According to the article, a product for big-toe arthritis is on the market and alternatives for the thumb, knee and shoulder are being tested.

HSS associate scientist Stephen Lyman, PhD, shared his perspective on the new treatment option. "What I'm worried about is the long-term risks about having [synthetic cartilage] in the body," he said.

Dr. Lyman added that additional, larger studies are needed to ensure safety.

Read the full article at wsj.com [subscription required]. This also appeared in the September 17, 2018 print issue.

According to the article, the current standard medical practice involves using validated surveys to collect patient-reported outcome measures (PROMs). Dr. Lyman noted that PROMs surveys could be limited by patient health literacy.

"We are increasingly becoming aware that patients have cultural biases. They are not biases of the patients. It is just how people from different cultures interpret the same question, even if they speak the same language, may be different," said Dr. Lyman.

He added that once the technological challenges associated with wearables are ironed out, they could be more reliable and unbiased compared with the PROMs surveys.

"From a researcher's perspective, active tasks allow us to assign dexterity tasks for patients with hand or wrist conditions or, for example, cerebral palsy patients. That gives you a direct measurement of patient functional ability without the limitations of self-administered questionnaires and things like that where patients might not answer the question the way we expect them to," noted Dr. Lyman.

Read the full article at healio.com [registration required]. This also appeared in the July 2018 print issue.

"While significant progress has been made collecting PROMs data for joint replacements, no guidelines exist on the most accurate way to analyze these data to objectively measure and improve performance," said lead author Stephen Lyman, PhD, associate scientist at HSS. "Before policies are enacted, clinicians and payers must reach a consensus about which measures reflects the meaningful improvement in joint-related health."

PROMs are considered the gold standard for evaluating the effectiveness of hip or knee replacement procedures. Two of the most commonly utilized PROMs for the hip and knee are the Hip Disability and Osteoarthritis Outcomes Survey (HOOS), the Knee Injury and Osteoarthritis Outcomes Survey (KOOS), respectively, and their short form versions HOOS, JR. and KOOS, JR., respectively. The Centers for Medicare and Medicaid Services (CMS) have adopted these surveys in their Comprehensive Care for Joint Replacement (CJR) Model, which is a bundled payment plan for all primary elective total joint replacements performed in eligible Medicare patients.

This study, performed at HSS, included 2,323 people who underwent a total hip replacement procedure, and 2,630 people who underwent a total knee replacement procedure. Meaningful change of PROMs can be assessed using three measures: Minimal Detectable Change (MDC), Minimal Clinically Important Change, and Substantial Clinical Benefit. Answers from the HOOS and KOOS (original or JR.) are used to score these measures and currently several different methods can be applied to calculate the total score.

The results showed that there is wide variability in benchmarks when these methods are used to calculate them:

• Distribution-based approach, which relies on distribution of the data and assumes a normal distribution of responses and does not include patient input.
• Anchor-based approach, a patient-centric approach where an anchor question on the HOOS/KOOS regarding patient perception of a change in health is used to assess the change in PROMs scores.
• Anchor-based ROC approach, which uses the area under the ROC curve to determine the optimal delta score that best predicts those who experienced a minimal improvement and those who did not and does not include patient input.

"We believe meaningful use of PROMs to assess care delivery and quality requires an understanding of how much change over time should be expected and how much change matters to patients," Alexander McLawhorn, MD, MBA, an orthopedic surgeon at HSS. "The anchor-based assessment is the only method that accounts for the patients’ perspective."

"We hope this analysis sparks important discussions about how quality and appropriateness are measured," said senior author Catherine H. MacLean, MD, PhD, chief value medical officer at HSS. "The orthopedic community must be careful before we start using PROMs scores for performance evaluations, and as a next step HSS researchers plan to explore in depth the care experience and broad outcomes of patients in relation to changes in their patient reported outcome scores."

"There are more than one million people annually who undergo hip and knee replacement in this country. Ensuring that we have a complete picture of their surgical recovery is an enormous job—one that can be helped by the emerging technology of wearable sensors and data collection," said Dr. Lyman.

He explained that he was interested in these devices as a way to monitor patient activity after treatment, such as their pain levels or daily steps.

Dr. Lyman studied 150 hip surgeries and 150 knee surgeries, tracking patients' steps for a month before and after surgery.

"My hypothesis is that patients in the group that returned to baseline were walking just a little preoperatively, and doing so in pain. I think the other group, however, included patients who were preoperatively more active, had been limited by their disability, and after surgery could return to their active lifestyles," said Dr. Lyman.

When discussing wearables and physical therapy, Dr. Lyman said that he hopes patients will someday be able to use an app and a wearable device to do physical therapy at home. "These devices have sensors that are much more robust than fitness trackers. They can pick up whether the patient is limping, how much knee flexion they have during the day, whether they are sitting or standing. The study is under IRB [Institutional Review Board] review at the moment and will move forward soon," he said.

Ultimately, Dr. Lyman hopes that wearables will enhance patient outcomes. "Assessing patient outcomes accurately, and on a large scale, is essential to providing the best care we can. Unfortunately, the long-term patient outcome data in orthopedics available today has significant limitations. This is one reason there is such a wide disparity in quality and cost of care for musculoskeletal conditions. For instance, the rate of complications after hip and knee surgery can be more than three times higher for procedures performed at some hospitals than others. Wearables are an important step forward to evaluating the success of orthopedic procedures and improving care."

Read the full article at ryortho.com [subscription required].