Publications (43)120.26 Total impact
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Article: Validation of a clinician questionnaire to assess reasons for antipsychotic discontinuation and continuation among patients with schizophrenia.
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ABSTRACT: The Reasons for Antipsychotic Discontinuation Questionnaire (RAD-Q) was designed to assess clinicians' perceptions of reasons for antipsychotic discontinuation or continuation. The current study examined psychometric properties of this instrument and patterns of antipsychotic discontinuation. The sample of 121 patients (81 discontinuation, 40 continuation) with schizophrenia or schizoaffective disorder was 66.9% male, with a mean age of 41.6 years. Treating clinicians reported a mean of 4.1 reasons for discontinuation and 7.5 reasons for continuation. RAD-Q domain scores were derived to quantify the impact of three factors on the decision to discontinue or continue: treatment benefits, adverse events, and distal reasons other than direct effects of the medication. Analysis of inter-rater reliability indicated an acceptable degree of agreement between clinicians (weighted Kappa for discontinuation scores=0.70-0.78). Correlations with symptom measures (Clinical Global Impression-Schizophrenia Scale (CGI-SCH), Positive and Negative Syndrome Scale (PANSS)) supported convergent validity of the benefits domain score (r=0.28-0.47; all p<0.05). Domain scores discriminated among groups of patients differing in clinician and patient-reported clinical variables. Results suggest that the RAD-Q is a useful detailed measure of reasons for antipsychotic discontinuation and continuation. Findings indicate that clinicians usually report multiple reasons for discontinuation, rather than a single reason for each patient.Psychiatry Research 07/2012; · 2.52 Impact Factor -
Article: An updated review of quality-of-life questionnaires for urinary incontinence and overactive bladder: Which ones to use and why
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ABSTRACT: Overactive bladder and stress urinary incontinence have a profound impact on patients’ health-related quality of life (HRQL). The purpose this paper is to update a previously published review of condition-specific HRQL measures validated among patients with symptoms of urinary incontinence or overactive bladder. For this update, MEDLINE (accessed via PubMed) and EMBASE literature searches were performed to identify articles or abstracts published since 2004 that focus on the development, psychometric validation, and use of relevant instruments. Target populations and psychometric properties (reliability, validity, responsiveness to change) of 22 questionnaires are summarized. A range of well-validated, condition-specific HRQL measures are available. Recommendations are provided regarding which measures to use in different situations. When choosing among instruments, psychometric evidence and the match of an instrument to the study population should be considered.Current Bladder Dysfunction Reports 04/2012; 1(2):71-80. -
Article: The Fatigue Associated with Depression Questionnaire (FAsD): responsiveness and responder definition.
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ABSTRACT: PURPOSE: The Fatigue Associated with Depression Questionnaire (FAsD) was developed to assess fatigue and its impact among patients with depression. The purpose of this study was to examine the questionnaire's responsiveness to change and identify a responder definition for interpretation of treatment-related changes. METHODS: Data were collected at baseline and at 6 weeks from patients with depression starting treatment with a new antidepressant. RESULTS: Of the 96 participants, 55.2% were women, with a mean age of 43.4 years. The total score and both subscales demonstrated statistically significant change with moderate to large effect sizes (absolute values ≥0.76). FAsD change scores were significantly correlated with change on the Brief Fatigue Inventory (r ≥ 0.73; p < 0.001). FAsD mean change scores discriminated among patient subgroups differing by degree of improvement in patient- and clinician-reported fatigue and depression. Responder definition for the two subscales and total score (0.67, 0.57, 0.62) was estimated primarily based on mean change among patients who reported a small but important improvement in fatigue. DISCUSSION: The FAsD was responsive to change, and the responder definition may be used when interpreting treatment-related change. Results add to previous findings suggesting the FAsD is a useful measure of fatigue among patients with depression.Quality of Life Research 03/2012; · 2.30 Impact Factor -
Article: Validation of a patient interview for assessing reasons for antipsychotic discontinuation and continuation.
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ABSTRACT: The Reasons for Antipsychotic Discontinuation Interview (RAD-I) was developed to assess patients' perceptions of reasons for discontinuing or continuing an antipsychotic. The current study examined reliability and validity of domain scores representing three factors contributing to these treatment decisions: treatment benefits, adverse events, and distal reasons other than direct effects of the medication. Data were collected from patients with schizophrenia or schizoaffective disorder and their treating clinicians. For approximately 25% of patients, a second rater completed the RAD-I for assessment of inter-rater reliability. All patients (n = 121; 81 discontinuation, 40 continuation) reported at least one reason for discontinuation or continuation (mean = 2.8 reasons for discontinuation; 3.4 for continuation). Inter-rater reliability was supported (kappas = 0.63-1.0). Validity of the discontinuation domain scores was supported by associations with symptom measures (the Positive and Negative Syndrome Scale for Schizophrenia, the Clinical Global Impression - Schizophrenia Scale; r = 0.30 to 0.51; all P < 0.01), patients' primary reasons for discontinuation, and adverse events. However, the continuation domain scores were not significantly associated with these other indicators. Results support the reliability, convergent validity, and known-groups validity of the RAD-I for assessing patients' reasons for antipsychotic discontinuation. Further research is needed to examine validity of the RAD-I continuation section.Patient Preference and Adherence 01/2012; 6:521-32. · 1.14 Impact Factor -
Article: Development and validation of a patient-report measure of fatigue associated with depression.
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ABSTRACT: Among researchers and clinicians who treat depression, there is growing interest in treatment of specific residual symptoms such as fatigue. However, there is no available measure that provides a detailed assessment of fatigue associated with depression. Thus, the purpose of the current study was to develop and validate a patient-reported outcome measure designed to assess depression-related fatigue and its impact. The Fatigue Associated with Depression Questionnaire (FAsD) was developed based on literature review, clinician interviews, and focus groups and cognitive debriefing interviews with patients. Then, a draft questionnaire was administered to a sample of patients with depression. Statistical analysis first focused on item reduction and subscale identification, followed by psychometric evaluation of the FAsD. The per protocol sample (n = 317) was primarily female (68.1%), with a mean age of 47.0 years. Based on item performance and exploratory factor analysis, three items were dropped from the draft FAsD, yielding a final 13-item questionnaire with two subscales (experience and impact). The FAsD demonstrated good internal consistency reliability (Cronbach's alphas ≥ 0.88) and test-retest reliability (intraclass correlation coefficients ≥ 0.78). The FAsD demonstrated construct validity through strong correlations with measures assessing fatigue/energy and symptoms of depression. The FAsD also discriminated among groups of participants differentiated by clinician ratings of global severity of depression (CGI-S). Limitations include heterogeneity of current treatments received by the sample, as well as lack of knowledge regarding the extent to which FAsD scores were influenced by patients' treatments rather than the depression itself. In this initial psychometric evaluation, the FAsD demonstrated good reliability, validity, and factor structure. This questionnaire may be a useful tool for evaluating treatment interventions that focus specifically on fatigue associated with depression.Journal of affective disorders 08/2011; 134(1-3):294-303. · 3.76 Impact Factor -
Article: Development of a clinician questionnaire and patient interview to assess reasons for antipsychotic discontinuation.
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ABSTRACT: Time to treatment discontinuation and rates of discontinuation are commonly used when evaluating effectiveness of antipsychotic medication. However, less is known about reasons for discontinuation. The purpose of this study was to develop two measures of reasons for discontinuation or continuation of antipsychotics for the treatment of schizophrenia. Based on literature review, a patient interview pilot study, and expert panel input, two measures were drafted: the clinician-reported Reasons for Antipsychotic Discontinuation/Continuation Questionnaire (RAD-Q) and the patient-reported Reasons for Antipsychotic Discontinuation/Continuation Interview (RAD-I). Patients and clinicians completed the draft measures and structured cognitive debriefing interviews. For the draft instruments, reasons for discontinuation/continuation were divided into 3 categories: therapeutic benefits (positive symptoms, negative symptoms, mood, cognition, functional status), adverse events, and reasons other than direct effects of the medication (e.g., cost, inadequate social support). In cognitive debriefings, 10 clinicians and 15 patients indicated that the RAD-Q and RAD-I were clear, easy to complete, and comprehensive. Clinicians and patients suggested minor revisions, and the instruments were revised accordingly. The RAD-Q and RAD-I appear to be useful instruments for assessing reasons for antipsychotic discontinuation and continuation. The next step is a psychometric evaluation of the measures in a larger sample.Psychiatry Research 06/2011; 189(3):463-8. · 2.52 Impact Factor -
Article: Preferences related to attention-deficit/hyperactivity disorder and its treatment.
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ABSTRACT: A growing body of literature has highlighted the importance of considering patient preferences as part of the medical decision-making process. The purpose of the current review was to identify and summarize published research on preferences related to attention-deficit/hyperactivity disorder (ADHD) and its treatment, while suggesting directions for future research. A literature search identified 15 articles that included a choice-based assessment of preferences related to ADHD. The 15 studies were grouped into four categories based on preference content: preference for a treatment directly experienced by the respondent or the respondent's child; preference for general treatment approaches; preference for a specific treatment attribute or outcome; and preference for aspects of ADHD-related treatment. Preference assessment methods ranged from global single items to detailed choice-based procedures, with few studies using rigorously developed assessment methods. Respondents included patients with ADHD, clinicians, parents, teachers, and survey respondents from the general population. Factors influencing preference include treatment characteristics, effectiveness for specific symptoms, side effects, and respondent demographics. Minimal research has examined treatment preferences of adults with ADHD. Because there is no dominant treatment known to be the first choice for all patients, ADHD is a condition for which individual preferences can play an important role when making treatment decisions for individual patients. Given the potential role of preferences in clinical decision-making, more research is needed to better understand the preferences of patients with ADHD and other individuals who are directly affected by the disorder, such as parents and teachers.Patient Preference and Adherence 01/2011; 5:33-43. · 1.14 Impact Factor -
Article: Identifying HAM-A cutoffs for mild, moderate, and severe generalized anxiety disorder.
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ABSTRACT: The aim of the current study was to identify and evaluate cutoffs for mild, moderate, and severe ranges of Hamilton Anxiety Rating Scale (HAM-A) scores. Data were from a four-week randomized trial of treatment for generalized anxiety disorder. Measures included the HAM-A, SF-36, Hospital Anxiety and Depression Scale (HADS), and Clinical Global Impressions of Severity (CGI-S) scale. HAM-A cutoffs were identified based on literature review, expert panel input, and MANOVA models. The optimal cutoff set was evaluated based on association with clinician CGI-S ratings. The sample included 144 patients (56.3% female; 73.6% white; mean age = 35.7 years; mean baseline HAM-A score = 23.7). The optimal HAM-A score ranges were: mild anxiety = 8-14; moderate = 15-23; severe ≥ 24 (scores ≤ 7 were considered to represent no/minimal anxiety). Analysis of variance (ANOVA) models found statistically significant differences among these groups in the SF-36 and HADS. The HAM-A severity ranges closely corresponded to clinicians' CGI-S ratings. The study represents the first step towards developing severity ranges for the HAM-A. These cutoffs should be used with caution and validated in larger samples. If the proposed cutoffs are accepted for general use, they could make results more meaningful and interpretable for researchers, clinicians, and patients.International journal of methods in psychiatric research. 12/2010; 19(4):223-32. -
Article: Utilities and disutilities for attributes of injectable treatments for type 2 diabetes.
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ABSTRACT: Although cost-utility models are frequently used to estimate treatment outcomes for type 2 diabetes, utilities are not available for key attributes of injectable treatments. The purpose of this study was to identify the utility or disutility of three injection-related attributes (dose frequency, dose flexibility, injection site reaction) that may influence patient preference. Patients with type 2 diabetes in Scotland completed standard gamble (SG) interviews to assess the utility of hypothetical health states and their own current health state. The EQ-5D, PGWB, IWQOL-Lite, and QIDS were also administered. Construct validity and differences among health states were examined. A total of 151 patients completed interviews. Of the three injection-related attributes, dose frequency was the only attribute with a statistically significant impact on utility (in a multiple regression model, p = 0.01). Weekly injections were associated with an average added utility of 0.023 in comparison to everyday injections. Flexible dosing and injection site reactions resulted in somewhat smaller utility shifts that were in the expected directions (+0.006 and -0.011, respectively). SG utility of current health (mean = 0.897) demonstrated construct validity through statistically significant correlations with patient-reported outcome measures. The three injection attributes were associated with small utility shifts in the expected directions. Dose frequency appears to be the most important of the three attributes from the patients' perspective. The vignette-based SG approach was feasible and useful for assessing added utility or disutility of injection-related attributes associated with treatments for type 2 diabetes.The European Journal of Health Economics 03/2010; 12(3):219-30. · 1.50 Impact Factor -
Article: Derivation and validation of the ASK-12 adherence barrier survey.
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ABSTRACT: The ASK-20 survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior. To derive and validate a shorter version of the ASK-20 scale. Patients with asthma, diabetes, and congestive heart failure were recruited from a university medical center. Participants completed the ASK-20 survey and other questionnaires. Approximately one-third of participants were randomized to a 2-week retest administration. Item performance and results of an exploratory factor analysis were examined for item reduction and subscale identification. Subsequent analyses examined reliability and validity of the shorter version of the ASK. A total of 112 patients participated (75.9% female; mean age 46.7 y; 53.6% African American). Eight items were dropped from the ASK-20 based on factor loadings, floor effects, Cronbach's alpha, and the ability of each item to discriminate between groups of patients differing in self-reported adherence. The new total score (ASK-12) had good internal consistency reliability (Cronbach's alpha 0.75) and test-retest reliability (intraclass correlation 0.79). Convergent validity was demonstrated through correlations with the Morisky Medication Adherence Scale (r -0.74; p < 0.001), condition-specific measures, the SF-12 Mental Component Score (r -0.32; p < 0.01), and proportion of days covered by filled medication prescriptions in the past 6 months as indicated by pharmacy claims data (r -0.20; p = 0.059). The ASK-12 total score also discriminated among groups of patients who differed in self-reported adherence indicators, including whether a dose was missed in the past week, the number of days medication was not taken as directed, and treatment satisfaction. Three subscales were identified (adherence behavior, health beliefs, inconvenience/forgetfulness), and results provided initial support for their validity. The ASK-12 demonstrated adequate reliability and validity, and it may be a useful brief measure of adherence behavior and barriers to treatment adherence.Annals of Pharmacotherapy 10/2009; 43(10):1621-30. · 2.13 Impact Factor -
Article: "We have to stop again?!": The impact of overactive bladder on family members.
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ABSTRACT: Overactive bladder (OAB), characterized by urinary urgency, with or without incontinence, and urinary frequency and nocturia, has a significant impact on patients' lives. Given the social context inherent in OAB, the purpose of this study was to identify issues faced by OAB family members. Incontinent OAB patients and their family members were recruited from a urology clinic. Continent OAB family members were recruited via newspaper advertisements. Focus groups were conducted to evaluate family impact; content analysis was used to analyze data. Participants included 14 dyads consisting of incontinent OAB patients and their family members (partners or daughters) and 17 continent OAB family members. Urinary frequency was the most bothersome symptom for family members as family members reported that their partners' urinary frequency significantly altered their lives by limiting activities (e.g., travel, social activities) and impacting time because of persistent, and urgent, need to find a toilet. Nocturia caused sleep disruption and fatigue for both patients and their partners. Family members indicated that their partner's OAB fostered significant emotions including embarrassment, anxiety, anger, worry, frustration, and sympathy. Several spouses reported that OAB limited their sexual interactions and intimacy. OAB has a significant impact on OAB patients' family members, regardless of whether the patient and family member live together. Consequently, it is important to assess the family impact of symptomatic conditions such as OAB to fully understand the outcomes of disease and treatment.Neurourology and Urodynamics 04/2009; 28(8):969-75. · 2.96 Impact Factor -
Article: The psychometric validation of the OAB family impact measure (OAB-FIM).
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ABSTRACT: Although overactive bladder (OAB) impacts patient health-related quality of life, the impact of OAB on family members is not known. Presently, no validated instruments exist to assess family impact, thus we examined the psychometric properties of a new instrument, the overactive bladder family impact measure (OAB-FIM). Dyads of OAB patient-family members and control patient-family members were recruited from clinics. Family members (spouses, significant others, or daughters) completed the 32-item draft OAB-FIM. Patients completed the overactive bladder questionnaire (OAB-q) and the patient perception of bladder condition (PPBC). Both patients and family members completed two validated relationship measures. Item and exploratory factor analyses were performed to determine subscale structure; reliability and validity were assessed. One hundred ninety-three patient-family member dyads (163 OAB, 30 control) participated. OAB patients were mostly women (82%); the control group was younger with fewer women (53%). Family members were predominantly men (OAB, 58%; control, 52%), and control family members were younger than OAB family members. Thirteen items were deleted from the draft OAB-FIM based on item performance and factor structure based on exploratory factor analyses, leaving 19-items in the final OAB-FIM. Four subscales (Irritation, Activities, Travel, Concern) were derived for use among all family members; two additional subscales (Sleep, Sex) were derived for use with spouses/significant others. The OAB-FIM discriminated between OAB and control family members with OAB family members demonstrating significant impact (all P < 0.0001). Internal consistency reliability (Cronbach's alpha >0.70) and 2-week test-retest reliability (intraclass correlation coefficients >0.73) were high for all subscales. Concurrent validity of the OAB-FIM was demonstrated through statistically significant (P < 0.001) Spearman correlations with the OAB-q (0.35-0.58) and the PPBC (0.31-0.56). The OAB-FIM also demonstrated known-groups validity, distinguishing between family members of OAB patients and family members of control patients. This study supports the reliability and validity of a new measure to assess the impact of OAB on family members and demonstrates that family members are affected by another's medical condition.Neurourology and Urodynamics 03/2009; 29(3):359-69. · 2.96 Impact Factor -
Article: Patient and caregiver perspective on pediatric eosinophilic esophagitis and newly developed symptom questionnaires*.
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ABSTRACT: Eosinophilic esophagitis (EE), a rare chronic inflammatory condition of the esophagus, is predominantly observed in children and is primarily manifested with feeding difficulties. To our knowledge, no self- or caregiver-reported questionnaires are available to assess pediatric EE symptoms and their impact as reported directly by children or their parents/caregivers. The objectives of this study were to characterize the symptoms and impact of EE among children as reported by patients and parents/caregivers and to assess the content validity of two newly developed pediatric eosinophilic esophagitis symptom questionnaires, one parent/caregiver-reported questionnaire for ages 2-7 years and one child-reported questionnaire for ages 8-17 years. The questionnaires were developed based on a review of the literature and clinical expert consultation. This cross-sectional study involving one-on-one interviews with patients and caregivers was conducted at an American Partnership for Eosinophilic Disorders conference. Parents of patients aged 2-7 years (n = 12) and patients aged 8-17 years (n = 16) were first asked about symptoms and their impact on everyday life, using open-ended questions. Participants then completed the appropriate symptom questionnaire and were asked to provide feedback on the relevance, comprehensiveness, and clarity of each item and other questionnaire issues (time to complete, length, format, etc.). All reported symptoms were enumerated, and the feedback on the symptom questionnaires was analyzed qualitatively. The majority of study participants were white (82%) and male (86%). The most frequently reported symptoms of 2-7-year olds were vomiting (92%), "reflux" (50%), dysphagia (25%), abdominal pain (25%), and trouble sleeping (25%). The 8-17-year group reported abdominal pain (56%), vomiting (31%), throat pain (25%), diarrhea (25%), and food getting stuck (25%). Symptoms and treatment were reported to have a major impact on daily life, particularly on school, after-school activities and social events, feeling frustrated regarding symptoms and treatment, and feeling "different". Overall, participants thought that the questionnaires were clear, relevant, and appropriate for symptom assessment. This study was based on a small and convenient sample of participants attending an EE conference and hence may not be representative of the general EE patient population. EE is associated with a range of symptoms that vary in terms of the type, frequency and severity across and within patients. The results provide adequate support for the content validity of the self- and caregiver-reported versions of the symptom-specific questionnaires. Minor modifications were made based on the feedback obtained. A psychometric evaluation of the revised questionnaires is needed next to assess the construct validity, reliability, and responsiveness of the measures.Current Medical Research and Opinion 01/2009; 24(12):3369-81. · 2.38 Impact Factor -
Article: Examining lower urinary tract symptom constellations using cluster analysis.
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ABSTRACT: To gain a better understanding of how patients experience lower urinary tract symptoms (LUTS) and to determine whether particular symptoms cluster together, as LUTS seldom occur alone. A secondary analysis of a cross-sectional, population-based survey of adults in Sweden, Italy, Germany, UK and Canada was undertaken to examine the presence of LUTS groups. Of the 19,165 telephone surveys, 13,519 respondents reported at least one LUTS and were included in the analysis. All respondents were asked about the presence of 14 LUTS (International Prostate Symptom Score plus seven additional LUTS). K-means cluster analyses, a statistical method for sorting objects into groups so that similar objects are grouped together, was used to identify groups of people based on their symptoms. Men and women were analysed separately. A split-half random sample was selected from the dataset so that exploratory analyses could be conducted in one half and confirmed in the second. On model confirmation, the sample was analysed in its entirety. Included in this analysis were 5014 men (mean age 49.8 years; 95% white) and 8505 women (mean age 50.4 years; 96% white). Among both men and women, six distinct symptom cluster groups were identified and the symptom patterns of each cluster were examined. For both, the largest cluster consisted of respondents with minimal symptoms (i.e. reporting essentially one symptom), 56% of men and 57% of women. The remaining five clusters for men and women were labelled based on their predominant symptoms. For men, the clusters were nocturia of twice or more per night (12%); terminal dribble (11%); urgency (10%); multiple symptoms (9%); and postvoid incontinence (5%). For women, the clusters were nocturia of twice or more per night (12%); terminal dribble (10%); urgency (8%); stress incontinence (8%); and multiple symptoms (5%). The multiple-symptom groups had several and varied LUTS, were older, and had more comorbidities. Clusters of terminal dribble and male postvoid incontinence had a lower prevalence of all other LUTS, but were fairly common (11% and 5% of men). This analysis provides an empirical approach to examining the presentation of multiple LUTS and suggests it is possible to identify subgroups of patients with LUTS based on their symptom presentation. These analyses need to be replicated to evaluate the clinical relevance of these findings.BJU International 06/2008; 101(10):1267-73. · 2.84 Impact Factor -
Article: Responsiveness of the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life Scale (AAQoL).
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ABSTRACT: This study examined responsiveness of the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life Scale (AAQoL), which was developed to assess health-related quality of life (HRQL) among adults with attention-deficit/hyperactivity disorder (ADHD). Adults with ADHD completed the AAQoL, Conners' Adult ADHD Rating Scale (CAARS), SF-36, and Endicott Work Productivity Scale (EWPS) at baseline and week 8 of a randomized, placebo-controlled trial of atomoxetine. Clinicians rated symptom severity and improvement (CGI-ADHD-S, CGI-ADHD-I). Responsiveness was examined through effect sizes and association with change in the measures listed previously (Spearman correlations, GLMs). Analyses included 328 patients (58.8% male; mean age = 36.9 years). All AAQoL scales reflected significant improvement from baseline to week 8 (P < 0.0001). AAQoL change scores were significantly correlated with change in the CGI-ADHD-S (r = -0.37 to -0.50), EWPS (r = -0.43 to -0.63), and CAARS (r = -0.35 to -0.62) (all P < 0.001). AAQoL change scores significantly discriminated among patients with various levels of symptom improvement. AAQoL effect sizes (-0.67 to -1.11) were larger than effect sizes for the SF-36 (0.15 to -0.39). The AAQoL was responsive to change in symptoms of ADHD, and it appears to be a useful outcome measure for treatments of ADHD in adults.Quality of Life Research 11/2007; 16(9):1511-20. · 2.30 Impact Factor -
Article: Obese versus non-obese patients with type 2 diabetes: patient-reported outcomes and utility of weight change.
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ABSTRACT: This study (1) used patient-reported outcome measures to assess and compare the health status of type 2 diabetes patients with and without obesity and (2) assessed the value of weight change among obese and non-obese subgroups, using standard gamble (SG) utility methodology. Among a sample with type 2 diabetes in the United Kingdom, individuals with obesity (BMI > or = 30 kg/m2) were identified and compared to non-obese patients. Patients completed the EQ-5D, Psychological General Well-Being Index, Appraisal of Diabetes Symptoms, and Diabetes Symptom Checklist-Revised (DSC-R). SG interviews assessed the utility of the 'basic' type 2 diabetes health state anchored to respondents' body weight, as well as health states with altered weight. A total of 129 patients (74 obese; 55 non-obese) completed interviews (mean age 55.9 years; 64.3% male). Obese patients reported lower health status (EQ-5D VAS; between-group difference: p < 0.001) and greater symptom impact (several DSC-R scales, p < 0.05). Utilities of the basic health state were 0.86 (obese) and 0.91 (non-obese; p = 0.02). Hypothetical health states with higher weight received lower utilities, whereas reduced weight was associated with increased utility. There was a between-group difference in the disutility associated with 5% higher weight (obese 0.068; non-obese 0.051; p = 0.03). Compared with non-obese patients, the obese group reported lower health status and greater symptom impact. SG interviews found an inverse relationship between weight and utility. Furthermore, obese patients with type 2 diabetes may value weight change differently than non-obese patients. Study limitations include the sample size and the use of a patient sample, rather than a sample selected from the general population. Overall, the results demonstrate that utilities can differ by patient subgroups, even among patients with the same diagnosis.Current Medical Research and Opinion 10/2007; 23(9):2051-62. · 2.38 Impact Factor -
Article: Utilities and disutilities for type 2 diabetes treatment-related attributes.
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ABSTRACT: Although cost-utility analyses are frequently used to estimate treatment outcomes for type 2 diabetes, utilities are not available for key medication-related attributes. The purpose of this study was to identify the utility or disutility of diabetes medication-related attributes (weight change, gastrointestinal side effects, fear of hypoglycemia) that may influence patient preference. Patients with type 2 diabetes in Scotland and England completed standard gamble (SG) interviews to assess utility of hypothetical health states and their own current health state. The EQ-5D, PGWB, and Appraisal of Diabetes Symptoms were administered. Construct validity and differences among health states were examined with correlations, t-tests, and ANOVAs. A total of 129 patients (51 Scotland; 78 England) completed interviews. Mean utility of diabetes without complications was 0.89. Greater body weight was associated with disutility, and lower body weight with added utility (e.g., 3% higher = -0.04; 3% lower = +0.02). Gastrointestinal side effects and fear of hypoglycemia were associated with significant disutility (p < 0.001). SG utility of current health (mean = 0.87) demonstrated construct validity through correlations with patient-reported outcome measures (r = 0.08-0.31). The vignette-based approach was feasible and useful for assessing added utility or disutility of medication-related attributes.Quality of Life Research 10/2007; 16(7):1251-65. · 2.30 Impact Factor -
Article: The patient experience of depression and remission: focus group results.
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ABSTRACT: Few depression measures were developed with the patient perspective. To obtain patient views on depression and early symptom resolution, 4 focus groups (N=31) were conducted. Patients also completed the Quick Inventory of Depressive Symptomology (Self-Report), SF-36, and a rating of the bothersomeness and significance of 12 symptoms of depression. Transcripts were reviewed for major themes. Irritability was a key symptom and it remitted earlier than others. Important to participants were low mood, low energy, lack of motivation, lack of focus/concentration, feelings of guilt, self-critical thoughts, feeling overwhelmed, lack of enjoyment, hypersomnia, restlessness, anger, and irritability. Gender differences emerged; most men reported irritability as one of the first symptoms to remit; for women, motivation level and energy commonly remitted first. Results suggest that new measures of treatment outcome should encompass irritability, anger, and ability to cope with life stressors.Journal of Nervous & Mental Disease 09/2007; 195(8):647-54. · 1.68 Impact Factor -
Article: Validation of two generic patient-reported outcome measures in patients with type 2 diabetes.
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ABSTRACT: Prior to using a generic patient-reported outcome measure (PRO), the measure should be validated within the target population. The purpose of the current study was to validate two generic measures in patients with type 2 diabetes. Patients with type 2 diabetes in Scotland and England completed two generic measures: EQ-5D and Psychological General Well-Being Index (PGWB). Two diabetes-specific measures were administered: ADS and DSC-R. Analyses assessed reliability and validity. There were 130 participants (53 Scotland; 77 England; 64% male; mean age = 55.7 years). Responses on the EQ-5D and PGWB reflected moderate impairment consistent with previous diabetes samples: mean EQ-5D Index score, 0.75; EQ-5D VAS, 68.8; PGWB global score, 67.9. All scales of the PGWB demonstrated good internal consistency reliability (Cronbach's alpha = 0.77 to 0.97). The EQ-5D and PGWB demonstrated convergent validity through significant correlations with the ADS (r = 0.48 to 0.61), DSC-R scales (r = 0.33 to 0.81 except ophthalmology subscale), and Body Mass Index (r = 0.15 to 0.38). The EQ-5D and PGWB discriminated between groups of patients known to differ in diabetes-related characteristics (e.g., history of hypoglycemia). Results support the use of the EQ-5D and PGWB among patients with type 2 diabetes, possibly in combination with condition-specific measures.Health and Quality of Life Outcomes 02/2007; 5:47. · 2.11 Impact Factor -
Article: Cost-effectiveness of intrathecal baclofen therapy for the treatment of severe spasticity associated with cerebral palsy.
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ABSTRACT: Spasticity is relatively common among children with cerebral palsy. This condition can be painful, can severely impair a child's ability to perform basic tasks, and can place an enormous emotional and financial burden on the family. Intrathecal baclofen delivered via an implantable pump is an effective treatment option for children unresponsive to oral medication and needing generalized motor control. However, the initial investment for the delivery device and its surgical placement can be a barrier to access. A cost-effectiveness analysis of intrathecal baclofen for adults in the British health care system concluded that intrathecal baclofen offered good value for the money. No similar analysis of intrathecal baclofen has been conducted in the context of the US health care system, and no study has specifically examined cost-effectiveness of intrathecal baclofen in a pediatric population. The aim of this article is to assess the cost-effectiveness of intrathecal baclofen among children with severe spasticity of cerebral origin who have not responded to less invasive treatments such as oral medications relative to alternative medical and surgical therapy. The authors used mathematical modeling and computer simulation to estimate the incremental cost per quality-adjusted life-year for identical cohorts of children treated with intrathecal baclofen or alternative therapy over a 5-year episode of treatment. Data on treatment costs representative of these children were derived from a health insurance claims database that included both commercial and Medicaid data. Utility values used to construct quality-adjusted life-years were obtained from a panel of expert clinicians who used the Health Utilities Index-2 to rate health states associated with the course of treatment. On average, intrathecal baclofen therapy increased the 5-year cost of treatment by $49 000 relative to alternative treatment. However, this was accompanied by an average gain of 1.2 quality-adjusted life-years. The net result was an incremental cost-effectiveness ratio of $42 000 per quality-adjusted life-year, a figure well within the $50 000 to $100 000 range that is widely accepted as offering good value for the money.Journal of Child Neurology 02/2007; 22(1):49-59. · 1.75 Impact Factor
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2012
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Agile Outcomes Research
Rochester, MN, USA
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2005–2012
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United BioSource Corporation
Chevy Chase, MD, USA
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2009
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Oxford Outcomes
Oxford, ENG, United Kingdom
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