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Objectives. To report on the further development of the Incontinence Quality of Life Instrument (I-QOL), a self-report quality of life measure specific to urinary incontinence (UI), including its measurement model, responsiveness, and effect size. Methods. Incontinent female patients (141 with stress, 147 with mixed UI) completed the I-QOL and comparative measures at screening, pretreatment, and four subsequent follow-up visits during participation in a multicenter, double-blind, placebo-controlled, randomized trial assessing the efficacy of duloxetine. Psychometric testing followed standardized procedures. Results. Factor analysis confirmed an overall score and three subscale scores (avoidance and limiting behaviors, psychosocial impacts, and social embarrassment). All scores were internally consistent (alpha = 0.87 to 0.93) and reproducible (ICC = 0.87 to 0.91). The pattern of previously reported correlations with the Short-Form 36-item Health Survey and Psychological Well-Being Schedule were confirmed. Responsiveness statistics using changes in the independent measures of stress test pad weight, number of incontinent episodes, and patient global impression of improvement ranged from 0.4 to 0.8. Minimally important changes ranged from 2% to 5% in association with these measures and effect sizes. Conclusions. In a clinical trial, the I-QOL proved to be valid, reproducible, and responsive to treatment for UI in women.

To examine the daily functioning, diabetes management, and economic burden of non-severe nocturnal hypoglycemic events (NSNHEs) in Canada and differences in impacts by diabetes type.A 20-min web-based survey, with items derived from the literature, expert and patient interviews, assessing the impact of NSNHEs, was administered to patients with self-reported diabetes aged ≥18 having an NSNHE in the past month.Two thousand, two hundred and seventy-nine Canadian persons with diabetes were screened with 200 respondents meeting criteria and included in the analysis sample. Out of 87 working respondents, 15 reported on average 3.5 h of lost work (absenteeism). The reduction in work productivity (presenteeism) reported was comparable to the impact of arthritis. Other functional impacts included sleep and daily activities. Additionally, respondents' increased their usual blood sugar monitoring practice, on average, 4.2 (SD = 7.5) extra tests were conducted in the week following the event and reduced their insulin over the following 4.8 days. Increased healthcare utilization was also reported. Increased costs as a result of NSNHE for lost work productivity, increased diabetes management, and resource utilization was CAD 70.67 per person per year in this sample. Limitations of the study include the biases which are associated with a web-based survey and self-reported data.NSNHEs have serious consequences for patients and diabetes management practices. Greater attention to treatments which reduce NSNHEs can have a major impact on improving functioning while reducing the economic burden of diabetes.

Background This study evaluated the measurement properties of a newly developed instrument – the Self-Management Profile for Type 2 Diabetes (SMP-T2D). Methods The 18-item SMP-T2D assesses 12 constructs: level and perceived ease of performance in five self-care domains (blood glucose monitoring, medication-taking, healthy eating, being physically active, and coping), and two global constructs (ease of weight management, confidence with ability to manage diabetes). Validation analyses were based on two studies involving 240 patients with T2D, Study 1 (Clinicaltrials.gov #NCT00637273) with SMP-T2D administration supplemented by SMP-T2D retest one week later, and Study 2 (Clinical trials.gov #NCT00877890) with SMP-T2D administration supplemented by 24-week SMP-T2D follow-up after medication change. Validation included clinical indicators and measures of patient reported quality of life, psychological well-being and treatment outcomes. Results All multi-item SMP-T2D measures showed acceptable internal consistency (alphas = 0.71 to 0.87); ten measures had test-retest reliability >0.75. Correlations among SMP-T2D measures and between SMP-T2D measures and validation measures, which were as hypothesized, provided evidence of convergent and discriminant validity. Scores for six SMP-T2D measures improved significantly during Study 2. Multiple regression analysis showed independent associations between change in SMP-T2D measures and change in trial outcomes from baseline to end-of-study. Conclusions Two studies provide preliminary evidence regarding the reliability, validity and responsiveness of the SMP-T2D. Further research on the utility of the instrument is needed.

Non-severe nocturnal hypoglycemic events (NSNHEs) may have a major impact on patients. The objective was to determine how NSNHEs affect diabetes management, sleep quality, functioning, and to assess if these impacts differ by diabetes type or country.An internet survey to adults with diabetes in the US, UK, Germany, and France.Of 6756 screened respondents, 1086 reported an NSNHE in the past month. For this last event, respondents with type 2 required significantly more time than type 1 to recognize and respond to the event (1.5 vs 1.1 hours), 25.7% (T1) and 18.5% (T2) decreased their normal insulin dose due to their most recent NSNHE. All respondents were likely to take 1-2 additional self-monitored blood glucose measurements on the day following. NSNHEs were associated with a high proportion of respondents contacting a healthcare professional (18.6% T1, 27.8% T2) reporting they could not return to sleep at night (13.3% T1, 13.4% T2), and tiredness on the day following the event (71.2% for both). Of the respondents working for pay, 18.4% T1 and 28.1% T2 reported being absent from work due to the NSNHE, and a substantial proportion of respondents (8.7% T1, 14.4% T2) also reported missing a meeting or work appointment or not finishing a task on time. Compared with other countries, respondents from France may experience a more substantial impact on diabetes management and daily functioning following an NSNHE. Potential limitations in this study include recall and selection bias; however, these biases are not believed to have impacted findings in any meaningful way.NSNHEs are associated with a substantial impact on diabetes management, sleep quality, and next-day functioning.

Background. The Rasch model prescribes procedures to ensure that a scale constructed from multiple items conforms to fundamental requirements of interval scales of measurement. Objective. To test the Rasch properties of the domains of the World Health Organization Quality of Life Instrument–abbreviated version (WHOQOL-BREF) in depressed patients from primary care settings. Design. Cross-sectional, cross-national study. Setting. Primary care. Patients. The sample consisted of 1193 patients having a confirmed diagnosis of depression from 6 countries (Australia, Brazil, Israel, Russia, Spain, and the United States) involved in the Longitudinal Investigation of Depression Outcomes (LIDO) study. Measurements. The Composite International Diagnostic Interview (CIDI) diagnosed depression, whereas the Center for Epidemiological Studies Depression Scale (CES-D) assessed severity of depression. The WHOQOL-BREF measured generic quality of life (QOL). Results. Three of the 4 WHOQOL-BREF domains (physical, psychological, and environment) conform to the Rasch model expectations, following adjustments required mainly because of individual item misfit or differential item functioning (DIF) due to age or country. The social domain showed relatively poor psychometric properties, as observed in previous studies. Conclusions. The Rasch analysis demonstrated that, with some modifications, all domains of the WHOQOL-BREF, except for the social domain, provide an interval scale measure of generic subjective QOL in the context of depressed primary care patients in 6 countries worldwide.

Patient reporting of type 2 diabetes symptoms in a questionnaire with a 7-day recall period was expected to be different from symptom reports using a 7-day diary with repeated 24-h recall based on cognitive theory of memory processes and prior literature. This study compared these two types of recall in patients diagnosed with type 2 diabetes (T2D). One hundred and forty adults with T2D completed a daily diary for 7 days containing 9 T2D-related symptom and impact items. On day 7, patients completed the same items with a 7-day recall period. We examined the concordance of 7-day recall with summary descriptors of the daily reports and compared the scores and the discriminant ability of 7-day recall and mean of daily reports. Seven-day recall was most concordant with the mean of daily reports. The average difference in scores was small (range 0.22–0.77 on 11-point scale) and less than 0.5 standard deviations. For some items, the difference was positively associated with the variation in daily reports. The discriminant ability was comparable. In this study population, a questionnaire with 7-day recall provided information consistent with a daily diary measure of the average week-long experience of T2D symptoms and impacts.

Background The use of prescription anti-obesity medication (AOM) is becoming increasingly common as treatment options grow and become more accessible. However, AOM may not be without a wide range of potentially negative impacts on patient functioning and well being. The Treatment Related Impact Measure (TRIM-Weight) is an obesity treatment-specific patient reported outcomes (PRO) measure designed to assess the key impacts of prescription anti-obesity medication. This paper will present the validation findings for the TRIM-Weight. Methods The online validation battery survey was administered in four countries (the U.S., U.K., Australia, and Canada). Eligible subjects were over age eighteen, currently taking a prescription AOM and were currently or had been obese during their life. Validation analyses were conducted according to an a priori statistical analysis plan. Item level psychometric and conceptual criteria were used to refine and reduce the preliminary item pool and factor analysis to identify structural domains was performed. Reliability and validity testing was then performed and the minimally importance difference (MID) explored. Results Two hundred and eight subjects completed the survey. Twenty-one of the 43 items were dropped and a five-factor structure was achieved: Daily Life, Weight Management, Treatment Burden, Experience of Side Effects, and Psychological Health. A-priori criteria for internal consistency and test-retest coefficients for the total score and all five subscales were met. All pre-specified hypotheses for convergent and known group validity were also met with the exception of the domain of Daily Life (proven in an ad hoc analysis) as well as the 1/2 standard deviation threshold for the MID. Conclusion The development and validation of the TRIM-Weight has been conducted according to well-defined principles for the creation of a PRO measure. Based on the evidence to date, the TRIM-Weight can be considered a brief, conceptually sound, valid and reliable PRO measure.

Objective: Treatment satisfaction (TS) is an important patient reported outcome (PRO) in diabetes as it is correlated with outcomes necessary for optimal treatment (e.g., compliance, self-management behaviour). The objective of this study was to examine the responsiveness of the DiabMedSat, a diseasespecific PRO measure, assessing Overall, Burden, Efficacy and Symptom TS. Methods: The DiabMedSat was included in an open label, observational study of the safety and efficacy of biphasic insulin aspart 30 (NovoMix 30*) in routine practice with type 2 diabetes. Responsiveness analyses, examining both internal and external responsiveness, were conducted and minimally important differences (MID) assessed. Results: In 18,817 patients, all TS scores significantly improved after 26 weeks of treatment (p

Purpose Diabetes is a debilitating illness requiring lifelong management. Treatments can be varied in terms of mode of administration as well as type of agent. Unfortunately, most patient reported outcome measures currently available to assess the impact of treatment are specific to diabetes type, treatment modality or delivery systems and are designed to be either a HRQoL or treatment satisfaction measure. To address these gaps, the Treatment Related Impact Measure-Diabetes and Device measures were developed. This paper presents the item development and validation of the TRIM Diabetes/Device. Methods Patient interviews were conducted to collect the patient perspective and ensure high content validity. Interviews were hand coded and qualitatively analyzed to identify common themes. A conceptual model of the impact of diabetes medication was developed and preliminary items for the TRIM-Diabetes/Device were generated and cognitively debriefed. Validation data was collected via an on-line survey and analyzed according to an a priori statistical analysis plan to validate the overall score as well as each domain. Item level criteria were used to reduce the preliminary item pool. Next, factor analysis to identify structural domains was performed. Reliability and validity testing was then performed. Results One hundred and five patients were interviewed in focus groups, individual interviews and for cognitive debriefing. Five hundred seven patients participated in the validation study. Factor analysis identified seven domains: Treatment Burden, Daily Life; Diabetes Management; Psychological Health; Compliance and Device Function and Bother. Internal consistency reliability coefficients of the TRIM-Diabetes/Device ranged from 0.80 and 0.94. Test-retest reliability of the TRIM-Diabetes/Device ranged from 0.71 to 0.89. All convergent and known groups validity hypotheses were met for the TRIM-Diabetes/Device total scores and sub-scales. Conclusion Validation is an ongoing and iterative process. These findings are the first step in that process and have shown that both the TRIM-Diabetes and the TRIM-Diabetes Device have acceptable psychometric properties. Future research is needed to continue the validation process and examine responsiveness and the validity of the TRIM-Diabetes/Device in a clinical trial population.

Study aims were to develop and assess the measurement properties of a four-part treatment satisfaction measure for patients with asthma. The Asthma Treatment Satisfaction Measure (ATSM) incorporates specific attributes representing patient expectations, treatment preferences, self-reported treatment outcomes, and overall treatment satisfaction. This paper describes patients' ability to detect change in their satisfaction with asthma therapies using the ATSM.Adult patients with chronic asthma requiring a change in their asthma controller medications were recruited from sites in the US and Canada. Interviews were conducted with 22 patients to elicit areas important to patients in asthma treatment for measurement of satisfaction, providing the basis for the four-part questionnaire that was then tested for clarity. An additional 105 patients participated in the validation study and completed the first two parts of the ATSM (expectations and importance of treatment) at their initial visit (baseline) prior to a change in treatment. Parts 3 and 4 (treatment outcomes and treatment satisfaction) were completed after 4 weeks on the new treatment. A daily diary was completed by patients at home between visits. During clinical visits, patients also completed the Asthma Specific Quality of Life Questionnaire Standardized version assessing HRQL (AQLQ(S)), the Asthma Control Questionnaire 6-item version (ACQ-6), a 9-item asthma symptom checklist, items assessing symptom severity, and a single item overall rating of satisfaction (numerical analog scale between 0 and 10). Derived total satisfaction scores were compared to scores produced by the single global treatment satisfaction item using score variation and distribution plots.Qualitative results identified 11 key attributes of asthma treatment. Internal consistency for the expectations, outcomes, and satisfaction parts of the measures (11 items each) were 0.73, 0.82 and 0.95, respectively. ATSM scores were able to discriminate between control and lack of control measured by ACQ-6 scores (F = 30.09; p0.001); between improvement, no change, or worsening of symptoms using the 4-week diary (F = 7.05; p0.001); between mild, moderate and severe levels of self-reported severity of asthma (F = 2.07; p0.001); and levels of self-reported health status (F = 5.96; p0.001). Compared to the single overall satisfaction item, the ATSM satisfaction score demonstrated a broader and more normal distribution. Irrespective of the variety of treatment regimens being changed from and changed to in the normal care setting, 4 of the 11 attributes still detected statistically significant differences in (p0.05) levels of patient satisfaction related to their new asthma treatment regimen.By augmenting a satisfaction rating with the constructs that help define satisfaction with treatment (expectation, importance and actual treatment experience), the ATSM scores demonstrated greater ability to detect changes in treatment and provide a potentially useful measurement system for pharmacologic evaluation. This study was conducted using a normal care setting to identify patients undergoing a change in treatment. Therefore, the main limitations were the inability to control for efficacy of treatment, and a relatively small sample. Several individual ATSM satisfaction scores were able to detect significant levels of patient satisfaction related to their treatment, while the global satisfaction scores were unable to detect any significant differences.

Background Successfully managing diabetes is a complex process that includes addressing issues of drug efficacy, safety and treatment satisfaction. Additionally, the combined impact of patient/disease characteristics and treatment outcomes on treatment satisfaction is not well understood. The purpose of this study was to examine the impact of age, weight, gender, co-morbid conditions, diabetes history, treatment burden, efficacy (HbA1c) and side effects (weight gain, hypoglycemic events) on patients' appraisal of treatment satisfaction using linear regression models. Methods Data from a multi-center, randomized clinical trial comparing the efficacy/safety of biphasic insulin aspart 70/30 (BIAsp 70/30) vs. glargine (Glar) among insulin naïve type 2 patients were analyzed. Subjects were between ages 18–75, with baseline HbA1c > 8% and BMI ≤ 40 kg/m2 (N = 233). Treatment satisfaction was assessed by the Insulin Treatment Satisfaction Questionnaire (ITSQ). Results When factors were examined independently, multiple significant relationships (age, co-morbidity, hypoglycemic events, and weight gain) with overall and/or domains of treatment satisfaction were found. However, when all significant relationships were examined together, only neuropathy, treatment efficacy, and number of hypoglycemic events maintained their previous significance. Conclusion By examining predictors independently, significant relationships were identified. However, not all findings remained significant when examined in combination with each other. Thus, to more accurately characterize the impact of factors on treatment satisfaction, a more comprehensive approach may be necessary. By improving patient treatment satisfaction, the efficacy of treatments, as well as critical treatment outcomes such as compliance and cost of care should be improved.

INTRODUCTION Few women seek help for urinary incontinence. Subsequently, there may be many women accessing primary care services who would benefit from treatment or advice. If high levels of unexpressed need are present in this population, a more proactive approach to continence management may be appropriate, but the feasibility of this depends on an accurate assessment of the level of unmet need in this population. AIM To assess the prevalence of urinary incontinence in a female population attending primary care and the extent of treatment seeking in relation to level of need. METHODS A cross-sectional survey of urinary incontinence of adult women attending primary care practices in West Yorkshire, London, Glasgow and Leicestershire during a 10- or 15-day period. RESULTS Three thousand two hundred and seventy-three (54%) women responded. Twenty-one per cent reported stress urinary incontinence only, 3.5% reported urge incontinence only and 21% reported mixed stress and urge incontinence during the preceding month (9% had moderate or severe symptoms). Fifty-three per cent of these had not consulted a health care professional, which is equivalent to 1 in 20 of women in GP waiting rooms, most of whom have stress and urge incontinence (75%) or stress incontinence only (21%). CONCLUSIONS Nearly half of female primary care attendees had experienced incontinence during the preceding month, but only a minority had sought help. Even amongst the nearly 1 in 10 women with moderate or severe incontinence only about half had sought help. There remains considerable health decrement due to urinary incontinence in those not receiving help in a population readily accessible to primary care services.

ObjectiveThe EQ-5D is a standardized, nondisease-specific instrument for evaluating patients' preference-based valuations of health-related quality of life (HRQoL). This study's purpose was to determine the psychometric properties of EQ-5D in patients with irritable bowel syndrome (IBS).MethodsData from four European IBS studies were assessed: UK (n = 161 and n = 297), Spain (n = 503), and Germany (n = 100). The EQ-5D is a five-item health state descriptive system used to develop health states (EQ-5DINDEX) and a visual analog scale (VAS) (0–100 from worst to best imaginable health state, EQ-5DVAS). Measures used with the EQ-5D included the SF-36, Irritable Bowel Syndrome—Quality of Life (IBS-QOL), and both subjective and clinical global assessments of IBS. Convergent validity was assessed using SF-36 and IBS-QOL data, discriminant validity using global ratings of IBS severity, and responsiveness by subjective and physician assessment of condition.ResultsModerate-to-high associations (r ≥ 0.33) were seen between the EQ-5DVAS and the SF-36 and IBS-QOL subscales. Mean response scores to EQ-5DINDEX dimensions and the EQ-5DVAS score were significantly better for control patients than for patients with IBS (all P < 0.01). The EQ-5DVAS was able to discriminate between levels of pain severity (quartiles, P < 0.001; mild/moderate/severe, P < 0.05) and general health severity (mild/moderate/severe, P < 0.001). The EQ-5DVAS and the EQ-5DINDEX were responsive in patients using both a self-perceived (Subject's Global Assessment) and physician-rated (Clinic Global Assessment) improvement.ConclusionsThe EQ-5D performs well in comparison to general and disease-specific outcomes. It is a valid and responsive measure that can be used to generate preference-based valuations of HRQoL in patients with IBS and useful for comparisons in clinical and cost-effectiveness studies.

Irritable bowel syndrome (IBS) is a chronic and episodic illness characterized by altered bowel habits and associated abdominal pain. At present, IBS is one of the most common functional gastrointestinal and motility disorders affecting countries around the world. Surveys have found that patients with IBS have a significantly lower health-related quality of life.The aim of this study was to translate and examine the validity of the Irritable Bowel Syndrome-Quality of Life questionnaire (IBS-QOL) in patients suffering from IBS in China.A structured procedure was used for the translation and cultural adaptation of the original English IBS-QOL into Chinese. The questionnaire was administered to 73 clinical patients with IBS and 70 healthy individuals. Psychometric testing for reliability, validity and responsiveness followed standardized procedures. Test-retest reliability (10-20 hours) was assessed using the clinical patients. Follow-up (4 weeks) was collected for 61 clinical patients. All enrolled patients also completed the Short Form-36 Health Survey (SF-36) at the baseline visit. Responsiveness to treatment (Venlafaxine and traditional Chinese herbal medicine) was assessed by one-way ANOVA methods.The average length of time required to complete the questionnaire was short (5.63 min for IBS patients and 5.54 min for healthy subjects by self-administration). Internal consistency (Cronbach's alpha) values ranged from 0.722 to 0.914 for the Chinese IBS-QOL subscales and test-retest reliability coefficients were higher than 0.920 on all subscales. The convergent and discriminate validity results comparing the Chinese translation of the IBS-QOL overall score and the SF-36 subscales confirmed our predicted hypotheses. The Chinese IBS-QOL scores are more highly correlated with social functioning, vitality and general health (SF-36) and show weaker associations with physical functioning, role physical, mental health, and bodily pain (SF-36). The Chinese translation of the IBS-QOL was responsive to treatment.In general, the Chinese translation of the IBS-QOL, after cultural adaptation and revision, possesses good reliability, validity and responsiveness. It is a reliable and valid instrument to assess the quality of life in Chinese patients suffering from IBS and is an appropriate measure to use in further clinical trials or for related research projects in China.

Objectives Clinical trials and community-based studies often include the Center for Epidemiologic Studies-Depression scale (CES-D) as a measure of depression outcome. We compared responses to symptom-related items on the CES-D by depressed stroke and primary-care patients for several purposes: 1) to illustrate the use of Item Response Theory (IRT)-based (Rasch) models for comparing scale functioning across different patient subgroups; and 2) to inform clinicians and outcome researchers about scale functioning and depressive symptomatology in stroke- compared with primary care-based depression. Methods Two data sources were analyzed, including 32 depressed patients who were 3 months poststroke, and 366 depressed primary-care patients. Presence of depression was based on a CES-D score 16 or higher. Rasch models were used to assess item fit and compare item hierarchies between depressed primary-care and stroke patients. Results Item hierarchies were similar for poststroke depression and primary care-based depression. Interpersonal disruption items were the most difficult to endorse for both groups. No items misfit the scale in primary-care depression. Items relating to restless sleep, unfriendliness, and crying slightly misfit the scale in stroke patients, that is, may measure a different trait. Differential item functioning (DIF) between the groups was identified for items relating to appetite, restless sleep, crying, and feeling disliked. Conclusions Results generally supported the use of the CES-D as measure of depression outcome, particularly in primary care-based depression. DIF may imply that slightly different clusters of depressive symptoms are reported by depressed stroke patients compared with primary care, but this is conjectural given the small stroke sample size and the same items have been previously associated with bias in studies of large nonstroke samples. This study found Rasch models to be useful tools to investigate scale performance for different clinical applications.

PATRICK, DONALD L., DONALD M. BUSHNELL, AND MARGARET ROTHMAN. Performance of two selfreport measures for evaluating obesity and weight loss. Obes Res. 2004;12:48 –57. Objectives: To evaluate performance of the Obesity and Weight-Loss Quality-of-Life (OWLQOL) and Weight-Related Symptoms (WRSM) measures. Research Methods and Procedures: Four studies of obese persons 18 to 75 years of age were analyzed: a 12-week initial validation study, a clinical trial using blinded endpoint data at 50 to 83 weeks, and community studies conducted in the U.S. and Europe. Fifty-six initial validation study subjects visited 1 week after screening to evaluate reproducibility. Results: Overall, 6107 obese persons completed one assessment, 291 completed follow-up at 12 weeks, and 642 at 50 weeks. Psychometric analyses resulted in a 17-item OWLQOL with a single score tested on five samples that was internally consistent ( values 0.90) and reproducible (intraclass correlation coefficient 0.95). The OWLQOL score (higher is better) was associated, as expected, with the symptom measure (lower is better, 0.54), generic quality of life measure (0.53), and measures of physical (0.40) and mental functioning (0.47). The 20-item WRSM was internally consistent ( 0.87) and reproducible (intraclass correlation coefficient 0.83). The OWLQOL discriminated between genders (p 0.001), presence of disability days (p 0.05), levels of BMI (p 0.05), and levels of symptom bothersomeness (p 0.001). Evaluation at 12 weeks yielded an effect size for 2.5% weight loss of 0.77 for the OWLQOL and 0.54 for the WRSM. At 50 weeks for 10% weight change, effect sizes were 1.63 and 0.73, respectively. Discussion: The OWLQOL and WRSM are brief, valid, reproducible, and responsive self-reported outcomes for evaluating obesity and weight loss.

To translate and validate a urinary incontinence-specific measure of quality of life (I-QOL) in French, Spanish, Swedish, and German and provide translations only into seven other languages and variants of these languages.Quality of life and linguistic experts prepared two forward translations from American English to their native languages and helped to harmonize these translations at a meeting. In the four European countries, the adapted versions of the I-QOL were administered to 259 women with stress, urge, and mixed incontinence. Principal component analyses were used to confirm the proposed measurement model suggested by patient interviews. Psychometric testing was conducted using standardized procedures.Translation procedures resulted in a change in the original instrument's Likert response scale from 4 to 5 points. Principal component analyses confirmed three patient-derived subscales and higher-order factor analysis confirmed a total summary score. In all countries, the internal consistency (alpha) and reproducibility (ICC) were high (alpha ranged between 0.87 and 0.93); (ICC ranged between 0.92 and 0.95). In all countries, I-QOL scores were significantly worse (p0.001) as perceived severity of incontinence, use of services, and number of incontinent episodes increased.The I-QOL has been adapted successfully into eleven languages and six variants of these languages. The cross-sectional psychometric properties of the US version were confirmed in four European countries. The I-QOL fills the need for a valid, international quality-of-life instrument for incorporation in clinical trials covering patients with varying types and severity of urinary incontinence.

13.) I like to lean on my doctor when I feel sick 1 2 3 4 5 • After providing informed consent, participants were randomized to complete the PDHCO on either paper or computerized format at their first study visit. The alternate format was completed at the second study visit (24 hours later) and the one-week retest was completed from home (Figure 2). VALIDATION AND PSYCHOMETRIC EVALUATION OF A HEALTH CARE ORIENTATION ASSESSMENT

OBJECTIVES: Previous researchers (Ren, 1999) have used a 5-item shortened version of the Medical Outcomes Study Social Support Scale (MOS-SSS; Sherborne, 1991), but the measurement properties of this brief measure have not been established. We filled this gap by evaluating the psychometric properties of a 5-item perceived social support instrument (the SS-5) and testing equivalence between paper and web-based administration modes. METHODS: The SS-5 and other questionnaire measures were administered to a sample of adults recruited through newspaper and web-based advertisements in 8 U.S. cities. Participants were randomized to complete the SS-5 on either paper or computerized format followed by a one-week retest. The intraclass correlation coefficient (ICC) was calculated to assess reproducibility of the SS-5 and equivalence between administration modes. Cronbach’s alpha was calculated to assess internal consistency. To assess known groups’ validity, differences in SS-5 scores between marital status/living arrangement groups and (separately), trichotomous groupings of a validated measure of dispositional optimism, the Life Orientation Test (LOT-R), were assessed with analysis of variance (ANOVA) models. RESULTS: Of the 258 participants that completed the baseline assessment, 251 (97%) completed the retest. Mean age of participants was 48.6 years, 61% were female, and 71% were Caucasian. Participants included 44% married or living with a partner; 24% had never been married. The mean SS-5 score was 17.3 4.9, and the ICC between paper and webbased was 0.89. Reproducibility was strong (ICC=0.92), and the instrument was internally consistent (alpha=0.88). The SS-5 significantly discriminated between participants living with a partner and those living alone (means: 19.1 vs. 15.9; p

ObjectiveTo assess individualized satisfaction with migraine treatment, patient expectations, importance rankings, treatment outcomes, and overall satisfaction were combined using a four-part conceptual model. This article describes the measurement properties of the Migraine Treatment Satisfaction Measure (MTSM) using participants from a randomized controlled trial evaluating a Headache Management Program (HMP).MethodsParticipants completed the first two parts of the MTSM upon enrollment and the final two parts at 6 months. Internal consistency reliability was computed within each of the four modules. Discriminant validity was ascertained using Migraine Disability Assessment Survey (MIDAS), Patient Health Questionnaire-9, and MSFB scores. Convergent validity was established by hypothesized positive correlations between MTSM scores, Medical Outcomes Study Short-Form (SF-36), MIDAS, and Migraine Symptom Frequency Bother (MSFB).ResultsIn total, 124 participants (mean age 45.4 years, 75% women, 59.7% Caucasian) enrolled. Internal consistency for expectations, importance rankings, outcomes, and satisfaction measures was 0.83, 0.95, 0.86, and 0.95, respectively. As the severity of depression increased, MTSM scores decreased significantly. ANOVA between MTSM scores and symptom bothersomeness and symptom frequency tertiles showed a significant decrease in satisfaction in the moderate-to-severe groups. MTSM scores showed expected associations with MSFB scores (−0.301; P < 0.01), MIDAS (−0.267; P < 0.01), general health (0.253; P < 0.05), mental health (0.217; P < 0.05), and vitality subscales of SF-36 (0.214; P < 0.05). Patients in the HMP reported significantly higher MTSM scores (43.2 vs. 31.4; P < 0.001). Patients on triptans reported a significantly higher satisfaction compared to patients on analgesics (39.5 vs. 32.9; P < 0.05).ConclusionThe MTSM is a valid and reliable patient-reported outcome that can be used to evaluate differences in treatment satisfaction associated with migraine therapies.

Purpose Responsiveness is defined as the ability of an instrument to accurately detect change when it has occurred and is an essential psychometric property of a patient-reported outcomes (PRO) measure to understand and interpret study findings. This study examined the responsiveness of 2 Treatment Related Impact Measures (TRIMs): The TRIM-Diabetes (TRIM-D) and TRIM-Diabetes Device (TRIM-DD) as well as confirmed their measurement models in a randomized controlled trial (RCT) design. Methods The data were collected in a multi-center, randomized, open-label (2 × 12 week), cross-over study of two prefilled pens in subjects with type 1 or type 2 diabetes, age 18 or older. Internal and external responsiveness were examined. To confirm the measurement model identified in the previous study, the Bentler comparative fit index (CFI) and internal consistency for the RCT sample scores were examined and compared. Results Based on a priori criteria, tests of responsiveness were confirmed with patients having significant improvements over time ranging from 2.7 (Psychological Health) to 11.1 (Treatment Burden) (P

Objectives Hypoglycemia is a common complication of treatment with certain diabetes drugs. Non-severe hypoglycemic events (NSHEs) occur more frequently than severe events and account for the majority of total events. The objective of this multi-country study was to identify how NSHEs in a working population affect productivity, costs, and self-management behaviors. Methods A 20-minute survey assessing the impact of NSHEs was administered via the Internet to individuals (≥ 18 years of age) with self-reported diabetes in the United States, United Kingdom, Germany, and France. The analysis sample consisted of all respondents who reported an NSHE in the past month. Topics included: reasons for, duration of, and impact of NSHE(s) on productivity and diabetes self-management. Results A total of 1404 respondents were included in this analysis. Lost productivity was estimated to range from $15.26 to $93.47 (USD) per NSHE, representing 8.3 to 15.9 hours of lost work time per month. Among individuals reporting an NSHE at work (n = 972), 18.3% missed work for an average of 9.9 hours (SD 8.4). Among respondents experiencing an NSHE outside working hours (including nocturnal), 22.7% arrived late for work or missed a full day. Productivity loss was highest for NSHEs occurring during sleep, with an average of 14.7 (SD 11.6) working hours lost. In the week following the NSHE, respondents required an average of 5.6 extra blood glucose test strips. Among respondents using insulin, 25% decreased their insulin dose following the NSHE. Conclusions NSHEs are associated with substantial economic consequences for employers and patients. Greater attention to treatments that reduce NSHEs could have a major, positive impact on lost work productivity and overall diabetes management.