Framework To Guide The Collection And Use Of Patient-Reported Outcome Measures In The Learning Healthcare System.

BACKGROUND: Web-based collection of patient-reported outcome measures (PROMs) in clinical practice is expanding rapidly as electronic health records include web portals for patients to report standardized assessments of their symptoms. As the value of PROMs in patient care expands, a framework to guide the implementation planning, collection, and use of PROs to serve multiple goals and stakeholders is needed. METHODS: We identified diverse clinical, quality, and research settings where PROMs have been successfully integrated into care and routinely collected and analyzed drivers of successful implementation. Findings are based on key informant interviews with 46 individuals representing 38 organizations, of whom 40 participated in a webinars series, and 25 attended an in-person workshop designed to enable broad stakeholder input, review and refinement of the proposed PROMs implementation model. Stakeholders identified differing uses of PROMs to support: 1) individual patient care decisions, 2) quality improvement initiatives, 3) payer mandates, and 4) population health and research. RESULTS: The implementation framework and steps that are consistently identified by stakeholders as best practices to guide PROM capture and use are described. Of note, participants indicate that web-based informatics tools are necessary but not sufficient for PROM use, suggesting that successful PROM implementation requires integration into clinic operations and careful planning for user's analytic needs. Each of the four identified uses may require implementation modifications at each step to assure optimal use. CONCLUSIONS: The proposed framework will guide future PROM implementation efforts across learning health care systems to assure that complete PROMs are captured at the correct time, and with associated risk factors, to generate meaningful information to serve diverse stakeholders.

Patient-reported outcome measures in arthroplasty registries.

The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population. A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA).

Patient-reported outcome measures in arthroplasty registries Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis.

- The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question ("During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?"; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome ("How satisfied are you with your [right/left] [hip/knee] replacement?"; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or missing data.

Incorporating Patient-Reported Outcomes Into Health Care To Engage Patients And Enhance Care.

The provision of patient-centered care requires a health care environment that fosters engagement between patients and their health care team. One way to encourage patient-centered care is to incorporate patient-reported outcomes into clinical settings. Collecting these outcomes in routine care ensures that important information only the patient can provide is captured. This provides insights into patients' experiences of symptoms, quality of life, and functioning; values and preferences; and goals for health care. Previously embraced in the research realm, patient-reported outcomes have started to play a role in successful shared decision making, which can enhance the safe and effective delivery of health care. We examine the opportunities for using patient-reported outcomes to enhance care delivery and outcomes as health care information needs and technology platforms change. We highlight emerging practices in which patient-reported outcomes provide value to patients and clinicians and improve care delivery. Finally, we examine present and future challenges to maximizing the use of patient-reported outcomes in the clinic.

The Importance of Risk Adjustment in Reporting Total Joint Arthroplasty Outcomes.

BACKGROUND: This study describes and tests a risk adjustment model developed for the California Joint Replacement Registry to report predictors of complication rates. METHODS: Complication rates were analyzed for 9960 patients enrolled in the California Joint Replacement Registry at 22 medical centers. Multivariable logistic risk models were created to analyze risks of postoperative complications. RESULTS: Age and American Society of Anesthesiologists class were the strongest predictors of complication rates (P < .0001). Congestive heart failure and peripheral vascular disease were also statistically significant predictors of complications. Three hospitals were found to have statistically significantly worse than expected complication rates, and one was found to have a better than expected complication rate after case mix risk adjustment. CONCLUSION: Adequate risk adjustment is a key element in objective comparison of surgeons, hospitals, and devices using total joint arthroplasty registry data.

Responsiveness of patient reported outcome measures in total joint arthroplasty patients.

UNLABELLED: This study reports the responsiveness to change and minimal clinically important difference (MCID) of three patient reported outcome measures following total hip arthroplasty (THA) and total knee arthroplasty (TKA). Patient-reported outcome measures were collected preoperatively and 3 months postoperatively for 391 patients enrolled in the California Joint Replacement Registry. Effect size, standardized response means, and MCID were calculated for each measure. The WOMAC and the SF12v2 physical component summary (PCS) score were the most responsive to perioperative changes. The MCID was 4.97 for the SF12v2 PCS and 10.21 for the WOMAC. THA patients were more likely to exhibit improvements above the MCID than TKA patients. The WOMAC and SF12v2 PCS are useful to measure health status changes in TJA patients. LEVEL OF EVIDENCE: Prognostic Level II.

Collecting Patient-Reported Outcomes: Lessons from the California Joint Replacement Registry.

CONTEXT: While patient-reported outcomes (PROs) have long been used for research, recent technology advancements make it easier to collect patient feedback and use it for patient care. Despite the promise and appeal of PROs, substantial barriers to widespread adoption remain-including challenges in interpreting privacy regulations, educating patients and physicians about the power that PRO collection can provide to patient-centered care. CASE DESCRIPTION: This article describes lessons learned from the California Joint Replacement Registry's (CJRR) five-year effort to collect PROs from patients undergoing total hip and total knee replacement surgeries. CJRR is a voluntary, multi-institutional registry in California that collects clinical and device information, as well as PROs from patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) surgeries. PROPOSED SOLUTIONS: The CJRR encountered and developed solutions to overcome several key issues: (1) limitations of electronic PRO collection, (2) challenges in patient recruitment and tracking, (3) challenges in encouraging patients to complete PRO surveys, (4) real and perceived administrative burden to clinic and hospital staff, (5) surgeon engagement, and (6) survey costs. CONCLUSION: The CJRR's field experience can inform growing numbers of providers and researchers who seek to more fully understand the impact of care from the patient's perspective. In addition, the authors believe that these challenges can best be addressed through a combination of policy changes and increased incentives.

Patient, surgeon, and healthcare purchaser views on the use of decision and communication aids in orthopaedic surgery: a mixed methods study.

BACKGROUND: Despite evidence that decision and communication aids are effective for enhancing the quality of preference-sensitive decisions, their adoption in the field of orthopaedic surgery has been limited. The purpose of this mixed-methods study was to evaluate the perceived value of decision and communication aids among different healthcare stakeholders. METHODS: Patients with hip or knee arthritis, orthopaedic surgeons who perform hip and knee replacement procedures, and a group of large, self-insured employers (healthcare purchasers) were surveyed regarding their views on the value of decision and communication aids in orthopaedics. Patients with hip or knee arthritis who participated in a randomized controlled trial involving decision and communication aids were asked to complete an online survey about what was most and least beneficial about each of the tools they used, the ideal mode of administration of these tools and services, and their interest in receiving comparable materials and services in the future. A subset of these patients were invited to participate in a telephone interview, where there were asked to rank and attribute a monetary value to the interventions. These interviews were analyzed using a qualitative and mixed methods analysis software. Members of the American Hip and Knee Surgeons (AAHKS) were surveyed on their perceptions and usage of decision and communication aids in orthopaedic practice. Healthcare purchasers were interviewed about their perspectives on patient-oriented decision support. RESULTS: All stakeholders saw value in decision and communication aids, with the major barrier to implementation being cost. Both patients and surgeons would be willing to bear at least part of the cost of implementing these tools, while employers felt health plans should be responsible for shouldering the costs. CONCLUSIONS: Decision and communication aids can be effective tools for incorporating patients preferences and values into preference-sensitive decisions in orthopaedics. Future efforts should be aimed at assessing strategies for efficient implementation of these tools into widespread orthopaedic practice.

Shared decision making in patients with osteoarthritis of the hip and knee: results of a randomized controlled trial.

BACKGROUND: Despite evidence that shared decision-making tools for treatment decisions improve decision quality and patient engagement, they are not commonly employed in orthopaedic practice. The purpose of this study was to evaluate the impact of decision and communication aids on patient knowledge, efficiency of decision making, treatment choice, and patient and surgeon experience in patients with osteoarthritis of the hip or knee. METHODS: One hundred and twenty-three patients who were considered medically appropriate for hip or knee replacement were randomized to either a shared decision-making intervention or usual care. Patients in the intervention group received a digital video disc and booklet describing the natural history and treatment alternatives for hip and knee osteoarthritis and developed a structured list of questions for their surgeon in consultation with a health coach. Patients in the control group received information about the surgeon's practice. Both groups reported their knowledge and stage in decision making and their treatment choice, satisfaction, and communication with their surgeon. Surgeons reported the appropriateness of patient questions and their satisfaction with the visit. The primary outcome measure tracked whether patients reached an informed decision during their first visit. Statistical analyses were performed to evaluate differences between groups. RESULTS: Significantly more patients in the intervention group (58%) reached an informed decision during the first visit compared with the control group (33%) (p = 0.005). The intervention group reported higher confidence in knowing what questions to ask their doctor (p = 0.0034). After the appointment, there was no significant difference between groups in the percentage of patients choosing surgery (p = 0.48). Surgeons rated the number and appropriateness of patient questions higher in the intervention group (p < 0.0001), reported higher satisfaction with the efficiency of the intervention group visits (p < 0.0001), and were more satisfied overall with the intervention group visits (p < 0.0001). CONCLUSIONS: Decision and communication aids used in orthopaedic practice had benefits for both patients and surgeons. These findings could be important in facilitating adoption of shared decision-making tools into routine orthopaedic practice.

Barriers to completion of Patient Reported Outcome Measures.

Patient Reported Outcomes Measures (PROMs) are commonly used in total joint arthroplasty (TJA) to assess surgical outcomes. However certain patient populations may be underrepresented due to lower survey completion rates. The purpose of this study is to evaluate factors that influence PROM completion rates for 1997 TJA patients between 7/1/2007 and 12/31/2010. Completion rates were lower among patients who were over 75, Hispanic or Black, had Medicare or Medicaid, TKA patients and revision TJA patients (P<0.05 for all comparisons). Having multiple risk factors further reduced completion rates (P<0.001). Overall participation increased significantly during the study period, after electronic data capture methods were introduced. Awareness of these factors may help physicians and researchers improve participation of all patient populations so they are well represented in TJA outcomes research.

Health policy implications of outcomes measurement in orthopaedics.

BACKGROUND: An emphasis on "value" over volume in health care is driving new healthcare measurement, delivery, and payment models. Orthopaedic surgery is a major contributor to healthcare spending and, as such, is the focus of many of these new models. WHERE ARE WE NOW?: An evaluation of "value" in orthopaedics requires information that has not traditionally been collected as part of routine clinical practice. If value is defined as patient outcomes in relation to healthcare costs, we need to collect information about both. In orthopaedics, patient-reported functional status is not routinely measured, and a poor understanding of the costs associated with the provision of musculoskeletal care limits our ability to quantify and report on financial measures. WHERE DO WE NEED TO GO?: To improve the value of musculoskeletal care, we need to focus on both improving outcomes and controlling costs. To improve outcomes, orthopaedists must agree on a set of outcome measures for appropriate care and advocate for their collection through the use of registries. Orthopaedic registries in several countries provide best practices for this information collection and sharing. In the United States, we should make comparable investments in registries to measure patient-reported outcomes. To address escalating costs, we need to improve the accuracy of cost data by applying modern cost accounting processes. HOW DO WE GET THERE?: Orthopaedists should take a leadership position in the promotion and implementation of value-based health care by advocating for the use of registries to measure risk-adjusted patient specific outcomes, negotiating with payors for value-based payment incentives and applying modern cost accounting processes to control costs rather than waiting for public and private payors to define components of the value equation that will affect how orthopaedic surgeons are evaluated and compensated in the future.

The emerging case for shared decision making in orthopaedics.

The Institute of Medicine outlined a standard for patient-centered care, which has become the centerpiece of healthcare reform in the United States. Shared decision-making interventions, which include decision and communication aids, are formal embodiment of this philosophy. Although the concept of shared decision making has been shown to be an effective tool, and its relevance to orthopaedic medicine has been well documented, it has not been widely adopted by orthopaedic surgeons. It is helpful to examine the benefits of shared decision making, along with incentives to encourage adoption and implementation of this important philosophy.

Use of patient-reported outcomes in the context of different levels of data.

There is increasing interest in measuring patient-reported outcomes as part of routine medical practice, particularly in fields like total joint replacement surgery, where pain relief, satisfaction, function, and health-related quality of life, as perceived by the patient, are primary outcomes. We review some well-known outcome instruments, measurement issues, and early experiences with large-scale collection of patient-reported outcome measures in joint registries. The patient-reported outcome measures are reviewed in the context of multidimensional outcome assessment that includes the traditional clinical outcome parameters as well as disease-specific and general patient-reported outcome measures.

The impact of health plan delivery system organization on clinical quality and patient satisfaction.

OBJECTIVES: The purpose of this study was to examine the extent to which measures of health plan clinical performance and measures of patient perceptions of care are associated with health plan organizational characteristics, including the percentage of care provided based on a group or staff model delivery system, for-profit (tax) status, and affiliation with a national managed care firm. DATA SOURCES: Data describing health plans on region, age of health plan, for-profit status, affiliation with a national managed care firm, percentage of Medicare business, total enrollment, ratio of primary care physicians to specialists, HMO penetration, and form of health care delivery system (e.g., IPA, network, mixed, staff, group) were obtained from InterStudy. Clinical performance measures for women's health screening rates, child and adolescent immunization rates, heart disease screening rates, diabetes screening rates, and smoking cessation were developed from HEDIS data. Measures of patient perceptions of care are obtained from CAHPS survey data submitted as Healthplan Employer Data and Information Set, Consumer Assessment of Health Plans 2.0 H. STUDY DESIGN: Multivariate regression cross-sectional analysis of 272 health plans was used to evaluate the relationship of health plan characteristics with measures of clinical performance and patient perceptions of care. PRINCIPAL FINDINGS: The form of delivery system, measured by percent of care delivered by staff and group model systems, is significantly related (p < or = .05) with four of the five clinical performance indices but none of the three satisfaction performance indices. Other variables significantly associated with performance were being geographically located in the Northeast, having nonprofit status, and for patient satisfaction, not being part of a larger insurance company. CONCLUSIONS: These comparative results provide evidence suggesting that the type of delivery system used by health plans is related to many clinical performance measures but is not related to patient perceptions of care. These findings underscore the importance of the form of the delivery system and the need for further inquiry that examines the relationship between organizational form and performance.