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The Madison Avenue effect: How drug presentation style influences adherence and outcome in patients with asthma

      Background

      Little is known about how drug presentation influences medication adherence.

      Objective

      To examine the effect of an educational program aimed at increasing expectations of treatment benefit on medication adherence.

      Methods

      Data are analyzed from 99 participants who underwent electronic drug monitoring during the Trial of Asthma Patient Education, a randomized, placebo-controlled, multicenter trial. Participants with suboptimally controlled asthma were randomized to placebo or montelukast in conjunction with a presentation mode that was either neutral or designed to increase outcome expectancy. Adherence was monitored electronically over 4 weeks and was defined as ≥80% use of prescribed doses. Outcome expectancy, peak expiratory flow, prebronchodilator FEV1, asthma control (Juniper asthma control questionnaire), and asthma-related quality of life were assessed at baseline and at the 4-week follow-up.

      Results

      Average electronic medication adherence was 69.9%. There was a significant interaction between presentation mode and drug assignment, with participants in the enhanced/montelukast group having a higher change in outcome expectancy (Δ 2.1 points; P < .001) and better medication adherence (odds ratio, 4.0; 95% CI, 1.1-14.3) compared with those in the neutral/placebo group. There was no difference in asthma symptoms, quality of life, or clinical outcomes on the basis of presentation mode. Rather, increased outcome expectancy was associated with modest improvements in asthma symptoms after adjusting for presentation mode, drug assignment, and medication adherence.

      Conclusion

      The use of an enhanced presentation aimed at increasing outcome expectancy may lead to improved medication adherence.

      Key words

      Abbreviations used:

      ACQ (Juniper asthma control questionnaire), OE (Outcome expectancy), PEF (Peak expiratory flow), TAPE (Trial of Asthma Patient Education)
      It is well recognized that adherence to asthma controller therapy is often suboptimal, and that poor adherence can lead to increased asthma-related morbidity and health care expenditures.
      • Bender B.G.
      • Rand C.
      Medication non-adherence and asthma treatment cost.
      • Delea T.E.
      • Stanford R.H.
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      • Stempel D.A.
      Association between adherence with fixed dose combination fluticasone propionate/salmeterol on asthma outcomes and costs.
      • Williams L.K.
      • Pladevall M.
      • Xi H.
      • Peterson E.L.
      • Joseph C.
      • Lafata J.E.
      • et al.
      Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma.
      Results from several studies have shown that patient beliefs regarding therapy are predictors of adherence, with negative beliefs and concerns about the safety of therapy associated with decreased medication adherence.
      • Conn K.M.
      • Halterman J.S.
      • Lynch K.
      • Cabana M.D.
      The impact of parents’ medication beliefs on asthma management.
      • Horne R.
      • Weinman J.
      Patients’ beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness.
      In contrast, positive beliefs about treatment efficacy (ie, outcomes expectancy) and safety have been shown to be associated with increased adherence.
      • Conn K.M.
      • Halterman J.S.
      • Lynch K.
      • Cabana M.D.
      The impact of parents’ medication beliefs on asthma management.
      • Menckeberg T.T.
      • Bouvy M.L.
      • Bracke M.
      • Kaptein A.A.
      • Leufkens H.G.
      • Raaijmakers J.A.
      • et al.
      Beliefs about medicines predict refill adherence to inhaled corticosteroids.
      • Ponieman D.
      • Wisnivesky J.P.
      • Leventhal H.
      • Musumeci-Szabo T.J.
      • Halm E.A.
      Impact of positive and negative beliefs about inhaled corticosteroids on adherence in inner-city asthmatic patients.
      As a result, most intervention studies of asthma adherence have included educational components aimed at addressing patients’ beliefs and concerns about therapy,
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      Adherence feedback to improve asthma outcomes among inner-city children: a randomized trial.
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      • et al.
      Test of an interactive voice response intervention to improve adherence to controller medications in adults with asthma.
      using methods such as shared decision-making
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      • Strub P.
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      • Lavori P.W.
      • Lapidus J.
      • et al.
      Shared treatment decision making improves adherence and outcomes in poorly controlled asthma.
      and motivation-enhancing strategies.
      • Borrelli B.
      • Riekert K.A.
      • Weinstein A.
      • Rathier L.
      Brief motivational interviewing as a clinical strategy to promote asthma medication adherence.
      We are unaware of any studies that have examined the effect of specifically promoting the benefits of a therapy (ie, enhancing outcomes expectancy) on medication adherence.
      As part of the Trial of Asthma Patient Education (TAPE),
      • Wise R.A.
      • Bartlett S.J.
      • Brown E.D.
      • Castro M.
      • Cohen R.
      • Holbrook J.T.
      • et al.
      Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.
      a randomized clinical multicenter trial, we conducted a substudy electronically monitoring adherence to examine the effect of an educational intervention designed to enhance outcome expectancy on medication adherence. We hypothesized that using an enhanced presentation would lead to more positive outcomes expectancy, which in turn would be associated with higher rates of medication adherence. In addition, the effect of the educational intervention on clinical and patient-reported outcomes was also examined.

      Methods

       Study design and organization

      This study was carried out as a substudy of TAPE.
      • Wise R.A.
      • Bartlett S.J.
      • Brown E.D.
      • Castro M.
      • Cohen R.
      • Holbrook J.T.
      • et al.
      Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.
      Briefly, this is a multicenter, randomized clinical trial conducted by the American Lung Association Asthma Clinical Research Centers to examine the placebo effect in asthma and to assess whether it could be augmented by using an educational program that targeted patients’ expectations of drug efficacy. Participants were enrolled at 19 centers participating in the American Lung Association Asthma Clinical Research Centers located across the United States. The study was approved by institutional review boards at all participating sites.
      The parent study involved 4 study visits over a 6-week period (Fig 1). After enrollment (visit 1), there was a 2-week run-in period during which participants were asked to maintain an asthma diary. Baseline data (outcome expectancy, lung function, asthma questionnaires) were collected during visit 2 and before randomization to 1 of 4 intervention groups: enhanced/placebo, enhanced/montelukast, neutral/placebo, and neutral/montelukast. After randomization, participants were shown the first educational session and were dispensed the study drug. The educational session was repeated 2 weeks later during an interim visit with collection of interim pulmonary function and asthma symptom data. Outcome measures (outcome expectancy, lung function, and asthma symptoms) were reassessed at the end of the study, and unused study drugs were collected.

       Inclusion and exclusion criteria

      Eligible participants were patients with suboptimally controlled asthma age 15 years or older who could potentially benefit from use of an additional asthma controller medication. Inclusion criteria were a history of physician diagnosed asthma with regular use of asthma medication in the preceding year and 1 or more indicators of poor asthma control. Suboptimal asthma control was defined as a Juniper asthma control questionnaire (ACQ) score ≥1.5,
      • Juniper E.F.
      • O’Byrne P.M.
      • Guyatt G.H.
      • Ferrie P.J.
      • King D.R.
      Development and validation of a questionnaire to measure asthma control.
      use of β-agonists for asthma symptoms 2 or more times per week, or nocturnal awakening for asthma 1 or more times per week. Participants were excluded if they had other serious health problems or were currently using or had previous intolerance to montelukast.

       Drug assignment

      Study tablets were overencapsulated with gelatin capsules and back-filled with methylcellulose. The active medication treatment was montelukast taken 10 mg orally at bedtime (Singulair; Merck & Co, Whitehouse Station, NJ). Encapsulation had no effect on the absorption or elimination characteristics of montelukast. The placebos consisted of identical capsules filled with methylcellulose.

       Presentation mode

      The educational intervention consisted of an interactive computer-based multimedia presentation about asthma self-care and treatment. The program was given postrandomization after collection of baseline data and repeated 2 weeks later at an interim visit. A copy of the presentations can be viewed at http://www.cctrials.org/Public/TAPE_Patient_Education_Presentation.htm.
      The enhanced presentation was designed to increase expectancy regarding the ability of montelukast to control asthma symptoms adequately. Specifically, it included a scripted introduction by a study coordinator, followed by a multimedia presentation embedded with both direct and indirect messages aimed at increasing expectancy of optimal asthma control with use of the medication. As part of the presentation, participants were also shown a consumer-directed television commercial for montelukast to reinforce further the positive message regarding drug efficacy. In contrast, the neutral presentation consisted of a scripted introduction followed by a multimedia presentation with information on asthma care and self-management but without discussion of the benefits of montelukast. An asthma action plan was provided to all participants as part of the study.

       Substudy description

      Participants at the 5 participating centers with electronic adherence monitoring capabilities were enrolled in the substudy. Electronic monitoring was carried out by using Medication Events Monitoring Systems caps (AARDEX Ltd, Zug, Switzerland), which are devices fitted on the study drug bottles to record the date and time of each bottle opening. Adherence was monitored electronically postrandomization over 4 weeks. In addition, medication adherence was assessed using 2-week recall, daily asthma diaries, and pill count.

       Outcome measures

      The primary outcome of interest was adherence based on electronic monitoring. Adherence data were collected postrandomization for 4 weeks and truncated at 100% per day, with credit given for 1 opening per 24-hour period to account for inappropriate use or medication dumping.
      • Apter A.J.
      • Boston R.C.
      • George M.
      • Norfleet A.L.
      • Tenhave T.
      • Coyne J.C.
      • et al.
      Modifiable barriers to adherence to inhaled steroids among adults with asthma: it’s not just black and white.
      Mean adherence was calculated as the percent of medication taken as prescribed (actual use/prescribed use ∗ 100) over the monitoring period. Good adherence was defined as appropriate use on ≥80% of the monitored days based on the Medication Events Monitoring Systems recorded events.
      Outcome expectancy was evaluated using 2 Likert scale questions completed at randomization before viewing the multimedia presentation and at completion of the study. Participants were asked to rate their agreement or disagreement with the following items embedded in an asthma perception questionnaire, using a scale of 1 to 9: (1) “If I were to take Singulair (montelukast), it would help my asthma” and (2) “Singulair (montelukast) is likely to help people with asthma.” Outcomes expectancy was analyzed as the sum of the ratings given to the 2 questions.
      Asthma outcomes, including peak expiratory flow (PEF), FEV1, ACQ,
      • Juniper E.F.
      • O’Byrne P.M.
      • Guyatt G.H.
      • Ferrie P.J.
      • King D.R.
      Development and validation of a questionnaire to measure asthma control.
      and the Asthma Quality of Life Questionnaire,
      • Juniper E.F.
      Health-related quality of life in asthma.
      were obtained at baseline before randomization, during the interim visit, and at the end of the study. The ACQ scores range from 0 to 6, with higher scores reflecting poorer asthma control. The Asthma Quality of Life Questionnaire consists of 15 questions with scores ranging from 1 (severely impaired) to 7 (not at all impaired). The change in FEV1, PEF, ACQ, and quality of life over the 4-week monitoring period was calculated as the difference between visit 4 and baseline.

       Statistical analysis

      Descriptive statistics were calculated by using means and SDs for continuous variables and proportions for categoric variables. Continuous outcome measures were analyzed as changes from baseline values. Statistical analysis of outcomes was performed by using 1-way ANOVA with Bonferroni adjustment and logistic regression. Models were adjusted for age, sex, ethnicity, education level, drug assignment, the interaction of presentation mode and treatment assignment, and mean adherence as indicated. On the basis of the sample size of 50 participants per group (enhanced presentation, regular presentation), we had ≥80% power to detect a 30% between-group difference in adherence. All analyses were performed on the basis of treatment assignment (intention to treat) by using STATA Version 10.0 (StataCorp, College Station, Tex).

      Results

       Participant characteristics

      Table I shows the baseline characteristics of the 4 study groups: enhanced/placebo, enhanced/montelukast, neutral/placebo, and neutral/montelukast. The majority were white (60.6%) and female (71.7%), with a mean ± SD age of 34.7 ± 14.5 years. Despite imbalances in some baseline characteristics, including the number of females, percentage of participants with higher education, and previous asthma-related hospitalization in the enhanced/placebo group compared with the other groups, these were not statistically significant. The groups had other similar baseline characteristics except for significantly higher baseline PEF in the enhanced/placebo group.
      Table IBaseline characteristics
      Patient characteristicsEnhancedNeutral
      Placebo

      n = 26
      Montelukast

      n = 25
      Placebo

      n = 23
      Montelukast

      n = 25
      P value
      Demographic characteristics
       Age33.3 (2.9)33.2 (2.8)39.6 (3.2)33.1 (2.8).92
       Female sex (%)53847476.10
       Race or ethnicity (%).12
      White50527080
      Black46442212
      Hispanic4444
      Other0044
       Education level (%)
      Completed high school only1516224.35
      Higher education65807488.27
      Former smoker (%)12122224.53
      Asthma history
       Hospitalized or seen in acute

      care over past year (%)
      2316178.54
      Current asthma medication/treatment, no. (%)
       Long-acting β-agonist14 (54)11 (44)9 (39)9 (36).60
       Inhaled corticosteroids16 (62)15 (60)14 (61)14 (56).98
       Oral antileukotriene001(4)0.45
      Lung function
       FEV1 % predicted82.8 (2.1)81.0 (2.5)82.2 (2.5)83.3 (3.0).44
       FVC % predicted88.5 (2.3)88.5 (2.7)88.5 (2.4)92.6 (3.1).46
       PEF (L/min)433.3 (21.5)366.8 (13.4)379.1 (19.4)384.0 (13.8).04
      ACQ1.1 (0.6)0.9 (0.6)1.4 (0.8)1.1 (0.7).09
      Asthma Quality of Life5.1 (1.2)5.0 (1.1)5.2 (1.0)5.1 (1.0).97
      Outcome expectancy score12 (3)11 (2)12 (3)12 (3).26
      FVC, Forced vital capacity.
      Values represent mean (± SD) unless otherwise indicated.

       Effect of presentation mode on outcome expectancy

      At baseline, the majority of participants (95%) agreed that montelukast was an effective drug for asthma, with a mean expectancy score (OE) of 12 of 18 among the groups. At completion of the study, outcome expectancy tended to increase in those participants exposed to active drug, enhanced presentation, or both (Fig 2). The effects of exposure to active drug on OE was additive to that of the enhanced presentation, with the enhanced/montelukast group having the greatest change in OE (Δ 2.7 ± 3.0 points) compared with the neutral/placebo group (Δ 0.1 ± 2.8 points).
      Figure thumbnail gr2
      Fig 2Change in outcome expectancy score over 4-week treatment period.

       Effect of presentation mode on medication adherence

      Of the 4 adherence measures, electronic monitoring had the lowest overall mean adherence, with 69.9% of doses taken as prescribed compared with pill count (88.1%), 2-week patient recall (95.2%), and asthma diary (89.7%). Medication adherence was not associated with baseline demographics, except for lower adherence rates in those with a history of acute care use in the previous 12 months.
      Because there was a significant interaction between treatment assignment and presentation mode in predicting adherence, subsequent analyses were stratified by treatment assignment. There was a differential effect of presentation mode on medication adherence depending on whether it was combined with active drug or placebo (Fig 3), with increased adherence (76.0%) when combined with active drug and decreased adherence (26%) when combined with placebo (P < .001). There was no difference in adherence to active drug or placebo using the neutral presentation mode (52.0% vs. 47.8%, respectively; P = .78). Compared with those in the neutral/placebo group, participants in the enhanced/montelukast group had significantly higher adherence rates (odds ratio, 4.0; 95% CI, 1.1-14.3), which persisted after adjusting for age, race, and sex (Table II). Although those in the enhanced/placebo group had the lowest adherence rate (26.9%), this was not statistically significant compared with the neutral/placebo group.
      Figure thumbnail gr3
      Fig 3Mean adherence rate over 4 weeks by study condition in participants with asthma.
      Table IIOdds of adherence to study drug on the basis of study condition
      Study groupAdherence
      RateOR
      Odds ratio from multiple regression analysis adjusted for age, race, and sex.
      (95% CI)
      P value
      Neutral/placebo (n = 23)47.8Referent
      Neutral/montelukast (n = 25)52.01.2 (0.4-3.8).77
      Enhanced/placebo (n = 26)26.90.5 (0.1-1.6).13
      Enhanced/montelukast (n = 25)76.04.0 (1.1-14.3).04
      Odds ratio from multiple regression analysis adjusted for age, race, and sex.

       Effect of presentation mode on asthma outcomes

      Presentation mode was not associated with any significant change in any of the asthma outcome measures assessed, including asthma control (P = .50), asthma quality of life (P = .16), FEV1 (P = .12), and peak flow (P = .39). There was an overall trend for improvements in patient-reported outcomes over the 4-week treatment period (Table III), especially in the enhanced/montelukast group. Compared with the neutral/placebo group, the enhanced/montelukast group showed a trend for higher improvements in quality of life (Δ 0.62; 95% CI, 0.28-0.97), along with statistically greater improvements in FEV1 (Δ 0.15; 95% CI, 0.03-0.26; Table IV).
      Table IIIMean change in asthma symptoms and asthma quality of life over 4 weeks by study condition
      Patient-reported outcomesCrude mean change (95% CI)MLR
      Multiple linear regression of the change in patient-reported outcomes (ie, ACQ and Asthma Quality of Life) for each group compared to the neutral/placebo group adjusted for age, race, and sex.
      Regression coefficient (95% CI)P value
      ACQ
      Lower scores represent better asthma control.
       Neutral/placebo (n = 23)−0.24 (–0.47, –0.00)0.00
       Neutral/montelukast (n = 25)−0.41 (–0.68, –0.13)−0.20 (–0.62, 0.22).34
       Enhanced/placebo (n = 26)−0.26 (–0.62, 0.02)−0.11 (–0.52, 0.31).61
       Enhanced/montelukast (n = 25)−0.56 (–0.89, –0.22)−0.32 (–0.74, 0.10).14
      Asthma Quality of Life
       Neutral/placebo (n = 23)0.13 (–0.1, 0.44)0.00
       Neutral/montelukast (n = 25)0.58 (0.29, 0.88)0.47 (–0.31, 0.76).08
       Enhanced/placebo (n = 26)0.62 (0.13, 1.10)0.50 (–0.28, 0.77).06
       Enhanced/montelukast (n = 25)0.62 (0.28, 0.97)0.47 (–0.30, 0.76).08
      Multiple linear regression of the change in patient-reported outcomes (ie, ACQ and Asthma Quality of Life) for each group compared to the neutral/placebo group adjusted for age, race, and sex.
      Lower scores represent better asthma control.
      Table IVMean change in selected tests of pulmonary function after 4 weeks by study condition
      Lung functionCrude mean change (95% CI)MLR
      Multiple linear regression of the change in physiologic outcomes (ie, FEV1 and PEF) for each group compared with the neutral/placebo group adjusted for age, race, and sex.
      Regression coefficient (95% CI)P value
      FEV1 (L)
       Neutral/placebo (n = 23)−0.01 (–0.07, 0.06)0.00
       Neutral/montelukast (n = 25)0.04 (–0.02, 0.09)0.06 (–0.06, 0.17).34
       Enhanced/placebo (n = 26)0.03 (–0.06, 0.12)0.04 (–0.08, 0.15).53
       Enhanced/montelukast (n = 25)0.13 (0.02, 0.24)0.15 (0.03, 0.26).02
      PEF (L/min)
       Neutral/placebo (n = 23)2.56 (–2.36, 7.48)0.00
       Neutral/montelukast (n = 25)0.26 (–5.23, 5.75)−2.71 (–11.15, 5.74).53
       Enhanced/placebo (n = 26)−1.17 (–5.78, 3.44)−4.13 (–12.53, 4.24).33
       Enhanced/montelukast (n = 25)9.19 (1.15, 17.24)6.84 (–1.61, 15.28).11
      Multiple linear regression of the change in physiologic outcomes (ie, FEV1 and PEF) for each group compared with the neutral/placebo group adjusted for age, race, and sex.

       Effect of outcome expectancy on asthma outcomes

      Outcome expectancy was associated with significant improvements in asthma control scores (regression coefficient, –0.08; P = .004) regardless of age, sex, race, drug assignment, or adherence. This effect was clinically modest, however, requiring large changes in outcome expectancy (approximately 7 points) for a meaningful change in asthma control to occur. OE was associated with a trend for modest improvements in asthma quality of life (regression coefficient, 0.06; P = .08), with no statistically significant effect on FEV1 (P = .12) or PEF (P = .23).

      Discussion

      In this prospective multicenter intervention trial, an enhanced presentation mode designed to influence patients’ outcome expectancy regarding treatment efficacy was associated with improved adherence to taking active drug and FEV1, with potentially detrimental effects on adherence to placebo. In addition, increased outcome expectancy was found to be independently associated with improved ACQ with a trend for improvements in asthma-specific quality of life. These results suggest that the manner in which medications are introduced to patients may affect not only their expectations about the potential benefits of a therapy but also their level of adherence.
      According to social cognitive theory, an individual’s expectations of a given outcome can act as an incentive (either positive or negative) to influence subsequent behavior.
      • Bandura A.
      • Wood R.
      Effect of perceived controllability and performance standards on self-regulation of complex decision making.
      Thus, beliefs regarding the outcome of an action/behavior may influence both a person’s motivation and behavior. This theory is well recognized by advertisers. Marketing messages are effective in promoting sales when the message convinces consumers that they will benefit from buying the product. Similarly, in the current study, we were able to increase outcome expectancy successfully by using a multimedia presentation increasing a patient’s expectations of treatment benefit, with an additive effect of presentation mode and drug assignment on medication adherence.
      Few studies have focused on assessing the role of increasing outcome expectancy on medication adherence. A study by Olsen et al
      • Olsen S.
      • Smith S.
      • Oei T.P.
      Adherence to continuous positive airway pressure therapy in obstructive sleep apnoea sufferers: a theoretical approach to treatment adherence and intervention.
      examined the effect of expectancy on adherence to continuous positive airway pressure and found that positive expectancies explained most of the variance in continuous positive airway pressure adherence. Le et al
      • Le T.T.
      • Bilderback A.
      • Bender B.
      • Wamboldt F.S.
      • Turner C.F.
      • Rand C.S.
      • et al.
      Do asthma medication beliefs mediate the relationship between minority status and adherence to therapy?.
      found negative beliefs regarding asthma treatment were a significant mediator of the association between minority status and poor adherence. Taken together, these findings suggest that the improved adherence to active drug in response to enhanced presentation may in part be mediated via increased outcome expectancy.
      The interaction between outcome expectancy and medication adherence is, however, rather complex. Our study also found that although enhanced presentation was associated with increased adherence and FEV1, enhanced expectancy had a negative effect on medication adherence when paired with an ineffective treatment (placebo). This highlights the importance of aligning patients’ expectations with the potential benefits of the treatment. Although the reason for the decreased adherence to placebo in the enhanced group is uncertain, we speculate that this finding may be caused by a discrepancy between outcome expectancy and drug efficacy, such that failure to notice the expected benefit may have negatively affected adherence. The effect of the enhanced presentation on adherence to placebo was seen within the first week of follow-up, with mean adherence rates of 52% versus 85% in the enhanced/montelukast group. This difference persisted over the 4-week follow-up despite a progressive decline in mean adherence over time in all 4 groups.
      We also found outcome expectancy to be associated with improvements in patient-reported outcomes, mainly with regard to asthma control. This effect was independent of drug assignment or medication adherence, suggesting that patient expectations may play a role in perceived benefit, especially as measured by patient-reported outcomes. Patients who believed that their therapies were effective reported health benefits, even when objective measures such as spirometry failed to capture those benefits. This may account for the observed improvements in patient-reported outcome in the enhanced/placebo group. Such observation is consistent with findings from the parent TAPE study, which showed a placebo effect that was augmented by using the enhanced presentation mode.
      • Wise R.A.
      • Bartlett S.J.
      • Brown E.D.
      • Castro M.
      • Cohen R.
      • Holbrook J.T.
      • et al.
      Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.
      One of the strengths of the current study is the use of electronic monitoring to measure medication adherence objectively. Studies comparing electronic monitoring, pill count, and self-report to biological measures of adherence have shown electronic monitoring to be the most valid measure of adherence.
      • Remington G.
      • Kwon J.
      • Collins A.
      • Laporte D.
      • Mann S.
      • Christensen B.
      The use of electronic monitoring (MEMS) to evaluate antipsychotic compliance in outpatients with schizophrenia.
      • Lee J.Y.
      • Kusek J.W.
      • Greene P.G.
      • Bernhard S.
      • Norris K.
      • Smith D.
      • et al.
      Assessing medication adherence by pill count and electronic monitoring in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study.
      As with other studies, we found that pill counts and self-reports significantly overestimated actual medication use. The current study design is further strengthened by the use of a formalized protocol to increase outcome expectancy, which standardized the intervention. The generalizability of our findings is, however, uncertain. Because participants were aware that they would be randomized to placebo or active drug as part of the consent process, the possibility of taking a placebo drug may have influenced their adherence to the therapy. Furthermore, although patients were randomized to the 4 study groups by center, there were imbalances in baseline demographics, which were adjusted for by using multiple regression analyses. In addition, the 2-week run-in period may have led to the selection of a very motivated group with higher adherence compared to the general population. However, one would expect such selection bias, if present, to underestimate the effect of the intervention on adherence. It is also unclear whether the observed effect of enhanced presentation on adherence to montelukast would apply to other therapies prescribed to control asthma, such as inhaled corticosteroids, or whether these effects would persist longer than 4 weeks.
      In conclusion, we observed that the manner in which information about an asthma drug was presented to patients significantly influenced their expectations about treatment efficacy and resulted in increased medication adherence to active drug, along with improvements in FEV1. Borrowing a lesson from Madison Avenue, we found that marketing the benefits of therapy increased “sales.” In addition, increased outcome expectancy was associated with improvements in patient-reported outcomes, although not objectively measured indices of asthma control. These results suggest that the methods by which treatment options are introduced to patients affect not only adherence to therapy and clinical outcomes but also self-reported outcomes.
      Clinical implications
      The way treatment is presented to patients may affect their adherence to therapy. Interventions aimed at increasing patients’ expectancy of treatment efficacy may lead to increased medication adherence.

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