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. 2021 Sep 8;9(9):CD013381.
doi: 10.1002/14651858.CD013381.pub2.

Interventions to improve adherence to pharmacological therapy for chronic obstructive pulmonary disease (COPD)

Sadia Janjua  1 , Katharine C Pike  2 , Robin Carr  3 , Andy Coles  4 , Rebecca Fortescue  1 , Mitchell Batavia  5
Affiliations

Interventions to improve adherence to pharmacological therapy for chronic obstructive pulmonary disease (COPD)

Sadia Janjua et al. Cochrane Database Syst Rev. .

Abstract

Background: 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.

Objectives: 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.

Search methods: 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.

Selection criteria: 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.

Data collection and analysis: 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).

Main results: 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 certainty).

Authors' conclusions: 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.

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Conflict of interest statement

SJ: is employed full‐time as a systematic reviewer by a National Institute for Health Research (NIHR) Programme Grant to complete work on this review.

KP: is a senior clinical lecturer in paediatric medicine at Great Ormond Street Hospital, London, UK; has acted as a consultant on an advisory board for Respiri for development of a symptom monitoring device for asthma; and has given a lecture paid by GlaxoSmithKline. KP has also attended a Novartis severe asthma consultation to develop educational material.

RC: retired in 2018 as a general practitioner and has given lectures to primary care staff funded by GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Chiesi in the last 36 months.

AC: has COPD and is part of the patient advisory group for the current NIHR Programme Grant. He has given advice on the development of the protocol, and will provide further advice in the reviewing process.

RF: is a UK qualified general practitioner and Co‐ordinating Editor of Cochrane Airways. She is funded by grants from the NIHR.

MB: none known

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Single component intervention versus control, Outcome 1: Adherence: number of people completing treatment (12 weeks' duration)
1.2
1.2. Analysis
Comparison 1: Single component intervention versus control, Outcome 2: Adherence: compliance by prescription refill (21.6–26 weeks' duration)
1.3
1.3. Analysis
Comparison 1: Single component intervention versus control, Outcome 3: Adherence: Adherence among Patients with Chronic Disease scale (8 weeks)
1.4
1.4. Analysis
Comparison 1: Single component intervention versus control, Outcome 4: Adherence % (change to pharmacotherapy) (12 weeks)
1.5
1.5. Analysis
Comparison 1: Single component intervention versus control, Outcome 5: Quality of life: St George's Respiratory Questionnaire or Clinical COPD Questionnaire total scores (26–52 weeks)
1.6
1.6. Analysis
Comparison 1: Single component intervention versus control, Outcome 6: Hospital service utilisation: number of people admitted to hospital (all cause) (52 weeks)
1.7
1.7. Analysis
Comparison 1: Single component intervention versus control, Outcome 7: Exacerbations: number of people experiencing exacerbations (16–52 weeks)
1.8
1.8. Analysis
Comparison 1: Single component intervention versus control, Outcome 8: Adverse events: number of people experiencing adverse events (16–52 weeks)
1.9
1.9. Analysis
Comparison 1: Single component intervention versus control, Outcome 9: Adverse events: number of people experiencing adverse events (COPD‐related) (52 weeks)
1.10
1.10. Analysis
Comparison 1: Single component intervention versus control, Outcome 10: Adverse events: number of people experiencing a serious adverse event (26–52 weeks)
1.11
1.11. Analysis
Comparison 1: Single component intervention versus control, Outcome 11: Mortality (52 weeks)
2.1
2.1. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 1: Adherence: risk ratio and 95% CI (6‐52 weeks)
2.2
2.2. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 2: Quality of life: St George's Respiratory Questionnaire total scores (26–52 weeks)
2.3
2.3. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 3: Quality of life: Short Form Chronic Respiratory Disease Questionnaire total score (39 weeks)
2.4
2.4. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 4: Quality of life: COPD Assessment Test (4–39 weeks)
2.5
2.5. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 5: Hospital service utilisation: number of people admitted to hospital (all‐cause) (13–52 weeks)
2.6
2.6. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 6: Hospital service utilisation: number of people admitted to hospital (COPD‐related) (26–52 weeks)
2.7
2.7. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 7: Exacerbations: number of people experiencing exacerbations (moderate or severe) (13 weeks)
2.8
2.8. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 8: Self‐efficacy: Stanford Self‐Efficacy for Managing Chronic Disease Scale (39 weeks)
2.9
2.9. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 9: Adverse events: number of people experiencing adverse events (39 weeks)
2.10
2.10. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 10: Serious adverse events: number of people experiencing a serious adverse event (52 weeks)
2.11
2.11. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 11: Mortality (26–52 weeks)
2.12
2.12. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 12: Inhaler technique: number of people achieving correct inhaler technique (13–39 weeks)
2.13
2.13. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 13: Inhaler technique: number of people achieving correct inhaler technique; sensitivity analysis (13–39 weeks)
2.14
2.14. Analysis
Comparison 2: Multi‐component intervention versus control, Outcome 14: Inhaler technique: published versus unpublished; SGA, number of people achieving correct inhaler technique (13–39 weeks)
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    1. Vanhaecht K, Lodewijckx C, Sermeus W, Decramer M, Deneckere S, Leigheb F, et al. Impact of a care pathway for COPD on adherence to guidelines and hospital readmission: a cluster randomized trial. International Journal of COPD 2016;11(1):2897-908. - PMC - PubMed
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    1. Van Wijk BL, Klungel OH, Heerdink ER, Boer A. Effectiveness of interventions by community pharmacists to improve patient adherence to chronic medication: a systematic review. Annals of Pharmacotherapy 2005;39(2):319-28. - PubMed
Vestbo 2009 {published data only}
    1. Vestbo J, Anderson J, Calverley P, Celli B, Ferguson G, Jenkins C. Adherence to medication, mortality and severe exacerbations in the TORCH study. European Respiratory Society 18th Annual Congress; 2008 Oct 3-7; Berlin 2008:383.
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    1. Vestbo J, Anderson JA, Willits LR, Celli B, Ferguson GT, Jenkins CR, et al. The TOwards a Revolution in COPD Health (TORCH) study, the effects of compliance on mortality over 3 years. American Thoracic Society International Conference; 2008 May 16-21; Toronto.
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    1. Viejo JI, Alcazar B, Garcia I, Guallar J, Hernandez S, Martin P, et al. A realistic study assessing inhaled treatment compliance in COPD patients. European Respiratory Journal 2001;18:25s.
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References to studies awaiting assessment

ACTRN12618000410257 {published data only}
    1. ACTRN12618000410257. Medication adherence management in a community pharmacy setting (AdherenciaMED): a cluster randomised controlled trial [The effect of a medication adherence management service in a community pharmacy setting on patient's adherence to medications: a cluster randomized controlled trial]. ictrptest.azurewebsites.net/Trial2.aspx?TrialID=ACTRN12618000410257 (first received 21 March 2018).
Bookser 2018 {published data only}
    1. Bookser M, Drennen C, Leonard E, McConaha J. Pharmacist-led medication intervention for patients with asthma and COPD within a primary care setting. Journal of the American Pharmacists Association 2018;58(3):e24.
Davis 2016 {published data only}
    1. Davis E, Marra C, Gamble J-M, Farrell J, Lockyer J, FitzGerald JM, et al. Effectiveness of a pharmacist-driven intervention in COPD (EPIC): study protocol for a randomized controlled trial. Trials 2016;17(1):502. - PMC - PubMed
Elliot 2016 {published data only}
    1. Boyd M, Waring J, Barber N, Mehta R, Chuter A, Avery AJ et al. Protocol for the new medicine service study: a randomised controlled trial and economic evaluation with qualitative appraising comparing the effectiveness and cost-effectiveness of the new medicine service in community pharmacies in England. Trials 2013;14:411. - PMC - PubMed
    1. Elliott RA, Boyd MJ, Salema NE, Davies J, Barber N, Mehta RL. Supporting adherence for people starting a new medication for a long-term condition through community pharmacies: a pragmatic randomised controlled trial of the new medicine service. British Medical Journal Quality and Safety 2016;25(10):747-58. - PubMed
    1. Elliott RA, Boyd MJ, Tanajewski L, Barber N, Gkountouras G, Avery AJ et al. New medicine service: supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial. British Medical Journal 2020;29(4):286-95. - PMC - PubMed
    1. Elliott RA, Tanajewski L, Gkountouras G, Avery AJ, Barber N, Mehta R et al. Cost-effectiveness of support for people starting a new medication for a long-term condition through community pharmacies: an economic evaluation of the new medicine service (NMS) compared with normal practice. Pharmacoeconomics 2017;35(12):1237-55. - PMC - PubMed
    1. NCT01635361. Understanding and appraising the new medicine service in England (NMS). https://clinicaltrials.gov/ct2/show/NCT01635361 2012.
EUCTR2016‐001435‐13‐FR {published data only}
    1. EUCTR2016-001435-13-FR. Description of the ability to learn how to handle inhaler devices in COPD [Description of the ability to learn how to handle inhaler devices in COPD – INTUITIVE]. ictrptest.azurewebsites.net/Trial2.aspx?TrialID=EUCTR2016-001435-13-FR (first received 17 June 2016).
Godycki‐Cwirko 2014 {published data only}
    1. Godycki-Cwirko M, Zakowska I, Kosiek K, Wensing M, Krawczyk J, Kowalczyk A. Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial. Trials 2014;15(1):109. - PMC - PubMed
Gregoriano 2015 {published data only}
    1. Gregoriano C, Dieterle T, Breitenstein AL, Durr S, Baum A, Giezendanner S, et al. Does a tailored intervention to promote adherence in patients with chronic obstructive pulmonary disease affect exacerbations? A randomised controlled trial. Respiratory Research 2019;23(6):e204. [DOI: 10.2196/resprot.7522] - DOI - PMC - PubMed
    1. Gregoriano C, Dieterle T, Durr S, Arnet I, Hersberger KE, Leuppi JD. Impact of an electronic monitoring intervention to improve adherence to inhaled medication in patients with asthma and chronic obstructive pulmonary disease. JMIR Research Protocols 2017;3(20):273. - PMC - PubMed
    1. Gregoriano C, Dieterle T, Flamm A-L, Durr S, Maier S, Arnet I. Objective adherence to inhaled medication and health-related outcomes in asthma and chronic obstructive pulmonary disease after an electronic monitoring intervention. Respiration 2018;95(6):486.
    1. Gregoriano C, Henny-Reinalter S, Handschin A, Flamm A-L, Dieterle T, Arnet I, et al. Patients' adherence to chronic treatment of pulmonary diseases. European Respiratory Journal 2015;46:PA1061.
    1. Gregoriano C, Henny-Reinalter S, Han d schin A, Lisa Flamm A, Dieterle T, Arnet I, et al. How do patients adhere to chronic treatment of pulmonary diseases? Baseline data from an adherence study. Praxis 2015;104:127-8.
Hesselink 2004 {published data only}
    1. Hesselink AE, Penninx BW, Van der Windt DA, Van Duin BJ, Vries P, Twisk JW, et al. Effectiveness of an education programme by a general practice assistant for asthma and COPD patients: results from a randomised controlled trial. Patient Education and Counselling 2004;55(1):121-8. - PubMed
ISRCTN10844309 2019 {published data only}
    1. ISRCTN10844309. Study of inhaler use in asthma and COPD [Cluster randomized controlled trial of the effectiveness and the cost-effectiveness of a pharmacist-led educational inhaler technique intervention on asthma and chronic obstructive pulmonary disease (COPD) patients (INspira)]. ictrptest.azurewebsites.net/Trial2.aspx?TrialID=ISRCTN10844309 (first received 3 May 2019).
ISRCTN62025354 {published data only}
    1. ISRCTN62025354. Minimal interventions to improve medication adherence in people with multiple long-term conditions (MINIMA) study. ictrptest.azurewebsites.net/Trial2.aspx?TrialID=ISRCTN62025354 (first received 24 January 2017).
Kristeller 2017 {published data only}
    1. Kristeller J, Snyder F, Kong F, Musheno M. Collaboration between hospital and community pharmacists to improve medication management from hospital to home. Innovations in Pharmacy 2017;8(2):1-9.
    1. NCT02047448. Improving medication adherence through a transitional care pharmacy practice model. www.clinicaltrials.gov/ct2/show/NCT02047448 (first received 28 January 2014).
Maricoto 2019 {published data only}
    1. Maricoto T, Correla-de-Sousa, Taborda-Barata L. Inhaler technique education in elderly patients with asthma or COPD: impact on disease exacerbations-a protocol for a single-blinded randomised controlled trial. BMJ Open 2019;9:e022685. - PMC - PubMed
Navarre 2007 {published data only}
    1. Navarre M, Patel H, Johnson CE, Durance A, McMorris M, Bria W, et al. Influence of an interactive computer-based inhaler technique tutorial on patient knowledge and inhaler technique. Annals of Pharmacotherapy 2007;41:216-21. - PubMed
NCT04195191 {published data only}
    1. NCT04195191. Intervention to improve the adherence in community pharmacies [Effectiveness of an intervention to improve the adherence to treatment of new medicines from the community pharmacist]. clinicaltrials.gov/ct2/show/NCT04195191 (first received 11 December 2019).
Nimmo 1993 {published data only}
    1. Nimmo CJ, Chen DN, Martinusen SM, Ustad TL, Ostrow DN. Assessment of patient acceptance and inhalation technique of a pressurized aerosol inhaler and two breath-actuated devices. Annals of Pharmacotherapy 1993;27(7):922-7. - PubMed
NTR5187 {published data only}
    1. Kemerink A, Steenhuis LH, Klemmeier TJ, Vroegop JS, Schokker S. Inhalation technique education in asthma or COPD: the value of a visual instruction card. European Respiratory Journal 2016;48:PA5006. [DOI: 10.1183/13993003congress-2016.PA5006] - DOI
O'Dwyer 2016 {published data only}
    1. NCT02203266. Teaching inhaler use with the INCA device in a community pharmacy setting [A randomised, parallel-group, multi-centre trial using a novel INCA tracker device to measure and monitor compliance and technique of Seretide Diskus inhaler in a community pharmacy setting]. www.clinicaltrials.gov/ct2/show/NCT02203266 (first received 29 July 2014).
    1. O'Dwyer S, Greene G, MacHale E, Cushen B, Sulaiman I, Boland F, et al. Personalised biofeedback on inhaler adherence and technique by community pharmacists: a cluster randomised clinical trial. Journal of Allergy and Clinical Immunology Practice 2020;8:635-44. - PubMed
Qin 2016 {published data only}
    1. Qin Q, Chen R, Lei W, Bian Y-C, Gu B-C, Bao J-A. Evaluation and analysis of inhaler drug device adherence in asthma and COPD patients. Chinese Pharmaceutical Journal 2016;51(5):413-6.
RBR‐5bw2wt {published data only}
    1. RBR-5bw2wt. The role of the pharmacist in the team care of hospitalised patients with chronic bronchitis or emphysema [Pharmaceutical care programme for inpatients with chronic obstructive pulmonary disease in a tertiary teaching hospital in southern Brazil – PHARBE: PHARmaceutical Care Programme for Inpatients with COPD in a Tertiary Teaching Hospital in Southern Brazil]. ictrptest.azurewebsites.net/Trial2.aspx?TrialID=RBR-5bw2wt (first received 1 May 2012).
SAM30001 GSK {published data only}
    1. SAM30001 GSK. Compliance in asthma and COPD. www.gsk-studyregister.com/en/trial-details/?id=SAM30001#documents-section (first received 1 May 1999).
Serra‐Batlles 2002 {published data only}
    1. Serra-Batlles J, Plaza V, Badiola C, Morejon E, Inhalation Devices Study Group, Morejon E, et al. Patient perception and acceptability of multidose dry powder inhalers: a randomized crossover comparison of Diskus/Accuhaler with Turbuhaler. Journal of Aerosol Medicine 2002;15(1):59-64. - PubMed
Suhaj 2016 {published data only}
    1. Abdulsalim S, Unnikrishnan K, Manu MK, Alrasheedy AA, Godman B, Morisky DE. Structured pharmacist-led intervention programme to improve medication adherence in COPD patients: a randomised controlled trial. Research in Social and Administrative Pharmacy 2018;14:909-14. - PubMed
    1. Suhaj A, Manu MK, Unnikrishnan MK, Vijayanarayana K, Mallikarjuna CR. Effectiveness of clinical pharmacist intervention on health-related quality of life in chronic obstructive pulmonary disorder patients – a randomized controlled study. Journal of Clinical Pharmacy and Therapeutics 2016;41(1):78-83. - PubMed
    1. Suhaj A, Unnikrishnan M, Mohan MK, Rao CM, Vijayanarayana K. The effectiveness of clinical pharmacist intervention on health related quality of life in chronic obstructive pulmonary disorder patients – a randomized controlled study. Respirology 2015;20:58. - PubMed
Xin 2016 {published data only}
    1. Xin C, Xia Z, Jiang C, Lin M, Li G. The impact of pharmacist-managed clinic on medication adherence and health-related quality of life in patients with COPD: a randomized controlled study. Patient Preference and Adherence 2016;10:1197-203. - PMC - PubMed

References to ongoing studies

ISRCTN10567920 {published data only}
    1. ISRCTN10567920. Maximising adherence and gaining new information for your COPD [A pragmatic, cluster randomized trial evaluating the impact of an enhanced adherence package (dual bronchodilator + add-on + app) on time to treatment failure and other clinical outcomes in exacerbating COPD patients with poor adherence to mono or dual therapy over one year]. ictrptest.azurewebsites.net/Trial2.aspx?TrialID=ISRCTN10567920 (first received 25 July 2019).
ISRCTN77785397 {published data only}
    1. ISRCTN77785397. Using the internet to help individuals stay healthy and prevent further reductions in health from existing chronic diseases [Maximizing the effects of self-management interventions on chronic disease outcomes: the development of a chronic obstructive pulmonary disease (COPD) web-based patient portal]. ictrptest.azurewebsites.net/Trial2.aspx?TrialID=ISRCTN10567920 (first received 8 November 2011).

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