Outcomes Study Short-Form General Health Research Articles

Physical, social, mental and spiritual functioning of COVID-19 intensive care unit-survivors and their family members one year after intensive care unit-discharge: A prospective cohort study

ObjectiveTo describe the long-term functioning of patients who survived a COVID-19-related admission to the intensive care unit and their family members, in the physical, social, mental and spiritual domain. DesignA single-centre, prospective cohort study with a mixed-methods design. SettingThe intensive care unit of the University Medical Center Groningen in the Netherlands. Main outcome measuresTo study functioning 12 months after intensive care discharge several measurements were used, including a standardised list of physical problems, the Clinical Frailty Scale, the Medical Outcomes Study Short-Form General Health Survey, the McMaster Family Assessment Device, the Hospital Anxiety and Depression Scale, and the Spiritual Needs Questionnaire, as well as open questions and interviews with survivors and their family members. ResultsA total of 56 survivors (77%) returned the 12-month questionnaire, whose median age was 62 (inter-quartile range [IQR]: 55.0–68.0). Moreover, 67 family members (66%) returned the 12-month questionnaire, whose median age was 58 (IQR: 43–66). At least one physical problem was reported by 93% of the survivors, with 22% reporting changes in their work-status. Both survivors (84%) and their family members (85%) reported at least one spiritual need. The need to feel connected with family was the strongest. The main theme was ‘returning to normal’ in the interviews with survivors and ‘if the patient is well, I am well’ in the interviews with family members. ConclusionsOne year after discharge, both COVID-19 intensive care survivors and their family members positively evaluate their health-status. Survivors experience physical impairments, and their family members’ well-being is strongly impacted by the health of the survivor.

MEASUREMENT OF PATIENT-REPORTED OUTCOMES AT APPROXIMATELY ONE MONTH FOLLOWING A HOSPITAL OR ED DISCHARGE FOR COVID-19

TYPE: Abstract TOPIC: Chest Infections PURPOSE: To collect data for prolonged morbidity in COVID-19 infections using validated questionnaires. METHODS: An IRB-approved telephone survey was administered to 54 patients who were discharged from the hospital or ED for COVID-19 approximately one month earlier. PRO included the Modified Medical Research Council questionnaire (MRC, 0-4 scale), Short Fatigue Questionnaire (SFQ), Patient Health Questionnaire for Depression and Anxiety (PHQ– 4), the Cognitive Change Questionnaire (CCQ8), and the Medical Outcomes Study Short-Form General Health Survey (SF-20). Published thresholds for abnormality in these outcomes were utilized. RESULTS: Age was 50 ± 16 years; 54% were female, 81% were hospitalized while 19% were treated only in the ED. Higher dyspnea ratings (MRC >2) were present in 37%. Elevations in PRO at 32 ± 10 days were: PHQ anxiety (28%) and depression (19%), SFQ fatigue (57%), CCQ8 (19%). Mean ± SD values for the SF-20 health measures were as follows (range = 0 to 100, higher scores = greater functioning): Physical Functioning 69 ± 25, Role Functioning 53 ± 45, Social Functioning, 53 ± 41, Mental Health 71 ± 19, Health Perceptions 50 ± 30, Pain 61 ± 29. These scores were all lower (worse) compared to a cohort of Canadians (age range = 66-70) living at home (Carver et al., Age and Ageing, 1999; 28:169-174). CONCLUSIONS: Substantial abnormality in PRO remains at approximately one month after COVID-19 infection. CLINICAL IMPLICATIONS: Patients who have recovered from COVID-19 require follow-up care to address prolonged morbidity, and further analysis is needed to determine causation. DISCLOSURE: Nothing to declare. KEYWORD: COVID-19

Post-COVID-19 Condition and Health Status

Background: Observational studies of the long-term effects of COVID-19 infection generally focus on individual symptoms rather than health status. Objective: Longitudinal assessment of general health status following COVID-19 infection. Design: Observational study, with data collected from two telephone surveys at 32 ± 10 and 89 ± 25 days after discharge from the hospital or emergency department (ED) for a COVID-19 infection. Medicaid or no insurance was our marker of low socioeconomic status (SES). Acute disease severity was determined by summing 10 severity markers (yes-no) from the health encounter. Baseline comorbidity was a modified Charlson Index. Participants: 40 patients. Mean age was 54 ± 15 years, 50% were female, and 40% had low socioeconomic status. Main Measures: (1) the 20-item Medical Outcomes Study Short-Form General Health Survey (SF-20); (2) Dyspnea (modified Medical Research Council); (3) Psychological symptoms (Patient Health Questionnaire for Anxiety and Depression); (4) Cognitive function (Cognitive Change Questionnaire); (5) Fatigue (Short Fatigue Questionnaire); (6) A 10-item review of systems (ROS) questionnaire. Key Results: Percentages with abnormal symptoms at the first and second surveys were (respectively): Dyspnea (40, 33), Fatigue (53, 50), Anxiety (33, 18), Depression (20, 10), PHQ-4 Composite (25, 13), and Cognitive (18, 10). Mean scores on the SF-20 subscales, Physical Functioning, Role Functioning, Social Functioning, Health Perception, Mental Health, and Pain were numerically lower than means from a published study of elderly outpatients. With the exception of Pain, all SF-20 subscale scores improved significantly by the second survey. In multivariable analyses, dyspnea was predictive of impairment in all SF-20 subscales at the second survey. Conclusions: COVID-19 infection causes persistent abnormality across multiple patient-reported outcome areas, including health status. The persistence of impairment in each health status component is influenced by baseline dyspnea.

Is high job control a risk factor for poor quality of life in workers with high autism spectrum tendencies? A cross-sectional survey at a factory in Japan.

To examine the effect of autism spectrum (AS) tendencies and psychosocial job characteristics on health-related quality of life (HRQOL) among factory workers. A questionnaire survey was administered to 376 Japanese factory employees from the same company (response rate: 83.6%) in 2010. Psychosocial job characteristics, including job demand, job control, and social support, were evaluated using the Job Content Questionnaire (JCQ). AS tendencies was assessed using the Autism-Spectrum Quotient (AQ), and HRQOL was assessed using the Medical Outcomes Study Short-Form General Health Survey (SF-8). Associations were investigated using multiple logistic regression analysis adjusted for confounders. In the multivariate analysis, AQ was positively (odds ratio [OR]: 3.94; 95% confidence interval [CI]: 1.70-9.73) and social support in the workplace was inversely (OR: 0.25; 95% CI: 0.10-0.57) associated with poor mental HRQOL. No significant interaction was observed between AQ and JCQ subitems. Only social support was inversely associated with poor physical HRQOL (OR and 95% CI for medium social support: 0.45 and 0.21-0.94), and a significant interaction between AQ and job control was observed (p=0.02), suggesting that high job control was associated with poor physical HRQOL among workers with high AQ, whereas low job control tended to be associated with poor physical HRQOL among others. Our results suggest that AS tendencies have a negative effect on workers' HRQOL and social support is a primary factor in maintaining HRQOL. Moreover, a structured work environment can maintain physical HRQOL in workers with high AS tendencies since higher job control will be stressful.

Health-related quality of life and working conditions on public transport workers in the Metropolitan Region of Belo Horizonte, Brazil, 2012.

Drivers and conductors working in public transport are frequently exposed to inadequate working conditions and consequently to health problems relating to their work activities. This study investigates the relationship between the working conditions of drivers and conductors in the Metropolitan Region of Belo Horizonte and their perception of health-related quality of life. Health-related quality of life was measured in a sample of 1,607 public transport workers in the city of Belo Horizonte using the SF-12 (Medical Outcomes Study Short-Form General Health Survey). The presence and magnitude of independent associations between the SF-12 domains and the exposure variables were determined by means of odds ratios obtained through logistic regression. After adjustments, the PCS (Physical Component Score) was found to be negatively associated with the existence of breaks during the working day and positively associated with unavailability of technical resources for meeting needs. The MCS (Mental Component Score) was positively associated with being female, having two or more medical diagnoses of illnesses, absenteeism and recent episodes of aggression or threats, and feeling vibration in the whole body. The MCS was negatively associated with the practice of physical exercise. Both components were negatively associated with older age and positively associated with having a poor self-assessment of health. Exposure to a variety of risk factors while performing work worsened health-related quality of life. The results obtained may provide support for rethinking and guiding public policies directed towards metropolitan populations.

Evaluation of sexuality, health-related quality-of-life and depression in advanced cancer patients: A prospective study in a Phase I clinical trial unit of predominantly targeted anticancer drugs

BackgroundThe advent of molecular targeted agents (MTA) has opened a new era of therapy in oncology. However, some of the toxicities and side-effects of these new drugs are not explored as is the case with the potential impact of MTA on sexuality. This study aimed to prospectively evaluate health-related quality of life (HRQoL), depression and sexual function in advanced cancer patients treated in a Phase I drug unit evaluating MTA. Patents and methodsIn total, 63 of 74 eligible patients agreed to participate in the study. Four validated self-questionnaires were used: the Medical Outcomes Study Short-Form General Health Survey (SF12), the short form Beck Depression Inventory (BDI), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). Forty-seven patients (75%) responded at baseline and 31 (65%) at 1-month. ResultsThis is the first evaluation of HRQoL, depression and sexual function in a Phase I drug unit. At baseline, patients had a good mental and physical function despite their disease progression. The response rate was 75% for sexual questionnaires. For 57% of females and 68% of males, quality of sexual life was a subject of interest. After 1-month of treatment, sexual dysfunction included lack of lubrication and comfort in females and erectile dysfunction in males with a statistical association of anti-angiogenic inhibitors in males (p=0.04). ConclusionsPatients on MTA in Phase I clinical trials had a preserved mental and physical activity whereas their sexual activity declined in both sexes. The impact of MTA on HRQoL and especially sexual function should be routinely assessed in further studies to better understand their potential impact in advanced cancer patients.

1463P - Evaluation of Sexuality, Quality-of-Life and Depression in Advanced Cancer Patients Treated in A Drug Development Unit

ABSTRACT Background The advent of molecular targeted agents (MTA) opened a new era therapy in oncology. The objective of this study was to investigate quality of life, depression and sexual function in patients treated in a phase I drug unit evaluating MTA. Patients and methods All patients included in a phase I clinical trial at the Gustave Roussy Institute were proposed a personal interview regarding their quality of life, depression, and sexual function. They completed 4 self-questionnaires containing the Medical Outcomes Study Short-Form General Health Survey (SF12), the Beck Depression Inventory (BDI-II), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). Results This is, to our knowledge, the first evaluation of quality of life, depression and sexual function in a phase I drug unit. Sixty-three patients were evaluated at baseline. Patients had a good mental and physical function despite their disease progression. The response rate was 75% for sexual questionnaires. For 57% of females and 68% of males, quality of sexual life was a subject of interest. After one month treatment, sexual dysfunction increased especially in lubrication and pain in females and erection in males with a statistical association of anti-angiogenic inhibitors in males (p = 0.04). Conclusions Patients on MTA in phase I clinical trials had a preserved mental and physical activity whereas their sexual activity decline in both sexes. The impact of MTA on sexual function should be routinely assessed. Disclosure All authors have declared no conflicts of interest.

Effect of Biologic Agents on Non-PASI Outcomes in Moderate-to-Severe Plaque Psoriasis: Systematic Review and Meta-Analyses

IntroductionThe objective of this review was to conduct a systematic review with meta-analysis and Bayesian mixed treatment comparisons (MTC) evaluating the impact of biologics on non-Psoriasis Area and Severity Index (PASI) health outcomes in patients with moderate-to-severe plaque psoriasis.MethodsMEDLINE and Cochrane Central Register of Controlled Trials were searched from 1966 to May 2009. Citations were screened for randomized, controlled trials of biologics versus either placebo or each other in adults with moderate-to-severe plaque psoriasis and reported any of several outcomes. Traditional and Bayesian MTC meta-analyses were conducted for each endpoint using either a random- or fixed-effect model where appropriate.ResultsThirty-eight studies met eligibility criteria. All biologics showed significant improvement in achieving a good response on the static physician’s global assessment (PGA) versus placebo while, in the MTC, differences were noted between individual drugs. In achieving a good response on the dynamic PGA, all biologics showed significant improvements over placebo, while the MTC showed significant improvements with the anti-interleukins versus anti-T cells. Relative to placebo, antitumor necrosis factor (TNF) agents and anti-interleukins showed significant improvements in the Dermatology Life Quality Index (DLQI). Compared with placebo, the anti-TNF agents showed significant improvements in both 36-item Medical Outcomes Study Short-Form General Health Survey (SF-36) mental and physical component scores, while anti-T cell agents showed no improvements. The MTC showed no differences between any biologics for either the DLQI or SF-36.ConclusionIndividual biologics and classes showed consistent benefits across non-PASI health outcomes in patients with moderate-to-severe plaque psoriasis while MTC meta-analyses suggested that some differences exist.

Adverse Psychosocial Working Conditions and Poor Quality of Life among Financial Service Employees in Brazil

Workers in the financial services sector are exposed to great stress at work. This study investigates whether exposure to adverse psychosocial work conditions is independently associated with poor health-related physical and mental quality of life among financial services workers. We studied a nationwide representative sample of 2,054 workers of a large Brazilian state bank in 2008. Adverse psychosocial work conditions were investigated by the Effort-reward imbalance (ERI) scale and the Job content questionnaire (JCQ). Health-related quality of life (HRQL) was assessed using the Medical Outcomes Study Short-Form General Health Survey (SF-12). Poor mental and physical HRQL was defined by the lowest quartiles of the SF-12 final score distributions. Associations were investigated using multiple logistic regression analysis. In the multivariate analysis, exposures to low control and lack of social support at work (JCQ) were associated with poor HRQL in the physical domain. Increasing effort-reward imbalance and overcommitment (ERI), on the other hand, were associated with poor HRQL in the mental domain, with a significant statistical trend. Overcommitment was also associated with poor physical HRQL. The results suggest that exposure to adverse psychosocial work conditions has a negative impact on both domains of HRQL among financial service workers. They also indicate that ERI and DC models capture different aspects of job strain.

Recruitment bias in chronic pain research: whiplash as a model

In science findings which cannot be extrapolated to other settings are of little value. Recruitment methods vary widely across chronic whiplash studies, but it remains unclear whether this generates recruitment bias. The present study aimed to examine whether the recruitment method accounts for differences in health status, social support, and personality traits in patients with chronic whiplash-associated disorders (WAD). Two different recruitment methods were compared: recruiting patients through a local whiplash patient support group (group 1) and local hospital emergency department (group 2). The participants (n=118) filled in a set of questionnaires: the Neck Disability Index, Medical Outcome Study Short-Form General Health Survey, Anamnestic Comparative Self-Assessment measure of overall well-being, Symptom Checklist-90, Dutch Personality Questionnaire, and the Social Support List. The recruitment method (either through the local emergency department or patient support group) accounted for the differences in insufficiency, somatization, disability, quality of life, self-satisfaction, and dominance (all p values <.01). The recruitment methods generated chronic WAD patients comparable for psychoneurotism, social support, self-sufficiency, (social) inadequacy, rigidity, and resentment (p>.01). The recruitment of chronic WAD patients solely through patient support groups generates bias with respect to the various aspects of health status and personality, but not social support. In order to enhance the external validity of study findings, chronic WAD studies should combine a variety of recruitment procedures.

Depressão e qualidade de vida em jovens de 18 a 24 anos no sul do Brasil

OBJETIVO: Investigar a associação entre depressão e qualidade de vida em jovens de 18 a 24 anos de idade. MÉTODO: Estudo transversal de base populacional, composto por 1.560 jovens de 18 a 24 anos residentes na zona urbana de Pelotas (RS). A seleção amostral foi realizada por conglomerados: da divisão censitária de 448 setores, 97 foram sorteados aleatoriamente. A avaliação da depressão foi realizada através do Mini-International Neuropsychiatric Interview (MINI), e a qualidade de vida foi mensurada pela Medical Outcomes Study Short-Form General Health Survey (SF-36), ambos validados para uso em língua portuguesa. RESULTADOS: A prevalência de depressão foi de 12,6%. A média dos escores de qualidade de vida entre os oito domínios do SF-36 foi menor entre os jovens com depressão, apresentando associação significativa no teste t para todos os domínios (p = 0,000). CONCLUSÃO: Jovens com indicativo de depressão apresentaram menores níveis de qualidade de vida nos domínios explorados.

Long-term functioning following whiplash injury: the role of social support and personality traits

Transition from acute whiplash injury to either recovery or chronicity and the development of chronic whiplash-associated disorders (WAD) remains a challenging issue for researchers and clinicians. The roles of social support and personality traits in long-term functioning following whiplash have not been studied concomitantly. The present study aimed to examine whether social support and personality traits are related to long-term functioning following whiplash. One hundred forty-three subjects, who had experienced a whiplash injury in a traffic accident 10-26months before the study took place, participated. The initial diagnoses were a 'sprain of the neck' (ICD-9 code 847.0); only the outcome of grades I-III acute WAD was studied. Long-term functioning was considered within the biopsychosocial model: it was expressed in terms of disability, functional status, quality of life and psychological well-being. Participants filled out a set of questionnaires to measure the long-term functioning parameters (i.e. the Neck Disability Index, Medical Outcome Study Short-Form General Health Survey, Anamnestic Comparative Self-Assessment measure of overall well-being and the Symptom Checklist-90) and potential determinants of long-term functioning (the Dutch Personality Questionnaire and the Social Support List). The results suggest that social support (especially the discrepancies dimension of social support) and personality traits (i.e. inadequacy, self-satisfaction and resentment) are related to long-term functioning following whiplash injury (Spearman rho varied between 0.32 and 0.57; p < 0.01). Within the discrepancy dimension, everyday emotional support, emotional support during problems, appreciative support and informative support were identified as important correlates of long-term functioning. Future prospective studies are required to confirm the role of social support and personality traits in relation to long-term functioning following whiplash. For such studies, a broad view of long-term functioning within the biopsychological model should be applied.

Trauma Exposure and Posttraumatic Stress Disorder in Primary Care Patients

Posttraumatic stress disorder (PTSD) is one of the most common but least recognized anxiety disorders in primary care. This study aimed to describe the association of PTSD and trauma exposure with somatic symptoms, psychiatric comorbidity, functional impairment, and the actual treatment of PTSD in primary care. This cross-sectional criterion standard study included 965 consecutive primary care patients from 15 civilian primary care clinics in the United States. The Structured Clinical Interview for DSM-IV (SCID) was used to establish diagnosis of PTSD and other anxiety disorders. Somatic symptoms, depression, and anxiety were measured with the Patient Health Questionnaire (PHQ), and functional impairment was measured with the Medical Outcomes Study Short-Form General Health Survey (SF-20). The study was conducted from November 2004 to June 2005. PTSD was diagnosed in 83 patients (8.6%; 95% CI, 7.0%-10.5%), and trauma exposure without fulfilling DSM-IV criteria for PTSD was reported by 169 patients (17.5%; 15.2%-20.0%). With odds ratios ranging between 2.1 (95% CI, 1.2-3.6) for headache and 9.7 (3.8-24.8) for chest pain, PTSD patients had markedly elevated somatic symptom rates compared to the reference group of patients with no PTSD or trauma exposure. PTSD was significantly associated with elevated rates of psychiatric comorbidity, pain, and impaired functioning. Patients reporting trauma but no PTSD had rates of somatic symptoms, psychiatric comorbidity, and functional impairment that were intermediate between PTSD and reference group patients. Adjusting for depression substantially attenuated the association of PTSD and trauma with somatic symptoms, suggesting that depression may be an important mediator of the PTSD-somatic symptoms relationship. The high frequency of PTSD in primary care and its association with psychiatric comorbidity and functional impairment underscore the need to better detect and treat PTSD in primary care. Recognizing the frequent somatic presentation of PTSD and appreciating the salience of comorbid depression may be especially important in optimizing PTSD care.

The Effect of Eszopiclone in Patients With Insomnia and Coexisting Rheumatoid Arthritis

To evaluate the efficacy and safety of eszopiclone 3 mg, a nonbenzodiazepine medication/hypnotic indicated for the treatment of insomnia with comorbid rheumatoid arthritis (RA). This multicenter, double-blind, placebo-controlled pilot study was conducted in 153 patients aged 25-64 years with American College of Rheumatology-defined RA who met DSM-IV criteria for insomnia. The data were collected from February to November of 2004. Patients were randomly assigned to either eszopiclone or placebo nightly for 4 weeks, followed by a 2-week placebo run out. Efficacy was evaluated using patient reports of sleep (wake time after sleep onset [WASO], sleep latency [SL], and total sleep time [TST]), daytime function, pain, and RA assessments. Insomnia severity was evaluated using the Insomnia Severity Index. Safety was also evaluated. Eszopiclone significantly improved all patient-reported sleep measures (WASO, SL, and TST), sleep quality, depth of sleep, and daytime function (P < .05 vs placebo). At week 4, 48% of eszopiclone-treated patients had no clinically meaningful insomnia as assessed by ISI score (versus 30% of placebo-treated patients, P = .03). Eszopiclone was significantly better than placebo on some RA-associated pain measures: (1) overall (P = .05), pain (P = .006), and pain and other symptoms (P = .02) scores of the Arthritis Self-Efficacy Scale, (2) tender joint counts (P = .03) and pain severity scores (P = .023), (3) the activities domain of the Health Assessment Questionnaire-Disability Index (P = .04), and (4) the role physical (P = .03) and bodily pain (P = .01) scales of the 36-item Medical Outcomes Study Short-Form General Health Survey. The most commonly reported adverse events with eszopiclone were unpleasant taste and transient increases in RA symptoms. In this pilot study of patients with insomnia comorbid with RA, eszopiclone 3 mg improved all assessed sleep and daytime function measures over the treatment period, as well as some measures of RA-associated pain, disability, and quality of life. clinicaltrials.gov Identifier: NCT00367965.

Long term outcome after delirium in the intensive care unit

This research studied the long term outcome of intensive care delirium defined as mortality and quality of life at three and six months after discharge of the intensive care unit. Delirium in the intensive care unit is known to result in worse outcomes. Cognitive impairment, a longer stay in the hospital or in the intensive care unit and a raised mortality have been reported. A prospective cohort study. A population of 105 consecutive patients was included during the stay at the intensive care unit in July-August 2006. The population was assessed once a day for delirium using the NEECHAM Confusion Scale and the CAM-ICU. Patients were visited at home by a nurse researcher to assess the quality of life using the Medical Outcomes Study Short-Form General Health Survey at three and six months after discharge of the intensive care unit. Delirious and non delirious patients were compared for mortality and quality of life. Compared to the non delirious patients, more delirious patients died. The total study population discharged from the intensive care unit, scored lower for quality of life in all domains compared to the reference population. The domains showed lower results for the delirious patients compared to the non delirious patients. Mortality was higher in delirious patients. All patients showed lower values for the quality of life at three months. The delirious patients showed lower results than the non delirious patients. Nurses are the first caregivers to observe patients. The fluctuating delirious process is often not noticed. Long term effects are not visible to the interdisciplinary team in the hospital. This paper would like to raise the awareness of professionals for long term outcomes for patients having experienced delirium in the intensive care unit.

Trospium chloride and oxybutynin hydrochloride in a german study of adults with urinary urge incontinence: Results of a 12-week, multicenter, randomized, double-blind, parallel-group, flexible-dose noninferiority trial

Objectives: The aims of this study were to determine whether oral trospium chloride is noninferior to oxy-butynin for urinary urge incontinence and to evaluate its efficacy, tolerability, and health-related quality of life parameters. Methods: In this randomized, double-blind, active-controlled, parallel-group, multicenter, Phase IIIb trial conducted in Germany, male and female outpatients aged ≥18 years with documented urinary frequency (≥8 micturitions/24 hours) plus urge incontinence (≥5 episodes/week) were randomized to receive oral treatment with trospium chloride 15 mg TID or oxybutynin hydrochloride 2.5 mg TID for 12 weeks. Daily doses could be adjusted upward after 4 weeks, to 90 mg of trospium (30 mg TID) and 15 mg of oxybutynin (5 mg TID), respectively, if needed. The absolute reduction in weekly episodes of urinary urge incontinence was evaluated as the primary efficacy variable. Secondary variables included the absolute reduction of micturitions per 24 hours, intensity of urgency, and mean voided volume. Qualitative symptom changes were recorded from the patients' entries in their micturition diaries at baseline, at week 4, and at week 12 of treatment. Subjective treatment outcome was assessed by patient ratings on a visual analog scale (VAS), the King's Health Questionnaire (KHQ), and the 36-Item Medical Outcomes Study Short-Form General Health Survey (SF-36); intensity of dry mouth was also recorded on a scale. Adverse events (AEs) were assessed. Results: Of the 1658 patients treated, 828 patients (49.9%) received trospium 45 mg/d and 830 patients (50.1%) received oxybutynin 7.5 mg/d. After 4 weeks, daily doses were doubled in 29.2% (242/828) of patients in the trospium chloride group, and in 23.3% (193/830) of patients in the oxybutynin group, until the end of treatment. No clinically relevant differences in demographic characteristics were observed between the treatment groups. Trospium was noninferior to oxybutynin hydrochloride in terms of the reduction in the number of weekly urge incontinence episodes after 4 and 12 weeks of treatment. In the per-protocol population, the median change after 12 weeks was −11.0 in both groups. In the full analysis set, the median change was −10.42 with trospium chloride and −10.00 with oxybutynin ( P < 0.001 for the noninferiority hypothesis, for both the per-protocol and the full analysis set calculations). There was also no indication of a difference between groups concerning the observed reductions of daily micturitions and intensity of urgency as well as the increase in micturition volume at the end of 12 weeks. VAS, KHQ, and SF-36 scores were improved to a similar extent in both treatment groups at the end of treatment. Worsening of dry mouth was less common in the trospium group than in the oxybutynin group after 4 and 12 weeks (46.9% vs 63.9% and 51.2% vs 64.4%, respectively; bothtime points, P < 0.001 between groups). Treatment-related AEs were reported by 22.7% (188/828) of the trospium chloride group and 26.5% (220/830) of the oxybutynin group. Dry mouth was the most frequently occurring AE, reported by 4.1% (34/828) of patients in the trospium group and 7.7% (64/830) of the oxybutynin group. Conclusions: Our findings indicate that trospium chloride was noninferior to oxybutynin hydrochloride, both with flexible dosing, over 12 weeks in these patients with urinary urge incontinence. Both drugs were generally well tolerated in the population studied, but fewer patients who received trospium reported worsening of dry mouth than those who received oxybutynin. German Federal Institute for Drugs and Medical Devices Registration Number 4022383.

Alexithymia–A Disorder of the Regulatory Mechanism of the Emotion Elaboration–and Quality of Life in Gynecologic Surgery

Study Objective Alexithymia is a disorder of the regulatory mechanism of the emotion elaboration. To verify the influence of the personality trait in the evaluation of quality of life (QoL), we analyzed the effect of alexithymia on the outcome of gynecologic surgery. The purpose of this study was to investigate the presence of alexithymia by using the Toronto Alexithymia Scale (TAS)-20, and to examine the relationship between alexithymia and self-reported descriptors of QoL in a gynecologic population. Design All patients were evaluated in a semistructured interview in which personal, medical, and social data were collected. They were provided with a set of questionnaires that included both measure of alexithymia (TAS-20) and QoL perception (the Medical Outcomes Study short-form general health survey-36 [SF-36]). The patients were assessed before the surgical procedure and 1 month postoperatively. Setting Campus BioMedico Hospital in Rome, Italy. Patients In all, 40 consecutive patients with benign gynecologic pathology were enrolled in the study. Interventions A total of 20 of the patients underwent laparoscopy (LPS) and 20 underwent laparotomy (LPT). Measurements and Main Results Patients were separated into 2 groups, with respect to the TAS questionnaire score: the high-level alexithymia (HA) group, with scores above 59, and the low-level alexithymia group, with scores below 59. The HA group represented 61% in patients who underwent LPS and 50% in patients who were submitted to LPT. Patients who underwent LPS showed a slight decrease in the QoL score after the surgical procedure. Patients who underwent LPT showed different QoL scores depending on the high or low TAS level: high-level TAS group showed higher SF-36 domain scores compared with the presurgical scores, whereas low-level TAS group showed lower scores compared with the presurgical scores. Conclusion Our data show that the subjective QoL tested with SF-36 in patients with gynecologic conditions undergoing surgery is clearly influenced by the level of alexithymia. This influence is clearly detectable when a more invasive surgery is performed. In this case, patients with low-level alexithymia show a worsening of QoL. Contrarily, patients with HA have a better perception of QoL after more invasive surgery.

Relationship of Optimism–Pessimism and Health-Related Quality of Life in Breast Cancer Survivors

ABSTRACT Few studies have investigated the influence of optimism–pessimism in breast cancer survivors. This study used a retrospective design with 268 adult women who completed the Minnesota Multiphasic Personality Inventory (MMPI) as part of their medical care approximately 10 years prior to their breast cancer diagnosis and Medical Outcome Study Short-Form General Health Survey (SF-36 or SF-12), on average, 8 years after diagnosis. MMPI pessimism scores were divided into quartiles, and t tests were used to determine differences between those highest and lowest in pessimism on health-related quality-of-life (QOL) measures, demographics, and disease status. The mean age at diagnosis of breast cancer was 63 years, and 74% had early-stage breast cancer. Patients age 65 years and older were significantly lower on physical health–related QOL scales. There were no significant differences in health-related QOL scores by stage of disease. Patients with a pessimistic explanatory style were significantly lower on all of the health-related QOL scores, compared to those with a nonpessimistic style. Breast cancer survivors who exhibit a pessimistic explanatory style report lower health-related QOL for years after receiving a cancer diagnosis, compared to nonpessimistic women.

Quality of life as an outcome indicator in patients with seasonal affective disorder: results from the Can-SAD study

Although a host of studies have now examined the relationship between quality of life (QoL) and non-seasonal depression, few have measured QoL in seasonal affective disorder (SAD). We report here on results from the Can-SAD trial, which assessed the impact of treatment with either antidepressant medication or light therapy upon QoL in patients diagnosed with SAD. This Canadian double-blind, multicentre, randomized controlled trial included 96 patients who met strict diagnostic criteria for SAD. Eligible patients were randomized to 8 weeks of treatment with either: (1) 10000 lux light treatment and a placebo capsule or (2) 100 lux light treatment (placebo light) and 20 mg fluoxetine. QoL was measured with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and the Medical Outcomes Study (MOS) Short-Form General Health Survey (SF-20) at baseline and 8 weeks. Both intervention groups showed significant improvement in QoL over time with no significant differences being detected by treatment condition. Q-LES-Q scores increased significantly in seven of eight domains, with the average scores rising from 48 x 0 (S.D.=10 x 7) at baseline to 69 x 1 (S.D.=15 x 6) at week 8. Treatment-related improvement in QoL was strongly associated with improvement in depression symptoms. Patients with SAD report markedly impaired QoL during the winter months. Treatment with light therapy or antidepressant medication is associated with equivalent marked improvement in perceived QoL. Studies of treatment interventions for SAD should routinely include broader indices of patient outcome, such as the assessment of psychosocial functioning or life quality.

A Brief Measure for Assessing Generalized Anxiety Disorder

Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity.A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use.A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale.The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.