Journal of General Internal Medicine

, Volume 9, Issue 2, pp 96–105

Patient compliance and medical research

Issues in methodology
  • Joy Melnikow
  • Catarina Kiefe
Clinical Reviews

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Feinstein AR. On white-coat effects and the electronic monitoring of compliance. Arch Intern Med. 1990;150:1377–8.PubMedCrossRefGoogle Scholar
  2. 2.
    Agras WS. Understanding compliance with the medical regimen: the scope of the problem and a theoretical perspective. Arthritis Care Res. 1989;2(suppl):S2-S7.PubMedCrossRefGoogle Scholar
  3. 3.
    Haynes RB. Introduction. In: Haynes RB, Taylor DW, Sackett DL (eds). Compliance in Health Care. Baltimore: Johns Hopkins University Press, 1979;1–7.Google Scholar
  4. 4.
    Steiner JF, Fihn SD, Blair B, Inui TS. Appropriate reductions in compliance among well-controlled hypertensive patients. J Clin Epidemiol. 1991;44:1361–71.PubMedCrossRefGoogle Scholar
  5. 5.
    Sackett DL. A compliance practicum for the busy practitioner. In: Haynes RB, Taylor DW, Sackett DL (eds). Compliance in Health Care. Baltimore: Johns Hopkins University Press, 1979;121.Google Scholar
  6. 6.
    Meichenbaum D, Turk DC. Facilitating Treatment Adherence: A Practitioner’s Guidebook. New York: Plenum Press, 1987;21, 44–5.Google Scholar
  7. 7.
    Haynes RB, Dantes R. Patient compliance and the conduct and interpretation of therapeutic trials. Controlled Clin Trials. 1987;8:12–9.PubMedCrossRefGoogle Scholar
  8. 8.
    Goldsmith CH. The effect of compliance distributions on therapeutic trials. In: Haynes RB, Taylor DW, Sackett DL (eds). Compliance in Health Care. Baltimore: Johns Hopkins University Press, 1979;297–308.Google Scholar
  9. 9.
    Lang JM, Buring JE, Rosner B, Cook N, Hennekens CH. Estimating the effect of the run-in on the power of the Physicians’ Health Study. Stat Med. 1991;10:1585–93.PubMedGoogle Scholar
  10. 10.
    Maenpaa H, Manninen V, Heinonen OP. Compliance with medication in the Helsinki Heart Study. Eur J Clin Pharmacol. 1992;42:15–9.PubMedCrossRefGoogle Scholar
  11. 11.
    Maenpaa H, Manninen V, Heinonen OP. Comparison of the digoxin marker with capsule counting and compliance questionnaire methods for measuring compliance to medication in a clinical trial. Eur Heart J. 1987;8:39–43.PubMedGoogle Scholar
  12. 12.
    Caron HS. Compliance: the case for objective measurement. J Hypertens. 1985;3(suppl 1):11–7.Google Scholar
  13. 13.
    Gordon ME, Kass MA. Validity of standard compliance measures in glaucoma compared with an electronic eyedrop monitor. In: Cramer JA, Spilker B (eds). Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press, 1991;163–73.Google Scholar
  14. 14.
    Fletcher W, Pappius EM, Harper SJ. Measurement of medication compliance in a clinical setting. Arch Intern Med. 1979;139:635–8.PubMedCrossRefGoogle Scholar
  15. 15.
    Sackett DL, Haynes RB, Guyatt G, Tugwell P. Clinical Epidemiology, 2nd ed. Boston: Little, Brown, 1991;258–61.Google Scholar
  16. 16.
    Pullar T, Kumar S, Tindall H, Feely M. Time to stop counting tablets? Clin Pharmacol Ther. 1989;46:163–8.PubMedCrossRefGoogle Scholar
  17. 17.
    Rudd P, Ahmed S, Zachary V, Barton C, Bondoelle D. Improved compliance measures: applications in an ambulatory hypertensive trial. Clin Pharmacol Ther. 1990;48:676–85.PubMedCrossRefGoogle Scholar
  18. 18.
    Haynes RB, Gibson ES, Hackett BC, et al. Improvement of medication compliance in uncontrolled hypertension. Lancet. 1976;I:1265–8.CrossRefGoogle Scholar
  19. 19.
    Spilker B. Methods of assessing and improving patient compliance in clinical trials. In: Cramer JA, Spilker B (eds). Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press, 1991;37–56.Google Scholar
  20. 20.
    Cramer JA, Scheyer RD, Mattson RH. Compliance declines between clinic visits. Arch Intern Med. 1990;150:1509–10.PubMedCrossRefGoogle Scholar
  21. 21.
    Johnson CE, Carlin SA, Super DM, et al. Cefixime compared with amoxicillin for treatment of acute otitis media. J Pediatr. 1991;119:117–22.PubMedCrossRefGoogle Scholar
  22. 22.
    Cramer JA. Overview of methods to measure and enhance patient compliance. In: Cramer JA, Spilker B (eds). Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press, 1991;3–10.Google Scholar
  23. 23.
    Cramer JA, Mattson RH, Prevey ML, Scheyer RD, Ouellette VL. How often is medication taken as prescribed? JAMA. 1989;261:3273–7.PubMedCrossRefGoogle Scholar
  24. 24.
    Cheung R, Sullen CM, Seal D, et al. The paradox of using a 7 day antibacterial course to treat urinary tract infections in the community. Br J Clin Pharmacol. 1988;26:391–8.PubMedGoogle Scholar
  25. 25.
    Spector SL, Mawhinny H. Aerosol inhaler monitoring of asthmatic medication. In: Cramer JA, Spilker B (eds). Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press, 1991;149–62.Google Scholar
  26. 26.
    Kruse W, Weber E. Dynamics of drug regimen compliance-its assessment by microprocessor-based monitoring. Eur J Clin Pharmacol. 1990;38:561–5.PubMedCrossRefGoogle Scholar
  27. 27.
    Kruse W, Eggert-Kruse W, Rampmaier J, Runnebaum B, Weber E. Compliance with short-term high-dose ethinyl oestradiol in young patients with primary infertility. New insights from the use of electronic devices. In: AAS 29: Risk Factors for Adverse Drug Actions. Basel: Birkhauser Verlag, 1990;105–15.Google Scholar
  28. 28.
    Olivieri NF, Matsui D, Hermann C, Koren G. Compliance assessed by the medication event monitoring system. Arch Dis Child. 1991;66:1399–402.PubMedGoogle Scholar
  29. 29.
    Eisen SA, Woodward RS, Miller D, Spitznagel E, Windham CA. The effect of medication compliance on the control of hypertension. J Gen Intern Med. 1987;2:298–305.PubMedCrossRefGoogle Scholar
  30. 30.
    Rudd P, Ahmed S, Zachary V, Barton C, Bondelle D. Compliance with medication timing: implications from a medication trial for drug development and clinical practice. J Clin Res Pharmaco-epidemiol. 1992;6:15–27.Google Scholar
  31. 31.
    Probstfield JL. Clinical trial prerandomization compliance (adherence) screen. In: Cramer JA, Spilker B (eds). Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press, 1991;323–33.Google Scholar
  32. 32.
    Sackett DL, Gent M. Controversy in counting and attributing events in clinical trials. N Engl J Med. 1979;30l:1410–2.CrossRefGoogle Scholar
  33. 33.
    Katz R. Regulatory view: use of subgroup data for determination of efficacy. In: Cramer JA, Spilker B (eds). Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press, 1991;251–63.Google Scholar
  34. 34.
    Feinstein A. Intent-to-treat policy for analyzing randomized trials: statistical distortions and neglected clinical challenges. In: Cramer JA, Spilker B (eds). Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press, 1991;359–70.Google Scholar
  35. 35.
    Hasford J. Biometric issues in measuring and analyzing partial compliance in clinical trials. In: Cramer JA, Spilker B (eds). Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press, 1991;265–81.Google Scholar
  36. 36.
    Lasagna L, Hutt PB. Health care, research, and regulatory impact of noncompliance. In: Cramer JA, Spilker B (eds). Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press, 1991;393–403.Google Scholar
  37. 37.
    Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial Results II: the relationship of reduction in incidence of coronary heart disease to cholesterol lowering. JAMA. 1984;251:365–74.CrossRefGoogle Scholar
  38. 38.
    Cohen SJ (ed). New Directions in Patient Compliance. Lexington, MA: Lexington Books, 1979.Google Scholar
  39. 39.
    Sackett DL, Haynes RB (eds). Compliance with Therapeutic Regimens. Baltimore: Johns Hopkins University Press, 1976.Google Scholar
  40. 40.
    Peck CL, King NJ. Increasing patient compliance with prescriptions. JAMA. 1982;248:2874–7.PubMedCrossRefGoogle Scholar
  41. 41.
    Eraker SA, Kirscht JP, Becker MH. Understanding and improving patient compliance. Ann Intern Med. 1984;100:258–68.PubMedGoogle Scholar
  42. 42.
    Fletcher RH. Patient compliance with therapeutic advice: a modern view. Mt Sinai J Med (NY). 1989;56:453–8.Google Scholar
  43. 43.
    Pullar T, Birtwell AJ, Wiles PG, Hay A, Feely MP. Use of a pharmacologic indicator to compare compliance with tablets prescribed to be taken once, twice, or three times daily. Clin Pharmacol Ther. 1988;44:540–5.PubMedCrossRefGoogle Scholar
  44. 44.
    Eisen SA, Miller DK, Woodward RS, Spitznagel E, Przybeck TR. The effect of prescribed daily dose frequency on patient medication compliance. Arch Intern Med. 1990;150:1881–4.PubMedCrossRefGoogle Scholar
  45. 45.
    Clark LT. Improving compliance and increasing control of hypertension: needs of special hypertensive populations. Am Heart J. 1991;121:664–9.PubMedCrossRefGoogle Scholar
  46. 46.
    Rudd P. Medication packaging: simple solutions to non-adherence problems. Clin Pharmacol Ther. 1979;25:257–65.PubMedGoogle Scholar
  47. 47.
    Lima J, Nazarian L, Charney E, Lahti C. Compliance with short-term antimicrobial therapy: some techniques that help. Pediatrics. 1976;57:383–6.PubMedGoogle Scholar
  48. 48.
    Morris LA, Halperin JA. Effects of written drug information on patient knowledge and compliance: a literature review. Am J Public Health. 1979;69:47–52.PubMedGoogle Scholar
  49. 49.
    Samet JH, Libman H, Steger KA, et al. Compliance with zidovudine therapy in patients infected with human immunodeficiency virus, type 1: a cross-sectional study in a municipal hospital clinic. Am J Med. 1992;92:495–502.PubMedCrossRefGoogle Scholar
  50. 50.
    McKenney JM, Munroe WP, Wright JT Jr. Impact of an electronic medication compliance aid on long-term blood pressure control. J Clin Pharmacol. 1992;32:277–83.PubMedGoogle Scholar
  51. 51.
    Norell SE. Improving medication compliance: a randomized clinical trial. BMJ. 1979;2:1031–3.PubMedGoogle Scholar
  52. 52.
    Sackett DL, Haynes RB, Gibson ES, et al. Randomized clinical trial of strategies for improving medication compliance in primary hypertension. Lancet. 1975;1:1205–7.PubMedCrossRefGoogle Scholar
  53. 53.
    Inui TS, Yourtee EL, Williamson JW. Improved outcomes in hypertension after physician tutorials: a controlled trial. Ann Intern Med. 1976;84:646–51.PubMedGoogle Scholar
  54. 54.
    Epstein LH. The direct effects of compliance on health outcome. Health Psychol. 1984;3:385–93.PubMedCrossRefGoogle Scholar
  55. 55.
    Efron B, Feldman D. Compliance as an explanatory variable in clinical trials. J Am Stat Assoc. 1991;86:9–26.CrossRefGoogle Scholar
  56. 56.
    Frick MH, Elo O, Haapa K, et al. Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia. N Engl J Med. 1987;317:1237–45.PubMedCrossRefGoogle Scholar
  57. 57.
    Horowitz RI, Viscoli CM, Berkman L, et al. Treatment adherence and risk of death after a myocardial infarction. Lancet. 1990;336:542–5.CrossRefGoogle Scholar
  58. 58.
    Dorus W, Ostrow DG, Anton R, et al. Lithium treatment of depressed and nondepressed alcoholics. JAMA. 1989;262:1646–52.PubMedCrossRefGoogle Scholar
  59. 59.
    Urquhart J. Patient compliance as an explanatory variable in four selected cardiovascular studies. In: Cramer JA, Spilker B (eds). Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press, 1991;301–22.Google Scholar
  60. 60.
    Packer M. The placebo effect in heart failure. Am Heart J. 1990;120:1579–82.PubMedCrossRefGoogle Scholar
  61. 61.
    Lavin MR. Placebo effects on mind and body. JAMA. 1991;265:1753–4.PubMedCrossRefGoogle Scholar
  62. 62.
    Kessner DM. Infant death, an analysis by maternal risk and health care. In: Contrasts in Health Status, Vol. 1. Washington, DC: National Academy of Science, 1973.Google Scholar
  63. 63.
    Roth HP, Caron HS, Hsi BP. Estimating a patient’s cooperation with his regimen. Am J Med Sci. 1971;262:269–73.PubMedCrossRefGoogle Scholar
  64. 64.
    Davis KL, Estess FM, Simonton SC, et al. Effects of payment mode on clinic attendance and rehospitalization. Am J Psychol. 1977;134:576–8.Google Scholar
  65. 65.
    Orlinsky N, D’Elia E. Rehospitalization of the schizophrenic patient. Arch Gen Psychiatry. 1964;10:71–8.Google Scholar
  66. 66.
    Bigby JA, Pappius E, Cook EF, Goldman L. Medical consequences of missed appointments. Arch Intern Med. 1984;144:1163–6.PubMedCrossRefGoogle Scholar
  67. 67.
    Gortmaker SL. The effects of prenatal care on the health of the newborn. Am J Public Health. 1979;69:653–60.PubMedGoogle Scholar
  68. 68.
    Leveno KJ, Cunningham FG, Roark ML, et al. Prenatal care and the low birth weight infant. Obstet Gynecol. 1985;66:599–605.PubMedGoogle Scholar
  69. 69.
    Goldman L, Freidin R, Cook EF, Eigner J, Grich P. A multivariate approach to the prediction of no-show behavior in a primary care center. Arch Intern Med. 1982;142:563–7.PubMedCrossRefGoogle Scholar
  70. 70.
    Gates SJ, Colborn DK. Lowering appointment failures in a neighborhood health center. Med Care. 1976;14:263–7.PubMedCrossRefGoogle Scholar
  71. 71.
    Greenlick MR, Freeborn DK, Colombo TJ, et al. Comparing the use of medical care services by a medically indigent and a general membership population in a comprehensive prepaid group practice program. Med Care. 1972;10:187–200.PubMedCrossRefGoogle Scholar
  72. 72.
    Fiester AR, Rudestam KE. A multivariate analysis of the early dropout process. J Consult Clin Psychol. 1975;43:528–35.PubMedCrossRefGoogle Scholar
  73. 73.
    Deyo RA, Inui TS. Dropouts and broken appointments-a literature review and agenda for future research. Med Care. 1980;18:1146–57.PubMedCrossRefGoogle Scholar
  74. 74.
    Gruzd DC, Shear CL, Rodney WM. Determinants of no-show appointment behavior: the utility of multivariate analysis. Fam Med. 1986;18:217–20.PubMedGoogle Scholar
  75. 75.
    Frankel S, Farrow A, West R. Non-attendance or non-invitation? A case-control study of failed outpatient appointments. BMJ. 1989;298:1343–5.PubMedCrossRefGoogle Scholar
  76. 76.
    Dove HG, Schneider KC. The usefulness of patients’ individual characteristics in predicting no-shows in outpatient clinics. Med Care. 1981;19:734–40.PubMedCrossRefGoogle Scholar
  77. 77.
    Steinwachs DM. Measuring provider continuity in ambulatory care: as assessment of alternative approaches. Med Care. 1979;551–65.Google Scholar
  78. 78.
    Hermoni D, Mankuta D, Reis S. Failure to keep appointments at a community health centre-analysis of causes. Scand J Prim Healthcare. 1990;8:151–5.Google Scholar
  79. 79.
    Whitcher-Alagna S. Receiving medical help: a psychosocial perspective on patient reactions. In: Nadler A, Fisher JD, DePaulo BM. New Directions in Helping. New York: Academic Press, 1983.Google Scholar
  80. 80.
    Dunbar JM, Agras WS. Compliance with medical instructions. In: Ferguson JM, Taylor CB (eds). Comprehensive Handbook of Behavioral Medicine. New York: Spectrum, 1980.Google Scholar
  81. 81.
    Benjamin-Bauman J, Reiss ML, Bailey JS. Increasing appointment keeping by reducing the call-appointment interval. J Appl Behav Anal. 1984;17:295–301.PubMedCrossRefGoogle Scholar
  82. 82.
    Finnerty FA Jr, Mattie EC, Finnerty FA 3rd. Hypertension in the inner city. I. Analysis of clinic dropouts. Circulation. 1973;47:73–5.PubMedGoogle Scholar
  83. 83.
    Rosenblut A, Jonas S, Wassertheil S, et al. OPD waiting time reduced by use of an individual appointment system. Hosp Topics. 1972;49–53.Google Scholar
  84. 84.
    Oppenheim GL, Bergman JJ, English EC. Failed appointments: a review. J Fam Pract. 1979;8:789.PubMedGoogle Scholar
  85. 85.
    Hurtado AV, Greenlick MR, Colombo TJ. Determinants of medical care utilization: failure to keep appointments. Med Care. 1973;11:189–98.PubMedCrossRefGoogle Scholar
  86. 86.
    Kiefe C, Harrison P. Post-hospitalization followup appointment-keeping among the medically indigent. J. Community Health. 1993;18:271–82.PubMedCrossRefGoogle Scholar
  87. 87.
    Cohen SJ. New metaphors for old problems. In: Cohen SJ (ed). New Directions in Patient Compliance. Lexington, MA: Lexington Books, 1979;153–63.Google Scholar
  88. 88.
    Probstfield JL, Russell ML, Insull W, Yusuf S. Dropouts for a clinical trial, their recovery and characterization: a basis for dropout management and prevention. In: Health Behavior Change Handbook. New York: Springer, 1990;376–400.Google Scholar
  89. 89.
    Cramer JA, Collins JF, Mattson RH. Can categorization of patient background problems be used to determine early termination in a clinical trial? Controlled Clin Trials. 1988;9:47–63.PubMedCrossRefGoogle Scholar
  90. 90.
    Fletcher SW, Appel FA, Bourgois M. Improving emergency-room patient follow-up in a metropolitan teaching hospital. Effect of a follow-up clerk. N Engl J Med. 1974;291:385–8.PubMedCrossRefGoogle Scholar
  91. 91.
    Bigby JA, Giblin J, Pappius EM, Goldman L. Appointment reminders to reduce no-show rates-a stratified analysis of their cost-effectiveness. JAMA. 1983;250:1742–5.PubMedCrossRefGoogle Scholar
  92. 92.
    Grover S, Gagnon G, Flegel KM, Hoey JR. Improving appointment-keeping by patients new to a hospital medical clinic with telephone or mail reminders. Can Med Assoc J. 1983;129:1101–3.PubMedGoogle Scholar
  93. 93.
    Macharia WM, Leon G, Rowe BH, Stephenson BJ, Haynes RB. An overview of interventions to improve compliance with appointment keeping for medical services. JAMA. 1992;267:1813–7.PubMedCrossRefGoogle Scholar
  94. 94.
    Schroeder SA. Lowering broken appointment rates at a medical clinic. Med Care. 1973;11:75–8.PubMedCrossRefGoogle Scholar
  95. 95.
    Morse DL, Coulter MP, Nazarian LF, et al. Waning effectiveness of mailed reminders on reducing broken appointments. Pediatrics. 1981;68:846–9.PubMedGoogle Scholar
  96. 96.
    Smith PB, Weinman ML, Johnson TC, Wait RB. Incentives and their influence on appointment compliance in a teenage family-planning clinic. J Adolesc Health Care. 1990;11:445–8.PubMedCrossRefGoogle Scholar
  97. 97.
    Reuss ML, Piotrowski WD, Bailey JS. Behavioral community psychology: encouraging low-income parents to seek dental care for their children. J Appl Behav Anal. 1976;9:387–97.CrossRefGoogle Scholar
  98. 98.
    Ossip-Klein DJ, Vanlandingham W, Prue DM, Rychtarik RG. Increasing attendance at alcohol aftercare using calendar prompts and home-based contracting. Addict Behav. 1984;9:85–9.PubMedCrossRefGoogle Scholar
  99. 99.
    Levy RL, Clark H. The use of an overt commitment to enhance compliance: a cautionary note. J Behav Ther Exp Psychiatry. 1980;11:105–7.CrossRefGoogle Scholar
  100. 100.
    Barry SP, Daniels AA. Effecting change in outpatient failed appointments. J Fam Pract. 1984;18:739–42.PubMedGoogle Scholar

Copyright information

© Society of General Internal Medicine 1994

Authors and Affiliations

  • Joy Melnikow
    • 1
  • Catarina Kiefe
    • 2
  1. 1.the Department of Family PracticeUniversity of California-DavisSacramento
  2. 2.the Department of Medicine, Division of Preventive MedicineUniversity of Alabama at BirminghamBirmingham

Personalised recommendations