Patient-reported Outcomes Research Articles

Relationships between Patient-Reported Outcomes and Predictors of Second ACL Injuries during Unanticipated Jump Landings

ABSTRACT Background Reactive and external visual-cognitive demands are prevalent in sport and likely contribute to ACL injury scenarios. However, these demands are absent in common return-to-sport assessments. This disconnect leaves a blind spot for determining when an athlete can return to sport with mitigated re-injury risk. Purpose To characterize relationships between patient-reported outcome measures (PROMs) and cognitive-task interference (i.e., cognitive demands exacerbating neuromuscular impairments) for biomechanical predictors of second ACL injuries during jump landings that involved rapid unanticipated decision making. Methods Thirty-six persons following primary ACLR (26F/10M, 19.8±1.8 years; 1.71±0.1 m; 69.6±12.8 kg, 1.5±0.6 years post ACLR; Tegner: 6.8±1.8) participated. PROMs of ACL-RSI, and the Forgotten Joint Score-12 Knee (FJS-12) were selected to assess altered psychological state (e.g., confidence, attention toward knee). Jumping tasks under anticipated and unanticipated secondary jump directions were performed. Biomechanical variables were dual-task changes (unanticipated – anticipated) in 1) uninvolved limb hip rotator impulse (DTC_Uni-HRot_Imp), 2) asymmetry of knee extensor moment at initial contact (DTC_KEM_Asym), and 3) range of involved knee abduction angle (DTC_KAbA_Range). Regression models tested for relationships between PROMs and the dual-task change in biomechanical variables. Results: ACL-RSI (DTC_Uni-HRot_Imp (p < 0.001)) and FJS-12 (DTC_KAbA_Range (p = 0.001)) had significant relationships with dual-task change in the opposite direction as expected (worse PROM ➔ less dual-task change). A follow-up analysis indicated that dual-task change was inversely correlated with the baseline estimates for kinetic biomechanical variables (less risky single-task biomechanics ➔ greater dual-task change for Uni-HRot_Imp and KEM_Asym). Conclusions: The collective results are consistent with higher functioning participants (better PROMs) who also demonstrate desirable biomechanics during single-task conditions being prone to demonstrating the greatest risk-associated DTC in unanticipated scenarios.

Impact of Therapeutic Inertia on Patient-Reported Outcomes in Moderate-to-Severe Atopic Dermatitis: A 12-Month Longitudinal Study from the TARGET-DERM AD Registry

Background: Therapeutic inertia, the delay or reluctance to modify treatment when goals are unmet, is a significant challenge in managing chronic diseases, including atopic dermatitis (AD). This inertia can lead to suboptimal disease control and affect patient outcomes. Objectives: This study evaluates the effect of therapeutic inertia on patient-reported outcomes (PROs) in moderate-to-severe AD patients undergoing systemic treatment over 3 to 12 months. Methods: We analyzed longitudinal data from the TARGET-DERM AD registry, which includes 3,457 patients with moderate-to-severe AD from 39 centers across the U.S. and Canada. Eligible patients had documented patient-reported outcomes (PROs) at the initiation of systemic therapy and at subsequent 3-month intervals up to 12 months of follow-up. We assessed the proportion of patients not meeting treatment targets based on expert consensus. Patients had a validated Investigator Global Assessment (vIGA-AD) score of 3 or more at initiation of either an advanced systemic therapy (AST) such as biologics or JAK inhibitors or a conventional systemic therapy (CST) such as cyclosporine, methotrexate, or prednisone. PROs were evaluated at 3-month intervals up to 12 months, assessing achievement against the predefined treatment targets. PRO measures included Worst-Itch (PROMIS Itch-Severity), POEM, PO-SCORAD, NRS-sleep, and NRS-pain with specific moderate and optimal target levels established for each. Itch-Severity (range: 0–10; moderate target: ≥4-point reduction, optimal target: score ≤1), POEM (range: 0-28; moderate target: ≥4-point reduction, optimal target: score ≤2), PO-SCORAD (range: 0-103; moderate target: score ≤24; optimal target: score ≤10), NRS-sleep and NRS-pain (range: 0-10; moderate target: reduction ≥3-points; optimal target: score ≤1). Results: Out of 2107 patients with moderate-to-severe AD, 445 qualifying participants were included (63.8% adult, 62.0% female, 45.4% Non-Hispanic White, mean age of 31 years). Most patients (88.8%) initiated AST, with dupilumab being the most common (86.5%). At 6 months, significant proportions of AST-treated patients failed to reach moderate and optimal targets for itch (67% and 79%, respectively), POEM (46% and 69%), and NRS-sleep (59% and 47%). By 12 months, these figures were similar, with 66% and 88% failing to meet itch targets, 53% and 73% failing to meet POEM targets, and 62% and 45% failing to meet NRS-sleep targets, respectively. A similar pattern was observed for other PROs. CST-treated patients exhibited similar trends. Conclusions: The study highlights the profound impact of therapeutic inertia on the quality of life of patients with moderate-to-severe AD. Despite systemic therapy, a considerable proportion failed to meet treatment targets over a 12-month period, underscoring the need for more proactive and responsive treatment strategies in AD management.

Managing High Anisometropia with Blended Refractive Surgery: A Comparative Study on Patient Outcomes

Purpose: To compare patient-reported outcomes (PROs) and satisfaction results after blended refractive surgery with one eye Lasik laser/ PRK and another eye ICL. Patients and Methods: A Quality of life and Patient reported spectacle independence (PRISQ) questionnaire was administered to patients who had undergone blended Refractive surgery at 2 months of follow-up. Results: Overall PROs and satisfaction was similar among all the groups. Refractive outcome and accuracy were similar among the groups, Refractive outcome differences were not meaningful among the groups and were not a differentiating factor in PROs. Substantially fewer patients in the third group noticed glare and halo compared with the 3.0/3.0 group (P<0.0001. chi-square test). No new safety concerns were reported. Conclusion: The choice of blended refractive surgery resulted in a higher percentage of patients who were deemed unfit for LVC being satisfied with Near, intermediate, and distance vision, overall the fewer PRO differences were not statistically significant.

Bimekizumab impact on patient-reported outcomes in patients with moderate to severe hidradenitis suppurativa: Pooled Week 48 results from BE HEARD I&II

Introduction: Hidradenitis suppurativa (HS) has substantial negative effects on patients’ lives,1 with debilitating symptoms, such as intense pain/fatigue/draining and odor, which lead to overall low quality of life (QoL).1,2 Bimekizumab (BKZ) is a humanized IgG1 monoclonal antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A; clinical efficacy was previously shown in the phase 3 BE HEARD I&II trials.3 Here, the impact of BKZ on patient-reported outcomes (PROs) in patients with moderate to severe HS in BE HEARD I&II is reported. Procedure/Study: Pooled data included an initial (Weeks [Wks]0–16) and maintenance (Wks16–48) treatment period. Patients were randomized 2:2:2:1 (initial/maintenance) to BKZ 320 mg every 2 wks (Q2W)/Q2W, BKZ Q2W/ Q4W, BKZ Q4W/Q4W or placebo (PBO)/BKZ Q2W. HS Symptom Questionnaire (HSSQ; each symptom item scored 0–10) mean values are reported to Wk48 for skin pain, itch, smell/odor, and drainage/oozing. Proportions of patients achieving minimal clinically important difference (MCID) for Dermatology Life Quality Index (DLQI; scored 0–30; improvement from baseline score ≥4) were reported at Wk16 and Wk48. Data are reported as observed case. Results: Overall, 1,014 patients were randomized to BKZ Q2W/Q2W (N=288), BKZ Q2W/Q4W (N=292), BKZ Q4W/Q4W (N=288), PBO/BKZ Q2W (N=146). Within each HSSQ item, similar baseline scores were observed across treatment groups. At Wk16, for skin pain, itch, smell/odor and draining/oozing, greater improvements (i.e. score reduction) from baseline were seen in BKZ- vs PBO-treated patients. HSSQ item scores were substantially reduced from Wk16 to Wk48 in Wk16 PBO/BKZ switchers, further decreases were observed in those continually treated with BKZ. At Wk16, a greater proportion of BKZ- vs PBO-treated patients achieved MCID in DLQI: BKZ Q2W/Q2W, 64.6%; BKZ Q2W/Q4W, 54.9%; BKZ Q4W/Q4W, 63.5% vs PBO, 49.1%. At Wk48, a greater proportion of patients continually treated with BKZ achieved MCID in DLQI vs at Wk16; Wk16 PBO/BKZ switchers attained similar proportions (BKZ Q2W/Q2W: 73.4%; BKZ Q2W/Q4W: 63.5%; BKZ Q4W/Q4W: 74.5%; PBO/BKZ Q2W: 76.5%). Conclusion: At Wk16, BKZ-treated patients achieved a reduction from baseline of HS symptoms: skin pain, itch, smell/odor, and drainage/oozing. Clinically meaningful health-related QoL improvements from baseline were observed and maintained/slightly improved through Wk48. PBO/BKZ switchers experienced improvements in PRO responses from Wk16 to Wk48 and achieved comparable outcomes at Wk48 to patients continually treated with BKZ.

Why Do Optimal Targets for Itch and Skin Clearance Matter in Atopic Dermatitis Treatment? Insights from TARGET-DERM AD Registry

Introduction/Background: Atopic dermatitis (AD) patients undergoing treatment may only experience partial improvement in itch and skin lesions, often leading to suboptimal outcomes. The Aiming High in Eczema/Atopic Dermatitis (AHEAD) treat-to-target recommendations emphasize the importance of achieving optimal treatment targets, such as complete or near-complete itch relief and skin clearance. However, there is limited evidence on the impact of achieving these higher efficacy targets on patient-reported outcomes and quality of life in AD. Objectives: To evaluate the independent and combined effects of achieving optimal treatment targets for itch and skin clearance on patient-reported outcomes (PROs) in AD, based on the AHEAD treat-to-target recommendations. Method: A cross-sectional analysis was conducted on adult participants in TARGET-DERM AD, a longitudinal study with over 4,000 participants across 52 U.S. and Canadian clinical-practice sites (2019-2024). Itch severity was measured using the PROMIS Itch-Severity question (NRS-Itch, 0–10 scale), with scores of 0/1 indicating no or minimal itch. Skin severity was assessed using the validated Investigator Global Assessment (vIGA-AD), where 0/1 represents clear or almost clear skin. Associations between itch and skin severity with optimal patient outcomes including POEM 0–2 (clear/almost-clear disease), DLQI 0/1 (minimal/no impact on quality of life), NRS-Sleep 0/1, and NRS-Pain 0/1 were evaluated. Logistic regression models examined the main and interaction effects of itch and skin severity. Results: Among 1,920 patients (58.6% female; 54.5% Non-Hispanic White; 93.8% US; mean age 45 years), optimal DLQI, POEM, NRS-Sleep, and NRS-Pain occurred most frequently among those achieving the optimal treatment targets for itch (WI-NRS 0/1; 52.1%, 53.7%, 57.3%, and 83.1%, respectively) and skin clearance (vIGA-AD 0/1; 44.7%, 44.3%, 44.7%, and 74.3%, respectively). Compared to partial improvement, the adjusted odds ratios (aOR) of optimal PROs were greatest for participants with complete or near-complete resolution of both itch and skin lesions (DLQI 0/1: 20.0; POEM 0-2: 41.7; Sleep-NRS: 16.1; Pain-NRS: 6.0). Conclusions: Achieving optimal treatment targets for both itch and skin lesions markedly enhances patient-reported outcomes in AD. The results of this real-world study support treat-to-optimal targets to assess therapeutic effectiveness and optimize patient outcomes.

Generic vs. Disease-Specific Patient Reported Outcome (PRO) Instruments for Assessing HRQoL Burden Among Patients Diagnosed with Alopecia Areata: Evidence from TARGET-DERM AA

Introduction Alopecia areata (AA) is a chronic, autoimmune disease characterized by patchy hair loss. Compared to other disease areas, recent work has signaled a potential shortcoming, that generic quality of life (QOL) questionnaires are not sufficiently sensitive to the impact of AA disease severity. This cross-sectional analysis investigates the Short-Form 36, the dermatology life quality index (DLQI), and the Alopecia Areata Patient Priority Outcomes (AAPPO) for similar shortcomings. Methods Patients of all ages enrolled from December 2021 to June 2024 in TARGET-DERM AA (data collection on-going) in the United States and Canada were grouped by Severity of Alopecia Tool (SALT) score (1-20, 21-49, or 50-100). At enrollment, patients completed the AAPPO and DLQI questionnaire as well as the RAND MOS Short-Form 36. The SF-36 has 8 subdomain scores (vitality, physical function, bodily pain, general health, physical role function, emotional role function, social role function, mental health) along with the physical component summaries (PCS), mental component summaries (MCS), and the SF-6D utility index score. The Kruskal-Wallis test compared differences in mean scores across SALT subgroups defined by severity. Results Of the 141 AA patients, 61.7% were female; 95.0% adults, and 67.4% Non-Hispanic White. When comparing the SALT 1-20 and the >50 subgroups, significant differences in SF-36 derived mean scores were only observed in the PCS and the physical function score (p<0.05). None of the other scores (MCS, SF-6D, or other SF-36 subdomains) showed any differences. Mean DLQI scores were similar across subgroups (p>.05) Notably, the hair loss and activity limitation domains of the AAPPO demonstrated significant differences between the patient subgroups (p<.0001 and p<.05, respectively) Discussion In this real-world cohort, generic QoL instruments, namely the SF-36 and DLQI, did not capture differences in the underlying health-related QoL burden of AA patients with different AA severity. Such differences were clear when HRQoL was measured for AA patients with mild hair loss AAPPO.

Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomised controlled trial

Abstract Objectives To assess the efficacy and safety of the non-hormonal, neurokinin 3 receptor antagonist, fezolinetant, to treat moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy. Design Phase 3b randomised controlled trial. Setting 16 countries. Participants 453 individuals aged 40-65 years with moderate-severe vasomotor symptoms associated with menopause who were considered unsuitable candidates for hormone therapy (contraindicated, caution (based on medical history), stoppers (previous discontinuation of hormone therapy), or averse (informed choice not to use hormone therapy)) were randomised to receive fezolinetant (n=227) or placebo (n=226). Intervention Fezolinetant 45 mg or placebo once daily for 24 weeks. Main outcome measures The primary endpoint was mean change in daily frequency of moderate-severe vasomotor symptoms from baseline to week 24. Secondary endpoints were mean change in symptom severity, sleep disturbance using the Patient-Reported Outcome Measurement Information System Sleep Disturbance Short Form (PROMIS SD-SF) 8b total score, and safety. Results 370 (81.7%) participants completed the study (fezolinetant=195, placebo group=175). The safety and full analysis sets comprised 452 participants who received at least one dose of study drug. Mean age was 54.5 (standard deviation 4.7) years and most of the participants (435 (96.7%) were white and categorised as either hormone therapy averse (168 (37.2%)) or caution (165 (36.5%)). At week 24, fezolinetant significantly reduced the frequency (least squares mean difference –1.93, 95% confidence interval (CI) –2.64 to –1.22; P<0.001) and severity of vasomotor symptoms (–0.39, –0.57 to –0.21; P<0.001). At week 24, the fezolinetant group had a greater reduction in sleep disturbance (PROMIS SD-SF 8b total score) compared with placebo (–2.5, –3.9 to –1.1; P<0.001). Improvements over placebo were observed as early as week 1. Both groups showed similar incidences of treatment emergent adverse events (TEAEs, 147 (65.0%) in the fezolinetant group, 138 (61.1%) in the placebo group) and serious TEAEs (10 (4.4%) and 8 (3.5%), respectively). The most common TEAEs in the fezolinetant group were covid-19 (30 (13.3%)), headache (20 (8.8%)), and fatigue (13 (5.8%)). Conclusions Fezolinetant was efficacious and well tolerated over a six month period for treating moderate-severe vasomotor symptoms in individuals considered unsuitable for hormone therapy. These results highlight the utility of fezolinetant as an effective treatment option for those who have contraindications to or choose not to use hormone therapy. Trial registration ClinicalTrials.gov NCT05033886 ; EudraCT 2021-001685-38.

Application of Intelligent Management Model Based on Electronic Patient-Reported Outcome During Immunotherapy in Patients with Gastric Cancer: A Single-Center Retrospective Study

Aims/Background Gastric cancer is the third leading cause of cancer-related death worldwide, which seriously affects the health of patients. Immunotherapy is a commonly used clinical treatment for gastric cancer, but the adverse events caused by it seriously affect the prognosis of patients. Therefore, it is necessary to control and manage the disease risk of patients during immunotherapy. To explore the effect of applying an intelligent management model based on electronic patient-reported outcome (ePRO) in patients with gastric cancer during immunotherapy. Methods The clinical data of 184 gastric cancer patients receiving immunotherapy in The Fourth Hospital of Hebei Medical University from September 2021 to September 2023 were retrospectively analyzed. Ninety patients receiving ePRO-based intelligent management were selected, and 85 patients were included in the observation group after excluding 5 patients. For the reference group, 94 patients receiving common case management were selected, with 90 patients being included after excluding 4 patients. After 6 months of follow-up, the nutritional status score, quality of life, treatment compliance and adverse events were compared between the two groups. Results No significant difference was detected in nutritional status and World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores of the patients before discharge (p > 0.05). After 2 months of follow-up, compared with the reference group, the observation group had a higher proportion of patients in grade A and grade B, which was not statistically significant (p > 0.05), and significantly higher physiological and psychological scores (p < 0.001), but showed no meaningful differences in other fields (p > 0.05). After 4 months of follow-up, the nutritional status in the observation group was significantly improved (p < 0.05), and the subjects displayed higher WHOQOL-BREF scores (p < 0.05) than those in the reference group. No significant difference in the incidence of adverse events was detected (p > 0.05). After 6 months of follow-up, the treatment compliance of the observation group was 83.53%, which was significantly higher than that of the reference group (70.00%; p < 0.05). Conclusion The intelligent management model based on ePRO is conducive to improving the nutritional status of patients with gastric cancer during immunotherapy, as well as enhancing their quality of life and treatment compliance, making it worthy of clinical application.

Dupilumab Improves Patient-Reported Outcomes as Early as 1 Month among Adults with Prurigo Nodularis in Clinical Practice: Initial Results from the RELIEVE-PN Study

Introduction: Dupilumab is a monoclonal antibody approved in the United States (US) for patients aged ≥18 years with prurigo nodularis (PN). This analysis evaluated the real-world initial impact of dupilumab therapy on symptoms and treatment satisfaction among US adults with PN. Methods: RELIEVE-PN is an ongoing longitudinal prospective patient survey study assessing the real-world effectiveness of dupilumab in the treatment of adult patients with PN. Adults with PN were recruited through the US dupilumab patient support program and surveyed before (baseline) and 1 month after dupilumab initiation. PN symptoms over the last 7 days were assessed using the worst-itch numeric rating scale (WI-NRS), average-itch NRS, skin pain NRS, and skin burning or stinging/tingling NRS (range 0 [no symptom] to 10 [most severe symptom] for all). Treatment satisfaction with current therapy was evaluated using a 7-point Likert scale from “extremely satisfied” to “extremely dissatisfied”. Results: Of 84 patients (mean age, 57.5 years; 79.8% female; 83.3% White) completing the baseline survey and initiating dupilumab, 62 (mean age, 56.4 years; 77.4% female; 83.9% White) completed the Month 1 survey. At baseline, mean (SD) WI-NRS, average itch NRS, skin pain NRS, and skin burning/tingling NRS were 7.70 (2.24), 6.45 (2.25), 5.06 (2.87), and 5.51 (3.02), respectively. By month 1, mean (SD) WI-NRS, average itch NRS, skin pain NRS, and skin burning or stinging/tingling NRS improved to 5.56 (2.89), 4.35 (2.23), 3.40 (2.46), and 3.76 (2.60), respectively (p<0.001 for all). Additionally, significantly more patients reported they were satisfied with current PN treatment(s) at 1 month after dupilumab treatment initiation vs prior to starting dupilumab (77.4% vs 13.1%; p<0.001). Conclusion: Early results from the RELIEVE-PN study demonstrate improvement in symptoms and patient satisfaction with therapy as early as 1-month from treatment initiation of dupilumab. Further comparative research is needed to confirm these findings. Acknowledgment: Research was funded by Sanofi and Regeneron Pharmaceuticals Inc.

A Novel Nutraceutical Gummy for Hair Regrowth in Women: A Case Series

Introduction:Hair loss is a common concern among women, with female pattern hair loss (FPHL) and telogen effluvium (TE) being the most prevalent types. At least 50% of women experience hair loss by age 50 [1]. Many patients turn to nutritional supplements, with one hair loss clinic reporting that up to 81% of their patients use supplements [2]. While various nutraceuticals have demonstrated clinical efficacy in hair regrowth [2], none have been evaluated in gummy form. This case series aims to assess the efficacy of a novel nutraceutical gummy containing a proprietary blend of NAD, pumpkin seed extract, taurine, pea protein, ashwagandha, saw palmetto, and other anti-inflammatory ingredients in promoting hair regrowth in women with FPHL and TE. Procedure:Three women, aged 43, 52,64, with diagnoses of FPHL and TE, were included in this series. Each participant consumed two nutraceutical gummies daily for 2 or 3 months. One participant experiencing TE, also took oral minoxidil 1.25 mg daily. Baseline assessments included patient-reported outcomes related to hair shedding and photographic comparisons. Follow-up assessments were performed at 2 or 3 months. Results:All three women demonstrated noticeable improvements in hair density and a reduction in hair shedding by the 3-month mark. Participants also reported subjective improvements in hair quality, volume, and overall satisfaction with the product. No adverse effects were observed during the study period. Conclusion:This case series suggests that the novel nutraceutical gummy may be an effective, well-tolerated option for promoting hair regrowth in women with FPHL and TE. This nutraceutical can be efficacious as a sole treatment and in conjunction with traditional hair loss medical therapy. These findings highlight the potential for a gummy formulation to provide an accessible, evidence-based treatment for hair loss. Further studies with larger sample sizes are ongoing to validate these results.

Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 (TYK2) Inhibitor, in Patients With Moderate to Severe Scalp Psoriasis: Improvement in Scalp-Related Quality of Life and Symptoms in the Phase 3b/4 Multicenter, Randomized, Double-Blinded, Placebo-Controlled PSORIATYK SCALP Trial

Introduction: PSORIATYK SCALP (NCT05478499)—an ongoing 52-week, phase 3b/4, multicenter, randomized, double-blinded, placebo-controlled trial—assesses the efficacy and safety of deucravacitinib in patients aged ≥18 years with moderate to severe scalp psoriasis (Psoriasis Scalp Severity Index ≥12, scalp-specific Physician Global Assessment ≥3, scalp surface area involvement ≥20%, and body surface area [BSA] involvement ≥3%). We assessed Week 16 patient-reported outcomes using Scalpdex, a validated, scalp-specific quality-of-life instrument, and numeric rating scales (NRSs) for scalp-specific symptoms. Methods: Patients were randomized 1:2 to placebo or deucravacitinib 6 mg for 16 weeks, stratified by previous biologic use (yes or no) and body weight (<90 or ≥90 kg). Changes from baseline in Scalpdex total score and NRS scores for scalp-specific itch, pain, and flaking were assessed with an analysis of covariance (ANCOVA) model with treatment and randomization stratification factors as fixed effects and the baseline value as a covariate. Scalpdex total score change from baseline was further assessed in BSA subgroups (BSA 3–10%, BSA >10%), using an ANCOVA model with treatment as a fixed effect and the baseline value as a covariate. P values are nominal. Results: Mean baseline scores (placebo: n=51; deucravacitinib: n=103) indicated severe impact on quality of life (Scalpdex total score >44.0) and moderate to severe symptoms (NRS ≥4.0). At Week 16, adjusted mean change from baseline (95% CI) in Scalpdex total score was greater in patients receiving deucravacitinib versus placebo (−22.3 [−26.1, −18.6] vs −10.5 [−15.7, −5.2]; P=0.0003). Changes from baseline (95% CI) in scalp-specific NRS measures were greater in patients receiving deucravacitinib versus placebo (itch: −3.2 [−3.7, −2.7] vs −0.7 [−1.4, 0.0]; pain: −2.1 [−2.6, −1.6] vs −0.1 [−0.8, 0.5]; flaking: −3.9 [−4.5, −3.4] vs −1.0 [−1.8, −0.2]; all P<0.0001). In each BSA subgroup, patients receiving deucravacitinib versus placebo reported greater Week 16 change from baseline in Scalpdex total score (BSA 3–10%: −19.8 [−23.9, −15.6] vs −10.5 [−16.1, −4.9]; P=0.0096; BSA >10%: −26.2 [−33.2, −19.3] vs −11.2 [−22.3, 0.0]; P=0.0263). Conclusion: Deucravacitinib was efficacious in improving scalp-specific psoriasis symptoms and quality of life. Furthermore, scalp-related quality of life was improved in patients receiving deucravacitinib in both BSA subgroups.

Persistent Inadequate Disease Control and Therapeutic Inertia in Moderate-to-Severe Atopic Dermatitis: A 12-month Longitudinal Analysis of Real-world Outcomes from the TARGET-DERM AD registry

Background: Therapeutic inertia refers to the delay or failure in treatment escalation in patients not achieving adequate disease control; it is a challenge in the management of moderate-to-severe atopic dermatitis (AD). Despite the availability of conventional (CST) and advanced systemic therapies (AST) utilized for the treatment of moderate to severe AD, many patients do not achieve treatment success. However, the extent of this inadequacy in real-world clinical practice remains underexplored. Objectives: This study evaluates the occurrence of therapeutic inertia and the proportion of patients with moderate-to-severe AD who continue to show inadequate response after receiving systemic therapies for a duration from 3 to 12 months Methods: We conducted a longitudinal analysis of patients with moderate-to-severe AD (vIGA-AD≥3) from the TARGET-DERM AD registry, including 3,457 participants from 39 centers in the U.S. and Canada. Eligible patients had documented outcomes at the initiation of systemic therapy and after 3 months up to 12 months of follow up. We assessed clinician- and patient-reported outcomes to identify the proportion of patients not meeting treatment targets based on expert consensus. An inadequate response was defined as not achieving a validated Investigator Global Assessment (vIGA-AD) score ≤2, a 50% improvement in Body Surface Area (BSA), and a ≥4-point reduction in the Worst Pruritus Numeric Rating Scale (WP-NRS). An optimal response was defined as a vIGA-AD score ≤1 (clear or almost clear skin), BSA ≤2%, and WP-NRS itch score of 0/1 (complete or almost complete skin resolution). Results: Out of 2,107 patients with moderate-to-severe AD, 445 met the inclusion criteria. The majority were adults (63.8%), female (62.0%), and Non-Hispanic White (45.4%), with an average age of 31 years. Most patients (88.8%) initiated treatment with AST, with dupilumab being the most common (86.5%). The mean vIGA-AD was 3.3 for AST and 3.6 for CST at initiation (P<0.01). At 6 months, 37% and 67% of AST-treated patients had inadequate responses in terms of skin clearance and itch outcomes, respectively, while 82% and 79% did not achieve optimal responses. At 12 months, these figures were approximately 30% and 66% for inadequate responses and 85% and 88% for not achieving optimal responses, respectively. CST-treated patients showed a similar trend. Conclusions: The study reveals that a significant portion of moderate-to-severe AD patients fail to achieve adequate disease control with systemic therapies over 12 months, indicating substantial presence of therapeutic inertia. These findings suggest a need for more proactive management strategies in AD treatment.

The effect of positive mental well-being on patient reported outcome (PRO): finding from a cross-sectional multi-disease study in China.

This study aims to investigate the potential impact of positive mental well-being on responses of patient-reported outcome measures (PROMs), such as EQ-5D-5L. This study utilized the data collected in a cross-sectional study in a sample consisted of individuals with different health conditions. Spearman's rank correlations were employed to investigate the relationship between the responses to the dimensions of EQ-5D-5L and the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). A binary logistic regression analysis and ordered logistic multivariable regression were utilized to examine how SWEMWBS scores could impact the responses to EQ-5D-5L dimensions, while controlling for variables such as age, gender, education level, health conditions, caring experience, and data collection methods. The effects of SWEMWBS on EQ-VAS and utility values were also examined. One thousand nine individuals participated in the survey. Spearman's rank correlation revealed that all dimensions of EQ-5D-5L, except for the anxiety/depression dimension, exhibited weak correlations with all dimensions of SWEMWBS. Binary logistic regression and ordered logistic multivariable regression indicated that age, SWEMWBS scores, gender, health conditions, data collection methods, and caring experience significantly influenced the likelihood of reporting problems in EQ-5D-5L responses. Notably, better SWEMWBS outcomes increased the likelihood of reporting no or fewer problemsacross all EQ-5D-5L dimensions. Spearman's rank correlation suggested a moderate or strong positive correlation between SWEMWBS scores and EQ-5D-5L utility values and EQ-VAS. The results of multiple linear regression analysis revealed that SWEMWBS scores, health conditions, caring experience, and data collection methods were significantly associated with EQ-5D utility values and EQ-VAS. Individuals with better positive mental well-being results are more likely to report better results in PROMs like EQ-5D-5L. Future study is needed to understand the thought process and to explore strategies to cope with the response heterogeneity that led by the status of mental well-being.

Electronic patient-reported outcomes as digital therapeutics for patients with cancer: a narrative review of current practices and future directions.

Improved cancer treatment outcomes have increased the demand for medical care that considers the quality of life of patients with cancer. Patient-reported outcomes (PROs) help assess the quality of life because they involve direct evaluation of the patients. Recently, electronic PROs (ePROs) have been used in clinical cancer care settings in Europe and the United States. Electronic PROs positively affected communication between patients with cancer and healthcare providers, enhanced education, optimized self-management, contributed to healthcare economics, assisted in monitoring adverse events, and improved prognosis. However, challenges such as adherence, burden on healthcare providers, lack of personalized formats, low digital literacy, and implementation costs remain. Therefore, carefully selecting the items to be recorded by ePROs in alignment with specific objectives is essential. Additionally, developing systems using lifelogs-digital records of daily activities-and creating mechanisms that automatically encourage patient behavioral changes based on the reported data are crucial. This review delineates the advantages and challenges of ePROs according to their history and proposes the prospects of ePRO.

Modular versus monobloc dual mobility components for primary cementless total hip arthroplasty: a systematic review and meta-analysis of implants' survival, complication rates, clinical and radiographic outcomes.

The dual mobility cup (DMC) reduces the dislocation rates in total hip arthroplasty (THA). DMC systems include anatomical (non-modular or monoblock) (ADM) and modular dual mobility (MDM) components (Stryker Orthopaedics, Mahwah, NJ, USA). This review aims to assess differences between these two types of DMC implants concerning dislocation and revision rates, as well as patient-reported outcomes. This systematic review and meta-analysis of studies reports data from patients undergoing primary THA using MDM and/or ADM implants. Following the PRISMA guidelines, we analyzed articles from Science Direct/Scopus, PubMed, and the Cochrane Database of Systematic Reviews. We compared dislocation rates, revisions for any reason, aseptic loosening, infections, fractures, and functional outcomes between ADM and MDM components. Eleven studies were considered eligible for further analysis. A total of 3369 patients (mean age = 65.4years) underwent primary THA, including 3386 DMC implants. The mean follow-up for the MDM and ADM groups was 2.9years and 3.9years, respectively. The study revealed one dislocation in the MDM and none in the ADM. By proportion metanalysis, the review did not show statistical differences in all-cause revisions (p = 0.93, [CI [0.01;0.02]) or periprosthetic fractures (p = 0.18, CI [0.01;0.02]). MDM and ADM systems, both, represent safe DM options regarding dislocation, all-causes revisions and functional outcomes.

Symptom trajectories over time by cannabis use status among patients undergoing cancer treatment.

Adults with cancer may perceive cannabis as beneficial for managing their cancer-related symptoms, but the evidence supporting its medical use is varied and inconclusive. This study characterized associations of cannabis use with cancer-related symptom trajectories. Participants were adults undergoing cancer treatment at the Stephenson Cancer Center (SCC; n = 218) in Oklahoma; they were 71% female, 10% minoritized race, and 45% had stage III or IV cancer. Participants completed surveys at baseline and 2-, 4-, and 6-months post-baseline. Assessments queried about cannabis use behavior, physical and psychological distress via the Rotterdam Symptoms Checklist (RSCL), respiratory symptoms via the American Thoracic Society Questionnaire (ATSQ), and quality of life indices (physical and social functioning, pain interference, sleep quality, fatigue) via the Patient Reported Outcomes Measurement Information System (PROMIS-29). Cannabis use status was categorized based on self-reported past 30-day cannabis use at each assessment as non-use [no use at any assessment], occasional-use [use at 1-2 assessments], or consistent-use [use at 3-4 assessments]. Longitudinal hierarchical linear modeling evaluated associations of cannabis use status with average symptoms and symptom trajectories across all four assessments. One-third (33%) of participants reported past 30-day cannabis use at ≥ 1 assessment. Participants who reported cannabis use (occasional-use and consistent-use) had more severe symptoms overall across assessments. While most cancer symptom trajectories did not differ by cannabis use status, participants who reported consistent cannabis use uniquely showed worsening physical function over time. Cannabis use was associated with greater cancer-related symptom severity over time.

Females report worse outcomes than males one year after ventral hernia repair.

To assess sex differences in patient-reported quality of life, pain, and hernia recurrence after adjusting for confounding features of hernia disease in a large national registry one year after ventral hernia repair. Data were analyzed retrospectively from the Abdominal Core Health Quality Collaborative national registry from pre-operatively until one year post-operatively. 3,172 patients undergoing elective ventral hernia repair with 1-year follow-up data were included for analysis after propensity score matching (1:1 match; females: mean [interquartile range] age, 60 [49, 68]; body mass index, 32 [27, 36]; males: age, 60 [52, 68]; 31 [28, 35]. The primary outcome of interest between sexes was the Hernia Related Quality of Life survey (HerQLes), and secondary outcome measures included the Patient-Reported Outcomes Measurement Information System Pain Intensity (PROMIS) short form (3a) score and hernia recurrence. Female sex was associated with worse HerQLes and PROMIS pain 3a scores at 1 year follow up (adjusted mean difference, -2.42, 95% confidence interval (CI) -4.11 to -0.72; p = 0.004; adjusted mean difference, 1.27, 95% CI 0.67 to 1.87; p < 0.001) compared to male sex. Hernia recurrence rates at 1 year were not different between sexes. Females reported worse quality of life and higher levels of pain at 1-year post ventral hernia repair after accounting for age, BMI, hernia width, and baseline quality of life compared to males. There were no differences between females and males with respect to hernia recurrence at 1-year follow-up, and 1 in 5 patients experienced a recurrence at this time point.

Latent class analysis of post-acute sequelae of SARS-CoV-2 infection.

Symptoms post-SARS-CoV-2 infection may persist for months and cause significant impairment and impact to quality of life. Acute symptoms of SARS-CoV-2 infection are well studied, yet data on clusters of symptoms over time, or post-acute sequelae of SARS-CoV-2 infection (PASC), are limited. We aim to characterize PASC phenotypes by identifying symptom clusters over a six-month period following infection in individuals vaccinated (boosted and not) and those unvaccinated. Subjects with ≥1 self-reported symptom and positive RT-PCR for SARS-CoV-2 at CVS Health US test sites were recruited between January and April 2022. Patient-reported outcomes symptoms, health-related quality of life (HRQoL), work productivity and activity impairment (WPAI) were captured at 1 month, 3 months, and 6 months post-acute infection. Phenotypes of PASC were determined based on subject matter knowledge and balanced consideration of statistical criteria (lower AIC, lower BIC, and adequate entropy) and interpretability. Generalized estimation equation approach was used to investigate relationship between QoL, WPAI and number of symptoms and identified phenotypes, and relationship between phenotypes and vaccination status as well. LCA identified three phenotypes that are primarily differentiated by number of symptoms. These three phenotypes remained consistent across time periods. Subjects with more symptoms were associated with lower HRQoL, and worse WPAI scores. Vaccinated individuals were more likely to be in the low symptom burden latent classes at all time points compared to unvaccinated individuals.

How patient-reported outcomes and experience measures (PROMs and PREMs) are implemented in healthcare professional and patient organizations? An environmental scan.

Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are becoming essential parts of a learning health system, and using these measures is a promising approach for value-based healthcare. However, evidence regarding healthcare professional and patient organizations' knowledge, use and perception of PROMs and PREMs is lacking. The objectives of the study were to: 1- Describe the current knowledge and use of PROMs and PREMs by healthcare professional and patient organizations, 2- Describe the determinants of PROMs and PREMs implementation according to healthcare professional and patient organizations. We conducted an environmental scan using semi-structured interviews with representatives from healthcare professional and patient organizations. Interviews were recorded and live coded based on the Franklin framework. We used inductive and deductive thematic analysis to extract information about the main themes addressed during the interview (awareness of PROMs and PREMs, examples of implementation and use of PROMs and PREMs, tools used, vision for future implementation, barriers and facilitators to implementation and the best way to collect PROMs and PREMs data). 63% of healthcare professional organizations (n = 19) and 41% of patient organizations (n = 9) that were contacted agreed to have a representative interviewed. The representatives from both the healthcare professional and patient organizations acknowledged the importance of assessing patients' experience and outcomes. However, they considered the implementation of PROMs and PREMs tools to be scarce within their organizations, in clinical practice and in the education system. Patient organizations were worried that overuse of PROMs and PREMs could lead to depersonalization of practice. Barriers to implementing PROMs and PREMs included lack of awareness of tools, resistance to change and lack of motivation to complete or explain the questionnaire. Barriers also included factors such as lack of financial, technological and human resources and issues with integration of data and inconsistency of digital platforms. This environmental scan revealed a lack of awareness of tools by healthcare professional and patient organizations' representatives and limited implementation. Adequate training, technological integration, and demonstration of PROMs and PREMs benefits to foster broader adoption in clinical and organizational settings is dearly needed. Addressing these challenges is essential for enhancing value-based care.

UK medical cannabis registry: A clinical outcome analysis of medical cannabis therapy in chronic pain patients with and without co-morbid sleep impairment.

Chronic pain (CP) affects 35.0%-51.3% of the UK population, with 67%-88% reporting sleep disturbances. Cannabis-based medicinal products (CBMPs) have shown therapeutic potential in managing CP. Evidence suggests poor sleep worsens pain perception; therefore, this study aimed to assess patient-reported outcome measures (PROMs) following CBMP treatment in CP patients with and without co-morbid sleep impairment. A prospective cohort study of CP patients from the UK Medical Cannabis Registry was conducted. Participants were separated by baseline single-item sleep quality scale (SQS) score into sleep impaired (SQS ≤3) and unimpaired (SQS ≥4) cohorts. The primary outcome assessed changes in PROMs from baseline to 1-, 3-, 6-, and 12-months. Participants completed the following: SQS, General Anxiety Disorder-7, EQ-5D-5L, Brief Pain Inventory (BPI), and Short-Form McGill Pain Questionnaire-2. Significance was defined as p < 0.050. 1139 participants met the inclusion criteria (sleep impaired: n = 517, 45.4%; sleep unimpaired: n = 622, 54.61%). The sleep impaired cohort showed improvements in all PROMs at each follow-up (p < 0.010). The sleep unimpaired cohort showed similar results (p < 0.050), except in SQS and ED-5Q-5L: self-care and anxiety/depression scores (p > 0.050). However, the sleep impaired cohort observed greater improvements in BPI pain severity (p < 0.050) and SQS (p < 0.001) than the sleep unimpaired cohort at all follow-ups. 2817 adverse events were self-reported between both cohorts (p = 0.197). These findings align with literature that shows associated improvements in pain outcomes following CBMP administration. Sleep impaired individuals were more likely to experience greater pain severity improvements. However, this was not confirmed on multivariate logistic regression analysis and instead may be confounded by baseline pain severity. Whilst these results show promise for the effects of CBMPs on CP, they must be examined within the limitations of the study design. These findings provide further evidence to support the design of subsequent randomized controlled trials to verify causality between CBMPs and pain outcomes.