Pain Patient-reported Outcomes Research Articles

Patient-Reported Outcomes of Pain, Stiffness, and Fatigue Reduction in Rheumatoid and Psoriatic Arthritis With Cannabinoid Use

Patient-Reported Outcomes of Pain, Stiffness, and Fatigue Reduction in Rheumatoid and Psoriatic Arthritis With Cannabinoid Use

Patient-Reported Outcomes of Depression and Fibromyalgia Symptoms Do Not Predict Non-Inflammatory versus Inflammatory Diagnoses at Initial Rheumatology Consultation.

The objective of this study was to assess the potential value of patient-reported outcomes (PROs) of depression, fibromyalgia symptoms, and pain in predicting non-inflammatory vs. inflammatory diagnoses in rheumatology patients. This retrospective, single-center study evaluated electronic health record (EHR) data from adults who were seen for their first rheumatology consultation and subsequently received a diagnosis of an inflammatory (e.g., rheumatoid arthritis or spondyloarthritis) or non-inflammatory (e.g., osteoarthritis or fibromyalgia) condition. The PROs evaluated included depressive symptoms (Patient Health Questionnaire-2 [PHQ-2]), fibromyalgia symptom severity (FM SS), and pain. A total of 3669 patients were evaluated, including patients with (n = 984; 26.82%) and without (n = 2685; 73.18%) inflammatory rheumatologic disease, of whom 141 (3.8%) had fibromyalgia. The non-inflammatory subgroup reported higher FM SS scores, and the inflammatory subgroup had higher pain and inflammatory markers. Bivariate models based on PHQ-2 and FM SS had a very low specificity (0.3%) for predicting non-inflammatory conditions, resulting in the misclassification of >99% of inflammatory cases. Adding pain, inflammatory markers, and other relevant EHR variables increased specificity but still resulted in a high level of misclassification. The PROs evaluated in this study are not suitable for predicting non-inflammatory vs. inflammatory rheumatologic disease, even when combined with other EHR variables.

Acupuncture for fatigue in breast cancer survivors: a study protocol for a pragmatic, mixed method, randomised controlled trial

IntroductionFatigue is a common symptom observed in post-cancer treatment, yet its underlying mechanisms remain poorly understood. Acupuncture has been employed to alleviate cancer-related fatigue (CRF); however, its effectiveness in addressing...

Telehealth mindful exercise for people with knee osteoarthritis: A decentralized feasibility randomized controlled trial

ObjectiveNegative psychological beliefs like fear avoidance and catastrophizing can interfere with exercise engagement in people with knee osteoarthritis (OA). Mindfulness, when integrated with exercise, could potentially address both psychological and physical impairments. Our objectives were to optimize and assess the feasibility of a novel telehealth, group-based mindful exercise intervention for people with knee OA. MethodsWe conducted a decentralized randomized controlled trial where participants (n ​= ​40) with symptomatic knee OA were randomized into mindful exercise (n ​= ​21) or exercise-only (n ​= ​19) groups. Both groups received supervised group-based interventions weekly for 8-weeks via Zoom. Primary outcomes were safety, fidelity, and feasibility of the mindful exercise intervention. Participants completed patient-reported outcomes (PRO) for pain, function, and psychological measures at baseline, week-8, and week-14. ResultsParticipants were from 21 US states; >90% identified as having White race, 16% were from rural areas, and approximately 40% had an annual income < $50,000. At 8-weeks, mindful exercise and exercise groups had retention rates of 86% (18/21) and 100% (19/19), and attendance was 54% (11.4/21) and 68% (13/19) respectively. There were no adverse events in the mindful exercise group and four in the exercise group related to exacerbation of knee pain. Preliminary findings showed numerically larger improvements in several PROs for the mindful exercise group. ConclusionAn 8-week telehealth, group-based, mindful exercise intervention was safe for people with knee OA. Our decentralized approach was feasible in terms of recruitment and retention. Further refinement is needed to improve intervention attendance and participant diversity.

Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.

Prospective multicenter database post-hoc analysis. Opioids are frequently prescribed for painful spinal conditions to provide pain relief and to allow for functional improvement, both before and after spine surgery. Amidst a current opioid epidemic, it is important for providers to understand the impact of opioid use and its relationship with patient-reported outcomes. The purpose of this study was to evaluate pre-/postoperative opioid consumption surrounding ASD and assess patient-reported pain outcomes in older patients undergoing surgery for spinal deformity. Patients ≥60 years of age from 12 international centers undergoing spinal fusion of at least 5 levels and a minimum 2-year follow-up were included. Patient-reported outcome scores were collected using the Numeric Rating Scale for back and leg pain (NRS-B; NRS-L) at baseline and at 2 years following surgery. Opioid use, defined based on a specific question on case report forms and question 11 from the SRS-22r questionnaire, was assessed at baseline and at 2-year follow-up. Of the 219 patients who met inclusion criteria, 179 (81.7%) had 2-year data on opioid use. The percentages of patients reporting opioid use at baseline (n = 75, 34.2%) and 2 years after surgery (n = 55, 30.7%) were similar (P = .23). However, at last follow-up 39% of baseline opioid users (Opi) were no longer taking opioids, while 14% of initial non-users (No-Opi) reported opioid use. Regional pre- and postoperative opioid use was 5.8% and 7.7% in the Asian population, 58.3% and 53.1% in the European, and 50.5% and 40.2% in North American patients, respectively. Baseline opioid users reported more preoperative back pain than the No-Opi group (7.0 vs 5.7, P = .001), while NRS-Leg pain scores were comparable (4.8 vs 4, P = .159). Similarly, at last follow-up, patients in the Opi group had greater NRS-B scores than Non-Opi patients (3.2 vs 2.3, P = .012), but no differences in NRS-Leg pain scores (2.2 vs 2.4, P = .632) were observed. In this study, almost one-third of surgical ASD patients were consuming opioids both pre- and postoperatively world-wide. There were marked international variations, with patients from Asia having a much lower usage rate, suggesting a cultural influence. Despite both opioid users and nonusers benefitting from surgery, preoperative opioid use was strongly associated with significantly more back pain at baseline that persisted at 2-year follow up, as well as persistent postoperative opioid needs.

Association between clinical biomechanical metrics of cervical spine function and pain or disability in people with neuromusculoskeletal neck pain: Protocol for a systematic review and planned meta-analysis.

Neck pain is a burdensome condition associated with pain, disability, and economic cost. Neck pain has been associated with observable changes in neuromuscular function and biomechanics. Prior research shows impairments in kinematic control, including reduced mobility, velocity, and smoothness of cervical motion. However, the strength of association between these impairments and patient-reported pain and disability is unclear rendering development of novel and relevant rehabilitation strategies difficult. The aim of this systematic review is to synthesize existing evidence on the strength of association between clinical biomechanical metrics of neck function (ROM, strength, acceleration, accuracy, smoothness, etc.) and patient-reported neck pain and disability. This protocol follows Cochrane guidelines and adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). MEDLINE, EMBASE, CINAHL, SPORTDiscus, Web of Science and Scopus will be searched, along with the gray literature, up to 20 November 2023, using terms and keywords derived from initial scoping searches. Observational studies, including cohorts and cross-sectional studies, that explore associations between clinical biomechanics of the neck and patient-reported outcomes of neck pain or disability will be included. Two reviewers will independently perform study selection, data extraction, and risk of bias assessment (National Institute of Health tool). Data will be synthesized using either a random effects meta-analytic approach or qualitatively using a modified Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, dependent on the homogeneity of data available. This review addresses a gap in the literature by systematically synthesizing findings on the relationship between neck function impairments and patient-reported outcomes. It will identify priorities for neck pain rehabilitation and gaps in current knowledge. The results of this review will be disseminated through a peer-reviewed publication, conference presentation, and lay language summaries posted on an open-access website. PROSPERO Registration number: CRD42023417317. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023417317.

The influence of depression on clinical outcomes of total shoulder arthroplasty: a systematic Review.

Much of the current literature on total shoulder arthroplasty (TSA) has assessed the impact of preoperative medical comorbidities on postoperative clinical outcomes. The literature concerning the impact of psychological disorders such as depression on TSA has increased in popularity in recent years, but there lacks a thorough review of the influence of depression on postoperative pain and functional outcomes. We queried PubMed/MEDLINE and identified six clinical studies that evaluated the influence of a psychiatric diagnosis of depression on patient outcomes after TSA. Studies that discussed the impacts of depression on TSA, including PROs or adverse events in adults, were included. Studies focused on other psychologic pathology, non-TSA shoulder treatments, or TSA not for primary osteoarthritis were excluded. Non-clinical studies, systematic reviews, letters to the editor, commentaries, dissertations, books, and book chapters were excluded. Three cohort studies described patient-reported pain and functional outcomes and three database studies assessed the risk of postoperative complications. Cohort studies demonstrated that the prevalence of depression in patients undergoing TSA decreased from preoperatively to 12-months postoperatively. Two studies demonstrated that depression is an independent predictor of less pre- to postoperative improvement in the ASES score at minimum 2-year follow-up; however, one study found the difference between patients with and without depression did not exceed the minimum clinically important difference. Database studies demonstrated that depression was associated with higher rates of blood transfusion (n = 1, OR = 1.8), anemia (n = 1, OR = 1.65), wound infection (n = 2, OR = 1.41-2.09), prosthetic revision (n = 1, OR = 1.92), and length of hospital stay (n = 3, LOS = 2.5-3days). Although patients with a preoperative diagnosis of depression undergoing TSA can achieve satisfactory relief of shoulder pain and restoration of function, they may experience poorer patient-reported outcomes and a higher risk of postoperative adverse events compared to their peers. Surgeons should be cognizant of the influence of depression in their patients to facilitate proper patient selection that maximizes patient satisfaction, function, and minimizes the risk of adverse events following TSA. Level IV.

Pain control is comparable between opioid versus non-opioid management after otolaryngology procedures.

The current study aims to measure patient-reported satisfaction with pain control using opioid and non-opioid medications after undergoing the following otolaryngology procedures: parathyroidectomy, thyroid lobectomy, total thyroidectomy, and bilateral tonsillectomy. A prospective cohort study was performed at an academic medical center that included a telephone questionnaire and chart review. Opioid prescriptions, usage, and patient-reported pain outcomes were recorded. Bivariate analyses were used to compare opioid and non-opioid users. Of the 107 total patients undergoing otolaryngology procedures included in the study, 49 (45.8%) used an opioid for pain management postoperatively and 58 (54.2%) did not. Among the 81 patients who underwent endocrine procedures (parathyroidectomy, total thyroidectomy/lobectomy), most patients reported being "very satisfied" or "satisfied" with pain control whether they used opioids (n = 27/30, 90%) or not (n = 50/51, 98%). Of the 26 patients who underwent bilateral tonsillectomy, 19 (73%) were prescribed opioids and among these, most (n = 17/19, 89%) reported they were "very satisfied" or "satisfied" with pain control. In the non-opioid usage group, all patients (n = 7/7, 100%) reported they were "satisfied" with pain control. There was no statistically significant difference in patient-reported satisfaction with pain control between opioid and non-opioid users for any of the procedures listed. The results of our study suggest that patients who did not use opioids have a similar level of satisfaction with pain control compared to those using opioids after thyroid, parathyroid and tonsillectomy surgeries. Considering the magnitude of the opioid crisis, providers should reassess the need for opioid prescriptions following certain ENT procedures. IV.

Gastrocnemius Release in the Treatment of Achilles Tendinopathy: A Systematic Review.

The aim of this study is to evaluate the use of isolated gastrocnemius release in the treatment of Achilles tendinopathy. The primary outcome is the change in patient-reported pain outcomes. Secondary outcomes include the change in patient-reported foot and ankle function, ankle range of motion and strength, patient satisfaction and rate of surgical complications. A systematic review was undertaken of studies involving patients treated with an isolated gastrocnemius release for Achilles tendinopathy. Randomised controlled trials, cohort studies, case-control studies and case series were eligible and identified from the following databases: MEDLINE and EMBASE. Isolated gastrocnemius release results in improved patient-reported outcome scores for pain and foot and ankle function. There is an increase in ankle range of motion but a reduction in ankle strength. Patients report a high rate of overall satisfaction. The most common surgical complications are sural nerve injury and wound infection. Isolated gastrocnemius release may offer maintained and clinically meaningful improvements in pain and foot and ankle function with an associated reduction in ankle strength.

Is Postoperative Splinting Advantageous After Upper Extremity Fracture Surgery? Results From the Arm Splint Pain Improvement Research Experiment.

The authors report no conflict of interest.To determine if short-term immobilization with a rigid long arm plaster elbow splint after surgery of the arm, elbow, or forearm results in superior outcomes compared with a soft dressing with early motion. Prospective Randomized Control Trial. Academic Medical Center. Patients undergoing operative treatment for a mid-diaphysis or distal humerus, elbow, or forearm fracture were consented and randomized according to the study protocol for postoperative application of a rigid elbow splint (10-14 days in a plaster Sugar Tong Splint for forearm fracture or a Long Arm plaster Splint for 10-14 for all others) or soft dressing and allowing immediate free range of elbow and wrist motion (range of motion [ROM]). Self-reported pain (visual analog score or VAS), Healthscale (0-100, 100 denoting excellent health), and physical function (EuroQol 5 Dimension or EQ-5D) surveyed on postoperative days 1-5 and 14 were compared between groups. Patient-reported pain score (0-10, 10 denoting highest satisfaction) at week 6, time to fracture union, ultimate disabilities of the arm, shoulder, and hand score, and elbow ROM were also collected for analysis. Incidence of complications were assessed. Hundred patients (38 men to 62 women with a mean age of 55.7 years) were included. Over the first 5 days and again at postop day 14, the splint cohort reported a higher "Healthscale" from 0 to 100 than the nonsplint group on all study days ( P = 0.041). There was no difference in reported pain between the 2 study groups over the same interval ( P = 0.161 and 0.338 for least and worst pain, respectively), and both groups reported similar rates of treatment satisfaction ( P = 0.30). Physical function ( P = 0.67) and rates of wound problems ( P = 0.27) were similar. Additionally, the mean time to fracture healing was similar for the splint and control groups (4.6 ± 2.8 vs. 4.0 ± 2.2 months, P = 0.34). Ultimate elbow ROM was similar between the study groups ( P = 0.48, P = 0.49, P = 0.61, and P = 0.51 for elbow extension, flexion, pronation, and supination, respectively). Free range of elbow motion without splinting produced similar results compared with elbow immobilization after surgical intervention for a fracture to the humerus, elbow, and forearm. There was no difference in patient-reported pain outcomes, wound problems, or elbow ROM. Immobilized patients reported slightly higher "healthscale" ratings than nonsplinted patients and, however, reported similar rates of satisfaction. Both treatment strategies are acceptable after upper extremity fracture surgery. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Race-Based Differences in the Response to a Mindfulness Based Integrative Medical Group Visit Intervention for Chronic Pain.

Chronic pain is one of the most common drivers of healthcare utilization and a marked domain for health disparities, as African American/Black populations experience high rates of chronic pain. Integrative Medical Group Visits (IMGV) combine mindfulness techniques, evidence-based integrative medicine, and medical group visits. In a parent randomized controlled trial, this approach was tested as an adjunct treatment in a diverse, medically underserved population with chronic pain and depression. To determine race-based heterogeneity in the effects of a mindfulness based treatment for chronic pain. This secondary analysis of the parent trial assessed heterogeneity of treatment effects along racialized identity in terms of primary patient-reported pain outcomes in a racially diverse sample suffering from chronic pain and depression. The analytic approach examined comorbidities and sociodemographics between racialized groups. RMANOVAs examined trajectories in pain outcomes (average pain, pain severity, and pain interference) over three timepoints (baseline, 9, and 21weeks) between participants identifying as African American/Black (n = 90) vs White (n = 29) across both intervention and control conditions. At baseline, African American/Black participants had higher pain severity and had significantly different age, work status, and comorbidity profiles. RMANOVA models also identified significant race-based differences in the response to the parent IMGV intervention. There was reduced pain severity in African American/Black subjects in the IMGV condition from baseline to 9weeks. This change was not observed in White participants over this time period. However, there was a reduction in pain severity in White participants over the subsequent interval from 9 to 21week where IMGV had no significant effect in African American/Black subjects during this latter time period. Interactions between pain and racialization require further investigation to understand how race-based heterogeneity in the response to integrative medicine treatments for chronic pain contribute to the broader landscape of health inequity.

Outcomes and Proportions of Subsequent Contralateral Sports Hernia Repair Following Primary Unilateral Repair.

In the event that nonoperative treatment for sports hernia fails, surgical repair may be warranted. Bilateral repair can occur in up to 45% of surgically treated patients. To investigate the clinical outcomes of athletes who underwent unilateral sports hernia repair and determine the proportion of patients who required contralateral sports hernia repair. Case series; Level of evidence, 4. We identified patients at our institution who underwent primary unilateral sports hernia repair (rectus abdominis-adductor longus aponeurotic plate repair and adductor lengthening) with a single surgeon between 2015 and 2020. We assessed patient-reported outcomes using the Hip Outcome Score-Sport (HOS-Sport), the Numeric Pain Rating Scale, and an internally developed return-to-play questionnaire. We further collected data regarding subsequent sports hernia procedures on the ipsilateral or contralateral side. We calculated summary statistics for outcomes and examined the association between preinjury patient characteristics and the HOS-Sport score at follow-up or successful return to preinjury sport using linear and logistic regression, respectively. A total of 104 of 128 (81.3%) eligible patients (mean age at surgery, 23.0 ± 6.2 years; 94.2% male; 51.9% American football athletes) completed follow-up at a mean time of 4.4 ± 1.5 years. Overall, 79.8% of athletes (n = 83) were able to return to their preinjury sport/activity, but 90.2% (83/92) who attempted to return were able to do so. When examining reasons for not returning to preinjury sport, only 9 patients reported not returning to preinjury sport because of limitations or persistent symptoms from their original injury. Only 4 patients underwent subsequent sports hernia procedures (3 contralateral, 1 ipsilateral revision) after their index unilateral sports hernia repair. At follow-up, the mean HOS-Sport score was high (94.0 ± 10.8), and the mean Numeric Pain Rating Scale score was low (0.31 ± 1.26). There were no preinjury patient characteristics associated with either the HOS-Sport score at follow-up or the successful return to preinjury sport. Patients with unilateral sports hernia symptoms can undergo repair and return to sport at the preinjury level with little concern for injuries to the contralateral groin. In our cohort, patient-reported hip function and pain outcomes at follow-up were excellent.

Zanidatamab (zani) in previously treated HER2+ biliary tract cancer (BTC): Impact on patient-reported pain outcomes in the phase 2b HERIZON-BTC-01 study.

450 Background: The HER2 bispecific antibody zani showed rapid, durable responses and a manageable safety profile in patients with HER2+ BTC in the pivotal HERIZON-BTC-01 study. Here we report pain outcomes and opioid use for patients in this trial. Methods: HERIZON-BTC-01 (NCT04466891), an ongoing, open-label, Phase 2b study, is assessing zani (20 mg/kg IV Q2W) in patients with HER2+ (gene amplification and immunohistochemistry 2+ or 3+ [Cohort 1] and 0 or 1+ [Cohort 2]), locally advanced, unresectable or metastatic BTC (gallbladder cancer, intra-/extra-hepatic cholangiocarcinoma) who received prior gemcitabine-containing treatment (tx). Exploratory endpoints assessed at baseline (BL) and every 8 weeks included the Brief Pain Inventory short form, the visual analog scale (VAS), and analgesic opioid use. Results: Of the 80 patients with HER2+ BTC in Cohort 1 who were assessed for primary efficacy (median age 64 yrs; 56% female), 1 (1%) had complete response (CR), 32 (40%) partial response (PR), 22 (28%) stable disease (SD), and 24 (30%) progressive disease (PD); 1 patient was not evaluable. Responders (CR or PR) generally reported improved pain scores and less pain interference with activities of daily living. Patients with PD generally had worsening pain scores and pain interference by time of best on tx score (BONT) (Table). Overall, patients who responded to zani reported improved quality of life (VAS scores) vs BL. Fewer patients with CR (0.0%; n=1) and PR (3.1%; n=32) increased opioid use overall post-BL vs patients with SD (9.1%; n=22) or PD (34.8%; n=23). Conclusions: Patients with HER2+ BTC who responded to zani reported less pain and pain interference compared with BL, further supporting the development of zani as a tx option for these patients, with the goal of improving patient outcomes. Clinical trial information: NCT04466891 . [Table: see text]

Internet-delivered lifestyle physical activity intervention for cognitive processing speed in multiple sclerosis

BackgroundWe propose a randomized controlled trial(RCT) of a Social Cognitive Theory-based(SCT), Internet-delivered behavioral intervention targeting lifestyle physical activity(LPA) for yielding improvements in cognitive processing speed(CPS), learning and memory(L/M), symptoms, and quality of life(QOL) among persons with mild multiple sclerosis(MS)-related ambulatory impairment who have impaired CPS. Methods/designThe study involves a Phase-II, parallel group, RCT design. Participants with MS(N = 300) will be randomly assigned on an equal basis(1:1) into behavioral intervention(n = 150) or attention and social contact control(n = 150) conditions. The conditions will be administered over 6-months by trained behavior coaches who will be uninvolved in screening, recruitment, random assignment, and outcome assessment. We will collect outcome data remotely every 6-months over the 12-month period(baseline, immediate follow-up, and 6-month follow-up) using a treatment blinded assessor. The primary outcome is the raw, oral Symbol Digit Modalities Test as a neuropsychological measure of CPS. The secondary outcomes include the California Verbal Learning Test-II as an objective measure of L/M, and patient-reported outcomes of fatigue, depressive symptoms, anxiety, pain, and QOL. The tertiary outcome is accelerometry as an objective, device-based measure of steps/day for generating a minimal clinically important difference(MCID) value that guides the prescription of LPA for improving CPS in clinical practice. The primary data analyses will involve intent-to-treat principles, and mixed-effects models and logistic regression. DiscussionIf successful, the proposed study will provide Class I evidence for the efficacy of a theory-based, Internet-delivered behavioral intervention focusing on LPA for improving CPS and mitigating its negative impact on other outcomes in persons with MS.Clinicaltrials.gov: NCT04518657

Evaluating and improving the usability of a mHealth platform to assess postoperative dental pain.

The use of interactive mobile health (mHealth) applications to monitor patient-reported postoperative pain outcomes is an emerging area in dentistry that requires further exploration. This study aimed to evaluate and improve the usability of an existing mHealth application. The usability of the application was assessed iteratively using a 3-phase approach, including a rapid cognitive walkthrough (Phase I), lab-based usability testing (Phase II), and in situ pilot testing (Phase III). The study team conducted Phase I, while providers and patients participated in Phase II and III. The rapid cognitive walkthrough identified 23 potential issues that could negatively impact user experience, with the majority classified as system issues. The lab-based usability testing yielded 141 usability issues.; 43% encountered by patients and 57% by dentists. Usability problems encountered during pilot testing included undelivered messages due to mobile phone carrier and service-related issues, errors in patients' phone number data entry, and problems in provider training. Through collaborative and iterative work with the vendor, usability issues were addressed before launching a trial to assess its efficacy. The usability of the mHealth application for postoperative dental pain was remarkably improved by the iterative analysis and interdisciplinary collaboration.

Patient Interaction With the Health Care System Following a Nonopioid Discharge Strategy for Anterior Urethroplasty.

Continued efforts have been made to minimize postoperative opioids following urologic interventions. Studies show that patient-reported pain outcomes are similar between those patients discharged with and without opioids following anterior urethroplasty, but we do not know what impact this has on health care utilization. We aim to show that a nonopioid discharge following anterior urethroplasty does not increase postoperative health care utilization. Five hundred patients who underwent anterior urethroplasty from January 2016 to October 2022 were identified from retrospective chart review. Patient demographic information, surgical characteristics, and postoperative interactions with the health care system were extracted from the electronic medical record. We then compared these outcomes by discharge opioid prescription status. A total of 253 patients were discharged without an opioid prescription. Patients who received an opioid were more likely to have had a perineal incision (73% vs 64%, P = .02), more likely to have had an overnight hospital stay (30% vs 14%, P < .01), and were more likely to have been prescribed an opioid preoperatively (13% vs 7%, P = .03). There were overall low rates of interaction with the health system in both groups with no significant difference in 30-day unplanned office visits, emergency department visits, or office phone calls. Overall, by the end of our study period 97% were discharged without an opioid and 94% of patients were discharged the same day. Patients undergoing anterior urethroplasty can safely be discharged home without opioids following surgery without undue postoperative burden on the health care system.

Effectiveness and safety of vedolizumab induction with or without budesonide in patients with moderately to severely active Crohn’s disease in Europe: a retrospective observational study

BackgroundVedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking integrin antibody, is effective in treating patients with moderately to severely active Crohn’s disease (CD). In this study, we examined the real-world effectiveness and safety of induction therapy using VDZ alone or in combination with budesonide (VDZ + BUD) among patients with CD in Belgium, Israel, and Switzerland.MethodsThis retrospective chart review analysis included adult patients with moderately to severely active CD who started induction treatment with VDZ or VDZ + BUD (January 2015 through January 2019). The primary objective of this study was to assess the effectiveness in terms of clinical remission of VDZ alone or VDZ + BUD using patient-reported outcomes (PRO) of abdominal pain (AP) and/or loose stool frequency (LSF) (PRO-2) at weeks 0, 2, 6, 10, and 14. Regression models were used to assess differences and associations between the treatment groups.ResultsOverall, 123 patients were included (VDZ, n = 73; VDZ + BUD, n = 50). Clinical remission rates at week 14 were 71.4% (50/70) and 68.0% (34/50) with VDZ and VDZ + BUD, respectively. Mean percentage change in AP and LSF from baseline to week 14 was comparable between the groups. Median (95% confidence interval [CI]) time to clinical remission was 91 [70.0–98.0] and 95 [70.0–98.0] days, respectively. One patient in each group discontinued VDZ and 68.0% of patients in the VDZ + BUD group discontinued BUD before week 14. The rates of overall adverse events were similar between the groups (VDZ, 23.3%; VDZ + BUD, 26.0%).ConclusionsIn this retrospective study, VDZ alone and VDZ + BUD showed similar high remission rates in patients with moderately to severely active CD. Prospective randomized studies are needed to conclude on the role of combining VDZ with BUD.Trial registrationNot applicable.

The Impact of Diabetes Mellitus on Patient-Reported Outcomes of Chronic Low Back Pain with Modic Changes at One Year: A Prospective Cohort Study.

Prospective cohort study. Diabetes mellitus (DM) is associated with unfavourable patient-reported outcomes after spine surgery. Chronic low back pain (CLBP) with Modic Changes (MCs) in the lumbar vertebrae, as observed on MRI, forms a specific subgroup. This study aims to investigate the potential influence of DM on CLBP with MCs. This study involved 259 patients with CLBP accompanied MCs. We recorded the patient-reported outcomes (visual analogue scale (VAS), Oswestry Disability Index (ODI), and Roland-Morris Disability Questionnaire (RMDQ)) at baseline, 3, 6, and 12months. Multivariable linear regression analyses were performed to determine predictors of patient-reported outcomes. 103 patients had DM. Patients with DM exhibited higher VAS (P < .05), ODI (P < .001), and RMDQ (P < .001) scores at 3, 6, and 12months, while patients without DM experienced more significant improvements in the scores over time (P < .001). Patients with DM reported longer durations of physical exercise (P = .007). Additionally, patients without DM had a significantly higher patient satisfaction index (P < .001) and a lower prevalence of hypertension (P < .001). Notably, significant differences were observed in the distribution of MCs of lumbar vertebrae (P = .034) and Pfirrmann grades of intervertebral disc degeneration between two groups (P < .001). Patients with DM demonstrated poorer patient-reported outcomes compared to those without DM in 1-year. DM emerged as an independent predictor of adverse patient-reported outcomes. It can be utilized to enhance the management and treatment of CLBP in patients with MCs.

S1163 Impact of Tofacitinib Maintenance Therapy on Key Ulcerative Colitis Patient-Reported Outcomes of Fatigue, Urgency, Abdominal Pain, and Sexual Dysfunction Using IBDQ and SF-36 Individual Items as Proxies

S1163 Impact of Tofacitinib Maintenance Therapy on Key Ulcerative Colitis Patient-Reported Outcomes of Fatigue, Urgency, Abdominal Pain, and Sexual Dysfunction Using IBDQ and SF-36 Individual Items as Proxies

The Association of Cannabis Use After Discharge From Surgery With Opioid Consumption and Patient-reported Outcomes.

To compare outcomes of patients using versus not using cannabis as a treatment for pain after discharge from surgery. Cannabis is increasingly available and is often taken by patients to relieve pain. However, it is unclear whether cannabis use for pain after surgery impacts opioid consumption and postoperative outcomes. Using Michigan Surgical Quality Collaborative registry data at 69 hospitals, we analyzed a cohort of patients undergoing 16 procedure types between January 1, 2021, and October 31, 2021. The key exposure was cannabis use for pain after surgery. Outcomes included postdischarge opioid consumption (primary) and patient-reported outcomes of pain, satisfaction, quality of life, and regret to undergo surgery (secondary). Of 11,314 included patients (58% females, mean age: 55.1 years), 581 (5.1%) reported using cannabis to treat pain after surgery. In adjusted models, patients who used cannabis consumed an additional 1.0 (95% CI: 0.4-1.5) opioid pills after surgery. Patients who used cannabis were more likely to report moderate-to-severe surgical site pain at 1 week (adjusted odds ratio: 1.7, 95% CIL 1.4-2.1) and 1 month (adjusted odds ratio: 2.1, 95% CI: 1.7-2.7) after surgery. Patients who used cannabis were less likely to endorse high satisfaction (72.1% vs 82.6%), best quality of life (46.7% vs 63.0%), and no regret (87.6% vs 92.7%) (all P < 0.001). Patient-reported cannabis use, to treat postoperative pain, was associated with increased opioid consumption after discharge from surgery that was of clinically insignificant amounts, but worse pain and other postoperative patient-reported outcomes.