The role of psychological flexibility in cancer pain

Aims: This study tested psychological flexibility (thereinafter flexibility) in cancer patients with chronic pain. Our hypothesis is that greater flexibility correlates with less attentional focus on pain, less use of medications, less depression or anxiety symptoms, less distress and less pain interference on the quality of life. Methods: Thirty three consecutive patients (mean age = 64.7; sd=11.8) with pain and cancer diagnosis of different etiologies were recruited in the Oncology department of Sacro Cuore-Don Calabria Hospital in Verona, Italy. All patients presented chronic pain during hospitalization. A total of 78.8% was married, 42.4 % retired, 90.9 % had children and the mean years of education were 9.8. A proportion of 48.5% of patients was in active treatment, 39.4% in diagnostic phase and 12.1% in palliative care. Patients were assessed at preintervention with the following standardized self-report measures: Vital statistics form, Pain statistics form, Numerical Rating Scale (NRS) for pain, Brief Pain Inventory (BPI), Acceptance and Action Questionnaire II (AAQ-II), Hospital Anxiety Depression Index (HADS), Distress Thermometer (DT). Results: NRS and BPI showed these average scores: pain during hospitalization (M=2.69; sd=1.39), average pain during 24h measured by nurse (M=1.86; sd=1.88), average pain during 24h measured by BPI (M=3.09; sd=2.19) and number of days with pain during hospitalization (M=8.03; sd=7.66). Data showed a significant correlation between flexibility and distress (=-0.45; pb0.01), anxiety (=-0.73, pb0.001), depression (=-0.59, pb0.001) and HADS total score (=- 0.73; pb0.01). Results show lower correlation levels (pb0.05) for interference of pain on emotions (=- 0.36) and schooling age (=0.42). Conclusion: This study showed that higher levels of flexibility correlated with more advanced schooling age, less distress, less anxiety, less depression and less interference of pain on emotions. Conversely, age, medications, average pain and pain durability were not significant. Psychological flexibility can be a new construct to explain adaptation to pain and cancer. However, these are preliminary data and further studies are required to better understand the role of flexibility in cancer patient

Residential cognitive-behavioral weight-loss intervention for obesity with and without binge-eating disorder: A prospective case–control study with five-year follow-up

Objective: The aim of this prospective case–control study was to compare the long-term effects of a residential cognitive-behavioral treatment (CBT) for weight loss in severely obese patients with and without binge-eating disorder (BED). Methods: We assessed weight-loss outcomes and psychological impairment in 54 severely obese female patients with BED and 54 patients matched by age, gender, and body mass index (BMI) without BED admitted to a residential CBT program. Body weight was measured at baseline and at 6-month follow-up and was reported by patients in a telephone interview at 5-year follow-up. Depression, eating disorder psychopathology, general psychopathology, and quality of life were assessed using validated instruments at baseline and at 6-month follow-up. Results: Obese patients with and without BED had similar weight loss at 6-month and 5-year follow-ups. Although both groups showed improved psychosocial variables, at 6 months the BED group maintained higher psychological impairment. Nevertheless, at 5-year follow-up more than half of the BED participants were no longer classifiable as having BED. Discussion: The presence of BED does not affect weight-loss outcome in obese patients treated with the residential CBT for weight loss program considered. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2016; 49:723–730)

The Eating Disorder Examination Questionnaire: reliability and validity of the Italian version

Purpose: To examine the validity and reliability of a new Italian language version of the latest edition of the Eating Disorder Examination Questionnaire (EDE-Q 6.0). Methods: The sixth edition of the EDE-Q was translated into Italian and administered to 264 Italian-speaking inpatient and outpatient (257 females in their mid-20s) with eating disorder (75.4% anorexia nervosa) and 216 controls (205 females). Results: Internal consistency was high for both the global EDE-Q and all subscale scores. Test–retest reliability was good to excellent (0.66–0.83) for global and subscale scores, and for items assessing key behavioral features of eating disorders (0.55–0.91). Patients with an eating disorder displayed significantly higher EDE-Q scores than controls, demonstrating the good criterion validity of the tool. Confirmatory factor analysis revealed a good fit for a modified seven-item three-factor structure. Conclusions: The study showed the good psychometric properties of the new Italian version of the EDE-Q 6.0, and validated its use in Italian eating disorder patients, particularly in young females with anorexia nervosa

Exploring Emotional Distress, Psychological Traits and Attitudes in Patients with Chronic Migraine Undergoing OnabotulinumtoxinA Prophylaxis versus Withdrawal Treatment

This explorative cross-sectional study aims at exploring emotional distress, psychological profiles, and the attitude towards receiving psychological support in eighty-seven patients with chronic migraine (CM) undergoing OnabotulinumtoxinA prophylactic treatment (OBT-A, n = 40) or withdrawal treatment (WT, n = 47). The outcomes were explored through a specific battery of questionnaires. 25% of patients undergoing OBT-A and almost half of the patients undergoing WT reported psychological distress of at least moderate-severe level, respectively. Coping strategies, self-efficacy, and perceived social support were similar in the two groups. Patients undergoing OBT-A presented lower psychological inflexibility than patients undergoing WT. Predictors of higher psychological distress were low perceived social support by friends, low self-efficacy, and higher avoidance strategies. In both groups, most of the patients evaluated receiving psychological support to be useful (79%). The potential beneficial effects of OBT-A on the severity of symptoms and psychological distress might further support its role in the multidisciplinary management of patients with CM. Identifying patients with psychological vulnerabilities who may benefit from psychological support is relevant in patients with CM

Confirmatory factor analysis of the Patient Assessment of Constipation-Symptoms (PAC-SYM) among patients with chronic constipation

PAC-SYM is widely adopted to asses constipation severity. However, it has been validated in a small sample, few items have been included based on expert opinion and not on empirical grounds, and its factor structure has never been replicated. We aimed at evaluating the psychometric properties of PAC-SYM in patients with chronic constipation

Bloating is associated with worse quality of life, treatment satisfaction, and treatment responsiveness among patients with constipation-predominant irritable bowel syndrome and functional constipation

Background: The management of bloating is unclear and its relationship with patients' well-being and treatment satisfaction independent of other abdominal symptoms is uncharacterized. We evaluated the association of bloating with patient-reported outcomes. Methods: Thirty-nine centers for functional gastrointestinal disorders joined the laxative inadequate relief survey. We enrolled 2203 consecutive outpatients with functional constipation (FC) or constipation-predominant irritable bowel syndrome (IBS-C) in two cross-sectional waves. Both wave 1 and 2 included the SF-12, the patient assessment of constipation-symptoms (PAC-SYM), and the treatment satisfaction questionnaire for medication (TSQM-2). Wave 2 only included a global rating of change (GRC) scale to assess patients' assessment of efficacy concerning treatment switches occurred in the 3 months prior to the interview. Bloating in the abdomen was defined on the basis of PAC-SYM item 3. Key Results: The average age was 50.1 years (SD, 16.7) and 82.1% of patients were women. The prevalence of bloating was 91.6% (n = 1970). Bloating was associated with SF-12 Physical Composite Score (p < 0.01), SF-12 Mental Composite Score (p < 0.01), GRC (p < 0.01), Satisfaction with treatment effectiveness (p < 0.01), convenience of administration (p < 0.01), and side effects (p < 0.01) after adjustment for possible confounders. Conclusions & Inferences: Our data suggest that patients regard bloating as a key element in assessing clinical changes and treatments' efficacy as this symptom exerts a strong influence on patient-reported outcomes independent of possible confounders and other symptoms of constipation. Our data provide the rationale to investigate the efficacy and tolerability of new treatments specifically addressing this important, yet disregarded, patients' complain

Use of biosimilars in inflammatory bowel disease: a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

The first infliximab biosimilar for the treatment of inflammatory bowel disease (IBD) was introduced in 2013, and today eight anti-TNF alpha biosimilars (three for infliximab and five for adalimumab) have been approved and licensed by the European Medicines Agency. Biosimilars present great potential in terms of cost saving and possible consequential reinvestment in the health care system. The increasing knowledge about the process of biosimilar development and use in IBD and the publication of many prospective clinical studies and real-life clinical experiences have progressively changed the point of view of IBD physicians. In the present position paper, the Italian Group for the Study of Inflammatory Bowel Disease present and discuss their updated statements and positions on this topic, with emphasis on the concepts of biosimilarity and extrapolation across indications, safety and immunogenicity, interchangeability and switching, automatic substitution, and, finally, patient education about biosimilars

The PROSit cohort of infliximab biosimilar in IBD : a prolonged follow-up on the effectiveness and safety across Italy

Background: We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13. Methods: A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings. Results: Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn's disease [CD]) were enrolled. Four hundred fifty-nine patients were na\uefve to anti-TNF\u3b1 (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 \ub1 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19%), leading to cessation of the biosimilar in 103 subjects (12.7%). Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5%), being significantly more frequent in patients pre-exposed to anti-TNF\u3b1 (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 \ub1 202 days. Forty-eight patients had a primary failure (6.4%), and 188 (25.6%) lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71%, 64%. and 82% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P < 0.0001) compared with baseline. Conclusions: In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed