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2. Selective cutoff reporting in studies of the accuracy of the Patient Health Questionnaire-9 and Edinburgh Postnatal Depression Scale: Comparison of results based on published cutoffs versus all cutoffs using individual participant data meta-analysis

Author

Neupane, D, Levis, B, Bhandari, PM, Thombs, BD, Benedetti, A, Sun, Y, He, C, Wu, Y, Krishnan, A, Negeri, Z, Imran, M, Rice, DB, Riehm, KE, Saadat, N, Azar, M, Sanchez, TA, Chiovitti, MJ, Levis, AW, Boruff, JT, Cuijpers, P, Gilbody, S, Ioannidis, JPA, Kloda, LA, Patten, SB, Shrier, I, Ziegelstein, RC, Comeau, L, Mitchell, ND, Tonelli, M, Vigod, SN, Akena, DH, Alvarado, R, Arroll, B, Bakare, MO, Baradaran, HR, Beck, CT, Bombardier, CH, Bunevicius, A, Carter, G, Chagas, MH, Chaudron, LH, Cholera, R, Clover, K, Conwell, Y, Castro e Couto, T, de Man-van Ginkel, JM, Delgadillo, J, Fann, JR, Favez, N, Fung, D, Garcia-Esteve, L, Gelaye, B, Goodyear-Smith, F, Hyphantis, T, Inagaki, M, Ismail, K, Jetté, N, Khalifa, DS, Khamseh, ME, Kohlhoff, J, Kozinszky, Z, Kusminskas, L, Liu, SI, Lotrakul, M, Loureiro, SR, Löwe, B, Sidik, SM, Nakić Radoš, S, Osório, FL, Pawlby, SJ, Pence, BW, Rochat, TJ, Rooney, AG, Sharp, DJ, Stafford, L, Su, KP, Sung, SC, Tadinac, M, Darius Tandon, S, Thiagayson, P, Töreki, A, Torres-Giménez, A, Turner, Alyna, van der Feltz-Cornelis, CM, Vega-Dienstmaier, JM, Vöhringer, PA, White, J, Whooley, MA, Winkley, K, Yamada, M, Neupane, D, Levis, B, Bhandari, PM, Thombs, BD, Benedetti, A, Sun, Y, He, C, Wu, Y, Krishnan, A, Negeri, Z, Imran, M, Rice, DB, Riehm, KE, Saadat, N, Azar, M, Sanchez, TA, Chiovitti, MJ, Levis, AW, Boruff, JT, Cuijpers, P, Gilbody, S, Ioannidis, JPA, Kloda, LA, Patten, SB, Shrier, I, Ziegelstein, RC, Comeau, L, Mitchell, ND, Tonelli, M, Vigod, SN, Akena, DH, Alvarado, R, Arroll, B, Bakare, MO, Baradaran, HR, Beck, CT, Bombardier, CH, Bunevicius, A, Carter, G, Chagas, MH, Chaudron, LH, Cholera, R, Clover, K, Conwell, Y, Castro e Couto, T, de Man-van Ginkel, JM, Delgadillo, J, Fann, JR, Favez, N, Fung, D, Garcia-Esteve, L, Gelaye, B, Goodyear-Smith, F, Hyphantis, T, Inagaki, M, Ismail, K, Jetté, N, Khalifa, DS, Khamseh, ME, Kohlhoff, J, Kozinszky, Z, Kusminskas, L, Liu, SI, Lotrakul, M, Loureiro, SR, Löwe, B, Sidik, SM, Nakić Radoš, S, Osório, FL, Pawlby, SJ, Pence, BW, Rochat, TJ, Rooney, AG, Sharp, DJ, Stafford, L, Su, KP, Sung, SC, Tadinac, M, Darius Tandon, S, Thiagayson, P, Töreki, A, Torres-Giménez, A, Turner, Alyna, van der Feltz-Cornelis, CM, Vega-Dienstmaier, JM, Vöhringer, PA, White, J, Whooley, MA, Winkley, K, and Yamada, M

Abstract

Objectives: Selectively reported results from only well-performing cutoffs in diagnostic accuracy studies may bias estimates in meta-analyses. We investigated cutoff reporting patterns for the Patient Health Questionnaire-9 (PHQ-9; standard cutoff 10) and Edinburgh Postnatal Depression Scale (EPDS; no standard cutoff, commonly used 10–13) and compared accuracy estimates based on published cutoffs versus all cutoffs. Methods: We conducted bivariate random effects meta-analyses using individual participant data to compare accuracy from published versus all cutoffs. Results: For the PHQ-9 (30 studies, N = 11,773), published results underestimated sensitivity for cutoffs below 10 (median difference: −0.06) and overestimated for cutoffs above 10 (median difference: 0.07). EPDS (19 studies, N = 3637) sensitivity estimates from published results were similar for cutoffs below 10 (median difference: 0.00) but higher for cutoffs above 13 (median difference: 0.14). Specificity estimates from published and all cutoffs were similar for both tools. The mean cutoff of all reported cutoffs in PHQ-9 studies with optimal cutoff below 10 was 8.8 compared to 11.8 for those with optimal cutoffs above 10. Mean for EPDS studies with optimal cutoffs below 10 was 9.9 compared to 11.8 for those with optimal cutoffs greater than 10. Conclusion: Selective cutoff reporting was more pronounced for the PHQ-9 than EPDS.

Published
2021

3. The Accuracy of the Patient Health Questionnaire-9 Algorithm for Screening to Detect Major Depression: An Individual Participant Data Meta-Analysis

Author

He, C, Levis, B, Riehm, KE, Saadat, N, Levis, AW, Azar, M, Rice, DB, Krishnan, A, Wu, Y, Sun, Y, Imran, M, Boruff, J, Cuijpers, P, Gilbody, S, Ioannidis, JPA, Kloda, LA, McMillan, D, Patten, SB, Shrier, I, Ziegelstein, RC, Akena, DH, Arroll, B, Ayalon, L, Baradaran, HR, Baron, M, Beraldi, A, Bombardier, CH, Butterworth, P, Carter, G, Chagas, MHN, Chan, JCN, Cholera, R, Clover, K, Conwell, Y, de Man-van Ginkel, JM, Fann, JR, Fischer, FH, Fung, D, Gelaye, B, Goodyear-Smith, F, Greeno, CG, Hall, BJ, Harrison, PA, Harter, M, Hegerl, U, Hides, L, Hobfoll, SE, Hudson, M, Hyphantis, TN, Inagaki, M, Ismail, K, Jette, N, Khamseh, ME, Kiely, KM, Kwan, Y, Lamers, F, Liu, S-I, Lotrakul, M, Loureiro, SR, Loewe, B, Marsh, L, McGuire, A, Mohd-Sidik, S, Munhoz, TN, Muramatsu, K, Osorio, FL, Patel, V, Pence, BW, Persoons, P, Picardi, A, Reuter, K, Rooney, AG, da Silva dos Santos, IS, Shaaban, J, Sidebottom, A, Simning, A, Stafford, L, Sung, S, Tan, PLL, Turner, A, van Weert, HCPM, White, J, Whooley, MA, Winkley, K, Yamada, M, Thombs, BD, Benedetti, A, He, C, Levis, B, Riehm, KE, Saadat, N, Levis, AW, Azar, M, Rice, DB, Krishnan, A, Wu, Y, Sun, Y, Imran, M, Boruff, J, Cuijpers, P, Gilbody, S, Ioannidis, JPA, Kloda, LA, McMillan, D, Patten, SB, Shrier, I, Ziegelstein, RC, Akena, DH, Arroll, B, Ayalon, L, Baradaran, HR, Baron, M, Beraldi, A, Bombardier, CH, Butterworth, P, Carter, G, Chagas, MHN, Chan, JCN, Cholera, R, Clover, K, Conwell, Y, de Man-van Ginkel, JM, Fann, JR, Fischer, FH, Fung, D, Gelaye, B, Goodyear-Smith, F, Greeno, CG, Hall, BJ, Harrison, PA, Harter, M, Hegerl, U, Hides, L, Hobfoll, SE, Hudson, M, Hyphantis, TN, Inagaki, M, Ismail, K, Jette, N, Khamseh, ME, Kiely, KM, Kwan, Y, Lamers, F, Liu, S-I, Lotrakul, M, Loureiro, SR, Loewe, B, Marsh, L, McGuire, A, Mohd-Sidik, S, Munhoz, TN, Muramatsu, K, Osorio, FL, Patel, V, Pence, BW, Persoons, P, Picardi, A, Reuter, K, Rooney, AG, da Silva dos Santos, IS, Shaaban, J, Sidebottom, A, Simning, A, Stafford, L, Sung, S, Tan, PLL, Turner, A, van Weert, HCPM, White, J, Whooley, MA, Winkley, K, Yamada, M, Thombs, BD, and Benedetti, A

Abstract

BACKGROUND: Screening for major depression with the Patient Health Questionnaire-9 (PHQ-9) can be done using a cutoff or the PHQ-9 diagnostic algorithm. Many primary studies publish results for only one approach, and previous meta-analyses of the algorithm approach included only a subset of primary studies that collected data and could have published results. OBJECTIVE: To use an individual participant data meta-analysis to evaluate the accuracy of two PHQ-9 diagnostic algorithms for detecting major depression and compare accuracy between the algorithms and the standard PHQ-9 cutoff score of ≥10. METHODS: Medline, Medline In-Process and Other Non-Indexed Citations, PsycINFO, Web of Science (January 1, 2000, to February 7, 2015). Eligible studies that classified current major depression status using a validated diagnostic interview. RESULTS: Data were included for 54 of 72 identified eligible studies (n participants = 16,688, n cases = 2,091). Among studies that used a semi-structured interview, pooled sensitivity and specificity (95% confidence interval) were 0.57 (0.49, 0.64) and 0.95 (0.94, 0.97) for the original algorithm and 0.61 (0.54, 0.68) and 0.95 (0.93, 0.96) for a modified algorithm. Algorithm sensitivity was 0.22-0.24 lower compared to fully structured interviews and 0.06-0.07 lower compared to the Mini International Neuropsychiatric Interview. Specificity was similar across reference standards. For PHQ-9 cutoff of ≥10 compared to semi-structured interviews, sensitivity and specificity (95% confidence interval) were 0.88 (0.82-0.92) and 0.86 (0.82-0.88). CONCLUSIONS: The cutoff score approach appears to be a better option than a PHQ-9 algorithm for detecting major depression.

Published
2020

4. Equivalency of the diagnostic accuracy of the PHQ-8 and PHQ-9: a systematic review and individual participant data meta-analysis.

Author

Wu, Y, Levis, B, Riehm, KE, Saadat, N, Levis, AW, Azar, M, Rice, DB, Boruff, J, Cuijpers, P, Gilbody, S, Ioannidis, JPA, Kloda, LA, McMillan, D, Patten, SB, Shrier, I, Ziegelstein, RC, Akena, DH, Arroll, B, Ayalon, L, Baradaran, HR, Baron, M, Bombardier, CH, Butterworth, P, Carter, G, Chagas, MH, Chan, JCN, Cholera, R, Conwell, Y, de Man-van Ginkel, JM, Fann, JR, Fischer, FH, Fung, D, Gelaye, B, Goodyear-Smith, F, Greeno, CG, Hall, BJ, Harrison, PA, Härter, M, Hegerl, U, Hides, L, Hobfoll, SE, Hudson, M, Hyphantis, T, Inagaki, MD, Jetté, N, Khamseh, ME, Kiely, KM, Kwan, Y, Lamers, F, Liu, S-I, Lotrakul, M, Loureiro, SR, Löwe, B, McGuire, A, Mohd-Sidik, S, Munhoz, TN, Muramatsu, K, Osório, FL, Patel, V, Pence, BW, Persoons, P, Picardi, A, Reuter, K, Rooney, AG, Santos, IS, Shaaban, J, Sidebottom, A, Simning, A, Stafford, MD, Sung, S, Tan, PLL, Turner, A, van Weert, HC, White, J, Whooley, MA, Winkley, K, Yamada, M, Benedetti, A, Thombs, BD, Wu, Y, Levis, B, Riehm, KE, Saadat, N, Levis, AW, Azar, M, Rice, DB, Boruff, J, Cuijpers, P, Gilbody, S, Ioannidis, JPA, Kloda, LA, McMillan, D, Patten, SB, Shrier, I, Ziegelstein, RC, Akena, DH, Arroll, B, Ayalon, L, Baradaran, HR, Baron, M, Bombardier, CH, Butterworth, P, Carter, G, Chagas, MH, Chan, JCN, Cholera, R, Conwell, Y, de Man-van Ginkel, JM, Fann, JR, Fischer, FH, Fung, D, Gelaye, B, Goodyear-Smith, F, Greeno, CG, Hall, BJ, Harrison, PA, Härter, M, Hegerl, U, Hides, L, Hobfoll, SE, Hudson, M, Hyphantis, T, Inagaki, MD, Jetté, N, Khamseh, ME, Kiely, KM, Kwan, Y, Lamers, F, Liu, S-I, Lotrakul, M, Loureiro, SR, Löwe, B, McGuire, A, Mohd-Sidik, S, Munhoz, TN, Muramatsu, K, Osório, FL, Patel, V, Pence, BW, Persoons, P, Picardi, A, Reuter, K, Rooney, AG, Santos, IS, Shaaban, J, Sidebottom, A, Simning, A, Stafford, MD, Sung, S, Tan, PLL, Turner, A, van Weert, HC, White, J, Whooley, MA, Winkley, K, Yamada, M, Benedetti, A, and Thombs, BD

Abstract

BACKGROUND: Item 9 of the Patient Health Questionnaire-9 (PHQ-9) queries about thoughts of death and self-harm, but not suicidality. Although it is sometimes used to assess suicide risk, most positive responses are not associated with suicidality. The PHQ-8, which omits Item 9, is thus increasingly used in research. We assessed equivalency of total score correlations and the diagnostic accuracy to detect major depression of the PHQ-8 and PHQ-9. METHODS: We conducted an individual patient data meta-analysis. We fit bivariate random-effects models to assess diagnostic accuracy. RESULTS: 16 742 participants (2097 major depression cases) from 54 studies were included. The correlation between PHQ-8 and PHQ-9 scores was 0.996 (95% confidence interval 0.996 to 0.996). The standard cutoff score of 10 for the PHQ-9 maximized sensitivity + specificity for the PHQ-8 among studies that used a semi-structured diagnostic interview reference standard (N = 27). At cutoff 10, the PHQ-8 was less sensitive by 0.02 (-0.06 to 0.00) and more specific by 0.01 (0.00 to 0.01) among those studies (N = 27), with similar results for studies that used other types of interviews (N = 27). For all 54 primary studies combined, across all cutoffs, the PHQ-8 was less sensitive than the PHQ-9 by 0.00 to 0.05 (0.03 at cutoff 10), and specificity was within 0.01 for all cutoffs (0.00 to 0.01). CONCLUSIONS: PHQ-8 and PHQ-9 total scores were similar. Sensitivity may be minimally reduced with the PHQ-8, but specificity is similar.

Published
2020

5. Feasibility of a Telemedicine Urgent Care Program to Address Patient Complaints on First Contact

Author

Nabecker, S, Lu, AD, Junge, M, Garber, J, Abramson, AK, Whooley, MA, Smith, JE, Nabecker, S, Lu, AD, Junge, M, Garber, J, Abramson, AK, Whooley, MA, and Smith, JE

Abstract

Many health systems employ nurse telephone advice services to facilitate remote triage of patients to appropriate level of care. However, the effectiveness of these programs to reduce ED and subsequent health care utilization remains to be demonstrated. We describe a novel virtual urgent care program implemented within a Veterans Affairs (VA) health care system that interfaces with a nurse telephone advice line and leverages telemedicine tools to rapidly address and resolve nonemergent conditions. During a 4-month pilot period, 104 unique patients received care through the program, and over 85% of patients achieved timely resolution for their urgent complaints on first contact with the health care system. Demonstrating feasibility for such a program has potential implications for the optimization of remote triage and urgent care services to improve health care utilization and outcomes.

Published
2020

6. Estimating the sample mean and standard deviation from commonly reported quantiles in meta-analysis

Author

McGrath, S, Zhao, X, Steele, R, Thombs, BD, Benedetti, A, Levis, B, Riehm, KE, Saadat, N, Levis, AW, Azar, M, Rice, DB, Sun, Y, Krishnan, A, He, C, Wu, Y, Bhandari, PM, Neupane, D, Imran, M, Boruff, J, Cuijpers, P, Gilbody, S, Ioannidis, JPA, Kloda, LA, McMillan, D, Patten, SB, Shrier, I, Ziegelstein, RC, Akena, DH, Arroll, B, Ayalon, L, Baradaran, HR, Baron, M, Beraldi, A, Bombardier, CH, Butterworth, P, Carter, G, Chagas, MH, Chan, JCN, Cholera, R, Chowdhary, N, Clover, K, Conwell, Y, Ginkel, JMDM-V, Delgadillo, J, Fann, JR, Fischer, FH, Fischler, B, Fung, D, Gelaye, B, Goodyear-Smith, F, Greeno, CG, Hall, BJ, Harrison, PA, Harter, M, Hegerl, U, Hides, L, Hobfoll, SE, Hudson, M, Hyphantis, T, Inagaki, M, Ismail, K, Jette, N, Khamseh, ME, Kiely, KM, Kwan, Y, Lamers, F, Liu, S-I, Lotrakul, M, Loureiro, SR, Loewe, B, Marsh, L, McGuire, A, Sidik, SM, Munhoz, TN, Muramatsu, K, Osorio, FL, Patel, V, Pence, BW, Persoons, P, Picardi, A, Reuter, K, Rooney, AG, Santos, IS, Shaaban, J, Sidebottom, A, Simning, A, Stafford, L, Sung, SC, Tan, PLL, Turner, A, van der Feltz-Cornelis, CM, van Weert, HC, Vohringer, PA, White, J, Whooley, MA, Winkley, K, Yamada, M, Zhang, Y, McGrath, S, Zhao, X, Steele, R, Thombs, BD, Benedetti, A, Levis, B, Riehm, KE, Saadat, N, Levis, AW, Azar, M, Rice, DB, Sun, Y, Krishnan, A, He, C, Wu, Y, Bhandari, PM, Neupane, D, Imran, M, Boruff, J, Cuijpers, P, Gilbody, S, Ioannidis, JPA, Kloda, LA, McMillan, D, Patten, SB, Shrier, I, Ziegelstein, RC, Akena, DH, Arroll, B, Ayalon, L, Baradaran, HR, Baron, M, Beraldi, A, Bombardier, CH, Butterworth, P, Carter, G, Chagas, MH, Chan, JCN, Cholera, R, Chowdhary, N, Clover, K, Conwell, Y, Ginkel, JMDM-V, Delgadillo, J, Fann, JR, Fischer, FH, Fischler, B, Fung, D, Gelaye, B, Goodyear-Smith, F, Greeno, CG, Hall, BJ, Harrison, PA, Harter, M, Hegerl, U, Hides, L, Hobfoll, SE, Hudson, M, Hyphantis, T, Inagaki, M, Ismail, K, Jette, N, Khamseh, ME, Kiely, KM, Kwan, Y, Lamers, F, Liu, S-I, Lotrakul, M, Loureiro, SR, Loewe, B, Marsh, L, McGuire, A, Sidik, SM, Munhoz, TN, Muramatsu, K, Osorio, FL, Patel, V, Pence, BW, Persoons, P, Picardi, A, Reuter, K, Rooney, AG, Santos, IS, Shaaban, J, Sidebottom, A, Simning, A, Stafford, L, Sung, SC, Tan, PLL, Turner, A, van der Feltz-Cornelis, CM, van Weert, HC, Vohringer, PA, White, J, Whooley, MA, Winkley, K, Yamada, M, and Zhang, Y

Abstract

Researchers increasingly use meta-analysis to synthesize the results of several studies in order to estimate a common effect. When the outcome variable is continuous, standard meta-analytic approaches assume that the primary studies report the sample mean and standard deviation of the outcome. However, when the outcome is skewed, authors sometimes summarize the data by reporting the sample median and one or both of (i) the minimum and maximum values and (ii) the first and third quartiles, but do not report the mean or standard deviation. To include these studies in meta-analysis, several methods have been developed to estimate the sample mean and standard deviation from the reported summary data. A major limitation of these widely used methods is that they assume that the outcome distribution is normal, which is unlikely to be tenable for studies reporting medians. We propose two novel approaches to estimate the sample mean and standard deviation when data are suspected to be non-normal. Our simulation results and empirical assessments show that the proposed methods often perform better than the existing methods when applied to non-normal data.

Published
2020

7. Shortening self-report mental health symptom measures through optimal test assembly methods: Development and validation of the Patient Health Questionnaire-Depression-4

Author

Ishihara, M, Harel, D, Levis, B, Levis, AW, Riehm, KE, Saadat, N, Azar, M, Rice, DB, Sanchez, TA, Chiovitti, MJ, Cuijpers, P, Gilbody, S, Ioannidis, JPA, Kloda, LA, McMillan, D, Patten, SB, Shrier, I, Arroll, B, Bombardier, CH, Butterworth, P, Carter, G, Clover, K, Conwell, Y, Goodyear-Smith, F, Greeno, CG, Hambridge, J, Harrison, PA, Hudson, M, Jetté, N, Kiely, KM, McGuire, A, Pence, BW, Rooney, AG, Sidebottom, A, Simning, A, Turner, A, White, J, Whooley, MA, Winkley, K, Benedetti, A, Thombs, BD, Ishihara, M, Harel, D, Levis, B, Levis, AW, Riehm, KE, Saadat, N, Azar, M, Rice, DB, Sanchez, TA, Chiovitti, MJ, Cuijpers, P, Gilbody, S, Ioannidis, JPA, Kloda, LA, McMillan, D, Patten, SB, Shrier, I, Arroll, B, Bombardier, CH, Butterworth, P, Carter, G, Clover, K, Conwell, Y, Goodyear-Smith, F, Greeno, CG, Hambridge, J, Harrison, PA, Hudson, M, Jetté, N, Kiely, KM, McGuire, A, Pence, BW, Rooney, AG, Sidebottom, A, Simning, A, Turner, A, White, J, Whooley, MA, Winkley, K, Benedetti, A, and Thombs, BD

Abstract

Background: The objective of this study was to develop and validate a short form of the Patient Health Questionnaire-9 (PHQ-9), a self-report questionnaire for assessing depressive symptomatology, using objective criteria. Methods: Responses on the PHQ-9 were obtained from 7,850 English-speaking participants enrolled in 20 primary diagnostic test accuracy studies. PHQ unidimensionality was verified using confirmatory factor analysis, and an item response theory model was fit. Optimal test assembly (OTA) methods identified a maximally precise short form for each possible length between one and eight items, including and excluding the ninth item. The final short form was selected based on prespecified validity, reliability, and diagnostic accuracy criteria. Results: A four-item short form of the PHQ (PHQ-Dep-4) was selected. The PHQ-Dep-4 had a Cronbach's alpha of 0.805. Sensitivity and specificity of the PHQ-Dep-4 were 0.788 and 0.837, respectively, and were statistically equivalent to the PHQ-9 (sensitivity = 0.761, specificity = 0.866). The correlation of total scores with the full PHQ-9 was high (r = 0.919). Conclusion: The PHQ-Dep-4 is a valid short form with minimal loss of information of scores when compared to the full-length PHQ-9. Although OTA methods have been used to shorten patient-reported outcome measures based on objective, prespecified criteria, further studies are required to validate this general procedure for broader use in health research. Furthermore, due to unexamined heterogeneity, there is a need to replicate the results of this study in different patient populations.

Published
2019

8. A Framework for Leveraging 'Big Data' to Advance Epidemiology and Improve Quality: Design of the VA Colonoscopy Collaborative.

Author

Gupta, S, Liu, L, Patterson, OV, Earles, A, Bustamante, R, Gawron, AJ, Thompson, WK, Scuba, W, Denhalter, D, Martinez, ME, Messer, K, Fisher, DA, Saini, SD, DuVall, SL, Chapman, WW, Whooley, MA, Kaltenbach, T, Gupta, S, Liu, L, Patterson, OV, Earles, A, Bustamante, R, Gawron, AJ, Thompson, WK, Scuba, W, Denhalter, D, Martinez, ME, Messer, K, Fisher, DA, Saini, SD, DuVall, SL, Chapman, WW, Whooley, MA, and Kaltenbach, T

Abstract

OBJECTIVE: To describe a framework for leveraging big data for research and quality improvement purposes and demonstrate implementation of the framework for design of the Department of Veterans Affairs (VA) Colonoscopy Collaborative. METHODS: We propose that research utilizing large-scale electronic health records (EHRs) can be approached in a 4 step framework: 1) Identify data sources required to answer research question; 2) Determine whether variables are available as structured or free-text data; 3) Utilize a rigorous approach to refine variables and assess data quality; 4) Create the analytic dataset and perform analyses. We describe implementation of the framework as part of the VA Colonoscopy Collaborative, which aims to leverage big data to 1) prospectively measure and report colonoscopy quality and 2) develop and validate a risk prediction model for colorectal cancer (CRC) and high-risk polyps. RESULTS: Examples of implementation of the 4 step framework are provided. To date, we have identified 2,337,171 Veterans who have undergone colonoscopy between 1999 and 2014. Median age was 62 years, and 4.6 percent (n = 106,860) were female. We estimated that 2.6 percent (n = 60,517) had CRC diagnosed at baseline. An additional 1 percent (n = 24,483) had a new ICD-9 code-based diagnosis of CRC on follow up. CONCLUSION: We hope our framework may contribute to the dialogue on best practices to ensure high quality epidemiologic and quality improvement work. As a result of implementation of the framework, the VA Colonoscopy Collaborative holds great promise for 1) quantifying and providing novel understandings of colonoscopy outcomes, and 2) building a robust approach for nationwide VA colonoscopy quality reporting.

Published
2018

9. Erratum to:Methods for evaluating medical tests and biomarkers

Author

Gopalakrishna, G, Langendam, M, Scholten, R, Bossuyt, P, Leeflang, M, Noel-Storr, A, Thomas, J, Marshall, I, Wallace, B, Whiting, P, Davenport, C, GopalaKrishna, G, De Salis, I, Mallett, S, Wolff, R, Riley, R, Westwood, M, Kleinen, J, Collins, G, Reitsma, H, Moons, K, Zapf, A, Hoyer, A, Kramer, K, Kuss, O, Ensor, J, Deeks, JJ, Martin, EC, Riley, RD, Rücker, G, Steinhauser, S, Schumacher, M, Snell, K, Willis, B, Debray, T, Deeks, J, Di Ruffano, LF, Taylor-Phillips, S, Hyde, C, Taylor, SA, Batnagar, G, STREAMLINE COLON Investigators, STREAMLINE LUNG Investigators, METRIC Investigators, Seedat, F, Clarke, A, Byron, S, Nixon, F, Albrow, R, Walker, T, Deakin, C, Zhelev, Z, Hunt, H, Yang, Y, Abel, L, Buchanan, J, Fanshawe, T, Shinkins, B, Wynants, L, Verbakel, J, Van Huffel, S, Timmerman, D, Van Calster, B, Zwinderman, A, Oke, J, O'Sullivan, J, Perera, R, Nicholson, B, Bromley, HL, Roberts, TE, Francis, A, Petrie, D, Mann, GB, Malottki, K, Smith, H, Billingham, L, Sitch, A, Gerke, O, Holm-Vilstrup, M, Segtnan, EA, Halekoh, U, Høilund-Carlsen, PF, Francq, BG, Dinnes, J, Parkes, J, Gregory, W, Hewison, J, Altman, D, Rosenberg, W, Selby, P, Asselineau, J, Perez, P, Paye, A, Bessede, E, Proust-Lima, C, Naaktgeboren, C, De Groot, J, Rutjes, A, Reitsma, J, Ogundimu, E, Cook, J, Le Manach, Y, Vergouwe, Y, Pajouheshnia, R, Groenwold, R, Peelen, L, Nieboer, D, De Cock, B, Pencina, MJ, Steyerberg, EW, Cooper, J, Parsons, N, Stinton, C, Smith, S, Dickens, A, Jordan, R, Enocson, A, Fitzmaurice, D, Adab, P, Boachie, C, Vidmar, G, Freeman, K, Connock, M, Court, R, Moons, C, Harris, J, Mumford, A, Plummer, Z, Lee, K, Reeves, B, Rogers, C, Verheyden, V, Angelini, GD, Murphy, GJ, Huddy, J, Ni, M, Good, K, Cooke, G, Hanna, G, Ma, J, Moons, KGMC, De Groot, JAH, Altman, DG, Reitsma, JB, Collins, GS, Moons, KGM, Kamarudin, AN, Kolamunnage-Dona, R, Cox, T, Borsci, S, Pérez, T, Pardo, MC, Candela-Toha, A, Muriel, A, Zamora, J, Sanghera, S, Mohiuddin, S, Martin, R, Donovan, J, Coast, J, Seo, MK, Cairns, J, Mitchell, E, Smith, A, Wright, J, Hall, P, Messenger, M, Calder, N, Wickramasekera, N, Vinall-Collier, K, Lewington, A, Damen, J, Cairns, D, Hutchinson, M, Sturgeon, C, Mitchel, L, Kift, R, Christakoudi, S, Rungall, M, Mobillo, P, Montero, R, Tsui, T-L, Kon, SP, Tucker, B, Sacks, S, Farmer, C, Strom, T, Chowdhury, P, Rebollo-Mesa, I, Hernandez-Fuentes, M, Damen, JAAG, Debray, TPA, Heus, P, Hooft, L, Scholten, RJPM, Schuit, E, Tzoulaki, I, Lassale, CM, Siontis, GCM, Chiocchia, V, Roberts, C, Schlüssel, MM, Gerry, S, Black, JA, Van der Schouw, YT, Peelen, LM, Spence, G, McCartney, D, Van den Bruel, A, Lasserson, D, Hayward, G, Vach, W, De Jong, A, Burggraaff, C, Hoekstra, O, Zijlstra, J, De Vet, H, Graziadio, S, Allen, J, Johnston, L, O'Leary, R, Power, M, Johnson, L, Waters, R, Simpson, J, Fanshawe, TR, Phillips, P, Plumb, A, Helbren, E, Halligan, S, Gale, A, Sekula, P, Sauerbrei, W, Forman, JR, Dutton, SJ, Takwoingi, Y, Hensor, EM, Nichols, TE, Kempf, E, Porcher, R, De Beyer, J, Hopewell, S, Dennis, J, Shields, B, Jones, A, Henley, W, Pearson, E, Hattersley, A, MASTERMIND consortium, Scheibler, F, Rummer, A, Sturtz, S, Großelfinger, R, Banister, K, Ramsay, C, Azuara-Blanco, A, Burr, J, Kumarasamy, M, Bourne, R, Uchegbu, I, Murphy, J, Carter, A, Marti, J, Eatock, J, Robotham, J, Dudareva, M, Gilchrist, M, Holmes, A, Monaghan, P, Lord, S, StJohn, A, Sandberg, S, Cobbaert, C, Lennartz, L, Verhagen-Kamerbeek, W, Ebert, C, Horvath, A, Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine, Jenniskens, K, Peters, J, Grigore, B, Ukoumunne, O, Levis, B, Benedetti, A, Levis, AW, Ioannidis, JPA, Shrier, I, Cuijpers, P, Gilbody, S, Kloda, LA, McMillan, D, Patten, SB, Steele, RJ, Ziegelstein, RC, Bombardier, CH, Osório, FDL, Fann, JR, Gjerdingen, D, Lamers, F, Lotrakul, M, Loureiro, SR, Löwe, B, Shaaban, J, Stafford, L, Van Weert, HCPM, Whooley, MA, Williams, LS, Wittkampf, KA, Yeung, AS, Thombs, BD, Cooper, C, Nieto, T, Smith, C, Tucker, O, Dretzke, J, Beggs, A, Rai, N, Bayliss, S, Stevens, S, Mallet, S, Sundar, S, Hall, E, Porta, N, Estelles, DL, De Bono, J, CTC-STOP protocol development group, and National Institute for Health Research

Subjects
medicine.medical_specialty, Astrophysics::High Energy Astrophysical Phenomena, MEDLINE, 030204 cardiovascular system & hematology, BTC (Bristol Trials Centre), MASTERMIND consortium, 03 medical and health sciences, 0302 clinical medicine, medicine, 030212 general & internal medicine, Intensive care medicine, CTC-STOP protocol development group, lcsh:R5-920, business.industry, Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine, Published Erratum, STREAMLINE COLON Investigators, 3. Good health, STREAMLINE LUNG Investigators, Centre for Surgical Research, Family medicine, METRIC Investigators, High Energy Physics::Experiment, Erratum, business, lcsh:Medicine (General)
Abstract

[This corrects the article DOI: 10.1186/s41512-016-0001-y.].

Published
2017

10. A comparison of bivariate, multivariate random-effects, and Poisson correlated gamma-frailty models to meta-analyze individual patient data of ordinal scale diagnostic tests

Author

Simoneau, G, Levis, B, Cuijpers, P, Ioannidis, JPA, Patten, SB, Shrier, I, Bombardier, CH, Osorio, FDL, Fann, JR, Gjerdingen, D, Lamers, F, Lotrakul, M, Loewe, B, Shaaban, J, Stafford, L, van Weert, HCPM, Whooley, MA, Wittkampf, KA, Yeung, AS, Thombs, BD, Benedetti, A, Simoneau, G, Levis, B, Cuijpers, P, Ioannidis, JPA, Patten, SB, Shrier, I, Bombardier, CH, Osorio, FDL, Fann, JR, Gjerdingen, D, Lamers, F, Lotrakul, M, Loewe, B, Shaaban, J, Stafford, L, van Weert, HCPM, Whooley, MA, Wittkampf, KA, Yeung, AS, Thombs, BD, and Benedetti, A

Abstract

Individual patient data (IPD) meta-analyses are increasingly common in the literature. In the context of estimating the diagnostic accuracy of ordinal or semi-continuous scale tests, sensitivity and specificity are often reported for a given threshold or a small set of thresholds, and a meta-analysis is conducted via a bivariate approach to account for their correlation. When IPD are available, sensitivity and specificity can be pooled for every possible threshold. Our objective was to compare the bivariate approach, which can be applied separately at every threshold, to two multivariate methods: the ordinal multivariate random-effects model and the Poisson correlated gamma-frailty model. Our comparison was empirical, using IPD from 13 studies that evaluated the diagnostic accuracy of the 9-item Patient Health Questionnaire depression screening tool, and included simulations. The empirical comparison showed that the implementation of the two multivariate methods is more laborious in terms of computational time and sensitivity to user-supplied values compared to the bivariate approach. Simulations showed that ignoring the within-study correlation of sensitivity and specificity across thresholds did not worsen inferences with the bivariate approach compared to the Poisson model. The ordinal approach was not suitable for simulations because the model was highly sensitive to user-supplied starting values. We tentatively recommend the bivariate approach rather than more complex multivariate methods for IPD diagnostic accuracy meta-analyses of ordinal scale tests, although the limited type of diagnostic data considered in the simulation study restricts the generalization of our findings.

Published
2017

11. Erratum to: Methods for evaluating medical tests and biomarkers.

Author

Gopalakrishna, G, Langendam, M, Scholten, R, Bossuyt, P, Leeflang, M, Noel-Storr, A, Thomas, J, Marshall, I, Wallace, B, Whiting, P, Davenport, C, GopalaKrishna, G, de Salis, I, Mallett, S, Wolff, R, Riley, R, Westwood, M, Kleinen, J, Collins, G, Reitsma, H, Moons, K, Zapf, A, Hoyer, A, Kramer, K, Kuss, O, Ensor, J, Deeks, JJ, Martin, EC, Riley, RD, Rücker, G, Steinhauser, S, Schumacher, M, Snell, K, Willis, B, Debray, T, Deeks, J, di Ruffano, LF, Taylor-Phillips, S, Hyde, C, Taylor, SA, Batnagar, G, STREAMLINE COLON Investigators, STREAMLINE LUNG Investigators, METRIC Investigators, Di Ruffano, LF, Seedat, F, Clarke, A, Byron, S, Nixon, F, Albrow, R, Walker, T, Deakin, C, Zhelev, Z, Hunt, H, Yang, Y, Abel, L, Buchanan, J, Fanshawe, T, Shinkins, B, Wynants, L, Verbakel, J, Van Huffel, S, Timmerman, D, Van Calster, B, Zwinderman, A, Oke, J, O'Sullivan, J, Perera, R, Nicholson, B, Bromley, HL, Roberts, TE, Francis, A, Petrie, D, Mann, GB, Malottki, K, Smith, H, Billingham, L, Sitch, A, Gerke, O, Holm-Vilstrup, M, Segtnan, EA, Halekoh, U, Høilund-Carlsen, PF, Francq, BG, Dinnes, J, Parkes, J, Gregory, W, Hewison, J, Altman, D, Rosenberg, W, Selby, P, Asselineau, J, Perez, P, Paye, A, Bessede, E, Proust-Lima, C, Naaktgeboren, C, de Groot, J, Rutjes, A, Reitsma, J, Ogundimu, E, Cook, J, Le Manach, Y, Vergouwe, Y, Pajouheshnia, R, Groenwold, R, Peelen, L, Nieboer, D, De Cock, B, Pencina, MJ, Steyerberg, EW, Cooper, J, Parsons, N, Stinton, C, Smith, S, Dickens, A, Jordan, R, Enocson, A, Fitzmaurice, D, Adab, P, Boachie, C, Vidmar, G, Freeman, K, Connock, M, Court, R, Moons, C, Harris, J, Mumford, A, Plummer, Z, Lee, K, Reeves, B, Rogers, C, Verheyden, V, Angelini, GD, Murphy, GJ, Huddy, J, Ni, M, Good, K, Cooke, G, Hanna, G, Ma, J, Moons, KGMC, de Groot, JAH, Altman, DG, Reitsma, JB, Collins, GS, Moons, KGM, Kamarudin, AN, Kolamunnage-Dona, R, Cox, T, Borsci, S, Pérez, T, Pardo, MC, Candela-Toha, A, Muriel, A, Zamora, J, Sanghera, S, Mohiuddin, S, Martin, R, Donovan, J, Coast, J, Seo, MK, Cairns, J, Mitchell, E, Smith, A, Wright, J, Hall, P, Messenger, M, Calder, N, Wickramasekera, N, Vinall-Collier, K, Lewington, A, Damen, J, Cairns, D, Hutchinson, M, Sturgeon, C, Mitchel, L, Kift, R, Christakoudi, S, Rungall, M, Mobillo, P, Montero, R, Tsui, T-L, Kon, SP, Tucker, B, Sacks, S, Farmer, C, Strom, T, Chowdhury, P, Rebollo-Mesa, I, Hernandez-Fuentes, M, Damen, JAAG, Debray, TPA, Heus, P, Hooft, L, Scholten, RJPM, Schuit, E, Tzoulaki, I, Lassale, CM, Siontis, GCM, Chiocchia, V, Roberts, C, Schlüssel, MM, Gerry, S, Black, JA, van der Schouw, YT, Peelen, LM, Spence, G, McCartney, D, van den Bruel, A, Lasserson, D, Hayward, G, Vach, W, de Jong, A, Burggraaff, C, Hoekstra, O, Zijlstra, J, de Vet, H, Graziadio, S, Allen, J, Johnston, L, O'Leary, R, Power, M, Johnson, L, Waters, R, Simpson, J, Fanshawe, TR, Phillips, P, Plumb, A, Helbren, E, Halligan, S, Gale, A, Sekula, P, Sauerbrei, W, Forman, JR, Dutton, SJ, Takwoingi, Y, Hensor, EM, Nichols, TE, Kempf, E, Porcher, R, de Beyer, J, Hopewell, S, Dennis, J, Shields, B, Jones, A, Henley, W, Pearson, E, Hattersley, A, MASTERMIND consortium, Scheibler, F, Rummer, A, Sturtz, S, Großelfinger, R, Banister, K, Ramsay, C, Azuara-Blanco, A, Burr, J, Kumarasamy, M, Bourne, R, Uchegbu, I, Murphy, J, Carter, A, Marti, J, Eatock, J, Robotham, J, Dudareva, M, Gilchrist, M, Holmes, A, Monaghan, P, Lord, S, StJohn, A, Sandberg, S, Cobbaert, C, Lennartz, L, Verhagen-Kamerbeek, W, Ebert, C, Horvath, A, Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine, Jenniskens, K, Peters, J, Grigore, B, Ukoumunne, O, Levis, B, Benedetti, A, Levis, AW, Ioannidis, JPA, Shrier, I, Cuijpers, P, Gilbody, S, Kloda, LA, McMillan, D, Patten, SB, Steele, RJ, Ziegelstein, RC, Bombardier, CH, Osório, FDL, Fann, JR, Gjerdingen, D, Lamers, F, Lotrakul, M, Loureiro, SR, Löwe, B, Shaaban, J, Stafford, L, van Weert, HCPM, Whooley, MA, Williams, LS, Wittkampf, KA, Yeung, AS, Thombs, BD, Cooper, C, Nieto, T, Smith, C, Tucker, O, Dretzke, J, Beggs, A, Rai, N, Bayliss, S, Stevens, S, Mallet, S, Sundar, S, Hall, E, Porta, N, Estelles, DL, de Bono, J, CTC-STOP protocol development group, Gopalakrishna, G, Langendam, M, Scholten, R, Bossuyt, P, Leeflang, M, Noel-Storr, A, Thomas, J, Marshall, I, Wallace, B, Whiting, P, Davenport, C, GopalaKrishna, G, de Salis, I, Mallett, S, Wolff, R, Riley, R, Westwood, M, Kleinen, J, Collins, G, Reitsma, H, Moons, K, Zapf, A, Hoyer, A, Kramer, K, Kuss, O, Ensor, J, Deeks, JJ, Martin, EC, Riley, RD, Rücker, G, Steinhauser, S, Schumacher, M, Snell, K, Willis, B, Debray, T, Deeks, J, di Ruffano, LF, Taylor-Phillips, S, Hyde, C, Taylor, SA, Batnagar, G, STREAMLINE COLON Investigators, STREAMLINE LUNG Investigators, METRIC Investigators, Di Ruffano, LF, Seedat, F, Clarke, A, Byron, S, Nixon, F, Albrow, R, Walker, T, Deakin, C, Zhelev, Z, Hunt, H, Yang, Y, Abel, L, Buchanan, J, Fanshawe, T, Shinkins, B, Wynants, L, Verbakel, J, Van Huffel, S, Timmerman, D, Van Calster, B, Zwinderman, A, Oke, J, O'Sullivan, J, Perera, R, Nicholson, B, Bromley, HL, Roberts, TE, Francis, A, Petrie, D, Mann, GB, Malottki, K, Smith, H, Billingham, L, Sitch, A, Gerke, O, Holm-Vilstrup, M, Segtnan, EA, Halekoh, U, Høilund-Carlsen, PF, Francq, BG, Dinnes, J, Parkes, J, Gregory, W, Hewison, J, Altman, D, Rosenberg, W, Selby, P, Asselineau, J, Perez, P, Paye, A, Bessede, E, Proust-Lima, C, Naaktgeboren, C, de Groot, J, Rutjes, A, Reitsma, J, Ogundimu, E, Cook, J, Le Manach, Y, Vergouwe, Y, Pajouheshnia, R, Groenwold, R, Peelen, L, Nieboer, D, De Cock, B, Pencina, MJ, Steyerberg, EW, Cooper, J, Parsons, N, Stinton, C, Smith, S, Dickens, A, Jordan, R, Enocson, A, Fitzmaurice, D, Adab, P, Boachie, C, Vidmar, G, Freeman, K, Connock, M, Court, R, Moons, C, Harris, J, Mumford, A, Plummer, Z, Lee, K, Reeves, B, Rogers, C, Verheyden, V, Angelini, GD, Murphy, GJ, Huddy, J, Ni, M, Good, K, Cooke, G, Hanna, G, Ma, J, Moons, KGMC, de Groot, JAH, Altman, DG, Reitsma, JB, Collins, GS, Moons, KGM, Kamarudin, AN, Kolamunnage-Dona, R, Cox, T, Borsci, S, Pérez, T, Pardo, MC, Candela-Toha, A, Muriel, A, Zamora, J, Sanghera, S, Mohiuddin, S, Martin, R, Donovan, J, Coast, J, Seo, MK, Cairns, J, Mitchell, E, Smith, A, Wright, J, Hall, P, Messenger, M, Calder, N, Wickramasekera, N, Vinall-Collier, K, Lewington, A, Damen, J, Cairns, D, Hutchinson, M, Sturgeon, C, Mitchel, L, Kift, R, Christakoudi, S, Rungall, M, Mobillo, P, Montero, R, Tsui, T-L, Kon, SP, Tucker, B, Sacks, S, Farmer, C, Strom, T, Chowdhury, P, Rebollo-Mesa, I, Hernandez-Fuentes, M, Damen, JAAG, Debray, TPA, Heus, P, Hooft, L, Scholten, RJPM, Schuit, E, Tzoulaki, I, Lassale, CM, Siontis, GCM, Chiocchia, V, Roberts, C, Schlüssel, MM, Gerry, S, Black, JA, van der Schouw, YT, Peelen, LM, Spence, G, McCartney, D, van den Bruel, A, Lasserson, D, Hayward, G, Vach, W, de Jong, A, Burggraaff, C, Hoekstra, O, Zijlstra, J, de Vet, H, Graziadio, S, Allen, J, Johnston, L, O'Leary, R, Power, M, Johnson, L, Waters, R, Simpson, J, Fanshawe, TR, Phillips, P, Plumb, A, Helbren, E, Halligan, S, Gale, A, Sekula, P, Sauerbrei, W, Forman, JR, Dutton, SJ, Takwoingi, Y, Hensor, EM, Nichols, TE, Kempf, E, Porcher, R, de Beyer, J, Hopewell, S, Dennis, J, Shields, B, Jones, A, Henley, W, Pearson, E, Hattersley, A, MASTERMIND consortium, Scheibler, F, Rummer, A, Sturtz, S, Großelfinger, R, Banister, K, Ramsay, C, Azuara-Blanco, A, Burr, J, Kumarasamy, M, Bourne, R, Uchegbu, I, Murphy, J, Carter, A, Marti, J, Eatock, J, Robotham, J, Dudareva, M, Gilchrist, M, Holmes, A, Monaghan, P, Lord, S, StJohn, A, Sandberg, S, Cobbaert, C, Lennartz, L, Verhagen-Kamerbeek, W, Ebert, C, Horvath, A, Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine, Jenniskens, K, Peters, J, Grigore, B, Ukoumunne, O, Levis, B, Benedetti, A, Levis, AW, Ioannidis, JPA, Shrier, I, Cuijpers, P, Gilbody, S, Kloda, LA, McMillan, D, Patten, SB, Steele, RJ, Ziegelstein, RC, Bombardier, CH, Osório, FDL, Fann, JR, Gjerdingen, D, Lamers, F, Lotrakul, M, Loureiro, SR, Löwe, B, Shaaban, J, Stafford, L, van Weert, HCPM, Whooley, MA, Williams, LS, Wittkampf, KA, Yeung, AS, Thombs, BD, Cooper, C, Nieto, T, Smith, C, Tucker, O, Dretzke, J, Beggs, A, Rai, N, Bayliss, S, Stevens, S, Mallet, S, Sundar, S, Hall, E, Porta, N, Estelles, DL, de Bono, J, and CTC-STOP protocol development group

Abstract

[This corrects the article DOI: 10.1186/s41512-016-0001-y.].

Published
2017

12. Gender differences in the prospective associations of self-reported sleep quality with biomarkers of systemic inflammation and coagulation: Findings from the Heart and Soul Study

Author

Prather, AA, Epel, ES, Cohen, BE, Neylan, TC, and Whooley, MA

Subjects
Male, Sleep Wake Disorders, Coronary Disease, Cardiovascular, Medical and Health Sciences, Clinical Research, Behavioral and Social Science, Humans, Longitudinal Studies, Heart Disease - Coronary Heart Disease, Retrospective Studies, Aged, Veterans, Inflammation, Psychiatry, Sex Characteristics, Interleukin-6, Prevention, Psychology and Cognitive Sciences, Fibrinogen, Gender, Middle Aged, Hospitals, Coronary heart disease, C-Reactive Protein, Cross-Sectional Studies, Heart Disease, Female, Self Report, Sleep Research, Sleep, Biomarkers
Abstract

Systemic inflammation is proposed as a putative mechanism underlying the link between poor sleep and cardiovascular disease. The aim of present study was to investigate the cross-sectional and prospective associations of self-reported sleep quality with biomarkers of inflammation and coagulation implicated in coronary heart disease (CHD) and to explore whether these associations differed between men and women. To this end, measures of sleep quality and markers of inflammation, including circulating levels of interleukin-6 (IL-6), high-sensitivity C-reactive protein (CRP), and fibrinogen were assessed at baseline in 980 participants with established CHD and 626 at 5-year follow-up. In the sample as a whole, subjective sleep quality was unrelated to inflammatory markers in cross-sectional and prospective analyses. However, in gender stratified analyses, adjusting for age, ethnicity, education, body mass index, and regular snoring, poorer subjective sleep quality at baseline was prospectively associated with 5-year increases in IL-6 (b=0.14, SE=0.05, p=0.003), CRP (b=0.21, SE=0.09, p=0.02), and fibrinogen (b=18.02, SE=7.62, p=0.02) in women but not men. These associations remained independent of lifestyle/psychosocial factors, medical comorbidities, medication use, and cardiac function. Women who reported baseline sleep disturbances characterized by a tendency to wake up too early in the morning also showed significant 5-year increases in circulating IL-6 that withstood covariate adjustment. Further research is necessary to elucidate the pathways that underlie gender-specific associations between subjective sleep quality and markers of inflammation and coagulation as this may help clarify gender disparities in CHD.

Published
2013

13. CRP: more evidence suggests a link between inflammatory protein and heart disease. (Abstracts: a digest of recent research in geriatric care)

Author

Beattie, MS, Shlipak, MG, Liu, H, Browner, WS, Schiller, NB, and Whooley, MA

Subjects
Geriatrics -- Research, C-reactive protein -- Analysis, C-reactive protein -- Physiological aspects, Coronary heart disease -- Physiological aspects, Health, Seniors
Abstract

High levels of C-reactive protein (CRP) appear to be strongly and independently associated with inducible ischemia in patients with stable coronary disease, particularly among those who are not treated with [...]

Published
2003

14. Central nervous system active medications and risk for fractures in older women

Author

Ensrud, KE, Blackwell, T, Mangione, CM, Bowman, PJ, Bauer, DC, Schwartz, A, Hanlon, JT, Nevitt, MC, and Whooley, MA

Abstract

Background: Use of central nervous system (CNS) active medications may increase the risk for fractures. Prior studies are limited by incomplete control of confounders. Methods: To determine whether use of CNS active medications, including benzodiazepines, antidepressants, anticonvulsants, and narcotics, increases fracture risk in elderly, community-dwelling women, we examined use of these 4 categories of medications in a cohort of 8127 older women and followed the participants prospectively for incident nonspine fractures, including hip fractures. Current use of CNS active medications was assessed by interview with verification of use from containers between 1992 and 1994 and between 1995 and 1996. Use was coded as a time-dependent variable. Incident nonspine fractures occurring after the initial medication assessment until May 31, 1999, were confirmed by radiographic reports. Results: During an average follow-up of 4.8 years, 1256 women (15%) experienced at least one nonspine fracture, including 288 (4%) with first hip fractures. Compared with nonusers, women taking narcotics (multivariate hazard ratio [HR], 1.40; 95% confidence interval [CI], 1.06-1.83) and those taking antidepressants (multivariate HR, 1.25; 95% CI, 0.99-1.58) had increases in the risks for any nonspine fractures. Women taking tri-cyclic antidepressants and those using selective serotonin reuptake inhibitors (SSRIs) had similar fracture rates. There were no independent associations between benzodiazepine use or anticonvulsant use and risk for nonspine fracture. Women taking antidepressants compared with nonusers had a 1.7-fold increase in the risk for hip fracture (multivariate HR, 1.65; 95% CI, 1.05-2.57). We did not observe independent associations between use of any of the other 3 classes of CNS active medications and risk of hip fracture.

Published
2003

15. Central nervous system-active medications and risk for falls in older women

Author

Ensrud, KE, Blackwell, TL, Mangione, CM, Bowman, PJ, Whooley, MA, Bauer, DC, Schwartz, AV, Hanlon, JT, and Nevitt, MC

Abstract

OBJECTIVES: To determine whether current use of central nervous system (CNS)-active medications, including benzodiazepines, antidepressants, anticonvulsants, and narcotics, increases the risk for subsequent falls. DESIGN: Prospective cohort study. SETTING: Four clinical centers in Baltimore, Maryland; Portland, Oregon; Minneapolis, Minnesota; and the Monongahela Valley, Pennsylvania. PARTICIPANTS: Eight thousand one hundred twenty-seven women aged 65 and older participating in the fourth examination of the Study of Osteoporotic Fractures between 1992 and 1994. MEASUREMENTS: Current use of CNS-active medications was assessed with an interviewer-administered questionnaire with verification of use from medication containers. A computerized dictionary was used to categorize type of medication from product brand and generic names. Incident falls were reported every 4 months for 1 year after the fourth examination. RESULTS: During an average follow-up of 12 months, 2,241 women (28%) reported falling at least once, including 917 women (11%) who experienced two or more (frequent) falls. Compared with nonusers, women using benzodiazepines (multivariate odds ratio (MOR) = 1.51, 95% confidence interval (CI) = 1.14-2.01), those taking antidepressants (MOR = 1.54, 95% CI = 1.14-2.07), and those using anticonvulsants (MOR = 2.56, 95% CI = 1.49-4.41) were at increased risk of experiencing frequent falls during the subsequent year. We found no evidence of an independent association between narcotic use and falls (MOR = 0.99 for frequent falling, 95% CI = 0.68-1.43). Among benzodiazepine users, both women using short-acting benzodiazepines (MOR = 1.42, 95% CI = 0.98-2.04) and those using long-acting benzodiazepines (MOR = 1.56, 95% CI = 1.00-2.43) appeared to be at greater risk of frequent falls than nonusers, although the CIs overlapped 1.0. We found no evidence to suggest that women using selective serotonin-reuptake inhibitors (MOR = 3.45, 95% CI = 1.89-6.30) had a lower risk of frequent falls than those using tricyclic antidepressants (MOR 1.28, 95% CI = 0.90-1.84). CONCLUSIONS: Community-dwelling older women taking CNS-active medications, including those taking benzodiazepines, antidepressants, and anticonvulsants, are at increased risk of frequent falls. Minimizing use of these CNS-active medications may decrease risk of future falls. Our results suggest that fall risk in women taking benzodiazepines is at best marginally decreased by use of short-acting preparations. Similarly, our findings indicate that preferential use of selective serotonin-reuptake inhibitors is unlikely to reduce fall risk in older women taking antidepressants.

Published
2002

16. Mobile Health Intervention Promoting Physical Activity in Adults Post Cardiac Rehabilitation: Pilot Randomized Controlled Trial

Author

Park, Linda G, Elnaggar, Abdelaziz, Lee, Sei J, Merek, Stephanie, Hoffmann, Thomas J, Von Oppenfeld, Julia, Ignacio, Nerissa, and Whooley, Mary A

Subjects
Medicine
Abstract

BackgroundCardiac rehabilitation (CR) is an exercise-based program prescribed after cardiac events associated with improved physical, mental, and social functioning; however, many patients return to a sedentary lifestyle leading to deteriorating functional capacity after discharge from CR. Physical activity (PA) is critical to avoid recurrence of cardiac events and mortality and maintain functional capacity. Leveraging mobile health (mHealth) strategies to increase adherence to PA is a promising approach. Based on the social cognitive theory, we sought to determine whether mHealth strategies (Movn mobile app for self-monitoring, supportive push-through messages, and wearable activity tracker) would improve PA and functional capacity over 2 months. ObjectiveThe objectives of this pilot randomized controlled trial were to examine preliminary effects of an mHealth intervention on group differences in PA and functional capacity and group differences in depression and self-efficacy to maintain exercise after CR. MethodsDuring the final week of outpatient CR, patients were randomized 1:1 to the intervention group or usual care. The intervention group downloaded the Movn mobile app, received supportive push-through messages on motivation and educational messages related to cardiovascular disease (CVD) management 3 times per week, and wore a Charge 2 (Fitbit Inc) activity tracker to track step counts. Participants in the usual care group wore a pedometer and recorded their daily steps in a diary. Data from the 6-minute walk test (6MWT) and self-reported questionnaires were collected at baseline and 2 months. ResultsWe recruited 60 patients from 2 CR sites at a community hospital in Northern California. The mean age was 68.0 (SD 9.3) years, and 23% (14/60) were female; retention rate was 85% (51/60). Our results from 51 patients who completed follow-up showed the intervention group had a statistically significant higher mean daily step count compared with the control (8860 vs 6633; P=.02). There was no difference between groups for the 6MWT, depression, or self-efficacy to maintain exercise. ConclusionsThis intervention addresses a major public health initiative to examine the potential for mobile health strategies to promote PA in patients with CVD. Our technology-based pilot mHealth intervention provides promising results on a pragmatic and contemporary approach to promote PA by increasing daily step counts after completing CR. Trial RegistrationClinicalTrials.gov NCT03446313; https://clinicaltrials.gov/ct2/show/NCT03446313

Published
2021
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19. Accuracy and prognostic value of American Heart Association: recommended depression screening in patients with coronary heart disease: data from the Heart and Soul Study.

Author

Elderon L, Smolderen KG, Na B, Whooley MA, Elderon, Larkin, Smolderen, Kim G, Na, Beeya, and Whooley, Mary A

Abstract

BACKGROUND- In 2008, the American Heart Association (AHA) recommended a 2-step screening method, consisting of the 2-item Patient Health Questionnaire (PHQ-2) followed by the 9-item Patient Health Questionnaire (PHQ-9), for identifying depression in cardiovascular patients. The accuracy and prognostic value of this screening method have not been evaluated. METHODS AND RESULTS- We administered the 2-step AHA-recommended screening algorithm to 1024 patients with stable coronary heart disease and calculated sensitivity and specificity against a gold standard interview for major depressive disorder. Subsequent cardiovascular events (myocardial infarction, stroke, transient ischemic attack, heart failure, or death) were determined during a mean of 6.27 ± 2.11 years of follow-up. The AHA-recommended screening method had high specificity (0.91; 95% confidence interval, 0.89 to 0.93) but low sensitivity (0.52; 95% confidence interval, 0.46 to 0.59) for a diagnosis of major depressive disorder. Participants who screened positive on the AHA depression protocol had a 55% greater risk of events than those who screened negative (age-adjusted hazard ratio, 1.55; 95% confidence interval, 1.21 to 1.97; P=0.0005). After adjustment for age, sex, body mass index, history of myocardial infarction, hypertension, diabetes, heart failure, and high-density lipoprotein levels, screening positive remained associated with a 41% greater rate of cardiovascular events (hazard ratio, 1.41; 95% confidence interval, 1.10 to 1.81; P=0.008). CONCLUSIONS- Among outpatients with stable coronary heart disease, the AHA-recommended depression screening protocol is highly specific for depression and identifies patients at risk for adverse cardiovascular outcomes. [ABSTRACT FROM AUTHOR]

Published
2011
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20. The CHADS2 score predicts ischemic stroke in the absence of atrial fibrillation among subjects with coronary heart disease: data from the Heart and Soul Study.

Author

Welles CC, Whooley MA, Na B, Ganz P, Schiller NB, Turakhia MP, Welles, Christine C, Whooley, Mary A, Na, Beeya, Ganz, Peter, Schiller, Nelson B, and Turakhia, Mintu P

Abstract

Background: We sought to evaluate the prognostic performance of the CHADS(2) score for prediction of ischemic stroke/transient ischemic attack (TIA) in subjects with coronary heart disease (CHD) without atrial fibrillation (AF).Methods: In 916 nonanticoagulated outpatients with stable CHD and no AF by baseline electrocardiogram, we calculated CHADS(2) scores (congestive heart failure, hypertension, age ≥75 years, diabetes [1 point each], and prior stroke or TIA [2 points]). The primary outcome was time to ischemic stroke or TIA over a mean follow-up of 6.4 ± 2.3 years.Results: Over 5,821 person-years of follow-up, 40 subjects had an ischemic stroke/TIA (rate 0.69/100 person-years, 95% CI 0.50-0.94). Compared with subjects with low (0-1) CHADS(2) scores, those with intermediate (2-3) and high (4-6) CHADS(2) scores had an increased rate of stroke/TIA, even after adjustment for age, tobacco, antiplatelet therapy, statins, and angiotensin inhibitors (CHADS(2) score 2-3: HR 2.4, 95% CI 1.1-5.3, P = .03; CHADS(2) score 4-6: HR 4.0, 95% CI 1.5-10.6, P = .006). Model discrimination (c-statistic = 0.65) was comparable with CHADS(2) model fit in published AF-only cohorts.Conclusions: The CHADS(2) score predicts ischemic stroke/TIA in subjects with stable CHD and no baseline AF. The event rate in non-AF subjects with high CHADS(2) scores (5-6) was comparable with published rates in AF patients with moderate CHADS(2) scores (1-2), a population known to derive benefit from stroke prevention therapies. These findings should inform efforts to determine whether stroke prevention therapies or screening for silent AF may benefit subjects with stable CHD and high CHADS(2) scores. [ABSTRACT FROM AUTHOR]

Published
2011
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23. Diabetes, glycemic control, and new-onset heart failure in patients with stable coronary artery disease: data from the heart and soul study.

Author

van Melle JP, Bot M, de Jonge P, de Boer RA, van Veldhuisen DJ, Whooley MA, van Melle, Joost P, Bot, Mariska, de Jonge, Peter, de Boer, Rudolf A, van Veldhuisen, Dirk J, and Whooley, Mary A

Abstract

Objective: Diabetes is a predictor of both coronary artery disease (CAD) and heart failure. It is unknown to what extent the association between diabetes and heart failure is influenced by other risk factors for heart failure.Research Design and Methods: We evaluated the association of diabetes and A1C with incident heart failure in outpatients with stable CAD and no history of heart failure (average follow-up 4.1 years).Results: Of 839 participants, 200 had diabetes (23.8%). Compared with patients who did not have diabetes, those with diabetes had an increased risk of heart failure (hazard ratio [HR] 2.17 [95% CI 1.37-3.44]). Adjustment for risk factors for CAD (age, sex, race, smoking, physical inactivity, obesity, blood pressure, and LDL cholesterol), interim myocardial infarction, and myocardial ischemia did not alter the strength of the association between diabetes and heart failure. After inclusion also of other risk factors for heart failure (left ventricular ejection fraction, diastolic dysfunction, and C-reactive protein) and medication use, diabetes remained an independent predictor of heart failure (HR 3.34 [95% CI 1.65-6.76]; P = 0.001). Each 1% increase in A1C concentration was associated with a 36% increased HR of heart failure hospitalization (HR 1.36 [95% CI 1.17-1.58]).Conclusions: In patients with stable CAD who are free from heart failure at baseline, diabetes and glycemic control are independent risk factors for new-onset heart failure. The mechanisms by which diabetes and hyperglycemia lead to heart failure deserve further study, as the association is independent of baseline functional assessment of ischemia, systolic and diastolic function, and interim myocardial infarction. [ABSTRACT FROM AUTHOR]

Published
2010
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27. Depression screening and patient outcomes in cardiovascular care: a systematic review.

Author

Thombs BD, de Jonge P, Coyne JC, Whooley MA, Frasure-Smith N, Mitchell AJ, Zuidersma M, Eze-Nliam C, Lima BB, Smith CG, Soderlund K, Ziegelstein RC, Thombs, Brett D, de Jonge, Peter, Coyne, James C, Whooley, Mary A, Frasure-Smith, Nancy, Mitchell, Alex J, Zuidersma, Marij, and Eze-Nliam, Chete

Abstract

Context: Several practice guidelines recommend that depression be evaluated and treated in patients with cardiovascular disease, but the potential benefits of this are unclear. Objective: To evaluate the potential benefits of depression screening in patients with cardiovascular disease by assessing (1) the accuracy of depression screening instruments; (2) the effect of depression treatment on depression and cardiac outcomes; and (3) the effect of screening on depression and cardiac outcomes in patients in cardiovascular care settings. Data Sources: MEDLINE, PsycINFO, CINAHL, EMBASE, ISI, SCOPUS, and Cochrane databases from inception to May 1, 2008; manual journal searches; reference list reviews; and citation tracking of included articles. Study Selection: We included articles in any language about patients in cardiovascular care settings that (1) compared a screening instrument to a valid major depressive disorder criterion standard; (2) compared depression treatment with placebo or usual care in a randomized controlled trial; or (3) assessed the effect of screening on depression identification and treatment rates, depression, or cardiac outcomes. Data Extraction: Methodological characteristics and outcomes were extracted by 2 investigators. Results: We identified 11 studies about screening accuracy, 6 depression treatment trials, but no studies that evaluated the effects of screening on depression or cardiovascular outcomes. In studies that tested depression screening instruments using a priori-defined cutoff scores, sensitivity ranged from 39% to 100% (median, 84%) and specificity ranged from 58% to 94% (median, 79%). Depression treatment with medication or cognitive behavioral therapy resulted in modest reductions in depressive symptoms (effect size, 0.20-0.38; r(2), 1%-4%). There was no evidence that depression treatment improved cardiac outcomes. Among patients with depression and history of myocardial infarction in the ENRICHD trial, there was no difference in event-free survival between participants treated with cognitive behavioral therapy supplemented by an antidepressant vs usual care (75.5% vs 74.7%, respectively). Conclusions: Depression treatment with medication or cognitive behavioral therapy in patients with cardiovascular disease is associated with modest improvement in depressive symptoms but no improvement in cardiac outcomes. No clinical trials have assessed whether screening for depression improves depressive symptoms or cardiac outcomes in patients with cardiovascular disease. [ABSTRACT FROM AUTHOR]

Published
2008
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34. Association of cystatin C with poor exercise capacity and heart rate recovery: data from the heart and soul study.

Author

McManus D, Shlipak M, Ix JH, Ali S, Whooley MA, McManus, David, Shlipak, Michael, Ix, Joachim H, Ali, Sadia, and Whooley, Mary A

Abstract

Background: Cystatin C, an alternative serum measure of kidney function, is a stronger predictor of cardiovascular events than creatinine or estimated glomerular filtration rate (eGFR). We hypothesized that serum cystatin C concentration would have a stronger more linear association with cardiovascular functional status than creatinine-based measures in outpatients with established coronary heart disease (CHD).Methods: We measured serum cystatin C, serum creatinine, and eGFR in 906 outpatients with established CHD. We examined the association of these 3 measures of kidney function with treadmill exercise capacity (metabolic equivalent tasks achieved) and heart rate recovery (HRR) between peak and 1 minute after exercise by using linear and logistic regression.Results: Higher cystatin C concentrations were associated linearly with worse treadmill exercise capacity and HRR. The proportion of participants with poor exercise capacity (metabolic equivalent tasks achieved < 5) was 45% (99 of 222 participants) among those with cystatin C levels in the highest quartile (>1.30 mg/L) compared with 12% (29 of 241 participants) among those with cystatin C levels in the lowest quartile (<0.92 mg/L; adjusted odds ratio, 3.2; 95% confidence interval, 1.6 to 6.5; P = 0.001). The proportion of participants with poor HRR (<16 beats/min) was 42% (92 of 214 participants) among those with cystatin C levels in the highest quartile compared with 16% (37 of 238 participants) among those with cystatin C levels in the lowest quartile (adjusted odds ratio, 2.2; 95% confidence interval, 1.2 to 4.0; P = 0.01). The lowest quartile of eGFR (<61.8 mL/min [<1.03 mL/s]) was associated with decreased exercise capacity and prolonged HRR, but no difference was observed across the upper 3 quartiles of eGFR.Conclusion: In patients with established CHD, cystatin C concentrations are associated linearly with worse exercise capacity and HRR. Cystatin C detects an association of impaired kidney function with decreased HRR and exercise capacity that is not fully captured using creatinine-based measurements. [ABSTRACT FROM AUTHOR]

Published
2007
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36. N-terminal fragment of the prohormone brain-type natriuretic peptide (NT-proBNP), cardiovascular events, and mortality in patients with stable coronary heart disease.

Author

Bibbins-Domingo K, Gupta R, Na B, Wu AHB, Schiller NB, Whooley MA, Bibbins-Domingo, Kirsten, Gupta, Reena, Na, Beeya, Wu, Alan H B, Schiller, Nelson B, and Whooley, Mary A

Abstract

Context: Identification of individuals at high risk for cardiovascular events is important for the optimal use of primary and secondary prevention measures.Objective: To determine whether plasma levels of amino terminal fragment of the prohormone brain-type natriuretic peptide (NT-proBNP) predict cardiovascular events or death independent of other available prognostic tests.Design, Setting, and Participants: Prospective cohort study (2000-2002) of 987 individuals in California with stable coronary heart disease in the Heart and Soul Study, who were followed up for a mean of 3.7 (range, 0.1-5.3) years.Main Outcome Measures: The association of baseline NT-proBNP levels with death or cardiovascular events (myocardial infarction, stroke, or heart failure). Traditional clinical risk factors, echocardiographic measures, ischemia, other biomarkers, and New York Heart Association classification were adjusted for to determine whether NT-proBNP levels were independent of other prognostic factors. Receiver operating characteristic (ROC) curves were used to assess the incremental prognostic value of adding NT-proBNP level to these other measures.Results: A total of 256 participants (26.2%) had a cardiovascular event or died. Each increasing quartile of NT-proBNP level (range of quartile 1, 8.06-73.95 pg/mL; quartile 2, 74-174.5 pg/mL; quartile 3, 175.1-459 pg/mL; quartile 4, > or =460 pg/mL) was associated with a greater risk of cardiovascular events or death, ranging from 23 of 247 (annual event rate, 2.6%) in the lowest quartile to 134 of 246 (annual event rate, 19.6%) in the highest quartile (unadjusted hazard ratio [HR] for quartile 4 vs quartile 1, 7.8; 95% confidence interval [CI], 5.0-12.1; P<.001). Each SD increase in log NT-proBNP level (1.3 pg/mL) was associated with a 2.3-fold increased rate of adverse cardiovascular outcomes (unadjusted HR, 2.3; 95% CI, 2.0-2.6; P<.001), and this association persisted after adjustment for all of the other prognostic measures (adjusted HR, 1.7; 95% CI, 1.3-2.2; P<.001). The addition of NT-proBNP level to standard clinical assessment and complete echocardiographic parameters significantly improved the area under the ROC curves for predicting subsequent adverse cardiovascular outcomes (0.80 for clinical risk factors and echocardiographic parameters plus log NT-proBNP vs 0.76 for clinical risk factors and echocardiographic parameters only; P = .006).Conclusions: Elevated levels of NT-proBNP predict cardiovascular morbidity and mortality, independent of other prognostic markers, and identify at-risk individuals even in the absence of systolic or diastolic dysfunction by echocardiography. Level of NT-proBNP may help guide risk stratification of high-risk individuals, such as those with coronary heart disease. [ABSTRACT FROM AUTHOR]

Published
2007
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37. Cystatin C, left ventricular hypertrophy, and diastolic dysfunction: data from the Heart and Soul Study.

Author

Ix JH, Shlipak MG, Chertow GM, Ali S, Schiller NB, Whooley MA, Ix, Joachim H, Shlipak, Michael G, Chertow, Glenn M, Ali, Sadia, Schiller, Nelson B, and Whooley, Mary A

Abstract

Background: Impaired kidney function, as measured by serum cystatin C, is associated with risk of incident heart failure. Whether cystatin C is associated with preclinical cardiac structural abnormalities is unknown. We evaluate whether cystatin C is associated with left ventricular hypertrophy, diastolic dysfunction, and systolic dysfunction among 818 outpatients with coronary artery disease who were free of clinical heart failure.Methods and Results: The 818 study participants were categorized into quartiles based on serum cystatin C concentrations, with < or =0.91 mg/L constituting the lowest quartile (I) and > or =1.28 mg/L constituting the highest (IV). Left ventricular hypertrophy (left ventricular mass index >90 g/m(2) by truncated ellipsoid method), diastolic dysfunction (impaired relaxation, pseudo-normal, or restrictive filling patterns) and systolic dysfunction (left ventricular ejection fraction < or =50%) were determined by echocardiography. Left ventricular hypertrophy was present in 68% of participants in quartile IV, compared with 44% of those in quartile I (adjusted odds ratio [OR] 2.17; 95% confidence interval [CI] 1.34 to 3.52; P = .002). Diastolic dysfunction was present in 52% of participants in quartile IV, compared with 24% of those in quartile I (adjusted OR 1.79; 95% CI 1.04 to 3.11; P = .04). Systolic dysfunction was present in 12% of those in quartile IV, compared with 6% of those in quartile I (adjusted OR 1.83; 95% CI 0.75 to 4.46; P = .15).Conclusion: Higher cystatin C concentrations are strongly associated with left ventricular hypertrophy and diastolic dysfunction in outpatients with coronary artery disease and without heart failure. [ABSTRACT FROM AUTHOR]

Published
2006

38. Depression and cardiovascular disease: healing the broken-hearted.

Author

Whooley MA, Cooper DS, and Whooley, Mary A

Abstract

Major depressive disorder is a risk factor for the development of incident coronary heart disease events in healthy patients and for adverse cardiovascular outcomes in patients with established heart disease. Depression is present in 1 of 5 outpatients with coronary heart disease and in 1 of 3 outpatients with congestive heart failure, yet the majority of cases are not recognized or appropriately treated. It is not known whether treating depression improves cardiovascular outcomes, but antidepressant treatment with selective serotonin reuptake inhibitors is generally safe, alleviates depression, and improves quality of life. This article evaluates the importance of major depression in patients with cardiovascular disease, and provides practical guidance for identifying and treating this disorder. [ABSTRACT FROM AUTHOR]

Published
2006
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42. Depressive symptoms and health-related quality of life: the Heart and Soul Study.

Author

Ruo B, Rumsfeld JS, Hlatky MA, Liu H, Browner WS, Whooley MA, Ruo, Bernice, Rumsfeld, John S, Hlatky, Mark A, Liu, Haiying, Browner, Warren S, and Whooley, Mary A

Abstract

Context: Little is known regarding the extent to which patient-reported health status, including symptom burden, physical limitation, and quality of life, is determined by psychosocial vs physiological factors among patients with chronic disease.Objective: To compare the contributions of depressive symptoms and measures of cardiac function to the health status of patients with coronary artery disease.Design, Setting, and Participants: Cross-sectional study of 1024 adults with stable coronary artery disease recruited from outpatient clinics in the San Francisco Bay Area between September 2000 and December 2002. Main Measures Measurement of depressive symptoms using the Patient Health Questionnaire (PHQ); assessment of cardiac function by measuring left ventricular ejection fraction on echocardiography, exercise capacity on treadmill testing, and ischemia on stress echocardiography; and measurement of a range of health status outcomes, including symptom burden, physical limitation, and quality of life, using the Seattle Angina Questionnaire. Participants were also asked to rate their overall health as excellent, very good, good, fair, or poor.Results: Of the 1024 participants, 201 (20%) had depressive symptoms (PHQ score > or =10). Participants with depressive symptoms were more likely than those without depressive symptoms to report at least mild symptom burden (60% vs 33%; P<.001), mild physical limitation (73% vs 40%; P<.001), mildly diminished quality of life (67% vs 31%; P<.001), and fair or poor overall health (66% vs 30%; P<.001). In multivariate analyses adjusting for measures of cardiac function and other patient characteristics, depressive symptoms were strongly associated with greater symptom burden (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.3-2.7; P =.002), greater physical limitation (OR, 3.1; 95% CI, 2.1-4.6; P<.001), worse quality of life (OR, 3.1; 95% CI, 2.2-4.6; P<.001), and worse overall health (OR, 2.0; 95% CI, 1.3-2.9; P<.001). Although decreased exercise capacity was associated with worse health status, left ventricular ejection fraction and ischemia were not.Conclusions: Among patients with coronary disease, depressive symptoms are strongly associated with patient-reported health status, including symptom burden, physical limitation, quality of life, and overall health. Conversely, 2 traditional measures of cardiac function-ejection fraction and ischemia-are not. Efforts to improve health status should include assessment and treatment of depressive symptoms. [ABSTRACT FROM AUTHOR]

Published
2003
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45. Central nervous system-active medications and risk for falls in older women.

Author

Ensrud KE, Blackwell TL, Mangione CM, Bowman PJ, Whooley MA, Bauer DC, Schwartz AV, Hanlon JT, Nevitt MC, and Study of Osteoporosis Fractures Research Group

Abstract

OBJECTIVES: To determine whether current use of central nervous system (CNS)-active medications, including benzodiazepines, antidepressants, anticonvulsants, and narcotics, increases the risk for subsequent falls. DESIGN: Prospective cohort study. SETTING: Four clinical centers in Baltimore, Maryland; Portland, Oregon; Minneapolis, Minnesota; and the Monongahela Valley, Pennsylvania. PARTICIPANTS: Eight thousand one hundred twenty-seven women aged 65 and older participating in the fourth examination of the Study of Osteoporotic Fractures between 1992 and 1994. MEASUREMENTS: Current use of CNS-active medications was assessed with an interviewer-administered questionnaire with verification of use from medication containers. A computerized dictionary was used to categorize type of medication from product brand and generic names. Incident falls were reported every 4 months for 1 year after the fourth examination. RESULTS: During an average follow-up of 12 months, 2,241 women (28%) reported falling at least once, including 917 women (11%) who experienced two or more (frequent) falls. Compared with nonusers, women using benzodiazepines (multivariate odds ratio (MOR) = 1.51, 95% confidence interval (CI) = 1.14-2.01), those taking antidepressants (MOR = 1.54, 95% CI = 1.14-2.07), and those using anticonvulsants (MOR = 2.56, 95% CI = 1.49-4.41) were at increased risk of experiencing frequent falls during the subsequent year. We found no evidence of an independent association between narcotic use and falls (MOR = 0.99 for frequent falling, 95% CI = 0.68-1.43). Among benzodiazepine users, both women using short-acting benzodiazepines (MOR = 1.42, 95% CI = 0.98-2.04) and those using long-acting benzodiazepines (MOR = 1.56, 95% CI = 1.00-2.43) appeared to be at greater risk of frequent falls than nonusers, although the CIs overlapped 1.0. We found no evidence to suggest that women using selective serotonin-reuptake inhibitors (MOR = 3.45, 95% CI = 1.89-6.30) had a lower risk of frequent falls than those using tricyclic antidepressants (MOR 1.28, 95% CI = 0.90-1.84). CONCLUSIONS: Community-dwelling older women taking CNS-active medications, including those taking benzodiazepines, antidepressants, and anticonvulsants, are at increased risk of frequent falls. Minimizing use of these CNS-active medications may decrease risk of future falls. Our results suggest that fall risk in women taking benzodiazepines is at best marginally decreased by use of short-acting preparations. Similarly, our findings indicate that preferential use of selective serotonin-reuptake inhibitors is unlikely to reduce fall risk in older women taking antidepressants. [ABSTRACT FROM AUTHOR]

Published
2002
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46. Quality-of-life and depressive symptoms in postmenopausal women after receiving hormone therapy: results from the Heart and Estrogen/Progestin Replacement Study (HERS) trial.

Author

Hlatky MA, Boothroyd D, Vittinghoff E, Sharp P, Whooley MA, Heart and Estrogen/Progestin Replacement Study Research Group, Hlatky, Mark A, Boothroyd, Derek, Vittinghoff, Eric, Sharp, Penny, Whooley, Mary A, and Heart and Estrogen/Progestin Replacement Study (HERS) Research Group

Abstract

Context: Postmenopausal hormone therapy is commonly used by women for disease prevention, but its effects on quality of life have not been well documented.Objective: To determine the effect on quality of life of estrogen plus progestin therapy used as secondary prevention in women with coronary artery disease.Design, Setting, and Participants: A total of 2763 postmenopausal women with documented coronary artery disease (mean age, 67 years) in the Heart and Estrogen/Progestin Replacement Study, a randomized, placebo-controlled, double-blind trial conducted from January 1993 to July 1998 at outpatient and community settings at 20 US clinical centers.Intervention: Participants were randomly assigned to receive either 0.625 mg/d of conjugated equine estrogen plus 2.5 mg/d of medroxyprogesterone acetate (n = 1380) or placebo (n = 1383) for 36 months.Main Outcome Measures: Physical activity, measured by the Duke Activity Status Index; energy/fatigue and mental health, measured by RAND scales; and depressive symptoms, measured on the Burnam screening scale, at 3 years of follow-up.Results: In all patients, scores declined significantly over 3 years for physical function (-3.8; P<.001), mental health (-0.6; P =.05), and energy/fatigue (-3.8; P<.001), but depressive symptoms were not significantly changed (P =.20). The effect of hormone therapy on these measures depended on the presence (n = 434) or absence (n = 2325) of flushing at study entry. Women with flushing who were assigned to hormone therapy had improved mental health (+2.6 vs - 0.5; P =.04) and fewer depressive symptoms (-0.5 vs + 0.007; P =.01) over follow-up compared with those assigned to placebo. Women without flushing who were assigned to hormone therapy had greater declines in physical function (-4.2 vs -3.3; P =.04) and energy/fatigue (-4.6 vs -3.1; P =.03) over follow-up. Quality-of-life scores were significantly lower among patients with older age, diabetes, hypertension, chest pain, or heart failure. These differences in quality of life among women classified by clinical characteristics were much greater than the effects of hormone therapy.Conclusion: Hormone therapy has mixed effects on quality of life among older women. The effects of hormone therapy depend on the presence of menopausal symptoms; women without flushing had greater declines in physical measures, while women with flushing had improvements in emotional measures of quality of life. [ABSTRACT FROM AUTHOR]

Published
2002
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50. Adding heparin to aspirin reduces the incidence of myocardial infarction and death in patients with unstable angina. A meta-analysis.

Author

Oler A, Whooley MA, Oler J, Grady D, Oler, A, Whooley, M A, Oler, J, and Grady, D

Abstract

Objective: To estimate the risk of myocardial infarction (MI) and death in patients with unstable angina who are treated with aspirin plus heparin compared with patients treated with aspirin alone.Data Sources: Studies were retrieved using MEDLINE, bibliographies, and consultation with experts.Study Selection: Only published trials that enrolled patients with unstable angina, randomized participants to aspirin plus heparin vs aspirin alone, and reported incidence of myocardial infarction or death were included in the meta-analysis.Data Extraction: Patient outcomes including MI or death, recurrent ischemic pain, and major bleeding during randomized treatment; revascularization procedures after randomization; and MI or death during the 2 to 12 weeks following randomization were extracted by 2 authors, 1 of whom was blinded to the journal, institution, and author of each study.Data Synthesis: Six randomized trials were included. The overall summary relative risk (RR) of MI or death during randomized treatment was 0.67 (95% confidence interval [CI], 0.44-1.02) in patients with unstable angina treated with aspirin plus heparin compared with those treated with aspirin alone. The summary RRs for secondary endpoints in patients treated with aspirin plus heparin compared with those treated with aspirin alone were 0.68 (95% CI, 0.40-1.17) for recurrent ischemic pain; 0.82 (95% CI, 0.56-1.20) for MI or death 2 to 12 weeks following randomization; 1.03 (95% CI, 0.74-1.43) for revascularization; and 1.99 (95% CI, 0.52-7.65) for major bleeding. We found no statistically significant heterogeneity among individual study findings.Conclusions: Our findings are consistent with a 33% reduction in risk of MI or death in patients with unstable angina treated with aspirin plus heparin compared with those treated with aspirin alone. The bulk of evidence suggests that most patients with unstable angina should be treated with both heparin and aspirin. [ABSTRACT FROM AUTHOR]

Published
1996
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