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BACKGROUND: The Multidimensional Daily Diary of Fatigue-Fibromyalgia-17 instrument (MDF-Fibro-17) has been developed for use in fibromyalgia (FM) clinical studies and includes 5 domains: Global Fatigue Experience, Cognitive Fatigue, Physical Fatigue, Motivation, and Impact on Function. Psychometric properties of the MDF-Fibro-17 needed to demonstrate the appropriateness of using this instrument in clinical studies are presented. METHODS: Psychometric analyses were conducted to evaluate the factor structure, reliability, validity, and responsiveness of the MDF-Fibro-17 using data from a Phase 2 clinical study of FM patients (N = 381). Confirmatory factor analyses (CFA) were performed to ensure understanding of the multidimensional domain structure, and a secondary factor analysis of the domains examined the appropriateness of calculating a total score in addition to domain scores. Longitudinal psychometric analyses (test-retest reliability and responder analysis) were also conducted on the data from Baseline to Week 6. RESULTS: The CFA supported the 17-item, 5 domain structure of this instrument as the best fit of the data: comparative fit index (CFI) and non-normed fit index (NNFI) were 0.997 and 0.992 respectively, standardized root mean square residual (SRMR) was 0.010 and the root mean square error of approximation (RMSEA) was 0.06. In addition, total score (CFI and NNFI both 0.95) met required standards. For the total and 5 domain scores, reliability and validity data were acceptable: test-retest and internal consistency were above 0.9; correlations were as expected with the Global Fatigue Index (GFI) (0.62-0.75), Fibromyalgia Impact Questionnaire (FIQ) Total (0.59-0.71), and 36-Item Short Form Health Survey (SF-36) vitality (VT) (0.43-0.53); and discrimination was shown using quintile scores for the GFI, FIQ Total, and Pain Numeric Rating Scale (NRS) quartiles. In addition, sensitivity to change was demonstrated with an overall mean responder score of -2.59 using anchor-based methods. CONCLUSION: The MDF-Fibro-17 reliably measures 5 domains of FM-related fatigue and psychometric evaluation confirms that this measure meets or exceeds each of the predefined acceptable thresholds for evidence of reliability, validity, and responsiveness to changes in clinical status. This suggests that the MDF-Fibro-17 is an appropriate and responsive measure of FM-related fatigue in clinical studies.

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BACKGROUND: Fibromyalgia (FM), a disorder characterized by chronic widespread pain and tenderness, affects greater than five million individuals in the United States alone. Patients experience multiple symptoms in addition to pain, and among them, fatigue is one of the most bothersome and disabling. There is a growing body of literature suggesting that fatigue is a multidimensional concept. Currently, to our knowledge, no multidimensional Patient Reported Outcome (PRO) measure of FM-related fatigue meets Food and Drug Administration (FDA) requirements to support a product label claim. Therefore, the objective of this research was to evaluate qualitative and quantitative data previously gathered to inform the development of a comprehensive, multidimensional, PRO measure to assess FM-related fatigue in FM clinical trials. METHODS: Existing qualitative and quantitative data from three previously conducted studies in patients with FM were reviewed to inform the initial development of a multidimensional PRO measure of FM-related fatigue: 1) a concept elicitation study involving in-depth, open-ended interviews with patients with FM in the United States (US) (N = 20), Germany (N = 10), and France (N = 10); 2) a cognitive debriefing and pilot study of a preliminary pool of 23 items (N = 20 US patients with FM); and 3) a methodology study that explored initial psychometrics of the item pool (N = 145 US patients with FM). RESULTS: Five domains were identified that intend to capture the broad experience of FM-related fatigue reported in the qualitative research: the Global Fatigue Experience, Cognitive Fatigue, Physical Fatigue, Motivation, and Impact on Function. Seventeen of the original pool of 23 items were selected to best capture these five dimensions. These 17 items formed the basis of a newly developed multidimensional PRO measure to assess FM-related fatigue in clinical trials: the Multidimensional Daily Diary of Fatigue-Fibromyalgia-17 (MDF-Fibro-17). CONCLUSION: Qualitative analysis, and preliminary quantitative item level data, confirmed that FM-related fatigue is multidimensional and provided strong support for the content validity of the MDF-Fibro-17. The next stage was to quantitatively evaluate the measure to confirm the factor structure, psychometric properties, sensitivity to change, and meaningful change. This has been conducted and is being reported separately.

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To apportion the direct effect and the indirect effect (through erections) that sildenafil (vs placebo) has on individual satisfaction and couple satisfaction over time, longitudinal mediation modeling was applied to outcomes on the Sexual Experience Questionnaire. The model included data from weeks 4 and 10 (double-blind phase) and week 16 (open-label phase) of a controlled study. Data from 167 patients with erectile dysfunction (ED) were available for analysis. Estimation of statistical significance was based on bootstrap simulations, which allowed inferences at and between time points. Percentages (and corresponding 95% confidence intervals) for direct and indirect effects of treatment were calculated using the model. For the individual satisfaction and couple satisfaction domains, direct treatment effects were negligible (not statistically significant) whereas indirect treatment effects via the erection domain represented >90% of the treatment effects (statistically significant). Week 4 vs week 10 percentages of direct and indirect effects were not statistically different, indicating that the mediation effects are longitudinally invariant. As there was no placebo arm in the open-label phase, mediation effects at week 16 were not estimable. In conclusion, erection has a crucial role as a mediator in restoring individual satisfaction and couple satisfaction in men with ED treated with sildenafil.

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AIM: To determine the rate of newly detected underlying disease in men receiving their first (index) phosphodiesterase type 5 inhibitor (PDE5i) prescription. METHODS: This non-interventional, retrospective study used anonymised patient records from UK general practices identified from the THIN database. Records of men aged ≥ 18 years, who received an index PDE5i prescription between January 1999 and June 2008 and with a continuous medical history (≥ 60 months) before the index prescription were included. Primary end-points were the prevalence of underlying disease prior to the index prescription and to establish the detection rate, defined as cumulative incidence of such a diagnosis in the 3 months following the index prescription. Assessments included comparison with age-matched controls, comparison with identical time periods immediately before and 1 year after, index prescription, and changes over time during the study period. Descriptive statistics, analysis of proportions and multivariate logistic regression analysis were used. RESULTS: Among the 24,708 patients receiving a PDE5i, the prevalence of any underlying diagnosis before the index prescription was 70.23%; prevalence of vasculogenic disease was highest (48.20%). The detection rate of any underlying disease was 11.53%, and again highest for vasculogenic disease (4.07%). Compared with an age-matched control population, the additional detection rate of an unknown underlying disease at PDE5i prescription was 45 for hypertension, 61 for hypercholesterolaemia, 38 for diabetes and 5 for hypogonadism per 10,000 men. CONCLUSION: Only a minority of men with erectile dysfunction have a previously undiagnosed important underlying disease that is uncovered at the time of an initial PDE5i prescription by a GP.

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STUDY DESIGN: Double-blind, placebo-controlled, flexible-dose study. OBJECTIVE: To evaluate the efficacy, safety and tolerability of oral sildenafil in women with female sexual arousal disorder as a result of SCI (paraplegia/tetraplegia). SETTING: The study was conducted at clinical practice sites in North America (n =23), 11 European countries (n =23), Australia (n =4) and South Africa (n =2). METHODS: 129 women were randomized and treated with sildenafil or matching placebo. A 4-week baseline period was followed by 12 weeks of treatment, which could be increased from 50 to 100 mg or decreased to 25 mg once during the treatment period, depending on efficacy and tolerability. By use of an event log, sexual activity was monitored between screening and the end of treatment. The Sexual Function Questionnaire, the Sexual Quality of Life Questionnaire-Female, a global efficacy question and Sexual Distress Question were also assessed. RESULTS: Sildenafil-treated women and placebo-treated women had an increase in their percentage of sexual activities throughout the course of the study, with no statistically significant difference between groups in the percentage of successful sexual activities at end of treatment versus baseline. There were also no statistically significant differences between sildenafil- and placebo-treated women on the aforementioned measures. The most common adverse events included headache and vasodilatation. CONCLUSION: The results of this study are similar to other reports regarding a lack of clinically meaningful benefit of sildenafil in other populations of women. SPONSORSHIP: This study was sponsored by Pfizer Inc.

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AIMS: Understanding the patient's experience and symptom descriptions is critical to assess outcomes. Thus, there is a need for qualitative research to better understand how patients describe their symptoms and treatment expectations. METHODS: Eight focus groups were conducted in two research phases: Phase 1 focused on eliciting patient's descriptions of urinary symptoms, and Phase 2 assessed patient perspectives on treatment outcomes. Participants with a range of lower urinary tract symptoms (LUTS) were recruited from urology clinics and community settings in the United States. All interviews were audio recorded and transcribed. Content and descriptive analyses were performed. RESULTS: A total of 33 men and 30 women participated. Mean ages for men and women were 55 and 61 in Phase 1, and 57 and 61 in Phase 2, respectively. About 73% of participants were white people, and most had a high school education or greater. A wide range of LUTS were emergently described, and the words, concepts and phrases were generally similar across groups. Most participants identified with the word 'bother', and thought it was important to assess both the frequency and bother of each symptom. Reasons for seeking care included symptom bother and fears about cancer and bladder infections. Most participants thought that a 50% improvement in a single symptom or group of symptoms would be a meaningful treatment outcome. CONCLUSION: This qualitative research provides a better understanding on how men and women describe their LUTS and their perspectives on treatment outcomes. This research can be used to inform the development of a new LUTS outcomes' tool.

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Defining the minimal clinically meaningful improvement (MCMI) is crucial to understanding the treatment effects on health-status measures. We estimated the MCMI on the quality of erection questionnaire (QEQ), a validated measure specific to assess erectile quality during sexual intercourse. Data were from two controlled trials of an investigational phosphodiesterase type 5 inhibitor. Improvement on the Erectile Function domain of the International Index of Erectile Function was used as the anchor. For men who improved by exactly 1 erectile dysfunction severity category (anchor group (n=95)), clinically meaningful improvement (CMI, estimated with mean QEQ total change score from baseline to end of treatment) and MCMI (estimated with the lower limit of the 95% confidence interval of the mean) were 22.4 (s.d., 2.2) and 18.0 points, respectively. For the difference between the anchor group and men with no change in severity category (n=116), CMI and MCMI were 17.7 (s.d., 2.9) and 12 points, respectively. Distribution-based analyses (baseline s.e. of measurement (s.e.m.)=7.99, end-of-treatment s.e.m.=8.22 and s.e. of difference=11.46) supported a proposed MCMI of 12 points. Convergence of anchor-based and distribution-based criteria supports at least a 12-point difference in QEQ scores between treatments as clinically important.

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There are uncertain issues on the diagnostic methods of premature ejaculation (PE). The premature ejaculation diagnostic tool (PEDT) was developed to systematically apply the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria in diagnosing PE and the aim of this study is to carry out the Turkish validation of the PEDT and to evaluate its association with intravaginal ejaculatory latency time (IELT). A total of 94 patients with a self-reported complaint of PE and 88 men without PE were enrolled into the study and requested to complete the nine-item PEDT, which was translated into Turkish. The patients were also requested to measure IELT. All participants were requested to come for a second visit to assess the PEDT's retest reliability; data from 78 men in the PE group and 69 men in the control group were collected. The IELT data of 35 patients were also recorded. The mean age of the PE group and the control group were 39.4+/-9.7 (24-65) and 30.1+/-5.7 (20-56), respectively, (P=0.068). Among the patients in the PE group, 24 (68.5%) reported life-long PE, whereas 11 (31.5%) reported acquired PE. The geometric mean IELT of the PE group was 59.7+/-46.2 (6.5-197.7) s. The number of men reporting IELTs of <1, 1-<2 and >2 min were 20 (57.1%), 11 (31.5) and 4 (11.4%), respectively. The factor analysis assessment showed that the five-item combination (questions 1, 2, 3, 4 and 8) explained 74.4% of the variance, there were no other combinations that explained the variance more effectively. Cronbach's alpha score of five-item combination was calculated as 0.77, showing adequate internal consistency. The overall Cronbach's alpha score did not increase if any item combination was deleted. The test-retest correlation coefficients of each item were higher than 0.80 and the correlation coefficient of the total score was 0.90. The PEDT and IELT showed an adequate correlation (rho=0.44). As a conclusion, the validated five-item Turkish version of PEDT is a reliable questionnaire to screen PE among Turkish patients. Its significant association with IELT supports the fact that PEDT may be of benefit for the diagnosis of PE and measuring the response to treatment. In addition, PEDT seems to be more applicable than measuring IELT in our population, for the assessment of PE.

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Research in partners of men with erectile dysfunction suggests that a woman's sexual difficulties can be contingent on her partner's sexual dysfunction. However, little research has been conducted in partners of men with other sexual dysfunctions, such as premature ejaculation (PE). We evaluated 139 partners of men diagnosed with having PE and 89 age-matched women whose partners did not have any sexual dysfunction. Results showed that 77.7% of PE partners had at least one sexual dysfunction, compared to 42.7% of the control group. Further research needs to be undertaken to investigate the temporal relationship between sexual dysfunctions in both partners.

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OBJECTIVE: The purpose of this paper is to summarize the best evidence regarding the impact of providing patient-reported outcomes (PRO) information to health care professionals in daily clinical practice. METHODS: Systematic review of randomized clinical trials (Medline, Cochrane Library; reference lists of previous systematic reviews; and requests to authors and experts in the field). RESULTS: Out of 1,861 identified references published between 1978 and 2007, 34 articles corresponding to 28 original studies proved eligible. Most trials (19) were conducted in primary care settings performed in the USA (21) and assessed adult patients (25). Information provided to professionals included generic health status (10), mental health (14), and other (6). Most studies suffered from methodologic limitations, including analysis that did not correspond with the unit of allocation. In most trials, the impact of PRO was limited. Fifteen of 23 studies (65%) measuring process of care observed at least one significant result favoring the intervention, as did eight of 17 (47%) that measured outcomes of care. CONCLUSIONS: Methodological concerns limit the strength of inference regarding the impact of providing PRO information to clinicians. Results suggest great heterogeneity of impact; contexts and interventions that will yield important benefits remain to be clearly defined.

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This study details the further validation of the Premature Ejaculation Diagnostic Tool (PEDT), a five-item tool, developed to systematically apply the Diagnostic and Statistical Manual of Mental Disorders, revised version 4 (DSM-IV-TR), criteria in diagnosing presence or absence of premature ejaculation (PE). A total of 102 men completed the PEDT and were then interviewed by one of the seven clinical experts, who made a diagnosis of presence or absence of PE. The diagnoses from these two methods were compared to assess the convergent validity of PEDT. Retest reliability was also assessed, by men completing the PEDT a second time, approximately 2 weeks after the first administration. The level of agreement between clinical expert and PEDT diagnoses was very high (kappa-statistic=0.80 (95% CI=0.68-0.92)), and retest reliability was very good - Intraclass correlation coefficient=0.88. In summary, the PEDT is extensively validated, self-report measure that can systematically assess DSM-IV-TR criteria to provide accurate diagnoses of PE/no-PE.

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OBJECTIVE: To identify health-related quality-of-life (HRQoL) issues in patients with venous leg ulcers, with the aim of generating items for a treatment outcome measure. METHOD: Thirty-eight patients with venous leg ulcers were interviewed by a psychologist using a semi-structured guide; they also completed a HRQoL questionnaire (modified Skindex). Data from the questionnaire were examined to explore the impact of venous leg ulcers on patients' lives. Interview transcripts were analysed using qualitative methods to identify additional venous leg ulcer-specific HRQoL items. RESULTS: Skindex scores indicated that older patients had worse HRQoL (p<0.05), as did those with pain and non-healing ulcers. Ulcer duration and size did not correlate with HRQoL. Interviews revealed the following effects of ulceration: pain (80.5%); itching (69.4%); altered appearance (66.7%); loss of sleep (66.6%); functional limitation (58.3%); and disappointment with treatment (50%). Based on the interview transcripts, items were generated and discussed with an expert panel, with a view to including them in a venous leg ulcer-specific HRQoL questionnaire. CONCLUSION: Disease-specific HRQoL outcome measures should be considered when evaluating treatments for venous leg ulcers.

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No systematic study has examined the psychological impact of premature ejaculation (PE) on the man and his partner. This study explores this vital issue by reporting on interviews of 28 men with self-diagnosed PE. From a qualitative perspective, these interviews assess whether these men had concerns about their PE and, if so, what they were. These men focused on two major themes: impact on self-confidence and future/current relationships. This suggests that PE has a similar qualitative impact on the individual as erectile dysfunction. Further investigation will need to determine how prevalent these concerns are in the PE population and also to delineate the impact on the men s partners.

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The use of education in the clinical setting to help chronic sufferers cope with their back pain is not a new concept. Back schools and work hardening programs have been running for many years, but education about back pain at the primary care level, in industry specifically, has been slower in developing. Studies that have used back schools in industry have had some success but not as much as might be hoped, often not being very cost-efficient nor producing lasting changes in health behaviours. However, the use of educational pamphlets in the primary care setting have shown success in changing individuals knowledge about back pain and altering number of visits to a physician. Furthermore, when a pamphlet, designed on the basis of current knowledge about the management of non-specific low back pain, was distributed in a manufacturing industry, there were changes in beliefs about back pain which mirrored substantial change in absence behaviour. In conclusion, education through the medium of a pamphlet seems able to change knowledge and behaviours related to back pain and, with sufficiently large reductions in absence from the workplace it would appear to be a cost-efficient method. Further studies are required to confirm the validity and cost-efficiency of pamphlet education for back pain in the manufacturing industry, but also to determine pamphlet utility in other work environments and for other health problems.

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This study retrospectively surveyed 1,216 nurses at hospitals in Belgium and The Netherlands. Data concerning workloads, musculoskeletal symptoms, work loss and psychosocial factors were collected by questionnaire. Lifetime prevalence rates for musculoskeletal problems and low back trouble were significantly lower in the Dutch hospitals than the Belgian hospitals, but a significantly higher proportion of Dutch nurses had 'heavy' workloads. Overall, symptoms and work loss in the previous 12 months were not related to workload, nor was the perception that work was causative; a change of duties because of symptoms was rare (< 3%). The Dutch nurses differed strikingly from Belgian nurses on the psychosocial variables; they were less depressed and significantly more positive about pain, work and activity. It is proposed that ergonomic interventions alone may be sub-optimal in controlling musculoskeletal problems among nurses. The additional provision of psychosocial information to challenge misconceptions and encourage self-management is proposed.

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STUDY DESIGN: A survey of occupational risks for low back trouble in two police forces discordant for one known physical stressor (wearing body armor weighing approximately 8.5 kg. OBJECTIVES: To determine the hazard for first-onset and subsequent course of low back trouble associated with occupational physical and psychosocial stressors. SUMMARY OF BACKGROUND DATA: Various occupational physical stressor have been associated with the prevalence of back pain, but their relationship with first-onset low back trouble is uncertain. Psychosocial factors reportedly are important determinants of chronicity. METHODS: Anamnestic data on low back trouble were collected from representative random samples of "exposed" and control forces, along with variables describing exposure to occupational physical stressors and sports results. Psychometric tests were administered. RESULTS: Occupational risk factors for first-onset low back trouble were determined from lifetables based on officers with no previous back pain history. Survival time to first onset was affected adversely by wearing body armor and, less so, by vehicular exposure and sports participation. The proportion with persistent (chronic) trouble did not depend on length of exposure since onset, but longer service was associated with recurrent episodes. Chronicity was related to distress and blaming police work. Work loss was associated with blaming work and wearing body armor. Changing to lighter duties after development of low back trouble occurred rarely. CONCLUSIONS: Exposure to occupational physical stress seems detrimental; It reduced survival time to first-onset of low back trouble. Recurrence was associated with time since onset, but persistent trouble was not. Sports participation was a risk if occupational hazards were high.

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The Heliothis armigera entomopoxvirus (HaEPV) genome encodes a predicted 68 kDa polypeptide related to the 'rifampicin resistance' protein of vaccinia virus (with 30 % identity), and an homologous swinepox virus protein (27% identity). We were unable to isolate an HaEPV genotypic variant encoding a predicted C-terminal truncated form of the protein, suggesting that the C terminus of the molecule may be essential to protein function, and, in turn, that this function may be essential to viral replication. HaEPV replication was substantially reduced in host cells exposed to rifampicin, but the observed cytotoxic properties of the drug made it impossible to determine the specific cause of that inhibition. We suggest that possession of a gene encoding a member of this polypeptide family might represent a defining molecular characteristic of the Poxviridae.

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Recent evidence indicates that the influence of psychosocial factors on low back disability is as great as, if not greater than, ergonomic aspects; negative attitudes and beliefs are likely to be related to absenteeism. To measure workers attitudes and beliefs about low-back trouble, pain, work and activity five questionnaires were used. Two new instruments (Back Beliefs Questionnaire and Psychosocial Aspects of Work questionnaire) were developed and tested. The attitudes and beliefs were measured among workers in a biscuit manufacturing factory, and the responses related to absenteeism. Workers who had taken in excess of one week's absence due to low-back trouble had significantly more negative attitudes and beliefs when compared with workers who had taken shorter absence (or indeed those reporting no history of back trouble). A subset of the psychosocial parameters accounted for 32% of the variance in absence. Interventions designed to reduce negative attitudes and promote positive beliefs may help to reduce detrimental, inappropriate longer-term absenteeism due to low-back trouble.

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STUDY DESIGN: A 1-year prospective study in industry, assessing effects of an educational pamphlet on various psychosocial parameters and absenteeism resulting from low back trouble. OBJECTIVES: To determine the value of distributing an educational psychosocial pamphlet to reduce absenteeism resulting from back trouble. The pamphlet was designed to alter avoidance behaviors by encouraging a positive, active approach. SUMMARY OF BACKGROUND DATA: Attempts to control back-pain disability have failed. Fear of pain and activity seemingly leads to avoidance behaviors than contribute to chronicity and work loss. Avoidance behaviors are mediated by attitudes and beliefs; such attitudes and beliefs are a reasonable target for educational interventions designed to change "inappropriate" behaviors (e.g., extended absenteeism). Health education pamphlets are advocated widely but tested rarely. METHODS: Three factories participated in the study. Psychosocial data were collected by questionnaires; absence data were extracted from company records. A psychosocial pamphlet was distributed in one factory; the control subjects received either a nonspecific pamphlet or no intervention. The pamphlet emphasized a positive approach to low back trouble (reduction of negative beliefs and attitudes). RESULTS: In the company whose employees received pamphlets, a significant reduction occurred for the number of spells with extended absence and the number of days of absence (70% and 60%, respectively) compared with extrapolated values. A concomitant positive shift in beliefs concerning the locus of pain control and the inevitable consequences of low back trouble was found. CONCLUSION: A simple industrial intervention using a psychosocial pamphlet, which was designed to reduce avoidance behaviors by fostering positive beliefs and attitudes, successfully reduced extended absence resulting from low back trouble.

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