Symptom Subscale Research Articles

Health-Related Quality of Life and Thyroid Cancer-Specific Symptoms in Patients Treated for Differentiated Thyroid Cancer: A Single-Center Cross-Sectional Survey from Mainland China.

Background: The incidence of differentiated thyroid cancer in Mainland China has increased rapidly in recent years, yet the number of studies focusing on health-related quality of life (HR-QOL) is still limited. Additionally, some of the quality-of-life (QOL) issues specific to thyroid cancer have not been adequately described. The aims of this study were to assess the generic and disease-specific HR-QOL of differentiated thyroid cancer survivors and to identify the associated factors. Methods: A cross-sectional survey including 373 patients was conducted in Mainland China. Participants completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL), and a questionnaire on patient demographics and clinical characteristics. Results: The QLQ-C30 global mean score was 73.12 (standard deviation [SD] = 11.95), while the THYCA-QOL summary mean score was 34.50 (SD = 12.68). The two QLQ-C30 functional subscales with the lowest scores were the social functioning and role functioning subscales. The five symptom subscales of the THYCA-QOL with the highest scores were the subscales regarding less interest in sex, problems with scar, psychological problems, voice problems, and sympathetic problems. Factors associated with worse global QOL on the QLQ-C30 included a shorter time since completing primary treatment (≤6 months), a history of lateral neck dissection, and a lower current thyrotropin (TSH) level (≤0.5 mIU/L). Higher cumulative activities of radioiodine (RAI; >100 mCi), gender (women), postoperative hypoparathyroidism, and a history of lateral neck dissection were associated with worse thyroid cancer-specific QOL. In contrast, higher monthly household income (>5000￥) and a history of minimally invasive thyroid surgery were associated with better thyroid cancer-specific QOL. Conclusions: Thyroid cancer patients experience multiple health-related problems and disease-specific symptoms after completing primary treatment. Patients with a duration ≤6 months from the completion of primary treatment, those with a history of lateral neck dissection, and a current TSH level ≤0.5 mIU/L may be more likely to have impaired generic QOL. More thyroid cancer-specific symptoms may be associated with higher cumulative activities of RAI, gender (women), postoperative hypoparathyroidism, a history of lateral neck dissection, lower monthly household income, and conventional surgery.

Nonresponder does not mean not better: Improvement in nonsymptom domains in complex depressed patients who are not symptomatic responders to intensive treatment

In treatment studies of depression, response is typically defined as a 50% or greater reduction in symptom severity. However, multiple surveys of depressed patients have found that patients prioritize improved functioning and quality of life objectives over symptom improvement as the most important goal of treatment. The goal of the present study is to widen the lens of assessing outcome by examining response in nonsymptom domains in patients who are, by convention, considered nonresponders to treatment. Eight hundred and forty-four patients with major depressive disorder completed the Remission from Depression Questionnaire (RDQ), a self-report measure that assesses multiple constructs considered by patients to be relevant to assessing treatment outcome. At discharge, the patients made a global rating of the effectiveness of treatment. The 517 patients who were nonresponders on the depression symptom subscale of the RDQ are the focus of this report. The patients showed significant levels of improvement from admission to discharge in all nonsymptom domains, with medium to large effect sizes. Approximately one-third of the patients were responders on at least 1 of the nonsymptom domains. The failure to meet the conventional definition of treatment response based on symptom severity does not preclude significant improvement in nonsymptom domains.

Prevalence, risk factors and clinical correlates of glucose disturbances in a large sample of Han Chinese patients with first-episode drug-naïve major depressive disorder.

Glucose disturbances are a common comorbidity of major depressive disorder (MDD) patients and have been extensively studied in the past. However, few studies have explored glucose disturbances in first-episode drug-naïve (FEDN) MDD patients. The purpose of this study was to examine the prevalence and risk factors of glucose disturbances in FEDN MDD patients to understand the relationship between MDD and glucose disturbances in the acute early phase and provide important implications for therapeutic interventions. Using a cross-sectional design, we recruited a total of 1718 MDD patients. We collected their socio-demographic information, clinical data, and blood glucose indicators.17-item Hamilton Depression Rating Scale (HAMD), 14-item Hamilton Anxiety Rating Scale (HAMA), and the positive symptom subscale of the Positive and Negative Syndrome Scale (PANSS) were used to assess their depression, anxiety, psychotic symptoms, respectively. The prevalence of glucose disturbances in FEDN MDD patients was 13.6%. Depression, anxiety and psychotic symptoms, body mass index (BMI) levels and suicide attempts rates were higher in the group with glucose disorders than in the group without glucose disorders among patients with first-episode drug-naive MDD. Correlation analysis showed that glucose disturbances were associated with HAMD score, HAMA score, BMI, psychotic symptoms and suicide attempts. Furthermore, binary logistic regression showed that HAMD score and suicide attempts were independently associated with glucose disturbances in MDD patients. Our findings suggest that the prevalence of comorbid glucose disturbances is very high in FEDN MDD patients. Moreover, more severe depressive symptoms and higher suicide attempts are correlated with glucose disturbances in MDD FEDN patients in the early stage.

Positive and Negative Syndrome Scale (PANSS) predictors of hospitalization during home treatment on 1045 patients with schizophrenia in acute crisis

IntroductionSeveral factors related to the risk of requiring psychiatric hospitalization have been described in patients diagnosed with schizophrenia treated with methods other than home treatment. With regard to the symptoms, high global illness severity and positive symptoms of schizophrenia have been most frequently related to the risk of hospitalization in patients with schizophrenia. However, there are no studies describing which clinical factors increase the likelihood of being hospitalized while undergoing home follow-up.ObjectivesTo determine which of the clinical factors assessed in the PANSS predict the risk of hospitalization in patients diagnosed with schizophrenia following a home treatment program.MethodsAll patients with schizophrenia who were visited by a home treatment team in Barcelona between January 2017 and December 2021 were included in the study. A comparative, bivariate analysis of each item of the PANSS and of the global results of each category was conducted on those who were hospitalized and those who were not hospitalized. Finally, a logistic regression of each category of the PANSS was done on both groups, controlling for other socio-demographic and clinical factors.ResultsA total of 1045 patients with schizophrenia were evaluated in this study. PANSS positive symptom subscale (PANSS-S), PANSS General Psychopathology, PANSS Excited Component and PANSS Global Score scored higher in patients who were finally hospitalized in a conventional acute treatment unit. Regarding the PANSS negative symptom subscale, no significant differences were found between the two groups.In patients who required hospitalization, the scores of all the PANSS positive symptom subscale (PANSS-P) items and all items on the PANSS excited component (excitement, tension, hostility, uncooperativeness and poor impulse control) were significantly higher. Some items regarding general psychopathology (Somatic concern, anxiety, guilt feelings, tension, and mannerisms) were also significantly higher in the hospitalization group. Only 3 items—blunted affect, guilt feelings and motor retardation—scored significantly higher in patients who did not require hospitalization. In the logistic regression, only the global score of the PANSS-P reached statistical significance (P = 0.001).ConclusionsPositive symptoms scored in the PANSS seem to be the most predictive factors of hospitalization regarding clinical symptoms in patients with Schizophrenia following home treatment. Other items regarding exciting symptoms and general psychopathology also showed as relevant regarding the risk of conventional hospitalization in those patients.Disclosure of InterestNone Declared

Abstract P5-08-08: Ultrasound-guided injection with or without rehabilitation exercise in breast cancer survivors with sub-acromion-deltoid bursitis: a pilot randomized clinical study

Abstract BACKGROUND: Due to the increasing overall survival of breast cancer (BC) patients, a growing interest has been raised in the current literature on disabling consequences of cancer and its treatment [1,2]. In particular, after radical surgery for BC, patients might frequently be affected by functional limitation of the shoulder joint, potentially related to the immobilization, surgical scar tensions, axillary web syndrome, subpectoral prostheses or expanders, or peripheral nerve damage [3]. In this scenario, several challenges are still open in the therapeutic approach to this disabling condition and the optimal management of shoulder dysfunction in breast cancer patients is far from being fully characterized. Therefore, the aim of this study was to assess the effects of a comprehensive rehabilitation program including ultrasound-guided injection of the sub-acromion deltoid bursa (SAD) followed by a rehabilitation exercise protocol in terms of feasibility, pain relief, upper limb function, quality of life, and safety. METHODS: In this study, we recruited consecutive breast cancer women referring to a Physical Medicine and Rehabilitation in Northern Italy and suffering from SAD bursitis in the absence of tendon lesions. Patients were assessed for eligibility and subsequently randomly assigned 1:1 to two groups. Group A received ultrasound-guided percutaneous injection of the SAD bursa (lidocaine and triamcinolone acetate) followed by a rehabilitation exercise program of 5 sessions lasting 1 hour each., while Group B received ultrasound-guided percutaneous injection only. Patients were assessed at baseline (T0), after a week (T1), and after 3 months (T2). The outcomes were numerical pain rating scale (NPRS), handgrip strength (HGS) test, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Oxford Shoulder Score (OSS), Global Perceived Effect (GPE), and safety. RESULTS: Thirty-seven patients were enrolled and randomly assigned to Group A (n=19; mean age: 56.05 ± 10.30 years; body mass index (BMI): 23.58 ± 2.79 kg/m2) and Group B (n=18; mean age: 58.39 ± 12.09 years; BMI: 22.72 ± 3.16 kg/m2). No major or minor adverse events were reported after this multidisciplinary intervention. Statistically significant within-group differences were found in both groups in terms of NPRS after the treatment (p < 0.05) and after the follow-up (p < 0.05). The between-group analysis showed significant differences in pain intensity (NRS: 2.16 ± 1.39 vs 4.78 1.77; p < 0.05), isometric muscle strength (25.11 3.20 vs 20.33 4.92; p< 0.001), shoulder function (OSS: 17.00 3.27 vs 33.11 6.471; p< 0.0001), and EORTC QLQ-C30 (Functional subscale: 88.74 7.71 vs 77.67 13.64; p=0.017; Symptom subscale: 11.43 8.56 vs 19.61 13.72; p=0.048; Global Health subscale: 79.36 13.72 vs 70.56 8.26; p=0.022) of the after the follow-up. However, no significant differences (p > 0.05) were reported at T1. CONCLUSION: Our findings showed that a comprehensive rehabilitation approach including ultrasound-guided injection combined with rehabilitation exercise might be safe, well-tolerated, and effective in breast cancer patients with SAD bursitis. These data emphasized the positive role of an interdisciplinary rehabilitation management in pain management and improving overall well-being of breast cancer patients. Further studies with larger samples and longer follow-ups are needed to confirm our data. REFERENCES: 1. Nardin S et al. Breast Cancer Survivorship, Quality of Life, and Late Toxicities. Front Oncol 2020, 10, 864. 2. D’Egidio V et al. Counseling interventions delivered in women with breast cancer to improve health-related quality of life: a systematic review. Qual Life Res 2017, 26, 2573-2592, doi:10.1007/s11136-017-1613-6. 3. Hidding JT et al. Treatment related impairments in arm and shoulder in patients with breast cancer: a systematic review. PLoS One. 2014 May 9;9(5):e96748. Citation Format: Lorenzo Lippi, Alessandro de Sire, Arianna Folli, Francesco D’Abrosca, Alessio Turco, Giuseppina Bonizzi, Nicola Fusco, Marco Invernizzi. Ultrasound-guided injection with or without rehabilitation exercise in breast cancer survivors with sub-acromion-deltoid bursitis: a pilot randomized clinical study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-08-08.

Diminished Auditory Cortex Dynamic Range and its Clinical Correlates in First Episode Psychosis.

There is growing appreciation for the contribution of sensory disruptions to disease morbidity in psychosis. The present study examined auditory cortex (AC) dynamic range: the scaling of neurophysiological responses to stimulus intensity, among individuals with a schizophrenia spectrum illness (FESz) and its relationship to clinical outcomes at disease onset. Magnetoencephalography (MEG) was recorded from 35 FESz and 40 healthy controls (HC) during binaural presentation of tones at three intensities (75 dB, 80 dB, and 85 dB). MRIs were obtained to enhance cortical localization of MEG sensor-level activity. All participants completed the MATRICS cognitive battery (MCCB) and Global Functioning: Role and Social scales (GFR/GFS). Patients were administered the Positive and Negative Syndrome Scale (PANSS). FESz exhibited reduced AC response relative to HC. Enhancement of AC activity to tones of increasing intensity was blunted in FESz relative to HC. Reduced dynamic range (85-75 dB AC response) was associated with lower GFS (r = .58) and GFR (r = .45) scores, worse MCCB performance (r = .45), and increased PANSS Negative symptom subscale scores (r = -.55) among FESz, relationships not observed with AC responses to individual tones. Beyond an impaired AC response to pure tones, FESz exhibit reduced dynamic range relative to HC. This impairment was correlated with markers of disease morbidity including poorer community functioning as well as cognitive and negative symptoms. The relationship with impaired social functioning may reflect the role of AC dynamic range in decoding the emotional content of language and highlights its importance to future therapeutic sensory remediation protocols.

PATELLAR TENDON AUTOGRAFT IS ASSOCIATED WITH DIFFICULTY KNEELING BUT DOES NOT RESULT IN A MORE PAINFUL OR SYMPTOMATIC KNEE COMPARED WITH HAMSTRING TENDON AUTOGRAFT AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION

The bone-patellar tendon-bone (BTB) autograft is associated with difficulty kneeling following anterior cruciate ligament (ACL) reconstruction, however it is unclear whether it results in a more painful or symptomatic knee when compared to the hamstring tendon autograft. This study aimed to identify the rate of significant knee pain and difficulty kneeling following primary ACL reconstruction and clarify whether graft type influences the risk of these complications.Primary ACL reconstructions prospectively recorded in the New Zealand ACL Registry between April 2014 and November 2019 were analyzed. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was analyzed to identify patients who reported significant knee pain, defined as a KOOS Pain subscale score of ≤72 points, and kneeling difficulty, defined as a patient who reported “severe” or “extreme” difficulty when they kneel. The rate of knee pain and kneeling difficulty was compared between graft types via univariate Chi-square test and multivariate binary logistic regression with adjustment for patient demographics.4492 primary ACL reconstructions were analyzed. At 2-year follow-up, 9.3% of patients reported significant knee pain (420/4492) and 12.0% reported difficulty with kneeling (537/4492). Patients with a BTB autograft reported a higher rate of kneeling difficulty compared to patients with a hamstring tendon autograft (21.3% versus 9.4%, adjusted odds ratio = 3.12, p<0.001). There was no difference between graft types in the rate of significant knee pain (9.9% versus 9.2%, p = 0.49) or when comparing absolute values of the KOOS Pain (mean score for BTB = 88.7 versus 89.0, p = 0.37) and KOOS Symptoms subscales (mean score for BTB = 82.5 versus 82.1, p = 0.49).The BTB autograft is a risk factor for post-operative kneeling difficulty, but it does not result in a more painful or symptomatic knee when compared to the hamstring tendon autograft.

Gender differences in empathy and clinical symptoms in chronic schizophrenia patients: a large sample study based on a Chinese Han population

Background Empathy is social cognition and reduced empathy in schizophrenia (SCZ) has been noted; however, whether there are gender differences in empathy remains unclear. Therefore, the purpose of this study was to explore this issue by examining a large sample of the population with SCZ. Methods We recruited 987 SCZ patients (M/F = 638/349). The empathy was assessed by The Interpersonal Reactivity Index (IRI). The Positive and Negative Syndrome Scale (PANSS) was adopted to assess their clinical psychiatric symptoms and their ability to recognise the facial emotions of others was assessed by the Pictures Of Facial Affect (POFA). Results Female SCZ patients had higher IRI total score than male patients. In male patients, Pearson correlation analysis showed that empathy was negatively correlated with PANSS total score and negative symptom subscale scores, but positively correlated with anger identification. In female patients, IRI total score was negatively correlated with PANSS total score as well as its positive and negative symptom subscale scores (all p < 0.05). Conclusion There are gender differences in the empathy of SCZ patients, with female patients having greater empathy and a correlation with their clinical symptoms. This gender difference may provide potential clinical value for the treatment of SCZ. KEY POINTS Female SCZ were more likely to empathise than males; Female patients had more severe clinical symptoms than males; There were gender differences in the association between certain specific clinical presentations and empathy. In future studies, it may be useful to investigate gender differences in schizophrenia empathy for the diagnosis and treatment of the disorder.

Validity and reliability of the Indonesian version of the Scale for the Assessment of Negative Symptoms.

Negative symptoms have long been conceptualized as a core aspect of schizophrenia. Despite widespread recognition of the status of these symptoms as independent dimensions of schizophrenia, they are sometimes difficult to distinguish from depression or cognitive impairment. Therefore, objective assessment of schizophrenia symptoms is critical by obtaining a valid and reliable Indonesian version of the SANS instrument. This study aimed to determine the content validity, concurrent, internal consistency reliability, inter-rater, cut-off value, sensitivity, and specificity of the SANS instrument. This is a diagnostic study using the cross-sectional method to determine the relationship between the SANS and PANSS instruments on the negative symptom subscale. It was located at the Prof. Dr. M. Ildrem Mental Hospital of North Sumatera Province. Of the 400 subjects, 67.5% were males, and the median age of the subjects was 37 years (18-45). The results of the content validity test were good (mean I-CVI=1.00), and the concurrent validity test comparing the SANS and PANSS instruments on the negative symptom subscale obtained significant results (p < 0.001) with a strong correlation (r = 0.763). Additionally, the consistency reliability test had a very high internal score (Cronbach alpha = 0.969), the overall inter-rater reliability test was "very good" (ICC = 0.985), and the cut-off value was 10.5 with sensitivity and specificity values of 72.9 and 77.9%, respectively. The Indonesian version of the SANS instrument is valid and reliable for measuring negative symptoms in people with schizophrenia in Indonesia.

A retrospective case-control study of facial emotion recognition in male veterans with chronic schizophrenia and its correlation with interpersonal communication

ObjectiveTo understand the facial emotion recognition of male veterans with chronic schizophrenia and the relationship between facial emotion recognition and interpersonal communication to provide a reference for designing social skills training programmes.MethodFifty-six eligible male patients with chronic schizophrenia who were admitted to our hospital from October 2020 to April 2021 were selected, and 24 healthy people were selected as controls. Facial emotion recognition, social communication skills and self-perceived interpersonal disturbance were assessed using a facial emotion recognition stimulus manual, the Social Skills Checklist (SSC) and the Interpersonal Relationship Integrative Diagnostic Scale (IRIDS). Disease status was assessed using the Positive and Negative Syndrome Scale.ResultsBoth the control group and the patient group had the highest recognition accuracy for neutral faces. The recognition rate for neutral expression was higher in the control group than in the patient group (p = 0.008). The rate of neutral expressions identified as happiness was higher in the patient group than in the control group (p = 0.001). The identification of anger as happiness was higher in the control group than in the patient group (p = 0.026), and the pattern of misidentification was similar between the control group and the patient group. The accuracy of facial emotion recognition was negatively associated with the age of onset (p < 0.05). The recognition accuracy for happiness was negatively associated with negative symptoms, general pathological symptoms and total scale scores (p < 0.05). The total score for expression recognition was negatively associated with the negative symptom subscale scores (p < 0.05), and there was no correlation between expression recognition and positive symptoms (p > 0.05). The recognition accuracy for happiness was negatively correlated with the IRIDS conversation factor (p < 0.05). The recognition accuracy for happiness and anger and the total scores for facial emotion recognition were negatively correlated with the SSC subscale score and the total score (p < 0.05 and p < 0.01, respectively). The main influencing factors on facial emotion recognition were the SSC total score (p < 0.001) and the positive factor score (p = 0.039).ConclusionVeterans with chronic schizophrenia have facial emotion recognition impairments affected by negative symptoms. There is a correlation between facial emotion recognition and interpersonal communication.Highlights1. There are extensive facial expression recognition disorders in schizophrenia.2. The pattern of misidentification was similar in both the control group and the patient group, with the tendency for happiness to be identified as a neutral emotion, anger as happiness, and fear as neutral emotion and anger.3. Based on the comprehensive assessment of social cognitive impairment in patients with schizophrenia, prospective studies of standardised interventions are designed to provide support for clinical practice.

The Role of Ascending Ventral-Tegmental Fibers for Recovery after Stroke.

The integrity of cortical motor networks and their descending effector pathway (the corticospinal tract [CST]) is a major determinant motor recovery after stroke. However, this view neglects the importance of ascending tracts and their modulatory effects on cortical physiology. Here, we explore the role of such a tract that connects dopaminergic ventral tegmental midbrain nuclei to the motor cortex (the VTMC tract) for post-stroke recovery. Lesion data and diffusivity parameters (fractional anisotropy) of the ipsi- and contralesional VTMC tract and CST were obtained from 133 patients (63.9 ± 13.4 years, 45 women) during the acute and chronic stage after the first ever ischemic stroke in the middle cerebral artery territory. Degeneration of VTMC tract and CST was quantified and related to clinical outcome parameters (National Institute of Health Stroke Scale with motor and cortical symptom subscores; modified Fugl-Meyer upper extremity score; modified Ranking Scale [mRS]). A significant post-stroke degeneration occurred in both tracts, but only VTMC degeneration was associated with lesion size. Using multiple regression models, we dissected the impact of particular tracts on recovery: Changes in VTMC tract integrity were stronger associated with independence in daily activities (mRS), upper limb motor impairment (modified Fugl-Meyer upper extremity score) and cortical symptoms (aphasia, neglect) captured by National Institute of Health Stroke Scale compared to CST. Changes in CST integrity merely were associated with the degree of hemiparesis (National Institute of Health Stroke Scale motor subscale). Post-stroke outcome is influenced by ascending (VTMC) and descending (CST) fiber tracts. Favorable outcome regarding independence (modified Ranking Scale), upper limb motor function (modified Fugl-Meyer upper extremity score), and cortical symptoms (aphasia, neglect) was more strongly related to the ascending than descending tract. ANN NEUROL 2023;93:922-933.

Community-based multi-site randomized controlled trial of behavioral activation for patients with negative symptoms of schizophrenia

BackgroundNegative symptoms are closely related to the poor prognosis of schizophrenia, for which there is no effective treatment to date. Behavioral activation (BA), which is an effective treatment for depression, is a behavioral approach that targets low levels of response-contingent positive reinforcement. This study aimed to explore BA as an effective intervention for relieving the negative symptoms of schizophrenia. MethodsThis was a randomized single-blind controlled trial. Eighty-four patients with schizophrenia were enrolled in community mental health settings. Excluding 14 patients who opted out of the study, 70 were randomly assigned to receive BA in addition to treatment-as-usual (BA + TAU) or treatment-as-usual (TAU) only. Negative symptoms were assessed using the Clinical Assessment Interview for Negative Symptoms (CAINS) and Brief Negative Symptom Scale (BNSS) at baseline, post-treatment, and 6-months follow-up. ResultsSignificant differences between the BA + TAU and TAU only groups were observed in the measures of negative symptoms post-treatment. The total score of CAINS was significantly decreased after BA treatment (η2 = 0.13). The tendency of the BA + TAU treatment effect was also observed for the BNSS total score and PANSS negative symptom subscale (η2 = 0.10 and η2 = 0.11, respectively). However, the difference between the two groups was not sustained at the six-month follow-up. ConclusionsOur findings suggest that BA could be a promising time-limited and structured psychosocial intervention for schizophrenia-associated negative symptoms with the merit of easy dissemination. Further studies are needed to examine the factors involved in sustaining improvement.

Creative Arts Therapy Among Children With Cancer: Symptom Assessment Reveals Reduced Anxiety.

Symptom distress is related to decreased quality of life (QOL) among children with cancer, with high levels of pain, nausea, and anxiety reported. Creative arts therapy (CAT) has been related to improved QOL and symptoms in pediatric oncology, but the quality of evidence is mixed. This article aims to examine the QOL symptom subscales in relation to CAT over time in children during the first year of cancer treatment. A secondary analysis of prospective data was performed with linear mixed modeling on 267 observations with predictors of 2 groups: No CAT (n = 18) vs CAT (n = 65). The covariate of time (6 months) was used to explore the CAT relationship with the Pediatric Quality of Life Inventory (PedsQL) symptom subscales (pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication). Children (n = 83) were between 3 and 17 years old (M = 6), 51.2% female, and 32% minority. All tumor types were represented: liquid (37.3%), solid (24.1%), and central nervous system (38.6%). Reduced child report of procedural anxiety was significantly related to receiving CAT with a medium magnitude of association (adjusted effect size = 0.58, P = .01). Creative arts interventions were associated with a longitudinal improvement in anxiety in children with cancer. Further work is needed to target interventions to the appropriate specific burdensome symptoms. Pediatric oncology nurses can advocate for CAT as an effective intervention to ameliorate the burdensome procedural anxiety experienced by patients.

Patient-reported outcomes following selpercatinib treatment in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer and thyroid cancer, and RET-mutant medullary thyroid cancer in the phase II LIBRETTO-321 trial.

Patient-reported outcomes (PROs) are increasingly becoming an important part of clinical trials as they are helpful in analyzing the safety and efficacy of treatment in chronic diseases like cancer. We report PROs and health-related quality of life (HRQoL) with selpercatinib treatment among Chinese patients with rearranged in transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC), RET fusion-positive thyroid cancer (TC), and RET-mutant medullary TC (MTC) as an exploratory analysis of the LIBRETTO-321 trial. A total of 77 patients (47 RET fusion-positive NSCLC, 1 RET fusion-positive TC, and 29 RET-mutant MTC) were enrolled. Compliance for European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) was 100% at baseline and >90% at each time point. PROs were assessed using the EORTC QLQ-C30, and a bowel diary assessment for MTC patients with baseline diarrhea using the Systemic Therapy-Induced Diarrhea Assessment Tool. Data were collected at pre-dose; every 8 weeks from cycle 3; and every 12 weeks after cycle 13. A >10-point change from baseline was considered clinically meaningful. PRO changes were summarized through cycle 13. Most patients with NSCLC or MTC showed improvement or remained stable on the global health status and functional subscales. For global health status, 47.4% of NSCLC and MTC patients showed definite improvement with only 19.7% showing definite worsening. For functional subscales, less than 30% of the patients showed definite worsening. For symptom subscales, more than 64% of the patients either improved or remained stable for the symptoms. For MTC patients with bowel diary assessment (n = 5), there was no severity or worsening from baseline in the diarrheal episodes observed during treatment with selpercatinib. The study demonstrated favorable PROs in Chinese patients with RET fusion-positive NSCLC, TC, and RET-mutant MTC treated with selpercatinib. HRQoL was improved or stable as assessed by EORTC QLQ-30. This study was registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04280081) ClinicalTrials.gov Identifier: NCT04280081.

Menopausal Symptoms and Menopausal Rating Scale among Midlife Women: A Hospital-based Study.

Menopausal transition phase is a difficult time in a woman's life. Many factors such as age, socioeconomic status, education, ethnic cultural, and body physique determine the presence of menopausal symptoms. This study helps us to understand the severity and perseverance of menopausal symptoms in women of this locality. The aim of the study was to find distribution and severity of menopausal symptoms by self-rated Menopause Rating Scale (MRS) through different transition phases of menopause in women aged between 40 and 60 years. It is a hospital-based observational study. All the participants answered an 11-item MRS questionnaire. Out of 300 participants, 106 belonged to premenopausal state, 111 to perimenopausal state, and 83 were postmenopause. Overall, 47% of participants had one or the other menopausal symptoms. Most of them had mild-to-moderate symptoms. Only 3% had severe symptoms. Somatic subscale was the maximum reported symptoms in our study group. The most common symptom was physical and mental exhaustion (55%) and the least common was sexual problems (8%). Difficulty in sleeping and bladder symptoms were more and statistically significant in postmenopausal group where as hot flushes and irritability were more common in perimenopausal group. Somatic subscale symptoms are more common than urogenital or psychosocial subscales. Postmenopause women manifested higher symptoms than premenopause or perimenopause group women and most were mild to moderate in severity in women visiting our hospital.

Optimizing subjective wellbeing with amisulpride in first episode schizophrenia or related disorders.

Subjective response (SR) to antipsychotic medication is relevant for quality of life, adherence and recovery. Here, we evaluate (1) the extent of variation in SR in patients using a single antipsychotic; (2) the association between subjective and symptomatic response; and (3) predictors of SR. Open-label, single treatment condition with amisulpride in 339 patients with a first episode of a schizophrenia spectrum disorder, at most minimally treated before inclusion. Patients were evaluated at baseline, before start with amisulpride and after four weeks of treatment with the Subjective Wellbeing under Neuroleptic scale, the Positive and Negative Syndrome Scale, and the Calgary Depression Scale for Schizophrenia. (1) 26.8% of the patients had a substantial favorable SR, and 12.4% of the patients experienced a substantial dysphoric SR during treatment with amisulpride. (2) Modest positive associations were found between SR and 4 weeks change on symptom subscales (r = 0.268-0.390, p values < 0.001). (3) Baseline affective symptoms contributed to the prediction of subjective remission, demographic characteristics did not. Lower start dosage of amisulpride was associated with a more favorable SR (r = -0.215, p < 0.001). We conclude that variation in individual proneness for an unfavorable SR is substantial and only modestly associated with symptomatic response. We need earlier identification of those most at risk for unfavorable SR and research into interventions to improve SR to antipsychotic medication in those at risk.

The Alzheimer’s Disease‐Health Indices (AD‐HI): Development of Two Novel Outcome Measures for Use in Clinical Trials

AbstractBackgroundIn preparation for upcoming clinical trials, there is a clear need for improved clinical trial infrastructure to facilitate therapeutic assessment in Alzheimer’s disease, (AD), mild cognitive impairment (MCI), and related dementias. This research describes the development of a patient‐reported outcome measure, the Alzheimer’s Disease‐Health Index (AD‐HI), and a caregiver‐reported outcome measure, the Alzheimer’s Disease Caregiver‐Health Index (ADCR‐HI). These novel outcome measures were developed using large scale input from patients and caregivers and were designed in accordance with U.S. Food and Drug Administration (FDA) guidelines for use in drug labeling claims.MethodWe first conducted semi‐structured qualitative interviews with individuals with AD, MCI, or dementia and their caregivers to identify potential symptoms of importance to these disease populations. We subsequently performed a cross‐sectional study involving individuals with AD, MCI, or dementia and caregivers to determine the prevalence and relative importance of symptoms identified during preliminary qualitative interviews. Using this data, we developed two outcome measures known as the AD‐HI and the ADCR‐HI. Symptom questions and subscales were selected for the instruments based on their prevalence and importance to the patient populations, their generalizability, and ability to respond to therapeutic intervention. Factor analysis was used to group symptom questions into distinct symptomatic themes of patient health.ResultFifteen individuals with AD, MCI, or dementia and 15 caregivers provided 2,263 quotes regarding the symptomatic burden of AD, MCI, or dementia. One‐hundred and four patients and 329 caregivers participated in a cross‐sectional study to determine the prevalence and relative importance of the most relevant symptoms identified through interviews. The AD‐HI and the ADCR‐HI were developed based on this data and simultaneously measure overall patient disease burden and disease burden in 9 disease specific areas.ConclusionThe AD‐HI provides researchers and clinicians with a valid mechanism to measure disease burden during therapeutic trials involving individuals with AD, MCI, or dementia. Similarly, the ADCR‐HI provides a viable option when a patient can no longer complete a patient‐reported outcome measure on their own behalf. Ongoing steps will further optimize the usability and reliability of these instruments in preparation for upcoming clinical trials.

The Patient Health Questionnaire (PHQ-9) as a tool to screen for depression in people with multiple sclerosis: a cross-sectional validation study

Background:Depression has a point prevalence of 25% and lifetime prevalence of 50% in people with multiple sclerosis (pwMS). Due to accessibility and brevity, the 9-item Patient Health Questionnaire (PHQ-9) may be a useful tool in clinical practice for screening and monitoring of depressive symptoms in people with MS (pwMS).Methods:The objective of this study was to evaluate the reliability, validity and acceptability of the PHQ-9 as a screening tool for depressive symptoms in pwMS. PwMS completed online questionnaires at 3 time-points over 4-weeks. The PHQ-9, Multiple Sclerosis Impact Scale (MSIS-29), Centre for Disease Control Health-Related Quality of Life Measure (CDC-HQOL-4) and clinical history.Results:103 participants completed the PHQ-9 at three time points, 43% were categorised as depressed on at least one response. The PHQ-9 exhibited high internal reliability (Cronbach’s α = 0.89), and test-re-test agreement (ICC 0.89, 95% CI 0.85–0.91). Convergent validity was indicated through positive correlation with the mental health items on the MSIS-29 (r = 0.46 and r = 0.50) and CDC-HQOL-4 (r = 0.79 and r = 0.73) at both assessment points. Positive correlations between the PHQ-9 and the MSIS-29 (r = 0.86 and r = 0.84) and CDC-HQOL-4 (r = 0.55 and r = 0.37) physical symptom sub-scores did not indicate divergent validity. 93% of ratings evaluated the PHQ-9 as “Very” or “Completely” acceptable.Conclusion:The PHQ-9 is a reliable and valid measure of depressive symptoms in people with MS. Given its accessibility, ease of administration, and acceptability, we recommend the PHQ-9 as a tool to screen for depressive symptoms in people with MS.

Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma Treated with Talquetamab, a G Protein-Coupled Receptor Family C Group 5 Member D x CD3 Bispecific Antibody: Patient-Reported Outcomes from MonumenTAL-1

Introduction: Studies of multiple myeloma (MM) populations indicate that patients with more advanced and heavily pretreated disease have worse health-related quality of life (HRQoL) than those at earlier stages. In addition, treatment options are limited for triple-class exposed relapsed/refractory MM (RRMM), with little hope of improving HRQoL. Talquetamab is a first-in-class, off-the-shelf, T-cell redirecting bispecific antibody targeting both GPRC5D and CD3 receptors. MonumenTAL-1 is a phase 1/2 trial (NCT03399799/NCT04634552) of talquetamab in patients with RRMM. Patient-reported outcomes (PROs) data on HRQoL, symptoms, and functioning were collected in the phase 2 cohorts of MonumenTAL-1. Here, we report PROs, focusing on global health status (GHS), physical functioning, pain, and fatigue, for the 0.4 mg/kg subcutaneous (SC) weekly (QW) cohort. Data for the 0.8 mg/kg SC every 2 weeks (Q2W) cohort are immature currently. Methods. Patients enrolled in phase 2 must have previously received ≥3 prior lines of therapy, including ≥1 proteosome inhibitor, ≥1 immunomodulatory drug, and ≥1 anti-CD38 monoclonal antibody (ie, triple-class exposed). After screening, patients received talquetamab step-up doses, requiring hospitalization, before cycle 1. The European Organization for Research and Treatment of Cancer Quality of Life Core 30-item (EORTC QLQ-C30) questionnaire is a cancer-specific PRO instrument administered at screening, cycle 1, and then every other cycle. It includes a subscale to measure HRQoL, 5 functional scales, 3 symptom subscales, and 6 additional single items. Scores range from 0 to 100; higher scores indicate better GHS and functioning, whereas a higher score represents more symptom severity. Compliance with PROs was calculated as the number of completed assessments divided by the number of patients on study treatment at each assessment time point. Treatment effect was assessed with a mixed-effects model with repeated measures. For the analysis of the proportion of patients with meaningful improvement, the threshold for meaningful improvement from baseline was defined as a change of ≥10 points. Time to worsening was determined using the Kaplan-Meier estimate. Results: For patients treated with 0.4 mg/kg SC QW (n=122), compliance with completing the EORTC QLQ-C30 was 96% at screening and over 80% at most post-treatment visits. After an immediate decline in overall HRQoL between screening and cycle 1, patients reported meaningful improvements in EORTC QLQ-C30 GHS and a meaningful reduction in pain symptoms compared with baseline (Figure). Least squares [LS] mean change for fatigue symptoms was -8 (95% CI, -13.83, -2.26) at cycle 9 and reached a mean decrease (ie, improvement) of 11.2 points (95% CI, -18.9, -3.53) at cycle 13. Similar results were observed in the physical (LS mean change at cycle 9: 6.5 [95% CI, 2.05, 10.93]) and role (LS mean change at cycle 9: 11.4 [95% CI, 4.55, 18.25]) functioning subscales. With treatment, the proportion of patients with meaningful improvement was high; for example, at cycle 9 for the 0.4 mg/kg cohort, 42% improved in GHS, 34% in physical functioning, 40% in role functioning, 86% in pain symptoms, and 78% in fatigue symptoms. Median time to worsening ranged from 2 (role and social functioning) to 9 months (nausea/vomiting). Overall, changes in PROs were similar in the 0.8 mg/kg SC Q2W cohort in early cycles, but conclusions are limited due to short follow-up and small sample size. The 0.8 mg/kg SC Q2W cohort will be updated with additional follow-up. Conclusions: With talquetamab treatment, patients in the 0.4 mg/kg SC QW cohort reported improvement in overall HRQoL and physical and role functioning and a decrease in pain and fatigue. These findings are consistent with the clinical benefits of talquetamab as demonstrated by the efficacy results from the MonumenTAL-1 study. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Health-Related Quality of Life in Transplant-Eligible Patients with Newly Diagnosed Multiple Myeloma Treated with Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone: Patient Reported Outcomes from GRIFFIN

Introduction: GRIFFIN (NCT02874742) is a multicenter, randomized, open-label, active-controlled, phase 2 study comparing daratumumab in combination with bortezomib, lenalidomide and dexamethasone (D-RVd) vs RVd in transplant-eligible patients (pts) with newly diagnosed multiple myeloma (NDMM). In the primary analysis (median follow-up: 13.5 months), D-RVd improved the stringent complete response rate by end of post-autologous stem cell transplant (ASCT) consolidation; the rates of minimal residual disease (MRD) negativity (10-5) were also improved for D-RVd vs RVd at median follow-up of 22.1 months. With longer follow-up after all pts completed 2 years of maintenance therapy (median: 38.6 months), D-RVd continued to induce deeper responses and improve MRD negativity (10−5) rates vs RVd. Here, we present the patient-reported outcomes (PROs) from GRIFFIN at the final study analysis after all pts completed 1 year of follow-up post maintenance therapy with 49.6 months of median follow-up. Methods: Pts with NDMM who were eligible for ASCT were randomized to receive 4 cycles of D-RVd or RVd induction and ASCT, followed by 2 cycles of D-RVd or RVd consolidation, and D-R or R maintenance for up to 24 months. Pts could continue on R maintenance after study treatment completion per local standard of care. PROs were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30), EORTC QLQ Multiple Myeloma Module 20-item (EORTC QLQ-MY20), and EuroQol 5-dimensional (EQ-5D-5L) descriptive system. Questionnaires were completed at baseline (BL), on day 1 of cycles (C) 2, 3, 5, on day 21 of C4, post-ASCT consolidation, and after months 6, 12, 18 and 24 of maintenance. Analyses were conducted on all randomized pts. Compliance with PRO assessments was calculated by dividing the number of assessments received by the number of assessments expected at each time point. Time to first worsening, hazard ratios (HR), and associated 95% confidence intervals (CI) were estimated using Kaplan- Meier methods and Cox proportional hazards model. A distribution-based method was used to define worsening in scores. Mean change from BL was analyzed using a mixed-effects model with repeated measures. Results: A total of 207 pts were randomized (D-RVd, n=104; RVd, n=103). Compliance rates for all PRO questionnaires were >81% at BL, were 62.6% in the D-RVd group and 48.6% in the RVd group post-ASCT consolidation and decreased with follow-up during the maintenance phase (maintenance Month 24: D-RVd, 49.4%; RVd, 45.1%). Mean BL values for QLQ-C30 Global Health Status (GHS), functional and symptom subscales and EQ-5D-5L Visual Analog Scale (VAS) were comparable between the D-RVd and RVd groups. Least squares (LS) mean change from BL improved for GHS and physical functioning during the maintenance phase in the D-RVd group (Figure1A) and was numerically greater with D-RVd vs RVd (maintenance Month 24, LS mean change [95% CI] for GHS: 13.2 [7.9, 18.5] vs 8.8 [1.9, 15.6]; LS mean change [95% CI] for physical functioning: 21.6 [16.1, 27.2] vs 11.6 [4.5, 18.6)], P=0.0158). Reduction in pain symptoms was seen at most time points for pts in both treatment arms, with a large reduction (≥20-point change) in pain in favor of D-RVd at post-ASCT consolidation and throughout the maintenance phase (maintenance Month 24 [LS mean change {95% CI}: -29.7 {-37.3, -22.2} vs -18.4 {-28.1, -8.7}; P=0.0497; Figure 1B). Pts treated with D-RVd experienced a greater reduction in fatigue symptoms at maintenance Month 6 than those treated with RVd (LS mean change [95% CI]: -13.5 [-19.4, -7.6] vs -5.0 [-11.8, 1.7]; P=0.0347; Figure 1B). Similarly, EQ-5D-5L VAS was higher with D-RVd vs RVd at maintenance Month 18. Improvements from BL were seen in EORTC QLQ MY20 disease symptoms and future perspective for both treatment groups and generally favored D-RVd at several time points. Median time to first worsening in GHS was 45.2 months vs 14.4 months with D-RVd vs RVd (HR [95% CI]: 0.71 [0.46, 1.10]). Conclusions: The addition of daratumumab to RVd resulted in greater improvements in health-related quality of life (HRQoL) for pts who continued on maintenance treatment post-ASCT consolidation vs RVd alone, with a notable reduction in pain symptoms. Overall, these findings further support the addition of daratumumab to RVd in transplant-eligible pts with NDMM without compromise of HRQoL. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal