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. 2012 Mar 1;12(2):1–97.

Table 3: Summary of Findings by Topic and Research Question*.

Intervention Comparator Study Population No. Studies (N) Summary Findings GRADE Quality of Evidence
INFLUENZA VACCINATIONS
Research Question: What is the effectiveness, safety, and cost-effectiveness of influenza vaccination compared with no vaccination in COPD patients?
Influenza vaccine Placebo COPD patients 1 (125) Influenza vaccination significantly reduced the risk of influenza-related ARIs compared with placebo. HIGH
        Influenza vaccination had no significant impact on influenza-related ARI hospitalizations and the need for mechanical ventilation compared with placebo. LOW
        Influenza vaccinations significantly increased local adverse reactions, but there was no significant difference in systemic reactions compared with placebo. LOW
        Economic model
Excluded from model as appropriate inputs were not available in the literature.		 n/a
PNEUMOCOCCAL VACCINATIONS
Research Question: What is the effectiveness, safety, and cost-effectiveness of pneumococcal vaccination compared with no vaccination in COPD patients?
Pneumococcal vaccine Placebo COPD patients 1 (596) Pneumococcal vaccination significantly reduced the risk of pneumococcal pneumonia compared with placebo, but there was no significant difference in incidence of global pneumonia, episodes of global pneumonia, first episode of CAP, or time to first episode of CAP between the groups. HIGH
        Pneumococcal vaccination had no significant impact on hospitalizations due to CAP, hospital LOS, mortality, or local or systemic adverse reactions compared with placebo. LOW
        Economic model
Excluded from model as appropriate inputs were not available in the literature.		 n/a
SMOKING CESSATION
Research Question: What is the effectiveness and cost-effectiveness of smoking cessation interventions compared with usual care for patients with COPD?
SC counselling Usual care COPD patients who smoke 2(501) Intensive SC counselling (≥ 90 minutes) significantly increased abstinences rates compared with usual care, but there was no significant difference in abstinence between the minimal counselling (< 90 minutes) and usual care groups. MODERATE
SC counselling plus pharmacology (NRT and/or antidepressant) Usual care COPD patients who smoke 5 (6,802) Intensive SC counselling (≥ 90 minutes) plus NRT significantly increased abstinences rates compared with usual care, but there was no significant difference in abstinence between the minimal counselling (< 90 minutes) plus NRT and usual care groups, the minimal counselling plus antidepressant and usual care groups, and the minimal counselling plus NRT plus antidepressant and usual care groups. MODERATE (intensive SC counselling plus NRT)
LOW (all other comparisons)
NRT Placebo COPD patients who smoke 1 (183) NRT significantly increased abstinence rates compared with placebo. MODERATE
Antidepressant Placebo COPD patients who smoke 2 (596) Bupropion significantly increased abstinence rates compared with placebo; however, nortriptyline had no significant impact on abstinence compared with placebo. MODERATE
        Economic model

  1. Mean ICER: dominates (compared with usual care [or placebo where noted], the following interventions were cheaper and less costly: intensive counselling, NRT [compared with placebo], intensive counselling plus NRT, and bupropion [compared with placebo])

  2. Net Budget Impact for NRT: $10 million (Cdn)

 n/a
MULTIDISCIPLINARY CARE
Research Question: What is the effectiveness and cost-effectiveness of multidisciplinary care compared with usual care (single-care provider) for the treatment of stable COPD?
MDC (2 or more providers) Usual care (1 provider) Patients with stable COPD 6 (1,370) MDC significantly improved all-cause and COPD-specific hospitalizations and COPD-specific ED visits compared with usual care. MODERATE
        MDC significantly improved HRQOL compared with usual care. LOW
        MDC significantly improved lung function at 1 year compared with usual care. VERY LOW
        MDC had no significant impact on mortality and all-cause ED visits compared with usual care. LOW / VERY LOW
        Economic model

  1. Mean ICER: $14,000 ($0-$55,000)† (Cdn) per QALY

  2. Net Budget Impact: Unknown‡

 n/a
PULMONARY REHABILITATION
Research Question 1: What is the effectiveness and cost-effectiveness of pulmonary rehabilitation compared with usual care for patients with stable COPD?
PR Usual care Patients with stable COPD 17 (1,159) PR clinically and statistically significant improved HRQOL and functional exercise capacity (6MWT) compared with usual care. MODERATE
        Economic model
Excluded from model as appropriate inputs were not available in the literature.		 n/a
Research Question 2: Does early pulmonary rehabilitation (within 1 month of hospital discharge) in people who had an acute exacerbation of COPD improve outcomes compared with usual (or no rehabilitation)?
PR Usual care Patients within 1 month of discharge from hospital due to acute exacerbations of COPD 5 (276) PR within 1 month of hospital discharge after an acute exacerbation of COPD significantly reduced hospital readmissions and resulted in clinically significant improvements in HRQOL and functional exercise capacity compared with usual care. MODERATE
        Economic model

  1. Mean ICER: $18,000 ($0-$56,000)t per QALY

  2. Net Budget Impact: 1 time access, $17.2 million; repeat: $17.2 million

 n/a
Research Question 3: Do maintenance or post-rehabilitation programs for people with COPD who have completed a pulmonary rehabilitation program improve outcomes compared with usual care in people with COPD?
PR maintenance Usual care Patients after discharge from a pulmonary rehab program 3 (295) PR maintenance programs had no significant impact on HRQOL, hospital admissions and LOS in the hospital compared with usual care. LOW
        PR maintenance programs resulted in statistically significant but not clinically significant improvements in exercise capacity compared with usual care. LOW
        Economic model
Excluded from model as appropriate inputs were not available in the literature.		 n/a
LONG-TERM OXYGEN THERAPY
Research Question 1: What is the effectiveness, cost-effectiveness, and safety of LTOT compared with no LTOT in COPD patients with severe hypoxemia?
LTOT (> 15 hours/day) No LTOT therapy, usual care COPD patients with severe hypoxemia 4 (263) LTOT resulted in a borderline significant reduction in mortality compared with no LTOT. LOW
        LTOT significantly improved FEV1 and HRQOL compared with no LTOT. LOW/VERY LOW
        LTOT resulted in increased hospitalizations§ but no difference in hospital LOS compared with no LTOT. LOW
        Economic model

  1. Mean ICER: $39,000 per QALY

  2. Net Budget Impact: Funded by the MOHLTC ($65 million in fiscal year 2010)

 n/a
Research Question 2: What is the effectiveness, cost-effectiveness, and safety of LTOT compared with no LTOT in COPD patients with mild-to-moderate hypoxemia?
LTOT (> 15 hours/day) No LTOT, usual care COPD patients with mild-to-moderate hypoxemia 4 (539) LTOT had no significant impact on mortality compared with no LTOT. LOW
        LTOT had no significant impact on lung function (% predicted FEV1), endurance time, or dyspnea compared with no LTOT. VERY LOW
        Economic model
Excluded from the economic model because of very low quality of evidence for model input (FEV1).		 n/a
NPPV FOR THE TREATMENT OF ACUTE RESPIRATORY FAILURE DUE TO ACUTE EXACERBATIONS OF COPD
Research Question 1a: What is the effectiveness, cost-effectiveness, and safety of NPPV for the treatment of acute hypercapnic respiratory failure due to acute exacerbations of COPD compared with UMC?
NPPV + UMC UMC COPD patients with acute respiratory failure due to AECOPD 11 (1,000) NPPV significantly reduced the risk of endotracheal intubation and IMV, inhospital mortality, and mean hospital LOS compared with UMC. MODERATE
        NPPV resulted in fewer complications compared with UMC. LOW
        Economic model

  1. Mean ICER: dominates (NPPV + UMC less costly and more effective than UMC alone)

  2. Net Budget Impact: $42 million cost saving (hospital perspective)

 n/a
Research Question 1b: What is the effectiveness, cost-effectiveness, and safety of NPPV for the treatment of acute hypercapnic respiratory failure due to acute exacerbations of COPD for patients who failed medical treatment compared with IMV?
NPPV IMV COPD patients with acute respiratory failure who failed medical treatment‖ 2 (205) At this time, the data could not be pooled and the results were conflicting. LOW/VERY
        No conclusions can be drawn regarding the comparative effectiveness of NPPV and IMV for this patient population. LOW
        Economic model
Excluded from the economic model due to conflicting results in the clinical evidence.		 n/a
Research Question 2a: What is the effectiveness, cost-effectiveness and safety of NPPV compared with IMV for weaning COPD patients from IMV?
NPPV Pressure support IMV COPD patients being invasively ventilated who failed T-piece weaning trials 2 (80) NPPV resulted in significant reductions in mortality, nosocomial pneumonia, and weaning failure compared with pressure support IMV. MODERATE
        NPPV had no significant impact on LOS in the ICU and duration of mechanical ventilation compared with pressure support IMV. LOW
        Economic model

  1. Mean ICER: dominates (NPPV for weaning less costly and more effective than IMV for weaning)

  2. Net Budget Impact: $12 million cost saving (hospital perspective)

 n/a
Research Question 2b: What is the effectiveness, cost-effectiveness, and safety of NPPV compared with UMC for the prevention of acute respiratory failure in COPD patients after they have been extubated from IMV?
NPPV UMC COPD patients after they have been extubated from IMV 0 (0) No evidence was identified to evaluate the use of NPPV after extubation of COPD patients from IMV. n/a
        Economic model
Excluded from economic model due to lack of evidence.		 n/a
Research Question 2c: What is the effectiveness, cost-effectiveness, and safety of NPPV compared with IMV for the treatment of acute respiratory failure in COPD patients after they have been extubated from IMV?
NPPV IMV COPD patients who develop respiratory failure within 48 hours of extubation from IMV 1 (23) NPPV had no significant impact on the reintubation rate based on a post hoc subgroup analysis of 23 patients with COPD. LOW
        At this time, there is inadequate evidence to reach conclusions on the comparative effectiveness of NPPV and UMC for the treatment of COPD patients who have developed acute respiratory failure following extubation from IMV. n/a
        Economic model
Excluded from economic model due to lack of evidence.		 n/a
NPPV FOR THE TREATMENT OF CHRONIC RESPIRATORY FAILURE IN STABLE COPD
Research Question: What is the effectiveness and cost-effectiveness of NPPV compared with no ventilation while receiving usual care for stable COPD patients with chronic respiratory failure?
NPPV Usual care Stable COPD patients with chronic respiratory failure 8 (403) NPPV had no significant impact on mortality, lung function after 3 months, functional exercise capacity (6MWT) after 3 months, and hospitalizations compared with usual care. MODERATE
        NPPV clinically and statistically significantly improved functional exercise capacity (6MWT) during the first 3 months of treatment and had a beneficial impact on dyspnea compared with usual care. LOW
        Economic model
Excluded from economic model due to lack of clinical effectiveness.		 n/a
HOSPITAL-AT-HOME PROGRAMS FOR ACUTE EXACERBATIONS OF COPD
Research Question: What is the effectiveness, cost-effectiveness, and safety of hospital-at-home care compared with inpatient hospital care for acute exacerbations of COPD?
Early discharge and admission avoidance HaH programs Inpatient hospital care COPD patients presenting to the ED with acute exacerbations of COPD that require admission to hospital 6 (611) HaH had no significant impact on hospital readmissions, but the days to readmission were increased in the HaH group compared with inpatient care. LOW
        HaH had no significant impact on mortality, HRQOL, and patient/caregiver satisfaction with care compared with inpatient care. VERY LOW
        Economic model
Excluded from economic model due to low/very low quality of evidence and nonsignificant differences between groups.		 n/a
HOME TELEHEALTH
Research Question 1: What is the effectiveness, cost-effectiveness and safety of home telemonitoring compared with usual care for patients with COPD?
Home telemonitoring Usual care COPD patients 5 (310) Home telemonitoring significantly improved time free of exacerbations, time free of hospitalizations, and time to ED visits, but had no significant impact on number of exacerbations or ED visits. LOW
        The impact of home telemonitoring on HRQOL and hospitalizations could not be determined due to conflicting results in the literature. LOW/VERY LOW
        Home telemonitoring had no significant impact on mortality and LOS compared with usual care. LOW
        Economic model
Excluded from economic model due to very low quality of evidence for the model inputs and inability to pool data for hospitalizations.		 n/a
Research Question 2: What is the effectiveness, cost-effectiveness, and safety of telephone-only support programs compared with usual care for patients with COPD?
Telephone-only support Usual care COPD patients 1 (60) Telephone-only support significantly reduced ED visits and significantly improved HRQOL measured by the Chinese Self-Efficacy Scale compared with usual care. LOW
        Telephone-only support had no significant impact on hospitalizations and hospital LOS compared with usual care. LOW
        Economic model
Excluded from economic model due to the low quality of evidence and nonsignificant difference between groups.		 n/a
*

Abbreviations: 6MWT, 6 minute walking test; AECOPD, acute exacerbation of COPD; ARI, acute respiratory illness; CAP, community-acquired pneumonia; COPD, chronic obstructive pulmonary disease; ED, emergency department; FEV1, forced expiratory volume in 1 second; HaH, hospital-at-home; HRQOL, health-related quality of life; ICER, incremental cost-effectiveness ratio; ICU, intensive care unit; IMV, invasive mechanical ventilation; LOS; length of stay; LTOT, long-term oxygen therapy; MDC, multidisciplinary care; NPPV, noninvasive positive pressure ventilation; NRT, nicotine replacement therapy; PaO2, partial pressure of oxygen (in arterial blood); PR, pulmonary rehabilitation; SC, smoking cessation; UMC, usual medical care.

†

Ranges reflect the results of the one-way sensitivity analysis that was performed for multidisciplinary care and pulmonary rehabilitation.

‡

Based on the most recent FHT data, the costs of MDC programs to manage COPD were estimated at $85 million in FY 2010, with projected future expenditures of up to $51 million for incident cases, assuming the base case cost of program. However, this estimate does not accurately reflect the current costs to the province because of lack of report by FHTs, lack of capture of programs outside this model of care by any data set in the province, and because the resource utilization and frequency of visits/follow-up phone calls were based on the findings in the literature rather than the actual FHT COPD management programs in place in Ontario. Therefore, MDC resources being utilized in the province are unknown and difficult to measure.

§

In this study, patients in the LTOT arm had severe COPD, while patients in the no LTOT comparison arm had mild/moderate COPD.

‖

While it was clear in 1 study that the patients had first failed usual medical care, this was not clear in the second study although it has been assumed.