Patient-Reported Outcomes Measurement Information Research Articles

Qualitative and Psychometric Evaluation of 29-Item Patient-Reported Outcomes Measurement Information System® to Assess General Health-Related Quality of Life in Patients With Moderately to Severely Active Inflammatory Bowel Disease

ObjectivesTo evaluate content validity and psychometric properties of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) to determine its suitability in inflammatory bowel disease (IBD) clinical trials. MethodsContent validity of PROMIS-29 was evaluated using qualitative interviews, including concept elicitation and cognitive debriefing, among patients living with Crohn’s disease (Crohn’s disease n = 20) or ulcerative colitis (UC, n = 19). PROMIS-29 validity, reliability, and responsiveness were assessed using data from phase II clinical trials of Crohn’s disease (N = 360) and UC (N = 518). ResultsCommon (≥74%) symptoms reported in qualitative interviews were increased stool frequency, fatigue, abdominal pain/cramping, blood/mucus in stool, bowel urgency, and diarrhea. Disease impact aligned with PROMIS-29 content (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles/activities). Cognitive debriefing indicated that PROMIS-29 instructions were easily understood, items were relevant, and the recall period was appropriate. Psychometric evaluations demonstrated that PROMIS-29 scores indicating worse symptoms/functioning were associated with lower health-related quality of life and greater disease activity and severity. PROMIS-29 domain scores correlated (rs ≥ 0.40) with IBD Questionnaire domains and EuroQol-5-Dimension-5-Level dimensions measuring similar concepts. Test-retest reliability among patients with stable disease was moderate-to-excellent (0.64-0.94) for nearly all domains in all studies. PROMIS-29 was responsive to change in disease status from baseline to week 12. Thresholds for clinically meaningful improvement ranged from ≥3 to ≥8, depending on domain. ConclusionsPROMIS-29 is valid, reliable, and responsive for assessing general health-related quality of life and treatment response in IBD clinical trials.

Association between perceived quality of care and social isolation among cancer survivors in the US.

e23182 Background: Though social isolation has been linked to poorer survival outcomes among cancer survivors, studies assessing its association with perceived quality of care have not been explored in this population. We examined the association between perceived quality of care and self-reported social isolation among cancer survivors. Methods: Cross-sectional analyses were conducted using the Health Information National Trends Survey (HINTS) data collected from a nationally representative population of US adults from March to November 2022. Social isolation was assessed with the self-reported Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form. Multiple linear regression models were used to examine the association between perceived quality of care and self-reported social isolation among cancer survivors. Other factors associated with social isolation in this population were also assessed. Results: In the adjusted analyses, social isolation scores were 6.3 points (95% CI: 2.30–10.28) higher among cancer survivors who reported fair/poor quality health care relative to those that reported excellent/very good/good quality of care. When compared to Non-Hispanic White cancer survivors, Non-Hispanic Blacks (β: –2.96; 95% CI: –5.35– –0.57) and Hispanic survivors (β: –4.06; 95% CI: –7.71– –0.40) had lower social isolation scores. Cancer survivors who were married or cohabiting had 3.3 points (95% CI: –6.01– –0.55) lower social isolation scores relative to single cancer survivors. Cancer survivors with high school or less education had lower isolation scores (β: –2.03; 95% CI: –4.00– –0.07) than those with some college education or more and those with an income of $50,000 or higher reported lower isolation scores (β: –2.19; 95% CI: –4.17– –0.21) than their counterparts earning less than $50,000. Furthermore, those with a diagnosis of depression or anxiety had 5.2 points (95%: 3.23–7.21) higher social isolation scores than cancer survivors without depression/anxiety. Conclusions: Fair or poor quality of care was associated with higher social isolation among cancer survivors. Additionally, race/ethnicity, marital status, level of education, income, and depression/anxiety were correlated with social isolation. To reduce the impact of social isolation and improve the health outcomes of cancer survivors, healthcare providers need to prioritize delivering holistic care, promote social connectivity and incorporate mental health screening and referrals into standard care practices.

Deep Peroneal Neurectomy for Midfoot Arthritis: A Comprehensive Review, Surgical Technique, and Case Series

Patients with painful midfoot arthritis unsuccessfully treated with conservative measures have been historically left with the surgical option of midfoot arthrodesis as a definitive treatment. In recent years, excision of the deep peroneal nerve has been offered as a potential alternative. Existing literature on the outcomes of patients undergoing deep peroneal neurectomy for the treatment of midfoot arthritis is limited and piecemeal. In this comprehensive review, technique guide, and retrospective case series, we consolidate the evidence around deep peroneal neurectomy for midfoot arthritis, review operative technique, and determine the outcomes of 4 patients who underwent deep peroneal neurectomy from February 2021 to December 2022 using Patient-Reported Outcome Measurement Information System Physical Function and Pain Interference scores. Four original articles from National Center for Biotechnology Information Medline, published through May 2023, were included. The outcomes of patients treated with deep peroneal neurectomy for midfoot arthritis are discussed. In our case series, the average amount of time between surgery and final postoperative Patient-Reported Outcome Measurement Information System scores was 289 days. The average preoperative physical function score was 36.8. Three patients showed a minimal clinically important difference in physical function; postoperative average was 41.3. Three patients had a minimally clinical important reduction in pain levels (average preoperative pain interference score was 65.8; average postoperative pain interference score was 59.3). One patient underwent a revision neurectomy for inadequate pain relief, and another sought additional treatment for inadequate pain relief. All patients returned to walking in a shoe within 1 month. The outcomes of our case series are similar to those of previously published case series, which demonstrate satisfactory results and acceptable complication rates. For patients with symptomatic midfoot arthritis, deep peroneal neurectomy can be an effective treatment option to reduce pain and improve physical function while requiring minimal postoperative recovery time.

Cryoneurolysis Associated With Improved Pain, Function, and Sleep in Patients Following total Knee Arthroplasty: Use of a New Real-World Registry

BackgroundTotal knee arthroplasty (TKA) is performed on approximately 790,000 patients annually in the United States and is projected to increase to 1.5 million by 2050. This study aimed at assessing the use of preoperative cryoneurolysis on patients undergoing TKA by analyzing: (1) pain severity; (2) opioid use; (3) functional status; and (4) sleep disturbance (SD) over 6 months following discharge. MethodsPatients enrolled in the Innovations in Genicular Outcomes Registry between September 2021 and February 2024 were followed for 6 months. Our analyses included patients undergoing unilateral primary TKA with no preoperative opioid prescription, who either received cryoneurolysis, or did not. Baseline patient demographics were collected before TKA and tabulated. Pain management was assessed via the Brief Pain Inventory-Short Form instrument for pain severity. SD was measured using the patient-reported outcomes measurement information system questionnaire. Each outcome measure was assessed prior to TKA, weekly, and at monthly follow-up. Data were analyzed by a generalized linear mixed-effect regression model to compare cryoneurolysis versus control patients, with a P < .05 as significant. ResultsThere were 80 patients who were treated with preoperative cryoneurolysis, while 60 control patients did not have treatment. Patients receiving cryoneurolysis experienced significantly lower pain severity and SD over the 6-month follow-up than control patients (P = .046). Cryoneurolysis was also associated with a trend toward greater functional improvement that did not reach statistical significance (P = .061). Further, patients who underwent cryoneurolysis were 72% less likely than control group patients to take opioids over 6 months following discharge (P < .001). ConclusionsPreoperative cryoneurolysis therapy in opioid-naive patients undergoing TKA is associated with improved pain, decreased opioid use, and improved SD for 6 months postoperatively. Cryoneurolysis, a nonopioid pain relief modality administered preoperatively, demonstrated substantial benefits in patients who underwent TKA.

Honey Added to Yogurt with Bifidobacterium animalis subsp. lactis DN-173 010/CNCM I-2494 Supports Probiotic Enrichment but Does Not Reduce Intestinal Transit Time in Healthy Adults: A Randomized, Controlled, Crossover Trial

BackgroundHoney improves probiotic survival in vitro. However, if this effect translates to humans has not been investigated. ObjectivesWe aimed to determine effects of honey plus yogurt containing the probiotic Bifidobacterium animalis subsp. lactis DN-173 010/CNCM I-2494 (B. animalis) on intestinal transit time, probiotic enrichment, digestive health, mood, and cognition in adults. MethodsSixty-six healthy adults (34 female; 33.6 ± 9.8 y; 24.6 ± 3.0 kg/m2) in a crossover trial were randomly assigned to 2-wk yogurt conditions in a counterbalanced order with ≥4-wk washout: 1) Honey (HON): yogurt plus honey and 2) Negative Control (NC): heat-treated yogurt plus sugar. Of the participants, n = 62 completed the trial, and n = 37 (17 female; 32.0 ± 8.3 y; 25.0 ± 2.9 kg/m2) elected to enroll in a third condition (a nonrandomized study extension) after ≥4-wk washout with a reference Positive Control (PC): yogurt plus sugar. At baseline and end of each of the 3 conditions, intestinal transit time was measured with dye capsules; probiotic abundance with fecal DNA 16S sequencing; digestive health with symptom/function records, Bristol stool consistency, Gastrointestinal Tolerability, and Gastrointestinal Quality of Life Index; mood with Positive and Negative Affect Schedule-Short Form, Depression Anxiety Stress Scales-42, Patient-Reported Outcomes Measurement Information System questionnaires, and an emotional image task; and cognition with a spatial reconstruction task. Data were analyzed using linear mixed-effects models (LMMs) with significance at P ≤ 0.05. Baseline and end data were included in the LMM, with fixed effects being treatment, time, treatment by time interaction, and baseline covariate, and the random effect being the participant. ResultsB. animalis was enriched in HON (d = 3.54; P = 0.0002) compared to controls with linear discriminant analysis effect size. Intestinal transit time, gastrointestinal health, mood, and cognition did not differ between conditions (LMM: Ps > 0.05). ConclusionsYogurt + honey enriched B. animalis but did not reduce intestinal transit time or have other functional gastrointestinal, mood, or cognitive effects in adults.This trial was registered at www.clinicaltrials.gov as NCT04187950 and NCT04901390.

The Impact of Mind-Body Medicine on Patient-Reported Outcomes in the Management of Chronic Pelvic Pain.

Background Recent research has suggested a role for mindfulness-based therapy for patients with chronic medical conditions, but there is limited data on pelvic pain. We aim to determine if mindfulness improves patient-reported outcomes in pelvic pain and to determine the feasibility of implementation of this program. Methodology This is a pilot feasibility trial consisting of women with chronic pelvic pain at a single academic tertiary referral clinic.A convenience sample of 15 subjects was enrolled. Subjects were scheduled for three 60-minute virtual mind-body sessions with a certified counselor. Baseline scores were obtained using the Patient-Reported Outcomes Measurement Information System-Computer Adaptive Testing (PROMIS-CAT) platform. They were repeated three months and six months after enrollment. Descriptive statistics were performed. Results A total of 15 patients were enrolled in the study. Among the 13 patients who completed the three-month PROMIS-CAT scores, seven had a clinically significant 5-point improvement in sleep disturbance T-score.At least a 5-point improvement in fatigue, pain interference, and ability to participate in social roles and activities T-scores were observed in six patients each. There was a 40% dropout rate. Conclusions A formal mind-body counseling program can support patients with chronic pelvic pain. Our trial demonstrated the feasibility of establishing a program and modest improvement in patient-reported quality of life.

Physical activity and dexamethasone for cancer related fatigue: A preliminary placebo controlled randomized control trial.

12050 Background: Despite high frequency and significant impact on quality of life, there are limited treatment options available for cancer related fatigue (CRF) in patients with advanced cancer. The primary aim of the study was to determine the feasibility (adherence, safety, and satisfaction) of the combination therapy, physical activity (PA) plus Dexamethasone (Dex); and PA plus placebo (Pl) for CRF. The secondary aim was to explore the effects of PA+Dex, and PA+Pl on CRF as assessed by Functional Assessment of Cancer Illness Therapy–fatigue (FACIT-F). Methods: In this phase 2, randomized, double blind, placebo controlled trial, patients with advanced cancer with CRF ≥ 4/10 on Edmonton Symptom Assessment Scale were eligible. Patients were randomized to standardized PA for 4 weeks plus either 4mg of Dex (PA+Dex arm), or Pl (PA+PL arm) BID for the first 7 days. Changes in FACIT-F scores from baseline to Day 8, and Day 29 were assessed. Other outcomes included change in quality-of-life scores. Results: A total of64 (89%) patients were evaluable. The median (IQR) changes in FACIT-F scores at Day 8 and Day 29 from baseline were 9 (2,16), P&lt; 0.001; 5.75 (0,12.5), P=0.015 for PA+ Dex arm, and 3.5 (-2.13, 10), P=0.054; 6.50 (2.5, 15.5), P=0.006 for PA+ Pl arm respectively. Exploratory Linear Mixed Model (LMM) analysis showed significant treatment effect of PA +Dex, with treatment having improvement of 5.63 units for FACIT-F scores (95% Cl 1.74,9.52), P=0.005. Effect sizes for improvement of FACIT-F scores at Day 8 and Day 29 were -3.49, -2.43 in PA+Dex arm; and -1.93, -2.72 in PA+Pl arm, respectively. Effect sizes for change in fatigue related symptoms and quality of life scores as assessed by Patient-Reported Outcome Measurement Information System-Fatigue T-scores, Multidimensional Fatigue Symptom Inventory-Short Form total, and Functional Assessment of Cancer Therapy -General scores at Day 8, and Day 29 in PA+ Dex arm were 2.93 (P=0.005), 2.82 (P=0.005); 2.27 (P=0.023), 2.68 (P=0.007); -2.39 (P=0.017), -3.26 (P=0.001) respectively. Adherence to Dex and Pl were 91% and 92%, respectively, Satisfaction rates with PA+Dex and PA+Pl arms were 98% and 79%, respectively. There was no significant difference in grade ≥3 adverse events between the two arms (P = 0.36). Conclusions: Satisfaction, and tolerability to the combination therapy, and medication adherence was excellent.PA + Dex significantly improved CRF at day 8 and 29. The improvement was sustained 3 weeks after discontinuation of Dex. Further larger studies are justified. Clinical trial information: NCT03583255 .

Defining musical toxicity after breast cancer treatment: A classification tree analysis.

12048 Background: Playing music has been an important part of human culture for millennia. Today more than half of American households have at least one person who plays music, and in the UK 43% of adults play an instrument. Despite the overlap between musicians and people diagnosed with cancer, the effect of cancer treatment on musicianship has not been well-studied. We previously reported that 26% of a musician breast cancer survivor cohort reported difficulty with musicianship after treatment, and here we conduct further analysis to identify treatment and disease factors associated with this difficulty, termed acute musical toxicity (AMT). Methods: The Musical Toxicity Questionnaire was distributed to participants who had previously enrolled in the Mayo Clinic Breast Cancer Registry. PROMIS (Patient-Reported Outcomes Measurement Information System) scores were available through the Registry and treatment details were collected retrospectively. Due to the inter-dependency and high correlation between treatment and disease-related variables, a classification tree analysis (CTA) was performed to identify the combination of variables that most accurately classified patients by AMT. Sixteen variables were analyzed by the algorithm. Logistic regression was utilized for examining associations between AMT and continuous variables. Results: Of the 4075 surveys distributed, 1871 were returned and 535 respondents identified as musicians. Median time from diagnosis was 5.2 years, respondents were mostly stage I or II (71%), and 32% were node positive (N+). Over a quarter (26% or 144 respondents) reported AMT. In the final CTA model, being N+ was strongly associated with AMT (42% of those N+ had AMT, 20% of those not N+ had AMT). For respondents who were N+, those who received endocrine therapy were more likely to have AMT than those who did not (46% vs 21% respectively). Subsequent leaves identified not undergoing axillary lymph node dissection (ALND) and receiving chemotherapy as associated with AMT. For respondents who did not receive chemotherapy, breast reconstruction was associated with AMT (60% vs 19%). Variables such as mastectomy, radiation volume, specific chemotherapies, and stage of disease were not selected by the algorithm. The odds of having AMT decreased by 9.7% and 17% with each additional point in the composite mental health (p=0.003) and physical health (p&lt;0.001) PROMIS scores, respectively. The odds of having AMT increased by 3.5% with each lymph node removed (p=0.001). Conclusions: The final model suggests that the group with the largest proportion of AMT was N+, received endocrine therapy, did not have ALND, and received chemotherapy. Both physical and mental health PROMIS scores were associated with AMT, although the directionality of this relationship requires more study. Care teams should counsel patients on potential musical toxicity and engage in shared decision making with musical patients.

A Prospective Randomized Pilot Study: One-Year Outcomes of Ligament Reconstruction Tendon Interposition Versus Suture Tape Suspensionplasty for Thumb Carpometacarpal Joint Arthritis

We performed a randomized controlled trial assessing patient-reported outcome measures following trapeziectomy with ligament reconstruction and tendon interposition (LRTI) or suture tape suspensionplasty (STS) for treatment of thumb carpometacarpal joint osteoarthritis. Patients undergoing surgery for thumb carpometacarpal joint osteoarthritis were prospectively randomized to LRTI or STS. Outcome measures were collected at 2 weeks, 4 weeks, 3 months, and 1 year and included visual analog scale pain, Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity, return to work/activity, range of motion, grip/pinch strength, and complications. Thirty-one patients (32 thumbs) were randomized from 51 patients offered participation over two years. One-year follow-up was 97%. Both groups had a decrease in visual analog scale pain scores at all postoperative time points. The trajectory of postoperative Patient-Reported Outcomes Measurement Information System Upper Extremity scores was similar, and both groups achieved the meaningful clinically important difference for improvement in PROMIS Upper Extremity by three months. Grip strength was substantially increased in both groups at one year. Return to work/activity and surgical complications favored the LRTI group. Our study did not suggest any clinically relevant differences in the postoperative patient-reported outcome measures or objective clinical measurements between LRTI and STS, although LRTI patients had a faster return to work/activity and lower complication rates. Therapeutic IIB.

Age-normed patient-reported outcome measures among cancer survivors.

11122 Background: Patient-reported outcome measures (PROMs) are instruments used to collect health-related outcomes that are derived completely from the patient without interpretation from healthcare providers. Monitoring and subsequent intervention based on PROMs collection has demonstrated efficacy in clinical trial settings. This has resulted in implementation of PROMs in routine clinical cancer practices throughout the nation. PROMs have been normed to the general population, but establishing the norms among cancer patients is essential to understanding how PROMs can be evaluated on an individual basis in routine clinical cancer care. This study aims to characterize age-normed PROMs scores among survivors of cancer using the National Institute of Health’s Patient-Reported Outcome Measures Information System (PROMIS) depression, fatigue, pain interference, and physical function domains. Methods: Routine collection of PROMs using 4 domains (depression, fatigue, pain interference, and physical function) of PROMIS were offered to all patients with a diagnosis of cancer of any disease site at visits with an oncologic provider using computer adaptive testing. All patients ≥18 years old with a completed PROM at least 2 years since their diagnosis of cancer were eligible for inclusion in the analysis. Only completed PROMs were included in the final analysis. Generalized estimating equation models were used to assess the relationship between age and the estimated mean T-score for each PROMs domain, considering repeat measures within a single patient. Results: A total of 3,636 patients were included in this retrospective cohort study with a total of 26,173 completed PROMs among all 4 domains. Mean age at diagnosis was 61.2 years (SD=12.44), 64% (n=2324) were female, 68% (n=2,461) identified as White, and 25% (n=893) identified as Black. For fatigue, mean T-score ranged from 48.4 points (SD=9.6) among 18-29 years olds to 56.5 points (SD=10.1) among 90-99 years olds, with no significant change with age (p=0.27). For depression, mean T-score ranged from 48.9 points (SD=9.0) among 60-69 year olds to 51.1 points (SD=8.8) among 80-89 year olds with a 0.3 point/decade decrease in T-score (p=0.01). Pain interference T-scores ranged from 48.6 points (SD=10.5) among 18-29 year olds to 55.0 points (SD=9.4) among 80-89 year olds with a 0.4 point/decade average increase (p&lt;0.001). The largest differences were observed in physical function, where scores ranged from 53.5 points (SD=11.0) among 18-29 year olds to 34.3 points (SD=9.2) among 90-99 year olds. There was a 2.1 point/decade decrease in T-score (p&lt;0.001). Conclusions: Among survivors of cancer, mean PROMIS scores differed by age in the depression, pain interference, and physical function domains but not fatigue. These age-normed PROMIS T-scores, which are required to understand individualized assessments of PROMs, are essential as PROMs are integrated into routine cancer care.

Preoperative Rank of Expectations for Shoulder Surgery (PRESS): a novel survey

Patient expectations for orthopedic surgeries, and elective shoulder surgery in particular, have been shown to be important for patient outcomes and satisfaction. Current surveys assessing patient expectations lack clinical applicability and allow patients to list multiple expectations at the highest level of importance. The purpose of this study was to develop and evaluate the use of a novel, rank-based survey assessing the relative importance of patient expectations for shoulder surgery. The Preoperative Rank of Expectations for Shoulder Surgery (PRESS) survey was developed by polling 100 patients regarding their expectations for surgery. The PRESS survey consisted of 8 common expectations for elective shoulder surgery by importance and a 0%-100% scale of expected pain relief and range of motion improvement. After initial development of the PRESS survey, it was administered preoperatively to 316 patients undergoing surgery for shoulder arthritis, rotator cuff tear, subacromial pain syndrome, or glenohumeral instability between August 2020 and April 2021. Patients also completed preoperative outcome measures such as the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Physical Function 7a version 1.0 (PROMIS PF), and PROMIS Pain Interference short form 8a version 2.0 (PROMIS PI) surveys. Patient-reported outcome measure (PROM) surveys were administered 6 months postoperatively. Improvement in range of motion was the expectation most often ranked first for the entire study group (18%), arthritis subgroup (23%), and rotator cuff tear subgroup (19%). Subacromial pain syndrome patients most often ranked improving ability to complete activities of daily living and relieving daytime pain first (19%). Shoulder instability patients most often ranked improving ability to participate in sports first (31%). Patients who ranked improving range of motion or sports highly had better PROMs. Those who ranked relieving pain highly had worse PROMs. Patients with high (>90%) expectations of pain relief had better PROMIS PI scores. Patients with high pain relief expectations in the arthritis and subacromial pain syndrome groups had better PROMs, whereas patients with instability were less satisfied. The novel PRESS survey assesses patient expectations for shoulder surgery in a new, more clinically applicable rank-based format. The responses provided by patients provide actionable information to clinicians and are related to postoperative outcomes. Therefore, the PRESS survey represents a useful tool for guiding discussions between patients and surgeons, as well as aiding in overall patient-centered clinical decision making.

Patient-Reported Outcomes After Intramedullary Nailing of Oncologic Impending or Pathologic Fractures With Carbon Fiber or Titanium Implant.

Despite the benefits of intramedullary nailing (IMN) of impending or pathologic fractures in oncologic patients, literature on patient-reported outcomes (PROs) is scarce in patients treated with carbon fiber (CF) nails. Our study compared postoperative PROs after IMN with CF or titanium implants. We conducted a retrospective propensity score-matched cohort study of patients treated at our institution with CF or titanium nails for impending or pathologic fractures from metastatic bone disease. Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (SF) Physical, Mental, and Physical Function 10a scores were collected. Pain was assessed using visual analog scale (VAS). Absolute and differential scores were compared between groups. We included 207 patients, 51 treated with CF and 156 with titanium nails. One month postoperatively, patients had a one-point decrease in the pain VAS score while PROMIS scores did not improve. At 3 months, PROMIS SF Physical and SF 10a scores improved from preoperative values. Six months postoperatively, median PROMIS SF Physical, SF Mental, and SF 10a scores were higher than preoperative scores. Absolute and differential PROMIS and pain VAS scores were similar between groups at the 6-month and 1-year marks. Patient-reported outcomes were similar after intramedullary nailing with either CF or titanium implants.

Association of symptom severity, anxiety, and health literacy with portal usage among patients with cancer.

1567 Background: Patient portals within electronic health records (EHR) have become increasingly essential in promoting patient-centered oncology care. They offer opportunities for completing symptom surveys that can aid in symptom management, facilitate patient-clinician communication, and enable health monitoring. As part of the Northwestern University Improving the Management of Symptoms During and Following Cancer Treatment (NU IMPACT) study, we examined the relationship between symptom severity, anxiety, health literacy, and shared decision-making with usage of three common features in the patient portal (portal). Methods: This study included adults diagnosed with cancer in the NU IMPACT study. Participants completed baseline surveys on socio-demographics, health literacy (Single Item Literacy Screener), anxiety (Patient-Reported Outcomes Measurement Information System; PROMIS), with high anxiety scored as ≥60 vs &lt;60, shared decision-making (CollaboRATE), and symptom severity (Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events; PRO-CTCAE). Portal activities one year following enrollment were extracted from EHRs. Portal usage patterns of patient-initiated messages, portal lab and clinical note views were counted as number of days the activity was used over the year and categorized as tertiles. Multivariable ordinal logistic regression models were used to examine associations between survey measures and ordered tertiles of patient portal activities. Results: Participants (N=3,464) were mostly female (66%), White (85%), with a mean (SD) age of 61(13) years old. The frequency ranges of patient-initiated messages over a year were 0-163 days, labs viewed were 0-350 days, and clinical notes viewed were 0-103 days. Participants with at least one severe or very severe symptom on the PRO-CTCAE were more likely to be in higher tertiles of patient-initiated portal messages (OR: 1.37, 95% CI: 1.17-1.61), lab views (OR: 1.48, 95% CI: 1.26-1.74), and clinical note views (OR: 1.19, 95% CI: 1.01-1.40). Participants with higher levels of anxiety were more likely to be in higher tertiles of patient-initiated portal messages (OR: 1.54, 95% CI: 1.28-1.85), lab views (OR: 1.22, 95% CI: 1.01-1.46), and clinical note views (1.42, 95% CI: 1.18-1.71). Participants with higher health literacy were more likely to be in higher tertiles of patient-initiated portal messages (OR: 1.38, 95% CI: 1.09-1.74) and lab views (OR: 1.34, 95% CI: 1.06-1.69), but not note views (OR: 1.03, 95% CI: 0.82-1.30). Shared decision making was not associated with portal usage. Conclusions: Patients with greater symptom severity and anxiety may turn to the portal for symptom management. Certain features within the portal may demand a higher level of health literacy for engagement. Understanding the factors that promote and impede portal usage can help optimize cancer care delivery.

Long-Term Clinical Outcomes Following Nonsurgical Management of Salter-Harris Type II Fractures of the Proximal Phalanx of the Small Finger: A Prospective Cohort Study

Juxta-physeal fractures at the base of the proximal phalanx (FBPP) of the small finger are one of the most common hand fractures in children. Although many of these fractures are treated nonsurgically, it is unclear which fractures benefit from surgery or the degree of acceptable angulation appropriate for nonsurgical management. Our study aimed to assess long-term, patient-reported outcomes regarding function, appearance, and pain after nonsurgical management of FBPP of the small finger in a pediatric population. Our hospital Picture Archiving and Communication Systems database was queried to identify radiographs of the small finger of children between the ages of 8 and 16 years old taken from 2011 to 2021. Displacement on initial injury radiographs was calculated using the diaphyseal-metacarpal head angle. Patient-reported function, appearance, and pain were measured using standardized assessment tools sent to patients and parents electronically. Optional clinical photographs were uploaded by parents and assessed for residual clinical deformity. One hundred eighty-one eligible subjects were identified. Eighty (44%) agreed to participate, and 40 (22%) parent and 38 patient surveys were completed. The mean age at the time of injury was 11 years old (8-14 years), and the mean age at the time of survey completion was 17 years old (11-23 years). Patient T-scores were higher than the average reference T-score on the Patient-Reported Outcomes Measurement Information System Short Form v2.0-Upper Extremity. Overall, greater than 78% of patients and parents reported appearance as 8/10 or above on a VAS. Ninety-five percent (108/114) of patients reported no pain (0/10) for pain during activities and at rest. Children with up to 26° of initial coronal plane angulation reported better function than a reference population, good appearance, and no pain, at a mean of 6 years after injury. Our findings support nonsurgical management of most FBPP of the small finger in children. Therapeutic IV.

Peer-Led Symptom Management Intervention to Enhance Resilience in People With Systemic Sclerosis: Mediation Analysis From a Randomized Clinical Trial.

Facilitated self-management interventions have the potential to enhance resilience and well-being. We examined whether resilience is a mediator of improving physical and psychological symptoms for people with systemic sclerosis (SSc) who participated in a 12-week online peer-led symptom management intervention. We conducted a secondary data analysis from a randomized control trial comparing a peer health-coached intervention to a waitlist control. Participants completed the Connor-Davidson Resilience Scale, the Functional Assessment of Chronic Illness Therapy-Fatigue scale, and the Patient Reported Outcomes Measurement Information System measures of pain interference and depressive symptoms at the baseline and at weeks 6 and 12. Linear mixed effect regression models were used to assess the effect of intervention on changes in resilience. Causal mediation analyses were conducted to examine whether changes in resilience at week 12 mediated intervention effects on changes in fatigue, pain interference, and depressive symptoms at week 12. One hundred and seventy-three eligible participants were enrolled. Participants in the intervention group reported improvements in resilience (P < 0.001). These changes in resilience mediated the intervention effects on fatigue with indirect effect of -1.41 (95% confidence interval [CI] -2.41 to -0.41), pain interference of -0.86 (95% CI -1.65 to -0.08), and depressive symptoms of -1.99 (95% CI -3.16 to -0.81). For participants in the intervention who had positive improvements in their physical and psychological symptoms, increased resilience was a mechanism for these improvements. These findings support the importance of addressing resilience to improve symptoms in similar SSc interventions.

Enhancing the Evaluation of Physical Function Following Orthopaedic Trauma Care: Comparison of PROMIS Computerized Adaptive Testing and Short Musculoskeletal Function Assessment.

To compare measurement properties of Patient-Reported Outcomes Measurement Information System (PROMIS) (physical function [PF] and pain interference [PI]) computerized adaptive testing to traditional Short Musculoskeletal Function Assessment (SMFA) (dysfunction index [DI] and bother index [BI]). To explore factors associated with PROMIS scores. Cross-sectional study. Level I Trauma Center. Isolated upper/lower extremity fracture patients were recruited from the orthopaedic trauma outpatient clinic (October 1, 2021 to January 1, 2023). Correlations (Pearson), reliability (standard error [SE] [T score]), efficiency (amount of information per item [1 - SE2/Nitems]), and floor/ceiling effects were assessed. An r > 0.7 represented high correlation, and SE ≤ 2.2 represented sufficient reliability. Factors associated with worse PROMIS scores were also identified. In total, 202 patients completed PROMs at median 98 days follow-up. Correlations between PROMIS-PF and SMFA-DI, and PROMIS-PI and SMFA-BI were -0.84 and 0.65. Reliability was very high for both instruments (mean SE 2.0 [PROMIS-PF], SE 2.1 [PROMIS-PI], and SE 1.2 [SMFA-DI], SE 1.8 [SMFA-BI]). Relative efficiency for PROMIS-PF versus SMFA-DI, and PROMIS-PI versus SMFA-BI was 7.8 (SD 2.5) and 4.1 (SD 1.7), respectively. Neither PROMIS nor SMFA exhibited floor/ceiling effects. In the multivariable regression analyses, elevated levels of depression, among other factors, showed an (independent) association with worse PROMIS-PF and PROMIS-PI scores. PROMIS-PF and PROMIS-PI CATs showed a (high and moderate) correlation with SMFA and hence measure a comparable construct of physical function and discomfort. As computerized adaptive tests are much more efficient to administer, they present a compelling alternative to SMFA for evaluating impact of fracture treatment. The relation between symptoms of depression and PROMIS scores emphasizes the importance of psychosocial aspects of health in orthopaedic trauma patients. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

SleepSync: Early Testing of a Personalised Sleep-Wake Management Smartphone Application for Improving Sleep and Cognitive Fitness in Defence Shift Workers.

Shift work, long work hours, and operational tasks contribute to sleep and circadian disruption in defence personnel, with profound impacts on cognition. To address this, a digital technology, the SleepSync app, was designed for use in defence. A pre-post design study was undertaken to examine whether four weeks app use improved sleep and cognitive fitness (high performance neurocognition) in a cohort of shift workers from the Royal Australian Air Force. In total, 13 of approximately 20 shift-working personnel from one base volunteered for the study. Sleep outcomes were assessed using the Insomnia Severity Index (ISI), the Patient-Reported Outcomes Measurement Information System (PROMIS), Sleep Disturbance and Sleep-Related Impairment Scales, the Glasgow Sleep Effort Scale, the Sleep Hygiene Index, and mental health was assessed using the Depression, Anxiety, and Stress Scale-21. Sustained attention was measured using the 3-min Psychomotor Vigilance Task (PVT) and controlled response using the NBack. Results showed significant improvements in insomnia (ISI scores 10.31 at baseline and 7.50 after app use), sleep-related impairments (SRI T-scores 53.03 at baseline to 46.75 post-app use), and healthy sleep practices (SHI scores 21.61 at baseline to 18.83 post-app use; all p < 0.001). Trends for improvement were recorded for depression. NBack incorrect responses reduced significantly (9.36 at baseline; reduced by -3.87 at last week of app use, p < 0.001), but no other objective measures improved. These findings suggest that SleepSync may improve sleep and positively enhance cognitive fitness but warrants further investigation in large samples. Randomised control trials with other cohorts of defence personnel are needed to confirm the utility of this intervention in defence settings.

Examining patient reported outcome measures for phantom limb pain: measurement use in a sample of Veterans with amputation

Purpose Phantom limb pain (PLP) is treated with medications and non-drug treatments. Best clinical practices for measuring treatment outcomes have not been defined. The objective of this study was to evaluate the internal consistency of patient-reported outcomes measures (PROMs) in a sample of Veterans with lower limb amputation. Materials and Methods The Veteran phone survey included administering PROMs [1) PLP numeric rating scale (NRS), 2) general pain NRS, 3) Pain, Enjoyment, and General Activity (PEG) scale, 4) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b Replacement, 5) PROMIS Short Form Depression 4a and 6) PROMIS Short Form Anxiety 4a]. Results Fifty Veterans (48 male, 2 female; average age: 66 years) completed PROMs. In our sample, 40 Veterans (80%) experienced PLP with an average PLP NRS of 5 (±3.4). Internal consistency of each measure was good to excellent based on Cronbach’s alpha co-efficient of >0.80. Correlations were moderate between PLP NRS and all other measures (≤0.32). Although many Veterans expressed bothersome PLP, the scores reflecting pain interference and impact on function were lower than pain intensity. Consistent use of outcome measures is needed to determine the effect of interventions for amputation-related pain.

Defining the Patient Acceptable Symptom State (PASS) for PROMIS After Total Ankle Replacement.

Although patient-reported outcomes (PROs), such as the Patient-Reported Outcomes Measurement Information System (PROMIS), are a key element of evaluating success after total ankle replacement (TAR), many do not explicitly state a key factor of postoperative success: is the patient satisfied with their outcome after TAR? The patient acceptable symptom state (PASS) represents the symptom threshold beyond which patients consider themselves well. This study aimed to establish the PROMIS thresholds for the PASS in a primary cohort of TAR patients. This single-institution study included 127 primary TAR patients with preoperative and 2-year postoperative PROMIS scores. At 2 years postoperatively, patients answered 2 PASS anchor questions (Satisfaction, Delighted-Terrible scale) with Likert-scale responses. PASS thresholds with 95% confidence intervals (CIs) were calculated from PROMIS scores using an anchor-based method. Using a bootstrapping technique with 1,000 iterations, the Youden index was calculated to determine the best specificity and sensitivity coordinates to maximize their combination. Finally, preoperative variables associated with the likelihood of achieving the PASS were assessed. There was a strong association between PASS thresholds and PROMIS domains, especially Pain Interference (PASS threshold of <56.0, area under the receiver operating characteristic curve [AUC] = 0.940), Pain Intensity (<48.4, AUC = 0.936), and Physical Function (>44.7, AUC = 0.883). The likelihood of achieving the PASS was not affected by age, race, gender, American Society of Anesthesiologists (ASA) class, body mass index, or severity of ankle deformity. Patients with worse preoperative Physical Function and Global Mental Health scores were less likely to meet the PASS threshold for Physical Function postoperatively (p = 0.028 and 0.041). The ability to reach the PASS after TAR was most strongly associated with postoperative PROMIS pain scores. However, PASS thresholds were generally poorer than population means. This demonstrates that patients do not need to reach normal pain or physical function levels to have an acceptable symptom state after TAR. Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

The influence of body mass index on patient-reported outcome measures following total hip arthroplasty: a retrospective study of 3,903 Cases.

The influence of obesity on patient-reported outcome measures (PROMs) following total hip arthroplasty (THA) is currently controversial. This study aimed to compare PROM scores for pain, functional status, and global physical/mental health based on body mass index (BMI) classification. Primary, elective THA procedures at a single institution between 2018 and 2021 were retrospectively reviewed, and patients were stratified into four groups based on BMI: normal weight (18.5-24.99kg/m2), overweight (25-29.99kg/m2), obese (30-39.99kg/m2), and morbidly obese (> 40kg/m2). Patient-Reported Outcome Measurement Information System (PROMIS) and Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR) scores were collected. Preoperative, postoperative, and pre/post- changes (pre/post-Δ) in scores were compared between groups. Multiple linear regression was used to assess for confounders. We analyzed 3,404 patients undergoing 3,903 THAs, including 919 (23.5%) normal weight, 1,374 (35.2%) overweight, 1,356 (35.2%) obese, and 254 (6.5%) morbidly obese cases. HOOS, JR scores were worse preoperatively and postoperatively for higher BMI classes, however HOOS, JR pre/post-Δ was comparable between groups. All PROMIS measures were worse preoperatively and postoperatively in higher BMI classes, though pre/post-Δ were comparable for all groups. Clinically significant improvements for all BMI classes were observed in all PROM metrics except PROMIS mental health. Regression analysis demonstrated that obesity, but not morbid obesity, was independently associated with greater improvement in HOOS, JR. Obese patients undergoing THA achieve lower absolute scores for pain, function, and self-perceived health, despite achieving comparable relative improvements in pain and function with surgery. Denying THA based on BMI restricts patients from clinically beneficial improvements comparable to those of non-obese patients, though morbidly obese patients may benefit from additional weight loss to achieve maximal functional improvement.