Symptom Interference Research Articles

The Prenatal Obsessive-Compulsive Scale: Psychometric and descriptive study in a Portuguese sample

During pregnancy, obsessive-compulsive (OC) symptoms and disorder are underdiagnosed and undertreated. The Prenatal Obsessive-Compulsive Scale (PreOCS; Lord, Rieder, Hall, Soares, & Steiner, 2011) is the only self-report questionnaire that evaluates the severity and interference of specific pregnancy-related obsessions and compulsions. We aimed to analyze the validity and reliability of the PreOCS Portuguese version and to describe the prevalence, content, severity, interference, and onset of OC symptoms in pregnancy. Three hundred fifty-five pregnant women completed the PreOCS and other self-report instruments to evaluate perinatal anxiety and depression. Exploratory and confirmatory factor analyses revealed that a second-order model presented an acceptable fit. Cronbach's alphas were ≥.75 for the Severity and the Interference subscales and both were moderately correlated with depression and anxiety measures. Nearly 10% of the women presented OC symptoms with relevant severity. Co-occurrence of obsessions and compulsions (44.4%) was associated with significantly higher PreOCS scores. Obsessions about contamination, harm to the baby, others' judgment and baby's health presented the highest prevalence and increased the odds of having at least one compulsion. Searching for information, asking for reassurance, checking, and cleaning were the most reported compulsions. The Portuguese version of PreOCS has good psychometric properties, presenting itself as a valid and reliable instrument.

The Influence of Multiple Chronic Conditions on Symptom Clusters in People With Solid Tumor Cancers.

People with cancer who also have multiple chronic conditions (MCCs) experience co-occurring symptoms known as symptom clusters. To describe MCC and symptom clusters in people with cancer and to evaluate the relationships between MCCs and symptom severity, symptom interference with daily life, and quality of life (QoL). Weekly over a 3-week chemotherapy cycle, 182 adults with solid tumor cancer receiving chemotherapy completed measures of symptom severity, symptom interference with daily life, and QoL. Medical records reviewed to count number of MCCs in addition to cancer. Exploratory factor analysis was performed to identify symptom clusters. The relationships between the number of MCCs and the outcomes (symptom severity and symptom interference with daily life and QoL) at each time point were examined using the χ2 test. Longitudinal changes in outcomes were examined graphically. The number of MCCs ranged from 0 to 9, but most participants (62.1%) had 2 or fewer MCCs. Obesity was the most prevalent chronic condition. Four symptom clusters were identified: nutrition, neurocognitive, abdominal discomfort, and respiratory clusters. At each time point, no significant differences were found for MCCs and any outcome. However, symptom severity in all the symptom clusters, symptom interference with daily life, and QoL demonstrated a worsening in the week following chemotherapy. A majority of our sample had 2 or fewer MCCs, and MCCs did contribute to patient outcomes. Rather, timing of chemotherapy cycle had the greatest influence of patient outcomes. Additional support on day 7 of chemotherapy treatment is needed for people with MCCs.

Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study.

Background:Diroximel fumarate (DRF) is a novel oral fumarate approved for relapsing forms of multiple sclerosis (MS). DRF demonstrated significantly improved gastrointestinal (GI) tolerability versus dimethyl fumarate (DMF) with fewer days of Individual Gastrointestinal Symptom and Impact Scale (IGISIS) scores ⩾2, GI adverse events (AEs), and treatment discontinuations due to GI AEs. Our aim was to evaluate the impact of GI tolerability events on quality of life (QoL) for patients with relapsing–remitting MS who received DRF or DMF in EVOLVE-MS-2.Methods:A post hoc analysis was conducted in patients who were enrolled in the randomized, blinded, 5-week, EVOLVE-MS-2 [ClinicalTrials.gov identifier: NCT03093324] study of DRF versus DMF. Patients completed daily IGISIS and Global GISIS (GGISIS) eDiary questionnaires to assess GI symptom intensity and interference with daily activities and work.Results:In total, 504 patients (DRF, n = 253; DMF, n = 251) received study drug and 502 (DRF, n = 253; DMF, n = 249) completed at least one post-baseline questionnaire. With DRF, GI symptoms were less likely to interfere ‘quite a bit’ or ‘extremely’ with regular daily activities [IGISIS: DRF, 9.5% (24/253) versus DMF, 28.9% (72/249)] or work productivity [GGISIS: DRF, 6.1% (10/165) versus DMF, 11.3% (18/159)]. DRF-treated patients had fewer days with ⩾1 h of missed work (DRF, 43 days, n = 20 versus DMF, 88 days, n = 26). DMF-treated patients reported highest GI symptom severity and missed work at week 2–3 shortly after completing the titration period, which coincided with the majority of GI-related treatment discontinuations [58.3% (7/12)]. GI tolerability AEs [DRF, 34.8% (88/253); DMF, 48.2% (121/251)], concomitant symptomatic medication use [DRF, 19.3% (17/88) versus DMF, 30.6% (37/121)], and GI-related discontinuations (DRF, 0.8% versus DMF, 4.8%) were lower with DRF versus DMF.Conclusions:The improved GI tolerability with DRF translated into clinically meaningful benefits to QoL, as patients experienced less impact on daily life and work and required less concomitant symptomatic medication use.Trial registration:[ClinicalTrials.gov identifier: NCT03093324]

Self-care related to the performance of occupational roles in patients under antineoplastic chemotherapy treatment.

Objective:to analyze and correlate occupational roles, symptoms and self-care capacity in oncologic patients seen at the chemotherapy service of a university hospital.Method:cross-sectional study, in which the instruments were applied sociodemographic and clinical questionnaire, M.D Andersons Symptom Inventory - core, Appraisal of Self Care Agency Scale-Revised and Occupational Paper Identification List to oncologic patients seen in the chemotherapy service of a university hospital. Data analysis included absolute and relative frequency tables and multiple linear regression, adopting a significance level of =0.05.Results:the sample showed capacity for self-care operationalized with an average of X=57.8. In the correlation between the degree of importance of the occupational papers and the scores of the evaluation instrument for self-care was found statistical significance in the papers of volunteer (r=0.26; p=0.02) and friend (r=0.33; p= <0.001). The linear regression showed that the greater the interference of symptoms in life activities (=0.20; p=0.05) and greater the importance of the role of friend (p=0.001; p=0.43), the higher the rates of self-care.Conclusion:the operationalization of self-care can be directly related to the degree of importance attributed to the performance of social roles.

A prevalência da incontinência urinária em mulheres praticantes de exercícios físicos de alto impacto

INTRODUÇÃO: A IU atinge cerca de 10 milhões de brasileiros de todas as idades, sendo duas vezes mais comum no sexo feminino, de acordo com a Sociedade Brasileira de Urologia (SBU). Considerada qualquer perda involuntária de urina de acordo com a ICS, podendo ser classificadas em IUU, IUE e IUM. O tratamento para a IU pode ser cirúrgico, farmacológico ou fisioterapêutico. OBJETIVO: Identificar a prevalência de incontinência urinária em mulheres praticantes de exercício físico de alto impacto, em comparação com mulheres que não praticam atividade física. MATERIAIS E MÉTODOS: O estudo foi do tipo transversal, onde se realizou um estudo de caso, sobre a perda involuntária de urina por mulheres, durante o exercício físico de impacto. As participantes foram divididas dois grupos: Grupo 1, mulheres praticantes de exercícios físicos de alto impacto e Grupo 2, mulheres não praticantes de exercícios físicos. As voluntárias realizaram o Pad Test de uma hora, padronizado pela ICS. Além disso, todas responderam o questionário Internacional Consultation on Incontinence Questionnaire – Short Form (ICIQ-SF). RESULTADOS: Houve a presença de sintomas de IUE em ambos os grupos investigados. Entretanto, foi possível comprovar que no grupo onde as mulheres praticavam exercícios de alto impacto a perda de urina foi bem maior em quantidade e em qualidade, observando-se resultados superiores a 60% nas praticantes de exercícios de alto impacto. CONCLUSÃO: As mulheres praticantes de exercícios de alto impacto apresentaram maior perda urinária comprovada pelo Pad Test e uma maior interferência desses sintomas urinários na qualidade de vida comprovada pelo ICIQ-SF.

Humanistic burden of living with anaplastic lymphoma kinase-positive non-small-cell lung cancer: findings from the ALKConnect patient insight network and research platform.

Aim:Evaluate real-world patient preferences, experiences and outcomes (health-related quality of life [HRQoL]) from patients with anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) utilizing the ALKConnect Patient Insight Network.Patients & methods:Demographics, disease history/status/treatment, patient preferences and HRQoL (MD Anderson Symptom Inventory lung cancer module, reported as symptom severity and interference) were evaluated for US adults with ALK+ NSCLC.Results:Among 104 patients (median age: 53.0 years, 67.3% female, 40.0% employed), HRQoL and 3-month delay in disease progression were important treatment attributes. Burdensome symptoms included fatigue and disturbed sleep. Symptoms interfered most with work and day-to-day activity. Higher HRQoL was associated with ALK tyrosine kinase inhibitor (TKI) treatment and employment.Conclusion:ALKConnect demonstrated that disease progression, HRQoL, fatigue/sleep, ALK TKIs and employment matter in ALK+ NSCLC.

Patient-reported symptom severity, interference with daily activities, and adverse events in older and younger women receiving chemotherapy for early breast cancer.

To the authors' knowledge, it is unknown whether patient-reported symptom severity and symptom interference with daily activities differ between younger (aged <65 years) and older (aged ≥65 years) women receiving similar chemotherapy regimens for early breast cancer (EBC). Study participants rated 17 side effects of chemotherapy regimens currently in use in clinical practice (2014-2019). Of 284 women with EBC (stage I-III), approximately 57% were aged <65 years and 43% were aged ≥65 years. For anthracycline-based regimens, a higher percentage of younger women reported moderate, severe, or very severe (MSVS) hot flashes (49% vs 18%) (P < .001). For nonanthracycline regimens, a higher percentage of younger women reported MSVS hot flashes (38% vs 19%) (P = .009) and a lower percentage reported MSVS arthralgia (28% vs 49%) (P = .005). With regard to symptom interference with daily activities, a higher percentage of younger women being treated with anthracycline-based regimens reported MSVS hot flashes (32% vs 7%) (P = .001) and myalgia (38% vs 18%) (P = .02). For nonanthracycline chemotherapy, a higher percentage of younger women reported MSVS interference for hot flashes (26% vs 9%) (P = .006) and lower percentages reported abdominal pain (13% vs 28%) (P = .02). Overall, there were no significant differences noted among younger versus older patients with regard to hospitalizations (19% vs 12%; P = .19), dose reductions (34% vs 31%; P = .50), dose delays (22% vs 25%; P = .59), or early treatment discontinuation (16% vs 16%; P = .9546). Older and younger women with EBC who were treated with identical chemotherapy regimens generally experienced similar levels of symptom severity, symptom-related interference with daily activities, and adverse events. In this study, women receiving chemotherapy for early breast cancer rated the severity of 17 symptoms and symptom interference with their activities of daily living. Older (aged ≥65 years) and younger (aged <65 years) women who received identical chemotherapy regimens generally experienced similar levels of symptom severity, symptom-related interference with daily activities, and adverse events.

QOLP-13. COMPARISON OF SYMPTOM BURDEN AND ASSOCIATED IMPACT ON DAILY LIFE IN GLIOBLASTOMA PATIENTS TREATED WITH AND WITHOUT TUMOR TREATING FIELDS

Abstract INTRODUCTION Clinical trials have demonstrated that the use of low intensity alternating electric fields, known as Tumor Treating Fields (TTFields), via the Optune™ device extends overall survival times in patients with glioblastoma when combined with standard chemotherapy. In addition to survival time, quality of life (QOL) is an important factor in treatment decisions for life-limiting diagnoses. Examinations of the impact of TTFields on QOL have yielded mixed RESULTS: Here, we describe patient-reported symptoms in patients with glioblastoma undergoing treatment with TTFields and compare symptom burden and associated interference with daily life to that of a historic non-TTFields cohort. METHODS Patients with primary glioblastoma who chose treatment with the Optune™ device were prospectively enrolled and asked to complete the brain tumor-specific MD Anderson Symptom Inventory (MDASI-BT) approximately every 8 weeks through cessation of active disease treatment. MDASI-BT assessments were examined for symptom frequency, severity, and relationships between symptom severity and interference with daily life. These results were also compared with a matched cohort of patients who did not chose TTFields treatment and completed MDASI-BT assessments as part of a previous study. RESULTS The most commonly reported symptoms for Optune™ users were fatigue, sleep disturbance and speaking/word finding. Fatigue and sleep disturbance were also among the symptoms rated as most severe, along with feeling drowsy/sleepy. Interference with general activities and overall enjoyment of life as both were reported as both the most common and most severe impacts on daily life. When compared with historic data from non-Optune™ users at the same point in treatment, we found no difference in either symptom burden (p=0.48) or interference scores (p=0.72). CONCLUSION Attention to both survival benefit and symptom experience related to treatment options can inform patient decisions and direct approaches to symptom management as well as improved QOL.

QOLP-02. PATIENT-REPORTED OUTCOMES FOLLOWING PERTUZUMAB PLUS HIGH-DOSE TRASTUZUMAB IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER (MBC) AND CENTRAL NERVOUS SYSTEM (CNS) PROGRESSION POST-RADIOTHERAPY

Abstract Effective therapies are needed for the treatment of patients with HER2-positive MBC who develop brain metastases. In the open-label, phase II PATRICIA study (NCT02536339), 40 patients with HER2-positive MBC with CNS metastases and CNS progression post-radiotherapy (median age 48 years [range, 34–69]; prior CNS treatment [whole brain radiotherapy 71%, stereotactic radiosurgery 59%, both 31%]) were enrolled to receive pertuzumab plus high-dose trastuzumab (6-mg/kg weekly) until CNS or systemic disease progression or unacceptable toxicity. Following a median (range) treatment duration of 4.5 (0.3–37.3) months, the CNS-confirmed objective response rate per Response Assessment in Neuro-Oncology Brain Metastases criteria (primary endpoint) was 11% (95% confidence interval: 3.03, 25.42), and the clinical benefit rate at 4 months was 68%, indicating sustained clinical stability. Patient-reported outcomes (PROs) were evaluated using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), which includes sub-scales for symptom severity (average of 13 core symptom and 9 brain-tumor specific items) and symptom interference (average of 6 interference-with-life items representing overall symptom distress). Among 36 patients included in the PRO analyses, mean (standard deviation [SD]) symptom severity scores at baseline and weeks 12 and 28 were 1.65 (1.62), 2.24 (2.14), and 1.94 (2.55), respectively. Mean (SD) symptom interference scores at baseline and weeks 12 and 28 were 2.51 (2.63), 2.81 (3.39), and 1.76 (2.43), respectively. Mean (SD) changes in symptom severity and interferences scores from baseline to week 12 were 0.34 (1.54) and 0.33 (3.08), respectively. On average, patients who did not achieve stable disease or better in the CNS following treatment had worsened symptom severity and symptom interference scores over 12 weeks, while those with stable disease or better in the CNS exhibited stable or improving scores. Pertuzumab plus high-dose trastuzumab provided clinical benefit to the majority (68%) of patients in PATRICIA, without a decrement in quality of life.

Psychometric validity and reliability of the Danish version of the MD Anderson Symptom Inventory Brain Tumor Module.

The complexity of disease- and treatment-related symptoms causes profound distress and deterioration of health-related quality of life among patients with brain tumors. Currently, there is no Danish validated disease-specific instrument that focuses solely on measures of both neurologic and cancer-related symptoms of patients with brain tumors. The MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) is a validated patient self-report questionnaire that measures symptom prevalence, intensity, and interference with daily life. The aim of the present study was to determine the psychometric validity of the Danish translation of the MDASI-BT, and to test its utility in 3 cohorts of Danish patients across the spectrum of the brain cancer disease and treatment trajectory. A linguistic validation process was conducted. Danish patients with malignant primary brain tumors were included to establish the psychometric validity and reliability of the Danish MDASI-BT. Cognitive debriefing interviews were conducted to support the psychometric properties. A total of 120 patients participated in this study. Coefficient αs for the symptom and interference subscales indicate a high level of reliability across all items. Corresponding symptom and interference or functional items and subscales in the MDASI-BT and European Organisation for Research and Treatment of Cancer Brain Tumor Module BN20 were significantly correlated. Cognitive debriefing provided evidence for content validity and questionnaire utility as participants were comfortable answering the questions and had no problem with the understandability or number of questions asked. The MDASI-BT is a simple, concise symptom assessment tool useful for assessing the symptom severity and interference of Danish-speaking patients with brain cancer.

Patient-Reported Quality of Life Outcomes in Patients With Neurofibromatoses Undergoing Surgery

INTRODUCTION: Surgical excision of dermal neurofibromas and peripheral nerve sheath tumors in patients with neurofibromatosis and Schwannomatosis represents a therapeutic challenge as no evidence-based guidelines for indicating surgery in these patients exist. Mainstay of treatment is symptomatic, focused primarily on pain management. We report our Neurofibroma center’s experience with surgical excision of Neurofibromas and peripheral nerve sheath tumors by describing patient demographics, tumor characteristics, indications, and the impact of surgery on patient-reported quality of life outcomes. METHODS: Patients with Neurofibromatosis type 1, type 2, and Schwannomatosis undergoing surgery for excision of neurofibromas or peripheral nerve sheath tumors during a consecutive 10-year period (2009–2019) enrolled in a prospective database as approved by our Institutional Review Board. Demographics, medical history, radiology, and surgical pathology reports were collected from the electronic medical record. A survey consisting of questions regarding interference of symptoms with daily activities (eg, dressing, ambulating), pain scale, impression of overall state of health, and experience with surgery was applied either in-person or over the phone. Survey questions were answered using a Likert scale. Primary outcome was comparison of the quality of life survey questions before and after surgery. Measures of central tendency and descriptive statistics were used to describe absolute and mean results of patient demographics and tumor characteristics. Student’s t tests were used to analyze binary datasets. Statistical significance was predetermined at P < 0.05. RESULTS: A total of 154 excisions were performed on 106 patients. Seventy-seven patients (72.6%) carried the diagnosis of Neurofibromatosis Type 1, 11 (10.4%) were diagnosed with Neurofibromatosis Type 2, 11 (10.4%) were diagnosed with Schwannomatosis, and 7 (6.6%) of patients were found to be sporadic. Pain was the most common presenting symptom (79%). The most common locations for excision were the extremities with 32.2% of cases occurring in the upper extremity and 35.8% in the lower extremity. Tumor size ranged from 0.2 cm to 25.5 cm, and the majority (46.7%) of lesions were between 2 cm and 4.9 cm in size. Pathologic analysis from the 154 operations revealed 87 (56.5%) cutaneous neurofibromas, 42 (27.3%) peripheral nerve sheath tumors and 10 (6.5%) plexiform neurofibromas. Improvement in overall general health after surgery was reported by 79% of patients. Analysis of survey responses demonstrated significantly decreased bodily pain (P < 0.0001) and interference from pain (P < 0.0001) postoperatively. One hundred percent of respondents reported improved quality of life after surgery, 85% did not regret undergoing surgical excision and 86% reported that they would “Definitely” undergo surgery again if indicated. CONCLUSION: Our neurofibroma center’s patient-reported outcomes demonstrate that surgical excision of neurofibromas and peripheral nerve sheath tumors improves symptoms, function of daily activities and patients’ overall impression of their quality of life. These data can support the creation of multidisciplinary guidelines on the role of surgery in patients with neurofibromatosis and Schwannomatosis.

Factors Influencing Received Social Support Among Emerging Adults With Inflammatory Bowel Disease: A Cross-Sectional Study.

The majority of research among individuals with inflammatory bowel disease (IBD) focuses on perceived social support. A gap exists regarding the role of received social support in self-management enhancement. The purpose of this study was to examine specific contextual factors (individual, condition-specific, and emerging adulthood factors) that influence received social support (total, informational, emotional, and tangible) among emerging adults (ages 18-29 years) with IBD. A convenience sample of 61 emerging adults with a diagnosis of IBD was obtained. An association was found between high total received social support and several individual factors such as being closer to the younger end of the age range (ages 18-29 years), married, and fully employed. When controlling for time since diagnosis and symptom interference, high tangible received social support was associated with the use of immunomodulator and biological medications. Emerging adulthood factors were not associated with total or any types of received social support. Future research could examine differences between types of social support and self-management behaviors. These findings contribute a new direction for intervention development with a focus on individual and condition-specific factors to enhance received social support and ultimately health outcomes for individuals with IBD.

Implicações do transtorno disfórico pré menstrual na qualidade de vida das mulheres: uma revisão de literatura

Este artigo buscou reunir, avaliar e sintetizar estudos acerca dos sintomas e dos cuidados gerais em mulheres com Transtorno disfórico pré-menstrual (TDPM), bem como a interferência de tais sintomas nos campos de atuações sociais e na qualidade de vida dessas mulheres. O diagnóstico do TDPM é feito com base no Manual Diagnóstico e Estatístico de Transtornos Mentais (DSM-V) e caracteriza-se por um grupo de manifestações com exacerbação grave na semana anterior à menstruação. As consequências do TDPM na qualidade de vida das mulheres são, sobretudo, nos quesitos de relacionamentos e trabalho, com possibilidade de desfechos graves, como o suicídio. Os resultados apontam que o TDPM é um distúrbio grave que influencia a vida particular e profissional da paciente e, por isso, deve ser feita entrevista e anamnese precisa a fim de reconhecer o quadro clínico e, por conseguinte, dar seguimento ao tratamento adequado para um melhor prognóstico e bem estar global da paciente.

Predictors of Treatment Satisfaction Among Adolescents Following an Intensive Cognitive-Behavioral Intervention for Panic Disorder.

No studies to date examine predictors of treatment satisfaction following intensive cognitive-behavioral therapy interventions among adolescents. Given the challenges to treatment adherence among adolescents, and the promise intensive interventions hold for providing rapid symptom relief and increasing access to care, data examining adolescents' satisfaction with intensive programs are needed. Twenty-four adolescents (ages 12-17) with panic disorder received an eight-day intensive cognitive-behavioral therapy intervention. Pre-treatment characteristics and clinical outcome variables were examined as predictors of satisfaction at post-treatment and three-months follow-up. Multiple regression analyses revealed that higher levels of overall symptom interference at baseline and greater reductions in agoraphobic fear during treatment predicted greater treatment satisfaction at post-treatment. Only satisfaction at post-treatment significantly predicted treatment satisfaction at follow-up, highlighting the potential influence of treatment satisfaction on long-term perceptions of treatment. Considerations for fostering treatment satisfaction in the context of intensive interventions are discussed.

Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials.

BackgroundSymptoms are common among patients enrolled in phase I trials. We assessed the validity of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items in relation to previously validated assessments of quality of life and psychological distress. We used data from a randomized trial testing a palliative care support intervention for patients enrolled on phase I trials.MethodsPatients (n = 479) were accrued to the parent study prior to initiating a phase I clinical trial with data collected at baseline, 4, and 12 weeks. We determined the correlation of PRO-CTCAE with distress level, Functional Assessment of Cancer Therapy - General (FACT-G) total, and subscale domain scores.ResultsPatients were predominantly female (56.8%) and older than age 60 years, and 30.7% were from minority populations. The correlation coefficient for distress level for all PRO-CTCAE items was small to moderate (Pearson r = 0.33-0.46). Pearson correlation coefficient for FACT-G total was moderate (r = -0.45 to -0.69). Stronger associations were noted for mood items of the PRO-CTCAE only (with distress level, r = 0.55-0.6; with FACT-G, r = -0.54 to -0.6). PRO-CTCAE symptom interference scores had the strongest correlation with distress level (Pearson r = 0.46) and FACT-G total (Pearson r = -0.69). Correlations between PRO-CTCAE items and corresponding FACT-G (total and subscales) and distress levels reached statistical significance for all items (P <.001).ConclusionEvidence demonstrates validity of PRO-CTCAE in a heterogeneous US sample of patients undergoing cancer treatment on phase I trials, with small to moderate correlations with distress level for all PRO-CTCAE items and moderate correlations with quality of life as measured by FACT-G total.

Quality of life and added value of a tailored palliative care intervention in patients with soft tissue sarcoma undergoing treatment with trabectedin: a multicentre, cluster-randomised trial within the German Interdisciplinary Sarcoma Group (GISG)

ObjectivesThe choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating...

Validation of the Arabic Version of the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool

BackgroundChemotherapy-induced peripheral neuropathy results in multidimensional neurological and muscular symptoms, which interfere with the patients’ daily life. AimExamine the psychometric properties of the Arabic version of the chemotherapy-induced peripheral neuropathy assessment tool (CIPNAT) among adult cancer patients. MethodA descriptive study design was used. A convenience sample of 210 patients was assigned to two groups: 135 who received chemotherapies of known neurotoxic potential and 75 who served as a comparison group. Translation and back-translation considering cross-cultural issues to produce the Arabic version of CIPNAT was used. Test–retest and internal consistency reliability were used to test the reliability of the tool, whereas for the validity, content and construct validity were assessed. ResultsTest–retest scores for the overall scale (r = 0.98, p = < .001), for the symptom experience subscale (r = 0.97, p = <.001), and for the interference subscale (r = 0.96, p = < .001) all showed evidence of reliability. Cronbach α coefficients were 0.97, 0.96, and 0.95 for the total scores, symptoms experience, and interference scales, respectively. Items to total correlation ranged from moderate to strong (0.55-0.81). The Content Validity Index was 0.83. The data support the evidence of discriminant validity, as significant differences were found between the groups with regard to symptom experience (t = 8.51, p = < .001), interference (t = 5.60, p = <.001), and total score (t = 7.88, p = < .001). ConclusionsThe Arabic version of CIPNAT showed adequate reliability and validity to screen for chemotherapy-induced peripheral neuropathy symptoms and their interference in Arab countries. Further studies are needed to evaluate concurrent validity.

Exploring Associations Between Metabolites and Symptoms of Fatigue, Depression and Pain in Women With Fibromyalgia.

Fibromyalgia (FM) is a chronic noncommunicable disorder characterized by a constellation of symptoms that include fatigue, depression and chronic pain. FM affects 2%-8% of the U.S. population, 2% of the global population, with 61%-90% of FM diagnoses attributed to women. Key causal factors leading to the development and severity of FM-related symptoms have not yet been identified. The purpose of this article is to report relationships among identified metabolites and levels of fatigue, depression, pain severity, and pain interference in a sample of 20 women with FM. In this secondary analysis, we conducted global metabolomic analysis and examined the data for relationships of metabolite levels with self-reported symptoms of fatigue, depression, pain severity, and pain interference. Results revealed six metabolites (6-deoxy-hexose; pantothenic acid; ergothioneine; l-carnitine; n-acetylserotonin; butyrobetaine) and their associated metabolic pathways such as carnitine synthesis, lipid oxidation, tryptophan metabolism, beta-alanine metabolism and pantothenic and Coenzyme-A biosynthesis that were either positively or inversely related to pain severity, pain interference, or both. The preliminary data presented suggest that metabolites representing energy, amino acid, or lipid classification may be associated with pain symptom severity and interference in women with FM. Future work will confirm these findings in a large, comparative cohort, targeting metabolites and metabolite pathways to better understand the relationships of metabolites and symptomology.

Development and Testing of the Dysmenorrhea Symptom Interference (DSI) Scale.

Dysmenorrhea affects most reproductive-age women and increases the risk of future pain. To evaluate dysmenorrhea interventions, validated outcome measures are needed. In this two-phase study, we developed and tested the dysmenorrhea symptom interference scale. During the scale-development phase (n = 30), we created a nine-item scale based on qualitative data from cognitive interviews. During the scale-testing phase (n = 686), we evaluated reliability, validity, and responsiveness to change. The scale measures how dysmenorrhea symptoms interfere with physical, mental, and social activities. Internal consistency was strong with Cronbach's α > 0.9. Test-retest reliability was acceptable (r = 0.8). The scale showed satisfactory content validity, construct validity (supported by confirmatory factor analysis), concurrent validity, and responsiveness to change. The minimally important difference was 0.3 points on a scale with a possible total score ranging from 1 to 5. This new psychometrically sound scale can be used in research and clinical practice to facilitate the measurement and management of dysmenorrhea.

An Exploration of the needs of a Cardiac Rehabilitation Population using a Subjective Quality-of-Life Measure

Context: The aim of this study was to profile a cardiac rehabilitation population in the West of Ireland and establish Subjective Quality of Life (SQoL), using The Schedule for Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), a validated subjective QoL measure. Bothersome symptoms (SB) and Symptom Interference in SQoL (SBIQoL) were also assessed using a using a modified SEIQoL-DW. Objectives: QoL is a difficult concept to define, therefore the medical profession often premise QoL on health and illness. The focus of this study was to explore the QoL needs of a cardiac population, with a view to informing the development of a newly formed cardiac rehabilitation support group. The SEIQoL-DW was developed to overcome the limitations of quantitative questionnaires, as it is based on the individual’s personal view of life and its quality. Methods: SQoL, symptoms and SBIQoL, of 22 individuals, who had suffered a cardiac event were explored. SEIQoL-DW is a semi-structured interview, enabling the individual to convert their perspectives into scientific values. QoL areas of importance to patients are called ‘cues’. A modified SEIQoL-DW was used to assess SB and SBIQoL. Data were analysed using both quantitative analysis and qualitative descriptive analysis. Findings: Participants highlighted a range of QoL cues; findings from this study showed that 45% of participants did not rate ‘health’ in the first five QoL cues. A significant number of participants experienced symptoms; a medium negative correlation was found between symptom interference and QoL, rho = -0.353, with high levels of symptom interference associated with low levels of QoL. Conclusions: The range of QoL cues and bothersome symptoms identified in this study had implications for the development of the group, with participants eager to participate and talk candidly about their needs. SEIQoL-DW proved to be an acceptable, reliable and valid technique for measuring both individual QoL, SB and SBIQoL, taking greater consideration of individual perspectives compared with traditional measurement approaches. The significance of nominated symptoms and SBIQoL warrants further attention, especially if these symptoms are reversible.