Psychological General Well-Being Index Scores Research Articles

Long-term quality of life outcomes from a phase 4 study of tildrakizumab in patients with moderate-to-severe plaque psoriasis in a real-world setting

Background Tildrakizumab is an anti-interleukin-23 p19 monoclonal antibody approved for the treatment of moderate-to-severe plaque psoriasis. This report describes final primary results of a 64-week real-world study of the effect of tildrakizumab on patients’ health-related quality of life (HRQoL). Materials and methods In this open-label phase 4 study (NCT03718299), patients with moderate-to-severe plaque psoriasis received tildrakizumab 100 mg at week 0, week 4, and every 12 weeks thereafter through week 52. The primary endpoint was improvement from baseline in HRQoL measured by Psychological General Well-Being Index (PGWBI) total score at weeks 28 and 52. Secondary HRQoL endpoints included change from baseline in Dermatology Life Quality Index (DLQI) score through week 64. Missing data were not imputed. Results Of 55 patients enrolled, 45 were assessed at week 64. Mean ± standard deviation (SD) total PGWBI score improved from 78.1 ± 14.1 at baseline to 85.2 ± 12.0 at week 52 (p < .001). Mean ± SD DLQI score improved from 9.4 ± 5.2 at baseline to 2.0 ± 2.6 (p < .001) at week 64 with 62.2% of patients having a DLQI score of 0 or 1 at week 64. Conclusions Tildrakizumab improved long-term HRQoL in patients with psoriasis in a real-world setting.

Effect of sleep disordered breathing severity in children with Down syndrome on parental wellbeing and social support

IntroductionSleep disorders, particularly sleep disordered breathing (SDB), are common in children with Down syndrome (DS). We investigated the relationship between SDB severity and parental psychological wellbeing and their perception of social support. Methods44 children with DS (3–19 years) underwent overnight polysomnography and were categorised into three groups: primary snoring, Mild and Moderate/Severe obstructive sleep apnoea (OSA). Parents completed questionnaires about their child's behaviour (Child Behavior Checklist), sleep symptoms (Pediatric Sleep Survey Instrument) and SDB-related quality of life (OSA-18), together with the DUKE-UNC Functional Social Support (DUKE) and Psychological General Well-Being Index (PGWBI) questionnaires for themselves. 34 children completed a follow-up study after 2 years. ResultsThere were no significant differences between SDB severity groups for parental perceived social support or psychological wellbeing. Total scores on the DUKE were below average and PGWBI scores were indicative of moderate psychological distress in all three groups. Reduced perceived levels of social support were significantly correlated with externalising child behaviour and sleep disturbance. Diminished parental psychological wellbeing was also significantly correlated with increased sleep disturbances and reduced quality of life in children. At follow-up there were no significant changes in any questionnaire outcome, however parents of children with improved SDB severity had improved PGWBI vitality scores. ConclusionThe degree of parent-reported sleep disturbance in children with DS was linked to suboptimal perceived parental social support and poor psychological wellbeing. Our results emphasise the need for enhanced awareness of the detrimental effects of sleep problems in children with DS on parental wellbeing.

Studying the effects of stress, mental health and psychological well‐being on wound healing rates after oesophageal varices ligation in liver cirrhosis patients

AbstractIt is of utmost importance to comprehend the impact that psychological factors have on physical rehabilitation, specifically in regards to wound healing following ligation of oesophageal varices in patients with liver cirrhosis. The present study investigated the correlation between wound recovery rates and psychological well‐being, stress and mental health. From January 2022 to September 2023, 148 patients from were evaluated as part of this cross‐sectional observational study. The psychological well‐being of participants was evaluated utilizing the Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS) and Psychological General Well‐Being Index (PGWBI). The rates of wound recovery were assessed following ligation. The mean duration for wound recovery was 28.37 ± 9.65 days. The mean wounds healing time of patients who obtained higher PSS scores (18.55) was marginally longer. On the contrary, there was a moderate reduction in healing time associated with higher HADS scores (mean 14.10). On average (68.88), PGWBI scores indicated a negligible effect on wound healing. The variance in healing durations between Child‐Pugh classifications A, B and C (mean values of 28.65, 26.90 and 29.57 days respectively) suggested that the severity of liver disease has an impact. As a result of ligation of oesophageal varices, the study demonstrated that psychological factors and wound recovery in patients with liver cirrhosis are intricately intertwined. There seems to be the substantial and intricate relationship between stress, mental health and wound recovery. The results of this study supported the notion that psychological evaluation and support should be incorporated into the management of patients with liver cirrhosis.

Effect of Ayurvedic Formulations on Abnormal Uterine Bleeding (Asrigdara): A Prospective Uncontrolled Multicenter Clinical Study

IntroductionAsrigdara in Ayurveda simulates the dysfunctional type of abnormal uterine bleeding (AUB) and is a common gynaecological complaint. It negatively affects the quality of life and is associated with the poor health of women. This study aimed to evaluate the effect of Ayurvedic formulations, Pushyanuga churna (PC) and Usheerasava (UA) in managing AUB. MethodsA multicenter, single-arm clinical study was conducted on 80 diagnosed patients of AUB. PC 3 g and UA 20 ml were given twice daily for 90 days. Clinical assessment was done at baseline, every 15th day for the initial 3 months, and on 120th day. Pictorial blood loss assessment chart score, visual analogue scale, and Psychological General Well-being Index were utilised to measure the outcome parameters. The safety of formulations was evaluated by reporting adverse drug reactions and changes in liver function tests and renal function tests at baseline and on 90th day. ResultsSixty-eight participants completed the trial. Data were analysed using SPSS version 28.0. The mean age of the participants was 31.7 ± 6.3 years and majority (73.5%) were multiparous. The most typical presentation was heavy menstrual bleeding in 92.6%, followed by frequent bleeding (52.9%). At baseline, 94.2% participants had a pictorial blood loss assessment chart score >100, which decreased to 30.7% at the end of the study. Highly significant changes (P < 0.001) were observed in frequent, prolonged bleeding and psychological general well-being index score. No adverse drug reactions and significant changes in safety parameters were found. ConclusionsPC and UA are effective, well-tolerable, and safe in managing AUB.

Quality of life and patient-reported symptoms in a Phase 4, real-world study of tildrakizumab in patients with moderate-to-severe psoriasis: Week 28 interim analysis

BackgroundTildrakizumab is an anti–interleukin-23 p19 monoclonal antibody approved for the treatment of adults with moderate-to-severe plaque psoriasis. Little real-world evidence is available regarding the effects of tildrakizumab on patients’ health-related quality of life (HRQoL) and patient-reported symptoms.ObjectiveThis real-world study of tildrakizumab evaluated changes in HRQoL and clinical symptoms in patients with psoriasis.Materials and methodsIn this Week (W)28 interim analysis of a 64-week Phase 4 study (NCT03718299), patients received tildrakizumab 100 mg at W0, W4, and every 12 weeks thereafter. Endpoints were improvement from baseline in Psychological General Well-Being Index (PGWBI), Dermatology Life Quality Index (DLQI), and Itch-, Pain-, and Scaling-Numerical Rating Scale scores through W28.ResultsOf 55 patients enrolled, 53 were assessed at W28. Mean (standard deviation [SD]) total PGWBI score improved from baseline to W28 (change, 3.7 [12.4]; p = .033), as did the positive well-being (1.0 [2.9]; p = .018) and general health (1.5 [2.2]; p < .001) domain scores. Mean (SD) DLQI score improved by −3.9 (4.3) at W4 and by −7.6 (5.1) at W28 (p < .001). Patient-reported symptoms improved starting at W4 (p < .001).ConclusionTildrakizumab treatment improved HRQoL and patient-reported symptoms in patients with psoriasis in a real-world setting. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03718299

A hierarchical cluster analysis of the psycological impact of the COVID-19 pandemic on Italian severe asthma patients

Introduction In the context of COVID-19 pandemic, a consistent medical concern raised among severe asthma patients, though the studies excluded an increased risk of severe disease as well as an increased susceptibility. The aim of the study was to apply the Psychological General Well-Being Index (PGWBI) questionnaire to severe asthmatics during the COVID-19 pandemic and to evaluate the data with a hierarchical cluster analysis. Methods 114 severe asthmatics were asked to respond anonymously to the PGWBI questionnaire. The patients underwent a lung functional test, fractional exhaled nitric oxide (FeNO) measurement, Asthma Control Test (ACT), and Asthma Control Questionnaire (ACQ6). A hierarchical cluster analysis was performed using an agglomerative approach and complete linkage to evaluate the results. Results The study population predominantly included female (60%), middle-aged patients, with normal lung function parameters, mild signs of airway, and satisfactory asthma control. The PGWBI score (82.46 ± 16.53) of the study population showed a good state of psychological well-being and was similar to that of a representative sample of healthy adult Italian subjects. Thus, Hierarchical cluster analysis identified 3 groups of patients: Cluster 1 (32%), Cluster 2 (64%), and Cluster 3 (4%). Whilst the Cluster 2 patients’ PGWBI score fell within the normal range, the Cluster 1 patients had a significantly lower total score (68.57 ± 7.2; p < 0.05), suggesting moderate distress. The Cluster 3 patients presented a total score markedly low. Conclusion Although the majority of the severe asthma patients studied demonstrated good mental well-being during the COVID-19 pandemic, some did indeed show moderate to severe psychological distress.

Impact of COVID-19 emergency on the psychological well-being of susceptible individuals

The current pandemic has exerted an unprecedented psychological impact on the world population, and its effects on mental health are a growing concern. The present study aims to evaluate psychological well-being (PWB) during the COVID-19 crisis in university workers with one or more diseases likely to increase the risk of severe outcomes in the event of SARS-CoV-2 infection, defined as susceptible. 210 susceptible employees of an Italian University (aged 25–71 years) were recruited during the COVID-19 second wave (October–December 2020). A group comprising 90 healthy university employees (aged 26–69 years) was also recruited. The self-report Psychological General Well Being Index (PGWBI) was used to assess global PWB and the influence on six sub-domains: anxiety, depressed mood, positive well-being, self-control, general health, and vitality. We applied non-linear dimension-reduction techniques and regression methods to 45 variables in order to assess the main demographic, occupational, and general-health-related factors predicting PWB during the COVID-19 crisis. PGWBI score was higher in susceptible than in healthy workers, both as total score (mean 77.8 vs 71.3) and across almost all subscales. Age and jobs involving high social interaction before the pandemic were inversely associated with the PWB total score, general health, and self-control subscores. The current data suggest no decline in PWB during the second wave of COVID-19 health emergency in susceptible individuals of working age. Critically, higher risk for mental-health issues appears to be inversely related to age, particularly among individuals deprived of their previous level of social interaction at work.

Effect of Suryanamaskar on the Sleep Quality and General Well-being among Young Adults: A Quasi-experimental Study

Introduction: Rapid decline in physical functionality has an adverse impact on both physical and psychological health. Deteriorating sleep quality during the pandemic is one such common manifestation, that further affects the general well-being. Therefore, safe non pharmacological treatments are warranted, and the practice of suryanamaskar is one such intervention. Aim: To find the effectiveness of suryanamaskar on sleep quality and general well-being among young adults. Materials and Methods: This quasi-experimental study was conducted in Physiotherapy Department at Ashirwad Bhagwat Multispecialty Clinic, Sonipat, Haryana, from March 2021 to July 2021. A total of 30 young adults were enrolled in the study and randomly divided into two groups of 15 participants each. The experimental group practiced 8 weeks of suryanamaskar yogic exercise, also known as sun salutations, which comprises of 12 different postures performed with controlled breathing. The control group performed 20 mins of walk. Sleep quality and General Well-being (GWB) were evaluated preintervention and postintervention using the Pittsburgh Sleep Quality Index (PSQI) and Psychological General Well-Being Index (PGWBI) respectively, along with the resting Heart Rate (HR) and Blood Pressure (BP). A higher PGWBI score denotes greater psychological well-being and a total PSQI score of 5 or more indicates poor sleep quality. The effect of the intervention on GWB, sleep quality, BP and HR were assessed using Wilcoxon signed-rank test within the group and the Mann-Whitney test was used to find a statistical difference between the two groups. Results: After 8 weeks of yoga training, a significant difference was found in the overall sleep quality (9.53±1.68, p-value=0.001), GWB (78.33±14.76, p-value=0.001), HR (77.07±5.48, p-value=0.001), SBP (116.67±2.99, p-value=0.001) and BMI (23.01±3.17, p-value=0.019) in the experimental group. However, the control group revealed a significant difference only in the GWB (50.80±13.87, p-value=0.019) postintervention. Additionally, when compared to the control group, the experimental group revealed statistically significant results for sleep quality (p-value=0.001), GWB (p-value &lt;0.001) and HR (p-value=0.007). Conclusion: The study suggests, that yoga training comprising suryanamaskar has positive effects on sleep quality and general well-being.

Quality of Life and Burden of Disease in Italian Patients with Transfusion-Dependent Beta-Thalassemia.

Lifespan treatment in transfusion-dependent β-thalassemia (TDT) is expected to impact quality of life. This study aimed at evaluating health-related quality of life (HRQoL), well-being, and the burden of TDT on Italian patients. Patients (≥14 years) were invited to complete a cross-sectional, online volunteer survey. HRQoL was measured by the 36-item short-form health survey (SF-36) and wellbeing was measured by the Italian version of the Psychological General-Well-Being-Index (PGWBI). A total of 105/167 completed questionnaires were analyzed (46% males; median age 44, (IQR = 11)). Patients reported lower HRQoL compared with the general population in all SF-36 domains (except for emotional well-being (p = 0.7024) and role limitations due to emotional problems (p = 0.1389)). PGWBI domains general health and vitality and the total PGWBI score were all significantly lower (p = 0.0001) compared with the general population. On average, patients spent 16.62 h/month engaged in care activities that were additional to the time required for completing transfusions. Of the 16.62 h/month, 11.7 h/month were required for therapy management and 4.92 h/month for family management. This study found lower HRQoL and well-being in physical and psychological domains compared with the general population. Further, patients were found to have a high perceived burden of disease.

Effect of radiotherapy for rectal cancer on female sexual function: a prospective cohort study.

Abstract Background Clinical experience and limited data show that female sexual function is influenced negatively by preoperative radiotherapy (RT) for rectal cancer. The aim of this prospective study was to investigate the impact of RT on sexual function and ovarian reserve measured by levels of anti-Müllerian hormone (AMH). Methods Women with stage I–III rectal cancer scheduled for surgery with or without preoperative (chemo)RT were included and followed for 2 years. Female Sexual Function Index (FSFI) questionnaire responses and blood samples for hormone analyses, including AMH in women aged 45 years or less, were collected at baseline and during follow-up. Results In the group of 109 women who received preoperative RT, median scores in all FSFI domains decreased over time, as did the total FSFI score (from 18·5 (range 2·0–36·0) at baseline to 10·8 (2·0–34·8) at 2 years; P &amp;lt; 0·001). In the group of 30 women who did not receive preoperative RT, only satisfaction declined over time (from 3·2 (0·8–6·0) to 1·8 (0·8–6·0); P = 0·012). In longitudinal regression analysis, the mean decline in FSFI total score was –9·33 (95 per cent c.i. –16·66 to –1·99; P = 0·013) for women who had preoperative RT compared with those who did not, with adjustment for age, Psychological General Well-being Index score and relationship with partner. A corresponding association was seen for arousal, lubrication, orgasm and pain. Five of six women aged 45 years or less with detectable serum levels of AMH at baseline had undetectable levels after RT. Conclusion Preoperative RT was associated with impairment in sexual function in women with rectal cancer. This needs to be considered when discussing choice of treatment and rehabilitation. In younger women, undetectable AMH levels after RT indicate an irreversible loss of ovarian follicles.

Impact of A Short-Term, Mindfulness-Based Stress Reduction Program on the Well-Being of Infertile Women: A Mixed-Method Study

Background Mind-body skills groups represent an experiential approach to teaching antistress techniques that can enable a person to achieve mindfulness, self-awareness and self-reflection, to engage in self-care. This study examined whether a short-term mindfulness-based stress reduction (MBSR) program improved the well-being of infertile women. Methods A cohort of 25 women was enrolled at a public academic center of reproductive medicine, while on the waiting list for in vitro fertilization (IVF). The MBSR intervention consisted of 12 weekly sessions of mindfulness meditation, relaxation, autogenic training, biofeedback and guided imagery. The participants completed a qualitative, open-ended questionnaire and the Psychological General Well-Being Index (PGWBI) questionnaire to assess anxiety, depressed mood, positive well-being, self-control, general health and vitality, before and after the intervention period. Data were analyzed by paired t-test and by 95% confidence interval. Results The qualitative analysis revealed 5 central themes in patients’ responses to the questionnaires: connections, self-discovery, stress relief, learning and consciousness. Total PGWBI score increased by 17% (mean difference 14.1 ± 3.9 points, p&lt;0.01), and all subscales improved after the intervention course compared with the preintervention values. Conclusions Both qualitative and quantitative assessment suggest that a 12-week MBSR program may improve the general well-being of infertile women awaiting IVF.

Quality-of-life issues in survivors to anaphylactic reactions to drugs.

The aim of this cross-sectional observational study was to explore quality of life and well-being in patients with drug-induced anaphylaxis. Two validated tools were used: the Drug Hypersensitivity Quality-of-Life Questionnaire (DrHy-Q) and the Psychological General Well-Being Index (PGWBI). Sixty-five patients (13 males) underwent data analysis. The mean DrHy-Q score was 62.82 ± 12.1. Mean PGWBI score was 64.03 ± 17.66. DrHy-Q score was significantly correlated with PGWBI total score (r = -0.314; P = 0.011) and with the following domains: Anxiety (r = -0.260; P = 0.036), Depressed mood (r = -0.406; P = 0.001), Positive well-being (r = -0.251; P = 0.004), and General Health (r = -0.352; P = 0.004). Compared with the Italian reference population, patients had a significantly reduced PGWBI total and domain score. Our results highlight for the first time how impaired HRQoL and distress commonly feature in survivors to anaphylactic reactions to drug.

Mental state and quality of life after 10 session whole-body cryotherapy

The aim of this study was to evaluate the impact of a whole-body cryotherapy (WBCT) on various parameters of the mental state of patients depending on their age, gender, and diagnosed illness. The study included 55 subjects – 43 women and 12 men aged from 20 to 70 years. Based on the diagnosed illness, the patients were divided into two diagnostic groups. The first group consisted of patients with spinal pain syndromes (n = 34). The second group comprised patients with peripheral joint disease (n = 21). All patients underwent 10 WBCT sessions. The subjects completed a survey at two time points: before the first WBCT treatment (T1) and after completing the tenth treatment (T2). The World Health Organization Quality of Life-Bref (WHOQOL-Bref) questionnaire and the Psychological General Well-Being Index (PGWBI) questionnaire were used in the study. After a series of WBCT treatments, the WHOQOL-Bref and PGWBI scores significantly improved (p = .005161, p = .000862, respectively). WBCT proved to be more effective in enhancing the mood and well-being of the patients than in improving their quality of life. WBCT has a significant influence on improving the well-being and mood of patients (in terms of both psychological and somatic aspects) and consequently leads to an improvement in their quality of life. The worse the mental state of the patients is prior to the cryotherapy, the stronger its effect. The observed effectiveness of cryotherapy was the strongest in women, patients with spinal pains and in patients with severe depressive symptoms.

Five-year follow-up of levonorgestrel-releasing intrauterine system versus thermal balloon ablation for the treatment of heavy menstrual bleeding: a randomized controlled trial

BackgroundThe study was conducted to compare 5-year follow-up of levonorgestrel-releasing intrauterine system (LNG-IUS) or thermal balloon ablation (TBA) for the treatment of heavy menstrual bleeding (HMB). Study DesignA prospective, randomized controlled trial comparing LNG-IUS (n=30) and TBA (n=28) was performed. Hysterectomy rates, hemoglobin level, bleeding pattern, well-being status and satisfaction rates were assessed. Comparisons between groups were performed by χ2 test and by unpaired and paired t tests. ResultsAfter 5 years of follow-up, women treated with a TBA had higher rates of hysterectomy (24%) compared to the LNG-IUS group (3.7%) due to treatment failure (p=.039). Use of LNG-IUS resulted in higher mean hemoglobin (±SD) levels in comparison to the TBA group (14.1±0.3 vs 12.7±0.4 g/dL, p=.009). Menstrual blood loss was significantly higher in the TBA when compared to the LNG-IUS group (45.5% vs 0.0% p<.001). The psychological general well-being index scores were similar. Patient acceptability, perceived clinical improvement and overall satisfaction rates were significantly higher in women using LNG-IUS. ConclusionFive-year follow-up of HMB treatment with LNG-IUS was associated with higher efficacy and satisfaction ratings compared to TBA.

Urinary Incontinence in Young Nulligravid Women

Although pregnancy is a risk factor for urinary incontinence (UI), the extent of UI in nulligravid women has not been reported. To investigate the rate of UI in a sample of young nulligravid women and its potential risk factors and effect on quality of life. Cross-sectional, self-administered questionnaire-based study. University campuses and medical and allied health clinics. Nulligravid Australian women aged 16 to 30 years. The Questionnaire for Urinary Incontinence Diagnosis, the Psychological General Well-Being Index (PGWBI), the King's Health Questionnaire, and the International Physical Activity Questionnaire-Short Form. Demographic variables and potential risk factors were also documented. 1018 of 1620 questionnaires (63%) were returned, and 1002 provided analyzable data. The mean age of participants was 22.5 years (SD, 3.2). The rate of any UI was 12.6% (95% CI, 10.5% to 14.7%). Incontinence was slightly more common in students than in nonstudents (13.2% [CI, 11.0% to 15.8%] vs. 10.6% [CI, 6.7% to 14.6%]). Rates of UI varied according to sexual activity and use of combined oral contraceptives (COCs), with highest rates reported by students who were ever sexually active and not using COCs (21.5% [CI, 16.7% to 27.3%]). Women with UI reported significantly lower overall well-being than women without UI and had worse PGWBI scores related to anxiety, depression, positive well-being, and self-control. A convenience sample of healthy, well-educated women was recruited, and response rates and participant characteristics varied by setting. In a sample of young nulligravid women, UI was associated with ever being sexually active and no COC use, as well as lower psychological well-being. Further research is needed to assess the prevalence and risk factors for UI in nulligravid women. None.

Mindfulness-Based Cognitive Therapy Versus Psycho-Education for Patients with Major Depression Who Did Not Achieve Remission Following Antidepressant Treatment: A Preliminary Analysis

The objective of this study was to compare mindfulness-based cognitive therapy (MBCT) with a psycho-educational control group designed to be structurally equivalent to the MBCT program but excluding the claimed "active ingredient" of MBCT (i.e., mindfulness meditation practice) for the treatment of patients with major depression (MD). This was a randomized controlled trial. The study was conducted at the Institute of Psychiatry, University of Bologna, Italy. Patients who had MD and who did not achieve remission following at least 8 weeks of antidepressant treatment were considered for inclusion. Eligible subjects were randomized to receive MBCT or psycho-education and were prospectively followed for 8 weeks. MD severity was assessed with the Hamilton Rating Scale for Depression (HAMD). Measures of anxiety, mindfulness, and quality of life, as measured with the Beck Anxiety Inventory, Mindfulness Attention and Awareness Scale, and the Psychological General Well-being Index (PGWBI), respectively, were also included. All assessments were performed at baseline, 4 weeks, and 8 weeks. Changes of psychologic variables over the study period were analyzed by means of the repeated-measures analysis of variance. Of 29 screened subjects, 16 received MBCT or psycho-education. Both HAMD and PGWBI scores improved to a significantly higher extent in the MBCT group than in the psycho-educational control group. Although limited by a small sample size and the lack of follow-up measures, the results of this preliminary study suggest the superiority of MBCT over psycho-education for subjects who had MD and who did not achieve remission following antidepressant treatment.

Quality of life in European patients with Addison's disease: validity of the disease-specific questionnaire AddiQoL.

Patients with Addison's disease (AD) self-report impairment in specific dimensions on well-being questionnaires. An AD-specific quality-of-life questionnaire (AddiQoL) was developed to aid evaluation of patients. We aimed to translate and determine construct validity, reliability, and concurrent validity of the AddiQoL questionnaire. After translation, the final versions were tested in AD patients from Norway (n = 107), Sweden (n = 101), Italy (n = 165), Germany (n = 200), and Poland (n = 50). Construct validity was examined by exploratory factor analysis and Rasch analysis, aiming at unidimensionality and fit to the Rasch model. Reliability was determined by Cronbach's coefficient-α and Person separation index. Longitudinal reliability was tested by differential item functioning in stable patient subgroups. Concurrent validity was examined in Norwegian (n = 101) and Swedish (n = 107) patients. Exploratory factor analysis and Rasch analysis identified six items with poor psychometric properties. The 30 remaining items fitted the Rasch model and proved unidimensional, supported by appropriate item and person fit residuals and a nonsignificant χ(2) probability. Crohnbach's α-coefficient 0.93 and Person separation index 0.86 indicate high reliability. Longitudinal reliability was excellent. Correlation with Short Form-36 and Psychological General Well-Being Index scores was high. A shorter subscale comprising eight items also proved valid and reliable. Testing of AddiQoL-30 in this large patient cohort showed significantly worse scores with increasing age and in women compared with men but no difference between patients with isolated AD and those with concomitant diseases. The validation process resulted in a revised 30-item AddiQoL questionnaire and an eight-item AddiQoL short version with good psychometric properties and high reliability.

Psychological well‐being outcomes in disease‐free survivors of mid‐low rectal cancer following curative surgery

The aim of this cross-sectional study was to evaluate psychological well-being outcomes in disease-free survivors who previously underwent radical surgery for rectal adenocarcinoma. All patients with rectal adenocarcinoma who underwent primary surgery at a single institution from 1990 to 2002 were considered for inclusion in the study. We identified and sent questionnaires to 145 patients after excluding those who had died or had recurrent disease. One hundred and seventeen patients (men/women: 74/43; median age: 65 years) returned the questionnaires. Patients' well being was evaluated using the Psychological General Well-Being Index (PGWBI) questionnaire. The mean PGWBI score was compared with normative data of the general population. The impact of patient-, tumor- and treatment-related factors on patients' long-term psychological well-being status was also evaluated. Compared with the general population, study patients had significantly better anxiety, depressed mood, positive well being, general health, vitality scales and global index scores. On multivariate analysis, positive well being was independently affected by time from diagnosis (36 months; p=0.025) and occurrence of early major complications (p=0.024). Variables that were independently associated with worse self-control included primary education (p=0.04) and the presence of fecal urgency (p=0.049). General health was negatively affected by time from diagnosis (36 months; p=0.047) and fecal urgency (p=0.009). Patients who have survived cancer are likely to re-evaluate the importance of everyday events and this may explain why they had better PGWBI scores. This study also identified that a short time from diagnosis, early adverse events and bowel dysfunction had a negative impact on patients' well being.

Development and validation of the Drug Hypersensitivity Quality of Life Questionnaire

The impact of drug hypersensitivity has never been considered from the patient's perspective, and no questionnaire is currently available for this purpose. To develop and validate a questionnaire specifically designed for the assessment of quality of life in patients with drug hypersensitivity entitled the Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q). During the development procedure, an initial questionnaire of 34 items was generated and administered to 70 patients; the 20 most important items were detected and converted into questions evaluated with a 5-point Likert scale. This provisional questionnaire then underwent a validation procedure to assess its psychometric properties. The DrHy-Q and the Psychological General Well-Being Index (PGWBI) were completed by 365 patients (67.5% female; mean [SD] age, 40 [15] years). Statistical analysis revealed a 1-dimensional structure for the DrHy-Q that explained up to 50.7% of the total variance and showed good levels of internal consistency for the extracted factor (Cronbach α = 0.928). The correlations between the DrHy-Q and the PGWBI scores were low. However, the DrHy-Q scores of patients who experienced anaphylactic shock were significantly higher than the scores from patients with other reactions (analysis of variance; F = 5.991; df = 4; P < .001). The test-retest associations were good (R = 0.995; P < .001). DrHy-Q met the standards for construct validity, internal consistency, and reliability, indicating that it is appropriate for use alone or in combination with other patient-reported outcome questionnaires to explore the subjective experiences of patients with drug hypersensitivity.

Urinary incontinence is associated with lower psychological general well-being in community-dwelling women

There are few studies documenting the impact of urinary incontinence (UI) on well-being in women. The aim of this study was to evaluate the relationships between different types of UI and general well-being in women in the community. A cross-sectional survey of 542 community-dwelling women, aged 24 to 80 years, was conducted in July 2006. A detailed self-administered questionnaire was mailed to the study participants. UI was assessed using the Questionnaire for Urinary Incontinence Diagnosis, and well-being was assessed using the Psychological General Well-being Index (PGWBI). The relationships between types of UI and PGWBI scores were assessed using multiple regression analyses while adjusting for potential confounders. A total of 506 (94%) women provided data for analysis. Women with incontinence had a lower total PGWBI score (76.9 +/- 16.5) than did women with no UI (81.6 +/- 15.3; P = 0.001). The total PGWBI mean score was significantly lower in women with stress-only UI (77.8 +/- 16.2; P = 0.05) and mixed UI (74.2 +/- 17.8; P < 0.001) compared with women with no UI. There was no significant difference in the mean total scores between women with urge UI and women without UI. Stress-only UI was negatively associated with the PGWBI subdomains of self-control, general health, and vitality, whereas those with mixed UI had lower scores for all the PGWBI subdomains. The associations for UI remained significant after adjustment for age, systemic hormone therapy use, menopause status, smoking status, and regular exercise. Not only is UI associated with a significant reduction in well-being in community-dwelling women, but also, the relationship between different types of UI and well-being seems to differ.