ABSTRACT
BACKGROUND: Both the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines recommend that clinical trials follow a study framework that aligns with their objective to test the relative efficacy or safety (equality) or effectiveness (superiority, noninferiority, or equivalence) between interventions. We conducted a systematic review to assess the proportion of studies that demonstrated inconsistency between the framing of their research question, sample size calculation, and conclusion and those that should have framed their research question differently based on the compared interventions. METHODS: We included studies from 5 high-impact-factor orthopaedic journals published in 2017 and 2019 that compared at least 2 interventions using patient-reported outcome measures. RESULTS: We included 228 studies. The sample size calculation was reported in 60.5% (n = 138) of studies. Of these, 52.2% (n = 72) were inconsistent between the framing of their research question, sample size calculation, and conclusion. The majority (n = 137) of sample size calculations were for equality, but 43.8% of these studies concluded superiority, noninferiority, or equivalence. Studies that framed their research question as equality (n = 186) should have been framed as superiority (n = 129), equivalence (n = 52), or noninferiority (n = 3). Only 2 studies correctly framed their research question as equality. CONCLUSIONS: Studies published in high-impact journals were inconsistent between the framing of their research question, sample size calculation, and conclusion. Authors may be misinterpreting research findings and making clinical recommendations solely based on p values. Researchers are encouraged to state and justify their methodological framework and choice of margin(s) in a publicly published protocol as they have implications for sample size and the applicability of conclusions. CLINICAL RELEVANCE: The results of clinical research must be interpreted using confidence intervals, with careful consideration as to how the confidence intervals relate to clinically meaningful differences in outcomes between treatments. The more typical practice of relying on p values leaves the clinician at high risk of erroneous interpretation, recommendation, and/or action.
Subject(s)
Bibliometrics , Orthopedics , Periodicals as Topic , Research Design , HumansABSTRACT
Introduction: Tarlov cysts (TC) are sacral perineural cysts that are often found incidentally during spinal imaging. In a small fraction, symptomatic TC can cause pain, bowel, bladder and/or sexual dysfunction, as well as motor and sensory deficits. While many surgeons regard TCs as a non-operative entity, there have been suggestions that operative intervention in carefully selected symptomatic patients may be beneficial. The aim of this meta-analysis is to identify whether surgical treatment for symptomatic TCs is beneficial with an acceptable complication profile.Materials and methods: The authors conducted a systematic outcome analysis of symptomatic TCs treated either with surgery or conservatively managed.Results: Sixteen studies (N = 238) met the inclusion criteria for final meta-analysis. The literature search was performed using PubMed, Ovid MEDLINE, CINAHL, and EMBASE databases up to September 2017 and with an updated search in April 2019. The post-operative complication rate in patients undergoing surgical intervention was 16.9 (11.8 to 22.7) and cyst recurrence was 8.5 (3.5 to 15.4). When a complication occurred, the most frequent complication of surgical intervention was the development of a surgical site infection and/or CSF leak. Of the 15 studies reporting long-term follow-up, 81.0 (74.0-88.0) of patients remained symptom-free for more than 1 year (Mean: 27.5 months, SD = 11.5).Conclusion: We rigorously analyse the efficacy of open surgical decompression and repair of symptomatic TCs and corroborate the findings of sustained long-term resolution of symptoms.
ABSTRACT
BACKGROUND: The Consolidated Standards of Reporting Trials (CONSORT) Statement recommends that studies report results beyond p values and include treatment effect(s) and measures of precision (e.g., confidence intervals [CIs]) to facilitate the interpretation of results. The objective of this systematic review was to assess the reporting and interpretation of patient-reported outcome measure (PROM) results in clinical studies from high-impact orthopaedic journals, to determine the proportion of studies that (1) only reported a p value; (2) reported a treatment effect, CI, or minimal clinically important difference (MCID); and (3) offered an interpretation of the results beyond interpreting a p value. METHODS: We included studies from 5 high-impact-factor orthopaedic journals published in 2017 and 2019 that compared at least 2 intervention groups using PROMs. RESULTS: A total of 228 studies were analyzed, including 126 randomized controlled trials, 35 prospective cohort studies, 61 retrospective cohort studies, 1 mixed cohort study, and 5 case-control studies. Seventy-six percent of studies (174) reported p values exclusively to express and interpret between-group differences, and only 22.4% (51) reported a treatment effect (mean difference, mean change, or odds ratio) with 95% CI. Of the 54 studies reporting a treatment effect, 31 interpreted the results using an important threshold (MCID, margin, or Cohen d), but only 3 interpreted the CIs. We found an absolute improvement of 35.5% (95% CI, 20.8% to 48.4%) in the reporting of the MCID between 2017 and 2019. CONCLUSIONS: The majority of interventional studies reporting PROMs do not report CIs around between-group differences in outcome and do not define a clinically meaningful difference. A p value cannot effectively communicate the readiness for implementation in a clinical setting and may be misleading. Thus, reporting requirements should be expanded to require authors to define and provide a rationale for between-group clinically important difference thresholds, and study findings should be communicated by comparing CIs with these thresholds.
