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Cover of Monitoring

Monitoring

Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s

Evidence review L

NICE Guideline, No. 202

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4229-9

1. Monitoring

1.1. Review question: What is clinically and cost effective strategy for monitoring obstructive sleep apnoea/hypopnoea syndrome (OSAHS)/ obesity hypoventilation syndrome (OHS)/COPD-OSAHS overlap syndrome?

1.2. Introduction

Patients who have been diagnosed with OSAHS/OHS/COPD-OSAHS overlap syndrome can have a significant health burden. The provision of treatment by the health care provider to manage these conditions requires some form of follow-up and monitoring, similar to most conditions. Traditionally patients attend outpatient clinics after first treatment to discuss the care they are receiving, issues that are occurring, titration of the therapy as well as to allow for any further testing or answering clinical questionnaires. The timeliness of a patient’s review may impact on a number of factors including compliance and success of treatment. Yet the time to follow-up can vary between various health care providers. Services may see patients within the first two weeks after being set up on therapy, whilst others may not have the ability to review for 3 months. On-going reviews may also be varied from 2 weeks to 6, 12 months or 2 years and longer in some cases.

When a patient is reviewed, the type of monitoring of a patient’s treatment is also an area which is not uniform across the health service. There are differences in whether services repeat a sleep study, download patient’s device data, take a blood gas or overnight CO2 level. The advent of modems and the capability to use tele-monitoring allows review patient data and even titration of therapy without actually having the patient present. This has opened up further options, to examine what is clinically as well as cost effective in the monitoring of patients’ treatment.

1.3. PICO table

For full details see the review protocol in appendix A.

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

1.4. Clinical evidence

1.4.1. Included studies

OSAHS
CPAP

Ten studies were included in this review,3, 10, 14, 19, 23, 25, 26, 36, 40, 42 these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence table below (Table 3).

Six studies compared telemonitoring and in person follow-up with in-person follow-up. One study compared telemonitoring and phone follow-up with phone follow-up. One study compared multimodal telemonitoring with usual care. Two studies compared telemonitoring and tele visits with in person follow-up. The duration of all included studies was of one year or less.

All studies were in people using fixed level CPAP, except for one study in people using auto CPAP.

All studies included a severe OSAHS population determined by their baseline mean AHI. Studies were stratified based on the AHI/ODI severity of the population. When a mixed severity population was included the severity of the majority of the population was used by taking the mean AHI of the patients included and the study was downgraded for indirectness.

Follow-up of studies ranged from 2 to 12 months. Studies varied in size with the number of participants ranging from 45 in the smallest study to 306 in the largest.

Oral devices

No evidence was identified for monitoring of people using oral devices.

Positional modifiers

No evidence was identified for monitoring of people using positional modifiers.

Surgery

No evidence was identified for monitoring of people who have undergone surgery.

OHS

There was no evidence available for people with OHS.

COPD-OSAHS overlap syndrome

There was no evidence available for people with 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 H.

1.4.2. Excluded studies

See the excluded studies list in appendix I.

1.4.3. Summary of clinical studies included in the evidence review

Table 2. Summary of studies included in the evidence review.

Table 2

Summary of studies included in the evidence review.

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: Telemonitoring and in person follow up versus in person follow up – severe OSAHS population.

Table 3

Clinical evidence summary: Telemonitoring and in person follow up versus in person follow up – severe OSAHS population.

Table 4. Clinical evidence summary: Telemonitoring and phone follow-up versus phone follow up – severe OSAHS population.

Table 4

Clinical evidence summary: Telemonitoring and phone follow-up versus phone follow up – severe OSAHS population.

Table 5. Clinical evidence summary: Multimodal telemonitoring versus usual care – severe OSAHS population.

Table 5

Clinical evidence summary: Multimodal telemonitoring versus usual care – severe OSAHS population.

Table 6. Clinical evidence summary: Telemonitoring and tele-visits versus in person follow up – severe OSAHS population.

Table 6

Clinical evidence summary: Telemonitoring and tele-visits versus in person follow up – severe OSAHS population.

Narrative results

Data on machine usage outcomes were measured and reported inconsistently across the studies. Data have been presented narratively for studies where could not be analysed (data were presented as a percentage only). Narrative data was considered alongside the GRADE evidence by the committee when making recommendations. The overall study quality was taken into account as GRADE analysis for each outcome could not be performed.

1.

Telemonitoring and in person follow up compared to in person follow up

Hoet 2017 (n=46) (very low quality):

CPAP use of over 4 hours per night %

The study reported a lower rate of CPAP use of over 4 hours per night in the in person follow up group compared to the telemonitoring group (64% versus 82%).

2.

Telemonitoring and tele visits compared to in person follow up

Isetta 2015 (n=138) (very low quality): Mean % of nights CPAP used >4 hours

The study reported the mean percentage of nights where CPAP was used for > 4 hours. Results showed this was slightly higher in the telemonitoring plus in person follow up group compared to the in person follow up only group (65% versus 57%, p=0.329).

See appendix F for full GRADE tables.

1.5. Economic evidence

1.5.1. Included studies

Two health economic studies were identified with the relevant comparison and have been included in this review.19, 42 These are summarised in the health economic evidence profile below (Table 7) and the health economic evidence tables in appendix H.

1.5.2. Excluded studies

One economic study relating to this review question was identified but was excluded due to the availability of more applicable evidence.2 Reasons for exclusion are given in Appendix I:.

See also the health economic study selection flow chart in appendix G.

1.5.3. Summary of studies included in the economic evidence review

Table 7. Health economic evidence profile: Telemonitoring versus hospital follow-up.

Table 7

Health economic evidence profile: Telemonitoring versus hospital follow-up.

1.5.4. Health economic evidence statements

  • One cost-utility analysis found that hospital follow-up dominated telemonitoring for people with OSAHS. This study was assessed as being partially applicable with potentially serious limitations.
  • One cost-utility analysis found that hospital follow-up was cost-effective compared with telemonitoring for people with OSAHS, depending on the duration of the quality of life effect (£15,000-£60,000 per QALY gained). This study was assessed as being partially applicable with potentially serious limitations.

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 quality of life and mortality as critical outcomes for decision making. Other important outcomes included sleepiness scores (e.g. Epworth), Apnoea –Hypopnea index (AHI), oxygen desaturation index (ODI), CO2 control, hours of use (adherence), minor adverse effects of treatment, driving outcomes, neurocognitive outcomes, healthcare contacts, impact on co-existing conditions (HbA1c for diabetes, cardiovascular events for cardiovascular disease, systolic blood pressure for hypertension).

No evidence was identified for the critical outcome mortality in all ten studies.

1.6.1.2. The quality of the evidence
OSAHS (all severities)
CPAP

There was evidence from 10 studies - 6 studies compared telemonitoring (telemonitoring unit added to CPAP device which allows sleep laboratory staff and to connect to web portal to analyse patients data and arrange a visit or phone consultation when necessary) and in person follow-up, 1 study compared telemonitoring and phone follow-up with phone follow-up, 1 study compared multimodal telemonitoring (which included systolic and diastolic blood pressure and physical activity recorded by connected devices) with usual care, 2 studies compared telemonitoring and tele visits (tele visits via video conference (Skype)) with in person follow up.

The duration of all included studies was of one year or less. Studies varied in size with the number of participants ranging from 45 in the smallest study to 306 in the largest.

All studies were in people using fixed level CPAP except for one study in people using auto CPAP.

Studies were stratified based on the AHI/ODI severity of the population. When a mixed severity population was included the severity of the majority of the population was used by taking the mean AHI of the patients included and the study was downgraded for indirectness. The majority of studies included in this review were downgraded for indirectness.

All evidence was in people with severe sleep apnoea (AHI >/=30 severe) determined by their baseline AHI.

The quality of the evidence varied from very low to moderate quality; majority of evidence was downgraded due to risk of bias, imprecision, indirectness and inconsistency. Risk of bias was most commonly due to selection bias, performance bias and incomplete outcome data. Indirectness was present in many of the studies due to the inclusion of mixed severity OSAHS populations, combining people with mild, moderate or severe OSAHS. Imprecision was also present for many outcomes with confidence intervals crossing the MID thresholds. The low quality of evidence, small study sizes and uncertainty around the effect estimate was taken into consideration by the committee when assessing the evidence base for this review.

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.

Oral devices

No evidence was identified for monitoring of people using oral devices.

Positional modifiers

No evidence was identified for monitoring of people using positional modifiers.

Surgery

No evidence was identified for monitoring of people who have undergone surgery.

OHS

There was no evidence identified for people with obesity hypoventilation syndrome

COPD-OSAHS overlap syndrome

There was no evidence identified for people with COPD-OSAHS overlap syndrome.

1.6.1.3. Benefits and harms
OSAHS
CPAP
Telemonitoring and in person follow-up vs in person follow-up - severe OSAHS

The evidence suggested that adherence measures (nights CPAP used (hours/day), mean % nights CPAP use >4 hours and mean % days used) showed a clinically important benefit of telemonitoring with in person follow-up compared to in person follow-up alone. The committee however were not confident of this outcome as there was some uncertainty around the effect estimate. Additionally, one small study in which results were reported narratively demonstrated a benefit for mean % CPAP used >4 hours in the telemonitoring group compared to in person follow-up alone. This study however was unsuitable for GRADE analysis so was deemed to be very low quality. One of the adherence outcomes – hours that CPAP was used per day showed no clinically important difference.

The evidence suggested that there was no clinically important difference between telemonitoring with in person follow-up and in person follow-up alone for the critical outcomes quality of life measures (SF12 questionnaire - physical and mental composite, quality of life-EQ5D scale, and quality of life – GHQ12 scale).

There was no clinically important difference between telemonitoring and in person follow-up for the outcomes of systolic blood pressure, sleepiness (Epworth), apnoea-hypopnea index, and functional outcome of sleep questionnaire.

Follow-up evidence from the studies was available for 2 – 12 months. The committee agreed that this range of the follow-up in the studies is very wide.

Telemonitoring and phone follow-up vs phone follow-up - severe OSAHS

The evidence from one study suggested that that there was no clinically important difference between telemonitoring and phone follow-up for both adherence outcomes: hours per day used and days CPAP used >4 hours (% of patients). Follow-up evidence was available for 3 months.

Multimodal telemonitoring vs usual care - severe OSAHS

The evidence from one study suggested that there was no difference between multimodal telemonitoring and usual care for critical outcomes of quality of life SF12 physical composite and SF12 mental composite and important outcomes such as adherence (hours used) and systolic blood pressure. Follow-up evidence was available for 6 months.

Telemonitoring and tele visits vs in person follow-up - severe OSAHS

The evidence suggested that there was no difference between telemonitoring and tele visits and in person follow-up for the critical outcomes of quality of life (EQ5D VAS and FoSQ) and important outcomes of adherence (hours/day), sleepiness (Epworth), number of OSA related GP visits and number of OSA related specialist visits. One study in which results were reported narratively and of very low quality also showed no difference between the groups for % of nights CPAP used >4 hours.

There was a clinically important benefit of in person follow-up versus telemonitoring and tele visits for the critical outcome of EQ5D (quality of life measure) however this only just reached the threshold for clinical significance and there was uncertainty around the effect estimate with the confidence interval crossing the MID threshold. All follow-up evidence was available for 3-6 months.

Follow-up for people with OSAHS-the committee’s consideration of the evidence

The committee discussed that monitoring of patients on treatment for OSAHS should be used to assess control of symptoms, efficacy of therapy, impact on co-morbidities and adherence to treatment. They noted that follow-up should be tailored to the person’s overall treatment plan. This may include lifestyle changes, such as weight management, modifying use of sedative drugs and alcohol, and stopping smoking, and treating underlying lung disease and other comorbidities.

Follow-up for people using CPAP

The committee defined telemonitoring as the use of information and communication technologies to monitor patients remotely and transmit data related to their health. It provides data that can be downloaded including respiratory events, pressure requirements, mask leak and adherence and is used for follow-up with telephone or video consultations.

Overall, the evidence suggested that telemonitoring along with face-to-face or telephone consultations were equally effective as face to face or telephone consultations without telemonitoring. There was some evidence that adherence was improved by telemonitoring in people with severe OSAHS, and the committee discussed its advantages, such as early night-by-night access to data and remote adjustment of CPAP level. There was no evidence to suggest a difference between face-to-face, telephone and video consultations. None of the studies looked at telemonitoring for more than 12 months. The evidence was available for people with severe OSAHS; the committee agreed that the data could be extrapolated to people with mild and moderate OSAHS as well.

The committee discussed that although CPAP is considered the treatment of choice for OSAHS, CPAP adherence is a significant challenge. They agreed that CPAP follow-up through any means (face to face, telephone or video consultation, including review of telemonitoring data where available) would improve adherence and effectiveness of the treatment. The committee agreed that CPAP follow-up should be at less than one month and the subsequent follow-up according to person’s clinical needs, until optimal control of symptoms and AHI or ODI is achieved. They discussed that the pattern of CPAP adherence is established within the first week of therapy; therefore, early assessment of progress is helpful for problem-solving and providing support. From their experience the committee believe that greater benefits of CPAP use are associated with longer duration of use; therefore, patients should be encouraged to wear CPAP throughout the whole night, but ideally at least 4 hours/ night. Data from the CPAP machine is important so that CPAP settings can be adjusted to control residual respiratory events or to detect treatment emergent central sleep apnoea, and problems such as mask leak, rhinitis or poor tolerance to be identified. Some measures of adherence are improved by telemonitoring, and it allows early night-by-night access to data and remote adjustment of CPAP level without the need for patient visits.

The committee based on their experience discussed the advantages of telemonitoring. These include early night-by-night access to data which can lead to early detection of problems such as mask leaks or persistent respiratory events of sleep apnoea, and the ability to monitor that OSAHS so that it continues to be effectively controlled and the individual is adherent to therapy. Telemonitoring makes managing a person’s OSAHS more efficient for clinicians as they have ready access to the data should they need it. For example, if contacted by a person with an issue they can use the data to help identify the problem (for example, mask leak or inadequate pressure) and take appropriate action without the need for a scheduled appointment.

The committee agreed that video and telephone consultations along with telemonitoring is also advantageous to people with OSAHS as it can reduce the number of in-person visits needed to the sleep service. This can be particularly beneficial to patients who have difficulty in getting to clinics, for example, people who live in remote places or people with poor mobility, there would be fewer clinic visits in such cases. The reduction in the number of face-to-face consultations will also help reduce the risk of infection during the COVID-19 pandemic. The committee agreed that telemonitoring should be offered alongside CPAP for the first 12 months of treatment, and considered beyond 12 months where optimal control of symptoms and AHI or ODI has not been achieved, or to help with solving problems that people with OSAHS might experience. The committee did not make a research recommendation for long term use of telemonitoring as they believe telemonitoring is already becoming common practice and will remain so in the future. They agreed it is more convenient for CPAP users and clinicians. It also saves time as users do not need to download data and post or take it in to the sleep service.

The committee discussed how often long-term follow-up should happen. Annual and two-yearly follow-up were considered, they agreed that a two-yearly follow-up would probably be too long and interval and decided to make a recommendation to consider annual follow-up. The committee agreed that after CPAP treatment is established, annual follow-up allows continued efficacy of therapy and adherence to be assessed, along with co-morbidities and continuing need of therapy.

In between follow-up appointments the committee agreed that people with OSAHS using CPAP should be offered access to a sleep service for clinical support in case of problems, for provision of advice, and for replacement consumable equipment such as masks, circuitry and filters as needed.

Current practice includes a mixture of face-to-face, telephone, video consultations and telemonitoring. The increasing number of people being offered CPAP means that provision of regular outpatient follow-up is becoming increasingly difficult. Increasing website and app-based access to telemonitoring data will allow patients to access their own results and encourage self-management.

The committee stressed that telemonitoring crucially involves feedback to patients and time should be available for sleep centre staff to review data, act on this and share with the person using CPAP. Current practice already includes ready access to advice and CPAP equipment from sleep centres. Telemonitoring has facilitated remote assessment of patients during the coronavirus pandemic and has become a standard follow-up option in most sleep services. This use is likely to continue long term, because it is convenient for patients, enables them to assess progress themselves and allows access to efficacy and adherence data whenever needed, for example, for problem solving, routine follow-up and to complete DVLA reports. The committee noted that telemonitoring has changed practice for clinicians in terms of clinic staffing, and for patients in terms of saving time in attending the clinic. The committee also noted that in current practice follow-up is at is 1-3 months and 1 year, hence implementation of these recommendations would not change practice.

Follow-up for people using mandibular advancement splints (MAS) and positional modifiers

As there was no evidence available for monitoring people using MAS or positional modifiers, the committee drew on their clinical experience and agreed that people using mandibular advancement splints or positional modifiers should have follow-up through face to face, video or telephone consultations (including review of downloads from oral device or positional modifiers if available), with early (3 months for both mandibular advancement splints positional modifiers) and subsequent follow-up according to person’s clinical needs, until optimal control of symptoms and AHI or ODI is achieved. Adherence to oral devices is less easy to measure objectively. Early face to face follow-up is advisable as further gradual advancement of the mandible by the device may be required. However, the committee agreed that in light of COVID-19 video or telephone consultations may be preferable. Subsequent follow-up should be personalised, with assessment of side effects including impact on dentition and bite.

Objective adherence data can be obtained from positional devices for people with positional OSHAS, but early review allows assessment of symptom control and determination of whether respiratory events are minimised.

Recommendations on monitoring for positional modifiers and mandibular advancement splints are considered to be current practice in many areas and are not expected to lead to major changes in practice.

Follow-up for people who have had surgery

For people who have undergone surgery, initial follow-up consultation within 3 months of the operation should be to assess wound healing, side effects, control of symptoms and include respiratory polygraphy. Any subsequent follow-up is according to the person’s clinical needs. There was no evidence available for this population, so recommendations were based on the committee’s consensus opinion and clinical experience.

The recommendation on monitoring for surgery is considered to be current practice in many areas and are not expected to lead to major changes in practice.

Follow-up for drivers with excessive sleepiness

The committee agreed that people must not drive if they have excessive sleepiness, having or likely to have an adverse effect on driving, in keeping with DVLA guidance.8 Driving may resume after satisfactory symptom control, which needs medical confirmation if moderate or severe OSAHS. This is the patient’s responsibility, but sleep team professionals will help them assess the likely impact of their symptoms on their safety to drive, by taking a detailed driving history, including distances driven, episodes of drowsy driving, use of alerting mechanisms when driving to avoid falling asleep, or a history of a sleep related accident or near miss. Using a high Epworth Sleepiness Score alone for driving advice is unlikely to be adequate, as it is subjective. Many people can doze off in relaxed situations but retain concentration during specific tasks such as driving. Patients with excessive sleepiness having or likely to have an adverse impact on driving with confirmed moderate or severe obstructive sleep apnoea syndrome must inform the DVLA and their car insurance company of their diagnosis. If patients have excessive sleepiness having or likely to have an adverse impact on driving and a diagnosis of mild OSAHS, they must inform the DVLA of their diagnosis if they have not achieved symptom control in 3 months.8

For subsequent licensing, annual review is required by the DVLA for Group 2 licence holders (lorry and bus drivers) and a minimum of 3 yearly review for Group 1 licence holders (cars and motorcycles), to confirm control of OSAHS, improved sleepiness and treatment adherence.7 The committee noted that people with OSAHS who do not have symptoms of excessive sleepiness during waking hours will continue to have an annual review which includes assessment of any changes in symptoms.

Even though there was limited evidence on monitoring strategies for CPAP and lack of evidence on monitoring strategies for oral devices, positional modifiers and surgery for people with OSAHS, based on their experience the committee made strong recommendations hence they did not make any research recommendation for monitoring strategies for these treatments.

OHS

The committee noted the lack of evidence for monitoring strategies in OHS and decided to make consensus recommendations based on evidence reviewed for OSAHS, their experience and current practice.

The committee noted that CPAP and non-invasive ventilation are just part of treatment for OHS, and that follow-up should be tailored to the person’s overall treatment plan. This should also include lifestyle changes, such as weight management, modifying use of sedative drugs and alcohol, and stopping smoking, and treating underlying lung disease and other comorbidities.

For people with OHS using CPAP or non-invasive ventilation, early follow-up at 1 month is advised to ensure control of symptoms, sleep disordered breathing and adherence. Problem-solving can be achieved by face to face, telephone or video consultations, including review of telemonitoring data where available. The committee agreed that once optimised on CPAP or non-invasive ventilation (with or without oxygen supplementation), 6-monthly to one year follow-up should be considered according to person’s clinical needs. The committee agreed that video and telephone consultations with telemonitoring will help reduce the risk of infection during the COVID-19 pandemic.

The committee also agreed that although most studies of telemonitoring are in patients with OSAHS, and that there is not yet the ability to assess hypercapnia through telemonitoring, it is still of value to use for people with OHS.

The committee noted that in current practice follow-up is at is 4 weeks and 1 year, hence implementation of these recommendations would not change practice.

In addition to annual review, people with OSAHS and OHS on CPAP or non-invasive ventilation therapy need to be able to access the sleep service for advice and provision of consumables such as masks, circuitry and filters.

Current practice includes a mixture of face-to-face /telephone/video consultations and telemonitoring. The increasing number of people being offered CPAP means that provision of regular outpatient follow-up has become increasingly difficult. In addition, a more personalised approach enables attention to be focussed on people with problems adapting to therapy. Telemonitoring is included in the overall cost of CPAP devices by some manufacturers for variable periods and is increasingly available for non-invasive ventilators.

The committee discussed that routine use of telemonitoring should reduce the need for face-to-face consultations, and reduce pressure on outpatient clinics, but feedback and discussion with patients is still needed. Increasing website and app-based access to telemonitoring data will allow patients to access their own results to aid self-care.

The committee noted that there has been a significant move to video and telephone consultations to reduce the risk of infection during the COVID-19 pandemic.

Follow-up for drivers with excessive sleepiness

The committee agreed that people must not drive if they have excessive sleepiness, having or likely to have an adverse effect on driving, in keeping with DVLA guidance.8 Driving may resume after satisfactory symptom control, which needs medical confirmation if moderate or severe OSAHS. This is the patient’s responsibility, but sleep team professionals will help them assess the likely impact of their symptoms on their safety to drive, by taking a detailed driving history, including distances driven, episodes of drowsy driving, use of alerting mechanisms when driving to avoid falling asleep, or a history of a sleep related accident or near miss. Using a high Epworth Sleepiness Score alone for driving advice is unlikely to be adequate, as it is subjective. Many people can doze off in relaxed situations but retain concentration during specific tasks such as driving. Patients with excessive sleepiness having or likely to have an adverse impact on driving with confirmed moderate or severe OSAHS with their OHS must inform the DVLA and their car insurance company of their diagnosis. If patients have excessive sleepiness having or likely to have an adverse impact on driving and a diagnosis of mild OSAHS with their OHS, they must inform the DVLA of their diagnosis if they have not achieved symptom control in 3 months.8

For subsequent licensing, annual review is required by the DVLA for Group 2 licence holders (lorry and bus drivers) and a minimum of 3 yearly review for Group 1 licence holders (cars and motorcycles), to confirm control of OSAHS, improved sleepiness and treatment adherence.7 The committee noted that people with OHS who do not have symptoms of excessive sleepiness during waking hours will continue to have an annual review which includes assessment of any changes in symptoms.

Even though there was a lack of evidence on monitoring strategies for people with OHS, based on their experience the committee made strong recommendations hence they did not make any research recommendation for this topic.

COPD-OSAHS overlap syndrome

The committee noted the lack of evidence for monitoring strategies in COPD-OSAHS overlap syndrome and decided to make consensus recommendations based on evidence reviewed for OSAHS, their experience and current practice.

The committee noted that CPAP and non-invasive ventilation are just part of treatment for COPD-OSAHS overlap syndrome, and that follow-up should be tailored to the person’s overall treatment plan. This should also include lifestyle changes, such as weight management, modifying use of sedative drugs and alcohol, and stopping smoking, and treating underlying lung disease and other comorbidities. For people with severe COPD, it may also include discussions about care planning (for example COPD exacerbation action plan and advance care planning for those with severe COPD).

The committee agreed that for people with COPD-OSAHS overlap syndrome started on CPAP or non-invasive ventilation early follow-up is advised to ensure control of symptoms, sleep disordered breathing and adherence. Problem-solving can be achieved by face to face consultations, video or telephone consultations, including review of telemonitoring data where available. The committee also agreed that although most studies of telemonitoring are in patients with OSAHS, and that there is not yet the ability to assess hypercapnia through telemonitoring, it is still of value to use for people with COPD-OSAHS overlap syndrome for monitoring OSAHS. The committee agreed that video and telephone consultations with telemonitoring will help reduce the risk of infection during the COVID-19 pandemic.

In addition to their 6-monthly or annual review people with OSAHS and COPD-OSAHS overlap syndrome on therapy need open access to a sleep service for advice, and provision of consumables such as masks, circuitry and filters.

The committee noted that in current practice follow-up is at is 2 weeks and 1 year, hence implementation of these recommendations would not change practice.

Current practice includes a mixture of face-to-face, telephone, video consultations and telemonitoring. The increasing number of people being offered CPAP and non-invasive ventilation means that regular outpatient follow-up becomes increasingly difficult for sleep centres to provide. In addition, a more personalised approach enables attention to be focussed on people with problems adapting to therapy. Telemonitoring is included in the overall cost of CPAP devices by some manufacturers for variable periods. Increasing website and app-based access to telemonitoring data will allow patients to access their own results to aid self-care.

The committee noted that there has been a significant move to video and telephone consultations to reduce the risk of infection during the COVID-19 pandemic.

Follow-up for drivers with excessive sleepiness

The committee agreed that people must not drive if they have excessive sleepiness, having or likely to have an adverse effect on driving, in keeping with DVLA guidance.8 Driving may resume after satisfactory symptom control, which needs medical confirmation if moderate or severe OSAHS. This is the patient’s responsibility, but sleep team professionals will help them assess the likely impact of their symptoms on their safety to drive, by taking a detailed driving history, including distances driven, episodes of drowsy driving, use of alerting mechanisms when driving to avoid falling asleep, or a history of a sleep related accident or near miss. Using a high Epworth Sleepiness Score alone for driving advice is unlikely to be adequate, as it is subjective. Many people can doze off in relaxed situations but retain concentration during specific tasks such as driving. Patients with excessive sleepiness having or likely to have an adverse impact on driving with confirmed moderate or severe obstructive sleep apnoea syndrome must inform the DVLA and their car insurance company of their diagnosis. If patients have excessive sleepiness having or likely to have an adverse impact on driving and a diagnosis of mild OSAHS, they must inform the DVLA of their diagnosis if they have not achieved symptom control in 3 months.8

For subsequent licensing, annual review is required by the DVLA for Group 2 licence holders (lorry and bus drivers) and a minimum of 3 yearly review for Group 1 licence holders (cars and motorcycles), to confirm control of OSAHS, improved sleepiness and treatment adherence.7 The committee noted that people with COPD-OSAHS overlap syndrome who do not have symptoms of excessive sleepiness during waking hours will continue to have an annual review which includes assessment of any changes in symptoms.

Even though there was a lack of evidence on monitoring strategies for people with COPD-OSAHS overlap syndrome, based on their experience the committee made strong recommendations hence they did not make any research recommendation for this topic.

1.6.2. Cost effectiveness and resource use

Since treatments in these conditions are potentially for life it is important for cost effectiveness as well as for patient welfare to monitor whether a treatment is working and then, if necessary, to modify, switch or discontinue treatment.

The clinical evidence was mainly for telemonitoring compared with outpatient follow up for people with OSAHS. There was little difference in the clinical outcomes and so the question of which is less costly is important.

Different manufacturers seem to have different pricing models for telemonitoring.

  • Mostly telemonitoring for one year is included in the price of the CPAP machine and a fee is charged for subsequent years
  • Sometimes a small fee (e.g. £20) is charged for the modem that will cover the lifespan of the machine when purchased at the same time as the machine.

It might also be possible to turn on and off the modem and transfer it to other patients, thus reducing the price of telemonitoring. This might facilitate the use of telemonitoring to sample one month’s data ahead of a follow-up consultation.

Intuitively, there could be cost savings with telemonitoring if it reduces the need for face-to-face consultations (e.g. reduced need for fully equipped outpatient room and reduced staff time as well as reduced risk of transmission of infectious disease) but there are also costs.

Two cost-utility analyses were included, each comparing telemonitoring with hospital clinic follow-up for people with OSAHS. Both were randomised trials in a Spanish setting.

In one study the authors concluded that the telemonitoring strategy was dominated (less effective and more costly) by the hospital follow-up. In this within-trial study, people with OSAHS completed a biweekly six-item questionnaire about the status of their physical activity, sleep time, CPAP use and treatment side effects. Clinicians monitored responses and communicated with patients via the website messaging tool. In this scenario, the committee were of the view that one reason that telemonitoring may not be cost-effective was because clinicians may have been over-using the data, that is respond to all aspects of the remote data. The committee reasoned that the responses to the questionnaire may not be a reliable proxy to identify people with OSAHS who need further follow-up from a clinician because they are still symptomatic or have poor adherence with their CPAP device. Therefore, monitoring responses to this questionnaire may result in clinicians over engaging with participants who may not need this extra attention.

In contrast, the second study found that using an alarm-based system where clinicians only respond if certain events occur (e.g. mask leakage or poor adherence) resulted in standard care being more effective than telemonitoring but not being cost-effective at the £20,000 threshold. However, it should be noted the authors have equated improvements in quality of life measured by the EQ-5D to improvements in QALYs. However, a 0.003 higher EQ-5D at 3 months is not the same as a 0.003 gain in QALYs. Instead, to calculate the correct QALY gains over the three-month period the EQ-5D gains must be multiplied by 0.25 or else an assumption must be stated about how long the difference would be sustained. The results were very sensitive to this assumption.

An original comparative cost analysis was conducted (See Evidence Report F). It found that CPAP with re-titration using auto-CPAP was slightly less costly than CPAP with re-titration using telemonitoring, but this was largely based on assumption rather than evidence. In particular, it only assumed that telemonitoring would reduce the need for follow-up in those patients who needed re-titration.

The committee concluded that there is uncertainty about whether remote follow-up with telemonitoring is less costly than traditional outpatient follow-up and could be affected by local factors including the charges by manufacturers for telemonitoring. However, where telemonitoring for the first year is included in the price of the machine, this is likely to be cost effective. Longer term monitoring could also be cost effective if the price is relatively low. Furthermore, the evidence has not accounted for the need to avoid face-to-face consultations to reduce transmission of infectious disease

All the clinical evidence in the guideline review was for CPAP in the OSAHS population, however the committee used the evidence and their experience to establish principles that cover all interventions and all three guideline populations. The committee recommended that all patients provided with an intervention (CPAP, non-invasive ventilation, oral device or positional modifier), be offered follow-up through face to face, telephone or video consultations within 1 month and telemonitoring then follow-up as required. The provision of face to face appointments was usual practice but recently there has been a big shift to remote consultations. The committee do not expect there to be an additional resource impact as a result of this recommendation. Also, the number of appointments that people with OSAHS, OHS or OS would be expected to attend is not expected to increase.

1.6.3. Other factors the committee took into account

The committee noted that telemonitoring can be seen as beneficial to patients if it reduces the need for them to attend hospital. They also noted that there has been a significant move to video and telephone consultations to reduce the risk of infection during the COVID-19 pandemic. This change in practice along with telemonitoring has allowed less face to face to appointments while still enabling review of a patient’s CPAP data and changing their prescriptions. The committee were of the view that if the cost of modems comes down, then leaving a modem on a device would allow year on year CPAP review without seeing the patient. This can be augmented with telephone consultations where required. Potentially using IT Epworth sleepiness scores could be gained. There could be a lot of options gained from using IT monitoring.

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Appendices

Appendix A. Review protocols

Table 8. Review protocol: monitoring (PDF, 212K)

Table 9. Health economic review protocol (PDF, 185K)

Appendix B. Literature search strategies

Sleep Apnoea search strategy 5 monitoring

This literature search strategy was used for the following reviews;

  • What is the most clinically and cost effective strategy for monitoring OSAHS/OHS/OS (for example based on outpatient visits, download of data from devices or telemonitoring)?
  • What is the optimum frequency of monitoring of OSAHS/OHS/OS?

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.28

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, 366K)

B.2. Health Economics literature search strategy (PDF, 353K)

Appendix D. Clinical evidence tables

Download PDF (402K)

Appendix G. Health economic evidence selection

Figure 28. Flow chart of health economic study selection for the guideline (PDF, 242K)

Appendix H. Health economic evidence tables

Download PDF (246K)

Appendix I. Excluded studies

I.1. Excluded clinical studies (PDF, 154K)

I.2. Excluded health economic studies (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.

Copyright © NICE 2021.
Bookshelf ID: NBK574318PMID: 34613673

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