Review question
Which approaches help people maintain taking prescribed medication(s), improve quality of life and reduce hospital admissions in people with chronic obstructive pulmonary disease (COPD)?
Background
COPD is a lung condition that can cause long-term breathing problems and includes symptoms such as shortness of breath. Medications do exist that can help but sometimes people do not take them as prescribed. Different approaches could help people to take their medication as prescribed and help improve symptoms or quality of life and reduce hospital admissions.
We wanted to find out if any approaches could help people with COPD take their medication(s) as prescribed.
Studies identified and selected
We searched databases to find the studies. Four people working in pairs looked at the lists of studies separately and agreed on which ones were included. The latest search for studies was conducted in May 2020.
Study characteristics
We included studies comparing simple ways to help improve medication use (e.g. different medication doses or single inhalers instead of two separate inhalers) to usual COPD care. We also included studies that tested combination approaches (e.g. information or training from nurses or pharmacists and monitoring medication use).
What were the key results?
We included 14 studies (2191 people) in our analysis. No studies were masked (people knew whether they were receiving an approach to help them with adherence or the alternative). Six studies used simple approaches (e.g. change to medication dosage, change to type of inhaler, or a Bluetooth inhaler reminder device), and eight studies used combined approaches (e.g. nurses or pharmacists giving advice or information about how to improve medication use).
We were uncertain about the effects of a different medication dose on people adhering to medication because it was no different to usual care (one study). Two separate studies found that a Bluetooth inhaler reminder device or a change in oral medication dose did not help to improve adherence. Health professionals involved in giving information may help to improve adherence (one study). This was measured by prescription refills. Motivating people to change their behaviour could help to improve adherence their medication (one study). This was measured by people completing a questionnaire about adherence to their medication.
One study found that a Bluetooth inhaler device might help to improve quality of life. There may be little to no difference between those using single inhalers in the number of people admitted to hospital compared to those using two separate inhalers (one study). We found no difference between single approaches and usual care on the number of people who had side effects.
Combined approaches may help to improve the number of people taking their medication, but we were not confident of this finding (four studies). They may have little to no impact on quality of life (three studies). Combined approaches could be beneficial in reducing the number of people with COPD admitted to hospital for any reason or because of COPD symptoms (two studies).
There was no difference between combined approaches and in the number of people who had adverse events.
Take home message
We could not say for certain that simple approaches are useful to help people with COPD to improve medication use because of very limited information. Combined approaches may help people to take their medication(s) as prescribed and can help to reduce the number of people admitted to hospital, however, more information is needed to help answer this question with confidence.
Single component interventions (e.g. education or motivational interviewing provided by a health professional) can help to improve adherence to pharmacotherapy (low to very low certainty). There were slight improvements in quality of life with a Bluetooth inhaler device, but evidence is from one study and very low certainty. Change to pharmacotherapy (e.g. single inhaler instead of two, or different doses of roflumilast) has little impact on hospitalisations or exacerbations (very low certainty). There is no difference in people experiencing adverse events (all-cause or COPD-related), or deaths (very low certainty).
Multi-component interventions may improve adherence with education, motivational or behavioural components delivered by health professionals (low certainty). There is little to no impact on quality of life (low to very low certainty). They may help reduce the number of people admitted to hospital overall (specifically pharmacist-led approaches) (low certainty), and fewer people may have COPD-related hospital admissions (moderately certainty). There may be a small reduction in people experiencing severe exacerbations, but evidence is from one study (low certainty). Limited evidence found no difference in people experiencing adverse events, serious adverse events or deaths (low to very low certainty).
The evidence presented should be interpreted with caution. Larger studies with more intervention types, especially single interventions, are needed. It is unclear which specific COPD subgroups would benefit, therefore discussions between health professionals and patients may help to determine whether they will help to improve health outcomes.
Chronic obstructive pulmonary disease (COPD) is a chronic lung condition characterised by persistent respiratory symptoms and limited lung airflow, dyspnoea and recurrent exacerbations. Suboptimal therapy or non-adherence may result in limited effectiveness of pharmacological treatments and subsequently poor health outcomes.
To determine the efficacy and safety of interventions intended to improve adherence to single or combined pharmacological treatments compared with usual care or interventions that are not intended to improve adherence in people with COPD.
We identified randomised controlled trials (RCTs) from the Cochrane Airways Trials Register, CENTRAL, MEDLINE and Embase (search date 1 May 2020). We also searched web-based clinical trial registers.
RCTs included adults with COPD diagnosed by established criteria (e.g. Global Initiative for Obstructive Lung Disease). Interventions included change to pharmacological treatment regimens, adherence aids, education, behavioural or psychological interventions (e.g. cognitive behavioural therapy), communication or follow-up by a health professional (e.g. telephone, text message or face-to-face), multi-component interventions, and interventions to improve inhaler technique.
We used standard Cochrane methodological procedures. Working in pairs, four review authors independently selected trials for inclusion, extracted data and assessed risk of bias. We assessed confidence in the evidence for each primary outcome using GRADE. Primary outcomes were adherence, quality of life and hospital service utilisation. Adherence measures included the Adherence among Patients with Chronic Disease questionnaire (APCD). Quality of life measures included the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT) and Clinical COPD Questionnaire (CCQ).
We included 14 trials (2191 participants) in the analysis with follow-up ranging from six to 52 weeks. Age ranged from 54 to 75 years, and COPD severity ranged from mild to very severe. Trials were conducted in the USA, Spain, Germany, Japan, Jordan, Northern Ireland, Iran, South Korea, China and Belgium. Risk of bias was high due to lack of blinding. Evidence certainty was downgraded due to imprecision and small participant numbers.
Single component interventions
Six studies (55 to 212 participants) reported single component interventions including changes to pharmacological treatment (different roflumilast doses or different inhaler types), adherence aids (Bluetooth inhaler reminder device), educational (comprehensive verbal instruction), behavioural or psychological (motivational interview).
Change in dose of roflumilast may result in little to no difference in adherence (odds ratio (OR) 0.67, 95% confidence interval (CI) 0.22 to 1.99; studies = 1, participants = 55; low certainty). A Bluetooth inhaler reminder device did not improve adherence, but comprehensive verbal instruction from a health professional did improve mean adherence (prescription refills) (mean difference (MD) 1.00, 95% CI 0.46 to 1.54). Motivational interview improved mean adherence scores on the APCD scale (MD 22.22, 95% CI 8.42 to 36.02).
Use of a single inhaler compared to two separate inhalers may have little to no impact on quality of life (SGRQ; MD 0.80, 95% CI –3.12 to 4.72; very low certainty). A Bluetooth inhaler monitoring device may provide a small improvement in quality of life on the CCQ (MD 0.40, 95% CI 0.07 to 0.73; very low certainty).
Single inhaler use may have little to no impact on the number of people admitted to hospital compared to two separate inhalers (OR 1.47, 95% CI 0.75 to 2.90; very low certainty). Single component interventions may have little to no impact on the number of people expereincing adverse events (very low certainty evidence from studies of a change in pharmacotherapy or use of adherence aids). A change in pharmacotherapy may have little to no impact on exacerbations or deaths (very low certainty).
Multi-component interventions
Eight studies (30 to 734 participants) reported multi-component interventions including tailored care package that included adherence support as a key component or included inhaler technique as a component.
A multi-component intervention may result in more people adhering to pharmacotherapy compared to control at 40.5 weeks (risk ratio (RR) 1.37, 95% CI 1.18 to 1.59; studies = 4, participants = 446; I2 = 0%; low certainty).
There may be little to no impact on quality of life (SGRQ, Chronic Respiratory Disease Questionnaire, CAT) (studies = 3; low to very low certainty).
Multi-component interventions may help to reduce the number of people admitted to hospital for any cause (OR 0.37, 95% CI 0.22 to 0.63; studies = 2, participants = 877; low certainty), or COPD-related hospitalisations (OR 0.15, 95% CI 0.07 to 0.34; studies = 2, participants = 220; moderate certainty). There may be a small benefit on people experiencing severe exacerbations.
There may be little to no effect on adverse events, serious adverse events or deaths, but events were infrequently reported and were rare (low to very low certainty).