Outcomes Measurement Information System Instruments Research Articles

Assessment of Real-World Patient-Reported Outcomes in Patients Initiating Biologic Agents for the Treatment of Autoimmune Diseases: An Observational Study in Four Patient-Powered Research Networks.

The most reliable and meaningful approach for inclusion of patient-reported outcomes (PROs) in the evaluation of real-world clinical effectiveness of biologics in the treatment of autoimmune diseases is u ncertain. This study aimed to assess and compare the proportions of patients who had abnormalities in PROs measuring important general health domains at the initiation of treatment with biologics, as well as the effects of baseline abnormalities on subsequent improvement. PROs were collected for patient participants with inflammatory arthritis, inflammatory bowel disease, and vasculitis using Patient-Reported Outcomes Measurement Information System instruments. Scores were reported as T-scores normalized to the general population in the United States. Baseline PROs scores were collected near the time of biologic initiation, and follow-up scores were collected 3 to 8 months later. In addition to summary statistics, the proportion of patients with PROs abnormalities (scores ≥5 units worse than the population norm) was determined. Baseline and follow-up scores were compared, and an improvement of ≥5 units was considered significant. There was wide variation across autoimmune diseases in baseline PROs scores for all domains. For example, the proportion of participants with abnormal baseline pain interference scores ranged from 52% to 93%. When restricted to participants with baseline PROs abnormalities, the proportion of participants experiencing an improvement of ≥5 units was substantially higher. As expected, many patients experienced improvement in PROs following initiation of treatment with biologics for autoimmune diseases. Nevertheless, a substantial proportion of participants did not exhibit abnormalities in all PROs domains at baseline, and these participants appear less likely to experience improvement. For PROs to be reliably and meaningfully included in the evaluation of real-world medication effectiveness, more knowledge and careful consideration are needed to select the most appropriate patient populations and subgroups for inclusion and evaluation in studies measuring change in PROs.

Patient-reported outcomes measurement information system depression psychometrically underperforms compared to legacy measures and is poorly associated with postoperative functional outcomes in shoulder arthroplasty patients.

The purpose of this study was to investigate the associations between each mental health patient-reported outcome measure with postoperative functional outcomes following shoulder arthroplasty, and to compare psychometric properties of patient-reported outcomes measurement information system depression to the legacy (VR-12 Mental) patient-reported outcome measure. Patients who underwent primary shoulder arthroplasty from July 2018 to February 2019 were retrospectively reviewed. Patient-reported outcomes measurement information system depression and VR-12 Mental were administered preoperatively; American Shoulder and Elbow Surgeons and Single Assessment Numeric Evaluation were administered at 6-month and 1-year postoperatively. Rasch partial credit modeling analysis was used to compare psychometric properties of legacy versus patient-reported outcomes measurement information system instruments in assessing mental health. Ninety-three patients who underwent total shoulder arthroplasty (n = 52), reverse total shoulder arthroplasty (n = 39), or hemiarthroplasty (n = 2) were included. Preoperative VR-12 Mental scores were moderately associated with American Shoulder and Elbow Surgeons at 6-months (coefficient: 0.52, P = 0.026) and 1-year (coefficient: 0.65, P = 0.002), while preoperative patient-reported outcomes measurement information system depression scores were not. Patient-reported outcomes measurement information system depression demonstrated significant floor effects (16%); VR-12 Mental demonstrated minimal floor and ceiling effects (1.1% for both). VR-12 Mental demonstrated broader coverage of mental outlook on Rasch modeling than patient-reported outcomes measurement information system depression and had adequate model fit after one round of reiterative item elimination. Patient-reported outcomes measurement information system depression was poorly associated with postoperative American Shoulder and Elbow Surgeons scores, demonstrated significant floor effects, and had limited coverage of mental health on Rasch modeling with reiterative elimination. IV.

Employment, Work Productivity, and Biologic Treatments in Self-Reported Axial Spondyloarthritis: a Cross-Sectional Study in a Female Predominant Population from the ArthritisPower Registry.

IntroductionThe aim of this study was to characterize employment, work productivity, and biologic disease-modifying anti-rheumatic drug (bDMARD) treatment in a predominantly female population of axial spondyloarthritis (axSpA) patients in a real-world setting.MethodsThis was a cross-sectional study of axSpA participants within the ArthritisPower registry. Outcomes were assessed with surveys (Work Productivity and Activity Impairment [WPAI], Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], and Patient-Reported Outcomes Measurement Information System instruments) and compared between subgroups (employed vs. not employed; taking vs. not taking a bDMARD).ResultsAmong the 195 participants, 117 (60.0%) were employed and 78 (40.0%) were not employed entirely or partially due to axSpA. The mean age of the participants was 47.6 years and 86.7% were female. Current bDMARD use was reported by 57.4% of those surveyed (59.8% employed vs. 53.9% not employed; p = 0.408). Compared to not employed participants, employed participants had more favorable disease activity (BASDAI 6.0 vs. 7.6; p < 0.001) and overall health (self-rated health 2.5 vs. 1.8; p < 0.001). Employed participants, compared to not employed participants, were diagnosed at an earlier age (36.0 vs. 42.5 years, respectively) and experienced a shorter time between symptom onset and diagnosis (9.5 vs. 13.6 years, respectively). Employed participants reported missing on average 6.5 days of work and experienced a 52.7% impairment on work productivity due to axSpA over a 3-month period. Absenteeism and presenteeism were statistically similar between participants taking a bDMARD versus those not taking a bDMARD.ConclusionsAlthough bDMARD treatment rates were similar between employed and not employed participants, disease activity and overall health were better in employed than non-employed participants. Employed participants experienced substantial work productivity impairment due to axSpA.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-022-00428-x.

Physical activity and quality of life in African American cancer survivors: The Detroit Research on Cancer Survivors study.

The benefit of regular exercise in improving cancer outcomes is well established. The American Cancer Society (ACS) released a recommendation that cancer survivors should engage in at least 150minutes of moderate to vigorous physical activity (PA) per week; however, few report meeting this recommendation. This study examined the patterns and correlates of meeting ACS PA recommendations in the Detroit Research on Cancer Survivors (ROCS) cohort of African American cancer survivors. Detroit ROCS participants completed baseline and yearly follow-up surveys to update their health and health behaviors, including PA. This study examined participation in PA by select characteristics and reported health-related quality of life (HRQOL) as measured with the Functional Assessment of Cancer Therapy and Patient-Reported Outcomes Measurement Information System instruments. Among the first 1500 ROCS participants, 60% reported participating in regular PA, with 24% reporting ≥150min/wk. Although there were no differences by sex, prostate cancer survivors were the most likely to report participating in regular PA, whereas lung cancer survivors were the least likely (P=.022). Survivors who reported participating in regular PA reported higher HRQOL (P<.001) and lower depression (P=.040). Just 24% of African American cancer survivors reported meeting the ACS guidelines for PA at the baseline, but it was encouraging to see increases in activity over time. Because of the established benefits of regular exercise observed in this study and others, identifying and reducing barriers to regular PA among African American cancer survivors are critical for improving outcomes and minimizing disparities.

Patient-Reported Outcomes Measurement Information System instruments: outperforming traditional quality of life measures in patients with back and neck pain.

The Patient-Reported Outcomes Measurement Information System (PROMIS) has become increasingly popular due to computer adaptive testing methodology. This study aims to validate the association between PROMIS and legacy outcome metrics and compare PROMIS to legacy metrics in terms of ceiling and floor effects and questionnaire burden. A retrospective review of an outcomes database was performed at a single institution from December 2016 to April 2017. Inclusion criteria were age > 18 years and a chief complaint of back pain or neck pain. The PROMIS computer adaptive testing Pain Interference, Physical Function (PF), and Pain Intensity domains; Oswestry Disability Index (ODI); Neck Disability Index (NDI); and visual analog scale (VAS) back, VAS leg, VAS neck, and VAS arm were completed in random order. PROMIS was compared to legacy metrics in terms of the average number of questions needed to complete each questionnaire and the score distributions in the lower and higher bounds of scores. A total of 494 patients with back pain and 130 patients with neck pain were included. For back pain, ODI showed a strong correlation with PROMIS-PF (R = -0.749, p < 0.001), Pain Intensity (R = 0.709, p < 0.001), and Pain Interference (R = 0.790, p < 0.001) domains. Additionally, the PROMIS Pain Intensity domain correlated to both VAS back and neck pain (R = 0.642, p < 0.001 for both). PROMIS-PF took significantly fewer questions to complete compared to the ODI (4.123 vs 9.906, p < 0.001). When assessing for instrument sensitivity, neither survey presented a significant ceiling and floor effect in the back pain population (ODI: 0.40% and 2.63%; PROMIS-PF: 0.60% and 1.41%). In the neck pain cohort, NDI showed a strong correlation with PROMIS-PF (R = 0.771, p < 0.001). Additionally, PROMIS Pain Intensity correlated to VAS neck (R = 0.642, p < 0.001). The mean number of questions required to complete the questionnaire was much lower for PROMIS-PF compared to NDI (4.417 vs 10, p < 0.001). There were no significant differences found in terms of ceiling and floor effects for neck complaints (NDI: 2.3% and 6.92%; PROMIS-PF: 0.00% and 5.38%) or back complaints (ODI: 0.40% and 2.63%; PROMIS-PF: 1.41% and 0.60%). PROMIS correlates strongly with traditional disability measures in patients with back pain and neck pain. For both back and neck pain, the PROMIS-PF required patients to answer significantly fewer questions to achieve similar granularity. There were no significant differences in ceiling and floor effects for NDI or ODI when compared with the PROMIS-PF instrument.

High Patient Activation Is Associated With Remission in Patients With Inflammatory Bowel Disease.

High levels of patient activation (having the knowledge, skills, and confidence to effectively manage one's care), have been associated with improved outcomes in many chronic conditions. There have been few studies of the effects of activation in patients with inflammatory bowel disease (IBD). We performed a large, prospective Internet-based study to assess the relationship between patient activation level and clinical remission in patients with Crohn's disease or ulcerative colitis. We administered the Patient Activation Measure (Insignia Health) to 1486 cohort participants. Patients completed a follow-up survey within 13 months (median, 189 days). We collected demographic and clinical data; anxiety and depression were assessed using Patient-Reported Outcomes Measurement Information System instruments. We used bivariate analyses and multivariable logistic regression to identify characteristics associated with low or high patient activation and to evaluate the association between levels of patient activation and subsequent disease activity. Higher anxiety (adjusted odds ratio [aOR], 0.32; 95% confidence interval [CI], 0.29-0.36) and depression (aOR, 0.33; 95% CI, 0.29-0.37) scores were associated with a decreased odds of high patient activation. After we adjusted for education status, smoking, medication use, and other confounders, we found that patients with high activation at baseline were more likely to be in clinical remission during the follow-up period (aOR, 1.71; 95% CI, 1.20-2.45). In a large, prospective Internet-based cohort of patients with IBD, we found a strong association between patient activation and clinical remission. These findings suggest that patient activation affects disease outcomes.

Relationship and variation of diabetes related symptoms, sleep disturbance and sleep-related impairment in adults with type 2 diabetes.

The objective of this study was to examine whether diabetes-related symptoms (e.g. fatigue, neuropathic pain, diabetes distress and depressive symptoms) were related to sleep disturbance and sleep-related impairment in adults with type 2 diabetes while controlling for potential covariates. In people with type 2 diabetes, sleep disturbance and sleep-related impairment are common and likely associated with diabetes-related symptoms. However, limited research has investigated the predictive ability of diabetes-related symptoms on sleep. A correlational, cross-sectional design was used. Data were collected at a large university in the Midwestern United States from September 2013-March 2014. Multiple linear regression analyses were used to examine the relationship of diabetes-related symptoms (fatigue, neuropathic pain, distress and depressive symptoms) to sleep disturbance and sleep-related impairment. The instruments included Patient-Reported Outcomes Measurement Information System instruments, Diabetes Symptom Checklist and Diabetes Distress Scale. In this study of adults with type 2 diabetes (N=90; 52.2% female, mean age 57.4years), gender, A1C, neuropathic pain and fatigue were significantly related to sleep disturbance when age, diabetes duration, depressive symptoms and distress were controlled. Those variables collectively explained 52% of the variation in sleep disturbance. Fatigue was significantly associated with sleep-related impairment when the same covariates were controlled. Findings suggested that diabetes-related symptoms, including neuropathic pain and fatigue, are strongly related to sleep disturbance and sleep-related impairment in adults with type 2 diabetes, underscoring the need to include detailed assessments of neuropathic pain and fatigue when evaluating sleep.

Regenerative Peripheral Nerve Interfaces for the Treatment of Postamputation Neuroma Pain: A Pilot Study.

Background:Originally designed for prosthetic control, regenerative peripheral nerve interfaces (RPNIs) prevent neuroma formation by providing free muscle grafts as physiological targets for peripheral nerve ingrowth. We report the first series of patients undergoing RPNI implantation for treatment of symptomatic postamputation neuromas.Methods:A retrospective case series of all amputees undergoing RPNI implantation for treatment of symptomatic neuromas between November 2013 and June 2015 is presented. Data were obtained via chart review and phone interviews using questions derived from the Patient Reported Outcomes Measurement Information System instruments. Statistical analyses were performed using dependent sample t tests with a significance threshold of P < 0.01.Results:Forty-six RPNIs were implanted into 16 amputees for neuroma relief (3 upper extremities and 14 lower extremities). Mean age was 53.5 years (6 females and 10 males). All patients participated in postoperative phone interviews at 7.5 ± 3.4 (range: 3–15) months. Patients reported a 71% reduction in neuroma pain and a 53% reduction in phantom pain. Most patients felt satisfied or highly satisfied with RPNI surgery (75%), reporting decreased (56%) or stable (44%) levels of analgesic use. Most patients would strongly recommend RPNI surgery to a friend (88%) and would do it again if given the option (94%). Complications included delayed wound healing (n = 4) and neuroma pain at a different site (n = 2).Conclusions:RPNI implantation carries a reasonable complication profile while offering a simple, effective treatment for symptomatic neuromas. Most patients report a significant reduction in neuroma and phantom pain with a high level of satisfaction. The physiological basis for preventing neuroma recurrence is an intriguing benefit to this approach.

Validity and Reliability of Patient‐Reported Outcomes Measurement Information System Instruments in Osteoarthritis

Evaluation of known-group validity, ecological validity, and test-retest reliability of 4 domain instruments from the Patient-Reported Outcomes Measurement Information System (PROMIS) in osteoarthritis (OA) patients. We recruited an OA sample and a comparison general population (GP) sample through an internet survey panel. Pain intensity, pain interference, physical functioning, and fatigue were assessed for 4 consecutive weeks with PROMIS short forms on a daily basis and compared with same-domain Computer Adaptive Testing (CAT) instruments that use a 7-day recall. Known-group validity (comparison of OA and GP), ecological validity (comparison of aggregated daily measures with CAT instruments), and test-retest reliability were evaluated. The recruited samples matched the demographic characteristics (age, sex, race, and ethnicity) of the US sample for arthritis and the 2009 Census for the GP. Compliance with repeated measurements was excellent at >95%. Known-group validity for CATs was demonstrated with large effect sizes (pain intensity 1.42, pain interference 1.25, and fatigue 0.85). Ecological validity was also established through high correlations between aggregated daily measures and weekly CATs (≥0.86). Test-retest validity (7-day) was very good (≥0.80). PROMIS CAT instruments demonstrated known-group and ecological validity in a comparison of OA patients with a GP sample. Adequate test-retest reliability was also observed. These data provide encouraging initial data on the utility of these PROMIS instruments for clinical and research outcomes in OA patients.