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Published in: BMC Cancer 1/2012

Open Access 01-12-2012 | Research article

Adherence evaluation of endocrine treatment in breast cancer: methodological aspects

Authors: Anne S Oberguggenberger, Monika Sztankay, Beate Beer, Birthe Schubert, Verena Meraner, Herbert Oberacher, Georg Kemmler, Johannes Giesinger, Eva Gamper, Barbara Sperner-Unterweger, Christian Marth, Bernhard Holzner, Michael Hubalek

Published in: BMC Cancer | Issue 1/2012

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Abstract

Background

Current studies on adherence to endocrine therapy in breast cancer patients suffer from methodological limitations due to a lack of well-validated methods for assessing adherence. There is no gold standard for measuring adherence. The aim of our study was to compare four different approaches for evaluating adherence to anastrozole therapy for breast cancer with regard to concordance between methods.

Methods

Outpatients with early breast cancer treated with anastrozole completed the multi-method assessment of adherence. We implemented a self-report scale (the Simplified Medication Adherence Questionnaire), physician- ratings, refill records and determination of anastrozole serum concentration.

Results

Comparison of the four approaches using Spearman rank correlation revealed poor concordance across all methods reflecting weak correlations of 0.2-0.4. Considering this data incomparability across methods, we still observed high adherence rates of 78%-98% across measures.

Conclusion

Our findings contribute to the growing body of knowledge on the impact that methodological aspects exert on the results of adherence measurement in breast cancer patients receiving endocrine treatment. Our findings suggest that the development and validation of instruments specific to patients receiving endocrine agents is imperative in order to arrive at a more accurate assessment and to subsequently obtain more precise estimates of adherence rates in this patient population.
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Literature
1.
go back to reference Cuzick J, Sestak I, Baum M, Buzdar A, Howell A, Dowsett M, Forbes JF, investigators AL: Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncol. 2010, 11 (12): 1135-1141. 10.1016/S1470-2045(10)70257-6.CrossRefPubMed Cuzick J, Sestak I, Baum M, Buzdar A, Howell A, Dowsett M, Forbes JF, investigators AL: Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncol. 2010, 11 (12): 1135-1141. 10.1016/S1470-2045(10)70257-6.CrossRefPubMed
2.
go back to reference Urquhart J: Biological measures. Compliance in Healthcare and Research. edn. Edited by: Ockene LBI. 2001, Futura Publishing Company, New York, 105-117. Urquhart J: Biological measures. Compliance in Healthcare and Research. edn. Edited by: Ockene LBI. 2001, Futura Publishing Company, New York, 105-117.
3.
go back to reference Waterhouse DM, Calzone KA, Mele C, Brenner DE: Adherence to oral tamoxifen: a comparison of patient self-report, pill counts, and microelectronic monitoring. J Clin Oncol. 1993, 11 (6): 1189-1197.PubMed Waterhouse DM, Calzone KA, Mele C, Brenner DE: Adherence to oral tamoxifen: a comparison of patient self-report, pill counts, and microelectronic monitoring. J Clin Oncol. 1993, 11 (6): 1189-1197.PubMed
4.
go back to reference Chlebowski RT, Geller ML: Adherence to endocrine therapy for breast cancer. Oncology. 2006, 71 (1–2): 1-9.PubMed Chlebowski RT, Geller ML: Adherence to endocrine therapy for breast cancer. Oncology. 2006, 71 (1–2): 1-9.PubMed
5.
go back to reference Hershman DL, Shao T, Kushi LH, Buono D, Tsai WY, Fehrenbacher L, Kwan M, Gomez SL, Neugut AI: Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat. 2011, 126 (2): 529-537. 10.1007/s10549-010-1132-4.CrossRefPubMed Hershman DL, Shao T, Kushi LH, Buono D, Tsai WY, Fehrenbacher L, Kwan M, Gomez SL, Neugut AI: Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat. 2011, 126 (2): 529-537. 10.1007/s10549-010-1132-4.CrossRefPubMed
6.
go back to reference Partridge AH: Non-adherence to endocrine therapy for breast cancer. Ann Oncol. 2006, 17 (2): 183-184.CrossRefPubMed Partridge AH: Non-adherence to endocrine therapy for breast cancer. Ann Oncol. 2006, 17 (2): 183-184.CrossRefPubMed
7.
go back to reference Partridge AH, Avorn J, Wang PS, Winer EP: Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst. 2002, 94 (9): 652-61. 10.1093/jnci/94.9.652.CrossRefPubMed Partridge AH, Avorn J, Wang PS, Winer EP: Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst. 2002, 94 (9): 652-61. 10.1093/jnci/94.9.652.CrossRefPubMed
8.
go back to reference WHO: Adherence to long-Âterm therapies, evidence for action. 2003, Marketing and Dissemination, Geneva WHO: Adherence to long-­term therapies, evidence for action. 2003, Marketing and Dissemination, Geneva
9.
go back to reference Dunbar-Jacob J, Mortimer-Stephens MK: Treatment adherence in chronic disease. J Clin Epidemiol. 2001, 54 (Suppl 1): S57-S60.CrossRefPubMed Dunbar-Jacob J, Mortimer-Stephens MK: Treatment adherence in chronic disease. J Clin Epidemiol. 2001, 54 (Suppl 1): S57-S60.CrossRefPubMed
10.
go back to reference DiMatteo MR, Haskard KB: Further challenges in adherence research: measurements, methodologies, and mental health care. Med Care. 2006, 44 (4): 297-299. 10.1097/01.mlr.0000214527.98190.2a.CrossRefPubMed DiMatteo MR, Haskard KB: Further challenges in adherence research: measurements, methodologies, and mental health care. Med Care. 2006, 44 (4): 297-299. 10.1097/01.mlr.0000214527.98190.2a.CrossRefPubMed
11.
go back to reference Osterberg L, Blaschke T: Adherence to medication. N Engl J Med. 2005, 353 (5): 487-497. 10.1056/NEJMra050100.CrossRefPubMed Osterberg L, Blaschke T: Adherence to medication. N Engl J Med. 2005, 353 (5): 487-497. 10.1056/NEJMra050100.CrossRefPubMed
12.
go back to reference DiMatteo MR: Evidence-based strategies to foster adherence and improve patient outcomes. JAAPA. 2004, 17 (11): 18-21.PubMed DiMatteo MR: Evidence-based strategies to foster adherence and improve patient outcomes. JAAPA. 2004, 17 (11): 18-21.PubMed
13.
go back to reference DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW: Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002, 40 (9): 794-811. 10.1097/00005650-200209000-00009.CrossRefPubMed DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW: Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002, 40 (9): 794-811. 10.1097/00005650-200209000-00009.CrossRefPubMed
14.
go back to reference Cantrell CR, Eaddy MT, Shah MB, Regan TS, Sokol MC: Methods for evaluating patient adherence to antidepressant therapy: a real-world comparison of adherence and economic outcomes. Med Care. 2006, 44 (4): 300-303. 10.1097/01.mlr.0000204287.82701.9b.CrossRefPubMed Cantrell CR, Eaddy MT, Shah MB, Regan TS, Sokol MC: Methods for evaluating patient adherence to antidepressant therapy: a real-world comparison of adherence and economic outcomes. Med Care. 2006, 44 (4): 300-303. 10.1097/01.mlr.0000204287.82701.9b.CrossRefPubMed
15.
go back to reference Doggrell SA: Adherence to medicines in the older-aged with chronic conditions: does intervention by an allied health professional help?. Drugs Aging. 2010, 27 (3): 239-254. 10.2165/11532870-000000000-00000.CrossRefPubMed Doggrell SA: Adherence to medicines in the older-aged with chronic conditions: does intervention by an allied health professional help?. Drugs Aging. 2010, 27 (3): 239-254. 10.2165/11532870-000000000-00000.CrossRefPubMed
16.
go back to reference Ziller V, Kalder M, Albert US, Holzhauer W, Ziller M, Wagner U, Hadji P: Adherence to adjuvant endocrine therapy in postmenopausal women with breast cancer. Ann Oncol. 2009, 20 (3): 431-436.CrossRefPubMed Ziller V, Kalder M, Albert US, Holzhauer W, Ziller M, Wagner U, Hadji P: Adherence to adjuvant endocrine therapy in postmenopausal women with breast cancer. Ann Oncol. 2009, 20 (3): 431-436.CrossRefPubMed
17.
go back to reference Oberguggenberger A, Hubalek M, Sztankay M, Meraner V, Beer B, Oberacher H, Giesinger J, Kemmler G, Egle D, Gamper EM, et al: Is the toxicity of adjuvant aromatase inhibitor therapy underestimated? Complementary information from patient-reported outcomes (PROs). Breast Cancer Res Treat. 2011, 128 (2): 553-561. 10.1007/s10549-011-1378-5.CrossRefPubMed Oberguggenberger A, Hubalek M, Sztankay M, Meraner V, Beer B, Oberacher H, Giesinger J, Kemmler G, Egle D, Gamper EM, et al: Is the toxicity of adjuvant aromatase inhibitor therapy underestimated? Complementary information from patient-reported outcomes (PROs). Breast Cancer Res Treat. 2011, 128 (2): 553-561. 10.1007/s10549-011-1378-5.CrossRefPubMed
18.
go back to reference Knobel H, Alonso J, Casado JL, Collazos J, González J, Ruiz I, Kindelan JM, Carmona A, Juega J, Ocampo A, et al: Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study. AIDS. 2002, 16 (4): 605-613. 10.1097/00002030-200203080-00012.CrossRefPubMed Knobel H, Alonso J, Casado JL, Collazos J, González J, Ruiz I, Kindelan JM, Carmona A, Juega J, Ocampo A, et al: Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study. AIDS. 2002, 16 (4): 605-613. 10.1097/00002030-200203080-00012.CrossRefPubMed
19.
go back to reference Morisky DE, Green LW, Levine DM: Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986, 24 (1): 67-74. 10.1097/00005650-198601000-00007.CrossRefPubMed Morisky DE, Green LW, Levine DM: Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986, 24 (1): 67-74. 10.1097/00005650-198601000-00007.CrossRefPubMed
20.
go back to reference DunbarÂJacob J, Sereika S: Conceptual and methodological problems. Compliance in Healthcare and Research. Edited by: Ockene L, Burke I. 2001, Futura Publishing Company, New York, 93-106. Dunbar­Jacob J, Sereika S: Conceptual and methodological problems. Compliance in Healthcare and Research. Edited by: Ockene L, Burke I. 2001, Futura Publishing Company, New York, 93-106.
21.
go back to reference Beer B, Schubert B, Oberguggenberger A, Meraner V, Hubalek M, Oberacher H: Development and validation of a liquid chromatography-tandem mass spectrometry method for the simultaneous quantification of tamoxifen, anastrozole, and letrozole in human plasma and its application to a clinical study. Anal Bioanal Chem. 2010, 398 (4): 1791-1800. 10.1007/s00216-010-4075-z.CrossRefPubMed Beer B, Schubert B, Oberguggenberger A, Meraner V, Hubalek M, Oberacher H: Development and validation of a liquid chromatography-tandem mass spectrometry method for the simultaneous quantification of tamoxifen, anastrozole, and letrozole in human plasma and its application to a clinical study. Anal Bioanal Chem. 2010, 398 (4): 1791-1800. 10.1007/s00216-010-4075-z.CrossRefPubMed
22.
go back to reference DiMatteo MR, Haskard KB, Williams SL: Health beliefs, disease severity, and patient adherence: a meta-analysis. Med Care. 2007, 45 (6): 521-528. 10.1097/MLR.0b013e318032937e.CrossRefPubMed DiMatteo MR, Haskard KB, Williams SL: Health beliefs, disease severity, and patient adherence: a meta-analysis. Med Care. 2007, 45 (6): 521-528. 10.1097/MLR.0b013e318032937e.CrossRefPubMed
23.
go back to reference Hershman DL, Kushi LH, Shao T, Buono D, Kershenbaum A, Tsai WY, Fehrenbacher L: Lin Gomez S, Miles S, Neugut AI: Early discontinuation and nonadherence to adjuvant hormonal therapy in a cohort of 8,769 early-stage breast cancer patients. J Clin Oncol. 2010, 28 (27): 4120-4128. 10.1200/JCO.2009.25.9655.CrossRefPubMedPubMedCentral Hershman DL, Kushi LH, Shao T, Buono D, Kershenbaum A, Tsai WY, Fehrenbacher L: Lin Gomez S, Miles S, Neugut AI: Early discontinuation and nonadherence to adjuvant hormonal therapy in a cohort of 8,769 early-stage breast cancer patients. J Clin Oncol. 2010, 28 (27): 4120-4128. 10.1200/JCO.2009.25.9655.CrossRefPubMedPubMedCentral
24.
go back to reference Huiart L, Dell'Aniello S, Suissa S: Use of tamoxifen and aromatase inhibitors in a large population-based cohort of women with breast cancer. Br J Cancer. 2011, 104 (10): 1558-1563. 10.1038/bjc.2011.140.CrossRefPubMedPubMedCentral Huiart L, Dell'Aniello S, Suissa S: Use of tamoxifen and aromatase inhibitors in a large population-based cohort of women with breast cancer. Br J Cancer. 2011, 104 (10): 1558-1563. 10.1038/bjc.2011.140.CrossRefPubMedPubMedCentral
25.
go back to reference Dunbar-Â‐Jacob J, et al: Comparability of self-Â‐report, pill count and electronically monitored adherence data. Controlled Clinical Trials. 1996, 12 (Supplement 2): Dunbar-­‐Jacob J, et al: Comparability of self-­‐report, pill count and electronically monitored adherence data. Controlled Clinical Trials. 1996, 12 (Supplement 2):
26.
go back to reference Ziller V, Wetzel K, Kyvernitakis I, Seker-Pektas B, Hadji P: Adherence and persistence in patients with postmenopausal osteoporosis treated with raloxifene. Climacteric. 2011, 14 (2): 228-235. 10.3109/13697137.2010.514628.CrossRefPubMed Ziller V, Wetzel K, Kyvernitakis I, Seker-Pektas B, Hadji P: Adherence and persistence in patients with postmenopausal osteoporosis treated with raloxifene. Climacteric. 2011, 14 (2): 228-235. 10.3109/13697137.2010.514628.CrossRefPubMed
27.
go back to reference Larson ME, Richards TM: Quantification of a methadone metabolite (EDDP) in urine: assessment of compliance. Clin Med Res. 2009, 7 (4): 134-141. 10.3121/cmr.2009.859.CrossRefPubMedPubMedCentral Larson ME, Richards TM: Quantification of a methadone metabolite (EDDP) in urine: assessment of compliance. Clin Med Res. 2009, 7 (4): 134-141. 10.3121/cmr.2009.859.CrossRefPubMedPubMedCentral
28.
go back to reference van Rossum AM, Bergshoeff AS, Fraaij PL, Hugen PW, Hartwig NG, Geelen SP, Wolfs TF, Weemaes CM, De Groot R, Burger DM: Therapeutic drug monitoring of indinavir and nelfinavir to assess adherence to therapy in human immunodeficiency virus-infected children. Pediatr Infect Dis J. 2002, 21 (8): 743-747. 10.1097/00006454-200208000-00009.CrossRefPubMed van Rossum AM, Bergshoeff AS, Fraaij PL, Hugen PW, Hartwig NG, Geelen SP, Wolfs TF, Weemaes CM, De Groot R, Burger DM: Therapeutic drug monitoring of indinavir and nelfinavir to assess adherence to therapy in human immunodeficiency virus-infected children. Pediatr Infect Dis J. 2002, 21 (8): 743-747. 10.1097/00006454-200208000-00009.CrossRefPubMed
29.
go back to reference Yates RA, Dowsett M, Fisher GV, Selen A, Wyld PJ: Arimidex (ZD1033): a selective, potent inhibitor of aromatase in postmenopausal female volunteers. Br J Cancer. 1996, 73 (4): 543-548. 10.1038/bjc.1996.94.CrossRefPubMedPubMedCentral Yates RA, Dowsett M, Fisher GV, Selen A, Wyld PJ: Arimidex (ZD1033): a selective, potent inhibitor of aromatase in postmenopausal female volunteers. Br J Cancer. 1996, 73 (4): 543-548. 10.1038/bjc.1996.94.CrossRefPubMedPubMedCentral
30.
go back to reference Farmer KC: Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther. 1999, 21 (6): 1074-1090. 10.1016/S0149-2918(99)80026-5. discussion 1073CrossRefPubMed Farmer KC: Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther. 1999, 21 (6): 1074-1090. 10.1016/S0149-2918(99)80026-5. discussion 1073CrossRefPubMed
31.
go back to reference Fink AK, Gurwitz J, Rakowski W, Guadagnoli E, Silliman RA: Patient beliefs and tamoxifen discontinuance in older women with estrogen receptor–positive breast cancer. J Clin Oncol. 2004, 22 (16): 3309-3315. 10.1200/JCO.2004.11.064.CrossRefPubMed Fink AK, Gurwitz J, Rakowski W, Guadagnoli E, Silliman RA: Patient beliefs and tamoxifen discontinuance in older women with estrogen receptor–positive breast cancer. J Clin Oncol. 2004, 22 (16): 3309-3315. 10.1200/JCO.2004.11.064.CrossRefPubMed
32.
go back to reference Demissie S, Silliman RA, Lash TL: Adjuvant tamoxifen: predictors of use, side effects, and discontinuation in older women. J Clin Oncol. 2001, 19 (2): 322-328.PubMed Demissie S, Silliman RA, Lash TL: Adjuvant tamoxifen: predictors of use, side effects, and discontinuation in older women. J Clin Oncol. 2001, 19 (2): 322-328.PubMed
33.
go back to reference Kahn KL, Schneider EC, Malin JL, Adams JL, Epstein AM: Patient centered experiences in breast cancer: predicting long-term adherence to tamoxifen use. Med Care. 2007, 45 (5): 431-439. 10.1097/01.mlr.0000257193.10760.7f.CrossRefPubMed Kahn KL, Schneider EC, Malin JL, Adams JL, Epstein AM: Patient centered experiences in breast cancer: predicting long-term adherence to tamoxifen use. Med Care. 2007, 45 (5): 431-439. 10.1097/01.mlr.0000257193.10760.7f.CrossRefPubMed
34.
go back to reference Murthy V, Bharia G, Sarin R: Tamoxifen non-compliance: does it matter?. Lancet Oncol. 2002, 3 (11): 654-10.1016/S1470-2045(02)00895-1.CrossRefPubMed Murthy V, Bharia G, Sarin R: Tamoxifen non-compliance: does it matter?. Lancet Oncol. 2002, 3 (11): 654-10.1016/S1470-2045(02)00895-1.CrossRefPubMed
35.
go back to reference Miller LG, Hays RD: Measuring adherence to antiretroviral medications in clinical trials. HIV Clin Trials. 2000, 1 (1): 36-46. 10.1310/ENXW-95PB-5NGW-1F40.CrossRefPubMed Miller LG, Hays RD: Measuring adherence to antiretroviral medications in clinical trials. HIV Clin Trials. 2000, 1 (1): 36-46. 10.1310/ENXW-95PB-5NGW-1F40.CrossRefPubMed
36.
go back to reference Clayton CD, Veach J, Macfadden W, Haskins J, Docherty JP, Lindenmayer JP: Assessment of clinician awareness of nonadherence using a new structured rating scale. J Psychiatr Pract. 2010, 16 (3): 164-169. 10.1097/01.pra.0000375712.85454.c6.CrossRefPubMed Clayton CD, Veach J, Macfadden W, Haskins J, Docherty JP, Lindenmayer JP: Assessment of clinician awareness of nonadherence using a new structured rating scale. J Psychiatr Pract. 2010, 16 (3): 164-169. 10.1097/01.pra.0000375712.85454.c6.CrossRefPubMed
37.
go back to reference Hugen PW, Langebeek N, Burger DM, Zomer B, van Leusen R, Schuurman R, Koopmans PP, Hekster YA: Assessment of adherence to HIV protease inhibitors: comparison and combination of various methods, including MEMS (electronic monitoring), patient and nurse report, and therapeutic drug monitoring. J Acquir Immune Defic Syndr. 2002, 30 (3): 324-334.CrossRefPubMed Hugen PW, Langebeek N, Burger DM, Zomer B, van Leusen R, Schuurman R, Koopmans PP, Hekster YA: Assessment of adherence to HIV protease inhibitors: comparison and combination of various methods, including MEMS (electronic monitoring), patient and nurse report, and therapeutic drug monitoring. J Acquir Immune Defic Syndr. 2002, 30 (3): 324-334.CrossRefPubMed
Metadata
Title
Adherence evaluation of endocrine treatment in breast cancer: methodological aspects
Authors
Anne S Oberguggenberger
Monika Sztankay
Beate Beer
Birthe Schubert
Verena Meraner
Herbert Oberacher
Georg Kemmler
Johannes Giesinger
Eva Gamper
Barbara Sperner-Unterweger
Christian Marth
Bernhard Holzner
Michael Hubalek
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2012
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-12-474

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