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 sources PubMed, 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 Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.Main outcome measures The frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database.Results Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials.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 Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov.Conclusions Among this group of large clinical trials, non-publication of results was common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.
Clinical 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.
We 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.
Twenty-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%).
Discrepancies 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.
Objective
The purpose of this 2‐part study is to determine opioid prescribing patterns and opioid use and pain control after discharge following closed reduction of pediatric forearm fractures.
...Methods
A retrospective study was conducted from December 2016 to January 2018 at a level 1 trauma center to determine opioid prescribing habits for patients 1–17 years old with forearm fractures treated with closed reduction. A prospective study was then conducted from August 2019 to October 2020 to determine pain control and opioid use after discharge. Data were collected through chart review and with telephone surveys on post‐discharge days 1, 3, and 5 to collect pain scores and opioid use.
Results
Fifty patients with a median age of 8 (interquartile range IQR, 5–11) years old and 51 patients with a mean age of 9 (IQR, 6–11) years old were included in the retrospective and prospective cohorts, respectively. From the retrospective study, 21 patients (42%) were prescribed a median of 10 opioid doses (IQR, 8–12) at discharge. From the prospective study, 12 patients (24%) were discharged with a median of 8 opioid doses (IQR, 5.5–10), for a total of 98 total doses. Of those, only 7 doses (7%) were used by 3 patients. Higher weight and initial pain score were associated with increased rates of opioid prescription.
Conclusions
Pediatric patients who undergo closed reduction of a forearm fracture under procedural sedation in the emergency department are prescribed approximately 14 times the amount of opioid that is used. We propose that prescribing only non‐opioid analgesics to these patients would afford equivalent pain control without the side‐effects and abuse potential of opioid use at an early age.
To determine if preoperative administration of venous thromboembolism (VTE) chemoprophylaxis (PPx) before pelvic and acetabular fracture surgery affects estimated blood loss (EBL), perioperative ...change in hemoglobin (ΔHgb), or transfusion rates.
Retrospective cohort study.
Level 1 trauma center, southeastern United States.
All pelvic and acetabular surgeries performed between April 2014 and February 2020.
EBL, immediate and 24-hour postoperative ΔHgb, and intraoperative/postoperative transfusion.
In all, 267 surgeries were included: 97 prechange and 170 postchange. Median injury severity score was 17 before versus 14 after the change. One surgeon retired and two started during the study, producing differences in acetabular approaches. Median surgical duration was longer postchange. Cohorts were otherwise similar. No differences were observed in EBL, ΔHgb, or transfusion rates. Rates of VTE and surgical site complications were unchanged. No VTE-related deaths occurred. In the as-treated analysis (63 patients given low-molecular-weight heparin <12 hours preoperatively vs. 190 patients not given PPx), no differences were observed.
Administration of VTE PPx within 12 hours of pelvic and acetabular surgery had no effect on perioperative blood loss. This study is limited by changes in faculty, but it suggests that traumatologists need not advocate for holding VTE PPx before pelvic and acetabular trauma surgery.
Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Publication 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.
This 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.
Of 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.
Clinical 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.
•Proximal tibia fracture dislocations (PTFDs) represent 4% of proximal tibia fractures.•PTFDs are often unicondylar and may go unrecognized.•Malunion is common, and PTFD outcomes may be worse than ...bicondylar fractures.
Proximal tibia fracture dislocations (PTFDs) are a subset of plateau fractures with little in the literature since description by Hohl (1967) and classification by Moore (1981). We sought to evaluate reliability in diagnosis of fracture-dislocations by traumatologists and to compare their outcomes with bicondylar tibial plateau fractures (BTPFs).
This was a retrospective cohort study at 14 level 1 trauma centers throughout North America. In all, 4771 proximal tibia fractures were reviewed by all sites and 278 possible PTFDs were identified using the Moore classification. These were reviewed by an adjudication board of three traumatologists to obtain consensus. Outcomes included inter-rater reliability of PTFD diagnosis, wound complications, malunion, range of motion (ROM), and knee pain limiting function. These were compared to BTPF data from a previous study.
Of 278 submitted cases, 187 were deemed PTFDs representing 4% of all proximal tibia fractures reviewed and 67% of those submitted. Inter-rater agreement by the adjudication board was good (83%). Sixty-one PTFDs (33%) were unicondylar. Eleven (6%) had ligamentous repair and 72 (39%) had meniscal repair. Two required vascular repair. Infection was more common among PTFDs than BTPFs (14% vs 9%, p = 0.038). Malunion occurred in 25% of PTFDs. ROM was worse among PTFDs, although likely not clinically significant. Knee pain limited function at final follow-up in 24% of both cohorts.
PTFDs represent 4% of proximal tibia fractures. They are often unicondylar and may go unrecognized. Malunion is common, and PTFD outcomes may be worse than bicondylar fractures.
Purpose
Anterior cruciate ligament rupture is associated with characteristic bone contusions in approximately 80% of patients, and these have been correlated with higher pain scores. Bone bruising ...may indicate joint damage that increases inflammation and the likelihood of posttraumatic osteoarthritis. We sought to characterize the severity of bone bruising following acute anterior cruciate ligament injury and determine if it correlates with synovial fluid and serum levels of the proinflammatory chemokine monocyte chemoattractant protein-1 associated with posttraumatic osteoarthritis.
Methods
This was a retrospective analysis of data collected prospectively from January 2014 through December 2016. All patients who sustained an acute ligament rupture were evaluated within 15 days of injury, obtained a magnetic resonance imaging study, and underwent bone-patellar-tendon-bone autograft reconstruction were offered enrollment. The overall severity of bone bruising on magnetic resonance imaging was graded (sum of 0–3 grades in 13 sectors of the articular surfaces). Serum and synovial fluid levels of monocyte chemoattractant protein-1 were measured within 14 days of injury, and serum levels were again measured 6 and 12 months following surgery. Separate univariate linear regression models were constructed to determine the association between monocyte chemoattractant protein-1 and bone bruising severity at each time point.
Results
Forty-eight subjects were included in this study. They had a mean age of 21.4 years and were 48% female. Median overall bone bruising severity was 5 (range 0–14). Severity of bone bruising correlated with higher synovial fluid concentrations of monocyte chemoattractant protein-1 preoperatively (R
2
= 0.18,
p
= 0.009) and with serum concentrations at 12 months post-reconstruction (R
2
= 0.12,
p
= 0.04).
Conclusions
The severity of bone bruising following anterior cruciate ligament rupture is associated with higher levels of the proinflammatory cytokine monocyte chemoattractant protein-1 in synovial fluid acutely post-injury and in serum 12-months following anterior cruciate ligament reconstruction. This suggests that severe bone bruising on magnetic resonance imaging after ligament rupture may indicate increased risk for persistent joint inflammation and posttraumatic osteoarthritis.
Level of evidence
III ― retrospective cohort study.
Published complication rates after posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS) range from 1 to 22%. Complications are often minor and may be underestimated in registries. ...This study describes complications of PSF for AIS, classifies them according to a Clavien-Dindo-Sink (CDS) system, and investigates risk factors for occurrence of a complication.
This retrospective cohort study at two academic centers included all AIS patients aged 10-18 who underwent primary PSF 4/2014-12/2019. Data included demographics, comorbidities, curve magnitude, Lenke classification, levels osteotomized/fused, implant density, 90-day emergency department visits, readmissions, reoperations, and complications as defined by Harms Study Group.
Among 424 patients, mean age was 14.7, mean BMI 22, 77% were female, and 57% had no comorbidities. There were 270 complications (0.64 per patient); 198 patients (47%) had ≥ 1 complication; and 63 patients (15%) had CDS grade ≥ II complications (deviation from standard postoperative course). Complications not related to persistent pain occurred in 103 patients (24%). Ninety-three percent of complications did not require readmission or reoperation (CDS I-II). Within 90 days, 8% presented to an ED, 2% required readmission, and 2% required reoperation. Common complications were back pain > 6 weeks postoperatively (26%), surgical site complications (7%), and ileus/prolonged constipation (3%). Risk factors for experiencing any complication were BMI ≥ 34 (OR 3.44) and Lenke 6 curve (OR 1.95).
One in four AIS patients experiences a complication not related to persistent pain after primary PSF, higher than rates published from self-reported registries. Obesity and Lenke 6 curve may increase risk. While most do not require readmission or surgery, 15% of patients have their postoperative course altered by complications.
III-retrospective cohort study.
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