Measurement of Health-Related Quality of Life in the National Emphysema Treatment Trial

Robert M. Kaplan, PhD; Andrew L. Ries, MD, MPH, FCCP; John Reilly, MD; and Zab Mohsenifar, MD, FCCP

CHEST. 2004;126(3)

Discussion

There are very few published studies that have evaluated QOL measures for patients with advanced lung disease. Similarly, there are limited data on the impact of interventions on various lung-related QOL parameters. The NETT has provided the opportunity to study a large number of emphysema patients in a detailed manner. Disease-specific and general measures were included to elucidate any possible effect of surgery and pulmonary rehabilitation.

The disease-specific and general QOL measures used in the NETT are modestly correlated. These findings confirm those of previous reports^[27] identifying relationships among QOL measures. Preliminary evidence from the NETT has suggested that QOL measures improve following pulmonary rehabilitation. Although the QOL changes following rehabilitation were small, they may be clinically meaningful. A change in the QWB-SA of 0.04 U, for example, if maintained for 1 year, would produce the equivalent of about 1 year of life for every 25 patients treated. Although some studies^[28] have failed to find changes in QOL measures following rehabilitation, other studies^[29,30] have confirmed improvements in QOL measures following pulmonary rehabilitation. The generic measures used in this study had low, but statistically significant, correlations with physiologic and functional measures. Other studies^[31] have shown that disease-specific measures are more highly correlated with FEV₁. In terms of responsiveness to clinical change, the disease-specific measures performed only slightly better than the generic measures.

This analysis confirms the findings of previous studies^[32] suggesting that there are QOL benefits for pulmonary rehabilitation. In the NETT study, FEV₁ changed only very slightly during the rehabilitation phase (about 0.01 L). The results are also consistent with studies that have failed to show changes in pulmonary function measures following rehabilitation^[28] and with studies that have found low, but statistically significant, correlations between QOL and physiologic measures.^[33]

Although the QOL measures in the NETT were modestly correlated with one another, each has a specific purpose. Disease-specific measures, such as the SOBQ and SGRQ, may be more sensitive to clinical improvement following pulmonary rehabilitation. However, evidence from the NETT indicates that general measures also detect significant clinical change following rehabilitation. Thus, we did not find clear evidence that disease-specific measures were significantly more responsive to clinical change. General measures have some advantages because they allow comparisons with other benchmarks. For example, the impact of COPD can be compared with the impact of other chronic diseases. Patients in the NETT, for example, had lower QWB scores than patients in other clinical trials of rehabilitation. NETT patients were comparable to patients with macular degeneration in terms of QOL.^[34] Their QOL was higher than patients with Alzheimer disease.^[21] These comparisons cannot be made with disease-specific measures. Further, utility-based QOL measures are required for analyzing the cost-effectiveness of complex treatments.^[35] Because a utility-based measure was used in the NETT, it was possible to show that LVRS produces a quality-adjusted life-year for $190,000, when considered at 3 years, and $98,000 for a subgroup with predominantly upper lobe emphysema and lower exercise capacity at baseline.^[10,36]These results contributed to the Centers for Medicare and Medicaid Services decision to reimburse selected centers for LVRS. Finally, generic measures may capture unanticipated negative consequences of treatment.

In summary, the NETT offers an unusual opportunity to evaluate outcomes for patients with COPD. Evidence from the prerandomization phase of the trial suggests that the measurement of QOL is feasible, and that generic and disease-specific measures are associated with each other and with clinical changes following pulmonary rehabilitation. Furthermore, there are modest associations among QOL measures and measures of disease severity such as FEV₁ and 6MWD. We concluded that QOL measures are meaningful indicators of outcome in clinical trials for patients with COPD. Disease-specific measures may be slightly more sensitive to clinical change, although the responsiveness of the generic measures was comparable in these analyses. On the basis of these evaluations, we recommend either the SGRQ or the SOBQ as COPD-specific outcome measures. The SF-36 is the preferred generic measure for studies requiring a profile of health outcomes, while the QWB-SA is recommended for studies considering companion cost-effectiveness.

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Funding information

The National Emphysema Treatment Trial was supported by the National Heart, Lung, and Blood Institute (contracts N01HR76101, N01HR76102, N01HR76103, N01HR76104, N01HR76105, N01HR76106, N01HR76107, N01HR76108, N01HR76109, N01HR761010, N01HR761011, N01HR761012, N01HR761013, N01HR761014, N01HR761015, N01HR761016, N01HR76118, and N01HR761019), the Centers for Medicare and Medicaid Services, and the Agency for Healthcare Research and Quality.

Abbreviation Notes

ADL = activity of daily living; Dlco = diffusing capacity of the lung for carbon monoxide; LVRS = lung volume reduction surgery; MCS = mental component score; 6MWD = 6-min walk distance; NETT = National Emphysema Treatment Trial; PCS = physical component score; QOL = quality of life; QWBSA = self-administered version of the quality-of-well-being scale; SF-36 = medical outcomes study 36-item short form; SGRQ = St. George Respiratory Questionnaire; SOBQ = shortness-of-breath questionnaire

Reprint Address

Correspondence to: Robert M. Kaplan, PhD, Mail Code 0628, Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, CA 92093-0628; e-mail: rkaplan@ucsd.edu

Cite this: Measurement of Health-Related Quality of Life in the National Emphysema Treatment Trial - Medscape - Sep 01, 2004.

Abstract and Introduction
Materials and Methods
Results
Discussion
References
Appendix: Members of the NETT Research Group

Appendix: Members of the NETT Research Group

Alfred P. Fishman, MD (Chair); Betsy Ann Bozzarello; and Ameena Al-Amin.

Baylor College of Medicine, Houston, TX: Marcia Katz, MD (Principal Investigator); Carolyn Wheeler, RN, BSN (Principal Clinical Coordinator); Elaine Baker, RRT, RPFT; Peter Barnard, PhD, RPFT; James Carter, MD; Sophia Chatziioannou, MD; Karla Conejo-Gonzales; John Haddad, MD; David Hicks, RRT, RPFT; Neal Kleiman, MD; Mary Milburn-Barnes, CRTT; Chinh Nguyen, RPFT; Michael Reardon, MD; Joseph Reeves-Viets, MD; Steven Sax, MD; Amir Sharafkhaneh, MD; Christine Young PT; Rafael Espada, MD (Principal Investigator from 1996 to 2002); Rose Butanda (from 1999 to 2001); Kimberly Dubose, RRT (from 1998 to 2001); Minnie Ellisor (2002); Pamela Fox, MD (from 1999 to 2001); Katherine Hale, MD (from 1998 to 2000); Everett Hood, RPFT (1998 -2000); Amy Jahn (from 1998 to 2000); Satish Jhingran, MD (from 1998 to 2001); Karen King, RPFT (from 1998 to 1999); Charles Miller III, PhD (from 1996 to 1999); Imran Nizami, MD (Co-Principal Investigator, from 2000 to 2001); Todd Officer (from 1998 to 2000); Jeannie Ricketts (19982000); Joe Rodarte, MD (Co-Principal Investigator from 1996 to 2000); Robert Teague, MD (Co-Principal Investigator from 1999 to 2000); and Kedren Williams (from 1998 to 1999).

Brigham and Women's Hospital, Boston, MA: John Reilly, MD (Principal Investigator); David Sugarbaker, MD (Co-Principal Investigator); Carol Fanning, RRT (Principal Clinic Coordinator); Simon Body, MD; Sabine Duffy, MD; Vladmir Formanek, MD; Anne Fuhlbrigge, MD; Philip Hartigan, MD; Sarah Hooper, EP; Andetta Hunsaker, MD; Francine Jacobson, MD; Marilyn Moy, MD; Susan Peterson, RRT; Roger Russell, MD; Diane Saunders; and Scott Swanson, MD (Co-Principal Investigator, from 1996 to 2001).

Cedars-Sinai Medical Center, Los Angeles, CA: Rob McKenna, MD (Principal Investigator); Zab Mohsenifar, MD (Co-Principal Investigator); Carol Geaga, RN (Principal Clinic Coordinator); Manmohan Biring, MD; Susan Clark, RN, MN; Robert Frantz, MD; Peter Julien, MD; Michael Lewis, MD; Jennifer Minkoff-Rau, MSW; Valentina Yegyan, BS, CPFT; and Milton Joyner, BA (from 1996 to 2002).

Cleveland Clinic Foundation, Cleveland, OH: Malcolm De-Camp, MD (Principal Investigator); James Stoller, MD (Co-Princi-pal Investigator); Yvonne Meli, RN,C (Principal Clinic Coordinator); John Apostolakis, MD; Darryl Atwell, MD; Jeffrey Chapman, MD; Pierre DeVilliers, MD; Raed Dweik, MD; Erik Kraenzler, MD; Rosemary Lann, LISW; Nancy Kurokawa, RRT, CPFT; Scott Marlow, RRT; Kevin McCarthy, RCPT; Pricilla McCreight, RRT, CPFT; Atul Mehta, MD; Moulay Meziane, MD; Omar Minai, MD; Peter O'Donovan, MD; Mindi Steiger, RRT; Kenneth White, RPFT; Janet Maurer, MD (Principal Investigator, from 1996 to 2001); Charles Hearn, DO (from 1998 to 2001); Susan Lubell, PA-C (from 1999 to 2000); Robert Schilz, DO (from 1998 to 2002); and Terri Durr, RN (from 2000 to 2001).

Columbia University, New York, NY, in consortium with Long Island Jewish Medical Center, New Hyde Park, NY: Mark Ginsburg, MD (Principal Investigator); Byron Thomashow, MD (Co-Principal Investigator); Patricia Jellen, MSN, RN (Principal Clinic Coordinator); John Austin, MD; Matthew Bartels, MD; Yahya Berkmen, MD; Patricia Berkoski, MS, RRT (Site Coordinator, Long Island Jewish Medical Center); Frances Brogan, MSN, RN; Amy Chong, BS, CRT; Glenda DeMercado, BSN; Angela DiMango, MD; Sandy Do, MS, PT; Bessie Kachulis, MD; Arfa Khan, MD; Berend Mets, MD; Mitchell O'Shea, BS, RT, CPFT; Gregory Pearson, MD; Leonard Rossoff, MD; Steven Scharf, MD, PhD (Co-Principal Investigator, from 1998 to 2002); Maria Shiau, MD; Paul Simonelli, MD; Kim Stavrolakes, MS, PT; Donna Tsang, BS; Denise Vilotijevic, MS, PT; Chun Yip, MD; Mike Mantinaos, MD (from 1998 to 2001); Kerri McKeon, BS, RRT, RN (from 1998 to 1999); and Jacqueline Pfeffer, MPH, PT (from 1997 to 2002).

Duke University Medical Center, Durham, NC: Neil MacIntyre, MD (Principal Investigator); R. Duane Davis, MD (Co-Principal Investigator); John Howe, RN (Principal Clinic Coordinator); R. Edward Coleman, MD; Rebecca Crouch, RPT; Dora Greene; Katherine Grichnik, MD; David Harpole, Jr, MD; Abby Krichman, RRT; Brian Lawlor, RRT; Holman McAdams, MD; John Plankeel, MD; Susan Rinaldo-Gallo, MED; Jeanne Smith, ACSW; Mark Stafford-Smith, MD; Victor Tapson, MD; Mark Steele, MD (from 1998 to 1999); and Jennifer Norten, MD (from 1998 to 1999).

Mayo Foundation, Rochester, MN: James Utz, MD (Principal Investigator); Claude Deschamps, MD (Co-Principal Investigator); Kathy Mieras, CCRP (Principal Clinic Coordinator); Martin Abel, MD; Mark Allen, MD; Deb Andrist, RN; Gregory Aughenbaugh, MD; Sharon Bendel, RN; Eric Edell, MD; Marlene Edgar; Bonnie Edwards; Beth Elliot, MD; James Garrett, RRT; Delmar Gillespie, MD; Judd Gurney, MD; Boleyn Hammel; Karen Hanson, RRT; Lori Hanson, RRT; Gordon Harms, MD; June Hart; Thomas Hartman, MD; Robert Hyatt, MD; Eric Jensen, MD; Nicole Jenson, RRT; Sanjay Kalra, MD; Philip Karsell, MD; David Midthun, MD; Carl Mottram, RRT; Stephen Swensen, MD; Anne-Marie Sykes, MD; Karen Taylor; Norman Torres, MD; Rolf Hubmayr, MD (from 1998 to 2000); Daniel Miller, MD (from 1999 to 2002); Sara Bartling, RN (from 1998 to 2000); and Kris Bradt (from 1998 to 2002).

National Jewish Medical and Research Center, Denver, CO: Barry Make, MD (Principal Investigator); Marvin Pomerantz, MD (Co-Principal Investigator); Mary Gilmartin, RN, RRT (Principal Clinic Coordinator); Joyce Canterbury; Martin Carlos; Phyllis Dibbern, PT; Enrique Fernandez, MD; Lisa Geyman, MSPT; Connie Hudson; David Lynch, MD; John Newell, MD; Robert Quaife, MD; Jennifer Propst, RN; Cynthia Raymond, MS; Jane Whalen-Price, PT; Kathy Winner, OTR; Martin Zamora, MD; and Reuben Cherniack, MD (Principal Investigator, from 1997 to 2000).

Ohio State University, Columbus, OH: Philip Diaz, MD (Principal Investigator); Patrick Ross, MD (Co-Principal Investigator); Tina Bees (Principal Clinic Coordinator); Hamdy Awad, MD; Jan Drake; Charles Emery, PhD; Mark Gerhardt, MD, PhD; Mark King, MD; David Rittinger; and Mahasti Rittinger.

Saint Louis University, St. Louis, MO: Keith Naunheim, MD (Principal Investigator); Francisco Alvarez, MD (Co-Principal Investigator); Joan Osterloh, RN, MSN (Principal Clinic Coordinator); Susan Borosh; Willard Chamberlain, DO; Sally Frese; Alan Hibbit; Mary Ellen Kleinhenz, MD; Gregg Ruppel; Cary Stolar, MD; Janice Willey; and Cesar Keller, MD (Co-Principal Investigator, from 1996 to 2000).

Temple University, Philadelphia, PA: Gerard Criner, MD (Principal Investigator); Satoshi Furukawa, MD (Co-Principal Investigator); Anne Marie Kuzma, RN, MSN (Principal Clinic Coordinator); Roger Barnette, MD; Neil Brister, MD; Kevin Carney, RN, CCTC; Wissam Chatila, MD; Francis Cordova, MD; Gilbert D'Alonzo, DO; Michael Keresztury, MD; Karen Kirsch; Chul Kwak, MD; Kathy Lautensack, RN, BSN; Madelina Lorenzon, CPFT; Ubaldo Martin, MD; Peter Rising, MS; Scott Schartel, MD; John Travaline, MD; Gwendolyn Vance, RN, CCTC; Phillip Boiselle, MD (from 1997 to 2000); and Gerald O'Brien, MD (from 1997 to 2000).

University of California, San Diego, San Diego, CA: Andrew Ries, MD, MPH (Principal Investigator); Robert Kaplan, PhD (Co-Principal Investigator); Catherine Ramirez, BS, RCP (Principal Clinic Coordinator); David Frankville, MD; Paul Friedman, MD; James Harrell, MD; Jeffery Johnson; David Kapelanski, MD; David Kupferberg, MD, MPH; Catherine Larsen, MPH; Trina Limberg, RRT; Michael Magliocca, RN, CNP; Frank J. Papatheofanis, MD, PhD; Dawn Sassi-Dambron, RN; and Melissa Weeks.

University of Maryland at Baltimore, Baltimore, MD in consortium with Johns Hopkins Hospital, Baltimore, MD: Mark Krasna, MD (Principal Investigator); Henry Fessler, MD (Co-Principal Investigator); Iris Moskowitz (Principal Clinic Coordinator); Timothy Gilbert, MD; Jonathan Orens, MD; Steven Scharf, MD, PhD; David Shade; Stanley Siegelman, MD; Kenneth Silver, MD; Clarence Weir; and Charles White, MD.

University of Michigan, Ann Arbor, MI: Fernando Martinez, MD (Principal Investigator); Mark Iannettoni, MD (Co-Principal Investigator); Catherine Meldrum, BSN, RN, CCRN (Principal Clinic Coordinator); William Bria, MD; Kelly Campbell; Paul Christensen, MD; Kevin Flaherty, MD; Steven Gay, MD; Paramjit Gill, RN; Paul Kazanjian, MD; Ella Kazerooni, MD; Vivian Knieper; Tammy Ojo, MD; Lewis Poole; Leslie Quint, MD; Paul Rysso; Thomas Sisson, MD; Mercedes True; Brian Woodcock, MD; and Lori Zaremba, RN.

University of Pennsylvania, Philadelphia, PA: Larry Kaiser, MD (Principal Investigator); John Hansen-Flaschen, MD (Co-Principal Investigator); Mary Louise Dempsey, BSN, RN (Principal Clinic Coordinator); Abass Alavi, MD; Theresa Alcorn Selim Arcasoy, MD; Judith Aronchick, MD; Stanley Aukberg, MD; Bryan Benedict, RRT; Susan Craemer, BS, RRT, CPFT; Ron Daniele, MD; Jeffrey Edelman, MD; Warren Gefter, MD; Laura Kotler-Klein, MSS; Robert Kotloff, MD; David Lipson, MD; Wallace Miller, Jr, MD; Richard O'Connell, RPFT; Staci Opelman, MSW; Harold Palevsky, MD; William Russell, RPFT; Heather Sheaffer, MSW; Rodney Simcox, BSRT, RRT; Susanne Snedeker, RRT, CPFT; Jennifer Stone-Wynne, MSW; Gregory Tino, MD; Peter Wahl; James Walter, RPFT; Patricia Ward; David Zisman, MD; James Mendez, MSN, CRNP (from 1997 to 2001); and Angela Wurster, MSN, CRNP (from 1997 to 1999).

University of Pittsburgh, Pittsburgh, PA: Frank Sciurba, MD (Principal Investigator); James Luketich, MD (Co-Principal Investigator); Colleen Witt, MS (Principal Clinic Coordinator); Gerald Ayres; Michael Donahoe, MD; Carl Fuhrman, MD; Robert Hoffman, MD; Joan Lacomis, MD; Joan Sexton; William Slivka; Diane Strollo, MD; Erin Sullivan, MD; Tomeka Simon; Catherine Wrona, RN, BSN; Gerene Bauldoff, RN, MSN (from 1997 to 2000); Manuel Brown, MD (from 1997 to 2002); Elisabeth George, RN, MSN (Principal Clinic Coordinator from 1997 to 2001); Robert Keenan, MD (Co-Principal Investigator from 1997 to 2000); Theodore Kopp, MS (from 1997 to 1999); and Laurie Silfies (from 1997 to 2001).

University of Washington, Seattle, WA: Joshua Benditt, MD (Principal Investigator), Douglas Wood, MD (Co-Principal Investigator); Margaret Snyder, MN (Principal Clinic Coordinator); Kymberley Anable; Nancy Battaglia; Louie Boitano; Andrew Bowdle, MD; Leighton Chan, MD; Cindy Chwalik; Bruce Culver, MD; Thurman Gillespy, MD; David Godwin, MD; Jeanne Hoffman; Andra Ibrahim, MD; Diane Lockhart; Stephen Marglin, MD; Kenneth Martay, MD; Patricia McDowell; Donald Oxorn, MD; Liz Roessler; Michelle Toshima; and Susan Golden (from 1998 to 2000).

Agency for Healthcare Research and Quality, Rockville, MD: Lynn Bosco, MD, MPH; Yen-Pin Chiang, PhD; Carolyn Clancy, MD; and Harry Handelsman, DO.

Centers for Medicare and Medicaid Services, Baltimore, MD: Steven Sheingold, PhD; Tanisha Carino, PhD; Joe Chin, MD; JoAnna Farrell; Karen McVearry; Anthony Norris; Sarah Shirey; and Claudette Sikora.

Coordinating Center, The Johns Hopkins University, Baltimore, MD: Steven Piantadosi, MD, PhD (Principal Investigator); James Tonascia, PhD (Co-Principal Investigator); Patricia Belt; Karen Collins; Betty Collison; John Dodge; Michele Donithan, MHS; Vera Edmonds; Julie Fuller; Judith Harle; Rosetta Jackson; Heather Koppelman; Shing Lee, ScM; Charlene Levine; Hope Livingston; Jill Meinert; Jennifer Meyers; Deborah Nowakowski; Kapreena Owens; Shangqian Qi, MD; Michael Smith; Brett Simon, MD; Paul Smith; Alice Sternberg, ScM; Mark Van Natta, MHS; Laura Wilson, ScM; and Robert Wise, MD.

Cost Effectiveness Subcommittee: Robert M. Kaplan, PhD (Chair); J. Sanford Schwartz, MD (Co-Chair); Yen-Pin Chiang, PhD; Marianne C. Fahs, PhD; A. Mark Fendrick, MD; Alan J. Moskowitz, MD; Dev Pathak, PhD; Scott Ramsey, MD, PhD; Steven Sheingold, PhD; A. Laurie Shroyer, PhD; Judith Wagner, PhD; and Roger Yusen, MD.

Cost Effectiveness Data Center, Fred Hutchinson Cancer Research Center, Seattle, WA: Scott Ramsey, MD, PhD (Principal Investigator); Ruth Etzioni, PhD; Sean Sullivan, PhD; Douglas Wood, MD; Thomas Schroeder, MA; Robert Smith, MS; Kristin Berry, MS; and Nancy Myers.

CT Scan Image Storage and Analysis Center, University of Iowa, Iowa City, IA: Eric Hoffman, PhD (Principal Investigator); Janice Cook-Granroth, BS; Angela Delsing, RT; Junfeng Guo, PhD; Geoffrey McLennan, MD; Brian Mullan, MD; Chris Piker, BS; Joseph Reinhardt, PhD; Jered Sieren, RTR; and William Stanford, MD.

Data and Safety Monitoring Board: John A. Waldhausen, MD (Chair); Gordon Bernard, MD; David DeMets, PhD; Mark Ferguson, MD; Eddie Hoover, MD; Robert Levine, MD; Donald Mahler, MD; A. John McSweeny, PhD; Jeanine Wiener-Kronish, MD; O. Dale Williams, PhD; and Magdy Younes, MD.

Marketing Center, Temple University, Philadelphia, PA: Gerard Criner, MD (Principal Investigator); and Charles Soltoff, MBA.

Project Office, National Heart, Lung, and Blood Institute, Bethesda, MD: Gail Weinmann, MD (Project Officer); Joanne Deshler (Contracting Officer); Dean Follmann, PhD; James Kiley, PhD; and Margaret Wu, PhD (from 1996 to 2001).

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