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European orthopaedic community steps up its adoption of patient-based outcomes
Involving patients in assessing the effectiveness of their orthopaedic procedures is proving increasingly beneficial for promoting patient participation in treatments, fostering delivery of quality health care and performing postoperative surveillance. However, despite greater use of patient-reported outcomes measures (PROMs) among orthopaedic patients and surgeons, health authorities and researchers, this area is replete with challenges and questions. At issue are the identification of appropriate PROMs instruments for different conditions, such as spine surgery versus total joint replacement (TJR), the effective management of the data, and ways to clearly report the findings to stakeholders.
The overall goal of PROMs-based research is improved patient satisfaction and quality of life. Knowing and understanding these outcomes could ultimately enhance physician-patient relationships, align outcomes with patient expectations, ensure appropriateness of indications and treatments, see that those requiring additional evaluation get it and reduce health care costs, sources told Orthopaedics Today Europe.
“Generally we are waking up to the idea that the ultimate measure by which we should judge the quality of these medical or surgical efforts is whether they actually help the patients in terms of the factors of importance to them, such as pain and function,” Anne F. Mannion, PhD, of the Spine Center at the Schulthess Klinik in Zürich, said.
The push for specialty-wide patient-centric outcomes is noticeable. PROMs-related literature and increased governmental emphasis on this approach worldwide indicates orthopaedic surgeons may soon need to fully adopt PROMs practices, whether or not they are ready to do so, said those who spoke with Orthopaedics Today Europe who have devised or are involved with current and emergent PROMs instruments or have collected and analyzed these data.
“In Germany, we have several different levels of activity where PROMs are playing a role in orthopaedics,” including in hospitals and for quality control in rehabilitation medicine and at TJR centers, Klaus-Peter Günther, MD, an Orthopaedics Today Europe Editorial Board member, said.
A nationwide quality control-based PROMs program is also being considered in Germany.
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Image: Sava Hlavacek Fotografie |
Mannion said the U.S. Food and Drug Administration now recommends inclusion of patient-reported outcomes in U.S. clinical trials.
Part of practicing medicine
Using PROMs to judge the clinical success of a therapy extends beyond orthopaedic surgery, gaining momentum in such areas as Parkinson’s disease, amyotrophic lateral sclerosis, inguinal hernia surgery and varicose vein surgery.
“Understanding the patient through outcomes is a vital part of practicing medicine and surgery,” orthopaedist Gaurav Khanna, MD, of La Jolla, Calif., U.S.A., said, noting anyone operated on should be involved in rating their outcomes.
“Just as we ask patients to go to physical or occupational therapy, being able to provide some sort of an objective measure of their outcome is just as important.”
Khanna tackled this subject in a recent study. It explored the validity of patient-based total knee arthroplasty (TKA) outcomes assessed via a mail-home package for tracking satisfaction and range of motion (ROM) vs. the surgeon’s assessment.
Oxford PROMs research
For years, patient-based outcome measures have been available for total hip arthroplasty (THA) and TKA.
The Oxford Knee Score (OKS) and Oxford Hip Score (OHS) were validated in 1996 and 1998, respectively, according to David Churchman, PhD, of Isis Outcomes at Isis Innovation, the technology transfer company for the University of Oxford, U.K. He identified Professor Andrew Carr, FRCS, FmedSci, Head of Department at Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences (NDORMS) in Oxford, as the orthopaedist behind the PROMs initiative there.
Added joint- and disease-specific PROMs are being developed at the Univeristy of Oxford for shoulder pain, disability and instability, foot and ankle, and other areas, Andrew J. Price, FRCS, DPhil, at NDORMS, told Orthopaedics Today Europe.
In addition, electronic PROMs and touch screen technology will soon be introduced for entering these scores. Like the OKS and OHS, the new instruments will all have 12 questions, Price said.
“Data show they are very acceptable and patients are happy to use them.”
PROMs use in registers
An effort spearheaded by Göran Garellick, MD, PhD, led to the Swedish Hip Arthroplasty Register (SHAR) collecting PROMs data starting in 2002. Today they reflect the satisfaction of an entire nation’s THA patients based on pain and function measures, according to register project leader Johan Kärrholm, MD, PhD.
Despite high THA success rates reported in the SHAR, officials sought to understand why some patients continued to experience pain and were dissatisfied, finding pain as the best proxy for THA results and thus a good outcome parameter to track. However, since collecting that information in a nation where some 16,000 procedures a year were performed would be tedious with available questionnaires, officials identified the EuroQol-5D (EQ-5D) as a suitable quality of life assessment.
“[It] was the ideal questionnaire. It is just five questions. It is well validated and tells you something more than the general health profile,” Kärrholm said. Most patients complete the EQ-5D via touch-screens at their first follow-up visit and are mailed paper questionnaires for postoperative evaluations at 1, 6 and 10 years.
Nordic interest
PROMs have been included in several of the nearly 90 medical registers in Sweden, including the national spine register, as requested by the government.
“With time it became acknowledged, at least in Sweden and now internationally, that this is what we should do. If we provide sophisticated health care — more or less health care that costs a lot to our patients — we should ascertain they benefit from it,” Kärrholm said.
Accepting this approach to THA outcomes took 6 years, but today compliance is good, he said. There is increased international interest in PROMs among collaborators at the Danish, Norwegian and Finnish arthroplasty registers, with some starting PROMs data collection soon, Kärrholm said.
Why use PROMs?
Advocates of PROMs claim they aid informed and shared decision-making. Versus the traditional approach of relying solely on the practitioner’s assessment to determine if an intervention is successful or effective, “it is more important to collect patient-reported outcomes,” Mannion said. “Imaging results and the technical success of an operation or objective or physiological measures of function may not indicate whether the right thing was actually done in terms of alleviating the patients’ symptoms.”
Tracking PROMs also may mitigate any bias from a clinician’s sole impression of the result.
They are invaluable for understanding an intervention’s impact on the patient’s quality of life, ability to work and likelihood of using further health care resources, according to Mannion.
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“It is important we derive this information from the patient, because ultimately they are the best judge,” she said.
Spine outcomes
Mannion, who has published studies linking PROMs with health care quality, collaborated on developing the Core Outcomes Measures Index (COMI), a short multidimensional spine surgery PROM instrument used at European centers participating in the Spine Tango register and elsewhere. This approach in spine surgery is relatively new, she said. Mannion’s hospital is renowned for its spine outcomes work.
“Our lower extremities group is capitalizing on the knowledge acquired in our Spine Center … These days I could not imagine any study being published with ‘outcome’ in the title that did not include something to do with patient-related outcomes; certainly not in spine,” she said.
Other advantages of PROMs include weeding out technically perfect operations that result in dissatisfied patients from technically imperfect operations resulting in satisfied patients and then understanding why those differences occur, since such “imperfect” scenarios are common in spine care, Mannion said.
Modifying indications
PROMs data should help manage the steadily increasing number of THAs performed in Sweden. Arthroplasty is only one way to treat a disease that includes periods of feeling good and feeling bad. Not all patients need THA. It is essential to identify appropriate interventions that focus on exercise, physiotherapy and other modalities to reduce the number of patients operated on, Kärrholm said.
Already PROMs data have helped in identifying dissatisfied patients who, based on minimal differences in preoperative and 1-year postoperative scores, were possibly operated on for the wrong indications or too early in the disease process. Additionally, Kärrholm and colleagues found certain hospitals were associated with greater THA complication rates, raising the question whether some operated on patients with more comorbidities than others.
Oxford questionnaires
TKA and THA procedures have been tracked the longest using patient-centric outcomes, with an array of patient-based outcome scores available. According to Churchman, whose organization licenses Oxford’s PROMs, there is increased interest in the orthopaedic questionnaires and a growing library of the OKS and OHS adapted into European languages. Greater uptake of these questionnaires has been seen in the Nordic countries, Spain, Portugal, Turkey, Australia, Canada and the United States, he said.
“We are seeing a lot more interest in the Oxford scores as they become recognized as valuable tools for these sort of surgeries,” Churchman told Orthopaedics Today Europe.
Mannion said the COMI questionnaire is adapted into and validated in another new language every few months.
Shoulder scores
The shoulder area needs increased adoption of PROMs, according to Carlos Torrens, MD, of Barcelona, president of the Spanish Society for Shoulder and Elbow Surgery. Despite recent progress, orthopaedic surgeons are still not ready to fully adopt PROMs, he said.
Torrens and colleagues studied functional and pain-relief expectations from shoulder surgery, mainly for cuff arthropathy, and found SF-36 scores correlated poorly with Constant score results. Therefore, he said, clinicians should discuss with their patients what is possible after various shoulder procedures, perhaps showing them a video of similar patients’ range of motion after osteosynthesis and comparing that to their expected postoperative activities of daily living.
Furthermore, we found that elderly patients had higher expectations than younger ones from surgery, which highlighted the need for better preoperative patient education, Torrens said.
“Anything that helps create a more realistic expectation will probably make the patient more satisfied with the procedure because satisfaction depends on the extent your expectations are met,” he said.
Aids delivery of care
University of Oxford’s ongoing PROMs work consists of analyzing existing data, developing new scores and new applications for the existing scores, said Price, who with David Beard, GDPhys, MCSP, MSc, DPhil, recently presented TKA PROMs information at the British Association of Knee Surgeons meeting.
The white paper recently released in the United Kingdom highlighted the need for National Health Service (NHS) participants — particularly surgeons — to record patient outcomes. This promoted PROMs onto the national agenda in Great Britain and led to their mandated use in THA, TKA, hernia and varicose vein surgery in 2009, he said.
“They developed a new NHS outcome framework around this whole concept,” Price said, adding PROMs is now linked to the U.K. National Joint Register and hospital episode statistics or HES data.
“Until now no one has really thought about how you could use the PROMs data in the actual delivery of patient care. There is a great opportunity for this. A good example is earlier in the pathway they could be used to monitor someone’s symptoms before a treatment decision.”
Price said that developing one health status PROM to look at an individual’s osteoarthritis symptoms and response to treatment — using it across their entire management pathway — with a single score for all its parts, would provide continuity for patients and physicians and present health economic opportunities for the NHS.
According to Kärrholm, PROMs may aid in identifying whether subgroups of patients, such as immigrants or those with lower education levels, have a different quality of life prior to surgery and need to be informed in a better way.
“[PROMs] also is a continuous quality control of what we are doing in Sweden at the different hospitals and for all the patients we see, so we think it is a very valuable instrument.” Kärrholm said. With register studies indicating how many patients will be reoperated in 10 years, “if you also know what the patient thinks, then you really have the data that you should have.” – by Susan M. Rapp
References:
- Grob D, Mannion AF. The changing face of quality in spine surgery. Eur Spine J. 2009;18(suppl 3): 277-278.
- Khanna G. Patient-reported versus clinician-assessed outcomes following TKA. Paper #27. Presented at the Current Concepts in Joint Replacement 2010 Winter Meeting. Dec. 8-11. Orlando, Fla., USA.
- Martinez-Martos S, Torrens C, Marlet V, et al. Correlation of a patient’s expectations with Constant score and SF-36. Paper #109. Presented at the 2011 Annual Meeting of the American Academy of Orthopaedic Surgeon. Feb. 15-19. San Diego, Calif., USA.
- Mannion AF, Porchet F, Kleinstück F, Lattig F, et al. The quality of spine surgery from the patient’s perspective Part 1. The Core Outcomes Measures Index (COMI) in clinical practice. Eur Spine J. 18:367-373.
- Rolfson O, Salomonsson R, Dahlberg LE, et al. Patient-reported outcomes in the Swedish total hip arthroplasty population. Poster #963. Presented at the 2011 Orthopaedic Research Society Annual Meeting. Jan. 13-16. Long Beach, Calif., USA.
- David Churchman, PhD, can be reached at Isis Outcomes, Isis Innovation Limited, Ewert House, Ewert Place, Summertown, Oxford, UK OX2 7SG; +44-1865-280857; email: David.Churchman@isis.ox.ac.uk.
- Klaus-Peter Günther, MD, can be reached at University Carl-Gustav Carus, Fetscherstrasse 74, 01307 Dresden, Germany; +49-351-4-58-31-37; email: klaus-peter.guenther@uniklinikum-dresden.de.
- Gaurav Khanna, MD, can be reached at 11025 N. Torrey Pines Road, Ste. 140, La Jolla, CA 92037-1030 USA; +1-612-270-9397; email: khan0044@gmail.com.
- Johan Kärrholm, MD, PhD, can be reached at the Department of Orthopaedics, Sahlgrenska University Hospital, SE-431, Mölndal, Sweden; +46-31-343-1000; email: johan.karrholm@vgregion.se.
- Anne F. Mannion, PhD, can be reached at Spine Center Division, Department of Research and Development, Schulthess Klinik, Lengghalde 2, CH-8008 Zürich, Switzerland; +41-44-385-7584; email: anne.mannion@kws.ch.
- Andrew J. Price, FRCS, DPhil, can be reached at NDORMS, University of Oxford, Nuffield Orthopaedic Center, Windmill Road, Oxford, UK OX37LD; +44-1865-227374; email: andrew.price@ndorms.ox.ac.uk.
- Carlos Torrens, MD, can be reached at Hospital Del Mar, Passeig Marítim 25-29, Barcelona 08003, Spain; +34-609-753620; email: Ctorrens@parcdesalutmar.cat.
- Disclosures: Churchman, Günther, Khanna, Kärrholm, Mannion, Price and Torrens have no relevant financial disclosures.
Is the orthopaedic specialty ready to adopt patient reported outcome measures as a new standard? Why?
Optimistic about adoption
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Orthopaedics has led health care in its adoption of patient reported outcome measures (PROMs). In 2010, the British NHS mandated the use of PROMs to monitor outcomes of four elective surgical procedures and two of the four were hip and knee replacement surgery. There was sufficient confidence that there were validated measures available to monitor outcomes for these two orthopaedic procedures, specifically the Oxford Hip and Knee Scores, giving accurate evidence of outcomes not provided by conventional clinical, radiological and other indicators.
There are a number of reasons for optimism that orthopaedics will continue to embrace PROMs. Firstly, measures were developed through close collaboration between orthopaedic surgeons and methodologists. Instruments, such as the Oxford scores, address aspects of health that surgeons, patients and researchers have jointly agreed to be central to assessing outcomes of surgery.
Secondly, there is a growing and international body of evidence to support their validity. PROMs scores are found to have predicted statistical relationships with other factors: clinical assessments, experiences such as delays in receiving surgery as well as aspects of surgery itself, such as primary compared to revision, surgical approach, and surgeons’ level of experience.
Thirdly, there is now evidence that PROMs provide a convenient and inexpensive way of monitoring patients over long periods of post-surgical follow-up and they are powerful predictors of patients who may need revision. They can therefore be used to identify early on the minority of patients who warrant more intensive post-surgical monitoring.
Surgeons are beginning to explore the potential for PROMs to be a patient-friendly method of having a dialogue with the patient over key issues such as the decision to have surgery and what might be expected as a result of surgery.
Ray Fitzpatrick, BA, MSc, PhD, FMed Sci, is Professor of
Public Health and Primary Care, University of Oxford.
Disclosure:
He has no relevant financial disclosures.
Ready for new outcome tools
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The specialty is ready or should be ready to adopt them. While we need to follow the principles of evidence-based medicine, we need to do certain things. I don’t think any orthopaedic surgeon would object to using the principles of evidence-based medicine because that’s really how they serve their patients optimally. However, different tools can be used to record outcomes, including radiographic and laboratory findings or reading the physician’s medical record to gain insight into how the patient is doing. But it is much better to use standardized and validated questionnaires.
The big question then is should you rely on a medical staff person or the physician to interview patients, interpret the results and somehow creating a score, which is the traditional approach. We know that bias exists in that process because face-to-face with the staff assistant or the physician patients may be less prone to address negative outcomes to avoid disappointing the health care professionals or develop a bad relationship with the physician by reporting nonoptimal outcomes. Subsequently, in the last 10 to 15 years, considerable effort gone into developing PROMs. If they are validated to give the most optimal and objective description of the patient’s current health condition, then I believe everyone should accept using them.
In addition to creating medical evidence and optimizing treatment pathways, there is increasing demand from health care providers to document the benefits of medical treatments. We might face a situation, as some countries already have, of getting paid based on whether our performance is beneficial to the patient. If we can’t demonstrate that, we might get less or no reimbursement as such, which is another reason more and more physicians will move in this direction.
Finally, if you organize this appropriately as we have done at Massachusetts General, all patients prior to entering the physicians office complete several standardized and validated questionnaires so when you open the door for a consultation you have a better idea of the patient’s problem, your interview can be more focused, your time used more efficiently and the discussion is centered on the patient’s condition.
Today the New Zealand national registry uses PROMs and the Swedish registry uses the EQ-5D on all hip patients. Norway and Denmark will soon follow. A recent thesis from Sweden shows how useful this is for health economy planning. These are the reasons that we are ready to go.
Henrik Malchau, MD, PhD, Vice Chief of Research at
Massachusetts General Hospital, Boston, is full professor at Harvard Medical
School and attending orthopaedic surgeon.
Disclosure: He has no
relevant financial disclosures.