Evaluation of a strict protocol approach in managing women with severe disease due to hypertension in pregnancy: A before and after study

BACKGROUND: To evaluate whether the introduction of a strict protocol based on the systemic evaluation of critically ill pregnant women with complications of hypertension affected the outcome of those women. METHOD: Study group: Indigent South African women managed in the tertiary hospitals of the Pretoria Academic Complex. Since 1997 a standard definition of women with severe acute maternal morbidity (SAMM), also referred to as a Nearmiss, has been used in the Pretoria Academic Complex. All cases of SAMM and maternal deaths (MD) were entered on the Maternal Morbidity and Mortality Audit System programme (MaMMAS). A comparison of outcome of severely ill women who had complications of hypertension in pregnancy was performed between 1997–1998 (original protocol) and 2002–2003 (strict protocol). Data include women referred from outside the Pretoria Academic Complex area to the tertiary hospitals. RESULTS: Between 1997–1998 there were 79 women with SAMM and 18 maternal deaths due to complications of hypertension, compared with 91 women with SAMM and 13 maternal deaths in 2002–2003. The mortality index (MI) declined from 18.6% to 12.5% (OR 0.62, 95% CI 0.27–1.45). Statistically significant fewer women had renal failure (RR 0.37, 95% CI 0.21 – 0.66) and cerebral complications (RR 0.52, 95%CI 0.34 – 0.81) during the second period, and liver dysfunction (RR 0.27 95%CI 0.06 – 1.25) tended to be lower. However, there tended to be an increase in the number of women, who had immune system failure (RR 4.2 95%CI 0.93 – 18.94) and respiratory failure (RR 1.42 95%CI 0.88 – 2.29) although it did not reach significance. Cardiac failure remained constant (RR 0.84 95%CI 0.54 – 1.30). CONCLUSION: The strict protocol approach based on the systemic evaluation of severely ill pregnant women with complications of hypertension and an intensive, regular feedback mechanism has been associated with a reduction in the number of patients with renal failure and cerebral compromise

The growth of a culture of evidence-based obstetrics in South Africa: a qualitative case study

<p>Abstract</p> <p>Background</p> <p>While the past two decades have seen a shift towards evidence-based obstetrics and midwifery, the process through which a culture of evidence-based practice develops and is sustained within particular fields of clinical practice has not been well documented, particularly in LMICs (low- and middle-income countries). Forming part of a broader qualitative study of evidence-based policy making, this paper describes the development of a culture of evidence-based practice amongst maternal health policy makers and senior academic obstetricians in South Africa</p> <p>Methods</p> <p>A qualitative case-study approach was used. This included a literature review, a policy document review, a timeline of key events and the collection and analysis of 15 interviews with policy makers and academic clinicians involved in these policy processes and sampled using a purposive approach. The data was analysed thematically.</p> <p>Results</p> <p>The concept of evidence-based medicine became embedded in South African academic obstetrics at a very early stage in relation to the development of the concept internationally. The diffusion of this concept into local academic obstetrics was facilitated by contact and exchange between local academic obstetricians, opinion leaders in international research and structures promoting evidence-based practice. Furthermore the growing acceptance of the concept was stimulated locally through the use of existing professional networks and meetings to share ideas and the contribution of local researchers to building the evidence base for obstetrics both locally and internationally. As a testimony to the extent of the diffusion of evidence-based medicine, South Africa has strongly evidence-based policies for maternal health.</p> <p>Conclusion</p> <p>This case study shows that the combined efforts of local and international researchers can create a culture of evidence-based medicine within one country. It also shows that doing so required time and perseverance from international researchers combined with a readiness by local researchers to receive and actively promote the practice.</p

Translating research into policy: lessons learned from eclampsia treatment and malaria control in three southern African countries

<p>Abstract</p> <p>Background</p> <p>Little is known about the process of knowledge translation in low- and middle-income countries. We studied policymaking processes in Mozambique, South Africa and Zimbabwe to understand the factors affecting the use of research evidence in national policy development, with a particular focus on the findings from randomized control trials (RCTs). We examined two cases: the use of magnesium sulphate (MgSO₄) in the treatment of eclampsia in pregnancy (a clinical case); and the use of insecticide treated bed nets and indoor residual household spraying for malaria vector control (a public health case).</p> <p>Methods</p> <p>We used a qualitative case-study methodology to explore the policy making process. We carried out key informants interviews with a range of research and policy stakeholders in each country, reviewed documents and developed timelines of key events. Using an iterative approach, we undertook a thematic analysis of the data.</p> <p>Findings</p> <p>Prior experience of particular interventions, local champions, stakeholders and international networks, and the involvement of researchers in policy development were important in knowledge translation for both case studies. Key differences across the two case studies included the nature of the evidence, with clear evidence of efficacy for MgSO₄and ongoing debate regarding the efficacy of bed nets compared with spraying; local researcher involvement in international evidence production, which was stronger for MgSO₄than for malaria vector control; and a long-standing culture of evidence-based health care within obstetrics. Other differences were the importance of bureaucratic processes for clinical regulatory approval of MgSO₄, and regional networks and political interests for malaria control. In contrast to treatment policies for eclampsia, a diverse group of stakeholders with varied interests, differing in their use and interpretation of evidence, was involved in malaria policy decisions in the three countries.</p> <p>Conclusion</p> <p>Translating research knowledge into policy is a complex and context sensitive process. Researchers aiming to enhance knowledge translation need to be aware of factors influencing the demand for different types of research; interact and work closely with key policy stakeholders, networks and local champions; and acknowledge the roles of important interest groups.</p

The Magpie Trial follow up study: outcome after discharge from hospital for women and children recruited to a trial comparing magnesium sulphate with placebo for pre-eclampsia

Contributing member: Caroline Crowther is listed as a member of the Magpie Trial Follow Up Study Collaborative GroupBACKGROUND: The Magpie Trial compared magnesium sulphate with placebo for women with pre-eclampsia. 10,141 women were recruited, 8804 before delivery. Overall, 9024 children were included in the analysis of outcome at discharge from hospital. Magnesium sulphate more than halved the risk of eclampsia, and probably reduced the risk of maternal death. There did not appear to be any substantive harmful effects on the baby, in the short term. It is now important to assess whether these benefits persist, and to provide adequate reassurance about longer term safety. The main objective of the Magpie Trial Follow Up Study is to assess whether in utero exposure to magnesium sulphate has a clinically important effect on the child's chance of surviving without major neurosensory disability. Other objectives are to assess long term outcome for the mother, and to develop and assess appropriate strategies for following up large numbers of children in perinatal trials. STUDY DESIGN: Follow up is only feasible in selected centres. We therefore anticipate contacting 2800–3350 families, for 2435–2915 of whom the woman was randomised before delivery. A further 280–335 children would have been eligible for follow up if they had survived. The total sample size for the children is therefore 3080–3685, 2680–3210 of whom will have been born to women randomised before delivery. Families eligible for the follow up will be contacted, and surviving children screened using the Ages and Stages Questionnaires. Children who screen positive, and a sample of those who screen negative, will whenever possible have a paediatric and neurodevelopmental assessment. When women are contacted to ask how their child is, they will also be asked about their own health. The primary outcome is a composite measure of death or neurosensory disability for the child at 18 months. DISCUSSION: The Follow Up Study began in 2002, and now involves collaborators in 19 countries. Data collection will close at the end of 2003

Women's experiences of participating in the Magpie Trial: a postal survey in the United Kingdom.

BACKGROUND: The Magpie Trial compared magnesium sulfate with placebo for women with preeclampsia. The objective of this study was to explore women's views and experiences of participating in the Magpie Trial in the United Kingdom. METHODS: Postal questionnaires were sent to 771 women participants in the Magpie Trial to assess long-term health of UK women and children. The questionnaire included three questions exploring women's experience of participating in the trial: (a) If time suddenly went backward, and you had to do it all over again, would you agree to participate in the Magpie Trial? (b) Please tell us if there was anything about the Magpie Trial that you think could have been done better; and (c) Please tell us if there was anything about the Magpie Trial, or your experience of joining the trial, that you think was particularly good. RESULTS: Overall, 619 of the 771 women who were sent questionnaires returned them. In response to the three questions: (a) 58 percent (356) of women responded "definitely yes," 27 percent (169) "probably yes," 4 percent (23) "probably no," 5 percent (33) "definitely no," and 5 percent (34) "not sure." No clear evidence was shown of a relationship with allocated treatment, although women who responded "probably or definitely no" were more likely to have had side effects from trial treatment. (b) Although 44 percent of women stated that nothing could have been done better, free text suggestions related to content of recruitment information, and its timing, and wanting to know treatment allocation and trial results. c) Women were generally extremely positive about being followed up and receiving trial results. CONCLUSIONS: Women were largely positive about participation in the trial and its follow-up, but still reported ways they believed the study could have been improved, such as more information, given earlier, which also has implications for clinical care