The Importance of Pragmatic Study Design to the Scholarly Influence of Surgical Hip Fracture Randomized Controlled Trials.

BACKGROUND: Surgical randomized controlled trials (RCTs) have potential drawbacks, leading some to question their role in filling the information gap in orthopaedic surgery. Pragmatism in study design was introduced to increase the clinical applicability of study results. The purpose of this study was to examine how pragmatism affects the scholarly influence of surgical RCTs. METHODS: A search for surgical hip fracture-related RCTs published between 1995 and 2015 was done. Journal impact factor, citation number, research question, significance and type of outcome, number of centers involved, and the Pragmatic-Explanatory Continuum Indicator Summary-2 level of pragmatism score were recorded for each study. Scholarly influence was estimated by a study's inclusion into orthopaedic literature or guidelines or through the study's average yearly citation rate. RESULTS: One hundred sixty RCTs were included in the final analysis. A multivariate logistic regression identified large study sample size as the only predictor of an RCT being used in clinical guidance texts. Large sample size and multicenter RCTs were predictors of high yearly citation rates. The level of pragmatism in study design did not predict scholarly influence. CONCLUSIONS: Pragmatic design is not independently associated with increased scholarly influence; however, large study sample size was the most important study characteristic affecting scholarly influence.

Reporting on quality of reduction and fixation of intertrochanteric fractures-A systematic review.

BACKGROUND: Patient outcomes after intertrochanteric fracture fixation is the subject of a large body of published and ongoing clinical research. Fracture reduction and stable fixation are a pre-requisite for achieving optimal results. However, reporting on the quality of postoperative reduction and fixation, has been inconsistent in the literature on intertrochanteric fractures. The purpose of this study was to examine the quality and consistency of reporting of immediate postoperative reduction and fixation in clinical outcome studies of intertrochanteric fracture fixation. METHODS: Outcome studies of intertrochanteric fractures, published between 2001 and 2019, were identified using a PubMed. Six journals were identified as having a high impact on intertrochanteric fracture research by either having an impact factor greater than 3.0 or more than 30 published studies fulfilling inclusion criteria. Two independent reviewers reviewed each article for its reporting on immediate post-operative radiographic findings and whether an attempt was made to correlate these findings to outcomes. Quality and consistency of reduction reporting were assessed by recording the type and number of uniquely reported reduction metrics in all of the included studies. RESULTS: The reviewers identified 134 papers for the study, of which 110 (82%) reported on immediate postoperative radiographic findings. Of the papers reporting these findings, 84 (76%) reported quantitative measurements. Quantitative reporting changed from 79% in papers published between 2001-2014 to 86% in papers published between 2015-2019. Sixty-one (46%) papers reported Tip-Apex Distance, 56 (42%) reported degree of varus (compared to non-injured side), 42 (31%) reported Neck-Shaft Angle restoration, 31(23%) reported leg-length discrepancy, 18 (13%) reported rotation, 15(11%) reported on the status of the lateral wall, and 6 (4%) reported on calcar (medial buttress) reduction. Sixty-eight (51%) papers that measured reduction found an association between better immediate post-operative reduction and improved outcomes. CONCLUSIONS: Despite its recognized influence on outcomes of intertrochanteric fractures, leading peer-reviewed journals do not uniformly report on the immediate postoperative assessment of the quality of reduction and fixation. However, reporting has improved over the past five years. Standardized quantitative metrics will need to be reported in the future to allow meaningful comparisons between studies and accurate assessment of intertrochanteric fracture outcome.

The effectiveness of a free-standing lead-shield in reducing spine surgeon radiation exposure during intraoperative 3-dimensional imaging.

BACKGROUND: CONTEXT Intraoperative three-dimensional (3D) computed tomography (CT) imaging has become increasingly popular in spine surgery. Previous spine surgeon radiation exposure research has focused largely on procedures using fluoroscopy, however, few studies have been performed on the subject since the introduction of the 3D imaging systems. As a result, concerns have re-emerged over surgeon radiation exposure and the effectiveness of operating room (OR) protocols for decreasing workplace radiation. Current radiation safety guidelines require surgeons wear full body protective lead while any type of radiation is being administered during surgery. As a result, local institutions do not allow for the use of free-standing lead shields for sole radiation protection in the operating room. However, there is no data available to demonstrate whether the additional personal lead is required, or if in fact the lead shield alone is sufficient. PURPOSE: This study investigated the effectiveness of a free-standing lead shield in reducing spine surgeon radiation exposure in the operating room during intraoperative imaging. STUDY DESIGN/SETTING: A prospective clinical research study at a large, tertiary care center. PATIENT SAMPLE: Twenty-seven patients undergoing instrumented spinal procedures between June and August 2019. OUTCOME MEASURES: Fluoroscopy time, total fluoroscopy dose delivered, 3D dose delivered, total 3D spins, number of HD spins, number of standard spins, number of fluoroscopic images, number of spine levels operated on, patient size setting, shield distance from patient, radiation dose in front of shield, radiation dose behind shield. METHODS: Twenty-seven instrumented spinal procedures using the O-Arm Imaging System (Medtronic, Minneapolis, MN) were observed to determine radiation exposure to a spine surgeon standing behind a lead shield in the OR. Two thermoluminescent dosimeters were used to measure scatter radiation in front of and behind lead shields. Both fluoroscopy and intraoperative CT based radiation exposure was recorded. The dosimeter readings were compared to determine the degree of radiation attenuation by the lead shield. Regression analysis of the exposure values from behind the shield, shield distance from the patient, and radiation dose delivered by the imaging system was utilized to estimate the number of cases required to surpass annual exposure limits. Case numbers were calculated for the highest "worst case" and "average case" exposure values. The safe annual occupation exposure limit determined by the National Council on Radiation Protection is five roentgen equivalent man (rem) or 50,000 microsieverts (µSv). RESULTS: Average surgeon radiation exposure per case was 0.694 µSv (SD: 0.501, Range: 0.105-2.167) behind the lead shield compared to 14.577 µSv (SD: 9.864, Range: 2.185-44.492) in front of the lead shield. The average radiation dose reduction by the lead shield was 13.962 µSv (SD: 9.49, Range: 2.08-42.72) per case, which is equivalent to an average of 95.65% (SD: 1.71) radiation attenuation by lead shielding. If surgeons stand behind lead shields in the OR, the annual number of 3D image-guided spinal procedures required to surpass exposure limits is 15,479 and 67,060 based on "worst case" and "average case" analyses, respectively. CONCLUSIONS: Our study demonstrates standing behind intraoperative lead shields is very effective at decreasing radiation exposure to surgeons. Additionally, surgeon radiation doses behind lead shielding fall far below annual exposure limits. Surgeons should not need additional protective equipment when a lead shield is used.

Atrophy and Death of Nonpeptidergic and Peptidergic Nociceptive Neurons in SIV Infection.

HIV-associated sensory neuropathy is a common neurologic comorbidity of HIV infection and prevails in the post-antiretroviral therapy (ART) era. HIV infection drives pathologic changes in the dorsal root ganglia (DRG) through inflammation, altered metabolism, and neuronal dysfunction. Herein, we characterized specific neuronal populations in an SIV-infected macaque model with or without ART. DRG neuronal populations were identified by neurofilament H-chain 200, I-B4 isolectin (IB4), or tropomyosin receptor kinase A expression and assessed for cell body diameter, population size, apoptotic markers, and regeneration signaling. IB4+ and tropomyosin receptor kinase A-positive neurons showed a reduced cell body size (atrophy) and decreased population size (cell death) in the DRG of SIV-infected animals compared with uninfected animals. IB4+ nonpeptidergic neurons were less affected in the presence of ART. DRG neurons showed accumulation of cleaved caspase 3 (apoptosis) and nuclear-localized activating transcription factor 3 (regeneration) in SIV infection, which was significantly lower in uninfected animals and SIV-infected animals receiving ART. Nonpeptidergic neurons predominantly colocalized with cleaved caspase 3 staining. Nonpeptidergic and peptidergic neurons colocalized with nuclear-accumulated activating transcription factor 3, showing active regeneration in sensory neurons. These data suggest that nonpeptidergic and peptidergic neurons are susceptible to pathologic changes from SIV infection, and intervention with ART did not fully ameliorate damage to the DRG, specifically to peptidergic neurons.

Narrative feedback from OR personnel about the safety of their surgical practice before and after a surgical safety checklist intervention.

OBJECTIVE: To examine narrative feedback to understand surgical team perceptions about surgical safety checklists (SSCs) and their impact on the safety of surgical practice. DESIGN: We reviewed free-text comments from surveys administered before and after SSC implementation between 2011 and 2013. We categorized feedback thematically and as positive, negative or neutral. SETTING: South Carolina hospitals participating in a statewide collaborative on checklist implementation. PARTICIPANTS: Surgical teams from 11 hospitals offering free-text comments in both pre-and post-implementation surveys. INTERVENTION: Implementation of the World Health Organization SSC. MAIN OUTCOME MEASURE: Differences in comments made before and after implementation and by provider role; types of complications averted through checklist use. RESULTS: Before SSC implementation, the proportion of positive comments among provider roles differed significantly (P = 0.04), with more clinicians offering negative comments (87.9%, (29/33)) compared to other surgical team members (58.3% (7/12) to 60.9% (14/23)), after SSC implementation, these proportions did not significantly differ (clinicians 77.8% (14/18)), other surgical team members (50% (2/4) to 76.9% (20/26)) (P = 0.52). Distribution of negative comments differed significantly before and after implementation (P = 0.01); for example, there were more negative comments made about checklist buy-in after implementation (51.3 % (20/39)) compared to before implementation (24.5% (13/53)). Surgical team members most frequently reported that checklist use averted complications involving antibiotic administration, equipment and side/site of surgery. CONCLUSIONS: Narrative feedback suggested that SSC implementation can facilitate patient safety by averting complications; however, buy-in is a persistent challenge. Presenting information on the impact of the SSC on lives saved, teamwork and complications averted, adapting the SSC to fit the local context, demonstrating leadership support and engaging champions to promote checklist use and address concerns could improve checklist adoption and efficacy.