Is There Room for Individual Patient-Specified Preferences in the Patient-Reported Outcome Measurement Revolution?

Purpose: The study aim was to test the feasibility of collecting qualitative patient-preferred outcomes or goals and the degree of their attainment as an addition to a standardized process for collecting quantitative composite patient-reported outcome measures (PROMs) from patients undergoing knee joint replacement. Methods: Patients of a large Midwestern medical group scheduled to have total replacement of their knee joint have been asked to complete a PROMs survey preoperatively and at 3 and 12 months after surgery since 2014. In March 2020, an open-ended question about their most important preferred outcome was added to the existing questionnaire. The responses for all 3 time periods from the first 6 months of this addition were summarized quantitatively and analyzed by 2 reviewers. Results: During that 6-month period, 1481 people completed the main survey while 1463 (98.8%) also completed the open-ended question. At baseline, 90.8% of the 590 baseline respondents identified a preferred outcome. If multiple-choice categories had been used, 82.7% of the responses would have lost some or a large amount of their preferred goals' meaning. Of the 144 who completed surveys at both baseline and 3 months, 86.1% reported another outcome in addition to pain relief, while 54.2% reported "Complete or Mostly" achieving their self-identified preferred outcome. Conclusions: Most people who have joint replacement surgery and respond to a quantitative PROMs survey are willing to report on their other preferred outcomes as well. Adding an open-ended question to PROMs surveys may increase clinician focus on addressing outcomes important to each patient.

Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial.

BACKGROUND: A team approach is one of the most effective ways to lower blood pressure (BP) in uncontrolled hypertension, but different models for organizing team-based care have not been compared directly. METHODS: A pragmatic, cluster-randomized trial compared 2 interventions in adult patients with moderately severe hypertension (BP≥150/95 mm Hg): (1) clinic-based care using best practices and face-to-face visits with physicians and medical assistants; and (2) telehealth care using best practices and adding home BP telemonitoring with home-based care coordinated by a clinical pharmacist or nurse practitioner. The primary outcome was change in systolic BP over 12 months. Secondary outcomes were change in patient-reported outcomes over 6 months. RESULTS: Participants (N=3071 in 21 primary care clinics) were on average 60 years old, 47% male, and 19% Black. Protocol-specified follow-up within 6 weeks was 32% in clinic-based care and 27% in telehealth care. BP decreased significantly during 12 months of follow-up in both groups, from 157/92 to 139/82 mm Hg in clinic-based care patients (adjusted mean difference -18/-10 mm Hg) and 157/91 to 139/81 mm Hg in telehealth care patients (adjusted mean difference -19/-10 mm Hg), with no significant difference in systolic BP change between groups (-0.8 mm Hg [95% CI, -2.84 to 1.32]). Telehealth care patients were significantly more likely than clinic-based care patients to report frequent home BP measurement, rate their BP care highly, and report that BP care visits were convenient. CONCLUSIONS: Telehealth care that includes extended team care is an effective and safe alternative to clinic-based care for improving patient-centered care for hypertension. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02996565.

Is the Promise of PROMs Being Realized? Implementation Experience in a Large Orthopedic Practice.

Patient-reported outcome measures (PROMs), increasingly used for research and quality measurement, are lauded for their potential to improve patient-centered care, both through aggregate reporting and when integrated into clinical practice. However, there are few published studies of the resultant use of PROMs in clinical practice. This case study describes the implementation and use of PROMS in a Midwestern multispecialty medical group orthopedic practice among patients undergoing total knee and hip surgery. Specifically, rates of PROMs use by care teams are tracked over time once made available in the electronic health record. During this time, the orthopedics department achieved a patient PROMS survey response rate of 68% at baseline, 58% 3 months post-surgery, and 55% 12 months post-surgery. However, these data were only accessed by the care teams for fewer than 1% of associated clinical encounters. This suggests that making PROMs available for care team review in the electronic health record, even when coupled with relatively high response rates from patients and departmental leadership support is not enough to encourage integration of PROMs into clinical care for patients. Additional effort is required to identify barriers to PROMs use in clinical care and to test methods to enhance use.

Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence.

BACKGROUND: Explanatory trials are designed to assess intervention efficacy under ideal conditions, while pragmatic trials are designed to assess whether research-proven interventions are effective in "real-world" settings without substantial research support. METHODS: We compared two trials (Hyperlink 1 and 3) that tested a pharmacist-led telehealth intervention in adults with uncontrolled hypertension. We applied PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) scores to describe differences in the way these studies were designed and enrolled study-eligible participants, and the effect of these differences on participant characteristics and adherence to study interventions. RESULTS: PRECIS-2 scores demonstrated that Hyperlink 1 was more explanatory and Hyperlink 3 more pragmatic. Recruitment for Hyperlink 1 was conducted by study staff, and 2.9% of potentially eligible patients enrolled. Enrollees were older, and more likely to be male and White than non-enrollees. Study staff scheduled the initial pharmacist visit and adherence to attending this visit was 98%. Conversely for Hyperlink 3, recruitment was conducted by clinic staff at routine encounters and 81% of eligible patients enrolled. Enrollees were younger, and less likely to be male and White than non-enrollees. Study staff did not assist with scheduling the initial pharmacist visit and adherence to attending this visit was only 27%. Compared to Hyperlink 1, patients in Hyperlink 3 were more likely to be female, and Asian or Black, had lower socioeconomic indicators, and were more likely to have comorbidities. Owing to a lower BP for eligibility in Hyperlink 1 (>140/90 mm Hg) than in Hyperlink 3 (>150/95 mm Hg), mean baseline BP was 148/85 mm Hg in Hyperlink 1 and 158/92 mm Hg in Hyperlink 3. CONCLUSION: The pragmatic design features of Hyperlink 3 substantially increased enrollment of study-eligible patients and of those traditionally under-represented in clinical trials (women, minorities, and patients with less education and lower income), and demonstrated that identification and enrollment of a high proportion of study-eligible subjects could be done by usual primary care clinic staff. However, the trade-off was much lower adherence to the telehealth intervention than in Hyperlink 1, which is likely to reflect uptake under real-word conditions and substantially dilute intervention effect on BP. TRIAL REGISTRATION: The Hyperlink 1 study (NCT00781365) and the Hyperlink 3 study (NCT02996565) are registered at ClinicalTrials.gov.

Is Shared Decision-making Associated with Better Patient-reported Outcomes? A Longitudinal Study of Patients Undergoing Total Joint Arthroplasty.

BACKGROUND: Although shared decision-making (SDM) has knowledge and satisfaction benefits for patients and is promising, we lack data demonstrating that SDM is associated with better patient-reported functional outcomes. Such data would support the integration and prioritization of SDM into all aspects of orthopaedic care. QUESTIONS/PURPOSES: (1) Is a measure of SDM before total joint arthroplasty associated with better patient-reported outcome measures (PROMs) 1 year postoperatively? (2) What is the relationship between the measure of SDM and two measures of patient experience (patient rating of the provider and patient likelihood of recommending the provider) at 1 year postoperatively? METHODS: In this observational longitudinal survey-based study, patients receiving an initial THA or TKA from a large, multispecialty medical group in the Midwestern United States were surveyed after they were scheduled for surgery and again at 12 months after their procedure. The three-item collaboRATE measure of SDM was added to existing patient surveys of PROMs. However, the surgeons and their department had no organized approach to SDM during this time. The surveys also included the Oxford knee or hip score and two validated measures of patient experience (patient rating of the provider and whether a patient would recommend the provider). Of the 2779 eligible primary joint arthroplasties that occurred from April 23, 2018 to May 1, 2019, 48% (1334 procedures; 859 TKAs and 485 THAs) of the patients responded to both the preoperative and 12-month postoperative surveys. Most of the patients who were included in the analytic sample were white (93%; 1255 of 1344), with only 3% (37) using Medicaid benefits at the time of surgery. Differences between responders and nonresponders were present and explored in an analysis. Patient responses were analyzed in regression models to estimate the association between preoperative collaboRATE scores and the Oxford knee or hip scores, and patient experience measures 12 months postoperatively. RESULTS: There was a moderate, positive association between preoperative collaboRATE scores and the Oxford scores at 12 months, after adjustment for potential confounders such as patient age and preoperative functional score (ß = 0.58; 95% CI 0.14-1.02; p = 0.01). Similarly, patients with preoperative collaboRATE scores had marginally higher patient experience scores at 12 months postoperatively (ß = 0.14; 95% CI 0.05-0.24; p = 0.003) and were more likely to recommend their surgeon (OR 1.43; 95% CI 1.11-1.84; p = 0.005). The patient experience measures were also modestly correlated with collaboRATE scores in cross-sectional associations, both preoperatively and at 12 months postoperatively (0.29 ≤ r ≤ 0.54; p < 0.01). CONCLUSION: The association between preoperative collaboRATE scores and Oxford hip or knee scores suggests that SDM could be one tool to encourage better outcomes. Although previous studies have shown that SDM can improve patient experience, the lack of a strong correlation in our study suggests that PROMs and experience measures are separate domains, at least partly. Improving preoperative SDM between the surgeon and patient might help improve surgical outcomes for patients undergoing TKA and THA. LEVEL OF EVIDENCE: Level II, therapeutic study.

What Do Orthopaedists Believe is Needed for Incorporating Patient-reported Outcome Measures into Clinical Care? A Qualitative Study.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly promoted for use in routine orthopaedic care with the expectation that if they are made available during encounters, they will be incorporated into clinical practice. We investigated an initiative in which PROMs were systematically collected and provided via the electronic health record but were infrequently used. QUESTIONS/PURPOSES: In a qualitative study, we asked: (1) Why are PROM results not being used in clinical care when they are available to surgeons? (2) What aspects of PROMs are seen as useful for clinical care? (3) How are PROMs generally perceived by surgeons and orthopaedic leaders? METHODS: A cross-sectional qualitative study was conducted in a single health system in an urban setting using semistructured interviews with a purposive sample of orthopaedic surgeons and leaders who would have substantial knowledge of and experience with the organization's PROM system, which was embedded in the electronic health record and developed for use in clinical care but was not being used. We included surgeons whose practices consisted of at least 90% patients with osteoarthritis, including surgical and nonsurgical management, and thus their patients would be completing PROMs surveys, or surgeons who were leaders in one of the three orthopaedic divisions in the health plan. The senior research manager for orthopaedics identified 14 potential participants meeting these criteria, 11 of whom agreed to study participation. Participants included nine surgeons and two orthopaedic leaders; the majority were men, with a median of 13 years of clinical practice. Study interviews were conducted by an experienced interviewer not known to participants, in private conference rooms in the healthcare setting, and a median (range) of 27 minutes (16 to 40) in length. A content analysis approach was employed for data analysis, with thematic inductive saturation reached in the analysis and attention to trustworthiness and rigor during the analytic process. RESULTS: Interviewees reported that PROM scores are not being used in patient clinical care because of logistical barriers, such as access and display issues and the time required, and perceptual barriers, such as concerns about patient understanding and the validity and reliability of measures. Surgeons preferred talking with patients about the personal outcomes patients had identified as important; most patients preferred to assess progress toward their own goals than PROMs scores for other people. Surgeons also identified changes that could facilitate PROM use and reduce barriers in clinical care, including pushing PROM scores to physicians' inboxes, developing inserts for physician notes, using easy-to-understand graphical displays, and engaging patients about PROMs earlier in the care process. Participants all agreed that PROMs in aggregate use are valuable for the organization, department, and individual surgeons, but individual patient scores are not. CONCLUSION: Despite the availability of PROMs, there are important barriers to incorporating and using PROMs in clinical care. Providing access to PROM scores without clearly understanding how and why surgeons may consider using or incorporating them into their clinical practice can result in expensive and underused systems that add little value for the clinician, patient, or organization. CLINICAL RELEVANCE: Involving front-line orthopaedic surgeons and leaders in shaping the design and structure of PROM systems is important for use in clinical care, but these interviewees seemed to see aggregate data as more valuable than individual patient scores.

Experiences and Perceptions of Patients with Uncontrolled Hypertension Who are Dissatisfied with Their Hypertension Care.

BACKGROUND: Hypertension control has been decreasing recently. We compared the experience and attitudes toward care between patients with uncontrolled hypertension who are more and less satisfied with that care to identify ways to improve their care. METHODS: Baseline survey of 3072 patients with diagnosed hypertension and repeated blood pressure measurements at or above 150/95 mmHg during clinic appointments at 21 primary care clinics of a large Midwestern multi-specialty medical group. Survey questions were about previous hypertension care satisfaction, the degree to which that care was patient-centered, their feelings of self-confidence and treatment burden in managing hypertension, and medication side effects. RESULTS: A total of 1697 patients completed surveys (response rate = 55%). Of the 1697 patients, the 24% who were most dissatisfied (scored 0 to 5 on a 0 to 10 scale of satisfaction) significantly differed from those most satisfied (scored 9 to 10) on all demographic and clinical characteristics as well as on every measure of care experience and health status. After adjusting for those characteristics, reports of patient-centered care, self-confidence, stopping the medication because of side effects, and the burdensomeness of treatment were all significantly worse (P <.01 to P <.001) than for those with a higher rating of their hypertension care. Correlations among these measures were low, so the people with each problem with care seem to be different. CONCLUSIONS: Many patients with uncontrolled hypertension are dissatisfied with their care, but that is associated with different problems for different people. Identifying and attending to these problems may provide opportunities to help them achieve better control.

Personalized outcomes for hip and knee replacement: the patients point of view.

BACKGROUND: Patient reported outcome measures (PROMs) are increasingly being incorporated into clinical and surgical care for assessing outcomes. This study examined outcomes important to patients in their decision to have hip or knee replacement surgery, their perspectives on PROMs and shared decision-making, and factors they considered important for postoperative care. METHODS: A cross-sectional study employing survey methods with a stratified random sample of adult orthopedic patients who were scheduled for or recently had hip or knee replacement surgery. RESULTS: In a representative sample of 226 respondents, patients identified personalized outcomes important to them that they wanted from their surgery including the ability to walk without pain/discomfort, pain relief, and returning to an active lifestyle. They preferred a personalized outcome (54%) that they identified, compared to a PROM score, for tracking progress in their care and thought it important that their surgeon know their personal outcomes (63%). Patients also wanted to engage in shared decision-making (79%) about their post-surgical care and identified personal factors important to their aftercare, such as living alone and caring for pets. CONCLUSIONS: Patients identified unique personalized outcomes they desired from their care and that they wanted their orthopedic surgeons to know about. Asking patients to identify their personalized outcomes could add value for both patients and surgeons in clinical care, facilitating more robust patient involvement in shared decision-making.

What Outcomes Matter to Patients After Joint or Spine Surgery?

PURPOSE: Patient-reported outcome measures (PROMs) are increasingly used in clinical care, but there have been few studies of what patients identify as the most important outcomes. METHODS: Semi-structured interviews were conducted with 65 patients undergoing hip or knee replacement, spinal discectomy/laminotomy, or a spinal fusion. Interviews focused on outcomes patients identified as important, perceived usefulness of standardized PROMs measures, and contextual situations important to their care. Data were analyzed using a directed content analysis approach. RESULTS: Patients identified desired outcomes that were unique and important to them. Their preferred outcomes focused in the areas of freedom from pain, getting back to their normal life, and returning to an active lifestyle. Patients cared more about their individual preferred outcomes, which had more meaning for them, than a standardized PROM score. Patients also identified particular contextual situations that their care team was assumed to know about but that may not have been known. CONCLUSIONS: Patients identify specific preferred outcomes from these surgical procedures that are important and meaningful to them and that frame whether they see their surgery as a success. They also identified personal factors that they assume their surgeons know about, which affect their care and recovery. These findings underscore the importance of engaging patients in discussions about their preferences and contextual factors both prior to and after surgery.

Patient-Centered Outcomes Measurement: Does It Require Information From Patients?

PURPOSE: Since collecting outcome measure data from patients can be expensive, time-consuming, and subject to memory and nonresponse bias, we sought to learn whether outcomes important to patients can be obtained from data in the electronic health record (EHR) or health insurance claims. METHODS: We previously identified 21 outcomes rated important by patients who had advanced imaging tests for back or abdominal pain. Telephone surveys about experiencing those outcomes 1 year after their test from 321 people consenting to use of their medical record and claims data were compared with audits of the participants' EHR progress notes over the time period between the imaging test and survey completion. We also compared survey data with algorithmically extracted data from claims files for outcomes for which data might be available from that source. RESULTS: Of the 16 outcomes for which patients' survey responses were considered to be the best information source, only 2 outcomes for back pain and 3 for abdominal pain had kappa scores above a very modest level of ≥ 0.2 for chart audit of EHR data and none for algorithmically obtained EHR/claims data. Of the other 5 outcomes for which claims data were considered to be the best information source, only 2 outcomes from patient surveys and 3 outcomes from chart audits had kappa scores ≥ 0.2. CONCLUSIONS: For the types of outcomes studied here, medical record or claims data do not provide an adequate source of information except for a few outcomes where patient reports may be less accurate.

The Effect of Achieving Patient-Reported Outcome Measures on Satisfaction.

OBJECTIVE: To determine how frequently patients with advanced imaging for back or abdominal pain achieve outcomes that are identified by patients as important and whether those achieving those outcomes are more satisfied. METHODS: Cross-sectional analysis of survey responses from patients of an 800-physician multi-specialty group in Minnesota in 2013. A total of 201 patients with abdominal pain and 167 patients with back pain 1 year earlier that was serious enough for a computed tomography or magnetic resonance imaging scan (67% of those contacted). The main outcomes were the frequency of occurrence of 19 outcomes previously identified by patients as important, plus satisfaction with the results of care. RESULTS: The majority of patients surveyed had achieved most of the desired outcomes. For abdominal pain, 17 of 19 of the desired outcomes were achieved by >50% of patients, while 11 of 19 desired outcomes were achieved by >50% of patients with back pain. Seven of the desired outcomes were significantly associated with satisfaction. CONCLUSION: Achieving outcomes important to patients is associated with greater patient satisfaction. Such measures are potentially valuable measures of quality.