O53 PROMIS Physical Function severity is associated with physical therapy recommendations in primary care
Ryan Jacobson1, Robert Long2, Dan Kang1, Mark Amendola2, Jeff Houck1
1George Fox University, Newberg, OR, USA. 2Samaritan Health Services, Lebanon, OR, USA
Correspondence: Ryan Jacobson
rjacobson@georgefox.edu
Journal of Patient-Reported Outcomes 5(1): O53.
Objective: Triage treatment by physical therapists is an evolving service to improve diagnosis and outcomes in primary care. A challenge for health systems is to document outcomes of this service across a population. A potential outcome of primary care physical therapy (PC-PT) is to improve physical function across a population. However, current models of utilization focus on diagnosis rather than patient needs, as defined by the PROMIS Physical Function measure. The purpose of this study was to examine the association of recommendations from PC-PT for further physical therapy in primary care patients with musculoskeletal problems.
Methods: Patient records from Jan 2021 to April 2021 were requested from an evolving database to assess PC-PT in primary care (n = 383). PC-PTs were trained to use the PROMIS PF computer adaptive measure at intake to quickly assess perceptions of physical function. Training included interpreting the PROMIS PF measure in addition to other diagnostic decisions. Initial analysis was univariate (i.e. chi-square), followed by logistic regression, the outcome for both was referral to further outpatient PT. The predictor variables included: PROMIS PF severity (Very Low PF (< 40), Low PF (40.1–50), or Above Average PF (> 50.1)), age, gender, acuity of symptoms (acute, subacute, chronic), and area of injury (spine, extremity, other).
Results: Of 383 patients, 301 had complete data on all noted variables. A total of 40.5% (122/301) were recommended for physical therapy by the PC-PT. Chi square analysis showed no significant associations between recommendations for PT with gender p = 0.46), acuity categories (p = 0.07), or area of injury (p = 0.09). However, there was a strong association of PT referral with PROMIS PF categories (p < 0.001). The logistic regression analysis showed that age (p = 0.04), acuity (p = 0.07) and PROMIS PF (p = < 0.001) categories influenced the recommendation of further physical therapy by the PC-PT. The accuracy when these three variables were included in the model was 67.1%.
Conclusions: PC-PT decisions are consistent with patient needs as defined by the PROMIS PF measure severity when recommending further physical therapy services following a primary care visit with the PC-PT. To improve population health outcomes, specialized programs may be needed to address patient needs (i.e. low PF) in addition to specific diagnostic categories.
O54 PROMIS measures in geriatric, cardiorespiratory, neurologic and orthopedic rehabilitation patient populations: a systematic review
Rehab Alhasani, Nowaz Syed, Zhen Lun Chen, Qinyang Du, Suzanne Tran, Judith Soicher, Sara Ahmed
McGill University, Montreal, Canada
Correspondence: Rehab Alhasani
rehab.alhasani@mail.mcgill.ca
Journal of Patient-Reported Outcomes 5(1): O54.
Objective: One of the most crucial pieces of information that a clinician can gather to guide optimal patient care is the patient’s own perception of their health, symptoms, and well-being. However, it is unclear to what extent PROMIS has been used within rehabilitation patient populations. In this context, the purpose of this systematic review was to provide a comprehensive overview of PROMIS measures used with rehabilitation populations that can be used to inform patient care and guide future evaluation of PROMIS measures. Specifically, the authors aimed to 1) evaluate publication trends of PROMIS in rehabilitation populations, 2) evaluate the measurement properties, feasibility, and interpretation of PROMIS measures in rehabilitation populations.
Methods: We conducted a systematic review following the PRISMA guidelines. Articles were identified in MEDLINE/PubMed, EMBASE and CINAHL. Articles were excluded if they were not published in English or French after the year of 2004, if they did not focus on the adult rehabilitation population (geriatric, cardiorespiratory, neurological, and orthopaedic populations), and if they did not address the psychometric properties. Four reviewers, divided into two teams, screened abstracts, reviewed full articles and extracted the necessary information for this synthesis. The COSMIN guidelines were used to summarize and assess the psychometric quality of the PROMIS measures.
Results: A Kappa > 0.7 was achieved between reviewers. From 153 initial articles, 41 articles met the inclusion criteria covering the PROMIS, Neuro-QoL SCI-QoL, TBI-QoL measurement systems, and 14 domains across four patient populations (chronic conditions, neurological, orthopedic and geriatric). The most studied measures were the PROMIS Physical Function Computer Adaptive Test (PF CAT) (14 papers), followed by the PROMIS Pain Interference Computer Adaptive Test (PI CAT) (5 papers). Psychometric evaluations were most frequently reported for construct validity (70 instances), reliability (37 instances), responsiveness (17 instances) whereas content validity was reported the least (1 instance). Ratings of evidence for psychometric properties ranged from low to high across measures, property evaluated, and patient population.
Conclusions: The PF-CAT and PI-CAT were most commonly tested and had the strongest support for use in the orthopaedic population. Further research on PROMIS psychometric properties of other domains across populations is needed.
P55 Common patient reported outcomes within the FDA Voice of the Patient Reports
Cameron Metz1, Polly McCracken2, Janel Hanmer3
1University of Pittsburgh, School of Medicine, Pittsburgh, PA, USA. 2Department of General Internal Medicine, University of Pittsburgh, Pittsburgh, USA. 3Department of Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA
Correspondence: Cameron Metz
cad214@pitt.edu
Journal of Patient-Reported Outcomes 5(1): P55.
Objective: Proponents of disease-specific PROMs often argue that disease-agnostic measures do not adequately capture the experience of their patient population. PROMIS provides a set of disease-agnostic domains that may adequately cover many diseases. This study seeks to investigate if PROMIS’s quality of life domain coverage can span PROs across unrelated, chronic diseases as reported by patients.
Methods: The FDA’s Voice of the Patient Reports were an initiative located in the public domain to elevate patient voices regarding their condition and the associated therapies. Two reviewers independently extracted patient-reported health-related quality of life domains from the Reports and categorized them into PROMIS domains or non-PROMIS domains. For each report, the domain coverage was summarized. Any extracted PROs not covered by PROMIS domains were placed in an ‘other’ category and analyzed for common themes.
Results: Throughout all 26 reports, PROMIS covered 339 of 452 (75%) of the Reports’ domains. Sarcopenia and Heritable Bleeding Disorders tied for the highest coverage, 86%. HIV had the lowest coverage, 64%. The most common PROMIS domain, “Ability to Participate in Social Roles”, appeared in 25 (96%) reports. The least common PROMIS domain, itch, covered 5 (19%) reports. The most common domains not included in PROMIS were stigma, sensitivities, and sensory deficits as evident in 19 (73%), 18 (69%), and 18 (69%) reports, respectively. If the top three unincluded domains (stigma, sensitivities, and sensory deficits) were amended into PROMIS, the total domain coverage would increase from 75 to 94%.
Conclusions: PRO domains elicited in the FDA Voice of the Patient Reports were widely captured by PROMIS. This suggests the domains patients experience are similar enough to to be recorded by appropriate PROMIS domains. PROMIS could increase its coverage by adding domains for stigma, sensitivities, and sensory deficits. PROMIS remains a good candidate for the universal integration of PROMs.
P56 Implementation of PROMIS CAT Pediatric Measures in outpatient behavioral health: adaptations and challenges during a pandemic
Kayla Hunt, Melissa Heatly, Linda Alpert-Gillis
University of Rochester School of Medicine & Dentistry, Rochester, NY, USA
Correspondence: Kayla Hunt
kmhunt2@gmail.com
Journal of Patient-Reported Outcomes 5(1): P56.
Objective: The purpose of this presentation is to discuss roll-out of the PROMIS CAT Pediatric and Parent Proxy measures during the COVID-19 crisis. Though we were scheduled to launch the PROMIS CAT measures via iPad during face-to-face visits in March 2020, we had to modify our original plan due to the onset of the pandemic. The launch was rescheduled for October 2020 with significant modifications for telehealth implementation; investigators collected feedback about the process from both families and clinicians. Presenters will discuss these modifications, strategies for adaptation, and reactions about the process obtained from families, youth, and clinicians.
Methods: The primary modification was the delivery method of the measures. While we were able to administer measures to some patients during face-to-face visits, the majority (80%) were seen via telehealth in October 2020. For telehealth visits, clinicians completed the measures with the patient/caregiver during the appointment, which took significantly more clinician time (10–30 min). Measures were administered to patients and caregivers via iPad during face-to-face visits. Patient/caregiver satisfactions surveys were distributed after completion of the measures. Clinician questionnaires assessed for attitudes, behaviors, and barriers related to utilization of standardized measures for both intake and progress monitoring and were administered pre-implementation and at 1, 3, and 6 months after implementation.
Results: Preliminary analyses included responses from 64 patients/caregivers and 38 clinicians. Overall, we received overwhelmingly positive responses from patients and caregivers about the process for completing the PROMIS CAT measures. Preliminary analyses of clinician questionnaires indicated that the administration time of measures was more of a barrier when completed via telehealth than when completed via iPad, which was consistent across time-points. Clinicians otherwise noted fewer barriers to implementation of measures over the six-month period. Future analyses will consider how implementation of the PROMIS measures are linked to changes in clinician attitudes about broader assessment and progress monitoring.
Conclusions: Despite the challenges we encountered during implementation during COVID-19, results indicate that the PROMIS CAT measures helped reduce barriers for use of standardized measures among clinicians, was an easier process for patients and caregivers, and will continue to help ensure that treatment our families receive high quality care.
P57 Patient and caregiver satisfaction with PROMIS CAT Pediatric Measures in an outpatient behavioral health clinic
Kayla Hunt, Melissa Heatly, Linda Alpert-Gillis
University of Rochester School of Medicine & Dentistry, Rochester, NY, USA.
Correspondence: Kayla Hunt
kmhunt2@gmail.com
Journal of Patient-Reported Outcomes 5(1): P57.
Objective: The purpose of this presentation is to discuss implementation of a custom bundle of seven PROMIS CAT Pediatric and Parent Proxy Measures in a hospital-based outpatient behavioral health setting. Prior to implementation of PROMIS, lengthier paper-and-pencil measures were used for assessment and progress monitoring, which resulted in increased time burden for patients and caregivers and were not given at consistent time-points during treatment. During this roll-out, we obtained patient and caregiver feedback about their satisfaction with this new process.
Methods: Patients and caregivers were asked to complete the PROMIS measures during intake and then every 75 days during treatment. The seven measures included in the bundle were: Anxiety, Depressive Symptoms, Cognitive Function, Sleep Disturbance, Peer Relationships, Family Relationships, and Anger. Upon completion of those measures, patients and caregivers were asked to fill out a survey designed to assess satisfaction with computerized adaptive testing measures (see Krishna, Velleru, Smith, 2019). It includes six questions, each with a five-point Likert scale, regarding ease of use, completion time, relevance, utility, helpfulness, and willingness to repeat the measure again. We also asked whether the survey was completed by the child/teen or parent/caregiver and if it was completed during a face-to-face or telehealth visit. Data was collected via a web-based survey and remained separate from their EMR.
Results: Preliminary analyses included responses from 64 patients/caregivers. The majority of responses (94%) were collected during face-to-face visits and two-thirds of the respondents were parents/caregivers. Most responders (86%) found the program easy to use and were able to complete the measures in a reasonable amount of time (75%). They also reported they were asked relevant questions (84%) and would be willing to answer the questions again to track symptoms over time (78%). Responders indicated the information collected from these measures would be useful for the visit (72%) and their answers would help the clinician better understand their current challenges (72%).
Conclusions: Overall, we received positive responses from patients and caregivers about the process for completing the PROMIS CAT measures. Presenters will discuss next steps, limitations, and opportunities for future Quality Improvement efforts.
O58 Turning data into information, information into insight and insight into action: data request system development
Allison W. McIntyre, Kathleen Fear, Judith Baumhauer
University of Rochester Medical Center, Rochester, NY, USA
Correspondence: Allison W. McIntyre
allisonw_mcintyre@urmc.rochester.edu
Journal of Patient-Reported Outcomes 5(1): O58.
Objective: Aggregate review of PRO data is necessary for clinical application and research and is only successful if there is access to robust datasets. However, it isn’t enough to have the data, it must be put to work.
Developing a standardized data request system that is nimble enough to adjust to the changing needs of the requestor, with access to data that was previously stuck in inaccessible silos, takes forethought. Only by planning ahead can systems be designed that are easy to use and manage and will produce data that can inform clinical decision making.
Methods: Transitioning from simple email requests to a standardized request process involved the use of a service desk software program. Once the single point of contact system was in place it was easier to collect required information, track requests and support regulatory requirements for research requests.
Consolidation was an important component of this project as data is pulled from multiple locations into one warehouse. Decisions about which components to include were based on previous data requests and review of similar systems across the enterprise.
Even with standardization, is often necessary to clarify requests. Having an integrated communication platform allows the analyst to exchange ideas, monitor changes and suggest tactics so the resulting data meets the needs of the requestor.
Results: Initial data requests were for administration metrics and patient PROMIS scores. After a year, with the introduction of monthly collection reporting, the majority of requests switched to longitudinal PROMIS and other PRO scores anchored by medical interventions or events. In 2020, 41 requests for data came through the system. 93% were for research or quality improvement initiatives and the rest for a variety of administrative evaluations. In the first quarter of 2021, all requests have been for research.
Conclusions: Clinical PRO data is typically not as clean as that collected as part of a research protocol. Having a standardized request system that guides the requestor and supports the data analyst is key to producing results that can yield new insight into how to improve clinical outcomes and value in healthcare.
O59 Aligning significant individual change with patient-perceived meaningful change on the PROMIS Physical Function 10a
John Devin Peipert1, Ron Hays2, David Cella1
1Northwestern University, Department of Medical Social Sciences, Chicago, IL, USA. 2UCLA, Department of Medicine/Division of General Internal Medicine & Health Services Research, Los Angeles, CA, USA
Correspondence: John Devin Peipert
john.peipert@northwestern.edu
Journal of Patient-Reported Outcomes 5(1): O59.
Objective: Individual change thresholds on patient reported outcomes (PRO) must be differentiable from error, or statistically significant. In addition, change should be meaningful to individuals. The reliable change index (RCI) identifies significant change but may be insensitive to patient-perceived meaningful change. An alternative is to relax the significance threshold for the RCI, creating a “likely change index” (LCI). We compared how RCI/LCIs categorized cancer patients as deteriorated with anchor-based methods on the physical function (PF) 10a Short Form.
Methods: In an observational, longitudinal study of 1129 adult cancer patients, the PF10a was given at baseline and 6 weeks later. A PF-specific patient global impression of change (PGIC) anchor categorized patients as deteriorated on PF (“a little worse” or “a lot worse”). We calculated an RCI (95% confidence) and LCIs (68% and 50% confidence). We estimated the group-level, anchor-based threshold for meaningful change using receiver operating characteristic (ROC) curve analysis. We compared how RCI/LCIs categorized patients as deteriorated with anchor-based thresholds (true condition) on the PF10a (individual threshold to group threshold comparison) and with the PGIC directly (individual threshold to individual threshold comparison).
Results: The ROC analysis suggested a threshold of -3 raw points. Agreement between the group-based threshold and the RCI/LCIs ranged between good [RCI 95% confidence: κ = 0.54] and perfect [LCI 50% confidence: κ = 1.00], and sensitivity increased as confidence level decreased. However, agreement between the PGIC anchor directly and RCI/LCIs always fell below the standard for “good” (κ < 0.40). Relaxing RCI/LCI to 68% and 50% confidence increased “false positives” (deteriorated on RCI/LCI but not on anchor) from 8 to 17% and 32%, respectively while “false negatives” (deteriorated on anchor but not on RCI/LCI) decreased as 22%, 17%, and 12%. Sensitivity and specificity were, respectively: RCI 95% = 0.40, 0.88; LCI 68% = 0.55, 0.73; LCI 50% = 0.68, 0.63.
Conclusions: Relaxing the significance threshold on the RCI increased its agreement with group-level anchor-based thresholds but not with an individual-level determination of meaningful deterioration. Since group-level thresholds average-out individual variation, more research is needed on how best to align significant and patient-rated meaningful change.
P60 Implementing PROMIS Computerized Adaptive Tests in Systemic Lupus Erythematosus clinical care: patient and physician perspectives
Shanthini Kasturi1, Neena Patel1, Shreya Shetty1, Lisa Mandl2,3, Timothy McAlindon1, Amy LeClair1
1Tufts Medical Center, Boston, MA, USA. 2Hospital for Special Surgery, New York,NY, USA. 3Weill Cornell Medicine, New York, NY, USA
Correspondence: Shanthini Kasturi
skasturi@tuftsmedicalcenter.org
Journal of Patient-Reported Outcomes 5(1): P60.
Objective: Patient-reported outcome measures (PROMs) are powerful tools that can facilitate person-centered care by highlighting individuals’ experience of illness. Little is known about the utility of implementing PROMs in the clinical care of patients with systemic lupus erythematosus (SLE), a chronic systemic autoimmune condition. This qualitative study aimed to evaluate the benefits and challenges of integrating PROMs into the routine clinical care of SLE from the perspective of patients and physicians participating in a multi-center longitudinal study.
Methods: SLE outpatients and treating rheumatologists participating in a longitudinal study of the implementation of PROMIS computerized adaptive tests in clinical care were invited to participate in focus groups and structured interviews. Focus groups of patients were conducted in-person and semi-structured interviews of physician were conducted via video teleconference. Patients and physicians were queried on the utility, benefits, challenges, and ideal implementation of PROMs in clinical care. All sessions were audio recorded and transcribed verbatim. Transcripts were reviewed to construct and refine a codebook using a comparison and consensus approach and a thematic analysis was performed.
Results: Twelve patients and 8 rheumatologists participated in focus groups and interviews. Patients and physicians reflected on the value of PROMs in facilitating communication and strengthening therapeutic relationships by highlighting and validating the patient experience of SLE. Patients found that PROMs enabled self-monitoring, but noted that the surveys were most useful when reviewed and discussed with their rheumatologists. Physicians believed PROMs promoted patient engagement and awareness, and emphasized their role in drawing attention to emotional health issues that might otherwise have been unaddressed. Both patients and physicians suggested that ideal clinical implementation of PROMs requires integration with the electronic health record, detailed guidance on score interpretation and population norms, and survey customization options.
Conclusions: SLE patients and rheumatologists participating in a longitudinal study of the implementation of PROMs in clinical care found that PROMs enhanced the care of SLE primarily by facilitating patient-physician communication and promoting patient self-reflection and validation. Optimal implementation of PROMs in routine SLE care requires physician engagement, easily interpretable scores, and integration with existing clinical platforms.
O61 Implementation of PROMIS Computerized Adaptive Tests in Systemic Lupus Erythematosus (SLE) clinical care
Shanthini Kasturi1, Lori Lyn Price1, David Curtis2, W. Benjamin Nowell2, Norma Terrin1, Jane Salmon3,4, Lisa Mandl3,4, Timothy McAlindon1
1Tufts Medical Center, Boston, MA, USA. 2Global Health Living Foundation, Upper Nyack, NY, NUSA. 3Hospital for Special Surgery, New York, NY, USA. 4Weill Cornell Medicine, New York, NY, USA
Correspondence: Shanthini Kasturi
skasturi@tuftsmedicalcenter.org
Journal of Patient-Reported Outcomes 5(1): O61.
Objective: Patient-reported outcome measures (PROMs) are powerful tools that can highlight the patient experience of illness. Although PROMs are standard metrics in SLE clinical research, they are not routinely integrated into the clinical care of this systemic condition. The aim of this study was to assess the feasibility and impact of implementing web-based PROMs in the routine clinical care of outpatients with SLE.
Methods: Outpatients fulfilling SLE classification criteria were enrolled in this longitudinal cohort study at two academic medical centers. Subjects completed PROMIS computerized adaptive tests at enrollment and prior to two consecutive routinely scheduled rheumatology visits using the ArthritisPower research registry mobile or web-based application. Score reports were shared with patients and providers before visits. Patients and rheumatologists completed post-visit surveys evaluating the utility of PROMs in the clinical encounters.
Results: A total of 105 SLE patients and 17 rheumatologists participated in the study. Subjects completed PROMs in 159 of 184 eligible encounters (86%, 95% CI 81 – 91) prior to study suspension due to the COVID-19 pandemic. Following baseline surveys, PROMs were completed for 90% (95% CI 82 – 95) of visit 1’s and 82% (95% CI 72 – 90) of visit 2’s. Nearly all PROMs (93%) were completed remotely. Patients and rheumatologists reported that PROMs were useful (91% and 83% of encounters respectively) and improved communication (86% and 72%). Rheumatologists found that PROMs impacted patient management in 51% of visits, primarily by guiding conversations (84%), but also by influencing medication changes (15%) and prompting referrals (10%). There was no statistically significant difference in visit length before (mean = 19.5 min) and after (mean = 20.4 min) implementation of PROMs (p = 0.52). Health-related quality of life and disease activity did not change significantly after implementation of PROMs, but patient activation improved in 14/23 (61%) of participants with low baseline activation levels.
Conclusions: The remote capture and subsequent integration of PROMs into clinical care was feasible in this diverse cohort of SLE outpatients. PROMs were useful to patients and rheumatologists, and promoted patient-centered care primarily by facilitating communication. Further studies are needed to clarify the impact of clinical integration of PROMs on activation and SLE-related outcomes.
P62 Acceptability of PROMIS in immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP): a mixed methods study
Deirdra Terrell1, Amanda Llaneza1, Rachel Kelley1, San Keller2, Sara Vesely1, James George1, Marshall Cheney3, Janna Journeycake1, Mohamad Khawandanah1, Adam Cuker4, Shruti Chaturvedi5, Neil Zakai6, Frank Akwaa7, Ming Lim8, Radhika Gangaraju9, Marshall Mazepa10, Spero Cataland11
1University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. 2American Institutes for Research, Chapel Hill, USA. 3University of Oklahoma, Norman, OK, USA. 4University of Pennsylvania, Philadelphia, PA, USA. 5Johns Hopkins, Baltimore, MA, USA. 6University of Vermont, Vermont, VT, USA. 7University of Rochester, Rochester, NY, USA. 8University of Utah, Utah, UT, USA. 9University of Alabama at Birmingham, Birmingham, AL, USA. 10University of Minnesota, Minneapolis, MN, USA. 11Ohio State University, Columbus, OH, USA
Correspondence: Deirdra Terrell
dee-terrell@ouhsc.edu
Journal of Patient-Reported Outcomes 5(1): P62.
Objective: Immune-mediated thrombotic thrombocytopenic purpura (iTTP) is a rare disorder characterized by acute episodes of systemic microvascular thrombosis and thrombocytopenia. Focus groups of iTTP survivors revealed that persistent cognitive impairment, fatigue and depression/anxiety seriously impacts daily living even years after diagnosis. However, patient-reported outcomes are not systematically evaluated during long-term follow-up. The objective of this study was to determine acceptability and the preferred mode of administration of PROMIS instruments in iTTP. Understanding the patient preference will assist in integrating PROMIS instruments into clinical care.
Methods: Multi-center recruitment of survivors included: Oklahoma University, Ohio State University, University of Minnesota, Johns Hopkins University, University of Rochester, University of Pennsylvania, University of Alabama at Birmingham, University of Utah and the University of Vermont. Following informed consent, survivors were given PROMIS cognitive function ability, anxiety, and fatigue instruments via their preferred mode of administration. Descriptive statistics were used to summarize participant scores relative to the PROMIS normed mean score on each domain. Additionally, typical internet usage, behaviors regarding searching for health information online and demographics were obtained. Qualitative assessment regarding acceptability of these PROMIS instruments is ongoing (completed 37 of planned 45 interviews).
Results: To date, 88 survivors have completed the surveys (82% female; 49% White; 33% Black; median age 49.5 years (range 25–85 years)). 52% preferred completing PROMIS surveys online vs. self-administered or telephone administered. However, among Black survivors, 31% preferred online compared to telephone/self-administered. Overall, survivors report that the internet is helpful to find health information and to assist in understanding doctor’s instructions. iTTP survivors descriptively scored worse than the general population (mean 50; standard deviation 10) on all PROMIS domains. Lower scores illustrate worse function on cognitive function ability and higher scores illustrate worse function on anxiety and fatigue. Means (standard deviations) were as follows: cognitive function ability 45 (9); anxiety 59 (10); fatigue 58 (10).
Conclusions: iTTP survivors in remission have cognitive, fatigue and anxiety scores that illustrate worse function than the US general population. Overall, survivors preferred online administration. However, Black survivors preferred other administration methods. Recognizing these preferences is a vital next step toward integrating PROMIS into routine care.
P63 Validation of PROMIS physical function item bank (CAT) in patients on kidney replacement therapies
Wajiha Ghazi, Evan Tang, Eric Mauti, Yingji Sun, Karma Gyatso, Rabail Siddiqui, Nasab El-Dassouki, Ward Hajjar, Anqi Chen, Aysha Afzal, Ghazaleh Ahmadzadeh, Istvan Mucsi
Multi-Organ Transplant Program and Division of Nephrology, University Health Network, Toronto, Canada
Correspondence: Wajiha Ghazi
wajihaghazi28@gmail.com
Journal of Patient-Reported Outcomes 5(1): P63.
Objective: Poor physical function (PF) is an independent risk factor for mortality among patients with chronic kidney disease. Here we validate the Patient Reported Outcome Measurement Information System (PROMIS) PF item bank administered using computer-adaptive test (CAT) among patients treated with kidney replacement therapies (dialysis or kidney transplant).
Methods: A cross-sectional sample of adults treated with kidney transplant or dialysis completed PROMIS PF CAT using tablet-based electronic data capture. Participants also completed a sociodemographic questionnaire and legacy questionnaires (12-item Medical Outcomes Study Short Form [SF-12] and the EQ-5D-5L). Clinical data was extracted from medical records. We assessed reliability on the participant level by standard errors of measurement (SEM) over the range of T-scores. SEMs were converted to reliability coefficients (1–SEM2). Average reliability was calculated as 1-∑(standard error)2. Test–retest reliability was assessed using the intraclass correlation coefficient (ICC) in a subgroup of participants who repeated PROMIS PF CAT within 3 to 14 days. Convergent validity was assessed using correlation between PROMIS PF CAT and SF-12 physical component summary (PCS). Discrimination was assessed using receiver operating characteristic (ROC) curves with the EQ-5D mobility item as a reference for “impaired mobility”, categorized as ‘no problems’ versus ‘any mobility problems’.
Results: Of the 371 participants, mean (SD) age was 56(16) years, 64% male and 46% White; 64% had received a kidney transplant whilst 36% were on dialysis. Mean (SD) hemoglobin level was 123(19) g/L. The mean (SD) PROMIS PF T-score was 44(11). The average reliability was high (0.94) with 98% of individual reliability coefficients > 0.90 over the T-score range of 15–66. Test–retest reliability was good (ICC = 0.91, n = 75). A strong correlation (Rho = 0.77) was observed between PROMIS PF T-score and SF-12-PCS. ROC analysis confirmed that PROMIS PF CAT had very good discrimination for “impaired mobility” (area under the ROC = 0.83). Overall similar results were seen in the dialysis and kidney transplant sub-cohorts.
Conclusions: Our results support the validity and reliability of PROMIS PF CAT among patients treated with kidney replacement therapies. PROMIS PF CAT may be useful to monitor physical function in clinical and research settings.
P64 Association of PROMIS-Cognitive Function Scores with the Montreal Cognitive Assessment Test in a clinical sample
Maria Edelen1,2, Janel Hanmer3, Jin-Shei Lai4, Michelle Langer4, Anthony Rodriguez2, Beth Dana2
1Brigham and Women's Hospital, Boston, MA, USA. 2RAND Corporation, Boston, MA, USA. 3University of Pittsburgh Medical Center, Pittsburgh, PA, USA. 4Northwestern University, Chicago, IL, USA
Correspondence: Maria Edelen
orlando@rand.org
Journal of Patient-Reported Outcomes 5(1): P64.
Objective: To assess the association of self-reported cognitive function using 2 PROMIS items to the clinician-administered Montreal Cognitive Assessment (MOCA) test in a clinical sample.
Methods: A large health system in western Pennsylvania began routine collection of 2 items from the PROMIS cognitive function item bank (PROMIS-CF) whenever a new patient-reported outcomes data collection was constructed for their electronic medical record (EMR) starting 12/2017. We extracted data from all patients with PROMIS-CF scores from the EMR, and examine the subset of patients who also had a MOCA assessment within 30 days of the PROMIS-CF. MOCA scores range from 0 to 30 with a score of 26 or higher considered normal. We hypothesize that 1) patients who have a recorded MOCA will have lower PROMIS-CF scores than those who do not, 2) the proportion of patients who have an abnormal MOCA score will increase as PROMIS-CF scores decrease, and 3) MOCA and PROMIS-CF scores will be positively correlated.
Results: PROMIS-CF was collected at least once in 50,820 people between 12/2017 and 3/2020. These data were collected primarily in Neurology clinics. Among patients who had a PROMIS-CF score, 1,303 had a MOCA score, with 75% of MOCAs administered on the same day as the PROMIS-CF and 25% within 30 days. The distribution of PROMIS-CF scores for all patients ranged from 29.7 to 62.2 with a mean of 48.9 and a median of 47.6. The distribution of PROMIS-CF scores for patients with a MOCA had the same range but a slightly lower mean (46.1) and median (44.0). The percentage of patients with an abnormal MOCA score increased with decreasing PROMIS-CF scores as hypothesized from 72% for patients with a PROMIS-CF score over 60, to 77% for scores 50–60, 79 for scores 40–50, and 89% for scores under 40. The MOCA and PROMIS-CF scores were only moderately correlated (r = 0.19) but that relationship increased to 0.25 when subset to patients completing both assessments on the same day.
Conclusions: These preliminary results indicate that a 2-item PROMIS-CF score may be clinically useful in identifying patients who need further cognitive function evaluation.
P65 Patient and family caregiver perspectives on self-assessment cognitive screening in primary care
Julia Bandini1, Lucy Schulson1, Jordan Harrison2, Sangeeta Ahluwalia3, Maria Edelen1,4
1RAND Corporation, Boston, MA, USA. 2RAND Corporation, Pittsburgh, PA, USA. 3RAND Corporation, Santa Monica, CA, USA. 4Brigham and Women's Hospital, Boston, MA, USA.
Correspondence: Lucy Schulson
schuls6on@rand.org
Journal of Patient-Reported Outcomes 5(1): P65.
Objective: To evaluate patient and family perspectives on cognitive screening through self assessment for early detection of cognitive impairment in primary care.
Methods: We conducted two virtual focus groups with 1) primary care patients age 65 and older and 2) family caregivers of patients with cognitive impairment/dementia. Participants included 18 patients and 5 family members. Participants were recruited from a large health system in western Pennsylvania. We used a structured guide to assess comfort answering questions for screening for cognitive impairment and preferences regarding mode of administration, types of screening questions, and follow-up for a positive screen.
Results: Patients expressed a general sense of comfort in answering questions around their memory. Patients preferred to have this conversation with a primary care provider (PCP) with whom they had an established relationship and were less comfortable answering questions if asked by other medical staff (e.g. a medical assistant). In terms of mode of screening, most patients preferred to complete a cognitive screener with their PCP during an appointment or in advance via online portal, as opposed to a mailed questionnaire or text message. Patients preferred screening questions that reflect specific actions rather than general debility. Patients expressed that they would want to be informed by their provider if experiencing any signs of cognitive decline and felt that follow-up actions are important.
The early signs of cognitive impairment that family caregivers noted in their loved ones were personality/mood changes, repetitive conversations, and difficulty adapting to new environments. Despite early warning signs, diagnosis of cognitive impairment/dementia often occurred after an acute episode such as a hospitalization not directly related to cognitive impairment. Caregivers expressed that early diagnosis may help facilitate planning for the future and felt it was critical for this process to begin with the PCP.
Conclusions: Preliminary findings suggest that self-assessment cognitive screener in primary care is acceptable to patients and family caregivers, though they emphasized the importance of having an established relationship with their PCP. Patients and caregivers preferred the PCP to have a central role in discussions around cognitive impairment, follow-up for a positive screen, and planning for the future.
P66 Multistep translation and cultural adaptation of the Chinese version of PROMIS Item Bank-Psychosocial Illness Impact
Danruo Wang1, Ling Yuan2, Lijuan Bian3, Ligui Wu3, Rui Wang4
1The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China. 2Department of Nursing of Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Nanjing, China. 3The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University, Najing, China. 4The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University, Nanjin, China
Correspondence: Danruo Wang
wangdanruo@163.com
Journal of Patient-Reported Outcomes 5(1): P66.
Objective: In order to complete the translation and measurement test of the Chinese version of PROMIS, and to promote the clinical application of PROMIS in China, our team voluntarily applied to join the Chinese version of PROMIS translation organized by Patient-Reported Outcomes Measurement Information System National Center-China (PNC-China) under the authorization of PROMIS Health Organization (PHO).
Methods: We set up a professional team of 10 people to complete the translation work, which leaded by the translation project manager (TPM), a deputy director of the nursing department. In this team, there are 2 medical experts, who are also doctoral mentors, 1 linguist, 3 nurse specialists with master's degree, 3 nursing postgraduates. To translate and culturally adapt the PROMIS Item Bank v1.0-Psychosocial Illness Impact-Negative and Positive, we followed the international standard Functional Assessment of Chronic Illness Therapy (FACIT) translation method required by PROMIS data management center.
Results: After simultaneous forward translation and reconciliation conducted by 3 Chinese speaking researchers, and back translation conducted 1 English speaking researcher who is proficient in Chinese back translation, the TPM conducted a back translation review. In the expert review step, 2 medical experts and 1linguist selected the most appropriate translation for each item. After that, the TPM collates and analyzes the three expert opinions, evaluates the advantages and disadvantages of each opinion and formed problems and comments. Based on the pre finalization review, the language coordinator (LC), whose mother language is Chinese, selected the most appropriate translation after careful analysis, combining with the expert opinions and the opinions of the TPM, and then decided the final translation.
Conclusions: To complete the harmonization and quality assurance, the TPM submitted the back translation and the relevant opinions of the whole translation process to PNC-China and PROMIS data management center for quality evaluation. Further verification and application will be carried out after receiving the feedback massage from the PROMIS data management center.
P67 Are biopsychosocial PROMIS measures associated with risk of persistent symptoms in outpatient physical therapy?
Jeff Houck1, Rebecca Dobler1, Chris Hoekstra2
1SUNY Upstate Medical University, Syracuse, NY. 2Therapuetic Associates, Inc, Tualatin, OR, USA
Correspondence: Jeff Houck
HouckJ@upstate.edu
Journal of Patient-Reported Outcomes 5(1): P67.
Objective: The newly validated Keele STarT MSK Tool © (MSK Tool) stratifies primary care patients into low, medium or high risk of persistent musculoskeletal (MSK) pain. The multidimensional tool includes items for pain, pain coping, comorbidities, and function and disability. Health domain specific Patient Reported Outcomes Measurement Information System (PROMIS) outcomes representing a biopsychosocial patient experience may also predict risk of persistent pain. The purpose of this study was to report which PROMIS health domains influence the MSK Tool score, and therefore assist clinicians select the best outcomes associated with the risk of persistent symptoms.
Methods: From April 2020 to October 2020 patients (n = 94, age = 46.7(18.9) years, 67.4% female) attending two outpatient orthopedic clinics agreed to complete questionnaires during their physical therapy visit. PROMIS computer adaptive tests were collected concurrently with the MSK Tool. Seven PROMIS measures categorized as physical (physical function [PF], pain interference [PI], Fatigue), psychological (Anxiety [Ax], Depression [Dep], Self-Efficacy of symptom management [SE]) and social (Satisfaction with Social Roles [SR]) were completed. Three logistic regression models were considered. Model one included physical health domains, model two included only psychological domains and model three included all three domains.
Results: The MSK Tool average score was 5.1(2.5). The majority of patients had extremity problems (44.6%) followed by spine (29.7%). A total of 46.8% were low risk, 43.6% moderate risk and 9.6% high risk. Two of the physical measures, PI and Fatigue, were retained with an r2 = 0.46. Standardized coefficients favored Fatigue (PI = 0.29 versus Fatigue = 0.46) as more influential. Two of the psychological measures, Dep and SE, were retained with an r2 = 0.38. Standardized coefficients favored SE (Dep = 0.23 versus SE = − 0.45) as more influential. Three measures were retained when all measures were included (i.e. SE, PI and Fatigue) with an r2 = 0.49. Standardized coefficients favored Fatigue (Fatigue = 0.35 then PI = − 0.24 then SE = − 0.21) as more influential.
Conclusions: Risk of persistent MSK symptoms is highly associated with PI, Fatigue and SE of symptom management. Utilization of the PROMIS SE and Fatigue measures with pain interference should be considered for predicting patients at risk of persistent MSK symptoms.
P68 Translation and linguistic validation of the PROMIS-29 + 2 Profile (PROPr) in seven African languages
Helena Correia1, Jiyoung Son1, Christina Dionesotes2, David Cella1
1Northwestern University, Chicago, IL, USA. 2RWS Life Sciences, East Hartford, CT, USA
Correspondence: Helena Correia
helena-correia@northwestern.edu
Journal of Patient-Reported Outcomes 5(1): P68.
Objective: To translate and linguistically validate the PROMIS-29 + 2 Profile (PROPr) in seven African languages: Dholuo, Dhopodhola, Lusoga, Swahili, Teso and Twi. We will discuss the linguistic and cultural issues encountered during the harmonization across languages and cognitive debriefing in three countries.
Methods: Translations were conducted according to the PROMIS standards, through an iterative process of forward and back-translation, multiple reviews and cognitive debriefing. Testing took place in Uganda, Kenya, and Ghana with five native-speaking participants from each language. Participants completed the questionnaire and participated in a cognitive debriefing interview to verify understandability, relevance and appropriateness of the translations. Qualitative analyses of participants’ comments assessed the conceptual equivalence across languages.
Results: One major challenge was that some of the English source concepts were not well distinguished from each other in the target languages. For example, in Dhopodhola, Luo, and Luganda, there is no clear distinction between "anxiety" and "depression". Experiencing emotional distress is often expressed as "being in deep thought" and this expression covers various feelings in the emotional distress spectrum such as feeling "anxious", "depressed", "worried", or "fearful". "Fatigued" proved difficult to translate in all languages, because it is not distinguished from "tired" or "run-down". Discussion of alternatives and clarification of intended meaning were necessary in order to find suitable equivalent wording in each language. Cognitive testing indicated that most translated items were well-understood in each language. When participants' comments revealed misunderstanding of an item's intended meaning, the translation was revised to ensure cultural appropriateness, conceptual equivalence and harmonization across similar languages.
Conclusions: The PROMIS-29 + 2 (PROPr) is now available in Dholuo, Dhopodhola, Lusoga, Swahili, Teso and Twi. Given the item overlap, the PROMIS-29 profile and its associated short forms are also available in these languages.
O69 Validation of the PROMIS physical function computer adaptive test among liver transplant recipients
Evan Tang1, Eric Mauti1, Nazia Selzner2, Ward Hajjar2, Nathaniel Edwards2, Istvan Mucsi2, Susan Bartlett3
1Temerty Faculty of Medicine, University of Toronto, Toronto, Canada. 2Kidney Transplant Program, Ajmera Transplant Centre, University Health Network, Toronto, Canada. 3Centre for Health Outcomes Research, McGill University, Montreal, Canada
Correspondence: Evan Tang
evan.tang@mail.utoronto.ca
Journal of Patient-Reported Outcomes 5(1): O69.
Objective: Physical function (PF) integrates motor function, motor control, and physical fitness. PF is an important component of everyday functioning and health-related quality of life. The Patient Reported Outcomes Measurement Information System (PROMIS) computer adaptive test (CAT) may offer greater precision and lower response burden compared to legacy questionnaires. Here we validate the PROMIS PF item bank administered as CAT in liver transplant recipients (LTR).
Methods: A cross-sectional, convenience sample of adult LTR completed the PROMIS PF CAT, the 36-Item Short Form Health Survey (SF-36), and the EQ5D5L questionnaire using electronic data capture. Socio-demographic and clinical data were also collected. Reliability was assessed using average reliability, measurement error (standard error of measurement [SEM]), and test–retest reliability (intraclass correlation coefficient [ICC]). Construct validity was assessed using Pearson correlation between PROMIS PF and SF-36 PF scores, and known-group comparisons (higher scores expected in individuals without anemia, with fewer comorbidities, with better self-reported health). Discrimination of PROMIS PF CAT was assessed using receiver operating characteristic analysis. Reference categories (mobility problems yes/no) were defined by responses the mobility domain of the EQ5D5L (no problem vs. any problems).
Results: Our sample included 160 LTR with a mean(SD) age of 55(15), 69% male, and 66% white. 57 participants (36%) reported mobility problems. Participants completed a mode (range) of 4 (4–12) PROMIS PF CAT questions, and 97% (n = 151) had SEM < 0.30 (reliability > 0.90). Average reliability was good at 0.95 and ICC was 0.92. The PROMIS PF T score correlated strongly with SF-36 PF domain (r = 0.84). Construct validity was further confirmed by known-groups comparisons, as higher PF scores were reported in participants without anemia (Cohen’s d [d] = 0.73; p < 0.001), lower comorbidity burden (d = 0.60; p < 0.001), better self-reported health (d = 1.19; p < 0.001), and greater mobility (d = 1.52; p < 0.001). The PROMIS PF CAT showed good discrimination for impaired mobility, with a c-statistic of 0.87.
Conclusions: The data supports the reliability and validity of the PROMIS PF CAT for measuring PF in LTR.
P70 Exploring the relationship between paediatric PROMIS profile-25 and a Kidscreen utility-mapping algorithm
John Chaplin1, Peter Adolfsson2
1Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden. 2Department of Pediatrics, Kungsbacka Hospital, Kungsbacka, Sweden
Correspondence: John Chaplin
john.chaplin@gu.se
Journal of Patient-Reported Outcomes 5(1): P70.
Objective: Few cost-utility studies of child and adolescent health use quality-adjusted life years as the outcome. A recent study has built an algorithm between the Child Health Utility (CHU9D), a generic instrument developed specifically for use in young people, and the Kidscreen-10 index. The purpose of this study was to calculate the CHU9D scores based on Kidscreen and compare these to PROMIS profile-25 scores within the same population of young people to assess the predictive value.
Methods: This is a cross‐sectional study of children with type 1 diabetes, recruited from tertiary care facilities. Children completed the PROMIS profile-25, Kidscreen-10 index, DISABKIDS-37 and other instruments. We calculated a utility score based on Kidscreen and the algorithm by Chen et al. (2014) [1] creating a Kidscreen utility score (KUS). We investigated internal consistency of the KUS, as well as convergent validity. The utility algorithm used a model based on MM estimate with six stepwise-selected Kidscreen items (Healthy, Energy, Sad, Lonely, School, Alert). A linear regression analysis was used to explain the variance in PROMIS profile scores.
Results: The study included 33 children receiving standard care for type 1 diabetes who completed the self-report instruments. Age range was 8–18 years (mean 13 years). The KUS ranged from 0.64 to 1.06 with a mean of 0.91. Having acceptable internal consistency (Chronbach’s alpha 0.809) it correlated strongly with DISABKIDS r(24) = 0.582, p < 0.002 and with the PROMIS profile scores (r = 0.378 to r = 0.596). A linear regression using the KUS as the independent variable explained a modest proportion of the variance of the PROMIS scores: Anxiety R2 = 0.074, Depressive symptoms R2 = 0.049, Physical function R2 = 0.160, Fatigue R2 = 0.144, Peer relationships R2 = 0.050, Pain interference R2 = 0.105.
Conclusions: This study explored the relationship between paediatric PROMIS-25 and a utility measure. A limitation of the study is the size of the population; however, the data collection provided the possibility of a preliminary investigation. Further exploration of the relationship between PROMIS-25 and utility measurements would benefit from a larger population and the calibration of the utility weights generated by different utility instruments.
References
[1] Chen C., Stevens S., Rowen D., Ratcliffe J. From KIDSCREEN-10 to CHU9D: creating a unique mapping algorithm for application in economic evaluation. Health and Quality of Life Outcomes 2014, 12:134.
O71 Implementation of PROMIS scales in a cerebrovascular clinic—experience after 10 years
Irene Katzan, Brittany Lapin, Nicolas Thompson, Andrew Russman, Ken Uchino
Cleveland Clinic, Cleveland, OH, USA
Correspondence: Irene Katzan
katzani@gmail.com
Journal of Patient-Reported Outcomes 5(1): O71.
Objective: Stroke patients often have “hidden deficits” that impair their health-related quality of life (hrQoL) such as fatigue, cognitive symptoms, and depression and which are best measured using patient self-report. To better understand and optimize outcomes of stroke survivors, the Cleveland Clinic Cerebrovascular Center began collection of patient-reported outcomes (PROs) within the ambulatory clinics in late 2008. We describe our experience with collection and clinical utilization of PROs in the cerebrovascular clinics of a large healthcare system.
Methods: Implementation occurred as part of a larger patient-entered data initiative within Cleveland Clinic. PROs were initially collected through an internally developed patient data collection platform and were migrated to Epic tools in November 2019. Patient questionnaires included PHQ-9 depression screen, a sleep apnea scale, PROMIS Global Health and computer adaptive testing versions of PROMIS physical function, fatigue, pain interference, sleep disturbance, satisfaction with social roles and NeuroQoL cognitive function. Clinicians also record clinical information regarding patients’ cerebrovascular disease in structured fields within the EHR. T-scores can be viewed graphically over time in Epic’s Synopsis reports. Score percentiles are automatically inserted into documentation templates.
Results: Since starting data collection in 2008, PROs have been collected in 39,863 visits, representing 22,542 unique patients. Completion rates have consistently been over 50%. Patients who complete questionnaires are younger (58.7 [SD 15.8] vs. 62.0 [SD 15.8], P < 0.001) and have lower clinician-reported disability scores (mean modified Rankin scale 1.13 [SD 1.13] vs. 1.39 [SD 1.26], P < 0.001). The majority (58.9%) of patients have at least one score ≥ 1 SD worse than the US population mean and 38.3% have 2 + scores besides PROMIS physical function that are ≥ 1 SD worse than the population mean. There is wide variability in severity of symptoms among patients with similar clinician-reported disability and neurological deficits. We will provide examples along with actions that can be taken based on PROMIS scores.
Conclusions: PRO collection in a cerebrovascular clinic is feasible. They have dramatically improved our understanding of the health status of our stroke patients and has informed clinical management. Development of evidence-based interventions for PRO scores will further improve their usefulness in ambulatory stroke care.
O72 Patient factors associated with improvements in PROMIS Physical Function and Pain Interference after spine surgery
Jacquelyn Pennings, Rogelio Coronado, Hiral Master, Kristin Archer
Vanderbilt University Medical Center, Nashville, TN, USA
Correspondence: Jacquelyn Pennings
jacquelyn.pennings@vumc.org
Journal of Patient-Reported Outcomes 5(1): O72.
Objective: To assess demographic and clinical/surgical characteristics associated with improvement in PROMIS physical function, and pain interference and contrast them with predictors of the typical legacy measures of ODI, NDI, and NRS pain intensity after spine surgery for degenerative conditions.
Methods: 727 degenerative lumbar and cervical spine surgery patients with preoperative and 12-month follow-up PROMIS data who underwent spine surgery at a single institution were analyzed. Demographic (age, gender, race, smoking status, education, insurance, liability claim, employment status), clinical/surgical characteristics (preop opioid use, comorbidities, procedure, revision status), and preoperative outcome scores were entered as predictors of 12-month PROMIS (PF and PI) and legacy measures (ODI/NDI, NRS axial pain, NRS extremity pain). The 4-item PROMIS short forms were used to assess PF and PI. Predictor importance, coefficients, and overall model R2 values are presented.
Results: As expected, the baseline scores associated with each outcome had the highest predictor importance. Other predictors that were significant for both 12-month PF (R2 = 0.38) and ODI/NDI (R2 = 0.37) included preop opioid use, preop PROMIS depression, employment status, comorbidity count, and education. BMI, smoking status, and age were only significant predictors of PROMIS PF while race, revision status, and pain intensity were only significant for ODI/NDI. Procedure, liability status, lumbar vs cervical, gender, and insurance status were not significant predictors of either outcome in these models. Significant predictors of PROMIS PI (R2 = 0.28) were preop score, preop opioid use, employment, education, PROMIS preop depression, smoking status, comorbidities, and race. Significant predictors of NRS pain scores were similar with a few differences.
Conclusions: Previous research shows PROMIS measures are reliable, valid, and responsive in spine surgery patients. As PROMIS measures are now being used to evaluate surgical outcomes more frequently through their incorporation into standard hospital data collection, registries, and trials, it is important to understand the patient demographic and clinical/surgical characteristics that are associated with PROMIS outcomes after spine surgery. Predictors of PROMIS and legacy measures were similar but not identical. Contrasting these predictors of PROMIS outcomes with legacy measures aids surgeons and researchers in understanding how these PROMIS measures are similar but distinct from legacy outcomes.
P73 Influence of goal attainment scaling on cognitive-behavioral based physical therapy outcomes after lumbar spine surgery
Rogelio Coronado1, Hiral Master1, Jordan Bley1, Payton Robinette1, Michael O'Brien1, Emma Sterling1, Abigail Henry1, Jacquelyn Pennings1, Susan Vanston1, Brittany Myczkowski1, Richard Skolasky2, Steven Wegener2, Kristin Archer1
1Vanderbilt University Medical Center, Nashville, TN, USA. 2Johns Hopkins Medicine, Baltimore, MD, USA
Correspondence: Jacquelyn Pennings
jacquelyn.pennings@vumc.org
Journal of Patient-Reported Outcomes 5(1): P73.
Objective: Patient-centered goal setting is an important component of behavioral interventions for chronic pain. Limited data exist on the relationship between goal attainment during cognitive-behavioral based physical therapy (CBPT) and pain-related outcomes. The objective was to examine the relationship between CBPT goal attainment and pain-related outcomes in a cohort of patients who completed a 6-week telephone-based CBPT intervention after lumbar spine surgery.
Methods: Secondary analysis from a randomized trial comparing postoperative CBPT and an education program was used for this study. 108 participants (mean 63.5 ± 11.3 years) who completed the CBPT intervention were included. Six and 12-month outcomes included physical function (PROMIS), pain interference (PROMIS), and back and leg pain intensity (Brief Pain Inventory). At each session, CBPT participants used Goal Attainment Scaling (GAS) to set goals and report goal attainment from the previous session. The number, type, and percentage of goals met was recorded. A GAS t-score for achievement of goals across all sessions was computed for each patient. Patients were grouped as high or low goal attainment based on a GAS t-score of 50 (goals met as expected). Outcome differences between groups at each follow-up time point were examined using linear regression controlling for baseline outcome score.
Results: Participants set a median of 3 goals (range: 1–6) at each CBPT session. The most common goals were related to participating in physical/recreational activity (36%), adopting a cognitive or behavioral strategy (28%), exercising (11%), or performing activities of daily living (11%). The least common goals related to social activities (2%). 43% participants met criteria for high goal attainment (mean % goals met = 87% compared to 64% in the low goal attainment group, p < 0.001). Greater improvements in the high goal attainment group were observed in PROMIS physical function at 6 (beta = 4.2, p < 0.05) and 12 months (beta = 3.5, p < 0.05) and back pain intensity at 12 months (beta = − 0.9 p < 0.05).
Conclusions: The attainment of personalized goals within a CBPT intervention was an important factor related to improvements in physical functioning after spine surgery. Implementing a structured process for setting personalized goals and tracking goal attainment may be an essential aspect of a biopsychosocial approach for addressing functional impairment following surgery.
P74 Trends in PROMS-29 throughout COVID-19 in the Canadian Early Arthritis Cohort (CATCH)
Susan Bartlett1,2, Orit Schieir3, Marie-France Valois4, Vivian Bykerk5
1McGill University, Montreal, Canada. 2Johns Hopkins Medicine, Baltimore, D, MUSA. 3University of Toronto, Toronto, Canada. 4McGill, Montreal, Canada. 5Hospital for Special Surgery, New York, NY, USA
Correspondence: Susan Bartlett
susan.bartlett@mcgill.ca.
Journal of Patient-Reported Outcomes 5(1): P74.
Objective: With the COVID-19 pandemic, adults with rheumatoid arthritis faced increased risks of infection and hospitalization and potentially greater social restrictions due to their use of potent immunosuppressant medications. We examined trends in PROMIS-29 domains prior to and during the first year of the COVID-19 pandemic in adults with RA.
Methods: Data were from RA patients enrolled in the Canadian Early Arthritis Cohort who had completed PROMIS-29 at study visits between 9/2019 and 1/2021. Descriptive statistics were calculated to evaluate changes in PROMIS-29 domains 6 months prior to, and during Wave 1 (March to June 2020) and Wave 2 (October to Jan 2021).
Results: Participants (N = 468) were mostly white (89%) women (70%) with a mean (SD) age of 60 (15) years. Prior to the pandemic, mean PROMIS-29 scores were in the normal range, with the lowest being Physical Function (46.7) and the highest Pain Interference (52.3). Analyses of monthly trends showed that HRQL impacts were greatest in April 2020. Average PROMIS-29 scores worsened for all domains except Participation (mean change − 0.2). The largest changes were in Depression (+ 4.8) and Anxiety (+ 4.3). As compared with Jan 2020, in April higher proportions of participants reported moderate-severe anxiety (28% vs 40%), depression (18% vs. 34%), fatigue (22% vs. 40%), sleep disturbance (18% vs. 34%), pain (23% vs. 38%), and disability (21% vs 34%).
By July 2020, mean PROMIS-29 scores had decreased in depression (− 4.4), anxiety (− 3.2), fatigue (− 1.6) and participation (− 1.4). The proportions of patients reporting moderate-severe symptoms (e.g., ≥ 60) were similar to before the pandemic for all domains except physical function where 29% continued to report moderate-severe impairments. In Wave 2, scores were higher than pre-pandemic levels, but lower than Wave 1, with the largest changes in depression and anxiety.
Conclusions: Modest impacts over the first year of variable COVID-19 pandemic restrictions were observed on HRQL of adults with RA in Canada. The largest changes were in anxiety and depression during both Waves. Greater impairments in physical function have persisted up to 12 months into the pandemic.
O75 Many better, many worse: mean PROMIS-29 Scores mask significant shifts during COVID-19 in RA
Susan Bartlett1,2, Dana DiRenzo2, Michelle Jones2, Clifton Bingham2
1McGill University, Montreal, Canada. 2Johns Hopkins Medicine, Baltimore, MD, USA
Correspondence: Clifton Bingham
cbingha2@jhmi.edu
Journal of Patient-Reported Outcomes 5(1): O75.
Objective: Rheumatic diseases (RD) are chronic conditions that require potent immunosuppressants to control systemic inflammation. Fears associated with increased vulnerability from being on immunosuppressants plus medications shortages (e.g., hydroxychloroquine) resulted in considerable stress for patients in the early months of the COVID-19 pandemic. We evaluated changes in HRQL in the initial months of the COVID-19 in adults with RD and hypothesized that multiple PROMIS-29 domains scores would be negatively impacted.
Methods: The sample included patients followed (virtually or in-person) in Rheumatic Disease clinics at Johns Hopkins 3/15/2020 to 6/30/2020. Patients complete the PROMIS-29 as part of routine care, and scores were compared with the most recent visit prior to 3/15. Anxiety was classified as worse (≥ 4.0 points), same (− 3.9 to 3.9) or better (≤ − 4.0) at the second visit.
Results: Data were available for 151 patients with a mean (SD) age of 55 who were mostly white (81%) women (73%) with RA (50%), PSA (27%), AS/SPA (15%) or other RD (9%). Mean (SD) changes in PROMIS-29 scores ranged from − 0.9 for Fatigue [7.6] and Depression [7.9] to 1.4 (9.7) for Anxiety. 45 (30%) patients were classified with worse anxiety, 40 (27%) with improved anxiety, and 66 (44%) the same. Change in anxiety was not associated with age, sex, race, or disease.
Among patients reporting worse anxiety (mean [SD] change + 12.3 [9.0]), Depression was significantly worse (3.2 [8.0]) compared to patients with same (− 1.2 [6.9] or improved anxiety (− 5.0 [7.0]) (p’s < 0.05). Among patients whose anxiety improved, Fatigue (− 4.4 [7.9]) and Participation (3.1 [7.8] improved. Changes in anxiety were not associated with changes in physical function.
Patient Global Impression of Disease Change scores (N = 128) indicated 34% of patient reported their disease was worse, 30% had improved, and 36% were the same. Most (88%) patients with worse anxiety reported worse (45%) or the same (43%) disease activity; 43% with improved anxiety had improved disease, 30% the same, and 27% were worse.
Conclusions: While the average within-person change in PROMIS-29 scores were trivial, a substantial proportion of patients experienced worsening or improved anxiety which also tracked with meaningful changes in several other PROMIS-29 domains.
P76 An investigation of the physical disability experienced by people with Multiple Sclerosis
Paul Kamudoni1, Jeffrey Johns2, Dagmar Amtmann3, Karon Cook4, Rana Salem3, Sam Salek5, Jana Raab1, Rod Middleton6, Christian Henke1
1Global Evidence & Value Development-R&D, Merck Healthcare KgaA, Darmstadt, Germany. 2Institute of Medicines Development, Cardiff, United Kingdom. 3Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA. 4Feral Scholars, Broaddus, TX, USA. 5School of Life and Medical Sciences, Hartfield, United Kingdom. 6UK MS Register, Swansea Medical School, Swansea, United Kingdom
Correspondence: Paul Kamudoni
pkamudoni@gmail.com.
Journal of Patient-Reported Outcomes 5(1): P76.
Objective: To evaluate patient-reported physical disability, based on physical function, walking ability and upper extremity (UE) function assessments, among Multiple Sclerosis (MS) patients with different disease characteristics, and to explore the feasibility of assessing the various domains.
Methods: Data were obtained from a 96-week longitudinal study carried out in the UK MS Register Cohort, from September 2018 to October 2020. Target outcome measures included the MSWS-12, the NeuroQoL Upper Extremity Short form, and the PROMISnq Physical Function-MS 15a. In addition, the PROMIS Physical Function-CAT was also analyzed. Analyses performed included summary descriptive statistics, ANOVA test for group differences, spearman’s correlation analysis, and item utilization rates for the CAT.
Results: In total, 284 patients were included in the current analyses (76% female; mean age, 50.9 ± 9.4). Mean ± SD scores on the MSWS-12, the NeuroQoL UE-SF, and the PROMISnq PF-MS 15a were 36.8 ± 27.02, 43 ± 9.6, and 40.7 ± 9.8, respectively. The largest proportion of the sample required no assistance with mobility (MSWS-12, scores 0 to 20; 37%), and had mild limitations or problems with upper extremity function (NeuroQoL UE-SF, T-scores 31 to 46; 50.4%), or physical function (PROMISnq PFMS 15a, T-scores 26 to 50; 47.5%). The proportion of patients with the highest/lowest possible score were 12%/2.11% (MSWS-12), 0.35%/38.4%, and 0.35%/4.6%, respectively. All three target measures showed expected differences across distinct disability patient groups. For the PROMIS PF-CAT, items related to upper extremity were least frequently selected (2 items of all 20 items administered) than mobility or activities of daily living questions, and at high disability levels only.
Conclusions: Impairments in physical function and upper extremity function were mild-to-moderate, whilst mobility was assistance-free or with gait problems (i.e., mild or no limitations), for most of our sample. Unlike mobility (MSWS-12) or physical function (PROMISnq PF-MS 15a), the measurement features of upper extremity function (NeuroQoL UE-SF) e.g., ceiling effects, suggested limited measurement feasibility in the current study population.
O77 Neighborhood environment and health related quality of life for children with chronic conditions
Jin-Shei Lai1, Katy Wortman1, Amy Paller1, Stewart Goldman2
1Northwestern University, Chicago, IL, USA. 2Phoenix Children’s Hospital & the University of Arizona College of Medicine Phoenix, Phoenix, AZ, USA
Correspondence: Jin-Shei Lai
js-lai@northwestern.edu
Journal of Patient-Reported Outcomes 5(1): O77.
Objective: Evidence has indicated that the social and physical neighborhood environment exerts significant effects on health and health-related quality of life. However, such research on children with chronic conditions was lacking. This study aims to evaluate whether social-economic (deprivation index and socio-economic status) and physical (walkability) attributes of the neighborhood environment are associated with health-related quality of life for children with brain tumors (BT) or atopic dermatitis (AD).
Methods: Data from 155 children with AD (mean age = 11.9 yrs) and 73 children with BT (mean age = 14.5 years) were analyzed. Children were recruited during their clinical visits and completed PROMIS Anxiety, Depression, Fatigue, Mobility, and Peer Relationship. Residential addresses of study participants were geocoded and assigned to community deprivation index by census block group using Decentralized Geomarker Assessment for Multi-Site Studies (DeGAUSS) technology. Median value of owner-occupied housing within block group represented neighborhood socio-economic status (SES). The national walkability index (walkability) was obtained using a nationwide geographic data resource that ranks block groups according to their relative walkability. PROMIS measures were reported on the T-score (mean = 50, SD = 10) metric. Multivariable regression models were used, with outcome variables: PROMIS Anxiety, Depression, Fatigue, Mobility, and Peer Relationship; and independent variables: deprivation index, walkability, SES, diagnosis (BT, AD), gender, and age.
Results: Deprivation index was significantly (p < 0.05) associated with Fatigue and Peer Relationship; in which more disadvantaged children (i.e., higher Deprivation index) reported worse fatigue and peer relationships. Gender was significantly (p < 0.05) associated with Anxiety and Depression; in which female children reported more anxiety and depression than male children. Disease was significantly associated with Mobility and Peer Relationships; in which children with AD reported better mobility and peer relationships than children with BT. Neighborhood SES, walkability, and age were not significantly associated with any PROMIS measures.
Conclusions: This study explored association of social and physical environmental factors with health-related quality of life in children with chronic conditions. Results showed deprivation index was associated with PROMIS scores but not neighborhood SES and walkability. Future studies should be conducted to evaluate whether the same conclusions can be made on children with other conditions.
P78 PROMIS Mental Health and Physical Health summary scores in patients on kidney replacement therapies
Istvan Mucsi1, Gaauree Chala1, Anqi Chen1, Nathaniel Edwards1, John D. Peipert2, Susan J. Bartlett3, Doris Howell4, Madeline Li5, Ron D. Hays6
1Ajmera Transplant Program, University Health Network, Toronto, Canada. 2Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. 33Center for Health Outcomes Research, McGill University, Montreal, Canada. 4Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada. 5Princess Margaret Cancer Center, Toronto, Canada. 6University of California, Los Angeles, Los Angeles, CA, USA
Correspondence: Istvan Mucsi
istvan.mucsi@utoronto.ca.
Journal of Patient-Reported Outcomes 5(1): P78.
Objective: PROMIS profiles include multiple health-related quality of life domains and higher-order summary scores. We assessed the construct validity of the PROMIS physical (PH) and mental health (MH) summary scores among patients treated with dialysis or kidney transplant.
Methods: A cross-sectional convenience sample of adults treated with kidney transplant or dialysis completed the PROMIS 29 2.0 or CATs using electronic data capture. Participants also completed a sociodemographic questionnaire and “legacy” questionnaires (Patient Health Questionnaire-9 [PHQ9], Medical Outcomes Study Short Form-12 [SF-12] and the EQ-5D-5L). The SF6D utility score was calculated from SF-12 item scores. Clinical data were extracted from medical records. Convergent validity was assessed using Pearson correlation between MH score vs PHQ9 and SF12 mental component summary (MCS); between PH score vs serum albumin and SF12 physical component summary (PCS). We assessed correlations between MH and PH summary scores and EQ5D-5L and SF-6D health utility scores. Furthermore, we compared the summary scores between groups expected to have different PH and MH based on prior literature or clinical knowledge: dialysis vs kidney transplant; anemia vs no anemia (Hb 125); high vs low comorbidity (Charlson comorbidity index [CCI] 3); no/mild vs moderate/severe depressive symptoms (PHQ9 10).
Results: Of the 602 participants, mean (SD) age was 58(17) years, 59% male and 45% White; 48% had received a kidney transplant. The mean(SD) PH and MH T-score was 42(11) and 49(10), respectively. Our analysis yielded correlations in the expected directions. For PH: PCS(r = 0.81), serum albumin (r = 0.37); for MH: PHQ9(r = − 0.74) and MCS(r = 0.65). Both PH and MH scores correlated with the EQ5D-5L (r = 0.65 and 0.61, respectively) and with the SF-6D (0.78 and 0.79, respectively). Both PH and MH scores were higher among kidney transplant recipients than patients on dialysis (48(10) vs 37(9); 51(9) vs 47(10), respectively; p < 0.001). The expected differences (> 5 point for each comparisons) were seen for the additional “known group” comparisons.
Conclusions: These results support the validity of PROMIS PH and MH scores among patients treated with kidney replacement therapies. These summary scores may be useful to monitor health-related quality of life in research and clinical settings.
