It appears crucial to identify those COPD patients who are “poorly or not at all compliant with their treatment,” as if they were a separate clinical phenotype, so as to give these patients the correct indications according to their individual characteristics.
One or more of the following characteristics contribute to defining the profile of non-adherent patients: they are very old, never quit smoking, suffer from mild-moderate COPD, take several different medications, live alone, are depressed, have limited economic resources, show cognitive/cultural deficits, have poor trust in physicians and medications, do not realize the gravity of the disease or don’t want to see themselves as such, justify or hide their symptoms, are reluctant to follow long-term therapies, are well documented on their disease and know that they need to take specific medications but do not take any action and criticize any kind of pharmacological option (evolved inactivity), and sometimes may not understand the Italian language [31].
In order to evaluate adherence to the medical therapy, several methods were proposed, the most effective of which turned out to be self-reports, i.e. simple, brief questionnaires (e.g. Morisky test [32]) that provide a clear overview of the respondents’ degree of compliance with their medical therapy.
To increase the likelihood of quickly identifying non-compliant patients, it may be useful to administer (for example, in the waiting room before an examination) a simple questionnaire including some specific items allowing to identify the patient’s key characteristics [33].
Depending on the answers, patients who do not comply with their pharmacological treatment may be classified as belonging to one of the following 6 phenotypes: 1) patients who consider the treatment too complex, 2) patients with wrong beliefs, 3) patients who are not aware of the importance to follow their prescriptions, 4) patients who doubt the efficacy of their medications, 5) patients who are poorly attentive, and 6) patients who believe that the efforts required to comply with the therapy overweigh the benefits of the therapy itself. Later on, other evaluations follow up to this initial assessment during treatment so as to investigate the reasons underlying any failure to comply with the therapy: wrong interpretation, forgetfulness, skepticism, unconscious reasons (denial of the problem, the drug reminds the patients of their disease), administration route, adverse events, fear of addiction, belief that the disease was finally cured, costs.
At this point, two homogeneous areas can be identified, each including indicators that can be correlated with the risk of poor adherence. The first area is geared towards assessing personal/family-related risk situations and the relationship with medications in general, while the second one is aimed at defining the risks of poor adherence which are directly linked to the relationship that COPD patients already under treatment have with inhaled medications.
Proposed psycho-socio-economic questionnaire to be administered to naive patients for the identification of their phenotype
In order to find out whether a patient will be compliant with the physician’s prescription, a simple, quick questionnaire with only 6 questions can be administered to naive patients in the waiting room before they are seen by a doctor, which might be even more effective if it were shared with Primary Care Medical Centers since it is not limited to the category of inhaled drugs [10]. The rationale behind the selection of such 6 questions is the result of the following considerations: several studies showed that patients’ compliance is inversely proportional to the number of administrations (Question 1), living with a family member could make it more likely for the patients to remember taking their medications (Question 2), worries, physical disorders and poor compliance with the medical examination schedule have a negative impact on adherence (Questions 3, 4, and 6), the patients’ opinion on inhaled medications is reflected on their consistent use (Question 5) [34]. See Additional file 1.
Questionnaires for patients who are already under treatment aimed at confirming their adherence status and phenotype
The proposal of this questionnaire is to asses of non-adherence in COPD patients with inhaled medication.
Here again, the indicators are gathered in a short questionnaire designed to be administered to patients who are already under treatment, during their follow up examinations. Based on few, simple questions, this questionnaire may help pulmonologists to identify compliant, poorly compliant, or non-compliant patients, and consequently to take the necessary measures.
The proposed reference questionnaire is again the Morisky scale [32], in a modified version with 3 specific questions on inhaled therapies. See Additional file 2.
Suggestions for possible solutions
It should not be underestimated that compliance with therapeutic choices is an indicator of quality of care, and some organizations are already planning to use this aspect through specific indicators (e.g. Centers for Medicare and Medicaid Services Five-Star Quality Rating System) because of its high impact on the quality of life and on health-care policies. The strategies for increasing adherence that were most frequently quoted in a survey conducted among pulmonologists were: to provide clear, simple information on therapy schemes, and to identify markers of non-compliance and defined clusters [35].
Once the risk of non-compliance is identified, the possible corrective actions might be:
– To engage patients in the therapeutic strategy and provide them with information on how to manage difficulties
– To facilitate continuity in the delivery of health-care services by the organization or specialists
– To treat comorbidities, especially depression and anxiety
– To offer near-term follow up examinations to patients at high risk of non-compliance
– To increase interactions between specialists and general practitioners
– To disseminate technical data sheets on inhaled medications in the most commonly spoken languages.
Another factor that should be taken into due consideration, since it turned out to have a significant impact on adherence to the prescribed therapy, is the selection of the device, whose characteristics should be as close as possible to those of an “ideal inhaler”:
– Dose reproducibility
– Operation under low flow peaks
– Lowest resistance to inhalation
– High release of fine particles
– Ability to check that the product was actually delivered.
In essence, four possible types of measures can be taken, namely: prescription-related (simplification of administration and dosage of the medications), educational, behavioral, and complex combined measures (combination of two or more actions).
However, it is unquestionable that compliance with a therapeutic regimen will improve if the patients are able to perceive the severity of their disease and the benefits of their treatment, if they become aware of being at risk of exacerbations/complications, if they establish a good relationship with their physician, and feel able to do what the therapeutic regimen requires so as to develop a good sense of self-efficacy and of locus of control.
Moreover, an important role in improving compliance could be played by nurses, who can be put in charge of conducting interviews with the patients before and during treatment in order to motivate them - especially if they are anxious and/or depressed - to adhere to their prescriptions [36].