Funding bias in shoulder arthroplasty research Haislup, Brett D.; Gupta, Suhasini; Fleisher, Ilan ...
Journal of shoulder and elbow surgery,
08/2024, Letnik:
33, Številka:
8
Journal Article
Recenzirano
Prior research has shown that industry funding can impact the outcomes reported in medical literature. Limited data exist on the degree of bias that industry funding may have on shoulder arthroplasty ...literature outside of the Journal of Shoulder and Elbow Surgery. The purpose of this study is to characterize the type and frequency of funding for recently published shoulder arthroplasty studies and the impact of industry funding on reported outcomes. We hypothesized that studies with industry funding are more likely to report positive outcomes than those without.
We performed a retrospective study searching all articles with the term “shoulder arthroplasty,” “reverse shoulder arthroplasty,” “anatomic total shoulder arthroplasty,” or “total shoulder arthroplasty” on PubMed from the years January 2020 to December 2022. The primary outcome of studies was coded as either positive, negative, or neutral. A positive result was defined as one in which the null hypothesis was rejected. A negative result was defined as one in which the result did not favor the group in which the industry-funded implant was used. A neutral result was defined as one in which the null hypothesis was confirmed. Article funding type, subcategorized as National Institutes of Health funding or industry funding was recorded. Author disclosures were recorded to determine conflicts of interest. Statistical analysis was conducted using the χ2 test and Fisher exact test.
A total of 750 articles reported on either conflict of interest or funding source and were included in the study. Of the total number of industry-funded studies, the majority were found to have a positive primary endpoint (58.1%, 104 of 179), as compared to a negative (7.8%, 14 of 179) or neutral endpoint (33.5%, 60 of 179) (P = .004). Overall, 363 articles reported an author conflict of interest, and the majority of these studies had positive primary endpoint (55.6%, 202 of 363) as compared to negative (9.1%, 33 of 363) or neutral endpoints (34.4%, 125 of 363) (P = .002).
The results of this study suggest that there is a significant relationship between conflicts of interest and the primary outcome of shoulder arthroplasty studies, beyond the overall positive publication bias. Studies with industry funding and author conflicts of interest both report positive outcomes more frequently than negative outcomes. Shoulder surgeons should be aware of this potential bias when choosing to base clinical practice on published data.
Subscapularis function is critical after anatomic total shoulder arthroplasty (aTSA). Recently, however, a technique has been described that features a chevron or V-shaped subscapularis tendon cut ...(VT). This biomechanical study compared repair of the standard tenotomy (ST), made perpendicular to the subscapularis fibers, to repair of the novel VT using cyclic displacement, creep, construct stiffness, and load to failure.
This biomechanical study used 6 pairs of fresh frozen paired cadaveric shoulder specimens. One specimen per each pair underwent VT, the other ST. Subscapularis tenotomy was performed 1 cm from the insertion onto the lesser tuberosity. For VT, the apex of the V was 3 cm from the lesser tuberosity. After tenotomy, each humerus underwent humeral head arthroplasty. Eight figure-of-8 sutures were used to repair the tenotomy (Ethibond Excel; Ethicon, US LLC). Specimens were cyclically loaded from 2 to 100 N at 45 degrees abduction at a rate of 1 Hz for 3000 cycles. Cyclic displacement, creep, and stiffness and load to failure were measured.
Cyclic displacement did not differ significantly between the ST and VT from 1 to 3000 cycles. The difference in displacement between the V-shaped and standard tenotomy at 3000 cycles was 1.57 mm (3.66 ± 1.55 mm vs. 5.1 ± 2.8 mm, P = .31, respectively). At no point was the V-shape tenotomy (VT) >3 mm of average displacement, whereas the standard tenotomy (ST) averaged 3 mm of displacement after 3 cycles. Creep was significantly lower for VT in cycles 1 through 3. For all cycles, stiffness was not significantly different in the VT group compared with the ST group. Load to failure was not statistically significant in the VT compared to the standard tenotomy throughout all cycles (253.2 ± 27.7 N vs. 213.3 ± 76.04 N; P = .25, respectively). The range of load to failure varied from 100 to 301 N for standard tenotomy compared with 216 to 308 N for VT.
This study showed that VT and ST demonstrated equivalent stiffness, displacement, and load to failure. VT had the benefit of less creep throughout the first 3 cycles, although there was no difference from cycle 4 to 3000. The VT had equivalent biomechanical properties to the ST at time zero, an important first step in our understanding of the technique. The VT technique warrants further clinical study to determine if the technique has clinical benefits over ST following aTSA.
The effect of academic influence, or the volume and quality of a surgeon’s publications, on industry payments and National Institutes of Health (NIH) funding has recently been studied in some ...academic orthopedic subspecialities. The purpose of this study is to evaluate the relationship between academic influence, industry payments, and NIH funding among American Shoulder and Elbow Surgeons accredited shoulder and elbow fellowship faculty.
Shoulder and elbow fellowships and affiliated faculty members were identified from the American Shoulder and Elbow Surgeons website. Academic influence, measured by the Hirsch (h)-index, and the number of articles published were determined for faculty members using the Scopus Database Author Identifier tool. Industry payments were derived from the Centers for Medicare and Medicaid Services Open Payments database. NIH funding was determined using the NIH’s Research Portfolio Online Reporting tool. Statistical analysis used Spearman correlations and the Mann-Whitney U-test with an alpha value of 0.05 (P < .05).
A total of 146 faculty members were included. Twenty-two percent (42 of 146) received nonresearch payments, whereas 78% (114 of 146) received industry research funding averaging $6364 (standard deviation = $21,213). NIH funding averaged $272,589 (standard deviation = $224,635), and 5% received NIH funding (7 of 146). Faculty members who received NIH funding had a higher average h-index than those who did not (38 ± 22 vs. 22.64 ± 22.7, P = .02), whereas those receiving industry research payments had a greater number of publications than those who did not (127.97 ± 127.2 vs. 100.3 ± 122.3, P = .03). Industry nonresearch payments did not impact the number of publications or the h-index.
This study demonstrated that academic influence among academic shoulder and elbow surgeons is not greater in those who receive nonresearch industry funding. However, surgeons with industry research funding did produce more publications, whereas NIH funding is associated with greater academic influence.
Background:
Dual semitendinosus allograft reconstruction of chronic Achilles tendon ruptures has several potential benefits including superior tensile strength compared with a turndown construct and ...avoidance of the morbidity and operative time associated with autograft augmentation. We present a series of chronic Achilles tendon ruptures reconstructed with dual semitendinosus allograft.
Methods:
We retrospectively reviewed the charts of patients aged 18 years and older who underwent reconstruction of chronic Achilles tendon ruptures using dual semitendinosus allograft. The primary outcome of this study was to evaluate the need for revision surgery. Secondary outcomes included patient-reported outcomes, for which Achilles Tendon Rupture Scores (ATRS) were collected at final follow-up. Nine patients with a mean age of 58.9 (range, 43-75) years met inclusion criteria.
Results:
Median follow-up was 66 months (range, 27-121 months). One patient (11.1%) required revision reconstruction after sustaining graft failure 9.5 years after her index procedure, and 1 patient reported a poor ATRS score at the 27-month final follow-up despite an intact surgical repair. At final follow-up, no patient required the use of an assistive device for ambulation or a walking boot. The median ATRS at final follow-up was 93 (range, 30-100).
Discussion:
Good clinical outcomes without rerupture were observed in 7 of 9 patients (77.8%) at short- to midterm follow-up, suggesting that dual semitendinosus allograft reconstruction is a viable option for the reconstruction of chronic Achilles tendon tears.
Level of Evidence:
Level IV, case series.
Total shoulder arthroplasty (TSA) is increasingly performed safely and efficiently as an outpatient procedure in certain patients. Patient selection is often based on surgeon choice, surgeon ...expertise, or institutional guidelines. One orthopedic research group released a publicly available shoulder arthroplasty outpatient appropriateness risk calculator that considers patient demographic characteristics and comorbidities with the aim of helping surgeons to predict successful outpatient TSA. This study aimed to retrospectively assess the utility of this risk calculator at our institution.
Records were obtained for patients undergoing procedure code 23472 at our institution between January 1, 2018, and March 31, 2021. Patients undergoing anatomic TSA in the hospital setting were included. Records were reviewed for demographic characteristics, comorbidities, American Society of Anesthesiologists classification, and surgery duration. These data were entered into the risk calculator to calculate the likelihood of discharge by postoperative day 1. Charlson Comorbidity Index, complications, reoperations, and readmissions were also collected from patient records. Statistical analyses assessed the model’s fit with our patient cohort and compared outcome measures between inpatient and outpatient groups.
Of the 792 patients whose records were initially obtained, 289 met the inclusion criteria of anatomic TSA performed in the hospital setting. Of these patients, 7 were excluded because of missing data, leaving 282 patients: 166 (58.9%) in the inpatient group and 116 (41.1%) in the outpatient group. We found no significant differences in mean age (66.4 years in inpatient group vs. 65.1 years in outpatient group, P = .28), Charlson Comorbidity Index (3.48 vs. 3.06, P = .080), or American Society of Anesthesiologists class (2.58 vs. 2.66, P = .19). Surgery time was longer in the inpatient group than the outpatient group (85 minutes vs. 77 minutes, P = .001). Overall complication rates were low (4.2% in inpatient group vs. 2.6% in outpatient group, P = .07). Readmissions and reoperations did not differ between groups. There was no difference in the average percentage likelihood of same-day discharge (55.4% in inpatient group vs. 52.4% in outpatient group, P = .24), and a receiver operating characteristic curve to assess fit with the risk calculator demonstrated an area under the curve of 0.55.
The shoulder arthroplasty risk calculator performed similarly to chance when retrospectively predicting discharge within 1 day after TSA in our patients. Complications, readmissions, and reoperations were not higher after outpatient procedures. Risk calculators for determining whether a patient should be admitted after TSA should be used cautiously because they may not provide measurable benefit over the use of surgeon experience and expertise in discharge decision making, and other factors may be relevant in the decision to perform outpatient TSA.
Biomimetic proteoglycan (BPG) diffusion into articular cartilage has the potential to restore the lost proteoglycan content in osteoarthritic cartilage given these molecules mimic the structure and ...properties of natural proteoglycans. We examined the diffusion characteristics of BPGs through cartilage with the use of a custom‐made in vitro cartilage diffusion model in both normal bovine and human osteoarthritic cartilage explants. BPGs were introduced into the cartilage through essentially one‐dimensional diffusion using osteochondral plugs. The molecular diffusion was shown to be size and concentration dependent. Diffusion profiles were found over different diffusion time intervals and the profiles were fit to a nonlinear Fickian diffusion model. Steady state 011012‐7diffusion coefficients for BPGs were found to be 4.01 and 3.53 μm2/s for 180 and 1600 kDa BPGs, respectfully, and these values are similar to other large molecule diffusion in cartilage. In both bovine and osteoarthritic human cartilage, BPGs were found localized around the chondrocytes. BPG localization was examined by labeling collagen type VI and soaking 5 μm thick sections of cartilage with BPG solutions demonstrating that the BPGs diffused into the cartilage and preferentially localized alongside collagen type VI in the pericellular matrix.
Purpose
The purpose of our study was to use the Altmetric Attention Score (AAS) to evaluate the 100 most impactful articles in online media pertaining to the rotator cuff and compare their ...characteristics to the most-cited rotator cuff articles in the scientific literature.
Methods
We performed an article extraction using Altmetric Explorer to identify all published articles pertaining to the rotator cuff. The top 100 articles with the highest AAS were included for analysis. Several data elements were extracted for each included article: title, article type, article topic, year of publication, journal name, authors, institutional affiliations, and online mentions (i.e. the number of times the article was mentioned in news, blog, Twitter, Facebook, and Wikipedia sources). The geographic origin of each article was also determined by the institutional affiliation of the first author, which was categorized as American (originating in the United States), European (originating in Europe), or other.
Results
The 100 articles with the highest AAS were published between 2009 and 2020, with AAS ranging from 47 to 676 (median: 74.5, 25
th
percentile: 59.5, 75
th
percentile: 114.5). Of all online media sources, Twitter correlated most strongly with AAS (
r
= 0.9007,
r
2
= 0.8112). The selected articles were most frequently published in the American Journal of Sports Medicine (13), the Journal of Shoulder and Elbow Surgery (11), and the Journal of Bone and Joint Surgery (7). The most common article type was Systematic Review/Meta-Analysis (29%), followed by Randomized Controlled Trial (15%). The top 3 AAS articles were all published by authors based in Europe.
Conclusion
The most impactful rotator cuff articles in online media generated substantial online attention. These studies were often performed in Europe and tended to be high level of evidence, focusing on treatment of rotator cuff pathology. The rotator cuff articles that produced the most online attention differed from a previous report of the most-cited rotator cuff articles, suggesting that alternative metrics may be used in concert with conventional bibliometrics to obtain a more complete representation of scientific impact.
Objectives:
To identify the top 100 most impactful anterior cruciate ligament articles in online media as measured by the Altmetric Attention Score and compare their characteristics to the most-cited ...anterior cruciate ligament articles in the scientific literature.
Methods:
The Altmetric database was queried to identify all published articles pertaining to the anterior cruciate ligament. The search yielded 9445 articles, which were stratified by highest to lowest Altmetric Attention Score. The top 100 articles were included. Collected data included article type, article topic, journal name, and online mentions in news, blogs, Twitter, Facebook, Wikipedia, and other sources. The geographic origin of each article was also determined based on the institutional affiliation of the first author.
Results:
Altmetric Attention Score of the top 100 anterior cruciate ligament articles ranged from 109 to 2193 (median 172.0, interquartile range 137.5–271.5). Of the 100 articles, 65 were published in three journals: American Journal of Sports Medicine, British Journal of Sports Medicine, and Journal of Orthopaedic & Sports Physical Therapy. The most prevalent article type was original research (60%), followed by systematic review/meta-analysis (18%). The most prevalent article topic was rehabilitation and return to play after anterior cruciate ligament reconstruction (22%), followed by epidemiology/risk factors (16%), injury prevention (14%), and biomechanics of anterior cruciate ligament injuries (14%). Of the top 100 articles, 54% were American, 31% were European, and 15% were published in other countries outside of the United States and Europe.
Conclusion:
This study used Altmetric Attention Score to identify the 100 most engaged anterior cruciate ligament articles in online media. The characteristics of these articles differed substantially from the most-cited anterior cruciate ligament articles in the literature with regard to article type, article topic, geographic origin, and publication journal. These findings suggest that alternative metrics measure distinct components of anterior cruciate ligament article engagement and add an important dimension to understanding the overall impact of published research on the anterior cruciate ligament.
Small changes in deltoid tension and moment arm due to glenosphere lateralization may be associated with an increase in acromion or scapular spine strain in reverse shoulder arthroplasty (RSA), which ...can lead to stress fracture. The coracoacromial ligament (CAL) may be protective and lower the strain seen on the acromion or scapular spine. This biomechanical study investigated the impact of glenosphere lateralization and CAL integrity on acromion and scapular spine strain after RSA.
Ten cadaveric specimens were tested on a custom dynamic shoulder frame. Acromial and scapular spine strain were measured at 0°, 30°, and 60° of abduction using strain rosettes fixed to the acromion (Levy Type 2) and the scapular spine (Levy Type 3). Specimens were first tested with a standard commercially available RSA implant with zero lateralization and then subsequently with the +3 and +6 lateralizing glenospheres for that implant. The CAL was then cut in each specimen and testing was repeated with the 0, +3, and +6 glenospheres. Maximal strain was recorded at both the acromion and scapular spine and analysis of variance compared strain across various abduction angles and glenospheres with and without CAL transection.
In the intact CAL group, maximal strain decreased significantly at the acromion with abduction from 0° to 30° and 0° to 60°, however, at the scapular spine abduction did not significantly impact strain. Maximal strain decreased significantly with increasing abduction from 0 to 30 and 0 to 60 at both the acromion and scapular spine in the cut CAL group. Average strain at the acromion was significantly higher in the cut group (844.7 με) versus the intact group (580.3 με), a difference of 31.3% (P = .0493). Average strain at the scapular spine, did not differ in the cut group (725 με) compared with the intact group (787 με) (P = .3666). There were no statistically significant differences in acromial or scapular spine strain between various levels of glenosphere lateralization in either the cut or intact state.
In this biomechanical study, arm abduction decreased acromial and scapular spine strain following RSA. Cutting the CAL significantly increased strain at the acromion, and did not significantly alter strain at the scapular spine for all angles of abduction, differing from prior literature. Glenosphere lateralization did not have a significant effect on strain at the levels studied regardless of CAL status. Continued study of the complexion relationship between surgical and implant factors on strain following RSA is needed.
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