Philippa Middleton

Grading quality of evidence and strength of recommendations.

Abstract Users of clinical practice guidelines and other recommendations need to know how much confidence they can place in the recommendations. Systematic and explicit methods of making judgments can reduce errors and improve communication. We have developed a system for grading the quality of evidence and the strength of recommendations that can be applied across a wide range of interventions and contexts. In this article we present a summary of our approach from the perspective of a guideline user. Judgments about the strength of a recommendation require consideration of the balance between benefits and harms, the quality of the evidence, translation of the evidence into specific circumstances, and the certainty of the baseline risk. It is also important to consider costs (resource utilisation) before making a recommendation. Inconsistencies among systems for grading the quality of evidence and the strength of recommendations reduce their potential to facilitate critical appraisal and improve communication of these judgments. Our system for guiding these complex judgments balances the need for simplicity with the need for full and transparent consideration of all important issues. Clinical guidelines are only as good as the evidence and judgments they are based on. The GRADE approach aims to make it easier for users to assess the judgments behind recommendations

Surgical simulation: a systematic review.

Objective:To evaluate the effectiveness of surgical simulation compared with other methods of surgical training. Summary Background Data:Surgical simulation (with or without computers) is attractive because it avoids the use of patients for skills practice and provides relevant technical training for trainees before they operate on humans. Methods:Studies were identified through searches of MEDLINE, EMBASE, the Cochrane Library, and other databases until April 2005. Included studies must have been randomized controlled trials (RCTs) assessing any training technique using at least some elements of surgical simulation, which reported measures of surgical task performance. Results:Thirty RCTs with 760 participants were able to be included, although the quality of the RCTs was often poor. Computer simulation generally showed better results than no training at all (and than physical trainer/model training in one RCT), but was not convincingly superior to standard training (such as surgical drills) or video simulation (particularly when assessed by operative performance). Video simulation did not show consistently better results than groups with no training at all, and there were not enough data to determine if video simulation was better than standard training or the use of models. Model simulation may have been better than standard training, and cadaver training may have been better than model training. Conclusions:While there may be compelling reasons to reduce reliance on patients, cadavers, and animals for surgical training, none of the methods of simulated training has yet been shown to be better than other forms of surgical training.

[CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration].

Background Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract. Methods and Findings We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item. Conclusions CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trials validity and the applicability of its results.

Stillbirths: the way forward in high-income countries

Stillbirth rates in high-income countries declined dramatically from about 1940, but this decline has slowed or stalled over recent times. The present variation in stillbirth rates across and within high-income countries indicates that further reduction in stillbirth is possible. Large disparities (linked to disadvantage such as poverty) in stillbirth rates need to be addressed by providing more educational opportunities and improving living conditions for women. Placental pathologies and infection associated with preterm birth are linked to a substantial proportion of stillbirths. The proportion of unexplained stillbirths associated with under investigation continues to impede efforts in stillbirth prevention. Overweight, obesity, and smoking are important modifiable risk factors for stillbirth, and advanced maternal age is also an increasingly prevalent risk factor. Intensified efforts are needed to ameliorate the effects of these factors on stillbirth rates. Culturally appropriate preconception care and quality antenatal care that is accessible to all women has the potential to reduce stillbirth rates in high-income countries. Implementation of national perinatal mortality audit programmes aimed at improving the quality of care could substantially reduce stillbirths. Better data on numbers and causes of stillbirth are needed, and international consensus on definition and classification related to stillbirth is a priority. All parents should be offered a thorough investigation including a high-quality autopsy and placental histopathology. Parent organisations are powerful change agents and could have an important role in raising awareness to prevent stillbirth. Future research must focus on screening and interventions to reduce antepartum stillbirth as a result of placental dysfunction. Identification of ways to reduce maternal overweight and obesity is a high priority for high-income countries.

A Systematic Review of Strategies to Improve Prophylaxis for Venous Thromboembolism in Hospitals

Objective:To assess the effectiveness of different strategies for increasing the uptake of prophylaxis for venous thromboembolism (VTE) in hospitalized patients through a systematic review of the literature. Methods:Literature databases and the Internet were searched from 1996 to May 2003. Studies of strategies to improve VTE prophylaxis practice were included. Studies where no policy or guideline was implemented or where the focus of the study was not VTE prevention were excluded. Results:Thirty studies were included. The quality of the available evidence was average with the majority of studies being uncontrolled before and after design and thus limited by the historical nature of much of the available data. Adherence to guidelines and the provision of adequate prophylaxis were poor in studies which relied on passive dissemination of guidelines. In general, the use of multiple strategies was more effective than a single strategy used in isolation. The most effective strategies incorporated a system for reminding clinicians to assess patients for VTE risk, either electronic decision-support systems or paper-based reminders, and used audit and feedback to facilitate the iterative refinement of the intervention. There were no studies adequately powered to demonstrate a reduction in rates of VTE. Insufficient evidence was available to make useful comparisons of strategies in terms of costs and resource utilization. Conclusions:Passive dissemination of guidelines is unlikely to improve VTE prophylaxis practice. A number of active strategies used together, which incorporate some method for reminding clinicians to assess patients for DVT risk and assisting the selection of appropriate prophylaxis, are likely to result in the achievement of optimal outcomes.

CONSORT for reporting randomised trials in journal and conference abstracts

www.thelancet.com Vol 371 January 26, 2008 281 To facilitate understanding of mechanisms that mediate the association between parental education and physical growth of children, two crucial issues need to be addressed. First, Semba and colleagues’ results highlight the importance of identifying factors that mediate the infl uence of paternal education, and we cannot assume that the same mediators will hold for mothers and fathers. Second, there is evidence that mediators of the association between parental education and children’s growth do not function in isolation from each other, but are interlinked. For example, women who have some degree of control over family-resource allocation, or women living in families with more economic resources are at lower risk for depression than women without control over resource allocation or women living in poorer families. Even more crucially, the eff ect of a given mediator may vary as a function of the operation of other mediators. For example, the relation between maternal education and the mother’s decision-making power on household expenditures will vary as a function of the overall level of family resources, while the risk of growth failure for children of depressed mothers varies as a function of level of maternal intelligence. These fi ndings mean that we should study what infl uences a child’s physical growth within a multidimensional systems framework, where the eff ect of one mediator depends on those of other mediators. This complexity is needed because, in the real world, mediators rarely act alone.

Stillbirths: recall to action in high-income countries

Variation in stillbirth rates across high-income countries and large equity gaps within high-income countries persist. If all high-income countries achieved stillbirth rates equal to the best performing countries, 19,439 late gestation (28 weeks or more) stillbirths could have been avoided in 2015. The proportion of unexplained stillbirths is high and can be addressed through improvements in data collection, investigation, and classification, and with a better understanding of causal pathways. Substandard care contributes to 20-30% of all stillbirths and the contribution is even higher for late gestation intrapartum stillbirths. National perinatal mortality audit programmes need to be implemented in all high-income countries. The need to reduce stigma and fatalism related to stillbirth and to improve bereavement care are also clear, persisting priorities for action. In high-income countries, a woman living under adverse socioeconomic circumstances has twice the risk of having a stillborn child when compared to her more advantaged counterparts. Programmes at community and country level need to improve health in disadvantaged families to address these inequities.

Antenatal Magnesium Sulfate and Neurologic Outcome in Preterm Infants

OBJECTIVE: To systematically review rates of neurologic outcomes reported in childhood for the preterm fetus exposed to antenatal magnesium sulfate. DATA SOURCES: We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register, CENTRAL (The Cochrane Library 2008, Issue 3), relevant references from retrieved articles, and abstracts submitted to major congresses. METHODS OF STUDY SELECTION: We sought all randomized controlled trials (RCTs) of antenatal magnesium sulfate with neurologic outcomes reported for the fetus. TABULATION, INTEGRATION, AND RESULTS: Five eligible RCTs with 6,145 fetuses were identified; in four studies (4,446 fetuses) the primary intent was neuroprotection of the fetus. Methods of the Cochrane Collaboration were used to analyze the data. Antenatal magnesium sulfate therapy given to women at risk of preterm birth substantially reduced the risk of cerebral palsy in their children (relative risk [RR] 0.69; 95% confidence interval [CI] 0.54–0.87; five trials; 6,145 infants). The number needed to treat to prevent one case of cerebral palsy was 63 (95% CI 43–155). Moreover, there was a significant reduction in the rate of substantial gross motor dysfunction (RR 0.61; 95% CI 0.44–0.85; four trials; 5,980 infants). No statistically significant effect of antenatal magnesium sulfate therapy was detected on pediatric mortality (RR 1.01; 95% CI 0.82–1.23; five trials; 6,145 infants), or on other neurologic impairments or disabilities in the first few years of life. There were no significant effects of antenatal magnesium sulfate on combined rates of mortality with neurologic outcomes, except in the studies where the primary intent was neuroprotection, where there was a reduction in death or cerebral palsy (RR 0.85; 95% CI 0.74–0.98; four trials; 4,446 infants). CONCLUSION: Antenatal magnesium sulfate therapy given to women at risk of preterm birth is neuroprotective against motor disorders in childhood for the preterm fetus.

FORM: An Australian method for formulating and grading recommendations in evidence-based clinical guidelines

BackgroundClinical practice guidelines are an important element of evidence-based practice. Considering an often complicated body of evidence can be problematic for guideline developers, who in the past may have resorted to using levels of evidence of individual studies as a quasi-indicator for the strength of a recommendation. This paper reports on the production and trial of a methodology and associated processes to assist Australian guideline developers in considering a body of evidence and grading the resulting guideline recommendations.MethodsIn recognition of the complexities of clinical guidelines and the multiple factors that influence choice in health care, a working group of experienced guideline consultants was formed under the auspices of the Australian National Health and Medical Research Council (NHMRC) to produce and pilot a framework to formulate and grade guideline recommendations. Consultation with national and international experts and extensive piloting informed the process.ResultsThe FORM framework consists of five components (evidence base, consistency, clinical impact, generalisability and applicability) which are used by guideline developers to structure their decisions on how to convey the strength of a recommendation through wording and grading via a considered judgement form. In parallel (but separate from the grading process) guideline developers are asked to consider implementation implications for each recommendation.ConclusionsThe framework has now been widely adopted by Australian guideline developers who find it to be a logical and intuitive way to formulate and grade recommendations in clinical practice guidelines.

Oral and dental health care practices in pregnant women in Australia: a postnatal survey

BackgroundThe aims of this study were to assess womens knowledge and experiences of dental health in pregnancy and to examine the self-care practices of pregnant women in relation to their oral health.MethodsWomen in the postnatal ward at the Womens and Childrens Hospital, Adelaide, completed a questionnaire to assess their knowledge, attitudes and practices to periodontal health. Pregnancy outcomes were collected from their medical records. Results were analysed by chi-square tests, using SAS.ResultsOf the 445 women enrolled in the survey, 388 (87 per cent) completed the questionnaire. Most women demonstrated reasonable knowledge about dental health. There was a significant association between dental knowledge and practices with both education and socio-economic status. Women with less education and lower socio-economic status were more likely to be at higher risk of poor periodontal health compared with women with greater levels of education and higher socioeconomic status.ConclusionMost women were knowledgeable about oral and dental health. Lack of knowledge about oral and dental health was strongly linked to women with lower education achievements and lower socioeconomic backgrounds. Whether more intensive dental health education in pregnancy can lead to improved oral health and ultimately improved pregnancy outcomes requires further study.