title: Clinical research on postoperative trauma care: has the position of observational studies changed?
abstract: OBJECTIVE
  The postoperative care regimes of ankle fractures are studied for over 30 years and recommendations have shifted only slightly in the last decades. However, study methodology might have evolved. The aim of this study was to evaluate the changes in time in the design, quality and outcome measures of studies investigating the postoperative care of ankle fractures.
  
  
  METHODS
  The MEDLINE and EMBASE database were searched for both RCTs and cohort studies. The original studies were divided into decades of publication over the last 30 years. The methodological quality of the studies was assessed using the 'traditional' risk of bias assessment tool provided by The Cochrane Collaboration and the 'newer' MINORS criteria.
  
  
  RESULTS
  The percentage of RCTs on this subject declined from 67 to 38 % in the last decades. According to the Cochrane tool, the reported quality of RCTs has improved in the last three decades whereas the reported quality of observational studies has remained unchanged. However, when quality was evaluated with the MINORS criteria, equal improvement was observed for both RCTs and observational studies. In the 80s, 67 % of all studies used the range of motion as the primary outcome measure, which decreased to 45 % in the 90s. In the 00s, none of the studies used the range of motion as the primary outcome.
  
  
  CONCLUSIONS
  For postoperative care of ankle fractures, results of this study showed a relative decrease in the published number of RCTs. The overall quality of the published articles did not decline. In addition, a gradual shift from physician measured to patient-reported outcome variables was observed. However, it should be borne in mind that the findings are based on a small sample (n = 25).
authors: Utrecht Traumacenter, Utrecht, The Netherlands. diederiksmeeing@hotmail.com.|Department of Surgery, University Medical Centre Utrecht, PO Box 85500, 3508, GA, Utrecht, The Netherlands. diederiksmeeing@hotmail.com.
authors: D P J
authors: DP
authors: Smeeing
authors: Utrecht Traumacenter, Utrecht, The Netherlands.|Department of Surgery, St Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands.
authors: R M
authors: RM
authors: Houwert
authors: Department of Orthopedic Surgery, University Medical Centre, Utrecht, The Netherlands.
authors: M C
authors: MC
authors: Kruyt
authors: Department of Orthopedic Surgery, SpaarneGasthuis, Hoofddorp, The Netherlands.
authors: O A J
authors: OA
authors: van der Meijden
authors: Department of Surgery, University Medical Centre Utrecht, PO Box 85500, 3508, GA, Utrecht, The Netherlands.
authors: F
authors: F
authors: Hietbrink
mesh_terms: D064386:Ankle Fractures / Q000601:surgery*; D035843:Biomedical Research; D006801:Humans; D064887:Observational Studies as Topic; D010043:Outcome and Process Assessment, Health Care; D011182:Postoperative Care; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
keywords: Ankle fracture; Epidemiology; Postoperative care; Research perspective; Study design