Thursday, May 24, 2018

Industrial payments and publication bias

Academic Influence and Its Relationship to Industry Payments in Orthopaedic Surgery

These authors point out that the Hirsch index (h-index) quantifies research publication productivity for an individual, and has widely been considered a valuable measure of academic influence. The Hirsch index (h-index) mathematically adjusts for the total number of publications and the number of times each publication has been cited. In orthopaedic surgery, higher h-indices have been associated with higher academic rank.
In 2010, the Physician Payments Sunshine Act (PPSA) was introduced as a way to increase transparency regarding U.S. physician-industry relationships. The purpose of this study was to investigate the relationship between industry payments and academic influence as measured by the h-index and number of publications among orthopaedic surgeons for the year 2014. They also examined the relationship of the h-index to National Institutes of Health (NIH) funding.

Of 3,501 surgeons, 78.3% received nonresearch payments, 9.2% received research payments, and 0.9% received NIH support. Nonresearch payments ranged from $6 to $4,538,501, whereas research payments ranged from $16 to $517,007. 

Surgeons receiving NIH or industry research funding had a significantly higher mean h-index and number of publications than those not receiving such funding. Surgeons receiving nonresearch industry payments had a slightly higher mean h-index and number of publications than those not receiving these kinds of payments. Both the h-index and the number of publications had weak positive correlations with industry nonresearch payment amount, industry research payment amount, and total number of industry payments.

Academic surgeons who receive industry research support or NIH funding tend to have higher hindices.

For the overall population of orthopaedic surgery faculty, the h-index correlates poorly with the dollar amount and the total number of industry research payments. Regarding nonresearch industry payments, the h-index also appears to correlate poorly with the number and the dollar amount of payments. 

Comment: While the authors conclude that "These results are encouraging because they suggest that industry bias may play a smaller role in the orthopaedic literature than previously thought," this conclusion is not supported by their data. A high h-index indicates only that the author has a relatively large number of relatively often referenced publications - it does not demonstrate that these publications are unbiased. 

When industry supports research, industry influences what is investigated, how the research is done, and what conclusions of the research are published.  If the results of the research do not satisfy the needs of the supporting company, the company can withdraw funding.  In addition, the powerful effect of non-research funding can be easily imagined when viewing the table above.



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Wednesday, May 23, 2018

Outpatient shoulder arthroplasty - surgeons' concerns about reimbursement.

Surgeons’ experience and perceived barriers with outpatient shoulder arthroplasty

These authors note that outpatient total shoulder arthroplasty (TSA) has been proposed as an alternative to the inpatient setting. They evaluated the expert shoulder surgeon’s experience with and perceived barriers to outpatient TSA.

They used a secure web application to perform an online survey of 484 active American Shoulder and Elbow Surgeons members. The survey assessed surgeon practice demographics, experience with TSA/outpatient TSA, and perceived barriers to successful outpatient TSA.

Of the 179 (37.0%) complete responses received, 20.7% perform outpatient TSA; of those, 78.4% reported an “excellent” experience. Outpatient surgeons were more likely to reside in the southern United States (P = .05) and performed a higher volume of TSAs annually (P = .03). Surgeons not performing outpatient TSA were more concerned with the potential of medical complications (P = .04). Perceived lack of experience (P = .002), low volume (P = .008), insurance contracts (P = .003), and reimbursement (P = .04) were less important barriers compared with outpatient TSA surgeons.

The authors note that as surgeons become more comfortable with outpatient TSA, there is a shift from concerns about medical complications to concerns about reimbursement.

Comment: There are many possible motivations for performing outpatient arthroplasty, including cost savings, patient convenience, marketing (Google "outpatient shoulder replacement"), surgeon ownership of an ambulatory operating facility, and other incentives. As physicians, our primary concern is the safety of the patient and the quality of the patient reported outcomes.  Further study is required to determine what patient characteristics, what surgeon experience, and what infrastructure elements are required to assure that the results of outpatient arthroplasty match those of inpatient arthroplasty. "Value" needs to be measured in terms of the benefit to the patient divided by the total cost of the procedure, including complications and readmissions.

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Changes acromial shape in patients with rotator cuff tears - cause or effect?

Acromial roof in patients with concentric osteoarthritis and massive rotator cuff tears: multiplanar analysis of 115 computed tomography scans

These authors point out that there are differences in scapular shape between shoulders with rotator cuff tears (RCT) and osteoarthritic shoulders (OA). They analyzed the orientation and shape of the acromion in 70 shoulders with massive degenerative RCT (apparently those having subsequent reverse total shoulders) and 45 shoulders with concentric OA (apparently those having subsequent anatomic total shoulders) using multiplanar computed tomography (CT) analysis.

They found that lateral acromial roof extension was an average of 4.6 mm wider and the acromial area was an average of 156 mm2 larger in RCT than in COA (P < .001). Significant differences of the lateral extension of the acromion margin were limited to the anterior two-thirds. Acromial roof orientation in RCT was average of 10.8° more “externally rotated” (axial plane: P < .001) and an average of 7.8° more tilted downward (coronal plane: P < .001) than in COA. The glenoid in RCT was an average of 5.5° (P < .001) more covered posteriorly compared with COA.

Comment: It is understood that loading of the acromion is different in patients with massive cuff tears than in patients with concentric osteoarthritis and that these changes are reflected by radiographic changes in acromial shape. Compare the acromial shape in the upper AP x-ray of a shoulder with a massive cuff tear with that in the lower AP x-ray of a shoulder with concentric osteoarthritis.


It seems likely that the acromial changes are likely to be adaptive in response to the change in loading of the acromion in patients with massive cuff tears. In 1972 Neer observed "a characteristic ridge of proliferative spurs and excrescences on the undersurface of the anterior process (of the acromion), apparently caused by repeated impingement of the rotator cuff and the humeral head, with traction of the coracoacromial ligament. . . . Without exception it was the anterior lip and undersurface of the anterior third that was involved."(see this link)

 Evidence remains lacking that surgical alteration of the acromial shape can change the natural history of cuff disease (see this link) or of osteoarthritis.

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Monday, May 14, 2018

359 failed primary shoulder hemiarthroplasties that were surgically revised

Primary Shoulder Hemiarthroplasty: What Can Be Learned From 359 Cases That Were Surgically Revised? (Clinic Orthop Relat Res, 476, 5, 1031-1040, 2018)

These authors analyzed the characteristics of patients having surgical revision of a prior primary humeral hemiarthroplasty with the goal of answering three questions

(1) What are the common characteristics of shoulder hemiarthroplasties having a revision? 
(2) What are the common characteristics of the subset of revised shoulder hemiarthroplasties that were performed for fracture? 
(3) What are characteristics of the subset of all revised hemiarthroplasties that were associated with glenoid bone erosion? 

These patients had severe loss of self-assessed shoulder comfort and function, with Simple Shoulder Test (SST) scores averaging 2.2 +/- 2.2 of the maximum score of 12. The average time from index arthroplasty to revision was 3.4 years.

Common characteristics of the revised hemiarthroplasties included 
female sex (81%), 
rotator cuff (89 of 359; 25%) or subscapularis (81 of 359; 23%) failure, 
problems related to prior fracture (154 of 359; 43%), 
glenoid erosion 125 of 359; 35%), and 
component malposition (89 of 359; 25%). 

Hemiarthroplasties performed for fracture-related problems often were associated with tuberosity malunion or nonunion (58 of 79; 73%) and decentering of the humeral component on the glenoid surface (45 of 71; 63%). 

Major erosion of the bony glenoid (Grade 3 or 4) was more common in decentered hemiarthroplasties (42 of 102; 41%) than for centered hemiarthroplasties (36 of 146; 25%) (Fisher's exact p = 0.008) and more common for hemiarthroplasties positioned in valgus (28 of 50; 56%) than for those positioned in neutral or varus (40 of 188; 21%) (Fishers' exact p < 0.0001). 


Based on these findings the authors suggested that some revisions of primary hemiarthroplasties may be avoided by surgical techniques directed at centering the prosthetic humeral articular surface on the glenoid concavity using proper humeral component positioning and soft tissue balance, by avoiding valgus positioning of the humeral component, and by managing glenoid disorders with a primary glenohumeral arthroplasty rather than a hemiarthroplasty alone. When durable security of the subscapularis, rotator cuff, and tuberosities is in question, the surgeon may consider a reverse total shoulder arthroplasty.

Comment: Primary shoulder hemiarthroplasty is a commonly used procedure for the treatment of various shoulder disorders. In the treatment of a proximal humeral fracture, primary hemiarthroplasty is considered when displaced fracture fragments cannot be treated with internal fixation or when there is concern regarding head collapse. In the treatment of shoulder arthritis, capsulorrhaphy arthropathy, or avascular necrosis, a primary hemiarthroplasty may be performed if there is minimal glenoid disease, if the patient is young, if the shoulder is too tight to admit a glenoid component, if there is insufficient bone stock to support a prosthetic glenoid, if there is concern for possible infection, if the patient wishes to avoid the risks and limitations associated with a glenoid component, or if the surgeon is not comfortable with performing another type of shoulder arthroplasty. Each of these indications can be associated with an increased risk of failure and subsequent revision.

This study calls attention to some of the factors that can be associated with a poor outcome and provides some possible approaches for reducing the need for surgical revision of a failed hemiarthroplasty.


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Diabetes, HbA1c, infection, and shoulder arthroplasty

Association of Perioperative Glycemic Control With Deep Postoperative Infection After Shoulder Arthroplasty in Patients With Diabetes (J Am Acad Orthop Surg 2018;0:1-8)

These authors queried the  PearlDiver Patient Records Databasefor patients with diabetes who underwent primary shoulder arthroplasty. They assessed the incidence of wound complications within 6 months within 1 year for each perioperative HbA1c level. 

Patients with DM had higher rates of wound complications (1.4% versus 0.9%; odds ratio, 1.22; P = 0.028) and deep infection (0.7% versus 0.4%; odds ratio, 1.47; P = 0.001). 

The rates of wound complications (P = 0.0008) and deep postoperative infection (P = 0.002) increased markedly as the perioperative HbA1c level increased. 



Comment: As the authors point out, the literature on the effects of preoperative optimization of HbA1c values and postoperative infection is lacking. Thus, while it seems compelling to do so, we cannot be sure that requiring our diabetic patients to 'get their HbA1c below 8' will lower their risk of infection.


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Total shoulder for post-Latarjet/Bristow arthritis - high complication rate

These authors point out that coracoid transfer (Latarjet or Bristow) has become increasingly popular as a surgical treatment for recurrent anterior shoulder instability, but that glenohumeral arthropathy develops in some patients. They point out that arthroplasty in this population is complicated by altered anatomy, scarring, and retained hardware. 

They evaluated 33 patients having shoulder arthroplasty after coracoid transfer at a minimum of 2 years or until reoperation. Arthroplasty procedures included hemiarthroplasty (HA) in 5, total shoulder arthroplasty (TSA) in 14, and reverse shoulder arthroplasty (RTSA) in 11. 

9 shoulders (30%) underwent revision for instability (1 TSA and 1 HA), glenoid loosening (1 TSA), instability and glenoid loosening (3 TSA), late cuff failure (1 TSA), and painful glenoid erosion (2 HA).

Radiographically, 2 additional anatomic glenoid components were considered loose, progressive medial erosion was seen in 1 HA, and grade 1 to 2 notching was observed in 2 RTSAs.

Neurologic complications developed in 2 shoulders in the RTSA group: a transient axillary nerve palsy developed in 1 patient and neuropathic pain developed in the other patient.

The overall rate of complications in the whole cohort was 43.3%.  Complications included instability in 6 (4 TSA and 2 HA), neurologic complications in 2 (RTSA), glenoid loosening in 2 (TSA), glenoid erosion in 2 (HA), and cuff tearing in 1 shoulder (TSA).

Survival free of revision was 56.8% at 5 years for the entire cohort.

Comment: Glenohumeral arthritis is a known consequence of a Latarjet procedure (see Glenohumeral arthritis after Latarjet procedure: Progression and it's clinical significance). 













If a shoulder arthroplasty is needed, a prior coracoid transfer can compromise the function of the subscapularis, challenge the stability of the arthroplasty, put the musculocutaneous and axillary nerve at risk, and complicate the stability of the glenoid component in shoulder arthroplasty, even in the hands of these experienced surgeons. 

These risks should be considered in the selection of the surgical procedure for glenohumeral instability.

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Reverse total shoulder: trends and value

Current Trends in the Use of Shoulder Arthroplasty in the United States

These authors point out that reverse total shoulder arthroplasty (rTSA) has become increasingly popular since its introduction to the United States. The purpose of their study was to assess the current trends and use of rTSA, anatomic total shoulder arthroplasty (aTSA), and hemiarthroplasty (HA) from 2011 to 2014. 

Shoulder arthroplasty data from the National (Nationwide) Inpatient Sample database were analyzed for the years 2011 to 2014 using International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes. For each procedure, use and patient and hospital characteristics were identified. 

Shoulder arthroplasties increased by 24% between 2011 and 2014, to 79,105 procedures. The proportion of arthroplasties that were aTSA did not change substantially (44% for both years; P=.0585), while the proportion that were rTSA surpassed aTSA in 2014, increasing from 33% to 46% (P<.0001). Use of rTSA topped use of aTSA by 2013 for Medicare patients. 

The proportion that were HA procedures declined from 23% to 11% (P<.0001). The use of rTSA for fracture increased from 26% to 58% (P<.0001) of all arthroplasties for this indication, while the use of HA for fracture decreased from 69% to 40% (P<.0001). 

Orthopedists performed rTSA more often than aTSA for Medicare patients by 2013 and the general population by 2014. The use of rTSA for fracture has grown significantly, with rTSA being performed more frequently than HA for this indication. 

Comment: There is no question that reverse total shoulder provides an attractive option for selected patients, for example those with complex fractures of the proximal humerus as suggested by the figure below.








It is of interest to note that almost half of the reverse total shoulders are being done for  osteoarthritis, especially since it has not been documented that the clinical outcomes for reverse total shoulders for osteoarthritis are equal to or superior to those for an anatomic total shoulder for osteoarthritis.










The authors note the substantially high cost of the reverse total shoulder; thus we need to be sure that for each indication the increased cost is justified by increased benefit to the patient. Specifically, is there evidence that a rTSA for OA is of greater value to the patient than a aTSA for the same diagnosis?





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