Patient-reported Outcomes In Patients Research Articles

Enthesitis and Dactylitis Resolution with Risankizumab for Active Psoriatic Arthritis: Integrated Analysis of the Randomized KEEPsAKE 1 and 2 Trials.

The presence (vs absence) of enthesitis/dactylitis is associated with greater psoriatic arthritis (PsA) activity and reduced health-related quality of life. Risankizumab, an interleukin 23 antagonist, demonstrated superior treatment efficacy over placebo in patients with PsA, including enthesitis/dactylitis. Herein, we report the efficacy of risankizumab on complete resolution of enthesitis and/or dactylitis and improvements in patient-reported outcomes in patients with PsA. This integrated post hoc analysis of data from KEEPsAKE 1 and KEEPsAKE 2 included patients with baseline enthesitis (Leeds Enthesitis Index > 0) and/or dactylitis (Leeds Dactylitis Index > 0). Efficacy outcomes at weeks 24 and 52 included proportion of patients achieving enthesitis and/or dactylitis resolution and minimal clinically important differences (MCID) in pain, Health Assessment Questionnaire-Disability Index, and Functional Assessment of Chronic Illness Therapy-Fatigue. Of 1407 patients, approximately 63%, 28%, and 20% had baseline enthesitis, dactylitis, and both enthesitis/dactylitis, respectively. At week 24, higher response rates were observed for risankizumab vs placebo for resolution of enthesitis, dactylitis, and both enthesitis/dactylitis (differences of 13.9%, 16.9%, and 13.3%, respectively; p < 0.05). By week 52, risankizumab treatment resulted in complete resolution of enthesitis, dactylitis, and both enthesitis and dactylitis in 55.0%, 76.1%, and 52.3% of patients; similar resolution rates occurred among patients who switched from placebo to risankizumab. Among risankizumab-treated patients who achieved resolution of enthesitis and/or dactylitis, MCIDs were also attained in patient-reported pain, disability, and fatigue at week 24 (all p < 0.05; except fatigue in patients with resolution of both enthesitis/dactylitis); responses were sustained through week 52. Higher proportions of risankizumab-treated (vs placebo-treated) patients achieved enthesitis and/or dactylitis resolution and meaningful improvements in patient-reported outcomes at week 24 and generally sustained responses at week 52. Thus, risankizumab may result in sustained alleviation of PsA-related pathognomonic musculoskeletal lesions of enthesitis/dactylitis. NCT03675308, and NCT03671148.

Impact and timing of pulmonary rehabilitation in patients undergoing bronchoscopic lung volume reduction with endobronchial valves: A multicentre randomized controlled trial in patients with severe emphysema.

Both bronchoscopic lung volume reduction with endobronchial valves (BLVR-EBV) and pulmonary rehabilitation (PR) are effective treatments for improving exercise capacity and patient-reported outcomes in patients with severe Chronic Obstructive Pulmonary Disease (COPD). According to current recommendations, all BLVR-EBV patients should have undergone PR first. Our aim was to study the effects of PR both before and after BLVR-EBV compared to BLVR-EBV alone. We included patients with severe COPD who were eligible for BLVR-EBV and PR. Participants were randomized into three groups: PR before BLVR-EBV, PR after BLVR-EBV or BLVR-EBV without PR. The primary outcome was change in constant work rate cycle test (CWRT) endurance time at 6-month follow-up of the PR groups compared to BLVR-EBV alone. Secondary endpoints included changes in 6-minute walking test, daily step count, dyspnoea and health-related quality of life. Ninety-seven participants were included. At 6-month follow-up, there was no difference in change in CWRT endurance time between the PR before BLVR-EBV and BLVR-EBV alone groups (median: 421 [IQR: 44; 1304] vs. 787 [123; 1024] seconds, p = 0.82) or in any of the secondary endpoints, but the PR after BLVR-EBV group exhibited a smaller improvement in CWRT endurance time (median: 107 [IQR: 2; 573], p = 0.04) and health-related quality of life compared to BLVR-EBV alone. The addition of PR to BLVR-EBV did not result in increased exercise capacity, daily step count or improved patient-reported outcomes compared to BLVR-EBV alone, neither when PR was administered before BLVR-EBV nor when PR was administered after BLVR-EBV.

Postoperative Negative Pain Thoughts and Their Correlation With Patient-Reported Outcomes After Arthroscopic Rotator Cuff Repair: An Observational Cohort Study.

Pain and pain perception are influenced by patients' thoughts. The short form Negative Pain Thoughts Questionnaire (NPTQ-SF) can be used to quantify unhelpful negative cognitive biases about pain, but the relationship between NPTQ-SF scores and orthopaedic surgery outcomes is not known. The purpose was to assess the relationship between negative pain thoughts, as measured by the NPTQ-SF, and patient-reported outcomes in patients undergoing arthroscopic rotator cuff repair, as well as to compare NPTQ-SF scores and outcomes between patients with and without a history of chronic pain and psychiatric history. It was hypothesized that patients with worse negative pain thoughts would have worse patient-reported outcomes. Cohort study; Level of evidence, 2. In total, 109 patients undergoing arthroscopic rotator cuff repair were administered the 4-item NPTQ-SF, 12-item Short Form Health Survey (SF-12), American Shoulder and Elbow Surgeons (ASES) Shoulder Evaluation Form, and visual analog scale pain survey preoperatively between July 2021 and August 2022. The same surveys were completed ≥6 months postoperatively by 74 patients confirmed to have undergone arthroscopic rotator cuff repair. Preoperative NPTQ-SF scores did not show any correlation with the postoperative patient-reported outcomes measured in this study. Postoperative NPTQ-SF scores were statistically significantly negatively correlated with postoperative SF-12 Physical Health Score, SF-12 Mental Health Score, ASES, and satisfaction scores (P < .05). Postoperative NPTQ-SF scores were statistically significantly positively correlated with postoperative visual analog scale scores (P < .001). Moreover, postoperative NPTQ-SF scores were statistically significantly negatively correlated with achieving a Patient Acceptable Symptom State and the minimal clinically important difference on the postoperative ASES form (P < .001 and P = .009, respectively). Postoperative patient thought patterns and their perception of pain are correlated with postoperative outcomes after rotator cuff repair. This correlation suggests a role for counseling and expectation management in the postoperative setting. Conversely, preoperative thought patterns regarding pain, as measured by the NPTQ-SF, do not correlate with postoperative patient-reported outcome measures. Therefore, the NPTQ-SF should not be used as a preoperative tool to aid the prediction of outcomes after rotator cuff repair.

Mapping the Evidence on the Impact of mHealth Interventions on Patient-Reported Outcomes in Patients With Breast Cancer: A Systematic Review.

To comprehensively synthesize the existing evidence concerning mHealth interventions for patients with breast cancer (BC). On July 30, 2023, we searched PubMed, PsycINFO, and Google Scholar for articles using the following inclusion criteria: evaluation of mHealth interventions in patients with cancer, at least 30 participants with BC, randomized control trials or prospective pre-post studies, determinants of health (patient-reported outcomes [PROs] and quality of life [QoL]) as primary outcomes, interventions lasting at least 8 weeks, publication after January 2015. Publications were excluded if they evaluated telehealth or used web-based software for desktop devices only. The quality of the included studies was analyzed with the Cochrane Collaboration Risk of Bias Tool and the Methodological Index for Non-Randomized Studies. We included 30 studies (20 focused on BC), encompassing 5,691 patients with cancer (median 113, IQR, 135.5). Among these, 3,606 had BC (median 99, IQR, 75). All studies contained multiple interventions, including physical activity, tailored information for self-management of the disease, and symptom tracker. Interventions showed better results on self-efficacy (3/3), QoL (10/14), and physical activity (5/7). Lifestyle programs (3/3), expert consulting (4/4), and tailored information (10/11) yielded the best results. Apps with interactive support had a higher rate of positive findings, while interventions targeted to survivors showed worse results. mHealth tools were not available to the public in most of the studies (17/30). mHealth interventions yielded heterogeneous results on different outcomes. Identifying lack of evidence on clinical scenarios (eg, patients undergoing systemic therapy other than chemotherapy) could aid in refining strategic planning for forthcoming research endeavors within this field.

Having More Tender Than Swollen Joints Is Associated With Worse Patient-Reported Outcomes in Patients With Early RA.

In patients with rheumatoid arthritis (RA), high tender-swollen joint differences (TSJDs) have been associated with worse outcomes. A better understanding of the phenotype and impact of high TSJD on patient-reported outcomes (PROs) in early RA may lead to earlier personalized treatment targeting domains that are important to patients today. Our objectives were to evaluate the impact of TSJD on updated PROs in patients with early RA over 1 year and to determine differences in associations by joint size. This longitudinal cohort study followed patients with active, early RA enrolled in the Canadian Early Arthritis Cohort between 2016 and 2022, who completed clinical assessments and PROMIS-29 measures over 1 year. Twenty-eight joint counts were performed and TSJDs calculated. Adjusted associations between TSJD and PROMIS-29 scores were estimated using separate linear-mixed models. Separate analyses of large versus small-joint TJSDs were performed. Patients with early RA (n = 547; 70% female; mean [SD] age, 56 [15] years; mean [SD] symptom duration, 5.3 [2.9] months) were evaluated. A 1-point increase in TSJD was significantly associated with worse PROMIS T-scores in all domains: physical function (adjusted regression coefficient, -0.27; 95% confidence interval [CI], -0.39, -0.15), social participation (adjusted regression coefficient, -0.34; 95% CI, -0.50, -0.19), pain interference (adjusted regression coefficient, 0.49; 95% CI, 0.35, 0.64), sleep problems (adjusted regression coefficient, 0.29; 95% CI, 0.16, 0.43), fatigue (adjusted regression coefficient, 0.34; 95% CI, 0.18, 0.50), anxiety (adjusted regression coefficient, 0.23; 95% CI, 0.08, 0.38), and depression (adjusted regression coefficient, 0.20; 95% CI, 0.06, 0.35). Large-joint TSJD was associated with markedly worse PROs compared with small-joint TSJD. Elevated TSJD is associated with worse PROs particularly pain interference, social participation, and fatigue. Patients with more tender than swollen joints, especially large joints, may benefit from earlier, targeted therapeutic interventions.

Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial

Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction - General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

Impact of residual skin lesions and previous biologic treatment failure on patient-reported outcomes in patients with psoriasis receiving biologic treatment.

Recent advances in biologic treatments have made clear skin a realistic treatment goal for psoriasis. However, clear skin may not uniformly translate to an absence of impact on patients' quality of life. This retrospective observational study aimed to elucidate the factors influencing patient-reported outcomes in patients with psoriasis who have demonstrated successful clinician-reported outcomes on using biologics. A total of 96 patients who have achieved a ≥75% improvement in Psoriasis Area and Severity Index (PASI) scores with ≥6 months of biologic treatment were included. Their median PASI score was 0.4, with 37.5% having achieved PASI 100 (clear skin). Furthermore, 47.9% reported no impact of psoriasis on their quality of life (Dermatology Life Quality Index [DLQI] score 0 or 1), while 52.1% reported a negative impact (DLQI score ≥2). Notably, 28.1% of the participants had a history of biologic treatment failure, defined as the inability to achieve or sustain a 75% PASI improvement with the previously used biologic agent. Multivariable logistic regression analysis revealed a positive association between achieving PASI 100 and reporting no impact of psoriasis on quality of life (adjusted odds ratio [aOR] 3.88, 95% confidence interval [CI] 1.49-10.91, P = 0.007). Conversely, prior biologic treatment failure was negatively associated with reporting no impact of psoriasis on quality of life (aOR 0.13, 95% CI 0.02-0.65, P = 0.023). Furthermore, among patients with clear skin, those with experience of previous biologic treatment failure reported significantly lower quality of life than those without such experience (P = 0.033). In conclusion, minimal residual skin lesions and prior biologic treatment failure were associated with poorer patient-reported outcomes in patients with psoriasis. Opting for a biologic agent with the highest predicted efficacy, rather than pursuing a "step-up" approach with a higher possibility of treatment failure, may be a more suitable strategy in the biologic treatment of psoriasis.

Remote Symptom Monitoring Using Patient-Reported Outcomes in Patients With Chronic Kidney Disease: Process Evaluation of a Randomized Controlled Trial.

In Denmark, outpatient follow-up for patients with chronic kidney disease (CKD) is changing from in-hospital visits toward more remote health care delivery. The nonuse of remote patient-reported outcomes (PROs) is a well-known challenge, and it can be difficult to explain which mechanisms of interventions influence the outcome. Process evaluation may, therefore, be used to answer important questions on how and why interventions work, aiming to enhance the implications for clinical practice. This study aimed to provide insight into the intervention process by evaluating (1) the representativity of the study population, (2) patient and physician use patterns, (3) patient adherence to the intervention, and (4) clinical engagement. A process evaluation determining the reach, dose, fidelity, and clinical engagement was carried out, alongside a multicenter randomized controlled trial (RCT). We developed and implemented an intervention using PRO measures to monitor outpatients remotely. Data were collected for the PRO intervention arms in the RCT from 4 sources: (1) PRO data from the participants to determine personal factors, (2) the web-based PRO system to identify key usage intervention patterns, (3) medical records to identify clinical factors relating to the use of the intervention, and (4) semistructured interviews conducted with involved physicians. Of the 320 patients invited, 152 (47.5%) accepted to participate. The study population reflected the target population. The mean adherence rate to the PRO intervention arms was 82% (95% CI 76-87). The questionnaire response rate was 539/544 (99.1%). A minority of 13 (12.9%) of 101 patients needed assistance to complete study procedures. Physicians assessed 477/539 (88.5%) of the questionnaires. Contact was established in 417/539 (77.4%) of the cases, and 122/539 (22.6%) of the patients did not have contact. Physicians initiated 288/417 (69.1%) and patients requested 129/417 (30.9%) of all the contacts. The primary causes of contact were clinical data (242/417, 58%), PRO data (92/417, 22.1%), and medication concerns and precautionary reasons (83/417, 19.9%). Physicians found the use of PRO measures in remote follow-up beneficial for assessing the patient's health. The inclusion of self-reported clinical data in the questionnaire motivated physicians to assess patient responses. However, some barriers were emphasized, such as loss of a personal relationship with the patient and the risk of missing important symptoms in the absence of a face-to-face assessment. This study demonstrates the importance and practical use of remote monitoring among patients with CKD. Overall, the intervention was implemented as intended. We observed high patient adherence rates, and the physicians managed most questionnaires. Some physicians worried that distance from the patients made it unfeasible to use their "clinical glance," posing a potential risk of overlooking crucial patients' symptoms. These findings underscore key considerations for the implementation of remote follow-up. Introducing a hybrid approach combining remote and face-to-face consultations may address these concerns. ClinicalTrials.gov NCT03847766; https://clinicaltrials.gov/study/NCT03847766.

Clinical and patient-reported outcomes in patients with chronic hepatitis B and C and non-alcoholic fatty liver disease from real-world practices in Saudi Arabia, Turkey and Egypt.

Patients with chronic liver disease (CLD) experience health-related quality of life (HRQoL) and patient-reported outcomes (PROs) impairments. We assessed and identified predictors of HRQoL and PROs in CLD patients from Saudi Arabia (SA), Turkey and Egypt. Patients enrolled in Global Liver Registry™ with chronic hepatitis B (CHB), chronic hepatitis C (CHC) and non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) were included. Clinical data and PRO questionnaires (FACIT-F, CLDQ and WPAI) were compared across countries. Linear regression identified PRO predictors. Of the 4014 included patients, 26.9% had CHB, 26.9% CHC and 46.1% NAFLD/NASH; 19.2% advanced fibrosis. Compared across countries, CHB patients were younger in Egypt (mean age [years] 41.2 ± 11.4 vs. 45.0 ± 10.3 SA, 46.1 ± 12.0 Turkey), most often employed in SA (64.8% vs. 53.2% Turkey) and had the lowest prevalence of obesity in Turkey (26.7% vs. 37.8% SA, 38.5% Egypt). In SA, CHB patients had lowest prevalence of fibrosis and comorbidities (all p < .01). There was a higher frequency of males with NAFLD/NASH in SA (70.0% vs. 49.6% Turkey, and 35.5% Egypt). Among NAFLD/NASH patients, CLDQ-NAFLD/NASH scores were highest in SA (mean total score: 5.3 ± 1.2 vs. 4.8 ± 1.2 Turkey, 4.1 ± 0.9 Egypt, p < .01). Independent predictors of worse PROs included younger age, female sex, advanced fibrosis, non-hepatic comorbidities and lack of regular exercise (all p < .05). Clinical presentation and PRO scores of CLD patients vary across SA, Turkey and Egypt. Impairment of HRQoL is associated with demographic factors, lack of regular exercise, advanced fibrosis and non-hepatic comorbidities.

Correlation Between Serum and Fecal Biomarkers and Patient-Reported Outcomes in Patients with Crohn's Disease and Ulcerative Colitis.

Patient-reported outcomes (PROs), such as the short CD activity index (sCDAI) and partial Mayo Score (PMS), are used to define clinical remission in IBD, but may not represent the true degree of inflammation and endoscopy is invasive. Non-invasive testing options include c-reactive protein (CRP) and fecal calprotectin (FCP). The aim of this study was to assess the degree of correlation of non-invasive biomarkers with PROs and the impact other clinical variables can have on their levels. We reviewed data collected from the prospective cohort, Study of a Prospective Adult Research Cohort with IBD (SPARC-IBD), comprised of over 3000 patients from 17 tertiary referral centers. Demographic and clinical variables were analyzed by disease type, disease severity was based on PROs, and baseline CRP and FCP were measured. For comparative analysis, we performed Fisher's exact test and Welch's t test, where p < 0.05 was significant. 1547 patients were included; 63% had CD, 56% were female, with an average disease duration of 13.6years. CRP and FCP were associated with symptom severity in inflammatory CD. CRP was useful to differentiate symptoms across different disease locations in CD, whereas FCP was associated with symptom severity in Crohn's colitis only. For UC, FCP was able to distinguish symptom severity better in distal UC, whereas in extensive or pancolitis, it was useful only to distinguish severe symptoms from other categories of symptom severity. PROs correlate with CRP and FCP; however, disease location and phenotype impact their ability to distinguish symptom severity.

Effect of pedicle type on breast reduction: Clinical and patient-reported outcomes

PurposeThe choice of pedicle in reduction mammaplasty is highly variable with prior studies demonstrating high patient satisfaction in the majority. This study aims to examine the impact of pedicle type on clinical and patient-reported outcomes in patients undergoing reduction mammaplasty. MethodsA total of 588 patients underwent a bilateral reduction mammaplasty with a wise-pattern or modified-Robertson incision by 13 surgeons at a single institution. Clinical outcomes were compared according to pedicle type in all patients and BREAST-Q responders (32% response rate). Survey respondents were sub-grouped by resection volume and BREAST-Q satisfaction scores were compared. ResultsAmong all included reduction mammoplasties, 439 (75%) were performed using an inferior pedicle, and 149 (25% using a superior or superomedial pedicle. Responders and non-responders were similar in preoperative characteristics including age, body measurements, and comorbidities. While a higher incidence of infection occurred among responders, clinical outcomes were comparable across pedicle types. A total of 187 patients completed the BREAST-Q. Compared to the superior pedicle group, respondents with inferior pedicles reported higher nipple satisfaction, even when adjusted for resection weight over 500 grams. In contrast, the superior pedicle had sexual well-being scores, which persisted in resection weight less than 500 grams, (all p values < 0.05). ConclusionInferior pedicles were associated with greater nipple satisfaction and superior pedicles were associated with greater sexual satisfaction. Our findings suggest that those with resections less than 500 grams were more satisfied with superior pedicles whereas those with greater resections were more satisfied with inferior pedicles.

Preoperative opioid use is associated with worse two-year patient-reported outcomes after hand surgery: A retrospective cohort study

IntroductionOpioid overprescribing has caused a substantial increase in opioid related deaths and billions of dollars in additional healthcare costs. Orthopaedic surgeons commonly prescribe opioids in the perioperative period; however, research has shown preoperative opioid use may be associated with worse postoperative outcomes. Despite this body of evidence, there are few studies investigating the association between preoperative opioid use and two-year outcomes after hand surgery. Materials and methodsThis study evaluated two-year postoperative patient-reported outcomes in patients who used opioids prior to hand surgery, and those who did not. Patients completed pre and postoperative questionnaires including Patient-Reported Outcomes Measurement Information System (PROMIS) domains, the Brief Michigan Hand Questionnaire (BMHQ), and other questionnaires related to pain, function, and satisfaction. 342 patients undergoing upper-extremity surgery were enrolled into a prospective orthopaedic surgery outcome registry, and 69.9% completed the follow-up surveys. Preoperative opioid use and its association to patient outcome scores was analyzed through bivariate analysis. Significant associations were further tested by multivariable analysis to determine independent predictors. ResultsPreoperative opioid use was associated with worse two-year PROMIS Fatigue (p ​< ​.01), PROMIS Anxiety (p ​< ​.01), PROMIS Depression (p ​< ​.01), SSQ-8 (p ​= ​.01), BMHQ (p ​= ​.01), NPS Hand (p ​< ​.01) and MODEMS met expectations (p ​= ​.03). No significant differences were observed in patient-reported outcome change scores. Multivariable analysis demonstrated that preoperative opioid use was predictive of worse two-year PROMIS Fatigue (p ​< ​.01), PROMIS Anxiety (p ​< ​.01), PROMIS Depression (p ​= ​.02), BMHQ (p ​= ​.01), SSQ-8 (p ​< ​.01), NPS Hand (p ​= ​.02) and MODEMS met expectations (p ​< ​.01). ConclusionPreoperative opioid use was associated with worse patient-reported outcomes two years after elective hand surgery. There was no significant difference in the improvement from baseline between the two groups. Clinically significant differences were observed in follow-up PROMIS Anxiety, BMHQ and NPS – Hand scores. Clinically significant change scores were noted in both groups for PROMIS PF, PROMIS PI, PROMIS SS, BMHQ, and NPS – Hand.

A comparison of patient-reported outcomes in patients undergoing abdominal wall repair with either synthetic or biosynthetic mesh: a pilot study.

Repair of midline ventral incisional hernias (VIHR) requires mesh reinforcement. Mesh types can be categorised into synthetic, biosynthetic, or biological. There is a lack of evidence to support one type of mesh over another. The aim of this pilot study was to compare mesh sensation in patients having undergone elective open repair with synthetic or biosynthetic mesh. Four years of prospectively collected data were retrospectively reviewed on 40 patients who had undergone VIHR, using either biosynthetic or synthetic mesh placed in the retromuscular plane. The decision on type of mesh used was governed by patient characteristics. Patients were invited to complete the Carolinas Comfort Scale (CCS) questionnaire, the higher the score indicating a poorer quality of life. The maximum length of follow-up was 36months. Twenty patients received permanent synthetic and 20 biosynthetic mesh. There was no clinical evidence of hernia recurrence in either group in the short to medium term. Overall, 97% (39/40) patients reported an average of either no or mild symptoms (mean CCS score 17.9 of 115). Patients with a biosynthetic repair had a significant lower CCS at ≥ 18months (p < 0.05). After VIHR, patients have low CCS scores, indicating good quality of life outcomes, in the short to medium term irrespective of the mesh used. However, biosynthetic mesh had lower CCS scores in the medium term. This may help surgeons and patients make better informed decisions about which mesh to use in their individual circumstances.

Effects of COVID-19 vaccines on patient-reported outcomes in patients with inflammatory bowel disease: a multicenter survey study in Korea.

The impact of vaccination on inflammatory bowel disease (IBD) patients is still unknown, and no studies have assessed the changes in patient-reported outcomes (PROs) after vaccination in patients with IBD. Therefore, in this study, we investigated the impact of vaccines on the PROs of patients with IBD. We conducted a questionnaire survey of patients with IBD who visited outpatient clinics at 4 specialized IBD clinics of referral university hospitals from April 2022 to June 2022. A total of 309 IBD patients were included in the study. Patient information was collected from a questionnaire and their medical records, including laboratory findings, were reviewed retrospectively. Risk factors associated with an increase in PROs after COVID-19 vaccination were analyzed using logistic regression analyses. In addition, we assessed whether there were differences in variables by vaccine order using the linear mixed model. In multivariate analysis, young age ( < 40 years) and ulcerative colitis (UC) were found to be independent risk factors for aggravation of PROs in patients with IBD. In all patients, platelet count significantly increased with continued vaccination in multiple pairwise comparisons. In UC patients, PROs such as the short health scale, UC-abdominal signs and symptoms, and UC-bowel signs and symptoms were aggravated significantly with continued vaccination. There was no significant increase in the variables of patients with Crohn's disease. Therefore, there may be a need to counsel patients with IBD younger than 40 years of age, and patients with UC before they receive COVID-19 vaccinations.

Arthroscopic Bankart versus Open Latarjet; Short-to-Mid-Term Outcomes of Recurrence and Patient-Reported Outcomes in Patients with Recurrent Anterior Shoulder Dislocation

Objectives This retrospective comparative study compared the short to mid-term outcomes of arthroscopic Bankart repair and open Latarjet procedures in patients with recurrent anterior shoulder instability. Methods Patients who underwent either arthroscopic Bankart repair or open Latarjet procedures between 2008 and 2020, with at least one year of follow-up, were included. Arthroscopic Bankart repairs were performed on shoulders with minimal glenoid bone loss (&lt;15%), and the Latarjet procedure was performed if the preoperative computed tomography (CT) scan showed a 15% bone loss on the glenoid side or 30-40% humeral head bone loss. Their surgery results and patient-reported outcome measures (PROMs) were assessed using the Oxford Shoulder Score (OSS) and Shoulder Pain and Disability Index (SPADI). Results 133 patients were analyzed in Latarjet (n = 67) and Bankart groups (n = 66). Before surgery, the two groups of patients were similar regarding surgery side, hand dominance, education level, occupation difficulty level, and smoking (P&gt;0.05). However, Latarjet’s patients were younger (32 vs. 35, P=0.04), had a higher proportion of males (96% vs. 82%, P=0.01), and had a significantly shorter follow-up period (3.2 vs. 6.4 years, P&lt;0.001) than the Bankart group. There was no significant difference between the Latarjet and Bankart groups regarding the follow-up’s OSS score (37 vs. 36; P=0.94) and SPADI score (22 vs. 24, P=0.80). Dislocation was observed in only one patient (1.5%) in the Latarjet group (P=1.0). Subluxation was observed in 5 patients (7.5%) of the Latarjet group and three patients (4.5%) of the Bankart group (P=0.4). The overall instability rate was similar (P&gt;0.05). Conclusion Our findings suggest that both arthroscopic Bankart repair and open Latarjet are reliable techniques in short to mid-term follow-up based on the glenoid bone loss cut-off of 15%. Level of Evidence Therapeutic Level III

Prospective Outcomes of Noma Facial Reconstructive Surgery in Sokoto, Nigeria.

Background: Noma is a gangrenous infection of the face that results in severe facial deformity, occurring primarily in malnourished and impoverished populations. Objective: To assess clinician- and patient-reported outcomes (PROs) before and after reconstructive surgery for patients with noma in northwest Nigeria. Methods: Objective outcomes were recorded using the noma-specific NOITULP (nose, outer cheek, inner cheek, trismus, upper/lower lip, particularities) classification system. PROs were recorded using a locally developed tool. Postsurgical changes were assessed by Wilcoxon signed-rank testing. Linear regression was used to look for associated risk factors. The inter-rater reliability (IRR) of the NOITULP score was assessed using the weighted kappa statistic. Results: Forty-nine patients (median age 25 years, 71% male) underwent local/regional flap reconstruction and/or trismus release. Twelve complications were reported. Univariate analysis showed a 3.20 change in PRO score (95% confidence interval 0.59 to 5.81, p = 0.018) per kilogram the patient underwent at time of surgery. The NOITULP score improved from a presurgery median of 3.5 to 2.3 (p < 0.0001), however, the IRR was poor (kappa = 0.0894, p < 0.0001). The PRO score also improved from a median of 7.0 to 12.0 (p < 0.0001). Conclusions: Facial reconstructive surgery improves the NOITULP score and PROs in patients with noma in northwest Nigeria. Clinical Trial Registration: OCA017-63.

Association of Social Determinants with Patient-Reported Outcomes in Patients with Cancer.

Patient-reported outcome (PRO) scores have been utilized more frequently, but the relationship of PRO scores to determinants of health and social inequities has not been widely studied. Our goal was to determine the association of PRO scores with social determinants. All patients with a new cancer diagnosis who completed a PRO survey from 2020 to 2022 were included. The PRO survey recorded scores for depression, fatigue, pain interference and physical function. Higher depression, fatigue and pain scores indicated more distress. Higher physical condition scores indicated improved functionality. A total of 1090 patients were included. Married patients had significantly better individual PRO scores for each domain. Patients who were able to use the online portal to complete their survey also had better individual scores. Male patients and non-White patients had worse pain scores than female and White patients, respectively. Patients with prostate cancer had the best scores while patients with head and neck and lung cancer had the worst scores. PRO scores varied by cancer disease site and stage. Social support may act in combination with specific patient/tumor factors to influence PRO scores. These findings present opportunities to address patient support at institutional levels.

Psychometric validation of the Psoriasis Symptom Scale, Functional Assessment of Chronic Illness Therapy–Fatigue and pain‐Visual Analogue Scale in patients with generalized pustular psoriasis

AbstractBackgroundGeneralized pustular psoriasis (GPP) is a rare, chronic, inflammatory skin disease associated with considerable patient burden. The Psoriasis Symptom Scale (PSS), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT‐Fatigue) and pain‐Visual Analogue Scale (pain‐VAS) are patient‐reported outcomes (PROs) that have not yet been validated in patients with GPP.ObjectivesTo evaluate the psychometric properties of the PSS, FACIT‐Fatigue and pain‐VAS using data from Effisayil 1, a randomised trial of spesolimab in patients with moderate‐to‐severe GPP.MethodsInter‐item correlations and confirmatory factor analysis (CFA) were performed using Week 1 data. Internal consistency was assessed with Cronbach's α coefficient using baseline and Week 1 data. Test–retest reliability was assessed using intraclass correlation coefficients (ICCs); change data for the GPP Physician Global Assessment total score and pustulation subscore were used to define a stable population. Convergent validity was assessed at baseline and Week 1 using Spearman's rank‐order correlations. Known‐groups validity was measured by analysis of variance using Week 1 data. Ability to detect change from baseline to Week 1 was evaluated by analysis of covariance.ResultsInter‐item and item‐to‐total correlations were moderate or strong for most PSS and FACIT‐Fatigue items. CFA demonstrated the unidimensionality of the PSS and FACIT‐Fatigue, with high factor loadings for most items (PSS range, 0.75–0.94; FACIT‐Fatigue range, 0.11–0.93) and acceptable fit statistics. Both scores demonstrated internal consistency (Cronbach's α, 0.71 and 0.95, respectively). The PSS, FACIT‐Fatigue and pain‐VAS demonstrated test–retest reliability (ICCs ≥0.70) and good evidence of convergent validity. Furthermore, the PROs could differentiate between known groups of varying symptom severity (range, p &lt; 0.0001–0.0225) and detect changes in symptom severity from baseline to Week 1 (range, p &lt; 0.0001–0.0002).ConclusionsOverall, these results support the reliability, validity and ability to detect change of the PSS, FACIT‐Fatigue and pain‐VAS as PROs in patients with GPP.

Estimating meaningful change thresholds for Skin Pain-Numeric Rating Scale, Sleep-Numeric Rating Scale and Dermatology Life Quality Index in patients with prurigo nodularis.

Prurigo nodularis (PN) is characterized by intensely itchy nodules/lesions and skin pain, which can have a substantial impact on health-related quality of life (HRQoL). Treatment benefits on such symptoms and impacts are best assessed in trials using patient-reported outcome (PROs) instruments such as Skin Pain Numerical Rating Scale (NRS), Sleep-NRS and Dermatology Life Quality Index (DLQI). However, no guidance exists for interpreting meaningful changes in scores using these PROs in patients with PN. The main objective was to derive within-patient (responder definition) and between-group improvement thresholds for interpreting Skin Pain-NRS, Sleep-NRS and DLQI total scores in patients with PN. The measurement properties of the three PROs were also evaluated. Intention-to-treat (ITT), blinded and pooled data were used from the Phase 3 PRIME (NCT04183335) and PRIME2 (NCT04202679) studies evaluating the efficacy of dupilumab in adult patients with PN. Anchor- and distribution-based methods were applied to derive responder definition and between-group thresholds for Skin Pain-NRS, Sleep-NRS and DLQI. Data were additionally used to examine the instrument measurement properties, including reliability, validity and responsiveness. A total of 311 patients (mean age 49.5 years, 65.3% female) were included in the pooled ITT population. The within-patient improvement threshold for Skin Pain-NRS was estimated as 4.0 points, 2.0 points for Sleep-NRS and 9.0 points for DLQI total score. A 1.5-point improvement in Skin Pain-NRS scores, 1.0-point in Sleep-NRS and 4.0-point in DLQI indicated a between-group meaningful change. Adequate to good psychometric properties were demonstrated for all three instruments. The results of this study can aid interpretation of Skin Pain-NRS, Sleep-NRS and DLQI scores in patients with PN in both clinical trials and clinical practice to better understand and treat PN-related skin pain and the impact of PN on sleep quality and HRQoL.

Body mass index and sex and their effect on patient-reported outcomes following cartilage repair: an insight from the International Cartilage Regeneration and Joint Preservation Society Patient Registry

IntroductionChondral injuries in the knee, whether isolated or accompanying other injuries are found in as many as 60% of arthroscopic examinations. Although current research has identified negative outcomes for patients with a body mass index (BMI) >30kg/m2 undergoing chondral repair, our understanding of the relationship between presurgery BMI and postoperative patient-reported outcomes across all BMI categories remains lacking. ObjectivesThrough the International Cartilage Regeneration and Joint Preservation Society (ICRS) Patient Registry, this study aimed to explore this relationship, taking into account sex variations. MethodsThe ICRS Patient Registry was used to extract the data for this study. The outcomes in focus were the Knee Osteoarthritis Outcome Score (KOOS) and EQ-5D scores. Pearson and Spearman correlation methods were applied and the level of significance was set as α= 0.05. ResultsOf 3194 Registry patients at the time of data extraction, 1757 had undergone a surgical procedure, and 336 of these had complete KOOS or EQ-5D scores available for 6-week, 6-month, and 1-year postoperation. Analyses revealed that neither male (average BMI – 28.2 kg/m2) nor female (average BMI – 25.3 kg/m2) data sets indicated a correlation between BMI and the patient-reported outcomes. ConclusionsBMI, irrespective of sex, is not correlated with patient-reported outcomes in patients enrolled in the ICRS Registry with a BMI <30 kg/m2. Although BMIs in the overweight classification were not associated with poorer outcomes than BMIs in the normal classification, the current literature continues to support the notion that a BMI >30 kg/m2 is linked to poor cartilage repair and failure.