Patient-rated Quality Of Life Research Articles

Impact of radiation-induced toxicities on quality of life of patients treated for head and neck cancer

PurposeThe aim of this study is to establish the relative impact of physician-rated toxicities and patient-rated symptoms in head and neck cancer (HNC) on quality of life (QOL) and to weigh the various toxicities and symptoms during treatment plan optimization and selection. Materials and methodsThis prospective cohort study comprised 1083 HNC patients (development: 750, validation: 333) treated with definitive radiotherapy with or without chemotherapy. Clinical factors were scored at baseline. Physician-rated and patient-rated outcome measures and QOL (EORTC QLQ-HN35 and QLQ-C30) were prospectively scored at baseline and 6, 12, 18 and 24 months after radiotherapy. The impact of 20 common toxicities and symptoms (related to swallowing, salivary function, speech, pain and general complaints) on QOL (0–100 scale) was established for each time point by combining principal component analysis and multivariable linear regression. ResultsRadiation-induced toxicities and symptoms resulted in a significant decline in QOL of patients with 12.4 ± 12.8 points at 6 months to 16.6 ± 17.1 points at 24 months. The multivariable linear models described the QOL points subtracted for each toxicity and symptom after radiotherapy. For example, xerostomia and weight loss had a significant but minor effect (on average –0.5 and –0.6 points) while speech problems and fatigue had a much greater impact (on average –11.9 and –17.4 points) on QOL. R2 goodness-of-fit values for the QOL models ranged from 0.64 (6 months) to 0.72 (24 months). ConclusionThe relative impact of physician-rated toxicities and patient-rated symptoms on QOL was quantified and can be used to optimize, compare and select HNC radiotherapy treatment plans, to balance the relevance of toxicities and to achieve the best QOL for individual patients.

T231. QUALITY OF LIFE IN ANTIPSYCHOTIC-NAïVE YOUTH: EXPLORING THE INTERPLAY WITH METABOLIC SIDE-EFFECTS

BackgroundThis observational, exploratory pilot study aims to understand changes in clinical presentation and quality of life (QoL) in antipsychotic-naïve youth. Outcomes for these first-episode psychosis patients will be explored in the context metabolic changes during their first three months of treatment.MethodsParticipants (n = 10) aged 14–29 years were followed throughout their first three months of treatment with an antipsychotic medication (of physician’s/patient’s choice). Participants were evaluated on metabolic indices including weight, waist circumference, and BMI, as well as QoL [Pediatric Quality of Life Index (PedsQL) and PedsQL General Well-Being Scale] and clinical presentation [Clinical Global Impression (CGI) scale]. Descriptive statistics and nonparametric tests were conducted to compare significant changes across these variables.ResultsSignificant changes in metabolic indices were observed over the first three months of treatment, as measured in weight gain (p = 0.02), increased waist circumference (p = 0.02) and increased BMI (p = 0.01). Physicians rated clinical improvement in participants, CGI score (p = 0.03). However, patient-rated QoL remained unchanged within all subcategories, including psychosocial (p = 0.52) and general well-being (p = 0.35).DiscussionIt appears that antipsychotic-related metabolic side effects may not impede upon early clinical improvement or impact QoL. In addition, there does not appear to be a relationship between clinical presentation and QoL as our small sample show QoL remains neutral or positive. Taken together, these findings suggest that clinical presentation and metabolic side effects may not be influential in early psychosis. From a clinical perspective, these early pilot data add to the literature highlighting the significant, early, antipsychotic-induced metabolic side effects in youth, and also encouraging clinicians to attend to the interplay between treatment and related QoL. This study is limited by its small sample size and naturalistic treatment allocation. These participants will be followed longitudinally to monitor development of adverse metabolic outcomes as well as changes in QoL in later stages of treatment/illness. The field must to understand how treatment and management of metabolic side effects can be augmented to promote clinical improvement and QoL, given the prevalence of adolescent patients who eventually wish to discontinue antipsychotic drugs because of metabolic side effects.

Early recovery in the first 24 months of treatment in first-episode schizophrenia-spectrum disorders

Studies assessing the treatment outcomes in first-episode schizophrenia have reported mixed results. While symptom improvement is frequently robust, when other domains are considered outcomes are generally poorer. We explored response trajectories, rates and predictors of recovery in the domains of core psychopathology, clinician-rated social and occupational functioning and patient-rated quality of life over 24 months of treatment in 98 patients with first-episode schizophrenia spectrum disorders who were treated with a long-acting antipsychotic medication. There was robust improvement in core psychopathology (effect size d = 3.36) and functionality (d = 1.78), with most improvement occurring within the first six months of treatment. In contrast, improvement in subjective quality of life was less marked (d = 0.37) and slower, only reaching significance after 12 months of treatment. Symptom remission was achieved by 70% of patients and over half met our criteria for functional remission and good quality of life. However, only 29% met the full criteria for recovery. Patients who met the recovery criteria had better premorbid adjustment, were less likely to be of mixed ethnicity and substance use emerged as the only modifiable predictor of recovery. Only 9% of our sample achieved both functional remission and good quality of life despite not being in symptom remission. We found high rates of symptom remission, functional remission and good quality of life in patients, although relatively few achieved recovery by meeting all three of the outcome criteria. Symptom remission is not a necessary prerequisite for functional remission and good quality of life, although few non-remitters achieve other recovery criteria.

Quality of life for patients diagnosed with bipolar disorder: Lifestyle and treatment

BackgroundAlthough bipolar disorder (BP) is associated with impaired quality of life (QOL), little is known about the clinical features associated with QOL. Better knowledge about this relationship may improve treatment. MethodsThis cross-sectional and retrospective study of 160 bipolar outpatients is part of an extensive study battery that includes patient-rated QOL with the World Health Organization QOL-100. The subscale “overall QOL” was used for analysis. QOL was divided into subgroups denoted “low”, “mid”, and “high”. Clinical data such as disease-specific factors, treatment efforts, and lifestyle were gathered from personal interviews and medical records. ResultsCompared to mid QOL, single analysis adjusted for age and sex revealed that low QOL was associated with BP II diagnosis, no previous hospitalization, low grade of current lithium medication, high grade of current antiepileptic medication, short disease duration with lithium, long disease duration without lithium, inactive lifestyle, high BMI, young age, and pre-menopausal women. Compared to mid QOL, high QOL was associated with a hypomanic/manic first affective episode, low BMI, non-smoker, and not currently using anxiolytic or sedatives. LimitationsNo longitudinal QOL data were collected. ConclusionsQOL for bipolar patients is determined by serval factors that potentially could be altered. To improve QOL, lithium prophylaxis and lifestyle factors seem the most promising.

P.002 Quality of life across types of dementia in rural and remote memory clinic patients

Background: Quality of life (QOL) is of great importance in dementia. We examined QOL across types of dementia in patients presenting to a rural and remote memory clinic (RRMC). Methods: This analysis included 343 RRMC patients seen between 2004 and 2016. Patients were diagnosed with mild cognitive impairment (MCI, n=74), frontotemporal dementia (FTD, n=42), Alzheimer’s disease (AD, n=187), vascular dementia (VD, n=22), or Lewy Body dementia (DLB, n=18). Patients and caregivers completed questionnaires at their initial visit. Data collection included patient-rated patient QOL (QOL-PT), caregiver-rated patient QOL (QOL-CG), MMSE score, age, and other patient demographics. Statistical analysis assessed patient variables and differences in QOL across types of dementia using one-way ANOVA, χ2 tests, and t-tests. Results: QOL-PT did not differ by diagnosis, whereas QOL-CG did. QOL-CG was significantly higher in MCI (34.6±7.1) compared to FTD (30.9±5.2) and AD (31.7±5.9). QOL-PT and QOL-CG differed in certain dementia types. QOL-PT was significantly higher than QOL-CG in MCI (QOL-PT=37.3±5.0, QOL-CG=35.3±7.3), FTD (QOL-PT=37.2±6.1, QOL-CG=31.7±5.5), and AD (QOL-PT=37.0±9.7, QOL-CG=32.1±5.9). Conclusions: We found that QOL-PT does not differ across dementia types, QOL-CG is higher in MCI compared to FTD and AD, and patients rate their own QOL higher than their caregivers do in MCI, FTD, and AD.

Apathy and its impact on patient outcome in amyotrophic lateral sclerosis.

Apathy is one of the most common behavioural symptoms of amyotrophic lateral sclerosis (ALS), yet there are few studies that have investigated the relationship between apathy and quality of life (QOL) as they are experienced by the patient. A cohort of 60 ALS patients were evaluated using the Apathy Evaluation Scale which measured cognitive, behavioural, emotional and non-specific symptoms of apathy combined with the Personal Wellbeing Index, a multidimensional measure of QOL. The relationship between patient-rated apathy and QOL scores, controlling for potential clinical and psychological confounders were analysed using univariate and multivariate methods. Apathy was identified in 30% of ALS patients. Patients with apathy reported higher levels of depression (p=0.0001). Compared to non-apathetic patients, patients with apathy had lower overall QOL (p=0.001), most pronounced in the domains related to achievements in life (p=0.001) and community-connectedness (p=0.0001). Of the cognitive, behavioural, emotional and non-specific manifestations of apathy, only the emotional symptoms explained a significant amount of variance in achievements in life (p=0.003) and community-connectedness (p=0.001). As such, emotional manifestations of apathy may underlie worse QOL in ALS patients presenting with behavioural impairment. Patient-reported outcomes, particularly those assessing psychosocial functioning may be important for demonstrating the efficacy of interventions designed to improve QOL in ALS patients with behavioural impairment.

To what extent is patient-rated quality of life associated with continuity of care, therapeutic relationships and unmet need for services? A study of outpatient mental health service users in Norway

In addition to attending to patients’ mental and somatic health, mental health services now often offer assistance across many spheres of patients’ lives, such as housing, social activities, and employment. Patient-centered recovery is an aim attempting not only to help patients to control symptoms, but also to help them manage everyday life and live as good lives as possible with their illness. Changes to the delivery of care have resulted in an increased emphasis on the quality of the therapeutic relationship between patients and clinicians, the continuity of care and to meeting as many of patients’ needs as feasible. Both the therapeutic relationship and continuity of care are key to mental health services' interaction with patients in their day-to-day lives, but have not been systematically investigated in relation to patient-rated outcomes including quality of life (QoL). There is scarce evidence of a relationship between the goal of improving patients’ QoL and their assessments of their therapeutic relationships as well as how they perceive continuity of care. In this study, we investigate whether there is an association between how mental health outpatients in Norway experience their therapeutic relationships, continuity of care and unmet needs, and how they assess the quality of their lives. A two stage cross sectional study was performed. Firstly, a national mapping among patients receiving mental health outpatient treatment during a fourteen day period in 2013 (n=23167), and at the same time a service user-generated Continuity of care-measure (n=15258). Secondly, a follow-up survey was performed ten months later among service users who accepted to be contacted again (n=4338). In total, 1327 responded in the follow-up study. Regression analysis was performed to investigate factors associated with QoL (measured by MANSA). The results show that patient-rated QoL-outcome is strongly related to therapeutic relationship with closest provider and to continuity of care. Also unmet need for unmet need for activity center/day center and meeting places for users were significantly associated (negative) with QoL, as were unmet need for social services and individual support contact. Furthermore, the results show that having good contact with family and friends is highly important for QoL. The same applies for living together with spouse or cohabitant as opposed to living alone. As in most other studies QoL associates with socioeconomic status. Also in line with other studies, the results show that QoL is actually higher among patients with a severe diagnosis (smi) compared to non-smi diagnosis. The findings show the importance of including relatively simple actions of everyday life in terms of activity and social life that give people with mental illness a good opportunity to improved QoL. Furthermore, that mental health services have to maintain focus on continuity of care and a good relation between patient and provider, and that support from family and friends should be utilized to the fullest. The study supports the importance of a recovery perspective.

The 22q11.2 deletion syndrome as a model to investigate the role of T-cells in psychosis?

Although bipolar disorder (BP) is associated with impaired quality of life (QOL), little is known about the clinical features associated with QOL. Better knowledge about this relationship may improve treatment.This cross-sectional and retrospective study of 160 bipolar outpatients is part of an extensive study battery that includes patient-rated QOL with the World Health Organization QOL-100. The subscale “overall QOL” was used for analysis. QOL was divided into subgroups denoted “low”, “mid”, and “high”. Clinical data such as disease-specific factors, treatment efforts, and lifestyle were gathered from personal interviews and medical records.Compared to mid QOL, single analysis adjusted for age and sex revealed that low QOL was associated with BP II diagnosis, no previous hospitalization, low grade of current lithium medication, high grade of current antiepileptic medication, short disease duration with lithium, long disease duration without lithium, inactive lifestyle, high BMI, young age, and pre-menopausal women. Compared to mid QOL, high QOL was associated with a hypomanic/manic first affective episode, low BMI, non-smoker, and not currently using anxiolytic or sedatives.No longitudinal QOL data were collected.QOL for bipolar patients is determined by serval factors that potentially could be altered. To improve QOL, lithium prophylaxis and lifestyle factors seem the most promising.

Development of a new lingual range-of-motion assessment scale: normative data in surgically treated oral cancer patients.

Surgical resection in oral cancer patients can result in altered speech, swallowing, and patient perception of quality of life (QOL). Oral surgery can result in reduced lingual range of motion (ROM). However, few studies have quantified the degree of lingual restriction after surgery. This pilot study describes a new measurement system to define tongue ROM in surgically treated tongue cancer patients. This measurement system was validated by comparing results in these treated surgical patients versus healthy individuals. This scale was further validated by correlating ROM with performance status, oral outcomes, and patient-rated QOL. Thirty-six patients who underwent oral tongue surgery and 31 healthy individuals were included. Tongue ROM was assessed using a novel ROM assessment system. This novel system was examined in these patients versus healthy subjects. This measurement tool was further validated by correlating tongue ROM in treated patients with performance status, oral outcomes, and patient-rated QOL. Tongue ROM was found to be significantly lower in the surgically treated patients than in the healthy individuals (p=0.0001). Tongue ROM correlated with performance status, oral outcomes, and all QOL measures. This new tongue ROM measurement system defined tongue deficits in surgically treated oral cancer patients. This tool was validated by comparing results to those in healthy individuals, as well as by correlating tongue ROM to performance status, oral outcomes, and QOL. This measurement tool can be used to define baseline and postsurgery tongue ROM in oral cancer patients, as well as track change over time with recovery and therapy. Future studies should examine use of this measurement tool with other populations demonstrating tongue deficits.

Differential perceptions of quality of life (QoL) in community-dwelling persons with mild-to-moderate dementia

Discordance between patient- and caregiver-reported quality of life (QoL) is well recognized. This study sought to (i) identify predictors of discrepancy between patient- and caregiver-rated QoL amongst community-dwelling persons with mild-to-moderate dementia, and (ii) differentiate between patients who systematically rate their QoL lower versus those who rate their QoL higher relative to their caregiver ratings. We recruited 165 patient-caregiver dyads with mild-to-moderate dementia. Quality of life in Alzheimer's disease (QoL-AD) scale was administered separately to patients and caregivers. Data on socio-demographics, interpersonal relationship, and disease-related characteristics (cognitive performance, mood, neuropsychiatric symptoms, functional ability, and caregiver burden) were collected. Patient-caregiver dyads were categorized based on whether patient-rated QoL was lower or higher than their respective caregiver ratings. Univariate analyses and multiple regression models were performed to identify predictors of dyadic rating discrepancy. Mean patient-rated QoL was significantly higher than caregiver rating (mean difference: 3.8 ± 7.1, p < 0.001). Majority (111 (67.2%)) of patients had more positive self-perceived QoL (QoL-ADp (QoL-AD self rated by the patient) > QoL-ADc (QoL-AD proxy-rated by a caregiver)), compared with those (44 (26.7%)) with poorer self-perceived QoL (QoL-ADp < QoL-ADc). Patient's education level, depressive symptoms, and severity of neuropsychiatric symptoms predicted magnitude of discrepancy. Depression (OR = 1.17, 95% CI = 1.02-1.35) and being cared for by other relative (non-spouse/adult child; OR = 7.54, 95% CI = 1.07-53.03) predicted poorer self-perceived QoL. Dyadic rating discrepancy in QoL should draw the clinician's attention to patient depression and neuropsychiatric symptoms. Consideration should also be given to nature of patient-caregiver relationship when discordance between patient and caregiver assessments of QoL is observed.

Tongue Strength as a Predictor of Functional Outcomes and Quality of Life after Tongue Cancer Surgery

Surgical resection of oral cancer can result in altered speech, swallowing, and quality of life (QOL). To date, the oral outcome variables of tongue strength, tongue and jaw range of motion, and saliva production have not been extensively assessed. This pilot study was done to assess tongue strength along with other oral outcomes and their relationship to performance status for speech, swallowing, and QOL after partial glossectomy. Our aim was to create a norm for what should be considered a normal tongue strength value in this population. We hypothesized that patients with tongue strength of 30 kPa or greater would perform better on the performance status scale and various QOL measures than do patients with tongue strength of less than 30 kPa. We used a cross-sectional design in this study. The postoperative assessment included 1) Performance Status Scale and Karnofsky Performance Status Scale; 2) oral outcome variables of tongue strength, jaw range of motion. and saliva production; and 3) patient-rated QOL ratings via Eating Assessment Tool, M. D. Anderson Dysphagia Inventory, EORTC-H&N35, and Speech Handicap Index. Patients with tongue strength of at least 30 kPa performed better on the performance status scales and various QOL measures. The cutoff score of 30 kPa for tongue strength measures revealed a trend in predicting performance on the scales and QOL measures. The oral outcome variables correlated with performance status for speech, swallowing, and QOL. We propose a norm for tongue strength in this population, based on the trend seen in this group of patients, as none previously existed. Future studies are under way that incorporate a larger sample size to further validate this norm. Future studies will also examine oral functional outcome measures in a larger population by inclu'ding other oral and oropharyngeal sites to help predict speech and swallow performance status and QOL.

427 EVALUATING COST AND QUALITY OF LIFE IN NON-MUSCLE INVASIVE BLADDER CANCER

INTRODUCTION AND OBJECTIVES: Bladder cancer is the most expensive cancer to treat on a per-patient and per-death basis in the Medicare system, with an estimated financial burden of $3.98 billion/year. The majority of patients initially present with non-muscle invasive bladder cancer (NMIBC), requiring primary treatment and strict surveillance protocols. Previous studies have explored cost-effective strategies that maximize survival, but not quality of life (QOL). Our aim was to evaluate the cost of NMIBC in the context of quality of life. METHODS: We reviewed our IRB-approved Columbia University Urologic Oncology Database for patients with an initial diagnosis of NMIBC from 2004-2012. One hundred patients were randomly selected, and the costs of all diagnostics, intravesical therapy (IVT), surgeries, complications, and imaging were tallied utilizing internal billing and national Medicare estimates. QOL was assessed using utility estimates (patient-rated QOL for each possible health state), and the number of quality-adjusted life years (QALYs) was calculated by multiplying the utilities by the total time spent in that utility state and summing these values. Dividing the total average cost by the total average number of QALYs gained per patient gives the cost required to add one QALY. Patients were stratified into four treatment groups: 1) IVT cystectomy (RC); 2) IVT maintenance RC; 3) IVT maintenance; and 4) immediate RC. RESULTS: The patient cohort was 73% male, median age at diagnosis was 67 years (38-90) and median follow-up was 44 months (1.5-103.5). Figure 1 demonstrates that IVT maintenance adds the most QALYs and is the most cost-effective for overall survival and quality of life, requiring $8862 to add one QALY to one patient’s life. The other three treatment strategies were approximately equal, with IVT maintenance delayed RC being the least cost-effective, at $21158/QALY. CONCLUSIONS: Treating NMIBC with IVT maintenance adds the most QALYs compared with treatments involving cystectomy. Therefore, delaying cystectomy with additional maintenance therapy may be the most cost-effective option (if medically advisable), since it has the potential to add QALY at low cost, and late RC costs no more than early RC to add the same QALY.

Physical Therapy Found to Have Short-Term Benefit in Parkinson's

Physical Therapy Found to Have Short-Term Benefit in Parkinson's

Predictors of Patient Self-Ratings of Quality of Life in Alzheimer Disease: Cross-Sectional Results From the Canadian Alzheimer's Disease Quality of Life Study

To assess whether the core symptoms of Alzheimer disease (AD) consistently predict patient self-rated quality of life (QOL) as assessed by a variety of QOL measures in a large national sample of AD patients. Cross-sectional. Fifteen dementia and geriatric clinics across Canada. Community-living patients with AD (n = 370) with Mini-Mental State Exam (MMSE) scores greater than 10. Patients rated their QOL by using two utility indexes, the European QOL-5 Dimensions and the Quality of Well-Being Scale, a global QOL Visual Analog Scale, and the disease-specific QOL-AD instrument. Cognition was assessed with the AD Assessment Scale-Cognitive subscale and MMSE, function with the Disability Assessment for Dementia, and behavioral and psychological symptoms with the Neuropsychiatric Inventory and the Geriatric Depression Scale (GDS). One-way analysis of variance and fully adjusted multiple linear regression were used to assess the relationship between core dementia symptoms and QOL ratings. The QOL measures had only small-to-moderate correlations with each other. For all QOL measures, patient ratings were significantly lower among patients with more depressive symptoms. In multivariable analyses, the GDS score was the only significant independent predictor of patient self-ratings for all four QOL measures. Self-rated symptoms of depression were a consistent independent predictor of patient-rated QOL across diverse QOL measures, while performance-based measures of cognition and informant-based functional status were not. These findings confirm the importance of identifying and treating depression in patients with AD and endorse the use of measures of self-rated depressive symptoms and QOL as outcomes in AD clinical trials.

Meta‐analysis of the comparative efficacy and safety of adjuvant treatment to levodopa in later Parkinson's disease

Levodopa initially provides good symptomatic control of the symptoms of Parkinson's disease, but motor complications often develop after long-term use. Other classes of antiparkinsonian drugs including dopamine agonists, catechol-O-methyl transferase inhibitors, or monoamine oxidase type B inhibitors are then added as adjuvant therapy. It is unclear whether one class of drug is more effective than another. This meta-analysis evaluates the comparative benefits and risks of these agents as adjuvant treatment in Parkinson's disease patients with motor complications. A systematic review of the literature from 1966 to the end of June 2010 was conducted to identify randomized trials involving a dopamine agonist, catechol-O-methyl transferase inhibitor, or monoamine oxidase type B inhibitor versus placebo, as adjuvant to levodopa therapy. Forty-five trials involving nearly 9,000 participants were included. The meta-analysis confirms reports from individual trials that compared with placebo, adjuvant therapy significantly reduces patient off-time and levodopa dose, with improved symptom severity scores (e.g., Unified Parkinson's Disease Rating Scale). However, dyskinesia and numerous other side effects are increased with adjuvant therapy. Few randomized comparisons between drugs have been undertaken, but indirect comparisons suggest that dopamine agonist therapy may be more effective than catechol-O-methyl transferase inhibitor and monoamine oxidase type B inhibitor therapy, which have comparable efficacy. No differences between drugs within each class were observed other than the catechol-O-methyl transferase inhibitor tolcapone appearing more efficacious than entacapone. This meta-analysis highlights the need for direct head-to-head randomized trials to assess the impact of adjuvant therapy on patient-rated quality of life and health economic outcomes.

Generic and Disease-Specific Measures of Quality of Life in Patients with Mild Alzheimer’s Disease

Background/Aim: The aim of the study was to investigate the pattern of association of generic and disease-specific quality of life (QoL) scales with standard clinical outcome variables in Alzheimer’s disease (AD). Methods: The participants were 321 home-living patients with mild AD and their primary caregivers from the Danish Alzheimer Intervention Study. QoL was assessed using the generic EuroQol-5D with visual analogue scale (VAS) and the disease-specific Quality of Life in Alzheimer’s Disease (QOL-AD) scales (both caregiver and patient rated). Depression, activities of daily living, cognitive performance and neuropsychiatric symptom severity were also assessed. Results: All 3 caregiver-rated QoL scales correlated significantly with each other (p < 0.001) and with clinical measures. Patient-rated QoL versions correlated inversely with depression (p < 0.001) but not significantly with any other clinical variables. Conclusion: The caregiver-rated QoL scales showed stronger interscale correlation as well as a similar correlation pattern with standard clinical outcome variables compared to the patient-rated versions. There is some indication that the EQ-5D + VAS could be a suitable alternative to the QOL-AD scale in specific research designs.

Evaluation of the efficacy and safety of adjuvant treatment to levodopa therapy in Parkinson´s disease patients with motor complications

One of the complications of long-term treatment of Parkinson's disease (PD) with levodopa is the development of motor complications. Generally, when motor complications develop, clinicians add in an additional drug (to the levodopa regimen) from one of three other classes of anti-Parkinsonian treatments (dopamine agonists, catechol-O-methyl transferase inhibitors (COMTIs) or monoamine oxidase type B inhibitors (MAOBIs)). However, despite trials having shown that these drugs are beneficial compared to placebo, it remains unclear as to the best way to treat patients experiencing motor complications and whether one class of drug is more effective than another. This meta-analysis aims to assess more reliably the benefits and risks of the three classes of drugs (dopamine agonists, COMTIs and MAOBIs) currently used as adjuvant treatment to levodopa in PD patients suffering from motor complications. The three drug classes were compared with the aim of determining whether one class of drug provides better symptomatic control than another. We searched CENTRAL (The Cochrane Library), MEDLINE, EMBASE, PubMed, LILACS and Web of Science, plus major journals in the field, abstract books, conference proceedings and reference lists of retrieved publications. Randomised trials comparing an orally administered dopamine agonist, COMTI or MAOBI versus placebo, both on a background of levodopa therapy, in PD patients experiencing motor complications. Two authors independently extracted data on off-time, levodopa dose, motor complications, side-effects, treatment concordance, clinician-rated disability, mortality, quality of life and health economic data. Forty-four eligible trials, involving 8436 participants were identified. Compared to placebo, adjuvant therapy significantly reduced off-time (-1.05 hours/day, 95% confidence interval (CI) -1.19 to -0.90; P<0.00001), the required levodopa dose (-55.65 mg/day, CI -62.67 to -48.62; P<0.00001) and improved UPDRS scores (UPDRS ADL score: -1.31 points, CI -1.62 to -0.99; P<0.00001; UPDRS motor score: -2.84 points, CI -3.36 to -2.32; P<0.00001; UPDRS total score: -3.26 points, CI -4.52 to -2.00; P<0.00001). However, dyskinesia (odds ratio (OR) 2.50, CI 2.21 to 2.84; P<0.00001) and side-effects including constipation (OR 3.19, CI 2.17 to 4.68; P<0.00001), dizziness (OR 1.57, CI 1.30 to 1.90; P<0.00001), dry mouth (OR 2.33, CI 1.22 to 4.47; P=0.01), hallucinations (OR 2.16, CI 1.70 to 2.74; P<0.00001), hypotension (OR 1.47, CI 1.18 to 1.83; P=0.0007), insomnia (OR 1.38, CI 1.09 to 1.74; P=0.007), nausea (OR 1.78, CI 1.53 to 2.07; P<0.00001), somnolence (OR 1.87, CI 1.40 to 2.51; P<0.0001) and vomiting (OR 2.56, CI 1.67 to 3.93; P<0.0001) were all increased with adjuvant therapy.Indirect comparisons of the three drug classes suggested that dopamine agonists were more efficacious in reducing off-time (dopamine agonist: -1.54 hours/day; COMTI: -0.83 hours/day; MAOBI: -0.93 hours/day; test for heterogeneity between drug classes P=0.0003) and levodopa dose (dopamine agonist: -116 mg/day; COMTI: -52 mg/day; MAOBI: -29 mg/day; test for heterogeneity between drug classes P<0.00001). UPDRS scores also improved more with dopamine agonists than with COMTI or MAOBI (UPDRS total scores - dopamine agonist: -10.01 points versus COMTI: -1.46 points versus MAOBI: -2.20 points; test for heterogeneity between drug classes P<0.00001), although more dyskinesia were seen with dopamine agonists (OR 2.70) and COMTI (OR 2.50) than with MAOBI (OR 0.94) (test for heterogeneity between drug classes P=0.009). Although the increase in the overall incidence of side-effects was generally more marked with dopamine agonists (OR 1.52) and COMTI (OR 2.0) than with MAOBI (OR 1.32), heterogeneity between drug classes was only of borderline significance (P=0.07). Compared to placebo, adjuvant therapy reduces off-time, levodopa dose, and improves UPDRS scores in PD patients who develop motor complications on levodopa therapy. However, this is at the expense of increased dyskinesia and numerous other side-effects. Indirect comparisons suggest that dopamine agonist therapy may be more effective than COMTI and MAOBI therapy, which have comparable efficacy. However, as indirect comparisons should be interpreted with caution, direct head-to-head randomised trials assessing the impact of these different drug classes on overall patient-rated quality of life are needed.

Clinician-rated functioning and patient-rated quality of life in schizophrenia: Implications of their correspondence for psychopathology and side effects

Past studies have found inconsistent associations between subjective and objective measures of quality of life (QOL) in schizophrenia. We hypothesized that this may be due to heterogeneity in the demographic and/or clinical variables inherent in the samples and we investigated this possibility. We stratified the patients according to a descriptive measure of correspondence between self-reported QOL and clinician-rated functioning. We then examined whether heterogeneous patterns existed among the subgroups in terms of demographic variables, symptom severity, associations between self-reported and clinician-rated psychopathology and associations between side effects, QOL and functioning. The subgroups significantly differed with respect to clinician-rated positive symptoms (F=3.075, p<.05), subjective symptoms (somatization, F=5.768, p<.01; obsessive-compulsive, F=3.885, p<.05; interpersonal sensitivity, F=8.278, p<.001; depression, F=9.368, p<.001; anxiety, F=6.909, p<.01; hostility, F=7.787, p<.01; phobic anxiety, F=9.551, p<.001; paranoia, F=5.304, p<.01; psychoticism, F=5.071, p<.01) and in- and outpatient ratio (Chi(2)=11.58, p<.01). Only the subgroup with relatively good correspondence between clinician-rated functioning and self-reported QOL showed significant low to moderate associations between the aforementioned measures and side effects. In addition, they showed similar levels of significant associations between the positive and subjective symptoms. In contrast, other discordant subgroups lacked overall associations between side effects, functioning and QOL as well as between subjective and objective measures of psychopathology. Low to moderate levels of correspondence between subjective QOL and objective functioning were partly supportive of the independence of the constructs. Insight is likely to be a mediating variable of the correspondence between self-report and clinician-rated measures and should be considered in studies using self-report measures.

International Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy

Compared with treatment options for early-stage breast cancer, few data exist regarding the optimal use of chemotherapy for metastatic breast cancer (MBC). The choice of using a combination of cytotoxic chemotherapies vs sequential single agents is controversial. At the 6th European Breast Cancer Conference, the European School of Oncology Metastatic Breast Cancer Task Force convened an open debate on the relative benefits of combination vs sequential therapy. Based on the available data, the Task Force recommends sequential monotherapy as the preferred choice in advanced disease, in the absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control. Patient- and disease-related factors should be used to choose between combination and sequential single-agent chemotherapy for MBC. Additional research is needed to determine the impact of therapy on patient-rated quality of life and to identify predictive factors that can be used to guide therapy.

Efficacy and Safety of Mistletoe Preparations (Viscum album) for Patients with Cancer Diseases

Background: Mistletoe is often used as a complementary approach in oncology. Despite experimental anti-tumour effects and several reviews there remains controversy about its clinical role. Patients and Methods: Potentially relevant trials were identified to perform a systematic review (databases: e.g. EMBASE, MEDLINE; hand search: e.g. bibliographies; search terms: e.g. mistletoe). To be included, randomised or comparative clinical trials at least had to examine mistletoe preparations standardized according to manufacturing process and to describe interventions explicitly. Additionally, cohort studies were included for reasons of external validity. Results were summarised in tables. Results: 18 clinical trials (>6,800 participants) were included. Their internal quality was mostly low. Due to heterogeneity between trials a meta-analysis was impossible. Regarding efficacy, findings were inconsistent regarding life expectancy, relation to tumour entity, dosing and treatment duration. Yet, studies indicate that quality of life (QoL) is improved. As these findings do not seem to be limited to one of the different parenteral mistletoe preparations reviewed the treatment may be summarised under the umbrella term ‘mistletoe therapy’. Regarding safety, 1 serious adverse event (AE) related to mistletoe was described; non-serious AEs were local reactions at injection site. Allergic reactions were rare. Conclusion: Supportive ‘mistletoe therapy’ seems safe and beneficial for QoL in adult patients with solid tumours. But there is an urgent need to confirm its efficacy in patient-centred care in a complex oncological setting. This has to be evaluated systematically in prospective observational trials with validated, multidimensional patient-rated QoL questionnaires and comparisons of different preparations and dosages.