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Approximately 55 000 children are born in Norway each year. It is sometimes necessary to induce labour artificially. With respect to induction with drugs, misoprostol and dinoprostone are used irrespective of whether the cervix is mature or not, while oxytocin only is used when the cervix is mature. The Norwegian Board of Health Supervision asked The Norwegian Knowledge Centre for the health Services to systematically review the efficacy and safety of misoprostol for induction of labour. Method This report is an overview of systematic reviews. We performed systematic searches in Cochrane Library, CRD and Ovid Medline and Embase. All included publications were evaluated for quality. In addition, we evaluated the quality of the evidence and the strength of recommendations for selected outcomes. We also performed an evaluation of legal aspects regarding the use of misoprostol for induction of labour. Results Five systematic reviews met our inclusion criteria. In the systematic reviews misoprostol was given vaginally, orally, sublingually or buccally. Misoprostol was used in different dosages and dosage intervals from study to study. Our main findings were that vaginal and oral misoprostol was at least as effective as dinoprostone in inducing labour within 24 hours. However, it may have increased frequency of adverse events such as uterine hyperstimulation both without and with changes in fetal heart rate. Conclusion It may appear that safety is more sensitive to the dose of misoprostol than efficacy. For sublingual and buccal administration of misoprostol the amount of data were limited and we were not able to conclude on efficacy and safety.

Outcome assessment (Medical care) --- Abortifacients.

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The Norwegian Knowledge Centre for the Health Services (NOKC) has considered evidence submitted from a producer / supplier of medical equipment. The issue was whether it would be advisable to use the serum marker S100B in the diagnosis of minor head injuries instead of CT, based on evaluation of efficacy, safety and cost effectiveness. Roche Diagnostics submitted evidence and made reasonable changes in the intended use. Estimates of diagnostic accuracy shows that the ability of S100B to discover head injuries is likely to be slightly less than 100% compared with CT. This means that there may be patients with head injuries not detected by measurement of S100B. Submitted documentation for evaluation of cost-effectiveness is a cost-minimization analysis. The analysis assumes that clinical outcomes for the patients would be the same irrespective of being diagnosed using CT or the new alternative, S100B and selected CT. NOKC believes a switch from evaluation with CT to S100B analysis may lead to organizational changes for example reallocation of personnel. This is not considered in the submission. NOKC concludes that S100B compared with CT for patients with minor head injury does not necessarily give identical results. Therefore, the results of the submitted documentation, a cost-minimization, will not fully be able to answer the question of RHA Forum (Regional Health Authorities Forum for the commissioning of HTAs).

Calcium-binding proteins --- Head --- Physiological effect. --- Tomography. --- Wounds and injuries.

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Thromboembolism --- Antithrombins --- Knee --- Prevention. --- Physiological effect. --- Surgery.

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Background Patients with the inflammatory bowel diseases ulcerative colitis and Crohn's disease need lifelong treatment and care. Effect of traditional treatments is varied and may cause serious adverse events. Biological drugs aimed at blocking specific molecular steps in the inflammatory process have been developed. Tumor necrosis factor (TNF)α is a proinflammatory cytokine with a role in the inflammatory process associated with inflammatory bowel disease. Hence, a drug blocking this cytokine might be useful for patients with ulcerative colitis and Crohn's disease. This report includes knowledge of the TNFα-inhibitors infliximab (Remicade(r)), adalimumab (Humira(r)), etanercept (Enbrel(r)) and certolizumab pegol (Cimzia(r)). Method We systematically reviewed and critically appraised available documentation on effect and safety of TNFα-inhibitors. In addition, we have reviewed health economic studies. We identified documentation by a systematic search in Cochrane Library, Medline, Embase, PubMed and NHS Economics Evaluation Database. Our evaluation on efficacy and safety was based on systematic reviews. However, to make sure that all available data was included, we searched for randomized controlled trials published afer the literature seach in the systematic reviews was performed. Results In patients with ulcerative colitis, infliximab was more effective than placebo in achieving improvement of the disease. Data on response and remission are available up to 54 weeks. Infliximab gives a higer proportion of patients with endoscopic remission compared to placebo. None of the other TNFα-inhibitors were tested in patients with ulcerative colitis. In patients with Crohn's disease, infliximab, adalimumab and certolizumab were more effective than placebo in achieving response after induction treatment (1-3 administrations of drug or placebo). Based on patients responding to induction treatment, it has been shown that maintenance treatment with infliximab, adalimumab and certolizumab is more effective than placebo in maintaining the initial response. Infliximab has been showed to be more effective than placebo in achieving fistula closure. Data on etanercerpt in treatment of Crohn's disease is limited. There is no basis to claim that etanercerpt has effect in treatment of Crohn's disease. We identified four economic evaluations in a systematic literature search. All studies were from countries outside Norway and dealt with infliximab treatment of patients with Crohn's disease. Conclusion Infliximab is effective in treatment of ulcerative colitis and Crohn's disease. Adalimumab and certolizumab have documented effect in treatment of Crohn's disease, while studies on patients with ulcerative colitis are lacking. There is too limited data available to conclude regarding safety of long-term treatment with TNFα-inhibitors for both ulcerative colitis and Crohn's disease. Based on results from countries outside Norway, infliximab does not seem to be cost-effective as continuous treatment for patients with Crohn's disease. There might be an exception in the case of patients exhibiting good and long-lasting response. No relevant economic studies were found for ulcerative colitis or for the other TNFα-inhibitors.

Tumor necrosis factor. --- Inflammatory bowel diseases --- Anti-inflammatory agents. --- Treatment.

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Approximately 55 000 children are born in Norway each year. It is sometimes necessary to induce labour artificially. With respect to induction with drugs, misoprostol and dinoprostone are used irrespective of whether the cervix is mature or not, while oxytocin only is used when the cervix is mature. The Norwegian Board of Health Supervision asked The Norwegian Knowledge Centre for the health Services to systematically review the efficacy and safety of misoprostol for induction of labour. Method This report is an overview of systematic reviews. We performed systematic searches in Cochrane Library, CRD and Ovid Medline and Embase. All included publications were evaluated for quality. In addition, we evaluated the quality of the evidence and the strength of recommendations for selected outcomes. We also performed an evaluation of legal aspects regarding the use of misoprostol for induction of labour. Results Five systematic reviews met our inclusion criteria. In the systematic reviews misoprostol was given vaginally, orally, sublingually or buccally. Misoprostol was used in different dosages and dosage intervals from study to study. Our main findings were that vaginal and oral misoprostol was at least as effective as dinoprostone in inducing labour within 24 hours. However, it may have increased frequency of adverse events such as uterine hyperstimulation both without and with changes in fetal heart rate. Conclusion It may appear that safety is more sensitive to the dose of misoprostol than efficacy. For sublingual and buccal administration of misoprostol the amount of data were limited and we were not able to conclude on efficacy and safety.

Outcome assessment (Medical care) --- Abortifacients.