The myCOPD app: This Guide Reviews the Literature About 4 Studies

ByDr. Mega Boo Boo
myCOPD NICE Guidance — GIVEMEA Study Guide
GIVEMEA Study Guide · Health Economics & Health Technology Assessment

myCOPD App for Managing Chronic Obstructive Pulmonary Disease: A NICE Medical Technology Guidance for a Digital Health Technology

Heather Davies, Mary Chappell, Yingying Wang, Angaja Phalguni, Stephanie Wake, Mick Arber, Judith Shore · Applied Health Economics and Health Policy 21:689–700 · 2023

Health Technology Assessment External Assessment Group Report NICE MTG68 Economic Evaluation
4Clinical Studies
£86kEAG AECOPD Savings/CCG
£23kEAG PR Savings/CCG
73.5%Prob. Cost-Saving (AECOPD)
86%Prob. Cost-Saving (PR)
MTAC Conclusion
Although myCOPD has potential to help adults manage their COPD, insufficient evidence currently supports routine NHS adoption. Further comparative research is recommended to address uncertainties about clinical benefits and healthcare resource use.

Assessment Context

York Health Economics Consortium served as External Assessment Group for NICE’s Medical Technologies Evaluation Programme pilot for digital health technologies. The assessment critiqued clinical and economic evidence submitted by my mHealth Ltd for myCOPD, a digital self-management platform for people with COPD.

Clinical Evidence Base

Four published peer-reviewed studies (three RCTs: RESCUE, EARLY, TROOPER; one observational study) plus 15 real-world evaluations across seven UK settings. RCTs had small sample sizes limiting statistical power. RESCUE and EARLY showed non-significant trends toward improved CAT scores; TROOPER demonstrated non-inferiority of digital PR versus face-to-face PR.

Economic Modeling Approach

Company submitted two de novo cost models for subgroups: people discharged from hospital post-AECOPD and people eligible for PR. EAG updated parameters and adjusted structures. Both models showed cost savings but with significant uncertainty around uptake rates and clinical effectiveness parameters.

EAG-Revised Results

AECOPD model: £86,297 savings per CCG (73.5% probability cost-saving). PR model: £22,779 savings per CCG assuming existing myCOPD license (86% probability cost-saving). Key drivers were hospital readmission rates, uptake, and PR referral volumes.

Critical Uncertainties

Small RCT sample sizes limiting power to detect effects; non-significant clinical outcomes in self-management trials; short follow-up periods (3 months); declining app usage over time in all studies; unclear link between engagement level and clinical outcomes; uncertainty about long-term effectiveness and sustained engagement.

EAG Economic Model Results Comparison

Model Company Base Case EAG Base Case Probability Cost-Saving Key Driver
AECOPD (per CCG) £204,641 savings £86,297 savings 73.5% 90-day readmission rate
PR (per CCG) £20,269 savings £22,779 savings 86% Uptake & referral volume
PR (per service) £8,707 savings £11,093 savings 87% Annual referrals (≥240)

■ HTA Process   ■ Study Evidence   ■ Economic Modeling   ■ Technology & Outcomes

HTA Process & Governance

NICE MTEP
tap to define
NICE MTEP
Medical Technologies Evaluation Programme. NICE process for evaluating medical technologies with potential to reduce costs and offer clinical benefits compared to standard care.
EAG
tap to define
EAG
External Assessment Group. Independent body (here, York Health Economics Consortium) that critically appraises clinical and economic evidence submitted by technology companies.
MTAC
tap to define
MTAC
Medical Technologies Advisory Committee. NICE committee that considers EAG reports, company submissions, and consultation feedback to develop final guidance recommendations.
DHT Guidance Process
tap to define
DHT Guidance Process
Pilot digital health technologies evaluation process commissioned by NHS England 2019, based on MTEP but adapted for characteristics of digital technologies. myCOPD was among the first assessments.

Study Evidence & Trial Design

RESCUE Trial
tap to define
RESCUE Trial
Randomized controlled feasibility trial (n=41) comparing myCOPD with usual care plus written support after AECOPD. Primary efficacy data source for the AECOPD economic model. 3-month follow-up.
EARLY Trial
tap to define
EARLY Trial
RCT (n=60) evaluating myCOPD for self-management in mild, moderate, and newly diagnosed COPD versus usual care. 3-month outcomes, small sample size limited ability to detect significant differences.
TROOPER Trial
tap to define
TROOPER Trial
Non-inferiority RCT (n=90) comparing myCOPD PR with face-to-face PR. Demonstrated non-inferiority for CAT score and 6-minute walk test. Primary efficacy source for PR model. Concerns about power calculation validity.
RWE
tap to define
RWE
Real-World Evidence. 15 evaluations (6 published, 9 unpublished) from seven UK settings. Focused on user acceptance and adherence, mainly pilot studies. Considered to have low internal validity but acceptable external validity.
Effective Engagement
tap to define
Effective Engagement
Framework concept (Yardley et al.) defining engagement as the level necessary to produce desired outcomes, not simply “more is better.” A key uncertainty in DHT evaluation, especially as app usage declined over time in all studies.

Economic Modeling & Parameters

CCG Perspective
tap to define
CCG Perspective
Clinical Commissioning Group costing perspective. Both models calculated cost savings per average CCG. Note: CCGs ceased to exist July 2022, replaced by integrated care systems; pricing model implications unclear.
Uptake Rate
tap to define
Uptake Rate
Proportion of eligible patients who register for and use myCOPD. Company assumed 100%; EAG adjusted to 46% for AECOPD model based on RESCUE trial data. Key driver of cost-effectiveness due to subscription pricing model.
90-Day Readmission Rate
tap to define
90-Day Readmission Rate
Proportion of AECOPD patients readmitted within 90 days. Most sensitive parameter in AECOPD model. RESCUE reported 0.39 standard care vs 0.24 myCOPD (adjusted OR 0.383). Breakeven point: 0.30 in EAG model.
PSA
tap to define
PSA
Probabilistic Sensitivity Analysis. Statistical technique varying multiple parameters simultaneously according to distributions. EAG PSA showed 73.5% probability myCOPD cost-saving for AECOPD, 86% for PR.
Threshold Analysis
tap to define
Threshold Analysis
Identifies parameter values where technology shifts from cost-saving to cost-incurring. PR model threshold: 240 annual referrals needed for cost savings. AECOPD: uptake ≥26.2% or readmission rate ≤0.30.

Technology & Clinical Outcomes

myCOPD Platform
tap to define
myCOPD Platform
Digital self-management app (my mHealth Ltd) for smartphone/tablet/computer. Features: patient education, symptom tracking, CAT assessments, medication records, 6-week online PR programme. Clinician dashboard for remote monitoring.
CAT Score
tap to define
CAT Score
COPD Assessment Test. Primary outcome measure in RCTs. RESCUE and EARLY showed non-significant trends toward improvement with myCOPD. TROOPER demonstrated non-inferiority (adjusted mean difference -1.0, 95% CI -2.9 to 0.86).
AECOPD
tap to define
AECOPD
Acute Exacerbation of COPD. Sudden worsening requiring hospital admission. First modeled population: people discharged post-AECOPD. Standard care comparator: written self-management plan at discharge.
Digital PR
tap to define
Digital PR
Pulmonary Rehabilitation delivered via myCOPD: 6-week programme with incremental exercise training and education sessions promoting self-management, conducted remotely. Used instead of standard care (deviating from NICE scope specifying add-on use).
Unlimited License Package
tap to define
Unlimited License Package
myCOPD pricing model at assessment: 3-year contract with CCG covering entire population (£0.25 per registered patient). Cost applied to whole CCG population, not just COPD patients, making uptake critical to cost-effectiveness.

Assessment Overview

York Health Economics Consortium served as EAG for NICE’s pilot DHT evaluation process. The team conducted de novo literature searches, critical appraisal of submitted evidence, economic model critique and revision, and consultation response analysis. Clinical experts provided advice via NICE’s published processes.

Literature Search Strategy

  • Company provided no search strategy documentation in submission; EAG conducted de novo searches
  • Original searches October 2019, updated January 2021 after DHT guidance selection
  • 7,761 total records retrieved; 3,280 after deduplication for screening
  • EAG searches identified five additional published RWE papers not in company submission
  • No meta-analysis conducted by company or EAG due to heterogeneity and small sample sizes

Quality Appraisal Approach

  • RCTs appraised using Centre for Reviews and Dissemination criteria (Khan et al. 2001)
  • Observational studies appraised using CASP UK 2013 cohort checklist
  • RCT internal and external validity judged acceptable despite small sample sizes
  • Observational study: acceptable external validity but low internal validity (limited reporting, no confounding assessment)
  • RWE not formally quality-assessed due to variation in methods and focus on service evaluation

Economic Model Revisions: AECOPD

  • Company model structure judged appropriate (TreeAge cost calculator, 1-year horizon, 3-month outcomes)
  • Key EAG change: uptake rate adjusted from 100% to 46% based on RESCUE trial enrollment
  • Efficacy parameters recalculated: exacerbations (adjusted rate ratio 0.581), readmissions (OR 0.383 converted to RR)
  • Cost updates: exacerbation costs (£53.59→£81.75), admissions (£1,583→£1,721), registration time doubled (15→30 min)
  • PSA conducted by EAG using company model framework with updated parameter distributions

Economic Model Revisions: PR

  • Company decision tree structure accepted; EAG added cost for patients starting but not completing PR
  • Decision point shifted: from “referral to PR” to “expressed willingness to use myCOPD” (aligns with scope and TROOPER population)
  • Treatment arm adjusted: removed face-to-face only option (scope specifies myCOPD as replacement, not add-on for PR)
  • Uptake recalculated to 12% for both hybrid and myCOPD-only based on Southend study completion rates
  • Key limitation acknowledged: no benefits captured for partial PR completion in model

Strengths

  • Comprehensive independent literature search addressing company submission gap
  • Transparent parameter adjustments with clear rationale and clinical expert input
  • Probabilistic sensitivity analysis providing uncertainty quantification beyond company deterministic scenarios
  • Threshold analyses identifying critical decision points for commissioners
  • Clear distinction between internal validity (low) and external validity (acceptable) for RWE

Limitations

  • Underlying clinical evidence limited by small RCT sample sizes and non-significant findings
  • Short follow-up periods (3 months) preclude assessment of long-term effectiveness or engagement patterns
  • Uptake parameter derived from RCT enrollment, not real-world adoption rates
  • No economic studies identified for inclusion; reliance on company de novo models only
  • CCG costing perspective outdated (CCGs abolished July 2022); implications for revised pricing structure unclear
  • Effective engagement framework not operationalized in models; unclear link between usage patterns and outcomes

Six key references exemplify the evidence categories and methodological touchpoints in this HTA. Click any card to expand the full analysis.

[7]

North et al. 2020 — RESCUE Trial: E-health Application Supported Care vs Usual Care After COPD Exacerbation

NPJ Digital Medicine · 3:145 · 2020
★★★ Primary Efficacy Data NPJ Digit Med 2020 AECOPD Model Foundation
▾
Why this reference matters

RESCUE is the primary source of clinical effectiveness data for the AECOPD economic model. As a randomized controlled feasibility trial, it provides the most rigorous evidence available for myCOPD in the post-exacerbation population, directly testing the intervention in the highest-risk COPD subgroup.

Key contribution to this paper’s argument

Supplies three critical model parameters: exacerbation rate (1.88 vs 1.06 over 90 days, adjusted rate ratio 0.581), hospital readmission rate (39% vs 24%, adjusted OR 0.383), and GP appointment frequency (2.28 vs 1.85). The EAG’s recalculation of company-reported values using adjusted statistics rather than raw risks demonstrates methodological rigor.

Connection to the wider citation network

RESCUE sits alongside EARLY and TROOPER as the RCT evidence base, but uniquely addresses the AECOPD population. The trial’s acknowledgment of limited power to detect effects on all outcomes foreshadows the EAG’s central concern about sample size across the evidence base.

[5]

Bourne et al. 2017 — TROOPER Trial: Online vs Face-to-Face Pulmonary Rehabilitation

BMJ Open · 7(7):e014580 · 2017
★★★ PR Model Foundation BMJ Open 2017 Non-Inferiority Evidence
▾
Why this reference matters

TROOPER is the only RCT comparing myCOPD PR with face-to-face PR, providing the effectiveness evidence for the PR economic model. Its non-inferiority design tests whether digital delivery can replace traditional PR, a fundamentally different question than add-on effectiveness.

Key contribution to this paper’s argument

Demonstrates non-inferiority for CAT score (adjusted mean difference -1.0, 95% CI -2.9 to 0.86) and 6-minute walk test (23.8m, 95% CI -4.5 to 52.2). However, the EAG identified concerns about power calculation validity: MCID distance higher than recommended (40.5m vs 30m) and power calculated at 58% rather than conventional 80-90%.

Connection to the wider citation network

Complements the self-management trials (RESCUE, EARLY) by addressing the PR use case. The deviation from NICE scope (replacement vs add-on) introduces ambiguity about the intended positioning of myCOPD PR, reflected in the company’s model structure showing three treatment pathways rather than two.

[23]

Yardley et al. 2016 — Understanding and Promoting Effective Engagement with Digital Behavior Change Interventions

American Journal of Preventive Medicine · 51(5):833–842 · 2016
★★ Conceptual Framework Am J Prev Med 2016 DHT Evaluation Methodology
▾
Why this reference matters

Yardley’s effective engagement framework addresses a fundamental challenge in DHT evaluation: the relationship between usage patterns and clinical outcomes. This concept is central to interpreting the observed decline in app usage across all myCOPD trials and RWE.

Key contribution to this paper’s argument

Defines “effective engagement” as the engagement necessary to produce desired outcomes, not simply “more engagement, the more effective.” This framework appears in consultation comments defending myCOPD completion rates in TROOPER and contextualizing why adherence metrics alone don’t determine effectiveness. The EAG acknowledges this concept but notes it remains unoperationalized in the economic models.

Connection to the wider citation network

Part of a broader behavioral intervention literature (Baumel 2022, Ainsworth et al. 2017) cited in consultation responses. These references situate myCOPD within digital health behavior change theory, though the RCT evidence doesn’t demonstrate the mechanism linking engagement to outcomes.

[30]

Chartered Society of Physiotherapy 2017 — COPD PRIME Tool

CSP Practice Guidelines · 2017
★ Reference Data CSP 2017 Model Parameters
▾
Why this reference matters

COPD PRIME provides UK-specific reference data for PR pathways and exacerbation rates where trial data are unavailable. It represents the standard-of-care baseline against which myCOPD’s cost-effectiveness is assessed.

Key contribution to this paper’s argument

Supplies multiple PR model parameters: 40% COPD patients eligible for PR referral, 15% offered PR of those eligible, 59% start rate among those referred, 71% completion rate, and annual exacerbation rates stratified by completion status (2.11 completers vs 3.31 non-completers). These cascade probabilities determine the modeled population flow.

Connection to the wider citation network

Used alongside NHS Digital QOF data, NACAP audit reports, and PSSRU cost references to construct the economic model structure. Together these sources create a composite picture of COPD care pathways in the NHS, grounding the model in UK-specific practice patterns.

[31-32]

NACAP 2019-2020 — National Asthma and COPD Audit Programme: Pulmonary Rehabilitation Reports

Royal College of Physicians · 2019-2020
★ Audit Data RCP 2019-2020 Service Capacity Parameters
▾
Why this reference matters

NACAP provides national audit data on PR service delivery and capacity, enabling threshold analyses for service-level cost-effectiveness. The median 495 referrals per CCG per year grounds the model in real-world service volumes.

Key contribution to this paper’s argument

Establishes the 240 annual referrals threshold for PR service cost savings and the 13-day median waiting time used to cost the opportunity cost of PR assessment delays. The 84% of referrals being COPD-specific justifies the disease-focused modeling approach.

Connection to the wider citation network

Complements COPD PRIME by providing service delivery context rather than clinical pathway probabilities. Together they enable both CCG-level and PR-service-level economic perspectives, though the latter requires assuming an existing myCOPD license to avoid double-counting setup costs.

[1]

NICE 2022 — myCOPD for Managing Chronic Obstructive Pulmonary Disease: Medical Technologies Guidance 68

NICE Medical Technologies Guidance · MTG68 · 2022
★★★ Final Guidance NICE MTG68 2022 Policy Outcome
▾
Why this reference matters

The final NICE guidance represents the policy outcome of the entire assessment process. Its recommendation against routine adoption despite potential benefits codifies the uncertainty threshold for DHT evidence in the NHS.

Key contribution to this paper’s argument

Provides the complete documentation including consultation responses, committee deliberations, and research recommendations. The consultation received 108 comments from 11 consultees challenging the draft recommendations on powering, engagement, economic uncertainty, and patient representation, revealing stakeholder perspectives.

Connection to the wider citation network

This Davies et al. 2023 paper is itself a synthesis of the MTG68 process, making the final guidance both a reference and the object of description. The circular reference structure reflects HTA methodology papers documenting processes that produce the primary guidance documents.

Question 1 of 5
What was the most sensitive parameter in the EAG’s revised AECOPD economic model?
Correct. The 90-day readmission rate was identified as the key driver in tornado analysis. The breakeven point was a readmission rate of 0.30 in the myCOPD arm. While uptake was important (affecting whether the model reached patients), readmission rate had the greatest impact on cost savings magnitude.
Question 2 of 5
Why did the EAG adjust the company’s assumed myCOPD uptake rate from 100% to 46% in the AECOPD model?
Correct. The EAG grounded the uptake parameter in actual enrollment data from the RESCUE trial, arguing that trial enrollment rates better reflect real-world willingness to register than assuming 100%. This was a major driver of the difference between company (£204,641 savings) and EAG (£86,297 savings) base case results.
Question 3 of 5
What was the MTAC’s primary concern leading to the recommendation against routine adoption?
Correct. Despite economic models showing potential cost savings, the MTAC concluded there was insufficient good-quality evidence to support routine adoption. The key issues were non-significant clinical findings in RCTs, small sample sizes limiting statistical power, and uncertainty about long-term effectiveness and engagement.
Question 4 of 5
How did the EAG characterize the quality of the real-world evaluation (RWE) evidence?
Correct. The EAG judged RWE to have acceptable external validity (representing real NHS settings) but low internal validity due to limited reporting of intervention details, variation in methods, unsubstantive outcome measures, and absence of confounding assessment. The studies were mainly interim service evaluations rather than rigorous evaluations.
Question 5 of 5
What methodological concern did the EAG identify with the TROOPER trial’s non-inferiority claim?
Correct. The EAG determined the sample size calculation likely underestimated required n by using a minimal clinically important difference of 40.5m for 6-minute walk test (higher than the 30m recommendation) and calculating power at 58% rather than conventional 80-90%. This raised questions about whether non-inferiority was conclusively demonstrated despite the reported findings.
— / 5 Your Score
  • 💡

    DHT Evidence Standards Remain Unresolved

    NICE’s pilot DHT evaluation process adapted MTEP methods but revealed persistent challenges: linking engagement to outcomes, interpreting declining usage patterns, valuing behavioral endpoints, and determining adequate follow-up duration. Yardley’s “effective engagement” framework offers conceptual clarity but lacks operational metrics for economic modeling.

  • 📊

    Small RCT Sample Sizes Create Compounding Uncertainty

    RESCUE, EARLY, and TROOPER totaled 191 participants across three trials. Non-significant findings don’t prove no effect; they prove insufficient power to detect effects. When these underpowered trials become model parameters (via point estimates and confidence intervals), uncertainty propagates through the economic analysis. PSA captures statistical uncertainty but can’t remedy the fundamental evidence gap.

  • 💰

    Subscription Pricing Makes Uptake the Critical Parameter

    myCOPD’s unlimited license model (£0.25 per registered patient across entire CCG population) means cost-effectiveness depends critically on how many eligible patients actually use the service. The EAG’s uptake adjustment (100% to 46%) more than halved projected savings. This pricing structure creates opposite incentives from per-patient licensing: providers want high uptake, but evidence for population-level adoption is weakest.

  • 🔍

    Model Population Definitions Shape Cost-Effectiveness

    The company focused on two high-value subgroups (post-AECOPD, PR-eligible) where benefits were most plausible, rather than the broader COPD population in the scope. This is methodologically sound but raises questions about generalizability and service design: would NHS implementation target these subgroups specifically, or offer the platform population-wide and accept lower uptake?

  • ⚖️

    Non-Inferiority Evidence Serves a Replacement Strategy

    TROOPER’s non-inferiority design tests whether myCOPD PR can replace face-to-face PR, not whether it adds value as a supplement. This deviation from the NICE scope (which specified add-on use) reflects a strategic ambiguity about positioning: is myCOPD a capacity-expansion tool for understaffed PR services, or a cost-saving replacement for traditional delivery? The answer determines the relevant comparator and economic model structure.

  • 🎯

    Threshold Analyses Identify Commissioning Decision Points

    EAG threshold analyses operationalize uncertainty for commissioners: AECOPD model cost-saving requires uptake ≥26.2% or readmission rate ≤0.30; PR model requires ≥240 annual referrals. These thresholds translate complex economic models into actionable decision rules, though they assume all other parameters stay at base-case values (a strong assumption given parameter correlation).

  • 📋

    HTA Process Transparency Enables Methodological Learning

    This paper exemplifies a meta-genre: the EAG team publishing their assessment methodology separately from the NICE guidance itself. Documenting search strategies, quality appraisal decisions, model revisions, and consultation themes creates a knowledge base for future DHT assessments. The 108 consultation comments reveal stakeholder perspectives on evidence standards, particularly around powering, engagement metrics, and patient representation.

© KMS / GIVEMEA · 2026
Study guide generated from Davies et al. (2023)
Educational use · Art. 19 URG (Swiss Copyright Act)
This guide summarizes published research for educational purposes. It does not constitute medical, clinical, or policy advice. Consult primary sources and current NICE guidance for decision-making.

Similar Posts

Leave a Reply