Clinical research on postoperative trauma care: has the position of observational studies changed?

Abstract

ObjectiveThe 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.MethodsThe 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.ResultsThe 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.ConclusionFor 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).

Comparison of analgesic interventions for traumatic rib fractures: a systematic review and meta-analysis

“…Another strength of this systematic review is that a considerable amount of extra studies was included due to inclusion of observational studies. In addition, as stated in recently published systematic reviews [15, 51, 52], the inclusion of both RCTs and observational studies might lead to more study power. If observational studies are of sufficient quality, the results will correspond with those of an RCT [15, 51, 52].…”

“…In addition, as stated in recently published systematic reviews [15, 51, 52], the inclusion of both RCTs and observational studies might lead to more study power. If observational studies are of sufficient quality, the results will correspond with those of an RCT [15, 51, 52]. Furthermore, it appears to give a better reflection of common clinical practice, which might improve the generalizability and applicability of the outcomes of a systematic review [51, 52].…”

“…If observational studies are of sufficient quality, the results will correspond with those of an RCT [15, 51, 52]. Furthermore, it appears to give a better reflection of common clinical practice, which might improve the generalizability and applicability of the outcomes of a systematic review [51, 52].…”