Regina Kunz

Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence

Objective To evaluate the effects of dietary and lifestyle interventions in pregnancy on maternal and fetal weight and to quantify the effects of these interventions on obstetric outcomes. Design Systematic review and meta-analysis. Data sources Major databases from inception to January 2012 without language restrictions. Study selection Randomised controlled trials that evaluated any dietary or lifestyle interventions with potential to influence maternal weight during pregnancy and outcomes of pregnancy. Data synthesis Results summarised as relative risks for dichotomous data and mean differences for continuous data. Results We identified 44 relevant randomised controlled trials (7278 women) evaluating three categories of interventions: diet, physical activity, and a mixed approach. Overall, there was 1.42 kg reduction (95% confidence interval 0.95 to 1.89 kg) in gestational weight gain with any intervention compared with control. With all interventions combined, there were no significant differences in birth weight (mean difference −50 g, −100 to 0 g) and the incidence of large for gestational age (relative risk 0.85, 0.66 to 1.09) or small for gestational age (1.00, 0.78 to 1.28) babies between the groups, though by itself physical activity was associated with reduced birth weight (mean difference −60 g, −120 to −10 g). Interventions were associated with a reduced the risk of pre-eclampsia (0.74, 0.60 to 0.92) and shoulder dystocia (0.39, 0.22 to 0.70), with no significant effect on other critically important outcomes. Dietary intervention resulted in the largest reduction in maternal gestational weight gain (3.84 kg, 2.45 to 5.22 kg), with improved pregnancy outcomes compared with other interventions. The overall evidence rating was low to very low for important outcomes such as pre-eclampsia, gestational diabetes, gestational hypertension, and preterm delivery. Conclusions Dietary and lifestyle interventions in pregnancy can reduce maternal gestational weight gain and improve outcomes for both mother and baby. Among the interventions, those based on diet are the most effective and are associated with reductions in maternal gestational weight gain and improved obstetric outcomes.

Interventions to Reduce or Prevent Obesity in Pregnant Women: A Systematic Review

BACKGROUNDnAround 50% of women of childbearing age are either overweight [body mass index (BMI) 25-29.9 kg/m(2)] or obese (BMI ≥ 30 kg/m(2)). The antenatal period provides an opportunity to manage weight in pregnancy. This has the potential to reduce maternal and fetal complications associated with excess weight gain and obesity.nnnOBJECTIVESnTo evaluate the effectiveness of dietary and lifestyle interventions in reducing or preventing obesity in pregnancy and to assess the beneficial and adverse effects of the interventions on obstetric, fetal and neonatal outcomes.nnnDATA SOURCESnMajor electronic databases including MEDLINE, EMBASE, BIOSIS and Science Citation Index were searched (1950 until March 2011) to identify relevant citations. Language restrictions were not applied.nnnREVIEW METHODSnSystematic reviews of the effectiveness and harm of the interventions were carried out using a methodology in line with current recommendations. Studies that evaluated any dietary, physical activity or mixed approach intervention with the potential to influence weight change in pregnancy were included. The quality of the studies was assessed using accepted contemporary standards. Results were summarised as pooled relative risks (RRs) with 95% confidence intervals (CIs) for dichotomous data. Continuous data were summarised as mean difference (MD) with standard deviation. The quality of the overall evidence synthesised for each outcome was summarised using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology and reported graphically as a two-dimensional chart.nnnRESULTSnA total of 88 studies (40 randomised and 48 non-randomised and observational studies, involving 182,139 women) evaluated the effect of weight management interventions in pregnancy on maternal and fetal outcomes. Twenty-six studies involving 468,858 women reported the adverse effect of the interventions. Meta-analysis of 30 RCTs (4503 women) showed a reduction in weight gain in the intervention group of 0.97 kg compared with the control group (95% CI -1.60 kg to -0.34 kg; p = 0.003). Weight management interventions overall in pregnancy resulted in a significant reduction in the incidence of pre-eclampsia (RR 0.74, 95% CI 0.59 to 0.92; p = 0.008) and shoulder dystocia (RR 0.39, 95% CI 0.22 to 0.70; p = 0.02). Dietary interventions in pregnancy resulted in a significant decrease in the risk of pre-eclampsia (RR 0.67, 95% CI 0.53 to 0.85; p = 0.0009), gestational hypertension (RR 0.30, 95% CI 0.10 to 0.88; p = 0.03) and preterm birth (RR 0.68, 95% CI 0.48 to 0.96; p = 0.03) and showed a trend in reducing the incidence of gestational diabetes (RR 0.52, 95% CI 0.27 to 1.03). There were no differences in the incidence of small-for-gestational-age infants between the groups (RR 0.99, 95% CI 0.76 to 1.29). There were no significant maternal or fetal adverse effects observed for the interventions in the included trials. The overall strength of evidence for weight gain in pregnancy and birthweight was moderate for all interventions considered together. There was high-quality evidence for small-for-gestational-age infants as an outcome. The quality of evidence for all interventions on pregnancy outcomes was very low to moderate. The quality of evidence for all adverse outcomes was very low.nnnLIMITATIONSnThe included studies varied in the reporting of population, intensity, type and frequency of intervention and patient complience, limiting the interpretation of the findings. There was significant heterogeneity for the beneficial effect of diet on gestational weight gain.nnnCONCLUSIONSnInterventions in pregnancy to manage weight result in a significant reduction in weight gain in pregnancy (evidence quality was moderate). Dietary interventions are the most effective type of intervention in pregnancy in reducing gestational weight gain and the risks of pre-eclampsia, gestational hypertension and shoulder dystocia. There is no evidence of harm as a result of the dietary and physical activity-based interventions in pregnancy. Individual patient data meta-analysis is needed to provide robust evidence on the differential effect of intervention in various groups based on BMI, age, parity, socioeconomic status and medical conditions in pregnancy.

A Web-Based Electronic Patient Record System as a Means for Collection of Clinical Data

Availability of valid data is a prerequisite for medical data analysis. Traditional data collection (prospective studies, registries, use of administrative data) tends to be either expensive or inaccurate. By transferring the workflow of routine patient care to an electronic patient record(EPR), large amounts of detailed information are stored in a retrievable format, but the maintainance of EPRs in mainframe- or client/server-architecture is expensive. We therefore investigated the feasibility of an EPR based entirely on Web-Technology. The system is now operational since two years and has replaced the former paper-based patient records of the outpatient clinic completely (now 789 patients). With an average duration of access to all values of a specific laboratory day for a given patient taking 0.9s (SD:0.5s) and the automatic composition of a discharge letter taking 6.1s (SD:2.4s) the speed is adequate. We intend to enlarge the data pool by proliferating the system to other institutions.

Evidenzbasierte Leitlinien – Wo stehen wir heute?

Zusammenfassung. Leitlinien dienen als wichtiges Hilfsmittel zu einer Verbesserung der Versorgung, wobei evidenzbasierten Leitlinien wegen der transparenten Erstellung und der expliziten Nutzung von patientenorientierten Studien eine besondere Glaubwürdigkeit eingeräumt wird. Mit der Erstellung der evidenzbasierten Leitlinie „Management der Frühen Rheumatoiden Arthritis” an der Schnittstelle Primär-/Sekundärversorgung durch eine interdisziplinäre Arbeitsgruppe sollen existierende Versorgungsdefizite ausgeglichen werden.Summary. Guidelines have proven to be an important tool for improving quality of health care. Evidence-based guidelines are particularly well accepted and have a high degree of credibility based on the transparent process of their development and the explicit use of clinical patient-oriented research, on which the recommendations are based. The goal of the guidelines „Management of early rheumatoid arthritis”, currently developed by an interdisciplinary working group, isu2009to minimize out existing deficiencies in the provision of health care.

Evidenzbasierte Medizin – Von der Evidenz-Produktion zu ihrer Nutzung

Zusammenfassung Dem zunehmenden Bedürfnis nach mehr Qualität und Transparenz in der individuellen Patientenversorgung wie den Leistungen im Gesundheitssystem kommen die Konzepte der evidenzbasierten Medizin und der evidenzbasierten Gesundheitsversorgung entgegen, die anhand von klaren und transparenten Kriterien die verfügbaren Handlungsstrategien im Gesundheitswesen kritisch auf Wirkung und Nutzen für den einzelnen Patient und Patientengruppen untersuchen. Damit liefert diese Methode einen wichtigen Beitrag für die Umsetzung einer rationalen Medizin.Summary Evidence-based medicine (EBM) and evidence-based health care (EBHC) is one answer to the increasing need for quality and transparency in the care of individual patients as well as health care services. Using explicit and sound methodological criteria, EBM and EBHC question current management strategies for their effectiveness and usefulness to individual patients and patient groups. This approach therefore supports the implementation of rational patient-oriented care.

Evidence-Based Assessment of PET in Germany

TO THE EDITOR: The article by Weber (1) offers some interesting interpretations of how PET is currently being assessed not only in Germany by the Institute for Quality and Efficiency in Health Care (IQWiG) but also in other countries. However, the author made an incorrect statement about IQWiG that needs to be clarified. IQWiG does not “typically give grants to small companies specialized in preparing systematic reviews.” IQWiG has actually established a diligent process of selecting and commissioning external partners who have profound expertise both in evidence-based methodology and in the clinical field concerned. In most cases, IQWiG’s external experts are based or have previously worked at highly reputed universities. This can be easily checked on our Web site. However, the full range of expertise involved in IQWiG reports is not presented on the Web site, as some external experts prefer not to be named. In addition, we would like to note that every report on PET published by IQWiG was prepared in collaboration with at least one experienced clinician.

Abschnitt A: Schritte eines systematischen Reviews

Abschnitt A begleitet Sie Schritt fur Schritt durch die einzelnen Phasen der Reviewerstellung. Es sind insgesamt nur funf Schritte. In jedem Schritt werden die grundlegenden Prinzipien eines Reviews anhand von Beispielen aus veroffentlichten Reviews erlautert. Viele Beispiele werden Ihnen in den einzelnen Schritten wieder begegnen und Ihnen auf diese Weise die Verknupfung der verschiedenen Reviewphasen vor Augen fuhren.

Ziele und Methoden klinischer Studien

Zusammenfassung Bei der klinischen Patienten-orientierten Forschung spielen bekannte und unbekannte Faktoren, die durch Bias, Confounding und Zufall Einfluß auf das Ergebnis nehmen können, eine nicht unerhebliche Rolle. Die gängigen Studientypen sind dieser Gefahr in unterschiedlichem Maße ausgesetzt. Nur durch die Bearbeitung fokusierter Fragestellungen und eine konsequente Integration methodischer Regeln aus der klinisch-epidemiologischen Forschung in der Planungs- und Durchführungsphase läßt sich falschen Ergebnissen angemessen vorbeugen.Summary The validity of clinical patient-oriented research is always threatened by the influence of bias, confounding factors or random effects that might distort the results. However, the susceptibility to distortion varies between different study designs. The best protection against spurious relationships or distorted results are specific focused research questions and rigorous integration of sound study methodology during the design and performance phase.

The Role of Evidence-Based Guidelines in Managed Care Pilot Projects in Germany

Purpose: This paper outlines recent fundamental changes in the framework of the German health care system and presents diverse managed care projects and initiatives to standarize patient management using guidelines as a response to these changes. Main findings: Increasing health care costs and a decline in budget to the statutory health insurances have urged fundamental structural changes in the long-existing German health care system. New legislation introduced competition between health insurers and pushed for pilot projects in managed care. The concepts of some of the new initiatives are presented. All initiatives recognized the need for standardization and disease management, supported by guidelines. The consensus-based guidelines produced by different stakeholders, however, did not prove helpful in patient management. The foundation for an evidence-based, scientifically sound guideline development process has been laid by physicians organizations. Conclusions: The most recent changes to the health care system are promising. Their impact on urgently needed changes in the health care system remains to be seen.