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Adherence
Evidence review N
NICE Guideline, No. 202
National Guideline Centre (UK).
1. Adherence
1.1. Review question: What support improves adherence to CPAP or other interventions?
1.2. Introduction
Adherence to interventions such as CPAP/non-invasive ventilation/oral devices/positional modifiers for obstructive sleep apnoea/hypopnoea syndrome (OSAHS), obesity hypoventilation syndrome (OHS) or COPD-OSAHS overlap syndrome is essential in order for these interventions to be effective. Optimal adherence to CPAP therapy is conventionally considered to be four or more hours per night or use for an average of more than 4 hours per night for 70% or more nights. There is some evidence suggesting that increased CPAP use of more than 5 hours a night in OSAHS benefits other aspects of health such as control of blood pressure and cardiovascular risk. However, it is recognised that use of CPAP for four hours per night or more is an arbitrary figure not based on good quality evidence and that people can gain some benefit from a shorter period of use. People should be encouraged to maximise their CPAP use to achieve optimal control of their symptoms, underlying conditions, sleep quality and quality of life. Adherence to other devices is thought to be equally important to gain any benefit.
An evidence review was conducted to assess interventions designed to inform participants about improving adherence of CPAP/non-invasive ventilation, positional modifiers and oral devices, to support them in using these interventions and to modify their behaviour in improving their use.
1.3. PICO table
For full details see the review protocol in appendix A.
Table 1
PICO characteristics of review question.
1.4. Clinical evidence
1.4.1. Included studies
OSAHS
CPAP
Total of 46 studies reviewing educational, supportive and behavioural interventions to improve usage of continuous positive airway pressure machines in adults with obstructive sleep apnoea were included in the review. This included one Cochrane review5 with 41 studies and 5 additional studies identified in re-runs12,34,43,57,61 these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 3).
Studies were categorised into the following comparisons:
- Behavioural vs. Control - interventions employing psychotherapeutic techniques deriving from behavioural, cognitive or cognitive-behavioural models of health behaviour change (e.g., specific models within this broad genre include motivational enhancement therapy [Miller], Transtheoretical/Stages of Change Model [Prochaska and DiClemente], CBT [Beck]). By definition, behavioural interventions under any of these related models involves at least a minimal degree of direct participant engagement or interaction (as opposed to purely educational, in which information is merely imparted to participants, even if the educational content or style of presentation was based on a cognitive/behavioural model). The objectives of such interventions included enhancing motivation for change, self-efficacy, outcome expectations and/or decisional balance in favour of CPAP. There were a broad range of interventions included in this category such as myofunctional therapy, progressive muscle relaxation training, audiotaped music along with softly spoken directions on relaxation techniques and habit-promoting instructions for using CPAP nightly, motivational interviewing, one to one sessions with a clinical psychologist, motivational enhancement which is devised on the principles of motivational interviewing, motivational enhancement therapy and telephone-linked communications.
- Educational vs. Control – interventions imparting information about CPAP treatment or about OSAHS more generally, delivered through video format, face-to-face didactic sessions, group educational sessions, written materials, or any combination of these. Interventions that did not involve a component of active engagement from the participants other than reading written materials or observing a presentation or demonstration, even if the content derived from a behavioural change model, were classified as educational.
- Supportive vs. Control - interventions in which participants were provided with additional clinical follow-up (e.g., additional office or home-based visits or phone check-ins by clinical staff) or with telemonitoring equipment that facilitated self-monitoring of CPAP usage or that facilitated monitoring by clinical staff to prompt as needed clinical follow-up (e.g., a phone call made to participants when CPAP usage fell below a predetermined threshold) for the purpose of addressing barriers or difficulties with CPAP usage in a timely manner (e.g. telemedicine systems, digitised phone calls or audio messages, and/or home visits)
- Mixed vs. Control – interventions that combined elements of the three previously listed intervention-types (e.g. educational video and material provided + telemedicine follow-up)
In cases where studies used a mixed combination of intervention-types (behavioural, educational or supportive), but had multiple active intervention arms that had distinct elements of one type of intervention (e.g. intervention 1 supportive vs. intervention 2 educational vs. control), the active interventions groups were separated and included in the appropriate comparison subcategory for meta-analysis.
Studies had people with moderate and severe OSAHS; however, the majority of the studies were in people with severe sleep apnoea.
No evidence was identified for the critical outcome mortality.
Oral devices
No studies identified educational, supportive and behavioural interventions to improve usage of oral devices in adults with obstructive sleep apnoea, OHS and COPD-OSAHS overlap syndrome.
Positional modifiers
No studies identified educational, supportive and behavioural interventions to improve usage of positional modifiers in adults with obstructive sleep apnoea, obstructive sleep apnoea/OHS and COPD-OSAHS overlap syndrome.
OHS
No evidence identified for improving adherence of CPAP and non-invasive ventilation (NIV) in OHS.
COPD-OSAHS overlap syndrome
No evidence identified for improving adherence of CPAP and non-invasive ventilation (NIV) in COPD-OSAHS overlap syndrome.
See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.
1.4.2. Excluded studies
See the excluded studies list in appendix H.
1.4.3. Summary of clinical studies included in the evidence review
Table 2
Summary of studies included in the evidence review for CPAP.
See appendix D for full evidence tables.
1.4.4. Quality assessment of clinical studies included in the evidence review
Table 3
Clinical evidence summary: Behavioural therapy + CPAP versus control + CPAP- Severe OSAHS.
Table 4
Clinical evidence summary: Educational interventions + CPAP versus usual care + CPAP- Severe OSAHS.
Table 5
Clinical evidence summary: Increased practical support and encouragement during follow-up + CPAP versus usual care + CPAP - Severe OSAHS.
Table 5
Clinical evidence summary: Mixed (SUP/EDU/BEH) Intervention + CPAP versus Usual Care + CPAP - Severe OSAHS.
See appendix F for full GRADE tables.
1.5. Economic evidence
1.5.1. Included studies
No health economic studies were included.
1.5.2. Excluded studies
No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.
See also the health economic study selection flow chart in appendix G.
1.5.3. Health economic modelling
Original modelling was not prioritised for this question.
1.5.4. Health economic evidence statements
No relevant economic evaluations were identified.
1.6. The committee’s discussion of the evidence
1.6.1. Interpreting the evidence
1.6.1.1. The outcomes that matter most
The committee considered the outcomes of proportion adherent >4hrs/night for CPAP/non-invasive ventilation, adherence in hours/night for CPAP and oral devices, self-reported adherence, quality of life and mortality as critical outcomes for decision making. Other important outcomes included , sleepiness scores (e.g. Epworth), apnoea-Hypopnoea index (AHI) or respiratory disturbance index, oxygen desaturation index , mood or anxiety, withdrawals, treatment related withdrawals, CO2 control, minor adverse effects of treatment, driving outcomes, neurocognitive outcomes and impact on co-existing conditions:HbA1c for diabetes, cardiovascular events for cardiovascular disease and systolic blood pressure for hypertension.
No evidence was identified for the outcomes of mortality, mood or anxiety, neurocognitive outcomes and impact on co-existing conditions: HbA1c for diabetes, cardiovascular events for cardiovascular disease and systolic blood pressure for hypertension for the OSAHS population.
1.6.1.2. The quality of the evidence
OSAHS
CPAP
The quality of the evidence for interventions to improve usage of CPAP in adults with OSAHS varied from moderate to very low quality; majority of the evidence was downgraded due to risk of bias, inconsistency, indirectness and imprecision. Risk of bias was most commonly due to selection bias. Studies were downgraded for indirectness if they included mixed severity OSAHS. The committee also acknowledged that some uncertainty existed across the effect sizes seen within the evidence, with some confidence intervals crossing the MID thresholds or line of no effect. The committee took into account the quality of the evidence, including the uncertainty in their interpretation of the evidence.
The committee considered the clinical importance for AHI on a case by case basis, taking into consideration the baseline AHI and the improvement in severity of sleep apnoea.
There was evidence from 46 studies evaluating educational, supportive and behavioural interventions to improve use of continuous positive airway pressure in adults with obstructive sleep apnoea. Interventions in the review were classified as: educational interventions, behavioural interventions, supportive interventions and mixed interventions. There was a huge variation in the specific type of interventions used in all the categories.
Educational interventions included imparting information about CPAP treatment or about OSAHS more generally, delivered through video format, face-to-face didactic sessions, group educational sessions, written materials, or any combination of these.
There were a broad range of behavioural interventions, with a huge variation in the type (motivational interviewing, oropharyngeal exercises, audio tape with CPAP information and relaxation techniques), delivery (by psychologists, nurses/nurse counsellors) and timing of interventions (after the first session of CPAP/1 week after CPAP/1 month after CPAP).
Supportive interventions included where participants were provided with additional clinical follow-up (e.g. additional office or home-based visits, video or phone check-ins by clinical staff) or with telemonitoring equipment that facilitated self-monitoring of CPAP usage or that facilitated monitoring by clinical staff to prompt ‘as needed’ clinical follow-up.
Mixed interventions combined elements of the three previously listed intervention-types.
Most of the studies included people who are new to CPAP, and there was very little evidence available on people who have difficulty using CPAP. Studies included people with moderate and severe OSAHS.
The committee recognised the lack of evidence in people with mild sleep apnoea and in people who have difficulty using CPAP.
Positional modifiers
There was no evidence for educational, supportive and behavioural interventions to improve usage of positional modifiers in adults with OSAHS.
Oral devices
There was no evidence for educational, supportive and behavioural interventions to improve usage of oral devices in adults with OSAHS.
OHS
No evidence was identified for improving adherence of CPAP and non-invasive ventilation (NIV) in OHS.
COPD-OSAHS overlap syndrome
No evidence was identified for improving adherence of CPAP and non-invasive ventilation (NIV) in COPD-OSAHS overlap syndrome.
1.6.1.3. Benefits and harms
OSAHS
CPAP
Behavioural therapy + CPAP versus control + CPAP
The evidence suggested that there was clinically important benefit with behavioural therapy + CPAP compared to control + CPAP for the outcomes CPAP device usage (hours/night) and number of participants deemed adherent (≥ four hours/night), although there was some uncertainty around the effect estimates. The evidence suggested that there was no clinically important difference between behavioural therapy + CPAP and control + CPAP for the outcomes of withdrawal, Epworth Sleepiness Scale, AHI on treatment, and quality of life.
Educational interventions + CPAP versus usual care + CPAP
The evidence suggested that there was clinically important benefit with educational interventions + CPAP compared to usual care + CPAP for the outcomes CPAP device usage (hours/night) and number of participants deemed adherent (≥ four hours/night), although there was some uncertainty around the effect estimates. The evidence suggested that there was no clinically important difference between educational interventions + CPAP and usual care + CPAP for the outcomes of withdrawal and Epworth Sleepiness Scale.
Increased practical support and encouragement during follow-up + CPAP versus usual care + CPAP
The evidence suggested that there was clinically important benefit with supportive interventions + CPAP compared to control + CPAP for the outcomes CPAP device usage (hours/night) , , number of participants deemed adherent (≥ four hours/night), mean adherence all days (min per day) , days CPAP used > 4 hours at 3 months and systolic and diastolic blood pressure, although there was some uncertainty around the effect estimates. The evidence suggested that there was no clinically important difference between supportive interventions + CPAP and control + CPAP for the outcomes of days CPAP used > 4 hours at 12 months, CPAP use (min/night), withdrawal, Epworth Sleepiness Scale, AHI on treatment. The evidence for quality was life was inconsistent, with no difference between supportive interventions + CPAP and control + CPAP for quality of life scales SF-36, SAQLI, FOSQ and benefit for increased practical support for quality life FOSQ-10.
Mixed (educational/supportive/behavioural) intervention + CPAP versus usual care + CPAP
The evidence suggested that there was clinically important benefit with mixed interventions + CPAP compared to control + CPAP for the outcomes CPAP device usage (hours/night) and number of participants deemed adherent (≥ four hours/night), although there was some uncertainty around the effect estimates. The evidence suggested that there was no clinically important difference between mixed interventions + CPAP and control + CPAP for the outcomes of withdrawal, Epworth Sleepiness Scale, and AHI on treatment. The evidence for quality was life was inconsistent, with no difference between mixed interventions + CPAP and control + CPAP for quality of life scale FOSQ and benefit for mixed interventions for quality life FOSQ-10 and SF-36 (physical health).
Interventions to improve adherence of interventions for OSAHS- committee’s consideration of the evidence
The overall evidence suggested that all types of interventions (educational, behavioural, supportive and mixed) increased CPAP usage to varying degrees in CPAP‐naive participants with moderate to severe OSAHS. However, it was unclear from the evidence whether any of these interventions also led to meaningful improvement of daytime symptoms or quality of life. There was no evidence of harm associated with these interventions. Although there was uncertainty around the effect estimates for some of the outcomes, the committee agreed that the direction of effect on the whole was positive and the evidence base was large enough to justify a recommendation. The evidence did not show which category of interventions is best suited for individual patients. Also, optimum duration/intensity and long‐term effectiveness of these interventions were not clear from the evidence. However, the committee did not make a research recommendation on this as they did not consider it to be a priority for research recommendation.
In current practice some form of educational interventions is offered, however the content and delivery of these interventions is not consistent across all centers.
Based on the evidence and their knowledge of current practice, the committee agreed that educational or supportive interventions or a combination of these, provided by specialist staff, would help to improve adherence to CPAP. Educational interventions include providing information about OSAHS, its treatment and outcomes, which can be delivered using a variety of different sessions and formats, whereas supportive interventions involve additional clinical follow-up (for example, extra clinic visits, teleconsultations, video consultations or use of telemonitoring) to provide support. Due to the lack of standardised content of behavioural interventions, delivery of interventions (psychologists or nurses or nurse counsellors) and the difficulty in identifying the effective components within these interventions, the committee agreed not to make a make recommendation for any specific behavioural intervention.
The committee discussed that though CPAP therapy is considered as the first line treatment of moderate and severe OSAHS and for symptomatic mild OSAHS if other management such as weight loss has not been effective (see discussion of evidence for CPAP in evidence reports E and F), the uptake and adherence can be low which limits its clinical effectiveness in patients with OSAHS. The committee from their experience stated that adhering to regular use of CPAP treatment has multiple benefits including improving the quality of sleep, reducing sleepiness during waking hours, preventing vehicle accidents, improving blood pressure control and reducing the risk of cardiovascular events. Therefore, they agreed that educational/supportive interventions to improve adherence of CPAP should be offered to all patients at initiation of therapy and as required at follow-up.
Optimal adherence to CPAP therapy is conventionally considered to be 4 hours or more per night or use for an average of more than 4 hours per night for 70% or more nights. Early adherence studies focused on control of sleepiness but there is evidence that increased CPAP use of more than 5 hours a night in OSAHS benefits other aspects of health such as control of blood pressure and cardiovascular risk. However, it is recognised that people can gain some benefit from a shorter period of use and individual response is variable. People should be encouraged to maximise their CPAP use to achieve optimal control of their symptoms, underlying conditions, sleep quality and quality of life.
Although evidence was available only for moderate and severe OSAHS, the committee agreed that the recommendations would be applicable to all severities, including people with mild OSAHS.
The committee stated that the choice of these interventions should be tailored to match individual patient needs. The committee agreed it is more helpful to focus on the content of the intervention rather than the specific type of intervention.
The committee highlighted the importance of timing of the delivery of CPAP education and support; they agreed that the initial contact and information session is a critical component in CPAP uptake and adherence.
The committee agreed that the recommendations reflect best practice, but current provision varies across NHS settings. Therefore, the recommendations will involve a change of practice for some providers.
The committee also discussed the importance of staff being appropriately trained to offer these interventions. They discussed that a low ratio of patients to staff should be maintained to allow individualised input but agreed that staffing issues are outside the remit of this guideline.
There was no evidence available for improving adherence for oral devices and positional modifiers in OSAHS; however, the committee agreed that the educational/supportive interventions for improving adherence for CPAP could be generalised for oral devices and positional modifiers as well.
There was no evidence for improving adherence in people who have difficulty using CPAP. The committee hence made a research recommendation for people who continue to find CPAP difficult to use despite having received some education from trained sleep professionals, access to support in the early adaptation period and/or clinical review to optimise aspects such as machine pressure, mask fit and humidification (Appendix I).
OHS
The committee agreed that the interventions to improve use of CPAP/non-invasive ventilation could be offered in people with OHS as the evidence for OSAHS population could be extrapolated to this population. The committee noted that the recommendations reflect best practice but are currently implemented to varying degrees across NHS settings and will involve a change of practice for some providers.
COPD-OSAHS overlap syndrome
The committee agreed that the interventions to improve use of CPAP/non-invasive ventilation could be offered in people with COPD-OSAHS overlap syndrome as the evidence for OSAHS population could be extrapolated to this population. The committee noted that the recommendations reflect best practice but are currently implemented to varying degrees across NHS settings and will involve a change of practice for some providers.
1.6.2. Cost effectiveness and resource use
There were no economic evaluations identified for this review question.
There was clinically important benefit for educational, supportive, behavioural and a mixture of these strategies for improving device usage (hours per night). There was also some evidence of better blood pressure control. The evidence for improvement in quality of life was mixed but from their experience, the committee explained that quality of life gains associated with using CPAP and other interventions could only be achieved and sustained if the device was used regularly. Poor adherence could lead to interventions no longer being cost-effective. The committee therefore agreed that providing education and support was reasonable because they can improve adherence and contribute to the cost-effectiveness of the intervention.
The provision of education and support is current practice for people who are newly provided with CPAP. This has traditionally been provided in the form of sleep specialist (usually nurse or physiologist)-led outpatient appointments but is now most likely to be conducted remotely. People receive their first outpatient appointment for CPAP when collecting the device. During this appointment people requiring CPAP receive advice and are educated on how to use their new device e.g. cleaning, plus are fitted with an appropriate mask and taught how to ensure the mask is on properly to avoid leaks. They have reminders of the importance of using the device regularly. This appointment when initiating people with CPAP is deemed to be important by the committee because they explained early encouragement and successful adherence is an important factor on whether people will be compliant over a longer time horizon. The provision of information is then typically provided again during a follow-up sleep specialist outpatient appointment 1 month after initiation with CPAP and then per annum thereafter. It is important to note that provision of education and advice are incorporated into these appointments, but they are not exclusively for providing education and support. For example, during the same appointment sleep specialist would explore whether people with OSAHS have adequate control of their symptoms and whether further assistance is required to improve symptoms (e.g. changing mask types, increasing machine pressure) and download data on adherence from the CPAP machine.
The provision of education and support is consistent with the minimum level of care all people should expect as explained in the Patient experiences guideline (CG138). It was therefore agreed provision of education and support should also be extended to people receiving positional modifiers or oral devices for OSAHS and CPAP or non-invasive ventilation for (COPD-OSAHS overlap syndrome and OHS). As these recommendations are consistent with what occurs in current practice, a significant resource impact is not expected due to these recommendations.
The committee noted that providing intensive behavioural interventions as described in some of the clinical studies would be quite costly. Due to the lack of cost effectiveness evidence and a concern that behavioural interventions could be interpreted in different ways (which would increase variation in practice) the committee opted to not make a recommendation for this intervention. Finally, in those people who have difficulty with using the device, the committee decided to make a research recommendation to explore a range of strategies (including behavioural strategies) that could be utilised to improve adherence.
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Appendices
Appendix A. Review protocols
Table 6. Review protocol: adherence (PDF, 415K)
Table 7. Health economic review protocol (PDF, 196K)
Appendix B. Literature search strategies
Sleep Apnoea search strategy 1_adherence
This literature search strategy was used for the following review;
- What support improves adherence to CPAP or other interventions?
The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.60
For more information, please see the Methods Report published as part of the accompanying documents for this guideline.
B.1. Clinical search literature search strategy (PDF, 303K)
B.2. Health Economics literature search strategy (PDF, 345K)
Appendix C. Clinical evidence selection
Figure 1. Flow chart of clinical study selection for the review of adherence (PDF, 154K)
Appendix D. Clinical evidence tables
Download PDF (468K)
Appendix E. Forest plots
E.1. Adherence for CPAP (PDF, 521K)
Appendix F. GRADE tables
Table 11. Clinical evidence profile: Behavioural therapy + CPAP versus control + CPAP - severe OSAHS (PDF, 166K)
Appendix G. Health economic evidence selection
Figure 31. Flow chart of health economic study for the guideline (PDF, 210K)
Appendix H. Excluded studies
H.1. Excluded clinical studies
Table 15. Studies excluded from the clinical review for CPAP (PDF, 149K)
Table 16. Studies excluded from the clinical review for oral devices and positional modifiers (PDF, 131K)
H.2. Excluded health economic studies
Published health economic studies that met the inclusion criteria (relevant population, comparators, economic study design, published 2003 or later and not from non-OECD country or USA) but that were excluded following appraisal of applicability and methodological quality are listed below:
None.
Appendix I. Research recommendations
I.1. Interventions to improve CPAP adherence (PDF, 130K)
Final
Intervention evidence review
Developed by the National Guideline Centre, hosted by the Royal College of Physicians
Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.
Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.
NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.
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