Quality of Life Research

Another major focus of Dr. Daniel Mark’s career has been incorporating quality of life assessments and patient-reported outcomes into cardiovascular clinical trials. Under his leadership, the DCRI Outcomes Research group has conducted detailed quality of life assessments in over 25 large-scale multi-center clinical trials and has collected quality of life data on over 25,000 patients. These studies include several NIH-funded landmark multi-center, multi-country clinical trials including the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), the Occluded Artery Trial (OAT), the Surgical Treatment of Ischemic Heart Failure (STICH) trial, the Home Automated Defibrillator Trial (HAT), the Trial to Assess Chelation Therapy (TACT), and the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE).  Each trial presents a different challenge to identifying and utilizing the appropriate patient-reported outcomes measures to assess the effectiveness of the therapies under study.  Similarly, the statistical and analytical approaches are fined tuned, evaluated, and improved as experience is gained and new methods emerge.  As Principal Investigator of these studies, Dr. Mark has been in a unique position to influence the evolution of the use of patient-reported outcomes measures in clinical trials. His group also developed and validated a disease-specific measure of functional status: the Duke Activity Status Index, which has been widely applied in cardiac studies.

Quality of Life Studies

Quality of Life Research Publications

Health-related quality of life outcomes with prasugrel among medically managed non-ST-segment elevation acute coronary syndrome patients: Insights from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial.

Kaul P, Ohman EM, Knight JD, Anstrom KJ, Roe MT, Boden WE, Hochman JS, Gašparović V, Armstrong PW, McCollam P, Fakhouri W, Cowper P, Davidson-Ray L, Clapp-Channing N, White HD, Fox KA, Prabhakaran D, Mark DB; TRILOGY ACS Investigators..

Am Heart J. 2016 Aug;178:55-64. doi: 10.1016/j.ahj.2016.03.017. PMID: 27502852

Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial.

Mark DB, Anstrom KJ, Sheng S, Baloch KN, Daniels MR, Hoffmann U, Patel MR, Cooper LS, Lee KL, Douglas PS; PROMISE Investigators..

Circulation. 2016 May 24;133(21):1995-2007. doi: 10.1161/CIRCULATIONAHA.115.020259. PMID: 27143676

Assessing Quality of Life and Medical Care in Chronic Angina: An Internet Survey.

Alexander KP, Stadnyuk O, Arnold SV, Mark DB, Ohman EM, Anstrom KJ.

Interact J Med Res. 2016 Apr 28;5(2):e12. doi: 10.2196/ijmr.4971. PMID: 27125492 Free PMC Article

Assessing quality-of-life outcomes in cardiovascular clinical research.

Mark DB.

Nat Rev Cardiol. 2016 May;13(5):286-308. doi: 10.1038/nrcardio.2016.10. Review. PMID: 26888169

How Reliable are Patient-Reported Rehospitalizations? Implications for the Design of Future Practical Clinical Studies.

Krishnamoorthy A, Peterson ED, Knight JD, Anstrom KJ, Effron MB, Zettler ME, Davidson-Ray L, Baker BA, McCollam PL, Mark DB, Wang TY.

J Am Heart Assoc. 2016 Jan 25;5(1). pii: e002695. doi: 10.1161/JAHA.115.002695. PMID: 26811163 Free PMC Article

Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial.

Alexander KP, Weisz G, Prather K, James S, Mark DB, Anstrom KJ, Davidson-Ray L, Witkowski A, Mulkay AJ, Osmukhina A, Farzaneh-Far R, Ben-Yehuda O, Stone GW, Ohman EM.

Circulation. 2016 Jan 5;133(1):39-47. doi: 10.1161/CIRCULATIONAHA.115.019768. PMID: 26555329

Comparison of quality-of-life measures after radial versus femoral artery access for cardiac catheterization in women: Results of the Study of Access Site for Enhancement of Percutaneous Coronary Intervention for Women quality-of-life substudy.

Hess CN, Krucoff MW, Sheng S, Anstrom KJ, Barham WB, Gilchrist IC, Harrington RA, Jacobs AK, Mehran R, Messenger JC, Mark DB, Rao SV.

Am Heart J. 2015 Aug;170(2):371-9. doi: 10.1016/j.ahj.2015.04.024. PMID: 26299236

Quality-of-life outcomes with coronary artery bypass graft surgery in ischemic left ventricular dysfunction: a randomized trial.

Mark DB, Knight JD, Velazquez EJ, Wasilewski J, Howlett JG, Smith PK, Spertus JA, Rajda M, Yadav R, Hamman BL, Malinowski M, Naik A, Rankin G, Harding TM, Drew LA, Desvigne-Nickens P, Anstrom KJ.

Ann Intern Med. 2014 Sep 16;161(6):392-9. doi: 10.7326/M13-1380. PMID: 25222386 Free PMC Article

Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial.

Mark DB, Anstrom KJ, Clapp-Channing NE, Knight JD, Boineau R, Goertz C, Rozema TC, Liu DM, Nahin RL, Rosenberg Y, Drisko J, Lee KL, Lamas GA; TACT Investigators..

Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):508-16. PMID: 24987051 Free PMC Article

Quality of life effects of automatic external defibrillators in the home: results from the Home Automatic External Defibrillator Trial (HAT).

Mark DB, Anstrom KJ, McNulty SE, Flaker GC, Tonkin AM, Smith WM, Toff WD, Dorian P, Clapp-Channing NE, Anderson J, Johnson G, Schron EB, Poole JE, Lee KL, Bardy GH.

Am Heart J. 2010 Apr;159(4):627-634.e7. doi: 10.1016/j.ahj.2010.01.013. PMID: 20362722 Free PMC Article

Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial.

Mark DB, Knight JD, Velazquez EJ, Howlett JG, Spertus JA, Djokovic LT, Harding TM, Rankin GR, Drew LA, Szygula-Jurkiewicz B, Adlbrecht C, Anstrom KJ; Surgical Treatment for Ischemic Heart Failure (STICH) Trial Investigators..

Am Heart J. 2009 May;157(5):837-44, 844.e1-3. doi: 10.1016/j.ahj.2009.03.008. PMID: 19376309 Free PMC Article

Quality of life after late invasive therapy for occluded arteries.

Mark DB, Pan W, Clapp-Channing NE, Anstrom KJ, Ross JR, Fox RS, Devlin GP, Martin CE, Adlbrecht C, Cowper PA, Ray LD, Cohen EA, Lamas GA, Hochman JS; Occluded Artery Trial Investigators..

N Engl J Med. 2009 Feb 19;360(8):774-83. doi: 10.1056/NEJMoa0805151. PMID: 19228620 Free PMC Article

Quality of life with defibrillator therapy or amiodarone in heart failure.

Mark DB, Anstrom KJ, Sun JL, Clapp-Channing NE, Tsiatis AA, Davidson-Ray L, Lee KL, Bardy GH; Sudden Cardiac Death in Heart Failure Trial Investigators..

N Engl J Med. 2008 Sep 4;359(10):999-1008. doi: 10.1056/NEJMoa0706719. PMID: 18768943 Free PMC Article

Medical costs and quality of life 10 to 12 years after randomization to angioplasty or bypass surgery for multivessel coronary artery disease.

Hlatky MA, Boothroyd DB, Melsop KA, Brooks MM, Mark DB, Pitt B, Reeder GS, Rogers WJ, Ryan TJ, Whitlow PL, Wiens RD.

Circulation. 2004 Oct 5;110(14):1960-6. PMID: 15451795 Free Article

Social support and quality of life in patients with coronary artery disease.

Bosworth HB, Siegler IC, Olsen MK, Brummett BH, Barefoot JC, Williams RB, Clapp-Channing NE, Mark DB.

Qual Life Res. 2000;9(7):829-39. PMID: 11297025

Quality of life after coronary revascularization in the United States and Canada.

Bourassa MG, Brooks MM, Mark DB, Trudel J, Detre KM, Pitt B, Reeder GS, Rogers WJ, Ryan TJ, Smith HC, Whitlow PL, Wiens RD, Hlatky MA.

Am J Cardiol. 2000 Mar 1;85(5):548-53. PMID: 11078265

Use of resources, quality of life, and clinical outcomes in patients with and without new Q waves after thrombolytic therapy for acute myocardial infarction (from the GUSTO-I trial).

Barbagelata A, Califf RM, Sgarbossa EB, Goodman SG, Knight D, Mark DB, Granger CB, Agranatti DA, Mautner B, Ohman EM, Suárez LD, Armstrong PW, Gates K, Wagner GS.

Am J Cardiol. 2000 Jul 1;86(1):24-9. PMID: 10867087

The relationship between self-rated health and health status among coronary artery patients.

Bosworth HB, Siegler IC, Brummett BH, Barefoot JC, Williams RB, Vitaliano PP, Clapp-Channing N, Lytle BL, Mark DB.

J Aging Health. 1999 Nov;11(4):565-84. PMID: 10848078

The association between self-rated health and mortality in a well-characterized sample of coronary artery disease patients.

Bosworth HB, Siegler IC, Brummett BH, Barefoot JC, Williams RB, Clapp-Channing NE, Mark DB.

Med Care. 1999 Dec;37(12):1226-36. PMID: 10599604

Medical care costs and quality of life after randomization to coronary angioplasty or coronary bypass surgery. Bypass Angioplasty Revascularization Investigation (BARI) Investigators.

Hlatky MA, Rogers WJ, Johnstone I, Boothroyd D, Brooks MM, Pitt B, Reeder G, Ryan T, Smith H, Whitlow P, Wiens R, Mark DB.

N Engl J Med. 1997 Jan 9;336(2):92-9. PMID: 8988886 Free Article

Importance of cost and quality of life in decisions about routine angiography after acute myocardial infarction. The role of cost-effectiveness models.

Eisenstein EL, Mark DB, Califf RM.

Circulation. 1996 Sep 1;94(5):869-71. No abstract available. PMID: 8790017 Free Article

Economics and Quality of Life After Acute Myocardial Infarction: Insights from GUSTO-I.

Mark DB.

J Thromb Thrombolysis. 1996;3(2):151-155. PMID: 10602556

Use of medical resources and quality of life after acute myocardial infarction in Canada and the United States.

Mark DB, Naylor CD, Hlatky MA, Califf RM, Topol EJ, Granger CB, Knight JD, Nelson CL, Lee KL, Clapp-Channing NE, et al.

N Engl J Med. 1994 Oct 27;331(17):1130-5. PMID: 7935638 Free Article

A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index).

Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB.

Am J Cardiol. 1989 Sep 15;64(10):651-4. PMID: 2782256