450 research outputs found

    Use of the metastatic breast cancer progression (MBC-P) questionnaire to assess the value of progression-free survival for women with metastatic breast cancer.

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    While overall survival (OS) has historically been the primary endpoint for clinical trials in oncology, progression-free survival (PFS) has gained acceptance as a valuable surrogate endpoint. However, there are no known published reports about the value of PFS from the patient's perspective. We developed a questionnaire that included items regarding quality of life (QoL) and the importance of different treatment outcomes and presented hypothetical scenarios for which respondents were asked to indicate their preferences concerning treatments as they relate to PFS. 282 women with metastatic breast cancer (MBC), ranging in age from 21 to 80 years completed an online version of this questionnaire. The majority of women (66 %) had been diagnosed with MBC within the previous 3 years and 56 % had been told their MBC had progressed. When asked to rank five treatment characteristics from most important to least important, respondents ranked "extending PFS" as the second most important treatment outcome after OS. When presented with a hypothetical scenario of two women receiving different treatments, respondents preferred the treatment that resulted in longer PFS (16 vs. 12 months), even when OS and side effects were assumed to be equal. Specifically, when asked to consider which woman within the hypothetical scenario had better QoL, physical functioning, and emotional well-being, respondents more often chose the woman who experienced longer PFS (QoL: 40 vs. 6 %; physical functioning: 32 vs. 8 %; emotional well-being: 58 vs. 6 %) compared to the woman within the hypothetical scenario who had a shorter time of progression. Respondents rated their own QoL highest after being told their MBC was responding to treatment (mean score 76.6) versus after the initial diagnosis of breast cancer and MBC (68.5 and 60.3). These findings suggest that extending PFS is an important treatment outcome and, from a patient perspective, improves overall QoL, physical functioning, and emotional well-being

    Measurement properties of the Flu-Like Symptom Index from the Hepatitis Physical Symptom Severity Diary

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    Purpose Chronic Hepatitis C (CHC) Virus infection is a serious health issue in the US. Standard treatment involves peginterferon alpha and ribavirin, often associated with adverse side effects including flu-like symptoms. These adverse effects are common reasons for the discontinuation of treatment and therefore represent a major obstacle in the effective treatment of CHC. Methods The Hepatitis Physical Symptom Severity Diary, a newly developed patient-reported outcome mea-sure for assessing physical symptoms in CHC patients, was recently developed. It contains four questions addressing flu-like symptoms [the Flu-Like Symptom Index (FLSI)]. Measurement properties of the FLSI in CHC patients were assessed using data from two randomized clinical trials. Results Exploratory factor analysis using data from baseline and the last visit while on treatment supported a single-factor solution for the FLSI. Internal reliability and test–retest reliability are acceptable (Cronbach’s alpha range 0.73–0.81; intraclass correlation coefficient range 0.85–0.97), and correspondence to several similar con-structs was acceptable. The FLSI score was higher among those with investigator-reported flu-like symptoms (mean = 4.1) versus those without (1.4), although not statistically significant (p = 0.12). Responsiveness of the FLSI was moderate, as measured by standardized effect sizes and response means, and the minimum important difference (MID) was estimated at 2.5–3.0 points. Conclusions While additional research should be con-ducted to evaluate validity with more closely related con-structs and to utilize anchor-based methods for estimating the MID, data suggest that the FLSI has acceptable mea-surement properties and can be an effective tool in assessing flu-like symptoms in CHC patients

    Anorexia Nervosa, Anxiety, and the Clinical Implications of Rapid Refeeding

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    The current study aimed to examine the temporal relationship between anxiety symptoms and weight gain for adolescents with anorexia nervosa over the course of an inpatient admission targeting weight restoration through rapid refeeding. Participants were 31 females presenting to a specialist inpatient unit. Psychometric assessments using standardized procedures were conducted to assess co-morbid anxiety diagnoses, and eating disorder symptom severity at admission and discharge. Study protocols were completed on a weekly basis over the course of their admission and were compared with weekly BMI change. Multiple mixed-effects linear models with random intercepts were used to assess change in weight status and psychological variables. Results indicated a reduction in anxiety over the course of hospitalization; however, there was no evidence to support a relationship between anxiety change and weight restoration. The clinical implications of these results are discussed and directions for future research recommended

    Validation of the Patient Perception of Intensity of Urgency Scale in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia

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    AbstractObjectiveTo assess the reliability and validity of scores derived from the Patient Perception of Intensity of Urgency Scale (PPIUS) in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).MethodsA post hoc analysis of the phase II Solifenacin and Tamsulosin in Males with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia trial (NCT00510406), a 12-week clinical trial in men with LUTS associated with BPH, assessed the measurement properties of six PPIUS-derived scores: mean score; maximum urgency score; total urgency and frequency score (TUFS; average sum of urgency scores over 3 days); and numbers of urgency episodes, urgency episodes of grade 3 or 4, and urgency incontinence episodes. Test-retest reliability, presence of floor/ceiling effects, responsiveness to change, known-group validity, and concurrent validity were assessed for each score.ResultsA total of 901 patients had at least one valid PPIUS assessment after baseline. TUFS demonstrated good test-retest reliability (intraclass correlation coefficient >0.8), discriminated between groups defined based on International Prostate Symptom Score storage score severity (known-groups validity), had high concurrent validity, and had high responsiveness to change (Guyatt’s responsiveness statistic 0.88), with an absence of floor or ceiling effects. The psychometric properties of other PPIUS-derived scores were not as consistently robust and showed either low-to-moderate responsiveness, presence of a floor or ceiling effect, or low-to-moderate test-retest reliability.ConclusionsThis study shows that the PPIUS is reliable and valid in patients with LUTS associated with BPH. TUFS provided the best combination of psychometric properties of the six scores derived from the PPIUS and appeared to be an appropriate measure of urgency and frequency

    Mediators of the relationship between thin-ideal internalization and body dissatisfaction in the natural environment

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    Social comparisons (i.e., body, eating, exercise) and body surveillance were tested as mediators of the thin-ideal internalization-body dissatisfaction relationship using ecological momentary assessment (EMA). Participants were 232 college women who completed a 2-week EMA protocol, responding to questions three times per day. Multilevel path analysis was used to examine a 2-1-1 mediation model (thin-ideal internalization assessed as trait; between-person effects examined) and a 1-1-1 model (component of thin-ideal internalization [thin-ideal importance] assessed momentarily; within- and between-person effects examined). For the 2-1-1 model, only body comparison and body surveillance were significant specific mediators of the between-person effect. For the 1-1-1 model, all four variables were significant specific mediators of the within-person effect. Only body comparison was a significant specific mediator of the between-person effect. At the state level, many processes explain the thin-ideal internalization-body dissatisfaction relationship. However, at the trait level, body comparison and body surveillance are more important explanatory factors

    A study of changes in genetic and environmental influences on weight and shape concern across adolescence

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    The goal of the current study was to examine whether genetic and environmental influences on an important risk factor for disordered eating, weight and shape concern (WSC), remained stable over adolescence. This stability was assessed in two ways: whether new sources of latent variance were introduced over development, and whether the magnitude of variance contributing to the risk factor changed. We examined an 8-item WSC sub-scale derived from the Eating Disorder Examination using telephone interviews with female adolescents. From three waves of data collected from female-female same sex twin pairs from the Australian Twin Registry, a subset of the data (which included 351 pairs at Wave 1) was used to examine three age cohorts: 12-13, 13-15, and 14-16 years. The best fitting model contained genetic and environmental influences, both shared and non-shared. Biometric model fitting indicated that non-shared environmental influences were largely specific to each age cohort, and results suggested that latent shared environmental and genetic influences that were influential at 12-13 years continued to contribute to subsequent age cohorts, with independent sources of both emerging at ages 13-15. The magnitude of all three latent influences could be constrained to be the same across adolescence. Ages 13-15 was indicated as a time of risk for the development of high levels of WSC given that most specific environmental risk factors were significant at this time (e.g., peer teasing about weight, adverse life events), and indications of the emergence of new sources of latent genetic and environmental variance over this period.NHMRC Grants 324715 and 480420

    Relationships between compulsive exercise, quality of life, psychological distress and motivation to change in adults with anorexia nervosa

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    Background: For people with anorexia nervosa (AN), compulsive exercise is characterized by extreme concerns about the perceived negative consequences of stopping/reducing exercise, dysregulation of affect, and inflexible exercise routines. It is associated with increased eating disorder psychopathology and poor clinical outcome. However, its relationships with two important clinical issues, quality of life (QoL) and motivation to change, are currently unknown. This study aimed to assess the cross-sectional relationships between compulsive exercise, QoL, psychological distress (anxiety and depressive symptoms, and obsessive-compulsive traits) and motivation to change in patients with AN. Method: A total of 78 adults with AN participated in this study, which was nested within a randomized controlled trial of psychological treatments for AN. At baseline (pre-treatment), participants completed questionnaires assessing compulsive exercise, eating disorder (ED) psychopathology, QoL, psychological distress and motivation to change. Results: Baseline correlational analyses demonstrated a moderate positive relationship between compulsive exercise and ED psychopathology, and a weak positive relationship between compulsive exercise and psychological distress. There was a moderate negative relationship between compulsive exercise and eating disorder QoL. Conclusions: These results indicate compulsive exercise is moderately associated with poorer QoL and weakly associated with higher distress. Targeting compulsive exercise in the treatment of anorexia nervosa may help reduce the burden of illness and improve patients’ engagement in treatment. Trial registration ACTRN12610000585022 . Taking a LEAP forward in the treatment of anorexia nervosa: a randomized controlled trial. NHMRC grant: 634922

    Weight-related teasing and non-normative eating behaviors as predictors of weight loss maintenance

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    Weight loss maintenance is essential for the reduction of obesity-related health impairments. However, only a minority of individuals successfully maintain reduced weight in the long term. Research has provided initial evidence for associations between weight-related teasing (WRT) and greater non-normative eating behaviors. Further, first evidence was found for associations between non-normative eating behaviors and weight loss maintenance. Hence, the present study aimed to examine the predictive value of WRT for weight loss maintenance and the role of non-normative eating behaviors as possible mediators of this relationship. The study was part of the German Weight Control Registry that prospectively followed individuals who had intentionally lost at least 10% of their maximum weight and had maintained this reduced weight for at least one year. In N = 381 participants, retrospective WRT during childhood and adolescence, current non-normative eating behaviors (i.e., restrained, external, emotional eating), and change in body mass index (BMI, kg/m2) over two years were examined using self-report assessments. Structural equation modeling was used to analyze the assumed mediational relationship. As a result, a greater effect of retrospective WRT during childhood and adolescence predicted less successful adult weight loss maintenance over two years. Current emotional eating fully mediated this relationship while current restrained and external eating yielded no mediational effects. Hence, a greater effect of WRT predicted greater current emotional eating, which in turn predicted a smaller decrease or a greater increase in BMI. Our findings suggest that suffering from WRT during childhood and adolescence might lead to emotional eating which in turn impairs long-term weight loss maintenance. Thus, our results highlight the need for interventions aiming at reducing weight stigmatization and targeting emotional eating for successful long-term weight loss maintenance

    The core symptoms of bulimia nervosa, anxiety, and depression: A network analysis.

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    Bulimia nervosa (BN) is characterized by symptoms of binge eating and compensatory behavior, and overevaluation of weight and shape, which often co-occur with symptoms of anxiety and depression. However, there is little research identifying which specific BN symptoms maintain BN psychopathology and how they are associated with symptoms of depression and anxiety. Network analyses represent an emerging method in psychopathology research to examine how symptoms interact and may become self-reinforcing. In the current study of adults with a Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM-IV) diagnosis of BN (N = 196), we used network analysis to identify the central symptoms of BN, as well as symptoms that may bridge the association between BN symptoms and anxiety and depression symptoms. Results showed that fear of weight gain was central to BN psychopathology, whereas binge eating, purging, and restriction were less central in the symptom network. Symptoms related to sensitivity to physical sensations (e.g., changes in appetite, feeling dizzy, and wobbly) were identified as bridge symptoms between BN, and anxiety and depressive symptoms. We discuss our findings with respect to cognitive-behavioral treatment approaches for BN. These findings suggest that treatments for BN should focus on fear of weight gain, perhaps through exposure therapies. Further, interventions focusing on exposure to physical sensations may also address BN psychopathology, as well as co-occurring anxiety and depressive symptoms. (PsycINFO Database Recor
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