title: A quality assessment tool to evaluate tocolytic studies.
abstract: Over the past 15 years, the use of beta-agonists has declined worldwide. Following the Royal College of Obstetricians and Gynaecologists guidelines in 2002, clinicians in the UK and beyond were faced with the dilemma of continuing to use beta-agonists, desist from using tocolytic therapy completely or choosing to change to atosiban or calcium channel blockers (CCBs). While grade A level 1 evidence exists to show that atosiban is significantly more efficacious than placebo and significantly safer than beta-agonists for the treatment of spontaneous preterm labour, the evidence for CCBs, such as nifedipine, is much less robust and no placebo-controlled trials have been performed. Published studies on nifedipine are largely investigator-led studies of small sample size, which lack sufficient power. As a result, most of the evidence has been based on meta-analyses of these studies, which look retrospectively at pooled data and are only as good as the quality of the studies included. In light of this, a tool was developed to produce a systematic review of studies on tocolytic effectiveness, which can and should be applied to all tocolytics and which considered both method- and topic-specific markers of quality. In the process of applying this tool to nifedipine, an extensive literature search identified 31 studies for a systematic review of the quality of nifedipine studies assessed by eight paired reviewers with wide experience in the subject of spontaneous preterm labour and preterm birth. Forty topic- and method-specific items of quality were assessed. The paucity of good quality studies of nifedipine used for the treatment of spontaneous preterm labour should be highlighted in meta-analyses or systematic reviews, which measure efficacy and should limit and influence the degree to which recommendations and guidelines are made on the basis of such studies.
authors.affiliation: Department of Obstetrics and Gynaecology, Northwick Park & St Mark's NHS Trust, London, UK.
authors.forename: R F
authors.initials: RF
authors.lastname: Lamont
mesh_terms: D000318:Adrenergic beta-Agonists / Q000627:therapeutic use; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000592:standards; D005260:Female; D006801:Humans; D015201:Meta-Analysis as Topic; D009543:Nifedipine / Q000627:therapeutic use; D007752:Obstetric Labor, Premature / Q000188:drug therapy*; D011247:Pregnancy; D011785:Quality Assurance, Health Care / Q000379:methods*; D015149:Tocolytic Agents / Q000627:therapeutic use*
chemical_list: D000318:Adrenergic beta-Agonists; D002121:Calcium Channel Blockers; D015149:Tocolytic Agents; D009543:Nifedipine