Factors Influencing Depression Endpoints Research (FINDER): baseline results of Italian patients with depression

Background  

Factors Influencing Depression Endpoints Research (FINDER) is a 6-month, prospective, observational study carried out in 12 European countries aimed at investigating health-related quality of life (HRQoL) in outpatients receiving pharmacological treatment for a first or new depressive episode. Baseline characteristics of patients enrolled in Italy are presented.     

Health-related quality of life in outpatients with schizophrenia: factors that determine changes over time

Purpose

The objective of this study was to analyze the clinical factors associated with changes in HRQoL in outpatients with schizophrenia using both generic and condition-specific HRQoL scales.

Methods

Adult outpatients with schizophrenia at least 18 years of age who did not have an acute psychotic exacerbation in the 3 months prior to baseline were recruited. PANSS dimensions were calculated based on Lindenmayer et al.’s five factors. HRQoL data were assessed by patients using the Schizophrenia Quality of Life Scale (SQLS), the Short Form-36 (SF-36), and the EuroQol-5 Dimension (EQ-5D) questionnaires.

Results

Out of the 1345 patients included at baseline, 1196 (89%) were evaluated at 12 months. Regression models showed that the factor most consistently associated with HRQoL at endpoint was change in the PANSS negative symptoms score. A decrease in the PANSS negative symptoms score from baseline to 1 year was associated with a decrease in HRQoL during the same period. There were also significant associations of the change in PANSS excitatory factor with all the HRQoL scales except the SF-36 PCS. Female gender was associated with a decrease in all HRQoL ratings. There was also a relationship between years since onset and HRQoL. The longer the time since illness onset, the larger the decrease in HRQoL.

Conclusions

This study has found that, in outpatients with schizophrenia, changes in negative and excitement symptoms may have a greater an association with HRQoL than changes in positive, cognitive and depressive symptoms.

     

Perceived Risk, Trust and Health-related Quality of Life Among Cancer Survivors

Background

To design effective interventions that improve cancer survivors’ health-related quality of life (HRQoL), it is necessary to understand how HRQoL is related to cancer cognitions and interpersonal/social factors.

Purpose

This study investigated whether perceived risk of recurrence is associated with HRQoL and whether trust in the follow–up care physician moderates the perceived risk/HRQoL relationship.

Method

A cross-sectional survey of cancer survivors (N?=?408).

Results

Higher perceived risk was associated with worse mental and physical HRQoL. Higher trust was associated with better mental (but not physical) HRQoL. The inverse association between perceived risk and mental HRQoL was eliminated among those with high trust in their physicians. Trust did not moderate the perceived risk/physical HRQoL relationship.

Conclusions

Addressing survivors’ perceived risk of recurrence and improving the provider-patient relationship may enhance interventions to improve mental HRQoL among cancer survivors. However, the causal relationships among the constructs should be explicated.     

Quality of life for patients with exacerbation in inflammatory bowel disease and how they cope with disease activity

Objective

Health-related quality of life (HRQoL) for patients with ulcerative colitis (UC) or Crohn's disease (CD) is influenced by symptoms and treatments. Periods with increased disease activity are specifically trying, but the knowledge of how patients manage this is sparse. The aim of this cross-sectional study was to examine (1) HRQoL for patients with UC or CD, (2) how patients cope with increased disease activity, and (3) if coping is associated with HRQoL.

Methods

A postal questionnaire was sent to patients with UC and CD who attended the gastroenterology and surgery department at a Swedish university hospital. Coping, HRQoL, and emotional well-being were assessed by Jalowiec Coping Scale, Short Form-36 Health survey, Short Health Scale, and the Hospital Anxiety and Depression Scale.

Results

Patients with increased disease activity reported impaired HRQoL and emotional distress. This was more prevalent among patients with CD, as compared to patients with UC. Optimistic, self-reliant and confrontive coping strategies were most frequently used to manage stressors, with no differences found between patients in exacerbation or remission or between patients with UC or CD.

Conclusion

Impaired HRQoL and emotional distress is prevalent among patients with exacerbation in UC and CD. Thus, a complete evaluation of psychosocial status and management of psychosocial distress should be included in the clinical treatment of the patient. Patients use a variety of coping strategies in an effort to manage increased disease activity. However, these results did not support any associations between coping and HRQoL.     

Health- related quality of life and self-worth in 10-year old children with congenital hypothyroidism diagnosed by neonatal screening

Background

Much is written about cognitive and motor development; less is known about social and emotional consequences of growing up with congenital hypothyroidism (CH). The objectives of the study were: (1) to compare health related quality of life (HRQoL) and self-worth of 10 year old patients with CH with the general population; (2) to explore associations of disease factors, IQ and motor skills with the outcomes.

Methods

Children with CH and their parents completed several questionnaires. Patients were classified to ‘severe CH, n?=?41’ or ‘moderate/mild CH, n?=?41’ based on pre-treatment FT4 concentration. Differences between CH and the general population were tested by analysis of covariance and one sample t-tests (mean scale scores HRQoL and self-worth), chi-square tests and binomial tests (% at risk of impaired HRQoL and self-worth). Linear regression analyses corrected for gender were conducted to explore associations of the outcomes with disease factors, IQ and motor skills.

Results

Patients with CH reported lower mean HRQoL on motor, cognitive and social functioning, and on autonomy and positive emotions (p?<?0.0001). Patients were also more often at risk for impaired HRQoL and self-worth. No differences were found between the severity groups. Lower IQ was only significant associated with worse cognitive HRQoL. Initial FT4 plasma, age at onset of therapy, initial T4 dose and motor skills were not significantly associated with HRQoL and self-worth.

Conclusions

Negative consequences in terms of HRQoL and self-worth are prevalent in children with CH, independent of disease factors, IQ and motor skills. Physicians should to be attentive to these consequences and provide attention and supportive care.     

Health-related quality of life among adolescents with eating disorders

Objective

Health-related quality of life (HRQoL) is an emerging area of research in eating disorders (EDs) that has not been examined in adolescents in detail. The aim of the current study is to investigate HRQoL in an adolescent ED sample, examining the impact of ED symptoms on HRQoL.

Methods

Sixty-seven treatment-seeking adolescents (57 females) with anorexia nervosa (AN), bulimia nervosa (BN), or eating disorder not otherwise specified (EDNOS) completed self-report measures of HRQoL and ED symptoms.

Results

Participants reported poorer HRQoL in mental health domains than in physical health domains. Disordered attitudes, binge eating, and compensatory behaviors were associated with poorer mental health HRQoL, and body dissatisfaction was associated with poorer physical health HRQoL.

Conclusion

The current study assessed HRQoL among adolescents with EDs, finding several consistencies with the literature on adults with EDs. Future research should compare adolescents and adults with EDs on HRQoL.     

Fever Burden and Health-Related Quality of Life After Intracerebral Hemorrhage

Background

Fever is associated with worse functional outcomes after intracerebral hemorrhage (ICH); however, there are few prospective data to quantify the relationship with health-related quality of life (HRQoL). We tested the hypothesis that increased burden of fever is independently associated with decreased HRQoL at follow-up.

Methods

In this prospective observational cohort study of 106 ICH patients admitted to a tertiary care hospital between 2011 and 2015, we recorded the highest core temperature each calendar day for 14 days after ICH onset. Fever burden was defined as the number of days with a fever?≥?100.4 °F (38 °C). HRQoL outcomes were measured with Neuro-QoL domains of Cognitive Function and Mobility at 28 days, 3 months, and 1 year. Results were analyzed using mixed effects regression analysis.

Results

Each additional day with a fever was independently associated with lower Mobility HRQoL (T-score ? 0.9, [? 1.6 to ? 0.2]; p?=?0.01) and Cognitive Function HRQoL (T-score ? 1.3 [? 2.0 to ? 0.6]; p?=?0.001) after correction for National Institutes of Health Stroke Scale score on admission, age, and time to follow-up.

Conclusions

Each additional day with a fever was predictive of worse HRQoL domains of Cognitive Function and Mobility after ICH up to 1 year. These data extend previous evidence on the negative association of fever and functional outcomes to the domains of Cognitive Function and Mobility HRQoL. HRQoL outcomes may be a sensitive and powerful way to measure the efficacy of fever control in future research.

     

Validation of a specific measure to assess health-related quality of life in patients with schizophrenia and bipolar disorder: the 'Tolerability and quality of life' (TOOL) questionnaire

Background  

Perception of quality of life may differ depending on the perspective. The aim of the study was to assess the psychometric properties of the Spanish version of the 'TOlerability and quality Of Life' (TOOL) questionnaire, a specific self-rated instrument to evaluate the impact of side effects of antipsychotic drugs on health-related quality of life (HRQoL). The questionnaire consists of eight items answered on a four-point Likert scale.     

Prospective,longitudinal, multicenter study on the provision of information regarding sudden unexpected death in epilepsy to adults with epilepsy

Objective

Despite increased awareness of the serious epilepsy complication sudden unexpected death in epilepsy (SUDEP), a substantial population of people with epilepsy (PWE) remain poorly informed. Physicians indicate concern that SUDEP information may adversely affect patients' health and quality of life. We examined SUDEP awareness and the immediate and long-term effects of providing SUDEP information to PWE.

Methods

Baseline knowledge and behaviors among PWE and behavioral adjustments following the provision of SUDEP information were evaluated in a prospective, multicenter survey using the following validated scales: Neurological Disorders Depression Inventory for Epilepsy for depression symptoms, the EuroQoL five-dimension scale for health-related quality of life (HRQoL), a visual analog scale for overall health, the revised Epilepsy Stigma Scale for perceived stigma, and the Seizure Worry Scale for seizure-related worries. The prospective study collected data through semiquantitative interviews before (baseline), immediately after, and 3 months after the provision of SUDEP information.

Results

In total, 236 participants (mean age = 39.3 years, range = 18–77 years, 51.7% women) were enrolled, and 205 (86.9%) completed long-term, 3-month follow-up. One patient died from SUDEP before follow-up. No worsening symptoms from baseline to 3-month follow-up were observed on any scale. At baseline, 27.5% of participants were aware of SUDEP. More than 85% of participants were satisfied with receiving SUDEP information. Three quarters of participants were not concerned by the information, and >80% of participants recommended the provision of SUDEP information to all PWE. Although most patients reported no behavioral adjustments, 24.8% reported strong behavioral adjustments at 3-month follow-up.

Significance

The provision of SUDEP information has no adverse effects on overall health, HRQoL, depressive symptoms, stigma, or seizure worry among PWE, who appreciate receiving information. SUDEP information provision might improve compliance among PWE and reduce but not eliminate the increased mortality risk.     

Preoperative Sleep Complaints Are Associated with Poor Physical Recovery in the Months Following Cardiac Surgery

Background

Sleep disturbance is associated with poorer outcomes in cardiac patients, but little is known about the independent role of sleep quality in coronary artery bypass graft (CABG) patients.

Purpose

This study aims to examine the relationship between preoperative sleep complaints and post-operative emotional and physical recovery in CABG surgery patients, independently of demographic, clinical and mood factors.

Methods

Two hundred thirty CABG patients (aged 67.81?±?9.07 years) completed measures of self-reported sleep complaints before surgery and health-related quality of life (HRQoL), physical symptoms and pain 2 months after surgery.

Results

Greater sleep complaints prior to surgery were associated with greater physical symptoms, poorer physical HRQoL and greater sensory pain after surgery (p?<?0.05), but not with affective pain or mental HRQoL. Preoperative mood was not able to explain these associations.

Conclusions

Sleep complaints may be implicated in physical recovery from CABG surgery but further work is needed to understand the role of causal pathways.     

Long-term health-related quality of life after decompressive hemicraniectomy in stroke patients with life-threatening space-occupying brain edema

Background

Although randomized clinical trials have reported significant improvement in mortality and functional outcome as measured with modified Rankin Scale (mRS) or Barthel index (BI) in stroke patients with space-occupying anterior circulation infarctions treated with hemicraniectomy, many clinicians are still concerned about the long-term health-related quality of life (HRQoL).

Aim

Assessment of HRQoL after hemicraniectomy to holistically reevaluate clinical outcome.

Methods

Eleven patients (6 men, 5 women; mean age 48 (SD 5.8) years) were examined at 9–51 months after hemicraniectomy. Test batteries comprised NIH stroke scale, BI, mRS, neuropsychological tests (Visual Object and Space Perception Battery and clock test), and HRQoL-scales (Short Form 36 Health Survey (SF-36), Nottingham Health Profile (NHP), Questions on Life Satisfaction, Hospital Anxiety and Depression Scale and EQ-5D).

Results

Median values for NIHSS, BI and mRS were 11.5, 55 and 3.5. In HRQoL-scales, subscales related to physical mobility and functioning were consistently severely impaired, while subscales related to psychological well-being were impaired to a lesser extent. Mean scores for physical functioning and physical role were 10.5 and 12.5 in the SF-36, and 61.3 and 43.3 for physical mobility and energy in the NHP; emotional role and mental health scored 63.3 and 66.4 (SF-36), scores for emotional reaction and social isolation were 18.9 and 16.0 (NHP), respectively.

Conclusion

Although, physical components of HRQoL are highly impaired, these stroke patients achieved a satisfying level of psychological well-being which was endorsed by a nearly unanimous retrospective appraisal of life-saving hemicraniectomy.     

Duration of disease does not equally influence all aspects of quality of life in Parkinson’s disease

Health related quality of life (HRQoL) is negatively impacted in patients suffering from Parkinson’s disease (PD). For the specific components that comprise HRQoL, the relationship between clinical variables, such as disease duration, is not fully characterized. In this cross-sectional study (n = 302), self-reported HRQoL on the Parkinson’s Disease Questionnaire (PDQ-39) was evaluated as a global construct as well as individual subscale scores. HRQoL was compared in three groups: those within 5 years of diagnosis, those within 6–10 years of diagnosis, and those greater than 11 years since diagnosis. Non-parametric analyses revealed lower HRQoL with increasing disease duration when assessed as a global construct. However, when subscales were evaluated, difficulties with bodily discomfort and cognitive complaints were comparable in individuals in the 1–5 years and 6–10 year duration groups. Exploratory regression analyses suggested disease duration does explain unique variance in some subscales, even after controlling for Hoehn and Yahr stage and neuropsychiatric features. Our findings show that HRQoL domains in PD patients are affected differentially across the duration of the disease. Clinicians and researchers may need to tailor interventions intended to improve HRQoL at different domains as the disease progresses.     

Development and validation of a spina bifida-specific pediatric quality of life questionnaire: the Spina Bifida Pediatric Questionnaire,SBPQ

Purpose

Based on existing questionnaires and patient interview, a health-related quality of life (HRQoL) questionnaire in spina bifida (SB) children is created and validated, the Spina Bifida Pediatric Questionnaire (SBPQ).

Methods

SB patients from the SB reference centre Ghent University Hospital, Belgium, with mental ability between 6 and 18 years old and their parents were asked to participate in the study, together with a control group.

Results

Thirty-nine patients and parents answered the questionnaire once, 20 patients and their parents the test-retest. Thirty-five controls answered the questionnaire once, 34 controls and their parents the test-retest. The final questionnaire was retained when 3 consecutive patients approved all items. Visual clues were added for children with a mental ability below 10 years of age. The test-retest showed a good to excellent agreement for child self-report in 5 domains (not for social functioning), for parent proxy report in all domains (6), for control self-report in 4 domains (not for domain home) and for control parent proxy report in all domains (5). Internal consistency reliability was good in child self-report and in parent proxy report, except for physical functioning in child self-report. There was parent–child agreement for 4 out of 6 domains. Regarding social and emotional functioning, QoL was rated lower by parents than by children themselves.

Conclusion

A SB HRQoL questionnaire was developed and validated. Because of visual aid, this questionnaire can be used by both young children and adolescents.

     

Predictors of health-related quality of life in patients with epilepsy and psychogenic nonepileptic seizures

Epilepsy and psychogenic nonepileptic seizures (PNES) are associated with reduced health-related quality of life (HRQoL). The present study investigated the profile, relationship, and predictive power of illness perceptions, psychological distress (depression and anxiety), seizure activity, and demographic factors on HRQoL in these patient groups. Patients with epilepsy (n = 62) and PNES (n = 45) were recruited from a United Kingdom hospital and from membership-led organizations for individuals living with seizures. Patients completed a series of self-report questionnaires assessing: anxiety (GAD-7), depression (NDDI-E), illness perceptions (B-IPQ), HRQoL (NEWQOL-6D), and seizure frequency and severity (LSSS-3). Correlational and hierarchical multiple regression analyses were conducted. Patients with epilepsy reported higher HRQoL and scored lower on measures of depression and anxiety. Patients with PNES perceived their condition as more threatening overall. In both conditions, HRQoL was negatively correlated with more severe illness perceptions and psychological distress. In epilepsy and PNES, psychological distress (epilepsy: 27%; PNES: 24.8%) and illness perceptions (epilepsy: 23.1%; PNES: 23.3%) accounted for the largest amount of variance in HRQoL. Clinical factors were found not to be significant predictors, while demographic factors predicted HRQoL in epilepsy (12.6%), but not in PNES. Our findings support the notion that psychological factors are a stronger predictor of HRQoL in epilepsy and PNES than condition-related and demographic variables. Prior research suggests that anxiety and depression are key predictors of HRQoL; this study demonstrates that the relationship between illness perceptions and HRQoL is similarly close. These findings highlight the importance of addressing patients' beliefs about their condition.     

Quality of life and treatment satisfaction in Spanish epilepsy patients on monotherapy with lamotrigine or valproic acid

BackgroundPatients suffering from epilepsy have an impaired health related quality of life (HRQoL) because of seizures and treatment adverse events. Epilepsy affects differently both genders, due to hormonal influence in women. The aim of this study is to assess the impact on HRQoL and treatment satisfaction in epilepsy patients treated with stable doses of lamotrigine and valproic acid.MethodsObservational cohort prospective study was conducted in 18 Spanish neurology sites. Patients with clinically stable partial or generalized epilepsy, already receiving lamotrigine or valproic acid on monotherapy, were assessed in two visits: baseline and at 6 months. Socio-demographic and clinical variables were recorded at baseline; HRQoL (QOLIE-10) treatment satisfaction and women image self-perception were assessed at both visits. Impact on HRQoL was assessed in both treatment arms overall and in the women subgroup.ResultsA total of 107 patients were evaluated; 53 (14 men, 39 women) on lamotrigine and 54 (27 men, 27 women) on valproic acid. Mean (SD) age was 30.4 (9.1) years and mean (SD) time since epilepsy diagnosis was 8 (8.1) years. Mean (SD) QOLIE-10 score at baseline was 73.9 (15.7) points (76.6 and 71.4 for lamotrigine and valproic, respectively). At follow up, patients reported better HRQoL on both lamotrigine (78.8 points) (p < 0.05) and on valproic (72.4 points) in comparison with baseline. Women's HRQoL at follow up was better on the lamotrigine arm compared with valproic acid: 78.8 (12.8) vs. 70.3 (15.9) (p < 0.05). Women on the lamotrigine arm declared higher satisfaction with treatment and higher disagreement with the different statements referred to a negative image self-perception.ConclusionsChronic patients with epilepsy already treated with lamotrigine slightly improved HRQoL at 6 month follow up, whereas no significant changes were observed in the valproic acid group. Lamotrigine impact on patients’ HRQoL seems to be even more positive in the subgroup of women.     

Chronic insomnia, quality-of-life, and utility scores: comparison with good sleepers in a cross-sectional international survey

Background

Chronic insomnia has a recognized impact on health-related quality-of-life (HRQoL) but data on utility scores across countries are lacking. The objective of the present study was to assess health related quality of life (HRQoL) and utility scores in individuals from three different countries (USA, France, and Japan), comparing sufferers of chronic insomnia to good sleepers.

Methods

A cross-sectional survey (SLEEPI-i) of 4067 persons in the US (n = 1298; 478 good sleepers and 820 patients with insomnia), France (n = 1858; 998 good sleepers and 860 patients with insomnia) and Japan (n = 911; 506 good sleepers and 405 patients with insomnia). Enrollment and data collection using consumer panels were web-based in the US and France, and gathered via a postal survey in Japan. People with chronic insomnia (>6 months) were selected based on Insomnia Severity Index scores (ISI). Severity of insomnia was assessed using the ISI score and HRQoL was assessed using the self-administered Short-Form SF-36 Health Survey. Utility scores were derived using the algorithm developed by Brazier et al. Multivariate analyses were used to adjust for potential confounding factors.

Results

In all countries, people with chronic insomnia (40% treated) reported lower SF-36 scores in each of eight domains compared with good sleepers (P < .0001). Chronic insomnia was associated with significantly lower utility scores compared with good sleepers (mean scores 0.63 versus 0.72 in the US, 0.57 versus 0.67 in France, and 0.67 versus 0.77 in Japan, P < .0001).

Conclusions

This survey suggests that chronic insomnia is associated with significant impairment of HRQoL and decreased utilities across the different geographical regions studied.     

Validity of Korean Versions of the Multiple Sclerosis Impact Scale and the Multiple Sclerosis International Quality of Life Questionnaire

Background and Purpose

Assessment of the health-related quality of life (HRQoL) is important in clinical evaluations of multiple sclerosis (MS) patients for quantifying the impact of illness and treatment on their daily lives. Although MS-specific HRQoL instruments have been used internationally, there are no data regarding HRQoL instruments specifically designed for patients with MS in Korea. The objective of this study was to determine the reliability and validity of the Korean Multiple Sclerosis Impact Scale (MSIS-29) and the Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire.

Methods

Fifty-six patients with MS were recruited from June 2009 to February 2010 at the National Cancer Center in Korea. The original English versions of the MSIS-29 scale and the MusiQoL questionnaire were translated into Korean and evaluated for their acceptability, reliability, and validity.

Results

The patients wereaged 36.5±8.6 years (mean±SD; range, 20-56 years). Their score on the Expanded Disability Status Scale was 2.0±1.9 (mean; range, 0-7.5), and their disease duration was 5.2±4.7 years (mean±SD; range, 1-24 years). The Korean versions of the MSIS-29 and MusiQoL questionnaires showed satisfactory psychometric properties, including construct validity (item-internal consistencies of 0.59-0.95 and 0.59-0.92, respectively; item-discriminant validities of 95-100% and 93.8-100%), internal consistency (Cronbach''s alpha coefficients of 0.96-0.97 and 0.77-0.96), reliability (intraclass correlation coefficients of 0.78-0.90 and 0.50-0.93), unidimensionality (Loevinger scalability coefficients of 0.70-0.78 and 0.63-0.90), and acceptability. External validity testing indicated the presence of significant correlations between similar aspects of the two questionnaires.

Conclusions

The Korean translated versions of the MSIS-29 and MusiQoL questionnaires demonstrated reliability and validity for measuring HRQoL in Korean patients with MS.     

Deep brain stimulation may be a viable option for resistant to treatment aggression in children with intellectual disability

Introduction

Deep brain stimulation (DBS) is a surgical technique used to manage aggression in patients who do not improve despite the use of appropriate drug treatment.

Objective

The objective of this study is to assess the impact of DBS on aggressive behavior refractory to the pharmacological and behavioral treatment of patients with Intellectual Disabilities (ID).

Methods

A follow-up was conducted on a cohort of 12 patients with severe ID, undergoing DBS in posteromedial hypothalamic nuclei; evaluated with the Overt Aggression Scale (OAS), before the intervention, at 6, 12, and 18 months of medical follow-up.

Results

After the surgical procedure, there was a significant reduction in the aggressiveness of patients in the follow-up medical evaluation at 6 months (t = 10.14; p < 0.01), 12 months (t = 14.06; p < 0.01), and 18 months (t = 15.34; p < 0.01), respect to the initial measurement; with a very large effect size (6 months: d = 2.71; 12 months: d = 3.75; 18 months: d = 4.10). From 12 months onward, emotional control stabilized and is sustained at 18 months (t = 1.24; p > 0.05).

Conclusion

DBS in posteromedial hypothalamic nuclei may be an effective treatment for the management of aggression in patients with ID refractory to pharmacological treatment.     

Amitriptyline vs divalproate in migraine prophylaxis: a randomized controlled trial

Objective

This study compares efficacy and safety of divalproate extended release (DVA‐ER) and amitriptyline (AMT) in migraine .

Materials and methods

Three hundred migraineurs having >4 attacks monthly were randomized into DVA‐ER or AMT. The primary end points were >50% reduction in frequency, ≥1 grade improvement in the severity, and >50% improvement in a visual analogue scale (VAS). Secondary end points were functional disability, rescue medication, and adverse events.

Results

The median age was 32 years, and 241 were women. 150 patients each received DVA‐ER and AMT. At 3 months, 74.7% in DVA‐ER and 62% patients in AMT group improved in headache frequency (P = 0.02) and at 6 months, 65.3% and 54%, respectively (P = 0.90). At 3 months, the VAS score improved by >50% in 80.7% in DVA‐ER and 64% in AMT (P = 0.005). At 6 months, there was no significant difference between the two groups in VAS score (69.3% vs 56%; P = 0.47) and other outcome parameters. The composite side effects were also not different between the two groups (68% vs 81%); however, hair fall, menstrual irregularity, polycystic ovary, and weight gain were commoner in DVA‐ER group.

Conclusion

Divalproate extended release is more effective at 3 months than AMT; however, at 6 months, both are equally effective in migraine prophylaxis.     

Quality of life in bipolar and schizoaffective disorder — A naturalistic approach

Purpose

The aim of this study was to evaluate the health-related quality of life (HRQoL) in bipolar type I (BD I) and schizoaffective (SQA) patients during a 2-year period in a naturalistic study.

Methods

This study was based on the data generated by the Bipolar Comprehensive Outcome Study, a prospective, non-interventional, observational study of participants with BD I and SQA disorder. Mixed-Model Repeated Measures Analysis was used to analyze changes in the SF-36 and EQ-5D.

Results

Participants exhibited low health status at baseline with SF-36 mean scores of 46.7 ± 10.5 and 36.9 ± 12.9 (best imaginable health = 100, normal population ≈ 50) for physical and mental components, respectively. No significant differences were found between the ratings of the BD I and SQA patients on HRQoL. The SF-36 SMC improved significantly over 24 months although SPC scores remained consistent across the study. On the whole, the lowest SMC score was observed among the depressed patients (38.20), followed by the patients with a mixed state (39.01) and the manic patients (39.83).

Limitations

The observational design may have limited the causal relationships and the generalizability within the current findings.

Conclusions

HRQoL was significantly impaired in all stages of BD and SQA when compared to the general population. The impairment of HRQoL was most pronounced in the depressed state, followed by the mixed state and then the manic state. The euthymic patients showed the least impairment. In addition, patients showed a global improvement in their mental health satisfaction over the 2 years follow up period.