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• W2057185692 abstract "In 1994, the results of the first Lung Health Study were published.1Anthonisen NR Connett JE Kiley JP et al.Effects of smoking intervention and the use of an inhaled anticholinergic bronchodilator on the rate of decline of FEV1. The Lung Health Study.JAMA. 1994; 272: 1497-1505Crossref PubMed Scopus (1745) Google Scholar The study was noteworthy for several of its findings. Most important, the study showed that the regular administration of inhaled bronchodilator neither accelerated nor slowed the rate of lung function decline seen in susceptible smokers. As had been suggested before, the only effective way to slow the rate of lung function decline in smokers is to convince them to become nonsmokers. But the Lung Health Study was also the first large study of respiratory care to demonstrate what appears to be a widespread phenomenon among our patients: “dose dumping.” A subset of Lung Health Study participants participated in a study of their compliance with scheduled inhaled medication.2Rand CS Wise RA Nides M et al.Metered-dose inhaler adherence in a clinical trial.Am Rev Respir Dis. 1992; 146: 1559-1564Crossref PubMed Scopus (294) Google Scholar The patients in this substudy were given inhalers equipped with Nebulizer Chronologs (Medtrac Technologies; Lakewood, CO), devices that measured not only how often they actuated their MDI canisters, but exactly when they did so. Unaware that the devices recorded the date and time of actuations but knowing that medication usage was being monitored, 14% of patients repeatedly actuated their canisters (sometimes up to 100 times successively) so as to give the appearance of complying with the recommended therapy. Although most physicians recognize that patient noncompliance is common in chronic disease settings, few would have anticipated the length to which patients will go to conceal their noncompliance (or to be more politically correct, their nonadherence).In the present issue of CHEST (see page 290), Simmons et al have extended these original findings. The estimate that 14% of patients dumped doses to conceal their noncompliance was based on the first 4 months of the 1-year monitoring period. In the present report, Simmons et al tallied the prevalence of dose-dumping behavior in the entire 1-year monitoring period and found that one third of their subjects engaged in such behavior. Far from being the practice of a small minority of our patients, it seems that many of those whom we treat will go to great lengths to conceal from us the degree to which they disagree with or cannot adhere to our treatment recommendations. Similar to studies of compliance vs noncompliance, Simmons et al could find no demographic or clinical variable that could distinguish deceptive patients from those who reported medication use accurately.The observations of Simmons et al have far-reaching implications. The investigators note, for example, that clinical trials seldom assess compliance rigorously. Instead, they rely on patient reports, canister weights, or pill counts, all notoriously unreliable means of gauging compliance with therapy. When therapy is inhaled, assays of medication in bodily fluids (blood, urine, or saliva) are difficult to perform, and reflect compliance only in the short period of time before fluid sampling. As demonstrated by the Lung Health Study data, patients frequently take steps to conceal their noncompliance in the few hours or days immediately preceding a return visit to the clinic. Various studies of patient compliance in the clinical and clinical trial setting suggest that patients seldom take more than half of the doses recommended for them. Thus, clinical trials that lead to the regulatory approval of new medications fail to give us an accurate estimate of dose-response relationships. It seems likely, for example, that patients using a new inhaled corticosteroid in a clinical trial actually take half the doses they are given.3Mawhinney H Spector SL Kinsman RA et al.Compliance in clinical trials of two nonbronchodilator, antiasthma medications.Ann Allergy. 1991; 66: 294-299PubMed Google Scholar4Spector SL Kinsman R Mawhinney H et al.Compliance of patients with asthma with an experimental aerosolized medication: implications for controlled clinical trials.J Allergy Clin Immunol. 1986; 77: 65-70Abstract Full Text PDF PubMed Scopus (158) Google Scholar5Alessandro F Vincenzo ZG Marco S et al.Compliance with pharmacologic prophylaxis and therapy in bronchial asthma.Ann Allergy. 1994; 73: 135-140PubMed Google Scholar If the compound is approved after such clinical trial data are analyzed and presented, a compliant clinic patient treated subsequently with doses outlined in a product monograph may be exposed to twice the medication needed to obtain disease control at the risk of twice the systemic side effects.Patient deception can perturb the results of clinical research trials in other ways. It astonishes me that regulatory authorities worldwide have come to rely on patient-recorded peak flow values as a primary end point in studies designed to assess antiasthma medications. Peak flow monitoring has been given far more credence than it deserves; whenever peak flow monitoring is studied in objective fashion, it is clear that patients fabricate at least half of the data they appear to record so assiduously.6Redline S Wright EC Kattan M et al.Short-term compliance with peak flow monitoring: results from a study of inner city children with asthma.Pediatr Pulmonol. 1996; 21: 203-210Crossref PubMed Scopus (93) Google Scholar7Malo JL Trudeau C Ghezzo H et al.Do subjects investigated for occupational asthma through serial peak expiratory flow measurements falsify their results?.J Allergy Clin Immunol. 1995; 96: 601-607Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar8Côté J Cartier A Malo JL et al.Compliance with peak expiratory flow monitoring in home management of asthma.Chest. 1998; 113: 968-972Abstract Full Text Full Text PDF PubMed Scopus (110) Google ScholarWhether or not patients take the medications prescribed for them and how well doctors determine this is at the heart of chronic disease management. For the respiratory physician, this is most evident in the management of asthma. Inhaled corticosteroids are remarkably effective for disease-control induction in the vast majority of patients with asthma. Easy-to-use inhalation devices and high-concentration inhaled corticosteroid formulations make it possible to achieve good disease control in almost all patients who are willing to and able to inhale a medication twice daily. Against this background, it is disheartening to watch the response of most physicians when patients with asthma fail to achieve disease control with such a simple strategy. Most think immediately of a third or fourth medication, and a surprising number of physicians treating asthma are anxious to begin looking for gastroesophageal reflux as a contributor to refractory asthma. An observant physician would recognize that most of these initial treatment failures are the consequence of noncompliance. When time and resources are available, patient education will be a far more cost-effective intervention than multiple prescriptions.9Greineder DK Loane KC Parks P Reduction in resource utilization by an asthma outreach program.Arch Pediatr Adolesc Med. 1995; 149: 415-420Crossref PubMed Scopus (147) Google Scholar10Boulet LP Chapman KR Green LW et al.Asthma education.Chest. 1994; 106: 184S-196SAbstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar Physicians’ reluctance to address noncompliance is not surprising. As Simmons et al report, there are no easy handles for the physician to grasp. Failure to take medication is not a behavior limited to the poorly educated, to patients with mild disease, to patients of limited means, or to any other obvious demographically or clinically characterized group. Our failure to address issues of compliance and noncompliance reflects our ignorance of the topic and our unease in this arena. It is much more comfortable for a physician to reach for a prescription pad, than to spend awkward moments probing a patient's attitudes toward medication taking. Most physicians’ exposure to issues of compliance is limited to a desultory lecture or two in medical school, a lecture typically ending with the nihilistic and self-fulfilling observation that most physicians are poor at gauging a patient's degree of compliance or noncompliance.If we are to assess new medications accurately and treat chronic diseases effectively, we will need to address the issue of actual medication use by our patients and how to monitor it. This will require considerable investment in health-care delivery research. It seems to me that whenever we wish to emphasize the importance of a scientific area, we invent a new terminology to describe it. For several years, I have had a grudging admiration for physicians who have invented the term evidence-based medicine. Finding themselves encumbered with the oxymoronic term clinical epidemiology to describe what they do, devotees of evidence-based medicine use just four syllables to dismiss all other thoughtful examinations of the literature as being just “wild-ass” guessing. I would therefore like to suggest that research into the ways in which patients take their medication be termed reality-based medicine. I will leave it to the reader to decide the implications of this terminology for those who neglect to measure compliance or probe for patient attempts to conceal such noncompliance. In 1994, the results of the first Lung Health Study were published.1Anthonisen NR Connett JE Kiley JP et al.Effects of smoking intervention and the use of an inhaled anticholinergic bronchodilator on the rate of decline of FEV1. The Lung Health Study.JAMA. 1994; 272: 1497-1505Crossref PubMed Scopus (1745) Google Scholar The study was noteworthy for several of its findings. Most important, the study showed that the regular administration of inhaled bronchodilator neither accelerated nor slowed the rate of lung function decline seen in susceptible smokers. As had been suggested before, the only effective way to slow the rate of lung function decline in smokers is to convince them to become nonsmokers. But the Lung Health Study was also the first large study of respiratory care to demonstrate what appears to be a widespread phenomenon among our patients: “dose dumping.” A subset of Lung Health Study participants participated in a study of their compliance with scheduled inhaled medication.2Rand CS Wise RA Nides M et al.Metered-dose inhaler adherence in a clinical trial.Am Rev Respir Dis. 1992; 146: 1559-1564Crossref PubMed Scopus (294) Google Scholar The patients in this substudy were given inhalers equipped with Nebulizer Chronologs (Medtrac Technologies; Lakewood, CO), devices that measured not only how often they actuated their MDI canisters, but exactly when they did so. Unaware that the devices recorded the date and time of actuations but knowing that medication usage was being monitored, 14% of patients repeatedly actuated their canisters (sometimes up to 100 times successively) so as to give the appearance of complying with the recommended therapy. Although most physicians recognize that patient noncompliance is common in chronic disease settings, few would have anticipated the length to which patients will go to conceal their noncompliance (or to be more politically correct, their nonadherence). In the present issue of CHEST (see page 290), Simmons et al have extended these original findings. The estimate that 14% of patients dumped doses to conceal their noncompliance was based on the first 4 months of the 1-year monitoring period. In the present report, Simmons et al tallied the prevalence of dose-dumping behavior in the entire 1-year monitoring period and found that one third of their subjects engaged in such behavior. Far from being the practice of a small minority of our patients, it seems that many of those whom we treat will go to great lengths to conceal from us the degree to which they disagree with or cannot adhere to our treatment recommendations. Similar to studies of compliance vs noncompliance, Simmons et al could find no demographic or clinical variable that could distinguish deceptive patients from those who reported medication use accurately. The observations of Simmons et al have far-reaching implications. The investigators note, for example, that clinical trials seldom assess compliance rigorously. Instead, they rely on patient reports, canister weights, or pill counts, all notoriously unreliable means of gauging compliance with therapy. When therapy is inhaled, assays of medication in bodily fluids (blood, urine, or saliva) are difficult to perform, and reflect compliance only in the short period of time before fluid sampling. As demonstrated by the Lung Health Study data, patients frequently take steps to conceal their noncompliance in the few hours or days immediately preceding a return visit to the clinic. Various studies of patient compliance in the clinical and clinical trial setting suggest that patients seldom take more than half of the doses recommended for them. Thus, clinical trials that lead to the regulatory approval of new medications fail to give us an accurate estimate of dose-response relationships. It seems likely, for example, that patients using a new inhaled corticosteroid in a clinical trial actually take half the doses they are given.3Mawhinney H Spector SL Kinsman RA et al.Compliance in clinical trials of two nonbronchodilator, antiasthma medications.Ann Allergy. 1991; 66: 294-299PubMed Google Scholar4Spector SL Kinsman R Mawhinney H et al.Compliance of patients with asthma with an experimental aerosolized medication: implications for controlled clinical trials.J Allergy Clin Immunol. 1986; 77: 65-70Abstract Full Text PDF PubMed Scopus (158) Google Scholar5Alessandro F Vincenzo ZG Marco S et al.Compliance with pharmacologic prophylaxis and therapy in bronchial asthma.Ann Allergy. 1994; 73: 135-140PubMed Google Scholar If the compound is approved after such clinical trial data are analyzed and presented, a compliant clinic patient treated subsequently with doses outlined in a product monograph may be exposed to twice the medication needed to obtain disease control at the risk of twice the systemic side effects. Patient deception can perturb the results of clinical research trials in other ways. It astonishes me that regulatory authorities worldwide have come to rely on patient-recorded peak flow values as a primary end point in studies designed to assess antiasthma medications. Peak flow monitoring has been given far more credence than it deserves; whenever peak flow monitoring is studied in objective fashion, it is clear that patients fabricate at least half of the data they appear to record so assiduously.6Redline S Wright EC Kattan M et al.Short-term compliance with peak flow monitoring: results from a study of inner city children with asthma.Pediatr Pulmonol. 1996; 21: 203-210Crossref PubMed Scopus (93) Google Scholar7Malo JL Trudeau C Ghezzo H et al.Do subjects investigated for occupational asthma through serial peak expiratory flow measurements falsify their results?.J Allergy Clin Immunol. 1995; 96: 601-607Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar8Côté J Cartier A Malo JL et al.Compliance with peak expiratory flow monitoring in home management of asthma.Chest. 1998; 113: 968-972Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar Whether or not patients take the medications prescribed for them and how well doctors determine this is at the heart of chronic disease management. For the respiratory physician, this is most evident in the management of asthma. Inhaled corticosteroids are remarkably effective for disease-control induction in the vast majority of patients with asthma. Easy-to-use inhalation devices and high-concentration inhaled corticosteroid formulations make it possible to achieve good disease control in almost all patients who are willing to and able to inhale a medication twice daily. Against this background, it is disheartening to watch the response of most physicians when patients with asthma fail to achieve disease control with such a simple strategy. Most think immediately of a third or fourth medication, and a surprising number of physicians treating asthma are anxious to begin looking for gastroesophageal reflux as a contributor to refractory asthma. An observant physician would recognize that most of these initial treatment failures are the consequence of noncompliance. When time and resources are available, patient education will be a far more cost-effective intervention than multiple prescriptions.9Greineder DK Loane KC Parks P Reduction in resource utilization by an asthma outreach program.Arch Pediatr Adolesc Med. 1995; 149: 415-420Crossref PubMed Scopus (147) Google Scholar10Boulet LP Chapman KR Green LW et al.Asthma education.Chest. 1994; 106: 184S-196SAbstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar Physicians’ reluctance to address noncompliance is not surprising. As Simmons et al report, there are no easy handles for the physician to grasp. Failure to take medication is not a behavior limited to the poorly educated, to patients with mild disease, to patients of limited means, or to any other obvious demographically or clinically characterized group. Our failure to address issues of compliance and noncompliance reflects our ignorance of the topic and our unease in this arena. It is much more comfortable for a physician to reach for a prescription pad, than to spend awkward moments probing a patient's attitudes toward medication taking. Most physicians’ exposure to issues of compliance is limited to a desultory lecture or two in medical school, a lecture typically ending with the nihilistic and self-fulfilling observation that most physicians are poor at gauging a patient's degree of compliance or noncompliance. If we are to assess new medications accurately and treat chronic diseases effectively, we will need to address the issue of actual medication use by our patients and how to monitor it. This will require considerable investment in health-care delivery research. It seems to me that whenever we wish to emphasize the importance of a scientific area, we invent a new terminology to describe it. For several years, I have had a grudging admiration for physicians who have invented the term evidence-based medicine. Finding themselves encumbered with the oxymoronic term clinical epidemiology to describe what they do, devotees of evidence-based medicine use just four syllables to dismiss all other thoughtful examinations of the literature as being just “wild-ass” guessing. I would therefore like to suggest that research into the ways in which patients take their medication be termed reality-based medicine. I will leave it to the reader to decide the implications of this terminology for those who neglect to measure compliance or probe for patient attempts to conceal such noncompliance." @default.
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