Skip to main content
SpringerLink
Log in

Patient compliance and medical research

Issues in methodology

  • Clinical Reviews
  • Published:
Journal of General Internal Medicine Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

References

  1. Feinstein AR. On white-coat effects and the electronic monitoring of compliance. Arch Intern Med. 1990;150:1377–8.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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. Steiner JF, Fihn SD, Blair B, Inui TS. Appropriate reductions in compliance among well-controlled hypertensive patients. J Clin Epidemiol. 1991;44:1361–71.

    Article  PubMed  CAS  Google Scholar 

  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. Meichenbaum D, Turk DC. Facilitating Treatment Adherence: A Practitioner’s Guidebook. New York: Plenum Press, 1987;21, 44–5.

    Google Scholar 

  7. Haynes RB, Dantes R. Patient compliance and the conduct and interpretation of therapeutic trials. Controlled Clin Trials. 1987;8:12–9.

    Article  PubMed  CAS  Google Scholar 

  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. 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.

    PubMed  CAS  Google Scholar 

  10. Maenpaa H, Manninen V, Heinonen OP. Compliance with medication in the Helsinki Heart Study. Eur J Clin Pharmacol. 1992;42:15–9.

    Article  PubMed  CAS  Google Scholar 

  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.

    PubMed  Google Scholar 

  12. Caron HS. Compliance: the case for objective measurement. J Hypertens. 1985;3(suppl 1):11–7.

    Google Scholar 

  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. Fletcher W, Pappius EM, Harper SJ. Measurement of medication compliance in a clinical setting. Arch Intern Med. 1979;139:635–8.

    Article  PubMed  CAS  Google Scholar 

  15. Sackett DL, Haynes RB, Guyatt G, Tugwell P. Clinical Epidemiology, 2nd ed. Boston: Little, Brown, 1991;258–61.

    Google Scholar 

  16. Pullar T, Kumar S, Tindall H, Feely M. Time to stop counting tablets? Clin Pharmacol Ther. 1989;46:163–8.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  18. Haynes RB, Gibson ES, Hackett BC, et al. Improvement of medication compliance in uncontrolled hypertension. Lancet. 1976;I:1265–8.

    Article  Google Scholar 

  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. Cramer JA, Scheyer RD, Mattson RH. Compliance declines between clinic visits. Arch Intern Med. 1990;150:1509–10.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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. Cramer JA, Mattson RH, Prevey ML, Scheyer RD, Ouellette VL. How often is medication taken as prescribed? JAMA. 1989;261:3273–7.

    Article  PubMed  CAS  Google Scholar 

  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.

    PubMed  CAS  Google Scholar 

  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. Kruse W, Weber E. Dynamics of drug regimen compliance-its assessment by microprocessor-based monitoring. Eur J Clin Pharmacol. 1990;38:561–5.

    Article  PubMed  CAS  Google Scholar 

  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. Olivieri NF, Matsui D, Hermann C, Koren G. Compliance assessed by the medication event monitoring system. Arch Dis Child. 1991;66:1399–402.

    PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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. 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. Sackett DL, Gent M. Controversy in counting and attributing events in clinical trials. N Engl J Med. 1979;30l:1410–2.

    Article  Google Scholar 

  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. 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. 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. 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. 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.

    Article  Google Scholar 

  38. Cohen SJ (ed). New Directions in Patient Compliance. Lexington, MA: Lexington Books, 1979.

    Google Scholar 

  39. Sackett DL, Haynes RB (eds). Compliance with Therapeutic Regimens. Baltimore: Johns Hopkins University Press, 1976.

    Google Scholar 

  40. Peck CL, King NJ. Increasing patient compliance with prescriptions. JAMA. 1982;248:2874–7.

    Article  PubMed  CAS  Google Scholar 

  41. Eraker SA, Kirscht JP, Becker MH. Understanding and improving patient compliance. Ann Intern Med. 1984;100:258–68.

    PubMed  CAS  Google Scholar 

  42. Fletcher RH. Patient compliance with therapeutic advice: a modern view. Mt Sinai J Med (NY). 1989;56:453–8.

    CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  45. Clark LT. Improving compliance and increasing control of hypertension: needs of special hypertensive populations. Am Heart J. 1991;121:664–9.

    Article  PubMed  CAS  Google Scholar 

  46. Rudd P. Medication packaging: simple solutions to non-adherence problems. Clin Pharmacol Ther. 1979;25:257–65.

    PubMed  CAS  Google Scholar 

  47. Lima J, Nazarian L, Charney E, Lahti C. Compliance with short-term antimicrobial therapy: some techniques that help. Pediatrics. 1976;57:383–6.

    PubMed  CAS  Google Scholar 

  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.

    PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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.

    PubMed  CAS  Google Scholar 

  51. Norell SE. Improving medication compliance: a randomized clinical trial. BMJ. 1979;2:1031–3.

    PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  53. Inui TS, Yourtee EL, Williamson JW. Improved outcomes in hypertension after physician tutorials: a controlled trial. Ann Intern Med. 1976;84:646–51.

    PubMed  CAS  Google Scholar 

  54. Epstein LH. The direct effects of compliance on health outcome. Health Psychol. 1984;3:385–93.

    Article  PubMed  CAS  Google Scholar 

  55. Efron B, Feldman D. Compliance as an explanatory variable in clinical trials. J Am Stat Assoc. 1991;86:9–26.

    Article  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  57. Horowitz RI, Viscoli CM, Berkman L, et al. Treatment adherence and risk of death after a myocardial infarction. Lancet. 1990;336:542–5.

    Article  Google Scholar 

  58. Dorus W, Ostrow DG, Anton R, et al. Lithium treatment of depressed and nondepressed alcoholics. JAMA. 1989;262:1646–52.

    Article  PubMed  CAS  Google Scholar 

  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. Packer M. The placebo effect in heart failure. Am Heart J. 1990;120:1579–82.

    Article  PubMed  CAS  Google Scholar 

  61. Lavin MR. Placebo effects on mind and body. JAMA. 1991;265:1753–4.

    Article  PubMed  CAS  Google Scholar 

  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. Roth HP, Caron HS, Hsi BP. Estimating a patient’s cooperation with his regimen. Am J Med Sci. 1971;262:269–73.

    Article  PubMed  CAS  Google Scholar 

  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.

    CAS  Google Scholar 

  65. Orlinsky N, D’Elia E. Rehospitalization of the schizophrenic patient. Arch Gen Psychiatry. 1964;10:71–8.

    Google Scholar 

  66. Bigby JA, Pappius E, Cook EF, Goldman L. Medical consequences of missed appointments. Arch Intern Med. 1984;144:1163–6.

    Article  PubMed  CAS  Google Scholar 

  67. Gortmaker SL. The effects of prenatal care on the health of the newborn. Am J Public Health. 1979;69:653–60.

    PubMed  CAS  Google Scholar 

  68. Leveno KJ, Cunningham FG, Roark ML, et al. Prenatal care and the low birth weight infant. Obstet Gynecol. 1985;66:599–605.

    PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  70. Gates SJ, Colborn DK. Lowering appointment failures in a neighborhood health center. Med Care. 1976;14:263–7.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  72. Fiester AR, Rudestam KE. A multivariate analysis of the early dropout process. J Consult Clin Psychol. 1975;43:528–35.

    Article  PubMed  CAS  Google Scholar 

  73. Deyo RA, Inui TS. Dropouts and broken appointments-a literature review and agenda for future research. Med Care. 1980;18:1146–57.

    Article  PubMed  CAS  Google Scholar 

  74. Gruzd DC, Shear CL, Rodney WM. Determinants of no-show appointment behavior: the utility of multivariate analysis. Fam Med. 1986;18:217–20.

    PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  76. Dove HG, Schneider KC. The usefulness of patients’ individual characteristics in predicting no-shows in outpatient clinics. Med Care. 1981;19:734–40.

    Article  PubMed  CAS  Google Scholar 

  77. Steinwachs DM. Measuring provider continuity in ambulatory care: as assessment of alternative approaches. Med Care. 1979;551–65.

  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.

    CAS  Google Scholar 

  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. 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. Benjamin-Bauman J, Reiss ML, Bailey JS. Increasing appointment keeping by reducing the call-appointment interval. J Appl Behav Anal. 1984;17:295–301.

    Article  PubMed  CAS  Google Scholar 

  82. Finnerty FA Jr, Mattie EC, Finnerty FA 3rd. Hypertension in the inner city. I. Analysis of clinic dropouts. Circulation. 1973;47:73–5.

    PubMed  Google Scholar 

  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.

  84. Oppenheim GL, Bergman JJ, English EC. Failed appointments: a review. J Fam Pract. 1979;8:789.

    PubMed  CAS  Google Scholar 

  85. Hurtado AV, Greenlick MR, Colombo TJ. Determinants of medical care utilization: failure to keep appointments. Med Care. 1973;11:189–98.

    Article  PubMed  CAS  Google Scholar 

  86. Kiefe C, Harrison P. Post-hospitalization followup appointment-keeping among the medically indigent. J. Community Health. 1993;18:271–82.

    Article  PubMed  CAS  Google Scholar 

  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. 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. 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.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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.

    PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  94. Schroeder SA. Lowering broken appointment rates at a medical clinic. Med Care. 1973;11:75–8.

    Article  PubMed  CAS  Google Scholar 

  95. Morse DL, Coulter MP, Nazarian LF, et al. Waning effectiveness of mailed reminders on reducing broken appointments. Pediatrics. 1981;68:846–9.

    PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  Google Scholar 

  100. Barry SP, Daniels AA. Effecting change in outpatient failed appointments. J Fam Pract. 1984;18:739–42.

    PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. the Department of Family Practice, University of California-Davis, Sacramento, California

    Joy Melnikow MD, MPH

  2. the Department of Medicine, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama

    Catarina Kiefe PhD, MD

Authors
  1. Joy Melnikow MD, MPH
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Catarina Kiefe PhD, MD
    View author publications

    You can also search for this author in PubMed Google Scholar

Additional information

Reprints are not available.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Melnikow, J., Kiefe, C. Patient compliance and medical research. J Gen Intern Med 9, 96–105 (1994). https://doi.org/10.1007/BF02600211

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF02600211

Keywords

Search

Navigation