Focusing on outcomes: Making the most of COPD interventions

Figures & data

Table 1 Reviews of clinical, psychosocial, and educational interventions and COPD outcomes

Primary outcome and investigators	Type of review	Selection criteriaa	Studies in review	Results	Implications for practice
Pulmonary function
Devine and Pearcy^Citation15	Meta-analysis (publication dates from 1954–1994)	Provided psycho-educational care to adults with COPD; experimental, quasi-experimental, or pre-post design; minimum 5 participants in each treatment group; all treatment groups from same setting; included outcome measures of physical or psychological well-being, knowledge of psychomotor skills, HCU. Excluded cognitive knowledge as an outcome and effect of inspiratory muscle training.	65	Methodological weaknesses limit confidence in positive findings, eg, only 38% of studies randomized to treatment condition and 15% included a placebo-type control group. Pulmonary rehabilitation (exercise + education + behavioral interventions) had significant positive effects on psychological well-being, endurance, functional status, dyspnea and adherence. Education VO2, alone only significantly improved inhaler skills. Relaxation alone significantly improved dyspnea and psychological well-being.	Methodological weaknesses highlight the need for additional randomized controlled studies. Current evidence indicates that multifaceted, comprehensive pulmonary rehabilitation yields improvements in multiple outcomes. Specific outcomes can be benefited by education alone or relaxation interventions.
O’Brien and colleagues^Citation16	Systematic review (update of Crowe and colleagues^Citation63) and meta-analysis	Adult participants with COPD; an IMT intervention; randomized comparison group that received an intervention other than ‘sham’.	18	Focused on 2 subgroup analyses. No significance difference in outcomes for IMT compared with exercise (5 studies). Some improvements seen in inspiratory muscle strength and exercise tolerance for COPD patients in combined IMT and exercise compared with exercise alone (3 studies).	More studies are needed to explore the effects of IMT or combined IMT plus other rehabilitation interventions compared to rehabilitation interventions without IMT. Data needed regarding frequency, timing and duration of IMT for maximum benefit.
Health care utilization
Adams and colleagues^Citation19	Systematic review (publication dates from 1966–2005)	Enrolled adults with COPD; contained intervention(s) with CCM components; included a comparison group or pre-post measurement; included relevant outcomes. Excluded articles evaluating the impact of specific therapeutic measures considered part of “standard care”.	32	20/32 were randomized clinical trials. Methodological issues found in underlying literature. Limited published data evaluating CCM components in COPD. Studies with reduced HCU included CCM components of extensive disease management intervention with individualized action plan, advanced access to care, guideline-based therapy, and a clinical registry system. Studies using disease management component only did not affect QOL or HCU outcomes.	Highlights the need for well-designed studies implementing the CCM components in COPD. Insufficient date to determine optimal combination of components, specific types and duration of interventions. Current evidence suggests that interventions with at least 2 CCM components yielded reduced hospital and ED use.
Bourbeau^Citation64	Comprehensive review (publication dates from 1966–2003)	Published in peer-reviewed journal; experimental or quasi-experimental design; participant diagnosis of COPD; intervention = disease management specific to care of patients with COPD; outcomes were health status or health care use.	10	Limited number of published prospective controlled trials comparing disease-specific management with usual care for patients with COPD. In this review, only one (Bourbeau and colleagues^Citation28) showed effects on both health status and use of health resources, including a 40%–60% reduction in hospitalizations and ED visits in the intervention compared with usual care. Intervention comprised eight weekly sessions of a multi-component educational intervention with action plan and monthly follow-up.	Evidence that a multi-component disease management intervention can have an impact on health status of patients with COPD. Interventions are not a substitute for pulmonary rehabilitation in COPD. Ongoing communication regarding disease management should be provided to patients by trained professionals, including the physician. Further research is needed to identify specific effective intervention components and strategies for long-term are of COPD patients.
Effing and colleagues^Citation21	Systematic review (publication dates from 1985–2005)	Controlled trials (randomized and nonrandomized) of disease management education in patients with COPD. Excluded studies focusing on pulmonary rehabilitation and studies without a “usual care” control group.	14	Compared to a control group, disease management education significantly reduced the likelihood of at least one hospital admission. QOL significant improvements did not reach clinical significance; small significant reduction in dyspnea observed. No significant effects found in other variables, eg, number of exacerbations, ED visits, lung function, exercise capacity, days lost from work, medication use.	Highlights the need for large RCT with long-term follow-up. Evidence found for disease management education resulting in a reduction in hospital admissions. Data insufficient to develop recommendations for form and content of disease management interventions in COPD.
Quality of life
Niesink and colleagues^Citation31	Systematic Review (publication dates from 1995–2005)	RCT trial with a usual care control group; patients with stable COPD; outpatient integrated care intervention; intervention duration of at least 8 weeks; general or disease-specific QOL measurement. Excluded studies exclusively focused on evaluation of case finding methods, prevention strategies, and provider education or feedback.	10	Limited studies available regarding the effect of chronic disease management interventions on health-related QOL in patients with COPD. Studies in this review did not include all elements of the chronic care model. Substantial variability in quality of studies. Inconclusive whether chronic disease management interventions with different levels of care coordination in people with stable COPD can improve HRQOL.	Highlights the need for further research to identify the most effective methods of integrating the various disciplines in COPD care.
Anxiety & depression
Brenes^Citation34	Review (publication dates from 1966–2002)	Articles that discuss the prevalence of anxiety among COPD patients, the impact of anxiety on patients with COPD, or the treatment of anxiety in COPD patients.	Not specified	Anxiety disorders occur at higher rates in people with COPD and significantly impact their QOL. Few studies have examined pharmacological, psychotherapeutic, or pulmonary rehabilitation treatments for anxiety in the context of COPD. Some evidence that cognitive-behavioral interventions and multi component pulmonary rehabilitation can reduce anxiety symptoms in people with COPD.	Highlights the need for randomized controlled studies with larger samples and instruments with demonstrated reliability and validity. Need to look at individual components of interventions with multiple components to determine which are most effective.
Coventry and Hind^Citation36	Systematic review and, eta-analysis (all publications through August 2005)	RCT only with standard care control group; participants with clinically stable moderate to severe COPD; outpatient pulmonary rehabilitation interventions of ≥4 weeks that included exercise component or comprehensive interventions; use of validated self-report anxiety and generic or disease-specific HRQOL measures.	6	In patients with moderate to severe COPD, comprehensive pulmonary rehabilitation that included up to 3 sessions/week of supervised exercise along with education and psychosocial support appeared to significantly reduce anxiety and depression compared to standard care.	Further research is needed to determine the most effective interventions for anxiety and depression in people with moderate to severe COPD.
Ofman and colleagues^Citation65	Systematic review (publication dates from 1987–2001)	Included interventions using a systematic approach and multiple modalities to manage or prevent a chronic disease; addresses a chronic condition affecting at least 1% of population; adult participants; included objective measurement of processes or outcomes; employed experimental or quasi-experimental designs. Excluded risk reduction interventions that did not target a specific chronic disease; evaluations of single treatment modalities; observational studies; studies of hospitalized patients.	102	Six studies addressed COPD. Overall, disease management interventions were associated with improvements in the quality of patient care. Relatively few studies evaluated the effect of disease management interventions on health care utilization and costs. Interventions for patients with depression had the highest percent of comparisons between intervention and control showing significant improvements in patient care, while those for COPD and chronic pain had the least.	Rigorous evaluations of interventions that appear most effective are indicated. Organizations that certify disease management interventions should use formal criteria to evaluate intervention effectiveness.
Rose and colleagues^Citation35	Systematic review (publication dates from 1985–2001)	RCT of psychologically-based intervention to treat anxiety and/or panic in patients with COPD; participants with diagnosis of COPD based on lung function testing, chronic bronchitis, emphysema. Excluded interventions with exercise or education only; studies that failed to measure anxiety pre/post intervention; studies with patients with asthma or industrial-related COPD.	6	Lack of evidence that psychologically- based interventions reduce anxiety in COPD, perhaps due to methodological problems in reviewed studies.	Highlights the need for more rigorous randomized controlled trials of longer duration; need panic measures specific to the COPD population; screening newly diagnosed COPD patients for anxiety and panic may result in earlier intervention for these conditions.

a Notes:In addition to being published in the English language.

Abbreviations:

Table 2 Randomized controlled trials of clinical, psychosocial, and educational interventions and COPD outcomes

	Study design Measurement	Participants/intervention	Outcomes Results/discussion
Pulmonary function
Sassi-Dambron and colleagues^Citation18a	Six dyspnea measures; 6-minute walk test; Quality of well-being (QWB) scale, Spielberger State-trait Anxiety Inventory (STAI); and CES-D. Data collection at baseline, 6 weeks post-treatment and 6 month follow-up	N = 89 with random assignment into treatment or education-control group. Treatment consisted of instruction and practice in techniques for dyspnea management and general education regarding lung disease. Control group received general health education lectures on nonlung disease topics.	No significant differences between groups on any outcome measure were found at the end of the 6-week treatment. At the 6-month follow-up, a significant group difference was found in only one dyspnea variable.
Watson and colleagues^Citation17ab	Saint George’s Respiratory Questionnaire (SGRQ) Pulmonary function tests Daily diary cards related to respiratory status, medications, health care use Data collection at baseline and 6 months	N = 56 participants with COPD recruited through general practitioners (GPs) completed the 6 month study. Intervention group received a booklet and Action Plan plus a supply of prednisone and antibiotic from their GP. Control group received usual care from their GP	There were significant changes in disease management behavior related to initiating medication use with increasing symptoms in the intervention group compared to controls. Participants in the intervention group did not show any difference in pulmonary function parameters or quality of life scores compared to controls.
Health care use
Boxall and colleagues^Citation22a	Hospital admission rates with exacerbation of COPD and average length of stay at readmission; SGRQ; 6-minute walk test; Borg score of perceived breathlessness. Data collection at baseline and 12 weeks follow-up	N = 60 housebound COPD patients older than 60 years. Intervention: 12-week home-based pulmonary rehabilitation intervention consisting of individually tailored walking and arm exercise intervention and multidisciplinary education sessions on COPD and its management. Control group usual care and a 12-week delay before receiving identical intervention.	Compared with the control group, intervention patients demonstrated a significant improvement in 6-minute walk test, Borg score of perceived breathlessness, St George’s Respiratory Questionnaire total score and impact sub score. Intervention group had a significantly shorter average length of stay for hospital readmission at six months follow-up.
Bourbeau and colleagues^Citation28a Reduction of Hospital Utilization in Patients With Chronic Obstructive pulmonary disease: A disease-specific self- management intervention.	Health care utilization 6-minute walk test Dyspnea after exercise Data collection at baseline, 4 and 12 months	N = 191 patients with COPD and at least 1 hospitalization for exacerbation in the previous year. Intervention group received comprehensive patient education specific to COPD (“Living Well with COPD”). Control group received standard care.	Hospitalizations for exacerbation of COPD were significantly reduced in the intervention group compared to controls, as were hospitalizations for other causes, emergency department visits, and unscheduled physician visits.
Gadoury and colleagues^Citation30 (See Bourbeau and colleagues^Citation28)	All-cause hospital admissions All-cause emergency visits Two year follow-up of health insurance usage and hospitalization	N = 191 patients with COPD and at least 1 hospitalization for exacerbation in the previous year with random assignment to intervention or control group. Intervention group received comprehensive patient education specific to COPD (“Living Well with COPD”). Control group received standard care.	Follow-up to clinical trial reported in Bourbeau, J et al 2003^Citation28, above. Significant reduction in all-cause hospitalizations and in all-cause emergency visits in intervention group compared to standard care (control) group over 2 years follow-up.
Gallefoss and Bakke^Citation66a	Spirometry; utilization of health resources and absenteeism from work were self reported monthly for 12 months. Hospital dates verified with medical records. SGRQ administered at 12 months follow-up.	N = 78 asthmatics and 62 COPD outpatients assigned to either intervention (2 2-hour group sessions and 1or 2 individual sessions with providers) or control group.	Patient education in asthmatics and COPD patients reduced the need for GP visits and kept a greater proportion of patients independent of GP The mean reduction in days off work for the educated was 69%. Patient education significantly increased QOL and FEV1 at 12 months among asthmatic patients but not those with COPD.
Griffiths and colleagues^Citation29a (Also ambulation and quality of life results)	SGRQ Hospital Anxiety and Depression Scale; Chronic Respiratory Disease Questionnaire (CRQ), SF- 36 10 m shuttle-walk test Health care use from hospital records Data collected at baseline, 6 weeks, and 1 year follow-up	N = 200 patients randomly assigned to a 6-week comprehensive multidisciplinary rehabilitation intervention (18 visits) or a standard care control group	No difference between rehabilitation and control groups in the number of patients admitted to hospital, but intervention group had significantly fewer hospital days. Rehabilitation group had significantly more primary care office visits and significant improvements in walking ability and quality of life.
Hernandez and colleagues^Citation25a	Hospital admissions, ER visits and outpatient provider visits; SGRQ, SF-12 Data collected at baseline and 8 week follow-up	N = 222 COPD patients randomly assigned to a Home Hospitalization (HH) intervention or conventional care. During HH, integrated care was delivered by a specialized nurse for an 8-week follow-up period. Control group received conventional care.	Mortality and hospital readmissions were similar in both groups. However, at the end of the follow-up period, HH patients had a significantly lower rate of ER visits and improvement in dimensions of quality of life.
Pushparajah and colleagues^Citation26	Hospitalizations and length of stay compared for one year before and after the intervention	N = 125 patients referred with COPD exacerbations Intervention was a community based COPD management intervention led by a respiratory physiotherapist versus control	Overall there was no reduction in length of stay, admission frequency or adjusted total hospitalization days with COPD, but median time interval to next hospitalized exacerbation increased 29% in intervention group. Additional benefits were seen in the more severe patients.
Rea and colleagues^Citation24a	Pre-test/post-test assessments included spirometry, Shuttle Walk Test, SF-36, Chronic Respiratory Disease Questionnaire (CRQ) at baseline and 12 month follow-up	N = 135 moderate to severe COPD patients identified from hospital administration data and general practice records. Assigned either intervention (intensive pulmonary rehabilitation implemented by GP) or conventional care	Mean hospital bed days per patients/year reduced significantly for intervention group, while control group increased. Intervention group also showed an improvement in two dimensions of QOL - fatigue and mastery.
Sridhar and colleagues^Citation27	Hospital readmission rate over 2 years Unscheduled consultations with the general practice (GP) physician over 2 years CRQ at baseline and 3 additional times over two years.	N = 122 patients who had been hospitalized with a primary diagnosis of acute exacerbation of COPD. All participated in a 4 week pulmonary rehabilitation program (8 sessions), received a baseline home visit by a specialist respiratory nurse and a personalized written CODP action plan. Intervention group then received monthly telephone calls and home visits every 3 months for 2 years. Control group received usual care from the GP.	No significant differences were found in hospital readmission rates. Intervention participants had significantly fewer unscheduled primary care consultations and a significant reduction in deaths due to COPD.
Quality of life
Hermiz and colleagues^Citation32a	SGRQ Hospitalizations and frequency of MD visits Three-month follow-up after acute care	N = 177 COPD patients assigned to intervention (home visits by community nurse at 1 to 4 weeks after discharge) and control group	Intervention improved patient’s knowledge and some aspects of QOL. No differences in admissions to hospital or overall functional status.
Maa and colleagues^Citation33	Pre- and post-tests using SGRQ, Dyspnea Visual Analogue Scale, modified Borg Scale, Bronchitis Emphysema Symptom Checklist, Six Minute walk test	N = 41 COPD outpatients, assigned to acupuncture and standard care (N = 11), acupressure (N = 17) and standard care, or standard care alone (N = 13) for 8 week treatment.	SGRQ results of acupuncture and acupressure groups increased significantly compared to the controls. The other variables did not differ significantly between intervention and control groups.
Monninkhof and colleagues^Citation67ab	SGRQ Six Minute Walking test Symptom diary Data collection at baseline, 6 and 12 month follow-up	N = 248 patients with stable moderately severe COPD, no history of asthma, current or former smoker, no exacerbation in month prior Randomized to skill-oriented disease management (five 2-hour group interventions) and fitness intervention or regular care control group	No differences in the SGRQ scores, walking distance, or symptoms found between groups after 1 year.
Anxiety and depression
Egan and colleagues^Citation40ab	SGRQ; Hospital Anxiety and Depression Scale (HADS); Subjective Well-Being Scale; hospital readmissions Data collection at baseline and 3 month follow-up	N = 66 patients randomized to an intervention or control group. Intervention group received a comprehensive nursing assessment by the CM who also coordinated their care during hospitalization, conducted a case conference as part of discharge planning for intervention patients, and provided follow-up care at 1 week and 6 weeks post-discharge. Control group received normal care.	Intervention group patients reported significantly less anxiety at 1 month post discharge; however, this effect was not sustained.
Emery and colleagues^Citation38a	CES-D score; SCL-90-R for depression/anxiety, STAI-State Anxiety and Sickness Impact Profile (SIP) total score; physiological function. Data collection at baseline and 10 weeks follow-up.	N = 79 outpatients with moderate to severe COPD randomized to: a) exercise, education, and stress management; 2) education and stress management; and 3) wait list control. Intervention consisted of Comprehensive Pulmonary Rehabilitation for 10 weeks. Control participants received standard care education, stress management, and psychosocial support	Intervention participants in the comprehensive pulmonary rehabilitation group, compared to the other 2 groups, reported improved endurance, reduced anxiety, and improved cognitive performance (verbal fluency).
Nguyen and Carrieri-Kohlman^Citation37	CES-D; CRQ; endurance treadmill test; SF-36 physical and social functions; spirometry Data collection at baseline and 2 month follow-up	N = 100 adults (>40 years of age) with moderate to severe COPD Randomly assigned to one of three disease management interventions: 1) Dyspnea Self-management Program (DM) and individualized home walking prescription; 2) DM education and 4 tread mill sessions; and 3) DM education and 24 treadmill sessions	All three versions of dyspnea self management significantly improved depressed mood. Patients at high risk of depression at baseline who received 24 sessions had greater reduction in dyspnea.
White and colleagues^Citation39ab	Spirometry; Shuttle walking test; Hospital Anxiety and Depression scale; CRQ, SF-36 Data collection at baseline and 3 month follow-up	N = 103 patients with severe COPD randomized to intervention or control. Intervention was a 6-week (12 sessions) rehabilitation intervention at the hospital. Control participants received a single education session at the hospital and home exercise advice.	At 3 months both groups reported reduced anxiety on the Hospital Anxiety and Depression Scale and dimensions of quality of life, but differences between groups were not significant. Shuttle walking distance increased significantly in the intervention group compared to controls.
Ambulation
Behnke and colleagues^Citation42a	Lung function; 6-minute walk test, Borg and Traditional Dyspnea Index (TDI); and CRQ Data collected in the hospital and 1, 2, 3, and 6 months after discharge	N = 46 patients randomized to an intervention or a control group. The intervention group performed walking training in the hospital, followed by a 6-month intervention of supervised walking training at home. The control group did not have exercise training in the hospital or at home	Six-minute walking distance in the intervention group improved significantly from day 1 to 10 and was maintained over 6 months and their quality of life scores changed significantly over 6 months. The control group showed no significant changes in exercise performance or QOL scores throughout the study period.
Cockcroft and colleagues^Citation41a	Spirometry; 12-minute walk test; treadmill exercise test; Lorr-McNair Mood Questionnaire scores for tension/anxiety and depression; Eysenck Personality Questionnaire (EPQ) Data collected at baseline, 2, 4, and 8–9 months (after controls completed training).	N = 34 outpatient men with respiratory disability were assigned to intervention or control. Intervention participants received 6 weeks of progressive exercise training. Control participants received standard care for 4 months, followed by the exercise training.	Walking distance improved significantly in the treatment group compared to controls, but no consistent associations between the increase in walking distance and changes in psychological scores were observed. No significant differences between intervention and control groups in anxiety levels or other psychological dimensions were found at follow up.
Exercise capacity
Foy and colleagues^Citation43	CRQ Attendance at sessions Heart rate achieved during exercise Measurement at baseline, 3 and 18 month follow-up	N = 140 COPD patients (>50 years if age) randomized to short-term (3 months) and long term (18 months) exercise therapy	Long-term group had significantly more favorable scores than the short-term group on dimensions of CRQ (dyspnea, fatigue, emotional function and mastery). Men in long-term group reported significantly more benefit than those in short-term group; no significant differences were observed for women between short or long term exercise therapy.
Guell and colleagues^Citation45a	SCL-90-R; 6-minute walk test; CRQ; Million Behavior Health Inventory (MBHI) Data collected at baseline and 16 weeks follow-up	N = 40 outpatients with severe COPD randomized either to a pulmonary rehabilitation group for 16 weeks or to a control group that received standard medical care with drug treatment for respiratory infections and dyspnea	Significant differences in favor of the intervention group were found in dimensions of the MBHI, the SCL-90-R, the dyspnea and mastery domains of the CRQ, and the 6-minute walk test. Pulmonary rehabilitation may decrease psychosocial morbidity in COPD patients even when no specific psychological intervention is performed.
Ries and colleagues^Citation68a	Pulmonary function tests; treadmill testing; Selfefficacy questionnaire; Quality of Well-Being scale; CES-D score; self-report hospitalization and ED use Data were collected at baseline, after the intervention ended (2 months) and at regular intervals for 6 years	N = 119 outpatients with moderate to severe COPD randomly assigned either to an 8 week comprehensive pulmonary rehabilitation intervention (plus 12 follow up reinforcement sessions for 1 year) or to the control group that received an 8week education intervention.	Rehabilitation produced a significantly greater increase in maximal exercise tolerance. Measures of lung function, depression, general quality of life, and health care use did not differ significantly between groups. Differences tended to diminish after 1 year of follow-up.
Self-efficacy
Davis and colleagues^Citation14b	Self-efficacy for walking and managing shortness of breath; 6-minute walk test with Borg scale; and CRQ Dyspnea subscale. Measured at baseline and after completion of the exercise interventions (8 weeks)	N = 102 participants with moderate to severe COPD Random assignment to one of three disease management interventions: 1) Dyspnea Self-management Program (DM) and individualized home walking prescription; 2) DM education and 4 treadmill sessions; and 3) DM education and 24 treadmill sessions	Education and a home walking intervention significantly improve patients’ self-efficacy for walking and for managing shortness of breath. The three intervention groups did not differ in their improvements in self-efficacy.
Scherer and colleagues^Citation47	CSES test: Assesses COPD patients’ level of confidence in ability to manage or avoid breathing difficulty while participating in certain activities Measurement at baseline, 1- and 6-month follow-up.	N = 59 patients randomized to participate in either the pulmonary rehabilitation intervention (combined education and supervised exercise training) or to a control group receiving an education-only intervention.	Participants’ self-efficacy scores improved significantly after the pulmonary rehabilitation intervention and remained improved 6 months later. Education alone was initially effective in significantly improving self-efficacy scores, but scores declined by 6 months.

a Notes: Reference is included in a review article;

b Findings nonsignificant at p ≤ 0.05

Figure 1 The continuous and reciprocal nature of self-regulation processes in asthma management.

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