Recall bias: can patients recall their preoperative comfort and function two years after reverse total shoulder?

Recall Bias in Retrospective Assessment of Preoperative American Shoulder and Elbow Surgeons Scores After Reverse Total Shoulder Arthroplasty

These authors sought to determine whether patients who undergo RTSA are susceptible to recall bias and, if so, which factors are associated with poor recollection.

72 patients completed the American Shoulder and Elbow Surgeons (ASES scores) Standardized Assessment Form at the time of preoperative assessment. Patients were contacted at a minimum of 24 months after surgery to retrospectively assess their preoperative condition.

Patient assessment of their preoperative shoulder condition showed poor reliability (intraclass correlation coefficient = 0.453, confidence interval, 0.237-0.623). 

Greater preoperative shoulder ASES scores were associated with a greater difference between preoperative ASES scores and recall ASES scores.

The greatest part of the difference was due to a greater amount of preoperative pain recalled two years after surgery in comparison to the amount of preoperative pain reported before surgery. In other words patients retrospecitively recalled an exaggerated amount of preoperative pain.

Comment: Patient satisfaction after surgery is based largely on the perceived improvement after the procedure. This study indicates that the perceived improvement may be greater than the actual improvement, especially for patients with less actual pain prior to surgery.

This finding also confounds to a degree the "anchor method" for determining the minimal clinically important difference (MCID) for a procedure (see this link). The anchor method asks each patient to rate his or her shoulder as “worse,” “unchanged,” “better,” or “much better” relative to the recalled preoperative condition. The MCID is the minimal difference in the preoperative-to-postoperative outcome measure between patients describing the treatment outcome as “worse” or “unchanged” compared to those describing the treatment outcome as “better.”  This study suggests that in this calculation, more patients may be placed in the "better" group than would be justified by their actual postop vs preop scores.

In conclusion, we need to recognize the existence and effects of recall bias in which patients may perceive more improvement than what actually occurred.

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Here are some videos that are of shoulder interest

Shoulder arthritis - what you need to know (see this link).

How to x-ray the shoulder (see this link).

The ream and run procedure (see this link).

The total shoulder arthroplasty (see this link).

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

The smooth and move procedure for irreparable rotator cuff tears (see this link).

Shoulder rehabilitation exercises (see this link).

Can patients accurately remember their pre-arthroplasty shoulder pain - impact on MCID calculation?

 Patients recall worse preoperative pain after shoulder arthroplasty than originally reported: a study of recall accuracy using the American Shoulder and Elbow Surgeons score

The benefit of shoulder arthroplasty is measured by the preoperative to postoperative change in shoulder comfort and function as perceived by the patient. When preoperative scores are not obtained, it is tempting to try to "retrieve" the preoperative state of the shoulder from the patient's memory. 

These authors investigated the accuracy of patient recall in determining the preoperative American Shoulder and Elbow Surgeons (ASES) score for patients having total shoulder arthroplasty (TSA). They compared actual ASES scores determined prior to surgery with ASES scores based on patient recall at  at 6 weeks, 3 months, 6 months, and 12 months after surgery.

They divided the ASES score into two subcomponents: functional ability and visual analog scale (VAS) for pain.

While recalled ASES function scores were comparable to corresponding preoperative scores across

all time points (analysis of variance, P = .21), recalled VAS pain was significantly higher at all time

points beyond 6 weeks after surgery.

As a result, the recalled preoperative total ASES score was worse than the measured preoperative score.

This indicates that the benefit of shoulder arthroplasty (preoperative to postoperative change) based on recall of the preoperative condition of the shoulder is likely to be exaggerated. Therefore, measurement of the benefit of shoulder arthroplasty needs to be based on the actual, rather than the recalled preoperative comfort and function of the shoulder.

Comment: The results of this study also create uncertainty about the commonly used "anchor method" for determining the minimal clinically important difference (MCID).  The "anchor"is often a questionnaire that asks patients to rate retrospectively the improvement in their shoulder after shoulder arthroplasty. For example, a 4-point anchor might ask patients to rate the change in pain after surgery as “worse,” “no different,” “improved,” or “much improved.” The MCID for the ASES score would be the difference in the average ASES scores of patients answering “worse” or “no change” and the average ASES scores of  patients who answered “improved.” Because this study found that patients inaccurately recalled their preoperative pain, their ability to rate the amount of change in pain may also be inaccurate. Specifically, if patients recall more pain than they actually had, some patients may rate their shoulder as "improved" whereas the actual change in pain was "unimproved". 

Follow on twitter: https://twitter.com/shoulderarth

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How you can support research in shoulder surgery Click on this link.

Here are some videos that are of shoulder interest

Shoulder arthritis - what you need to know (see this link)

Shoulder arthritis - x-ray appearance (see this link)

The smooth and move for irreparable cuff tears (see this link)

The total shoulder arthroplasty (see this link).

The ream and run technique is shown in this link.

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

Total joint FDA approvals and recalls

Analysis of FDA-Approved Orthopaedic Devices and Their Recalls.

These authors note that there are two paths by which medical devices, such as shoulder implants, can obtain approval for use by the U.S. Food and Drug Administration (FDA).  The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be "substantially equivalent" to existing devices.

They hypothesized that because 510(k) approval was less stringent, it would be more commonly used on one hand and devices approved by this mechanism would be more likely to be recalled.

They searched for the following: PMA and 510(k) clearances for orthopaedics and non-orthopaedic specialties from 1992 to 2012. They also searched for all device recall events from 2002 to 2012. For the top-twenty recall companies, they calculated the odds ratio that compares the likelihood of recall for 510(k)-approved devices with that for PMA-approved devices.

While non-orthopaedic devices are increasingly approved by PMA:

Orthopaedic devices continue to be approved principally by 510(k):

The type of approval process is strongly related to the frequency of recall:from 2002 to 2012, the percentage of recalled devices was 17.8% for 510(k)-cleared devices and 1.6% for PMA-approved devices. 

They conclude that 510(k)-cleared devices were 11.5 times more likely to be recalled than PMA-approved devices; therefore is concerning that most orthopaedic devices are cleared through the 510(k) process with limited clinical trials data.

Comment: These data suggest that the 510(k) process, being easier and less expensive, is being used for devices that are not, in fact, "substantially equivalent to existing devices. " If they were "substantially equivalent", the recall rate discrepancy would not be what it is. It may be time to re-look at what it takes to qualify for 510(k) approval.

When we see data, such as that shown below from the AOA registry, it makes us wonder how "new" implants come to market, and which ones were claimed to be "substantially equivalent".

A recent article discusses the surgeon's responsibility for the use of new technologies:

Introduction of New Technologies in Orthopaedic Surgery. The bullet points are

➢ The introduction of new devices, biologics, and combination products to the orthopaedic marketplace is increasing rapidly.


➢ The majority of these new technologies obtain clearance to market by demonstrating substantial equivalence to a predicate (previously approved device) according to the U.S. Food and Drug Administration (FDA) 510(k) process.


➢ Surgeons play a critical role in the introduction of new technologies to patients and must take a leadership role in promoting safe, efficacious, appropriate, and cost-effective care, especially for operative procedures.


➢ Surgeons should monitor and document their patients’ clinical outcomes and adverse events when using new technology, to ensure that the new technology is performing as desired.

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