Symptom Subscale Research Articles

Symptoms and atrial fibrillation burden measured by an insertable cardiac monitor in endurance athletes

Abstract Background Atrial fibrillation (AF) is the most common cardiac arrhythmia in athletes, but knowledge regarding AF burden, symptoms and quality of life (QoL) in endurance athletes with AF is limited. Purpose To study AF burden by continuous monitoring using insertable cardiac monitor (ICM), AF symptoms and QoL in endurance athletes with paroxysmal AF. Methods In endurance athletes diagnosed with paroxysmal AF who reported ≥2 episodes of AF, of which ≥1 during the past six months, we continuously monitored AF using ICM. Episodes recognized as AF by ICM were validated by a cardiologist. We defined AF burden as the cumulative duration of AF episodes lasting ≥30 secs divided by the total duration of monitoring. AF symptoms were assessed using the 21-item Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT). AFEQT produces a summary score and three subscale scores (symptoms, daily activities, treatment concerns), ranging from 0 (complete AF-related disability) to 100 (no AF-related disability). We defined any score <80 as clinically relevant AF symptoms. We classified athletes according to the modified European Heart Rhythm Association (mEHRA) classification. Sport participation was obtained by questionnaires. Height and weight were measured and physical fitness was examined during cardiopulmonary exercise testing. Results A total of 38 athletes (3 female, 8%) were included. Table 1 shows their characteristics. Eight of the athletes (21%) had recurrent AF after previous AF ablation therapy. ICM recordings were available in 30 athletes who were monitored for an average of 53±21 days (mean±SD). Eighteen athletes (60%) had ≥1 AF episode, the median number of AF episodes was 2 (interquartile range 8.75), and the mean AF burden was 1.4±2.5%. The mean AFEQT summary score was 84±12 and 11 athletes (29%) had an AFEQT summary score <80. The mean AFEQT symptom subscale score was 78±18). While 21 athletes (55%) had a symptom subscale score <80, indicating clinically relevant symptomatic AF, 9 (24%) scored <60, indicating more severely symptomatic AF. Figure 1 shows ICM-detected AF burden across categories of mEHRA classes and categories of the AFEQT summary score. The AF burden corresponded to both AFEQT scores and mEHRA categories, with a higher AF burden associated with more symptomatic AF (Figure 1). AF burden was numerically lower in athletes with recurrent AF after previous AF ablation therapy, compared to athletes previously not treated with AF ablation (0.6% vs. 1.7%, p= 0.66), but previously ablated athletes were more symptomatic (AFEQT symptom subscale score 68 vs. 80, p= 0.04). Conclusions Despite a relatively low AF burden during continuous monitoring with ICM, a majority of the athletes had clinically relevant symptomatic AF. Athletes with recurrent AF after previous ablation therapy had a numerically lower AF burden, but were more symptomatic compared to athletes with paroxysmal AF not previously treated with AF ablation.

Associations of diagnostic awareness with psychosocial symptoms and survival time in patients with advanced lung cancer.

Disclosing the diagnosis of lung cancer to patients is an issue, especially in the Middle East where cultural factors may prohibit disclosure from being done. The psychosocial consequences of diagnostic awareness and its impact on life expectancy of disclosure are an important issue that may influence this decision. The present study evaluated the effects of diagnostic awareness on psychosocial symptomatology and survival time in advanced lung cancer patients in Turkey. This prospective cohort study included 126 advanced lung cancer patients admitted to the oncology department between February 2021 and August 2021. A face-to-face survey included questions on age, gender, marital/employment statuses, comorbidities, and psychological symptoms (SCL-90-R). Diagnostic awareness was assessed by asking patients whether they knew their diagnosis. The correlation of diagnostic awareness with 2-year survival time was analyzed using Cox regression analysis. Of the 126 patients, 86 died at the time of follow-up. Survival time and scores on SCL-90-R symptom subscales were compared between diagnosis-aware (79.4%) and diagnosis-unaware groups (20.6%). Somatization (P = 0.04), depression (P = 0.01), hostility (P = 0.03), scores on additional symptom scales (P = 0.01), and Positive Symptom Total scores (P = 0.01) were significantly higher in the diagnosis-unaware group. No significant difference was found between diagnostic awareness and survival time (P = 0.24). Advanced lung cancer patients aware of their diagnosis experienced less psychosocial burden. However, no significant difference was found in survival time between diagnosis-aware and diagnosis-unaware patients. These findings suggest that the diagnosis should be disclosed to lung cancer patients after confirmation of diagnosis.

Initial Witnessing on Future Witnessing: A Mediation Analysis of Chronic Community Violence, Post-Traumatic Stress, and Delinquency in Urban, African American Youth.

Witnessing community violence can predict negative mental health outcomes for youth such as post-traumatic stress symptoms and delinquent behavior. Such outcomes differ by gender. Variables that predict witnessing community violence in youth are less understood. This study aims to explore potential pathways between initial witnessing and continued witnessing for early adolescents. The relationship between witnessing as a predictor and witnessing as an outcome is hypothesized to be mediated by both post-traumatic stress and delinquency and moderated by gender. A sample of 153 African American, sixth-grade students (M= 11.65, 59% female) in high crime, high poverty areas completed self-report surveys at baseline, 12 and 24 months. Moderated serial mediation was used to assess longitudinal associations. For the full model, delinquency at Time 3 was associated with a positive change in witnessing at Time 3. Gender moderated several paths. For girls, witnessing at Time 1 was predictive of high post-traumatic stress (aggregate) at Time 2 and high delinquency at Time 3. For girls, witnessing at Time 1 also was predictive of higher hyperarousal and higher intrusion subscale symptoms than other symptoms at Time 2. Analyses also indicated that hyperarousal at Time 2 significantly predicted witnessing at Time 3 for girls only. Lastly, delinquency at Time 3 was associated with a positive change in witnessing at Time 3. For boys, no analyses indicated witnessing at Time 1 as a significant predictor. Results contribute to our understanding of the trajectory of witnessing community violence and the roles both post-traumatic stress subscales and delinquency play in that trajectory, especially among girls.

Quality of Life After Pediatric Tympanomastoidectomy.

To assess quality of life (QOL) outcomes after canal wall up (CWU) and canal wall down (CWD) tympanomastoidectomy in the pediatric population. A retrospective review tabulated pediatric patients undergoing CWU and CWD tympanomastoidectomy for cholesteatoma by 2 senior surgeons at a single tertiary academic referral center between March 2017 and March 2023. Chronic Ear Survey (CES) and cosmetic survey outcomes were collected post-operatively. A total of 77 ears in 75 patients were identified, with 35 undergoing CWU and 42 undergoing CWD as the most recent (index) otologic surgery. Seventeen patients (23%) participated in the survey. Of this cohort, the mean age was 14.6 years, 12 (71%) were male, and 10 (59%) had CWD as the most recent otologic surgery. The mean time from index surgery to survey completion was 3.4 years (range, 0.1-6.7 years). Regarding QOL outcomes, there were no statistically significant differences in total CES score, CES subscores, and cosmetic survey scores between groups when categorizing by gender or index surgery. Total CES, symptom subscale, medical resource subscale, and cosmetic survey scores showed a tendency to decrease with an increasing number of surgeries (R = -.18, -.28, -.53, and -.56, respectively). Pediatric total CES scores appeared comparable to those reported in the published adult literature. It does not appear that there are worse QOL outcomes for pediatric patients who undergo CWD tympanomastoidectomy compared to those who undergo CWU tympanomastoidectomy. There appears to be no difference in QOL outcomes between pediatric and adult patients undergoing tympanomastoidectomy.

Clinical symptoms and psychosocial functioning in patients with schizophrenia spectrum disorders testing seropositive for anti-NMDAR antibodies: a case–control comparison with patients testing negative

Antibodies against the N-methyl-D-aspartate receptor (NMDAR) have been described in the serum of people with schizophrenia spectrum disorders (schizophrenia). However, the prevalence and clinical relevance of these antibodies in schizophrenia is unclear. This knowledge gap includes the possibility of such antibodies being associated with a distinct clinical profile, which in turn might warrant a distinct treatment approach. We aimed to assess the seroprevalence of anti-NMDAR antibodies in schizophrenia, and compare symptoms and psychosocial functioning between patients with schizophrenia who were seropositive and seronegative for these antibodies. In this case-control comparison, by combining new and existing studies, we included patients diagnosed with schizophrenia from four independent cohorts for whom anti-NMDAR serostatus had been assessed (or could be assessed by us) with live cell-based assays. Included cohorts were from the EULAST study (a trial conducted across 15 European countries and Israel), the OPTiMiSE study (an interventional study in Europe), and the PPiP1 and PPiP2 studies (conducted in the UK). Patients from these cohorts were analysed if they had complete Positive and Negative Syndrome Scale (PANSS) data. No participant had been diagnosed with autoimmune encephalitis or received treatment for this condition. After calculating the prevalence of serum anti-NMDAR antibodies, we examined possible differences in PANSS scores (negative, positive, and general symptom subscales, and total score) between anti-NMDAR-seropositive and anti-NMDAR-seronegative patients. Psychosocial functioning as measured by Personal Social Performance (PSP) score was also compared. All analyses were exploratory and no adjustment was done for multiple testing. People with lived experience were not involved in the conduct of this study. We collected individual patient data from 1114 patients with schizophrenia across the four cohorts. The study population had a mean age of 28·6 years (SD 7·6) and comprised 382 (34·3%) women and 732 (65·7%) men, including patients of White (929 [83·4%]), Asian (54 [4·8%]), Black (68 [6·1%]), and other (62 [5·6%]) ethnicities. Overall, 41 (3·7%) participants (range 3·1-4·0% across cohorts) tested positive for serum anti-NMDAR antibodies. Lower symptom severity on the negative symptoms PANSS subscale was observed for anti-NMDAR-seropositive patients (mean score 15·8 [SD 6·4]) than for anti-NMDAR-seronegative patients (18·2 [6·8]; Cohen's d=0·36; p=0·026), as well as on the general symptoms PANSS subscale (32·9 [8·9] vs 36·1 [10·1]; d=0·33; p=0·029) and total PANSS score (65·5 [18·5] vs 72·6 [19·3]; d=0·37; p=0·013). Mean PSP score was better in anti-NMDAR-positive patients (62·0 [17·0]) than in anti-NMDAR-negative patients (53·5 [16·3]; d=0·52; p=0·014). Serum NMDAR antibodies are present in 3-4% of patients with schizophrenia and are associated with relatively low severity of negative symptoms and relatively good psychosocial functioning. Thus, although the findings await replication in cohorts from other geographical regions, serum anti-NMDAR antibodies might be associated with a different form of psychotic illness. These findings could inform future prognostic and interventional studies examining whether anti-NMDAR antibodies are associated with a specific course of illness or with treatment response. None.

Depression and Anxiety Symptoms Before and After Breast-Cancer Diagnosis Among Young Women in the Northern Finland Birth Cohort 1966.

The aim of the study was to explore depressive, anxiety, and mental-health related somatic symptoms among young breast-cancer survivors by considering symptoms before and after cancer onset. The study sample included females from the prospective Northern Finland Birth Cohort 1966. Symptoms were assessed with the Hopkins Symptom Checklist-25 at the age of 31 and 46 years. We studied both subscales of depressive, anxiety, and somatic symptoms and single symptoms in secondary analyses. Thirty-one cases and 3.077 controls were included. Females diagnosed with breast cancer 3-8 years before the 46-year follow-up had increased depressive (p = 0.005) and somatic symptoms (p = 0.028) at the 46-year follow-up compared with the 31-year follow-up. This was not observed among those diagnosed <3 or >8 years before or among controls. Females diagnosed with breast cancer reported more lack of strength or energy compared with controls at the 46-year follow-up (p = 0.047). Among females who did not report feeling that the future is hopeless at the 31-year follow-up, significantly more females diagnosed with breast cancer reported this feeling at the 46-year follow-up compared with controls (p = 0.006). Depressive and somatic symptoms increased significantly among young females at 3-8 years after breast-cancer diagnosis compared with the time before the cancer diagnosis. Psychosocial measures of support for breast-cancer survivors should be provided over the long-term.

Clinical and cost-effectiveness of spironolactone in treating persistent facial acne in women: SAFA double-blinded RCT.

Acne is common, can cause significant impact on quality of life and is a frequent reason for long-term antibiotic use. Spironolactone has been prescribed for acne in women for many years, but robust evidence is lacking. To evaluate whether spironolactone is clinically effective and cost-effective in treating acne in women. Pragmatic, parallel, double-blind, randomised superiority trial. Primary and secondary healthcare and community settings (community and social media advertising). Women aged 18 years and older with facial acne persisting for at least 6 months, judged to potentially warrant oral antibiotic treatment. Participants were randomised 1:1, using an independent web-based procedure, to either 50 mg/day spironolactone or matched placebo until week 6, increasing to 100 mg/day spironolactone or matched placebo until week 24. Participants continued usual topical treatment. Primary outcome was the adjusted mean difference in Acne-Specific Quality of Life symptom subscale score at 12 weeks. Secondary outcomes included Acne-Specific Quality of Life total and subscales; participant self-assessed improvement; Investigator's Global Assessment; Participant's Global Assessment; satisfaction; adverse effects and cost-effectiveness. Of 1267 women assessed for eligibility, 410 were randomised (201 intervention, 209 control), 342 in the primary analysis (176 intervention, 166 control). Mean age was 29.2 years (standard deviation 7.2) and 7.9% (28/356) were from non-white backgrounds. At baseline, Investigator's Global Assessment classified acne as mild in 46%, moderate in 40% and severe in 13%. At baseline, 82.9% were using topical treatments. Over 95% of participants in both groups tolerated the treatment and increased their dose. Mean baseline Acne-Specific Quality of Life symptom subscale was 13.0 (standard deviation 4.7) across both groups. Mean scores at week 12 were 19.2 (standard deviation 6.1) for spironolactone and 17.8 (standard deviation 5.6) for placebo [difference favouring spironolactone 1.27 (95% confidence interval 0.07 to 2.46) adjusting for baseline variables]. Mean scores at week 24 were 21.2 (standard deviation 5.9) in spironolactone group and 17.4 (standard deviation 5.8) in placebo group [adjusted difference 3.77 (95% confidence interval 2.50 to 5.03) adjusted]. Secondary outcomes also favoured spironolactone at 12 weeks with greater differences at 24 weeks. Participants taking spironolactone were more likely than those taking placebo to report overall acne improvement at 12 weeks {72.2% vs. 67.9% [adjusted odds ratio 1.16 (95% confidence interval 0.70 to 1.91)]} and at 24 weeks {81.9% vs. 63.3% [adjusted odds ratio 2.72 (95% confidence interval1.50 to 4.93)]}. Investigator'sGlobalAssessment was judged successful at week 12 for 31/201 (18.5%) taking spironolactone and 9/209 (5.6%) taking placebo [adjusted odds ratio 5.18 (95% confidence interval 2.18 to 12.28)]. Satisfaction with treatment improved in 70.6% of participants taking spironolactone compared with 43.1% taking placebo [adjusted odds ratio 3.12 (95% confidence interval 1.80 to 5.41)]. Adverse reactions were similar between groups, but headaches were reported more commonly on spironolactone (20.4% vs. 12.0%). No serious adverse reactions were reported. Taking account for missing data through multiple imputation gave an incremental cost per quality-adjusted life-year of £27,879 (adjusted) compared to placebo or £2683 per quality-adjusted life-year compared to oral antibiotics. Spironolactone resulted in better participant-reported and investigator-reported outcomes than placebo, with greater differences at week 24 than week 12. This trial is registered as ISRCTN12892056 and EudraCT (2018-003630-33). This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/13/02) and is published in full in Health Technology Assessment; Vol. 28, No. 56. See the NIHR Funding and Awards website for further award information.

Use of video-recordings of site-based interviews for quality assurance in a study of subjects with schizophrenia and persistent negative symptoms

Site-independent ratings derived from audio-digital recordings of site-based interviews are often used for quality assurance monitoring to affirm ratings reliability in CNS clinical trials. The present study of subjects with schizophrenia and persistent negative symptoms used video instead of audio recordings of site-based interviews and thereby facilitated visual observation of the subject by the remote rater. “Paired” site-independent scores of the Positive and Negative Syndrome Scale (PANSS) and Brief Negative Symptom Scale (BNSS) were obtained from video-recordings of site-based interviews.The intraclass correlation between site-based and paired site-independent ratings was r = 0.839 for the total PANSS scores (n = 1006) and r = 0.871 for the total BNSS scores (n = 892); <5 % of paired scores deviated outside the acceptable confidence intervals. Ratings “outliers” were identified and remediated.We examined the pattern of paired scoring deviations for the BNSS, total PANSS, PANSS symptom subscales, and the Marder negative symptom factor. Each metric revealed a bidirectional pattern of scoring deviations such that mean site-based ratings were higher than site-independent ratings when symptom severity was high but lower than site-independent ratings when symptom severity was low.The pattern of bidirectional paired scoring deviations observed in this analysis has previously been noted in paired ratings analyses of subjects experiencing an acute exacerbation of psychosis in schizophrenia and major depressive disorder as well. The bidirectional pattern may reflect inherent differences between live ratings and remotely scored recorded ratings.This analysis affirms the utility of video-recordings of site-based ratings for surveillance in trials with subjects with schizophrenia and persistent negative symptoms.

Predictors of Patient-Reported Outcomes After Hyaluronic Acid Injections: Effect of Expectations and Psychological Stress.

Hyaluronic acid (HA) injections are a common nonsurgical treatment of knee osteoarthritis (OA). Patient expectations and psychological stress are believed to affect outcomes after orthopaedic procedures. This was a prospective cohort study seeking to identify factors predictive of greater patient-reported outcomes after HA injections, particularly expectations and psychological stress. 250 patients receiving a series of HA injections for knee OA were enrolled, with 196 being included for analysis. Demographics, surgical history, and preoperative Kellgren-Lawrence severity scores were collected, and patients completed the Knee Osteoarthritis Outcome Score (KOOS) questionnaire, a modified KOOS questionnaire assessing their 6-month postinjection expectations, and the Perceived Stress Scale before the first injection. Outcomes were assessed at 3 weeks and 3 and 6 months after the final injection. KOOS scores improved from preinjection to 6-month follow-up but did not meet patients' expectations or minimal clinically important difference. Expectations correlated with 6-month KOOS pain, activities of daily living, sport, and quality of life subscales (ρ = 0.19 to 0.34), but not the symptom subscale (P = 0.10). Expectations (ρ = 0.31 to 0.37), younger age (ρ = -0.17 to -0.18), and greater perceived stress (ρ = 0.23) correlated with greater improvement from baseline KOOSs. Lower body mass index (ρ = -0.19 to -0.22), male sex (ρ = -0.17), and greater preinjection function (ρ = 0.37 to 0.46) correlated with greater 6-month outcomes. Stress measured on the Perceived Stress Scale did not correlate with 6-month KOOSs (P ≥ 0.27). Lower Kellgren-Lawrence severity score was weakly associated with greater 6-month KOOS activities of daily living and sport scores (ρ = -0.15 to -0.16) and greater improvement in the KOOS symptom score (ρ = -0.15). This study identified that higher expectations, lower body mass index, younger age, male sex, lower radiographic severity, greater preinjection function, and greater perceived stress are associated with greater patient outcomes after HA injection. Physicians should consider these factors when counseling patients with knee OA about viscosupplementation. Prospective Cohort Study (Level of Evidence II).

Self and proxy symptom reporting in glioma patient-caregiver dyads: the role of psychosocial function in rating accuracy

BackgroundIllness-related communication and depressive symptoms within families may play an important role in caregivers’ ability to accurately understand patients’ symptom burden. We examined the associations between these psychosocial factors and symptom accuracy in patients with glioma and their family caregivers.MethodsPatients and caregivers (n = 67 dyads) completed measures of depressive symptoms (CES-D), illness communication (CICS), and QOL (SF-36). Patients reported on their own cancer-related symptoms (MDASI-BT) while caregivers reported on their perception of the patients’ symptoms (i.e., proxy reporting). Paired t-tests and difference scores were used to test for agreement (absolute value of difference scores between patients and caregiver proxy symptom and interference severity reports) and accuracy (caregiver underestimation, overestimation, or accurate estimation of patient symptom and interference severity).ResultsClinically significant disagreement was found for all means scores of the MDASI-BT subscales except for gastrointestinal symptoms and general symptoms. Among caregivers, 22% overestimated overall symptom severity and 32% overestimated overall symptom interference. In addition, 13% of caregivers underestimated overall symptom severity and 21% of caregivers underestimated overall symptom interference. Patient illness communication was associated with agreement of overall symptom severity (r=−0.27, p = 0.03) and affective symptom subscale (r=−0.34, p < 0.01). Caregivers’ reporting of illness communication (r=−0.33, p < 0.01) and depressive symptoms (r = 0.46, p < 0.0001) were associated with agreement of symptom interference. Caregiver underestimating symptom severity was associated with lower patient physical QOL (p < 0.01); caregiver underestimating symptom interference was associated with lower patient physical QOL (p < 0.0001) and overestimating symptom interference was associated with lower patient physical QOL (p < 0.05). Patient and caregiver mental QOL was associated with caregiver underestimating (p < 0.05) and overestimating (p < 0.05) symptom severity.ConclusionThe psychosocial context of the family plays an important role in the accuracy of symptom understanding. Inaccurately understanding patients experience is related to poor QOL for both patients and caregivers, pointing to important targets for symptom management interventions that involve family caregivers.

EMDR and standard psychotherapy for paediatric cancer patients and their families: a pilot study.

This study examined the efficacy of eye movement desensitisation and reprocessing (EMDR) therapy compared with standard psychotherapy (SP) in treating post-traumatic stress disorder (PTSD) in paediatric oncology patients and their families in the early stage of cancer treatment. The secondary aim of this study was to assess whether EMDR therapy has a different impact on post-traumatic growth compared to SP. Forty patients were randomly assigned to EMDR or SP groups. The Impact of Event Scale - Revised (IES-R) and the Distress Thermometer (DT) were used to assess PTSD symptoms at pre-treatment (at cancer diagnosis) and in the post-treatment stages (after 8 sessions). The Post-traumatic Growth Inventory-PTGI was administered in the post-treatment stage in order to evaluate positive changes. Both EMDR and SP are effective in reducing PTSD, but EMDR was significantly more effective than the SP in reducing scores on the IES-R, especially regarding the intrusive symptom subscale. Also, in the EMDR group there were higher scores of PTGI than in the standard group. EMDR thus represents a promising treatment in the paediatric psycho-oncology setting.

Precision targeting in the globus pallidus interna: insights from the multicenter, prospective, blinded VA/NINDS CSP 468 study.

Deep brain stimulation (DBS) targeting the globus pallidus interna (GPi) has been shown to significantly improve motor symptoms for the treatment of medication-refractory Parkinson's disease. Yet, heterogeneity in clinical outcomes persists, possibly due to suboptimal target identification within the GPi. By leveraging robust sampling of the GPi and 6-month postsurgical outcomes, this study aims to determine optimal symptom-specific GPi DBS targets. In this study, the authors analyzed the anatomical lead location and 6-month postsurgical, double-blinded outcome measures of 86 patients who underwent bilateral GPi DBS. These patients were selected from the multicenter Veterans Affairs (VA)/National Institutes of Neurological Disorders and Stroke (NINDS) Cooperative Studies Program (CSP) 468 study to identify the optimal target zones ("sweet spots") for the control of overall motor (United Parkinson's Disease Rating Scale [UPDRS]-III), axial, tremor, rigidity, and bradykinesia symptoms. Lead coordinates were normalized to Montreal Neurological Institute space and the optimal target zones were identified and validated using a leave-one-patient-out approach. The authors' findings revealed statistically significant optimal target zones for UPDRS-III (R = 0.37, p < 0.001), axial (R = 0.22, p = 0.042), rigidity (R = 0.20, p = 0.021), and bradykinesia (R = 0.23, p = 0.004) symptoms. These zones were localized within the primary motor and premotor subdivisions of the GPi. Interestingly, these zones extended beyond the GPi lateral border into the GPi-globus pallidus externa (GPe) lamina and into the GPe, but they did not reach the GPi ventral border, challenging traditional surgical approaches based on pallidotomies. Drawing upon a robust dataset, this research effectively delineates specific optimal target zones for not only overall motor improvement but also symptom subscores. These insights hold the potential to enhance the precision of targeting in subsequent bilateral GPi DBS surgical procedures.

Health-related quality of life in patients with metastatic basal cell carcinoma treated with cemiplimab: Analysis of a phase 2 trial.

A phase 2 cemiplimab study (NCT03132636) demonstrated a 24.1% objective response rate in patients diagnosed with metastatic basal cell carcinoma (mBCC) who were not candidates for continued hedgehog inhibitor (HHI) therapy due to intolerance to previous HHI therapy, disease progression while receiving HHI therapy, or having not better than stable disease on HHI therapy after 9 months. Here, health-related quality of life (QoL) for this patient population is reported. Adult patients with mBCC were treated with intravenous cemiplimab at a dose of 350 mg every 3 weeks for 5 treatment cycles of 9 weeks/cycle then 4 treatment cycles of 12 weeks/cycle. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Skindex-16 questionnaires at baseline and Day 1 of each cycle. Across Cycles 2 to 9, the overall change from baseline was analyzed using a mixed model with repeated measures. Responder analyses determined clinically meaningful improvement or deterioration (changes ≥10 points) or maintenance across all scales. Patients reported low symptom burden and moderate-to-high functioning at baseline. Maintenance for QLQ-C30 global health status (GHS)/QoL and across all functioning and symptom scales was indicated by overall mean changes from baseline. Clinically meaningful improvement or maintenance was reported at Cycle 2 for GHS/QoL (77%), functioning scales (77% to 86%), and symptom scales (70% to 93%), with similar proportions of improvement or maintenance at Cycles 6 and 9, excluding fatigue. On the Skindex-16, clinically meaningful improvement or maintenance was reported across the emotional, symptom, and functional subscales, in 76%-88% of patients at Cycle 2, which were generally maintained at Cycles 6 and 9. Overall mean changes from baseline showed maintenance across these subscales. The majority of patients treated with cemiplimab reported improvement or maintenance in GHS/QoL and functioning while maintaining a low symptom burden.

Acupuncture for hot flashes in hormone receptor-positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.

Hot flashes are a common side effect of endocrine therapy (ET) that contribute to poor quality of life and decreased treatment adherence. Patients with breast cancer wo were receiving ET and experiencing hot flashes were enrolled through three parallel, randomized trials conducted in the United States, China, and South Korea. Participants were randomized to either immediate acupuncture (IA) or delayed acupuncture control (DAC). IA participants received 20 acupuncture sessions over 10 weeks, whereas DAC participants received usual care, then crossed over to acupuncture with a reduced intensity. The primary end point was a change in score on the endocrine symptom subscale of the Functional Assessment of Cancer Therapy (FACT)-Endocrine Symptoms between baseline and week 10. Secondary end points included the hot flash score and the FACT-Breast score. A planned pooled analysis of individual patient data was performed using longitudinal mixed models. In total, 158 women with stage 0-III breast cancer were randomized (United States, n=78; China, n=40; South Korea, n=40). At week 10, IA participants reported statistically significant improvements in the endocrine symptom subscale score (mean change±standard error: 5.1±0.9 vs. 0.2±1.0; p=.0003), the hot flash score (-5.3±0.9 vs. -1.4±0.9; p<.003), and the FACT-Breast total score (8.0±1.6 vs. -0.01±1.6; p=.0005) compared with DAC participants. The effect of the acupuncture intervention differed by site (p=.005). Acupuncture led to statistically and clinically meaningful improvements in hot flashes, endocrine symptoms, and breast cancer-specific quality of life in women undergoing ET for breast cancer in the United States, China, and South Korea.

Quality of life assessment in diffuse large B-cell lymphoma (DLBCL) in REFLECT: a prospective, non-interventional, multicenter, German study, assessing Sandoz rituximab in combination with CHOP

Health-related quality of life (HRQoL) data are important indicators of health status in patients with lymphoma. The objective of this analysis was to assess the impact of treatment with Sandoz rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) on HRQoL in treatment-naïve adult patients with diffuse large B-cell lymphoma (DLBCL) included in the prospective, real-world REFLECT study. REFLECT is the first prospective study to assess HRQoL in patients with DLBCL treated with a rituximab biosimilar. HRQoL was assessed via the patient-reported European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire at baseline, mid-treatment (month 3), end of treatment (month 6), and follow-up (months 9 and 12). Subgroup analyses were performed to evaluate the influence of baseline characteristics on HRQoL, and associations between baseline HRQoL and treatment response. HRQoL was assessed in 169 patients. Mean global health status score remained stable from baseline (54.8) to mid-treatment (month 3; 54.7), before steadily improving through to end of treatment (month 6; 61.4), and follow-up month 9 (64.9) and month 12 (68.8). Similar trends were observed across most functional and symptom subscales. Higher cognitive, physical, or role functioning, and less appetite loss, diarrhea, fatigue, or pain at baseline, were all associated with an improved likelihood of reaching a complete versus partial response at the end of treatment. Overall, these findings confirm the HRQoL benefits of R-CHOP therapy in treatment-naïve adult patients with DLBCL, and suggest that baseline HRQoL may be predictive of treatment response.

Randomized Laboratory Study of Single-Dose Cannabis, Dronabinol, and Placebo in Patients With Schizophrenia and Cannabis Use Disorder.

Up to 43% of people with schizophrenia have a lifetime cannabis use disorder (CUD). Tetrahydrocannabinol (THC) has been shown to exacerbate psychosis in a dose-dependent manner, but little research has assessed its effects on schizophrenia and co-occurring CUD (SCZ-CUD). In this double-dummy, placebo-controlled trial (total n = 130), we hypothesized that a modest dose of THC would worsen cognitive function but not psychosis. Effects of single-dose oral THC (15mg dronabinol) or smoked 3.5% THC cigarettes vs placebo in SCZ-CUD or CUD-only on positive and negative symptoms of schizophrenia (only for SCZ-CUD), cognition, and drug experiences assessed several hours after drug administration. SCZ-only and healthy control participants were also assessed. Drug liking was higher in THC groups vs placebo. Neither smoked THC nor oral dronabinol predicted positive or negative symptom subscale scores 2 and 5h, respectively, after drug exposure in SCZ-CUD participants. The oral dronabinol SCZ-CUD group, but not smoked THC SCZ-CUD group, performed worse than placebo on verbal learning (B = -9.89; 95% CI: -16.06, -3.18; P = .004) and attention (B = -0.61; 95% CI: -1.00, -0.23; P = .002). Every 10-point increment in serum THC + THCC ng/ml was associated with increased negative symptoms (0.40 points; 95% CI: 0.15, 0.65; P = .001; subscale ranges 7-49) and trends were observed for worse positive symptoms and performance in verbal learning, delayed recall, and working memory. In people with SCZ-CUD, a modest single dose of oral THC was associated with worse cognitive functioning without symptom exacerbation several hours after administration, and a THC dose-response effect was seen for negative symptoms.

Development and Validation of a Simple and Multifaceted Instrument, Chronic Constipation-Therapeutic Efficacy and Satisfaction Test, for the Clinical Evaluation of Patients with Chronic Constipation

Introduction: This study evaluated the psychometric properties of the newly developed chronic constipation-therapeutic efficacy and satisfaction test (CC-TEST) among patients with chronic constipation. Methods: Japanese patients with moderate or severe chronic constipation underwent a 4-week remedy. The baseline, 2-week, and 4-week assessments included the CC-TEST, Constipation Scoring System (CSS), Medical Outcome Study Short Form-8 Health Survey (SF-8), and Hospital Anxiety and Depression Scale (HADS). The CC-TEST comprises three domains: (1) symptoms; chronic constipation symptom severity (seven items), defecation status (five items), (2) impact for daily life; dissatisfaction with daily life level (DS; four items), and (3) therapeutic response; therapeutic efficacy measured by patients and medication compliance (four items). Results: Of 201 eligible patients at baseline, 110 completed the 4-week treatment and the survey responses. Cronbach’s α values for the stool, defecation, and abdominal symptom subscales, as well as the total symptom score and DS subscale, showed good internal consistency reliability (0.72–0.80). Pearson’s r for comparisons between corresponding items (CC-TEST symptoms with CSS, and CC-TEST DS with SF-8 physical and mental component summary scores) was significant. After 4 weeks, scores for symptoms, defecation status, and DS items/subscales notably decreased, with a significant effect size (p < 0.005, Cohen’s d; 0.30–1.16). Statistically significant differences emerged between treatment responders and nonresponders using the three responder definitions, in changes in scores for most CC-TEST symptoms, defecation status, and DS items/subscales (p < 0.05). Conclusion: CC-TEST demonstrates commendable reliability, convergent and known-group validity, and responsiveness to treatment effects. As a simple, comprehensive, and versatile patient-reported outcome measure, CC-TEST may be well suited for clinical trials and primary care of Japanese patients with chronic constipation.

DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH PEMPHIGUS: A CROSS-SECTIONAL STUDY

Objective: The objective of the study is (1) to analyze the prevalence and severity of depression in cases of pemphigus and (2) to study the association of demographic factors with the presence of depression in cases with pemphigus. Methods: A cross-sectional single-interview study was carried out on 100 consecutively selected patients with pemphigus attending the dermatology out-patient department in a tertiary care hospital. The assessment was done with semi-structured pro forma, Beck depression inventory (BDI), and quality of life (QoL) measure – Skindex-16. The Statistical Package for the Social Sciences 24.0 was used for statistical analysis and p&lt;0.05 was taken as statistically significant. Results: Out of 100 cases, there were 60 (60%) males and 40 (40%) were females with M: F ratio of 1:0.66. The mean age of male and female patients was found to be comparable with no statistically significant difference (p=0.6061). The majority were married, employed, and from rural backgrounds. 22% satisfied the Diagnostic and Statistical Manual for Mental Disorders 5th edition criteria for major depressive disorder. Assessment using BDI in these patients for severity of depression showed mild depression in 12%, moderate depression in 7%, and severe depression in 3%. Patients having a longer duration of illness and a history of frequent hospitalization were found to have significantly high scores on the subscale for depressive symptoms. QoL assessment using the Skindex-16 scale among these patients showed that they experienced more severe emotional and symptomatic effects due to skin disease compared to functional effects, especially during relapse. Those who had poor QoL showed significantly high scores on the subscale for depressive symptoms. Conclusion: More than 20% of patients of pemphigus had diagnosable depression with significant effects on QoL. Therefore, regular screening for depression is important in pemphigus patients as it will help in planning early intervention.

Prenatal Iodine Intake and Maternal Pregnancy and Postpartum Depressive and Anhedonia Symptoms: Findings from a Multiethnic US Cohort.

Objective: Emerging evidence suggests that essential trace elements, including iodine, play a vital role in depressive disorders. This study investigated whether prenatal dietary iodine intake alone and in combination with supplemental iodine intake during pregnancy were associated with antepartum and postpartum depressive and anhedonia symptoms. Methods: The study population included 837 mothers in the PRogramming of Intergenerational Stress Mechanisms (PRISM) study. The modified BLOCK food frequency questionnaire was used to estimate prenatal dietary and supplemental iodine intake, while the 10-item Edinburg Postpartum Depression Scale (EPDS) ascertained depressive symptoms. Analyses considered the global EPDS score and the anhedonia and depressive symptom subscale scores using dichotomized cutoffs. Logistic regression estimating odds ratios and 95% confidence intervals (CIs) assessed associations of iodine intake in the second trimester of pregnancy and 6-month postpartum depressive and anhedonia symptoms considering dietary intake alone and combined dietary and supplementary intake in separate models. Results: Most women were Black/Hispanic Black (43%) and non-Black Hispanics (35%), with 39% reporting a high school education or less. The median (interquartile range, IQR) dietary and supplemental iodine intake among Black/Hispanic Black (198 (115, 337) µg/day) and non-Black Hispanic women (195 (126, 323) µg/day) was higher than the overall median intake level of 187 (116, 315) µg/day. Relative to the Institute of Medicine recommended iodine intake level of 160-220 µg/day, women with intake levels < 100 µg/day, 100-<160 µg/day, >220-<400 µg/day and ≥400 µg/day had increased adjusted odds of 6-month postpartum anhedonia symptoms (aOR = 1.74 (95% CI: 1.08, 2.79), 1.25 (95% CI: 0.80, 1.99), 1.31 (95% CI: 0.82, 2.10), and 1.47 (95% CI: 0.86, 2.51), respectively). The corresponding estimates for postpartum global depressive symptoms were similar but of smaller magnitude. Conclusions: Prenatal iodine intake, whether below or above the recommended levels for pregnant women, was most strongly associated with greater anhedonia symptoms, particularly in the 6-month postpartum period. Further studies are warranted to corroborate these findings, as dietary and supplemental iodine intake are amenable to intervention.

Safety and patient-reported outcomes in patients with hormone receptor-positive, HER2-negative advanced breast cancer treated with CDK4/6 inhibitors in China: A cross-sectional study.

1054 Background: It is reported that the adverse event (AE) profile may vary with different CDK4/6 inhibitors. With the prolongation of survival, AEs occurred during the treatment period may affect quality of life (QoL) for patients with advanced disease. Currently, there has been no study focusing on the safety and patient-reported outcomes in Chinese patients treated with different CDK4/6 inhibitors. Methods: This was a large cross-sectional study conducted at 10 sites in China. Randomly selected patients with hormone receptor-positive, HER2-negative advanced breast cancer and their physicians were asked to fill the self-designed questionnaires. Disease characteristics and AEs were collected from the perspectives of both patients and physicians, while the patient questionnaire additionally included feedback on the AE management and the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-breast cancer module (QLQ-BR23). Results: Between Jan 30, 2023 and Sep 15, 2023, a total of 1254 patients (median age, 55 years) were included; 212 (16.9%) patients were treated with palbociclib, 483 (38.5%) with abemaciclib, 550 (43.9%) with dalpiciclib, and 9 (0.7%) with ribociclib. Of them, 197 (15.7%) had switching history or dose adjustment of CDK4/6 inhibitor, with the main reason being AEs (51.8%). From the perspective of physicians, the most common AEs for patients were decreased white blood cell (63.3%), decreased neutrophil count (58.7%), and diarrhea (36.3%). The incidence of increased alanine aminotransaminase (ALT) and increased aspartate aminotransaminase (AST) was 9.3% (grade ≥3, 6.0%) and 8.4% (grade ≥3, 6.7%), respectively. Dalpiciclib showed the lowest incidence of increased ALT (3.5%; grade ≥3, none), increased AST (4.2%; grade ≥3, none), and diarrhea (10.5%) compared with other CDK4/6 inhibitors (P&lt;0.001). From the perspective of patients, dalpiciclib showed the lowest incidence of fatigue, alopecia, hot flashes, insomnia, arthralgia, nausea, vomiting, diarrhea, and anorexia (P&lt;0.05). Regarding QoL, the mean scores of upset by hair loss for different CDK4/6 inhibitors were higher than other symptom subscale scores. Dalpiciclib showed the lowest mean score of upset by hair loss compared with abemaciclib and palbociclib, whether in total (19.74 vs 27.23 vs 21.47, P=0.006) or in patients with &gt;6 months of treatment (12.59 vs 27.78 vs 17.95, P&lt;0.001). Conclusions: AEs are different among various CDK4/6 inhibitors. Dalpiciclib has the lowest risk of diarrhea and hepatotoxicity based on physicians' reports, and shows the best patient-perceived safety. Regarding QoL, CDK4/6 inhibitors can result in upset by hair loss, while patients have the least concern about this issue when using dalpiciclib, especially for those with long treatment duration (&gt;6 months).