Health Research Associates Inc.

Mountlake Terrace, WA, United States

Health Research Associates Inc.

Mountlake Terrace, WA, United States
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Brod M.,Julia Group, The | Christensen T.,Novo Nordisk AS | Bushnell D.M.,Health Research Associates Inc.
Journal of Medical Economics | Year: 2012

Objectives: 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. Methods: An internet survey to adults with diabetes in the US, UK, Germany, and France. Results: 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 12 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. Conclusions: NSNHEs are associated with a substantial impact on diabetes management, sleep quality, and next-day functioning. © 2012 Informa UK Ltd. All rights reserved.


Brod M.,Julia Group, The | Wolden M.,Novo Nordisk AS | Christensen T.,Novo Nordisk AS | Bushnell D.M.,Health Research Associates Inc.
Value in Health | Year: 2013

Objective Nonsevere hypoglycemic events are common and may occur in one-third of persons with diabetes as often as several times a week. This study's objective was to examine the economic burden of nonsevere nocturnal hypoglycemic events (NSNHEs). Methods A 20-minute Web-based survey, with items derived from the literature, expert input, and patient interviews, assessing the impact of NSNHEs was administered in nine countries to 18 years and older patients with self-reported diabetes having an NSNHE in the past month. Results A total of 20,212 persons were screened, with 2,108 respondents meeting criteria and included in the analysis sample. The cost of lost work productivity per NSNHE was estimated to be between $10.21 (Germany) and $28.13 (the United Kingdom), representing 3.3 to 7.5 hours of lost work time per event. A reduction in work productivity (presenteeism) was also reported. Compared with respondents' usual blood sugar monitoring practice, on average, 3.6 ± 6.6 extra tests were conducted in the week following the event at a cost of approximately $87.1 per year. Additional costs were also incurred for doctor visits as well as medical care required because of falls or injuries incurred during the NSNHE for an annual cost of $2,111.3 per person per year. When taking into consideration the multiple impacts of NSNHEs for the total sample and the frequency that these events occur, the resulting total annual economic burden was $288,000 or $127 per person per event. Conclusions NSNHEs have serious consequences for patients. Greater attention to treatments that reduce NSNHEs can have a major impact on reducing the economic burden of diabetes. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


Bushnell D.M.,Health Research Associates Inc. | Martin M.L.,Health Research Associates Inc. | Moore K.A.,Xanodyne | Richter H.E.,University of Alabama at Birmingham | And 2 more authors.
Current Medical Research and Opinion | Year: 2010

Objective: Menorrhagia, or heavy menstrual bleeding (HMB), has a negative impact on women's quality of life (QOL). The objective was to develop, validate, and assess the performance of a disease-specific patient-reported outcome (PRO) measurement instrument for HMB (the Menorrhagia Impact Questionnaire [MIQ]). Research design and methods: The MIQ was designed to measure the effect of HMB on a woman's self-assessment of menstrual blood loss (MBL), limitations in social/leisure activities, physical activities, and ability to work. Meaningfulness of these observed MBL changes were also measured. The development and psychometric validation of the MIQ was performed utilizing data from a long-term safety study of tranexamic acid (Lysteda* *Lysteda is a registered trade name of Ferring Pharmaceuticals Inc., Parsippany, NJ, USA.), with comparison to an age-matched normal control group recruited from the general population. Performance of the MIQ was also evaluated using data from a six-cycle, randomized, double-blind, clinical study of tranexamic acid for the treatment of HMB. Correlations and sensitivity of each pertinent MIQ item to the treatment-induced changes in MBL were assessed, and the minimally important differences (MID) for the individual MIQ items were determined. Results: The psychometric properties of the MIQ were fully validated. Correlations between individual MIQ items and changes in MBL were statistically significant (p<0.001). A clear differentiation between tranexamic acid and placebo groups confirmed sensitivity of the MIQ and its ability to detect treatment-induced changes in MBL. MIDs were estimated for the individual MIQ items, with sensitivities and specificities in the 6479 and 6382 ranges using receiver operating characteristic (ROC) curve analyses, respectively. MIDs were found to be equal to or greater than 0.5. Statistically significant treatment differences were also observed for the proportions of subjects achieving at least 1-point improvement in MIQ scores. Conclusion: The MIQ contains validated constructs important to women with HMB. Clinical trial registration: NCT00113568 and NCT00386308 (ClinicalTrials.gov ID) © 2010 Informa UK Ltd.


Brod M.,Julia Group, The | Christensen T.,Novo Nordisk AS | Bushnell D.M.,Health Research Associates Inc.
Journal of Medical Economics | Year: 2012

Objectives: To describe daytime non-severe hypoglycemic events (NSHEs), assess their impact on patient functioning and diabetes self-management, and examine if these impacts differ by diabetes type or country. Methods: Internet survey to adults with diabetes in the US, UK, Germany, and France. Results: Of 6756 screened respondents, 2439 reported a daytime NSHE in the past month. NSHEs occurred while active (e.g., running errands) (45.1%), 29.6% while not active (e.g., watching TV), and 23.8% at work. On average, it took half a day to respond and recover from NSHE. Respondents monitored their glucose 5.7 extra times on average over the following week. On the day of event, type 1 respondents tested significantly more often than type 2 (p<0.05). Type 2 were less likely to confirm NSHE with glucose test (p<0.001). Following NSHE, 12.6% of respondents reduced total insulin by an average of 7.6 units (SD=8.3). Total units and days with reduced dosing was significantly less, whilst number of additional glucose tests and time to recover was significantly longer if NSHE occurred at work (p<0.001). Type 1 decreased insulin doses more often (p<0.001); however, type 2 decreased a greater number of units (p<0.01). Compared with other countries, US respondents were more likely to eat a light or full meal and respondents in France took significantly longer than all other countries to recognize (p<0.05), respond to (p<0.001), and recover from (p<0.001) NSHE, used significantly more monitoring tests the day of (p<0.05) and over the subsequent week (p<0.001), and decreased their normal insulin dose more (p<0.001). Limitations of the study include potential recall bias and selection bias. Conclusions: NSHEs are associated with a significant impact on patient functioning and diabetes management. © 2012 Informa UK Ltd.


Brod M.,The Brod Group | Wolden M.,Novo Nordisk AS | Christensen T.,Novo Nordisk AS | Bushnell D.M.,Health Research Associates Inc.
Diabetes, Obesity and Metabolism | Year: 2013

Aims: The purpose of this study was to explore the burden and impact of non-severe nocturnal hypoglycaemic events (NSNHEs) on diabetes management, patient functioning and well-being in order to better understand the role that NSNHEs play in caring for persons with diabetes and facilitate optimal diabetes treatment management strategies. Methods: A 20-min survey assessing the impact of NSNHEs was administered to patients with self-reported diabetes age 18 or older via the Internet in nine countries (USA, UK, Germany, Canada, France, Italy, Spain, The Netherlands and Sweden) who experienced an NSNHE in the last month. Questions captured reasons for and length of the event, and impacts on diabetes management, daily function, sleep and well-being. Results: A total of 20212 persons with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM) were screened of which 2108 respondents were eligible. Respondents initiated, on average, an additional 3.6 glucose monitoring tests, and did not resume usual functioning for an average of 3.4hours after the NSNHE. Of the respondents using insulin, 15.8% decreased their insulin dose over an average of 3.6days. NSNHEs also impacted sleep, with 10.4% not returning to sleep that night. Next day functioning was affected with 60.3% (n=1273) feeling the need to take a nap and/or rest (with 65.5% of those actually taking a nap/rest) and 40.2% (n=848) wanting to go to bed earlier than usual. A total of 21.4% were restricted in their driving the next day. These events also resulted in decreased well-being with 39.6% of respondents feeling 'emotional low' the following day. Conclusions: NSNHEs have serious consequences for patients. Greater attention to patient and physician education regarding the burden of NSNHEs and incorporation of corrective actions in treatment plans is needed to facilitate patients reaching optimal glycaemic control. © 2012 Blackwell Publishing Ltd.


Globe G.,Amgen Inc. | Wiklund I.,Evidera | Lin J.,Gilead Sciences Inc. | Chen W.-H.,Evidera | And 7 more authors.
Journal of Allergy and Clinical Immunology: In Practice | Year: 2016

Background: No currently available asthma symptom diary has sufficient validation to be recommended for use as a core asthma outcome measure. Objective: The objective of this study was to provide validation data for the 10-item asthma symptom diary (ASD). Methods: Data were collected in a 4-week prospective, observational study. Subjects completed 3 study visits, completing the ASD twice daily at home for 28 days. Psychometric properties in terms of dimensionality, reliability, validity, and responsiveness were assessed. Results: Data from 276 subjects were analyzed; mean age was 42.9 (standard deviation [SD] = 16.4) years, mean asthma duration was 23.3 (SD = 16.8) years, and 69.6% were female. Confirmatory factor and Rasch analysis supported the ASD as unidimensional and adequately measuring the spectrum of asthma symptom severity. High Cronbach's α (0.94) and intraclass correlation coefficients (0.89-0.95) supported reliability. A high correlation between the 7-day average ASD score and the Asthma Control Questionnaire (ACQ) total score (r = 0.75) and Asthma Quality of Life Questionnaire total scores (r = -0.76), and a moderate correlation with FEV1% predicted (r = -0.30) supported convergent validity. Significant differences (P <.001) between groups classified by ACQ scores supported known-group validity. The 7-day average ASD scores were responsive to change, with significantly higher score changes (P <.001) in responders versus nonresponders. Minimally important differences were calculated and found to be in the range of 0.1-0.3. Conclusion: Results of this study indicated that the ASD is a reliable and valid asthma symptom measure for use in adult and adolescent asthma patients to evaluate the effect of treatment on asthma in clinical trials. © 2015 American Academy of Allergy, Asthma & Immunology.


Da Rocha N.S.,Hospital Of Clinicas Of Porto Alegre | Power M.J.,University of Edinburgh | Bushnell D.M.,Health Research Associates Inc. | Fleck M.P.,Hospital Of Clinicas Of Porto Alegre
Value in Health | Year: 2012

Objectives: To test the psychometric properties of the EUROHIS-QOL 8-item index, a shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version (WHOQOL-BREF). Methods: The sample consisted of 2359 subjects identified from primary care settings, with 1193 having a confirmed diagnosis of depression. Data came from six countries (Australia, Brazil, Israel, Russia, Spain, and the United States) involved in a large international study, the Longitudinal Investigation of Depression Outcomes. The structure of the EUROHIS-QOL 8-item index follows that of the WHOQOL-BREF assessment. Internal consistency was measured by using Cronbach's alpha. Convergent validity was assessed by using correlations with different measures for mental health (Symptom Checklist 90), physical health (self-evaluation), and quality of life (WHOQOL-BREF and short form 36 health survey). Discriminant group validity was assessed between diagnosed depressed and nondepressed patients. Differential item functioning and unidimensionality were analyzed by using Rasch analysis. Factor structure was assessed with structural equation modeling analyses. Results: Internal consistency was acceptable (ranged between 0.72 and 0.81 across countries), and the index discriminated well between depression (t = 6.31-20.33; P < 0.001) across all countries. Correlations between the EUROHIS-QOL 8-item index and different measures - Symptom Checklist 90 (r = -0.42), physical health (r = -0.42), WHOQOL-BREF domains (r = 0.61-0.77), and short form 36 health survey (r = 0.58) - were all significant (P < 0.001). The index is unidimensional with desired item fit statistics. Two items ("daily living activities" and "enough money to meet your needs") had residuals exceeding 4. Differential item functioning was observed with general quality of life, general health, relationships, and home items for age. A common one-factor structure with acceptable fit was identified in three out of six countries (comparative fit index = 0.85, root mean square error of approximation = 0.11). Conclusions: The EUROHIS-QOL 8-item index showed acceptable cross-cultural performance and a satisfactory discriminant validity and would be a useful measure to include in studies to assess treatment effectiveness. © 2012, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


Patrick D.L.,University of Washington | Burke L.B.,U.S. Food and Drug Administration | Gwaltney C.J.,Brown University | Leidy N.K.,United Biosource Corporation | And 4 more authors.
Value in Health | Year: 2011

The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts developers or users purport it to assess. A PRO instrument measures the concepts most relevant and important to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Part 1 of this task force report covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Building on qualitative interviews and focus groups used to elicit concepts, cognitive interviews help developers craft items that can be understood by respondents in the target population and can ultimately confirm that the final instrument is appropriate, comprehensive, and understandable in the target population. Part 2 details: 1) the methods for conducting cognitive interviews that address patient understanding of items, instructions, and response options; and 2) the methods for tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. The task force report's two parts are meant to be read together. They are intended to offer suggestions for good practice in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation. © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


Patrick D.L.,University of Washington | Burke L.B.,U.S. Food and Drug Administration | Gwaltney C.J.,Brown University | Leidy N.K.,United Biosource Corporation | And 4 more authors.
Value in Health | Year: 2011

The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts that developers or users purport it to assess. A PRO instrument measures the concepts most significant and relevant to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Developing content for, and assessing respondent understanding of, newly developed PRO instruments for medical product evaluation will be discussed in this two-part ISPOR PRO Good Research Practices Task Force Report. Topics include the methods for generating items, documenting item development, coding of qualitative data from item generation, cognitive interviewing, and tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. Part 1 covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Part 2 covers the instrument development process, the assessment of patient understanding of the draft instrument using cognitive interviews and steps for instrument revision. The two parts are meant to be read together. They are intended to offer suggestions for good practices in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation. © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


PubMed | University of Texas Health Science Center at San Antonio, Amgen Inc., Health Research Associates Inc and EMD Serono, Inc.
Type: Journal Article | Journal: Schizophrenia bulletin | Year: 2016

The assessment of real-world functional outcomes in clinical trials for medications targeting negative symptoms and cognitive impairment is extremely important. We tested the psychometric properties of the Daily Activity Report (DAR), a novel assessment of productive daily activity. We administered the DAR and additional assessments of functional outcome, functional capacity, cognition and symptomatology to 50 individuals with schizophrenia at 2 time points, 1 month apart and to 25 healthy controls. The DAR records a persons daily activity for 7 consecutive days based upon phone calls made 3 times a day. A total score and scores in 3 domains; instrumental activities (ie, independent living), social and work or school related activities are generated for the DAR. Inter-item consistency was high 0.89-0.94 for each domain and 0.88 overall. Test-retest reliability across 1 month for the total DAR score was 0.67,P< .0001. The total DAR score as well as scores for social activity and nondomestic work/school differed significantly between control and patient participants (P< .0001). DAR domain scores were associated with negative symptoms and functional outcomes, but the primary score related to these measures was the work/school dimension of the DAR. DAR scores were only weakly and nonsignificantly related to positive symptoms. This study provides preliminary support for the reliability and validity of the DAR using interviewer administration. The development of a patient reported version of the DAR using smart phone technology with automatic scoring is the next step.

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