Objective To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public. Design Cross sectional analysisSetting Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009. Data sourcesPubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database. Main outcome measuresThe frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database. ResultsOf 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov.Conclusions Among this group of large clinical trials, non-publication of results was common and the availability of results in the ClinicalTrials.gov database was limited. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results. IntroductionRandomized clinical trials are a critical means of advancing medical knowledge. Clinical trials depend on the willingness of participants to expose themselves to the risks of randomization, blinding, and unproven interventions. The ethical justification for these risks is that society will eventually benefit from the knowledge gained from the trial.1 Because the risks involved in trial participation may be significant, and because individual trial participants often do not benefit directly from trial participation, substantial safeguards have been implemented to protect the interests of study participants both prior to and during the trial.2 These safeguards take multiple forms, including oversight by institutional review boards, the informed consent process, and data and safety monitoring boards. Until recently, the protection of the interests of study participants after trial completion has received significantly less emphasis. This began to change in 1997 with the signing of the Food and Drug Administration Modernization Act in the United States, which mandated that the US Department of Health and Human Services establish a registry of clinical trials, thereby providing permanent, public access to information on the conduct of both publicly and privately funded clinical trials. In 2005 the International Committee of Medical...
BackgroundClinical trial registries can improve the validity of trial results by facilitating comparisons between prospectively planned and reported outcomes. Previous reports on the frequency of planned and reported outcome inconsistencies have reported widely discrepant results. It is unknown whether these discrepancies are due to differences between the included trials, or to methodological differences between studies. We aimed to systematically review the prevalence and nature of discrepancies between registered and published outcomes among clinical trials.MethodsWe searched MEDLINE via PubMed, EMBASE, and CINAHL, and checked references of included publications to identify studies that compared trial outcomes as documented in a publicly accessible clinical trials registry with published trial outcomes. Two authors independently selected eligible studies and performed data extraction. We present summary data rather than pooled analyses owing to methodological heterogeneity among the included studies.ResultsTwenty-seven studies were eligible for inclusion. The overall risk of bias among included studies was moderate to high. These studies assessed outcome agreement for a median of 65 individual trials (interquartile range [IQR] 25–110). The median proportion of trials with an identified discrepancy between the registered and published primary outcome was 31 %; substantial variability in the prevalence of these primary outcome discrepancies was observed among the included studies (range 0 % (0/66) to 100 % (1/1), IQR 17–45 %). We found less variability within the subset of studies that assessed the agreement between prospectively registered outcomes and published outcomes, among which the median observed discrepancy rate was 41 % (range 30 % (13/43) to 100 % (1/1), IQR 33–48 %). The nature of observed primary outcome discrepancies also varied substantially between included studies. Among the studies providing detailed descriptions of these outcome discrepancies, a median of 13 % of trials introduced a new, unregistered outcome in the published manuscript (IQR 5–16 %).ConclusionsDiscrepancies between registered and published outcomes of clinical trials are common regardless of funding mechanism or the journals in which they are published. Consistent reporting of prospectively defined outcomes and consistent utilization of registry data during the peer review process may improve the validity of clinical trial publications.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-015-0520-3) contains supplementary material, which is available to authorized users.
BackgroundPublication bias is a major threat to the validity of systematic reviews. Searches of clinical trials registries can help to identify unpublished trials, though little is known about how often these resources are utilized. We assessed the usage and results of registry searches reported in systematic reviews published in major general medical journals.MethodsThis cross-sectional analysis includes data from systematic reviews assessing medical interventions which were published in one of six major general medical journals between July 2012 and June 2013. Two authors independently examined each published systematic review and all available supplementary materials to determine whether at least one clinical trials registry was searched.ResultsOf the 117 included systematic reviews, 41 (35%) reported searching a trials registry. Of the 29 reviews which also provided detailed registry search results, 15 (52%) identified at least one completed trial and 18 (62%) identified at least one ongoing trial.ConclusionsClinical trials registry searches are not routinely included in systematic reviews published in major medical journals. Routine examination of registry databases may allow a more accurate characterization of publication and outcome reporting biases and improve the validity of estimated effects of medical treatments.
Study objective Publication bias compromises the validity of systematic reviews. This problem can be addressed in part through searching clinical trials registries to identify unpublished studies. This study aims to determine how often systematic reviews published in emergency medicine journals include clinical trials registry searches. Methods We identified all systematic reviews published in the 6 highest-impact emergency medicine journals between January 1 and December 31, 2013. Systematic reviews that assessed the effects of an intervention were further examined to determine whether the authors described searching a clinical trials registry and whether this search identified relevant unpublished studies. Results Of 191 articles identified through PubMed search, 80 were confirmed to be systematic reviews. Our sample consisted of 41 systematic reviews that assessed a specific intervention. Eight of these 41 (20%) searched a clinical trials registry. For 4 of these 8 reviews, the registry search identified at least 1 relevant unpublished study. Conclusion Systematic reviews published in emergency medicine journals do not routinely include searches of clinical trials registries. By helping authors identify unpublished trial data, the addition of registry searches may improve the validity of systematic reviews.
Background: Analgesic guidelines are lacking for most operative pediatric fractures, and little is known about postdischarge opioid use or pain control. We hypothesized that opioid/acetaminophen/non-steroidal anti-inflammatory drugs (NSAID) prescribing would vary, pain would be well controlled, and postdischarge opioid use would be low. Methods: This prospective cohort study included nonpolytraumatized patients aged 17 years and below with operative fractures at a level 1 trauma center from August 1, 2019 to March 31, 2021. Supracondylar humerus fractures were excluded since they have been studied extensively. Information regarding injury/surgery/ analgesics were collected. Discharged patients were called on postoperative days (POD) 1/3/5. Parents/guardians were asked about analgesic use and pain over the preceding 2 days. Complications, pain control, and opioid refills were recorded after first follow-up. Results: All 100 eligible patients were included. Mean age was 10.1 years (range: 1.8 to 17.8 y). Common fracture types were humeral condyle/epicondyle (28%), radius/ulna (15%), and femoral shaft (13%). Opioids were prescribed to 95% of patients with mean 14 doses (range: 2 to 45). Acetaminophen/NSAIDs were prescribed to 74% and 60% of patients, respectively. Eleven patients were excluded from telephone follow-up (7 non-English speaking, 3 prohibitive social situations, 1 inpatient POD1 to 5). Telephone follow-up was completed for 87/89 eligible patients (98%). Mean pain scores declined from 3.7/10 POD1 to 2.4/10 POD5. Opioids were taken by 50% POD1, 20% POD5. Acetaminophen/NSAID was given before opioid 82% of the time. By POD5, mean total doses of opioid taken postdischarge was 2.3; mean proportion of prescribed opioid doses taken was 22%; and 97% of patients took ≤ 8 opioid doses postdischarge. Two patients were evaluated early due to poor pain control which improved with cast changes. Pain was well controlled or absent at follow-up in 97% of patients.Conclusions: Pain is consistently well controlled after operative pediatric fractures. Nearly all were prescribed opioids, while acetaminophen/NSAIDs were inconsistently prescribed and used. Opioid prescriptions are written for 4 to 5 times the amount needed. Prescribing ≤ 8 doses of opioid is adequate for acute pain through POD5 in 97% of patients. Poorly controlled pain should prompt early evaluation for possible complications.
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