administer it safely, misoprostol (available in tablet form) is the current best alternative given that it is a simple and inexpensive product that is both light and heat stable. 4,5 Owing to the global imperatives to reduce maternal mortality, and given the existing knowledge base, international recommendations specify that the following aspects must be ensured in high-risk countries: uterotonic availability; medicines are listed on international (WHO) and national essential medicines lists (EML) in correct dosages; and international and national guidelines on PPH management are in place that support the provision of these uterotonics, and that the guidelines are fully utilized. 6 Ensuring the existence and implementation of evidence-based clinical guidelines is a key objective for many focus areas of global health concern. Regarding maternal health and PPH, evidence shows that it is an effective component. A recent systematic review evaluated the impact of new or updated guidelines for PPH management implemented in clinical practice. In four of seven trials in the review, the numbers of PPH cases declined after the intervention. 7 While an array of international clinical guidelines exist on the prevention and treatment of PPH, little is known about whether these guidelines are utilized, whether they are translated into national guidelines, or used to get medicines listed on national EMLs. The aim of the present study, arising from FIGO's interest in the use of international guidelines, was to understand whether new scientific evidence is incorporated into national clinical guidelines and EMLs-important steps toward improving maternal health. Thirdly, since FIGO has been involved in disseminating information on misoprostol, it was felt that the survey would provide information to improve or redirect its work.

| RESULTS
Completed surveys were received from 69 (53%) of the 130 MAs (  Table 2). Conditions under which misoprostol is recommended for prevention of PPH included: for every delivery in any facility, for "high-risk" deliveries, for deliveries outside facilities, when oxytocin is not available, and when an unskilled birth attendant is present at the delivery; some guidelines did not specify conditions for use. The same conditions were given in the case of misoprostol for treatment of PPH, with the additional condition "after failure of first line treatment with other agents." In response to the question about which international, regional, or other guidelines were used as principle referencing materials

| DISCUSSION
The findings of the present study support existing evidence that many countries either do not have national guidelines on PPH or that their guidelines are not sufficiently up-to-date. 10 Clinical guidelines must be disseminated in order to affect change; however, this survey identified healthcare provider lack of awareness of guidelines as a key challenge. It has been noted by others that clinical guidelines are often not disseminated to healthcare workers or are unclear and ambiguous, which makes them difficult to follow [13][14][15] ; whereas guidelines that are easy to access and understand have a greater chance of being read and implemented. 16 The finding that misoprostol was often absent from guidelines is of concern, especially in countries where a high number of women  adherence to the guidelines, which resulted in a significant reduction in maternal morbidity. Lack of familiarity with guideline content, lack of support from peers or superiors, and insufficient staff and time also impact implementation. 16 Thus, those involved with guideline development must also be involved with strategies that ensure that their implementation is possible.
A limitation of the study was that the information received from The survey also only focused on written national guidelines and, given wide access to the internet, it is unclear how many providers actually know about or rely on national documents versus information they obtain online using a range of sources. In this survey we did not ask if providers actually referred to their national guidelines or explore the use of other online resources such as videos and articles to guide clinical practice.
Further, the survey was limited in that it did not ask about which healthcare providers were able to give key medicines such as uterotonics, and was directed at the guidelines for obstetricians and gynecologists rather than other healthcare providers. It would also be interesting to examine guidelines provided for nonspecialist providers, such as midwives, who often attend deliveries, to see whether the same gaps and needs exist.
F I G U R E 2 Challenges in implementing guidelines that include use of misoprostol for PPH.

| CONCLUSION AND RECOMMENDATIONS
In FIGO's guideline document on prevention and treatment of postpartum hemorrhage in low-resource settings, 8 FIGO calls professional associations to action-to work toward incorporation of recommendations into current guidelines, competencies, and curricula, and ensure that current best-evidence regimens are adopted. FIGO reinforces this call to action and asks MAs without guidelines to initiate dialogue with the Ministry of Health to create new guidelines, and for MAs with guidelines that do not reflect new best evidence to advocate for timely revisions. Further, regional and international societies should prioritize clinical updates and dissemination of new guidance and practice to a range of provider cadres. Given the global shortage of specialist clinicians in lowresource settings, there is a need to create a pathway to better guidance, mentoring, and information sharing of the best clinical evidence within an environment of task sharing. Thus, rather than look at guidelines for PPH management by cadre, what is needed is more explicit discussion of task sharing within guidelines for different cadres of healthcare providers.
It is hoped that the findings presented here can be used in collaboration with partners to offer assistance to countries that do not have guidelines or are revising national guidelines to ensure that they are comprehensive, evidence-based, and appropriate for their setting.
These findings can also be used with partners to offer assistance to countries that do not have misoprostol listed on their EMLs. They could also be useful for discussion with partners when revising international guidelines to raise issues of conformity, dissemination, and implementation. They will also be used to guide FIGO's work disseminating evidence on misoprostol and other promising technologies for the management of PPH in the future.