Summary Scores (summary + score)

Distribution by Scientific Domains
Distribution within Medical Sciences

Kinds of Summary Scores

  • component summary score
  • mental component summary score
  • physical component summary score


  • Selected Abstracts


    Diagnostic Accuracy of a New Instrument for Detecting Cognitive Dysfunction in an Emergent Psychiatric Population: The Brief Cognitive Screen

    ACADEMIC EMERGENCY MEDICINE, Issue 3 2010
    Steven P. Cercy PhD
    Abstract Objectives:, In certain clinical contexts, the sensitivity of the Mini-Mental State Examination (MMSE) is limited. The authors developed a new cognitive screening instrument, the Brief Cognitive Screen (BCS), with the aim of improving diagnostic accuracy for cognitive dysfunction in the psychiatric emergency department (ED) in a quick and convenient format. Methods:, The BCS, consisting of the Oral Trail Making Test (OTMT), animal fluency, the Clock Drawing Test (CDT), and the MMSE, was administered to 32 patients presenting with emergent psychiatric conditions. Comprehensive neuropsychological evaluation served as the criterion standard for determining cognitive dysfunction. Diagnostic accuracy of the MMSE was determined using the traditional clinical cutoff and receiver operating characteristic (ROC) curve analyses. Diagnostic accuracy of individual BCS components and BCS Summary Scores was determined by ROC analyses. Results:, At the traditional clinical cutoff, MMSE sensitivity (46.4%) and total diagnostic accuracy (53.1%) were inadequate. Under ROC analyses, the diagnostic accuracy of the full BCS Summary Score (area under the curve [AUC] = 0.857) was comparable to the MMSE (AUC = 0.828). However, a reduced BCS Summary Score consisting of OTMT Part B (OTMT,B), animal fluency, and the CDT yielded classification accuracy (AUC = 0.946) that was superior to the MMSE. Conclusions:, Preliminary findings suggest the BCS is an effective, convenient alternative cognitive screening instrument for use in emergent psychiatric populations. ACADEMIC EMERGENCY MEDICINE 2010; 17:307,315 © 2010 by the Society for Academic Emergency Medicine [source]


    Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis,

    ANNALS OF NEUROLOGY, Issue 2 2010
    Bruce A. C. Cree MD
    Objective To evaluate the efficacy of 4.5mg nightly naltrexone on the quality of life of multiple sclerosis (MS) patients. Methods This single-center, double-masked, placebo-controlled, crossover study evaluated the efficacy of 8 weeks of treatment with 4.5mg nightly naltrexone (low-dose naltrexone, LDN) on self-reported quality of life of MS patients. Results Eighty subjects with clinically definite MS were enrolled, and 60 subjects completed the trial. Ten withdrew before completing the first trial period: 8 for personal reasons, 1 for a non,MS-related adverse event, and 1 for perceived benefit. Database management errors occurred in 4 other subjects, and quality of life surveys were incomplete in 6 subjects for unknown reasons. The high rate of subject dropout and data management errors substantially reduced the trial's statistical power. LDN was well tolerated, and serious adverse events did not occur. LDN was associated with significant improvement on the following mental health quality of life measures: a 3.3-point improvement on the Mental Component Summary score of the Short Form-36 General Health Survey (p = 0.04), a 6-point improvement on the Mental Health Inventory (p < 0.01), a 1.6-point improvement on the Pain Effects Scale (p =.04), and a 2.4-point improvement on the Perceived Deficits Questionnaire (p = 0.05). Interpretation LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted. ANN NEUROL 2010 [source]


    Trauma in the family: groupwork on family awareness for men in high security hospital

    CRIMINAL BEHAVIOUR AND MENTAL HEALTH, Issue 4 2000
    Estelle Moore BSc MSc PhD C.Psychol
    Introduction It is typically considered important in clinical practice to generate an understanding of the relationships and consequences of interaction patterns within the families of patients with serious interpersonal difficulties and histories of violent offending. Method Eight men on a dedicated treatment unit for patients with personality disturbance within a maximum security hospital participated in structured groupwork which focused on family awareness. Results Two measures of outcome were employed: their recollections of family life were assessed before and after the intervention, and their general progress in rehabilitation was followed up 12 months later. Summary scores of the participants' recall of feelings associated with familial figures indicate that the group reported changes in their feelings over the eight-month period. For the duration of the group, and during the subsequent year, the group members remained on the same ward; two had been transferred to medium security at follow-up. Discussion The inherent bias and the small numbers in the group prevent generalization. However, it seems that patients who participated in group work are likely to remain on the ward studied or be moved to lower security. The recollection and sharing experiences of family life may have reduced the patients' sense of isolation. Copyright © 2000 Whurr Publishers Ltd. [source]


    A comparison of published head and neck stage groupings in carcinomas of the oral cavity

    HEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 8 2001
    Patti A. Groome PhD
    Abstract Background The combination of T, N, and M classifications into stage groupings is meant to facilitate a number of activities, including the estimation of prognosis and the comparison of therapeutic interventions among similar groups of cases. We tested the UICC/AJCC 5th edition stage grouping and seven other TNM-based groupings proposed for head and neck cancer for their ability to meet these expectations in a specific site: carcinomas of the oral cavity. Methods We defined four criteria to assess each grouping scheme: (1) the subgroups defined by T, N, and M that make up a given group within a grouping scheme have similar survival rates (hazard consistency); (2) the survival rates differ among the groups (hazard discrimination); (3) the prediction of cure is high (outcome prediction); and (4) the distribution of patients among the groups is balanced. We identified or derived a measure for each criterion, and the findings were summarized by use of a scoring system. The range of scores was from 0 (best) to 7 (worst). The data are population based from a prospectively gathered series in Southern Norway, with 556 patients diagnosed from 1983 through 1995. Clinical stage assignment was used, and the outcome of interest was cause-specific survival. Results Summary scores across the eight schemes ranged from 1.66 for TANIS-3 to 6.50 for UICC/AJCC-5. The TANIS-7 staging scheme performed best on the hazard consistency criterion. The Kiricuta scheme performed best on the hazard discrimination criterion. Synderman predicted outcome best overall and Berg produced the most balanced distribution of cases among its groups. Conclusions UICC/AJCC stage groupings were defined without empirical investigation. When tested, this scheme did not perform as well as any of seven empirically derived schemes we evaluated. Our results suggest that the usefulness of the TNM system could be enhanced by optimizing the design of stage groupings through empirical investigation. © 2001 John Wiley & Sons, Inc. Head Neck 23: 613,624, 2001. [source]


    Quality of life and depression of people living with type 2 diabetes mellitus and those at low and high risk for type 2 diabetes: findings from the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD)

    INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 4 2008
    S. Grandy
    Summary Objectives:, This study compared health-related quality of life (HRQoL) and depression among individuals with type 2 diabetes mellitus (T2D) and those at low or high risk for T2D. Methods:, Respondents in a population-based US 2004 survey reported whether they had T2D (n = 3530) or risk factors for T2D [abdominal obesity, body mass index (BMI) , 28 kg/m2, dyslipidaemia, hypertension and history of cardiovascular disease]. Respondents without T2D were stratified into low risk (0,2 risk factors, n = 5335) and high risk (3,5 risk factors, n = 5051). SF-12 version 2 (SF-12) and Patient Health Questionnaire (PHQ)-9 were used to measure HRQoL and depression. Mean scores were compared across the three groups using analysis of variance. Linear regression identified factors associated with SF-12 Physical and Mental Component Summary scores (PCS and MCS), adjusting for age, gender, race, income, geographic region, household size, BMI and group. Results:, Respondents were mostly women (60%) with mean age of 54 years. Mean PCS scores for T2D and high risk (39.5 and 41.7, respectively) were significantly lower than for low risk (50.6, p < 0.001). After adjustment, high-risk and T2D groups were associated with lower PCS and MCS scores compared with low risk group (p < 0.05). Mean PHQ-9 scores and per cent with moderate-to-severe depression were significantly higher for T2D and high risk than for low risk (p < 0.01). Conclusions:, Health-related quality of life and depression scores in T2D were similar to those at high risk, and indicated significant decrements in physical health and greater depression compared with low-risk respondents. [source]


    Health-related quality of life in multiple sclerosis: effects of natalizumab

    ANNALS OF NEUROLOGY, Issue 4 2007
    Richard A. Rudick MD
    Objective To report the relationship between disease activity and health-related quality of life (HRQoL) in relapsing multiple sclerosis, and the impact of natalizumab. Methods HRQoL data were available from 2,113 multiple sclerosis patients in natalizumab clinical studies. In the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study, patients received natalizumab 300mg (n = 627) or placebo (n = 315); in the Safety and Efficacy of Natalizumab in Combination with Interferon Beta-1a in Patients with Relapsing Remitting Multiple Sclerosis (SENTINEL) study, patients received interferon beta-1a (IFN-,-1a) plus natalizumab 300mg (n = 589), or IFN-,-1a plus placebo (n = 582). The Short Form-36 (SF-36) and a subject global assessment visual analog scale were administered at baseline and weeks 24, 52, and 104. Prespecified analyses included changes from baseline to week 104 in SF-36 and visual analog scale scores. Odds ratios for clinically meaningful improvement or worsening on the SF-36 Physical Component Summary (PCS) and Mental Component Summary were calculated. Results Mean baseline SF-36 scores were significantly less than the general US population and correlated with Expanded Disability Status Scale scores, sustained disability progression, relapse number, and increased volume of brain magnetic resonance imaging lesions. Natalizumab significantly improved SF-36 PCS and Mental Component Summary scores at week 104 in AFFIRM. PCS changes were significantly improved by week 24 and at all subsequent time points. Natalizumab-treated patients in both studies were more likely to experience clinically important improvement and less likely to experience clinically important deterioration on the SF-36 PCS. The visual analog scale also showed significantly improved HRQoL with natalizumab. Interpretation HRQoL was impaired in relapsing multiple sclerosis patients, correlated with severity of disease as measured by neurological ratings or magnetic resonance imaging, and improved significantly with natalizumab. Ann Neurol 2007 [source]


    Depressive symptoms predispose females to metabolic syndrome: a 7-year follow-up study

    ACTA PSYCHIATRICA SCANDINAVICA, Issue 2 2009
    M. Vanhala
    Objective:, To evaluate the risk for developing metabolic syndrome when having depressive symptoms. Method:, The prevalence of depressive symptoms and metabolic syndrome at baseline, and after a 7-year follow-up as measured with Beck depression inventory (BDI), and using the modified National Cholesterol Education Program , Adult Treatment Panel III criteria for metabolic syndrome (MetS) were studied in a middle-aged population-based sample (n = 1294). Results:, The logistic regression analysis showed a 2.5-fold risk (95% CI: 1.2,5.2) for the females with depressive symptoms (BDI ,10) at baseline to have MetS at the end of the follow-up. The risk was highest in the subgroup with more melancholic symptoms evaluated with a summary score of the melancholic items in BDI (OR 6.81, 95% CI: 2.09,22.20). In men, there was no risk difference. Conclusion:, The higher risks for MetS in females with depressive symptoms at baseline suggest that depression may be an important predisposing factor for the development of MetS. [source]


    Efficacy of amisulpride in treating primary negative symptoms in first-episode psychosis: a pilot study

    HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 8 2006
    Brendan P. Murphy
    Abstract Objective Negative symptoms are debilitating and associated with poor role functioning and reduced quality of life. There is a paucity of research on antipsychotic efficacy against the primary negative symptoms, particularly in first-episode psychosis (FEP). We undertook a prospective, open-label pilot trial to investigate the use of amisulpride in the treatment of young people with FEP characterised by primary negative symptoms. Method Twelve male and two female first-episode patients with primary negative symptoms (aged 16,26) were commenced on low-dose amisulpride (mean 250,mg/day) and followed-up over a 6-month period. Primary outcome measures were the Scale for the Assessment of Negative Symptoms (SANS), the Quality of Life Survey (QLS) and their respective subscales. Results For the 12 completers there was a statistically significant improvement in SANS summary score (p,=,0.036), Affective Flattening subscale global score (p,=,0.046), QLS total score (p,=,0.021), QLS subscales of Instrumental Role (p,=,0.018) and Intra-psychic Foundations (p,=,0.009) from baseline to week 24. Conclusions Amisulpride appears to be associated with less severe negative symptoms and improved quality of life. Generalisabilty of the findings is limited by the small sample size and open-label design of our study, however the positive findings suggest that further controlled trials are warranted. Copyright © 2006 John Wiley & Sons, Ltd. [source]


    Long-term effect of the ICU-diary concept on quality of life after critical illness

    ACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 6 2010
    C. G. BÄCKMAN
    Background: Critically ill patients often spend time in the intensive care unit (ICU) either unconscious or sedated. On recovery, they are often in a state of confusion with memory loss that may be associated with a longstanding reduction in health-related quality of life (QoL). We hypothesised that the ICU-diary concept could improve their QoL by filling in their memory gaps. Methods: A non-randomised, prospective study in a non-academic eight-bedded general ICU. A group of patients (n=38) were selected to receive the ICU-diary concept (keeping a diary with photos while on the ICU plus a follow-up meeting) when a long and complicated course was expected. Health-related QoL at 6, 12, 24 and 36 months was compared with a group that did not receive the ICU-diary (n=224). The Medical Outcomes Study 36-Item Short-Form (SF-36) was used to measure health-related QoL. Multiple regression models adjusted for age, sex, illness severity, pre-existing disease and diagnostic category was used to analyse the effects of the ICU-diary concept at 6 months, and changes over time were analysed using repeated measures MANOVA. Results: Crude and adjusted scores for two dimensions of SF-36 (general health and vitality) and the physical component summary score were significantly higher at 6 months in the ICU-diary group (P<0.05) and some of the effects remained during the 3-year follow-up period (P<0.05). Conclusion: The ICU-diary concept was associated with improved health-related QoL during the 3-year follow-up period after a critical illness. The effect of this intervention needs to be confirmed in a larger randomised study. [source]


    Stopping to Rest During a 400-Meter Walk and Incident Mobility Disability in Older Persons with Functional Limitations

    JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 2 2009
    Sonja Vestergaard PhD
    OBJECTIVES: To examine the association between stopping to rest during a 400-m usual-pace walk test (400-MWT) and incident mobility disability in older persons with functional limitations. DESIGN: Prospective cohort study. SETTING: Community based. PARTICIPANTS: Four hundred twenty-four participants in the Lifestyle Intervention and Independence for Elders Pilot (LIFE-P) Study aged 70 to 89 with functional limitations (summary score ,9 on the Short Physical Performance Battery (SPPB)) but able to complete the 400-MWT within 15 minutes. MEASUREMENTS: Rest stops during the 400-MWT were recorded. The onset of mobility disability, defined as being unable to complete the 400-MWT or taking more than 15 minutes to do so, was recorded at Months 6 and 12. RESULTS: Fifty-four (12.7%) participants rested during the 400-MWT at baseline, of whom 37.7% experienced mobility disability during follow-up, versus 8.6% of those not stopping to rest. Performing any rest stop was strongly associated with incident mobility disability at follow-up (odds ratio (OR)=5.4, 95% confidence interval (CI)=2.7,10.9) after adjustment for age, sex, and clinic site. This association was weaker, but remained statistically significant, after further adjusting for SPPB and time to complete the 400-MWT simultaneously (OR=2.6, 95% CI=1.2,5.9). CONCLUSION: Stopping to rest during the 400-MWT is strongly associated with incident mobility disability in nondisabled older persons with functional limitations. Given the prognostic value, rest stops should be recorded as part of the standard assessment protocol for the 400-MWT. [source]


    Long-term physical outcome in patients with septic shock

    ACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 6 2009
    J. B. POULSEN
    Background: Limited information is available on physical function after septic shock. The aim of the present study was to assess the physical outcome in survivors 1 year after septic shock. Methods: The outcome status of all 174 adult patients admitted to a mixed ICU with the diagnosis septic shock in a 1-year period was registered. Survivors were interviewed about physical function and socioeconomic status using a questionnaire including the Short Form-36 survey. The pre-ICU-admission Functional Comorbidity Index (FCI) was also registered. Results: Of the 80 survivors, two were still hospitalised; thus, 78 were invited to participate and 70 replied (inclusion-rate 88%). Patients were followed up at median 351 days after hospital discharge. At follow-up the patients had a markedly reduced physical component summary score (PCS) compared with age- and sex-adjusted general population controls (36 vs. 47, P<0.0001). This was also observed in patients with no comorbidity before ICU admission (34 vs. 47, P<0.001). There was a negative correlation (r=,0.27, P=0.03) between pre-ICU-admission FCI values and the PCS at follow-up. According to 81% of the patients, loss of muscle mass was the main cause of decreased physical function. Only 43% (10 vs. 23, P=0.01) of the previously employed had returned to work, and the number of patients in need of home-based personal assistance had doubled (10/20, P=0.04). Conclusion: Physical function is substantially reduced in survivors of septic shock 1 year after discharge. [source]


    Health-related quality of life in a cohort of adult patients with mild hemophilia A

    JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 5 2008
    M. WALSH
    Summary.,Objectives:,To compare the health-related quality of life among adult males affected with mild hemophilia A due to the same mutation (Val2016ala) to that of unaffected age and sex matched controls from the same general population. Methods:,The Short-Form 36 (SF-36) and Health Assessment Questionnaire (HAQ) were used to measure health-related quality of life and physical function. Other measures included bleeding history, a measure of joint damage, body mass index, age, and viral infection status. Cross-sectional data were collected through research clinics and a retrospective chart audit over a two-year period. Results and Conclusions:,The study included 47 affected males and 33 controls. The affected males had a higher level of co-morbidity, prior bleeding, and existing joint damage than controls. With the exception of the social function and health transition scales, mean scores for each of the SF-36 domains were worse among affected males. Mean differences were more than a clinically important five points in five of eight domains, with the general health scale showing more than a 10-point difference. Despite the degree of difference noted, only two of the differences were statistically significant (general health and role emotional scales) because of the small sample size and considerable individual variation in SF-36 scale scores. Multiple regression analyses suggested existing joint damage and presence of heart disease as the strongest associates of lower physical health-related quality of life. Joint damage in turn was partly related to prior hemarthroses. Compared to the Canadian population, affected males had lower scores in six out of eight SF-36 domains as well as the physical component summary score. There were no significant differences found in the HAQ scores between the two groups. So-called mild hemophilia A was associated with a negative effect on physical health-related quality of life, contributed to by joint damage as a result of prior bleeding. [source]


    Health-related quality of life in multiple system atrophy

    MOVEMENT DISORDERS, Issue 6 2006
    Anette Schrag MD
    Abstract Although multiple system atrophy (MSA) is a neurodegenerative disorder leading to progressive disability and decreased life expectancy, little is known about patients' own evaluation of their illness and factors associated with poor health-related quality of life (Hr-QoL). We, therefore, assessed Hr-QoL and its determinants in MSA. The following scales were applied to 115 patients in the European MSA-Study Group (EMSA-SG) Natural History Study: Medical Outcome Study Short Form (SF-36), EQ-5D, Beck Depression Inventory (BDI), Mini-Mental state examination (MMSE), Unified MSA Rating Scale (UMSARS), Hoehn & Yahr (H&Y) Parkinson's disease staging scale, Composite Autonomic Symptom Scale (COMPASS), and Parkinson's Disease Sleep Scale (PDSS). Forty-six percent of patients had moderate to severe depression (BDI , 17); Hr-QoL scores on the SF-36 and EQ-5D were significantly impaired. Pain, the only domain with similar scores in MSA and published PD patients, was reported more frequently in patients with MSA-P (predominantly parkinsonian motor subtype) than MSA-C (predominantly cerebellar motor subtype; 76% vs. 50%; P = 0.005). Hr-QoL scores correlated most strongly with UMSARS motor, COMPASS, and BDI scores but not with MMSE scores, age at onset, or disease duration. The COMPASS and UMSARS activities of daily living scores were moderate-to-strong predictors for the SF-36 physical summary score and the BDI and UMSARS motor scores for the SF-36 mental summary score. This report is the first study to show that Hr-QoL is significantly impaired in MSA. Although not all possible factors related to impaired Hr-QoL in MSA could be assessed, autonomic dysfunction, motor impairment, and depression were most closely associated with poor Hr-QoL, and therapeutic management, therefore, should concentrate upon these aspects of the disease. © 2006 Movement Disorder Society [source]


    Longitudinal study of a health education program for Japanese women in menopause

    NURSING & HEALTH SCIENCES, Issue 2 2009
    Masumi Ueda phd
    Abstract In this longitudinal intervention study, a 6 week health education program consisting of lectures and exercises was implemented for 39 Japanese menopausal women. The effects of the program were assessed by measuring their exercise participation, climacteric symptoms, and quality of life immediately before, 6 weeks after, and 1 year after the program. The Simplified Menopausal Index was used to assess the climacteric symptoms and the Medical Outcomes Study 36-Item Short-Form Health (SF-36) Survey was used to assess the quality of life. Significant improvements were observed in the subscale score for general health perception and the summary score for the physical component summary in the SF-36 Survey. Favorable results also were found for women without a previous exercise habit before the program but who participated in regular exercise 1 year after the program. No improvements were observed in the climacteric symptoms. We concluded that our program was effective for menopausal women in spite of the intervention period being relatively short. [source]


    Measuring Quality of Life in Stroke Subjects Receiving an Implanted Neural Prosthesis for Drop Foot

    ARTIFICIAL ORGANS, Issue 5 2010
    Anke I. Kottink
    Abstract The aim was to determine if the treatment of a drop foot by means of an implantable two-channel peroneal nerve stimulator improves health-related quality of life (HRQoL). All subjects were measured at baseline and after a follow-up period of 12 and 26 weeks. Twenty-nine stroke survivors with chronic hemiplegia with drop foot who fulfilled the predefined inclusion and exclusion criteria were included in the present randomized controlled trial. The intervention group received an implantable two-channel peroneal nerve stimulator for correction of their drop foot. The control group continued using their conventional walking device, consisting of an ankle-foot orthosis, orthopedic shoes, or no device. HRQoL was assessed in two different ways: (i) by taking descriptive measures, that is, the Short Form-36 (SF-36; generic measure) and the Disability Impact Profile (DIP; specific measure); and (ii) by obtaining preference-based utilities both measured with the time trade-off (direct way) and by calculating them from the EuroQol (EQ-5D) and SF-36. A significant positive effect of the implantable device was found on the physical functioning domain, the general health domain, and the physical component summary score of the SF-36. For the DIP, a significant improvement was found on the domains mobility, self-care, and psychological status in the intervention group. Regarding the preference-based utility measures, a significant effect was found for the utility index calculated from the EQ-5D. The implantable two-channel peroneal nerve stimulator seems to be efficient to improve HRQoL, mainly the domains related to physical functioning. A relation was present between the utility indexes calculated from the EQ-5D and SF-36. [source]


    Measuring the psychosocial impact of population-based prostate-specific antigen testing for prostate cancer in the UK

    BJU INTERNATIONAL, Issue 4 2006
    Lucy A. Brindle
    OBJECTIVE To evaluate the psychosocial impact of participation in a population-based prostate-specific antigen (PSA) testing programme, akin to screening, and to explore the relationship between urinary symptoms reported before PSA testing and the response to the subsequent PSA result. PATIENTS AND METHODS This prospective questionnaire study was nested within the case-finding component of the ProtecT (prostate testing for cancer and treatment) feasibility study (ISRCTN20141297). Men aged 50,69 years from 18 general practices in three cities in the UK completed the Hospital Anxiety and Depression Scale (HADS), the Short Form-12 (SF-12) Health Survey, and the International Continence Society ,male' (ICSmale) questionnaires before giving consent for a PSA test in a community clinic (baseline). Men with an ,abnormal' PSA result returned for further investigation (including biopsy) and repeated these questionnaires before biopsy. RESULTS At baseline, study participants had similar levels of anxiety and depression to the general male population. There was no increase in the HADS scores, or reduction in the SF-12 mental health component summary score, on attendance at the biopsy clinic after receiving an ,abnormal' PSA result. Urinary symptoms were associated with levels of anxiety and depression before receiving a PSA result (baseline), but were not associated with anxiety and depression at biopsy independently of baseline scores. Therefore changes in anxiety or depression at biopsy did not appear to differ between those with and without urinary symptoms. CONCLUSIONS This study confirms the findings of other studies that the deleterious effects of receiving an abnormal PSA result during population screening are not identified by generic health-status questionnaires. Comparisons with outcomes of studies measuring cancer-specific distress and using qualitative research methods raise the question of whether a prostate cancer screening-specific instrument is required. However, a standardized measure of anxiety identified differences at baseline between those who did and did not report urinary symptoms. These findings suggest that it might be advisable to better inform men undergoing PSA testing about the uncertain relationship between urinary symptoms and prostate cancer, to minimize baseline levels of psychological distress. [source]


    Parent-proxy report of their children's health-related quality of life: an analysis of 13 878 parents' reliability and validity across age subgroups using the PedsQL 4.0 Generic Core Scales

    CHILD: CARE, HEALTH AND DEVELOPMENT, Issue 5 2007
    Richard Reading
    Parent-proxy report of their children's health-related quality of life: an analysis of 13 878 parents' reliability and validity across age subgroups using the PedsQL 4.0 Generic Core Scales . VarniJ. W., LimbersC. A. & BurwinkleT. M. ( 2007 ) Health and Quality of Life Outcomes , 5 , 2 . DOI:10.1186/1477-7525-5-2. Background, Health-related quality of life (HRQOL) measurement has emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. While paediatric patient self-report should be considered the standard for measuring perceived HRQOL, there are circumstances when children are too young, too cognitively impaired, too ill or fatigued to complete an HRQOL instrument, and reliable and valid parent-proxy report instruments are needed in such cases. Further, it is typically parents' perceptions of their children's HRQOL that influences healthcare utilization. Data from the PedsQL DatabaseSM were utilized to test the reliability and validity of parent-proxy report at the individual age subgroup level for ages 2,16 years as recommended by recent Food and Drug Administration (FDA) guidelines. Methods, The sample analysed represents parent-proxy report age data on 13 878 children ages 2,16 years from the PedsQL 4.0 Generic Core Scales DatabaseSM. Parents were recruited from general paediatric clinics, sub-specialty clinics and hospitals in which their children were being seen for well-child checks, mild acute illness or chronic illness care (n = 3,718, 26.8%), and from a State Children's Health Insurance Program in California (n = 10 160, 73.2%). Results, The percentage of missing item responses for the parent-proxy report sample as a whole was 2.1%, supporting feasibility. The majority of the parent-proxy report scales across the age subgroups exceeded the minimum internal consistency reliability standard of 0.70 required for group comparisons, while the total scale scores across the age subgroups approached or exceeded the reliability criterion of 0.90 recommended for analysing individual patient scale scores. Construct validity was demonstrated utilizing the known groups approach. For each PedsQL scale and summary score, across age subgroups, healthy children demonstrated a statistically significant difference in HRQOL (better HRQOL) than children with a known chronic health condition, with most effect sizes in the medium-to-large effect size range. Conclusion, The results demonstrate the feasibility, reliability and validity of parent-proxy report at the individual age subgroup for ages 2,16 years. These analyses are consistent with recent FDA guidelines which require instrument development and validation testing for children and adolescents within fairly narrow age groupings and which determine the lower age limit at which reliable and valid responses across age categories are achievable. Even as paediatric patient self-report is advocated, there remains a fundamental role for parent-proxy report in paediatric clinical trials and health services research. [source]


    ORIGINAL ARTICLE: The relationship between patients' perception of the effects of neurofibromatosis type 2 and the domains of the Short Form-36

    CLINICAL OTOLARYNGOLOGY, Issue 4 2010
    W.J. Neary
    Clin. Otolaryngol. 2010, 35, 291,299 Objectives:, To investigate the relationship between those issues concerning quality of life in patients with neurofibromatosis type 2 (NF2) as identified by the closed set NF2 questionnaire and the eight norm-based measures and the physical component summary (PCS) and mental component summary (MCS) scores of the Short Form-36 (SF-36) Questionnaire. Design:, Postal questionnaire study. Setting:, Questionnaires sent to subjects' home addresses. Participants:, Eighty-seven adult subjects under the care of the Manchester Multidisciplinary NF2 Clinic were invited to participate. Main outcome measures:, Sixty-two (71%) completed sets of closed set NF2 questionnaires and SF-36 questionnaires were returned. Results:, Subjects with NF2 scored less than the norm of 50 on both the physical component summary and mental component summary scores and the eight individual norm-based measures of the Short Form-36 questionnaire. Correlations (using Kendall's tau) were examined between patients' perceptions of their severity of difficulty with the following activities and the eight norm-based measures and the physical component summary and mental component summary scores of the Short Form-36 questionnaire: Communicating with spouse/significant other (N = 61). The correlation coefficients were significant at the 0.01 level for the mental component summary score, together with three of the norm-based scores [vitality (VT), social functioning and role emotional]. Social communication (N = 62). All 10 correlations were significant at the 0.01 or 0.001 level. Balance (N = 59). All 10 correlations were highly significant at the P < 0.001 level. Hearing difficulties (N = 61). All correlations were significant at either the 0.01 level or less apart from the mental component summary score and three of the norm-based scores (role physical, VT and mental health). Mood change (N = 61). All correlations were significant at the 0.01 level or less, apart from one norm-based score (role physical). Conclusions:, The Short Form-36 questionnaire has allowed us to relate patients' perceptions of their difficulties, as identified by the closed set NF2 questionnaire, to the physical and mental domains measured by this validated and widely used scale, and has provided further insight into areas of functioning affected by NF2. [source]


    Quality-of-Life Differences Between Patients With Episodic and Transformed Migraine

    HEADACHE, Issue 6 2001
    Dennis M. Meletiche PharmD
    Objective.,To determine whether there are any differences in health-related quality of life between patients with migraine and those with transformed migraine. Background.,There are no published reports comparing the health-related quality of life between patients with migraine and patients with transformed migraine. Methods.,We conducted a retrospective analysis examining the health-related quality of life of patients with transformed migraine and migraine seen at a specialty headache clinic. Data collected included the Short Form-36 (SF-36) and the Migraine Disability Assessment questionnaires as well as demographic information. Both of these forms are part of the initial evaluation at the headache clinic. A t test with Bonferroni correction was used to test for significant differences in the SF-36 domains between the groups. Results.,Data were collected for 90 patients, 46 with transformed migraine and 44 with migraine. There were no significant differences between groups with respect to sex, race, or age. Over the last 90 days prior to their first visit, patients with transformed migraine reported having a headache an average of 69 days compared with patients with migraine who averaged 18 days with headache (P<.05). Compared with patients with migraine, patients with transformed migraine had statistically (P<.05) and clinically significant (difference >5 points) lower mean scores on seven of the eight SF-36 domains and both the mental and physical summary scores of the SF-36. Conclusions.,The results of this study suggest that patients with transformed migraine have a lower health-related quality of life than patients with migraine. These findings indicate that the headache chronicity associated with transformed migraine has a significant influence on quality of life. The results highlight the importance of effective management of headaches to avoid the progression of migraine to the more disabling transformed migraine. [source]


    Health-related quality of life of children with acute lymphoblastic leukaemia: Comparisons and correlations between parent and clinician reports

    INTERNATIONAL JOURNAL OF CANCER, Issue 4 2003
    Elizabeth B. Waters
    Abstract The improving prognosis for children with cancer refocusses attention to long-term outcomes with an emphasis on quality of life. Few studies have examined relationships and differences in reported results between the parent, child and clinician. We examined parent-proxy and clinician-reported functional status and health-related quality of life for children and adolescents with acute lymphoblastic leukemia (ALL). Children and adolescents, 5,18 years, in the maintenance phase of treatment for ALL attending the Haematology/Oncology outpatient clinic at the Royal Children's Hospital, Melbourne, were eligible. Measures included: 1) parent-reported functional health and well-being (Child Health Questionnaire [CHQ]); 2) parent-reported condition specific quality of life (Pediatric Cancer Quality of Life inventory [PCQL]); 3) clinician ratings of physical and psychosocial health; and 4) clinical indicators. Insufficient numbers of older patients prohibited collection of adolescent self-reports. We had a 94% response and 31 participants. Mean time since diagnosis: 1.5 (SD 0.4) years. Parents reported significantly lower functioning and well-being than population norms for all CHQ scales, whereas cancer-specific quality of life was comparable to PCQL norms. Clinician reports of the child's global physical and psychosocial health were moderately associated with each other (rs = 0.56, p < 0.001), and with the parent-reported physical (rs = 0.47, p < 0.01) and psychosocial (rs = 0.56, p < 0.001) CHQ summary scores. Clinician reports of the child's psychosocial health were not associated with any clinical indicators reported regularly. The results demonstrate that the social, physical and emotional health and well-being of children with ALL is significantly poorer than the health of their community-based peers. Routinely collected indicators of clinical progress conceal the psychosocial burden of ALL. Data on health, well-being and quality of life can easily be incorporated into clinical care. © 2002 Wiley-Liss, Inc. [source]


    The health status burden of people with fibromyalgia: a review of studies that assessed health status with the SF-36 or the SF-12

    INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 1 2008
    D. L. Hoffman
    Summary Objective:, The current review describes how the health status profile of people with fibromyalgia (FM) compares to that of people in the general population and patients with other health conditions. Methods:, A review of 37 studies of FM that measured health status with the 36-item Medical Outcomes Study Short-Form Health Survey (SF-36) or the 12-item Short-Form Health Survey (SF-12). Results:, Studies performed worldwide showed that FM groups were significantly more impaired than people in the general population on all eight health status domains assessed. These domains include physical functioning, role functioning difficulties caused by physical problems, bodily pain, general health, vitality (energy vs. fatigue), social functioning, role functioning difficulties caused by emotional problems and mental health. FM groups had mental health summary scores that fell 1 standard deviation (SD) below the general population mean, and physical health summary scores that fell 2 SD below the general population mean. FM groups also had a poorer overall health status compared to those with other specific pain conditions. FM groups had similar or significantly lower (poorer) physical and mental health status scores compared to those with rheumatoid arthritis, osteoarthritis, osteoporosis, systemic lupus erythematosus, myofacial pain syndrome, primary Sjögren's syndrome and others. FM groups scored significantly lower than the pain condition groups mentioned above on domains of bodily pain and vitality. Health status impairments in pain and vitality are consistent with core features of FM. Conclusions:, People with FM had an overall health status burden that was greater in magnitude compared to people with other specific pain conditions that are widely accepted as impairing. [source]


    Quality of life in chronic kidney disease: effects of treatment modality, depression, malnutrition and inflammation

    INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 4 2007
    B. Kalender
    Summary In the present study, our aim is to investigate the effects of the treatment modality, depression, malnutrition and inflammation on quality of life (QoL) in chronic kidney disease (CKD). Twenty-six patients with CKD on conservative management, 68 patients on haemodialysis (HD), 47 patients on continuous ambulatory peritoneal dialysis (CAPD) and 66 healthy controls were enrolled in the study. QoL was measured by means of the Short Form-36 (SF-36) and subscale scores were calculated. All patients were evaluated for the presence of depression using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I Disorders , Clinician Version. The severity of depression was evaluated by means of the Beck Depression Inventory (BDI). Serum C-reactive protein (CRP), ferritin, albumin, haemoglobin and haematocrit (Hct) levels were measured. All the SF-36 subscale scores were lower in the patient groups compared with control group. The SF-36 scores were higher and BDI scores were lower in the CAPD group than CKD and HD groups. In patients with depression, all SF-36 subscale scores were lower than that of the patients without depression. There was a significant negative correlation between all the SF-36 subscale scores and the BDI scores. There was a significant positive correlation between the SF-36 physical and total summary scores and the Hct value and serum albumin levels, but an inverse correlation between the SF-36 physical, mental and total summary scores and the serum CRP level in the HD patients. The authors suggest that the treatment modality, depression, malnutrition and inflammation have an important role on QoL in CKD. [source]


    Night-time frequency, sleep disturbance and general health-related quality of life: Is there a relation?

    INTERNATIONAL JOURNAL OF UROLOGY, Issue 1 2009
    Koji Yoshimura
    Objectives: We conducted a community-based study to determine the relationship among night-time frequency, sleep disturbance and general health-related quality of life (GHQL). Methods: A total of 2271 participants, men and women, aged 41,70 and randomly selected in three Japanese towns completed a postal questionnaire survey. This questionnaire included: the International Prostate Symptom Score, the overall incontinence score of the International Consultation of Incontinence Questionnaire Short Form for lower urinary tract symptoms, the Pittsburg Sleep Quality Index for sleep problems, the Medical Outcome Study Short Form-8 for GHQL, and medical history of disease, cigarette smoking, and alcohol consumption. A multiple regression model was used for statistical analysis, and P < 0.05 was considered significant. Results: Although night-time frequency by itself was closely associated with most aspects of GHQL, this association disappeared in four domains (general health perception, vitality, mental health and emotional role) and in the two summary scores of the Medical Outcome Study Short Form-8 after inclusion of the influence of sleep problems represented by the total score on the Pittsburg Sleep Quality Index. However, three domains (physical function, physical role, and social function) remained significantly associated with night-time frequency. Sleep problems were by far the worst risk factor for the deterioration of GHQL. Conclusions: Night-time frequency appeared to be associated with GHQL mainly by affecting sleep conditions, a symptom that independently influenced some aspects of GHQL. [source]


    Does a telephone follow-up intervention for patients discharged with acute myocardial infarction have long-term effects on health-related quality of life?

    JOURNAL OF CLINICAL NURSING, Issue 9 2009
    A randomised controlled trial
    Aims., An earlier combined proactive and reactive telephone follow-up intervention for acute myocardial infarction patients after discharge from hospital showed positive effects after six months. The aim of the present study was to assess whether the intervention has long-term effects up to 18 months after discharge. Design., A prospective randomised controlled trial with 18 months follow-up. Method., The trial was conducted with 288 patients allocated to a telephone follow-up intervention group (n = 156) or control group (n = 132). The primary endpoint was health-related quality of life using the SF-36. Secondary endpoints included smoking and exercise habits, return to work and rehospitalisation due to chest pain. Results., There were significant improvements over time on most dimensions of health-related quality of life in both the intervention and control group to US norm population levels on most SF-36 dimensions and summary scores. The intervention group showed no overall significant improvement beyond six months in the physical or mental summary scores, but there was a significant effect for those aged 70 or above. Although there was a promising effect for rehospitalisation due to chest pain, no significant differences were found between the groups on the secondary endpoints after six months. Conclusion., This study demonstrated that despite positive short-term effects at six months, the telephone follow-up intervention had no long-term effects on health-related quality of life or secondary endpoints. However, the potential for improvement beyond six months was less than anticipated reflecting a reduced morbidity among acute myocardial infarction patients. Relevance to clinical practice., Telephone follow-up after discharge from hospital is an easy implementable follow-up intervention enabling individualised provision of information and support in a time often experienced as stressful by patients. Our study indicates that six months is an adequate support period. Despite positive results six months after discharge no significant added long-term effects of telephone follow-up, compared to usual care were found in this study. [source]


    Improvement in Quality of Life After Treatment for Alcohol Dependence With Acamprosate and Psychosocial Support

    ALCOHOLISM, Issue 1 2004
    Marsha Y. Morgan
    Abstract: Background: The impact of disease on health-related quality of life is now well recognized, as is the importance of this variable as a measure of treatment efficacy. Methods: Patients from five European countries were enrolled in an open, multicenter, prospective study designed to observe outcome in dependent drinkers treated for 6 months with acamprosate and psychosocial support. Version 1 of the 36-item Short Form Health Profile (SF-36v1) questionnaire was administered at inclusion and at 3 and 6 months. Responses were described as handicaps compared with an appropriately matched, healthy reference population. One-way fixed ANOVA and simultaneous stepwise linear regression analysis were used to identify potential predictors of quality of life at baseline and after treatment. Results: Baseline SF-36v1 data were obtained from 1216 patients (mean age, 43 ± 9 years; 77% male). Mean values for all SF-36v1 dimensions were significantly lower in the patient population than in the normative reference population; the most important deficits were observed in physical and emotional role limitations and in social functioning. The most important predictors of baseline quality of life were severity of alcohol dependence, employment status, psychiatric history, quantity and frequency of alcohol consumption, attendance at Alcoholics Anonymous, global alcohol health status, age, gender, and education. SF-36v1 data were obtained from 686 patients at 3 months and from 497 at 6 months. Significant improvements were observed in all SF-36v1 dimensional and summary scores after 3 months of treatment (p < 0.001); further marginal improvements were observed between 3 and 6 months. The most important predictors of quality of life following treatment were the SF-36v1 profile at baseline, followed by abstinence duration; patients who completed the trial and remained abstinent throughout showed the greatest improvement. Conclusions: Health-related quality of life is severly impaired in dependent drinkers. Treatment with acamprosate and psychosocial support, by promoting abstinence, improves the quality of life profile to levels comparable to those observed in healthy individuals. [source]


    The reliability of summative judgements based on objective structured clinical examination cases distributed across the clinical year

    MEDICAL EDUCATION, Issue 7 2007
    George R Bergus
    Context, Objective structured clinical examinations (OSCEs) can be used for formative and summative evaluation. We sought to determine the generalisability of students' summary scores aggregated from formative OSCE cases distributed across 5 clerkships during Year 3 of medical school. Methods, Five major clerkships held OSCEs with 2,4 cases each during their rotations. All cases used 15-minute student,standardised patient encounters and performance was assessed using clinical and communication skills checklists. As not all students completed every clerkship or OSCE case, the generalisability (G) study was an unbalanced student × (case : clerkship) design. After completion of the G study, a decision (D) study was undertaken and phi (,) values for different cut-points were calculated. Results, The data for this report were collected over 2 academic years involving 262 Year 3 students. The G study found that 9.7% of the score variance originated from the student, 3.1% from the student,clerkship interaction, and 87.2% from the student,case nested within clerkship effect. Using the variance components from the G study, the D study suggested that if students completed 3 OSCE cases in each of the 5 different clerkships, the reliability of the aggregated scores would be 0.63. The ,, calculated at a cut-point 1 standard deviation below the mean, would be approximately 0.85. Conclusions, Aggregating case scores from low stakes OSCEs within clerkships results in a score set that allows for very reliable decisions about which students are performing poorly. Medical schools can use OSCE case scores collected over a clinical year for summative evaluation. [source]


    Dietary patterns and the risk of colorectal cancer and adenomas

    NUTRITION REVIEWS, Issue 7 2010
    Giorgia Randi
    The association of colorectal cancer risk with select foods has been evaluated by dietary pattern analysis. This review of the literature was conducted to thoroughly examine the available evidence for the association between dietary patterns and colorectal cancers and adenomas. A total of 32 articles based on worldwide epidemiological studies were identified. Pattern identification was achieved by exploratory data analyses (principal component, factor, and cluster analyses) in most articles, and only a few used a priori -defined scores. Dietary patterns named as healthy, prudent, fruit and vegetables, fat-reduced/diet foods, vegetable/fish/poultry, fruit/whole grain/dairy, and healthy eating index-2005, recommended food and Mediterranean diet scores were all associated with reduced risk of colorectal cancer and the risk estimates varied from 0.45 to 0.90. In contrast, diets named Western, pork-processed meat-potatoes, meat-eaters, meat and potatoes, traditional patterns, and dietary risk and life summary scores were associated with increased risk of colorectal cancer with risk estimates varying from 1.18 to 11.7. Dietary patterns for adenomas were consistent with those identified for colorectal cancer. [source]


    Confounder summary scores when comparing the effects of multiple drug exposures,

    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 1 2010
    Suzanne M. Cadarette PhD
    Abstract Purpose Little information is available comparing methods to adjust for confounding when considering multiple drug exposures. We compared three analytic strategies to control for confounding based on measured variables: conventional multivariable, exposure propensity score (EPS), and disease risk score (DRS). Methods Each method was applied to a dataset (2000,2006) recently used to examine the comparative effectiveness of four drugs. The relative effectiveness of risedronate, nasal calcitonin, and raloxifene in preventing non-vertebral fracture, were each compared to alendronate. EPSs were derived both by using multinomial logistic regression (single model EPS) and by three separate logistic regression models (separate model EPS). DRSs were derived and event rates compared using Cox proportional hazard models. DRSs derived among the entire cohort (full cohort DRS) was compared to DRSs derived only among the referent alendronate (unexposed cohort DRS). Results Less than 8% deviation from the base estimate (conventional multivariable) was observed applying single model EPS, separate model EPS or full cohort DRS. Applying the unexposed cohort DRS when background risk for fracture differed between comparison drug exposure cohorts resulted in ,7 to,+,13% deviation from our base estimate. Conclusions With sufficient numbers of exposed and outcomes, either conventional multivariable, EPS or full cohort DRS may be used to adjust for confounding to compare the effects of multiple drug exposures. However, our data also suggest that unexposed cohort DRS may be problematic when background risks differ between referent and exposed groups. Further empirical and simulation studies will help to clarify the generalizability of our findings. Copyright © 2009 John Wiley & Sons, Ltd. [source]


    INCIDENCE AND OUTCOMES OF KNEE AND HIP JOINT REPLACEMENT IN VETERANS AND CIVILIANS

    ANZ JOURNAL OF SURGERY, Issue 5 2006
    Vanessa Wells
    Background: This article describes the incidence of total knee and hip replacement, and compares post-surgery health status outcomes in veterans and civilians. Methods: The numbers of male veterans and civilians who had a knee and/or a hip replacement in South Australia (1994,2002) were obtained. Standardized morbidity ratios, and odds ratios for age group by veteran/civilian interactions, were calculated. Presurgery and 1-year post-surgery Medical Outcomes Short Form (36) Health Survey, Knee Society and Harris hip scores were completed. Independent samples t -tests were used to compare presurgery scores. ancova models were used to determine any differences between veterans and civilians post-surgery. Results: For veterans, standardized morbidity ratios were 0.987 and 0.715 for knee and hip replacements, respectively (P < 0.0001). Veterans' odds ratios for knee and hip replacements were significantly lower in the 65- to 74-year age group (P < 0.001), similar in the 75- to 84-year and above 85-year age groups for hip replacement, but significantly higher in the above 85-year age group for knee replacement (P < 0.001). Presurgery, veterans reported significantly lower scores (P < 0.003) for knee function. After knee replacement, veterans reported significantly lower Medical Outcomes Short Form (36) Health Survey scores for bodily pain, physical functioning, role , physical, role , emotional, social functioning and physical component summary (P < 0.033). Significantly lower physical functioning, role , physical and physical component summary scores (P < 0.02) were reported by veterans post-surgery for hip replacement. Conclusion: Veterans are delaying joint replacement. Presurgical knee function is worse in veterans. Post-surgery, the veterans are worse off in a number of health status outcomes. [source]


    Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: Results of a randomized, double-blind, placebo-controlled trial,

    ARTHRITIS & RHEUMATISM, Issue 9 2010
    Lesley M. Arnold
    Objective To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day (50 mg twice daily) for monotherapy treatment of fibromyalgia. Methods A double-blind, placebo-controlled trial was performed to assess 1,025 patients with fibromyalgia who were randomized to receive milnacipran 100 mg/day (n = 516) or placebo (n = 509). Patients underwent 4,6 weeks of flexible dose escalation followed by 12 weeks of stable-dose treatment. Two composite responder definitions were used as primary end points to classify the response to treatment. The 2-measure composite response required achievement of ,30% improvement from baseline in the pain score and a rating of "very much improved" or "much improved" on the Patient's Global Impression of Change (PGIC) scale. The 3-measure composite response required satisfaction of these same 2 improvement criteria for pain and global status as well as improvement in physical function on the Short Form 36 (SF-36) physical component summary (PCS) score. Results After 12 weeks of stable-dose treatment, a significantly greater proportion of milnacipran-treated patients compared with placebo-treated patients showed clinically meaningful improvements, as evidenced by the proportion of patients meeting the 2-measure composite responder criteria (P < 0.001 in the baseline observation carried forward [BOCF] analysis) and 3-measure composite responder criteria (P < 0.001 in the BOCF). Milnacipran-treated patients also demonstrated significantly greater improvements from baseline on multiple secondary outcomes, including 24-hour and weekly recall pain score, PGIC score, SF-36 PCS and mental component summary scores, average pain severity score on the Brief Pain Inventory, Fibromyalgia Impact Questionnaire total score (all P < 0.001 versus placebo), and Multidimensional Fatigue Inventory total score (P = 0.036 versus placebo). Milnacipran was well tolerated by most patients, with nausea being the most commonly reported adverse event (placebo-adjusted rate of 15.8%). Conclusion Milnacipran administered at a dosage of 100 mg/day improved pain, global status, fatigue, and physical and mental function in patients with fibromyalgia. [source]