Secondary Logo

Journal Logo

Scientific Review

A Comparative Effectiveness Review

RESPONSIVENESS OF PATIENT OUTCOME MEASURES IN CARDIAC AND PULMONARY REHABILITATION

van Rotterdam, Joan BSc, MMS; Hensley, Michael PhD, MBBS; Hazelton, Michael PhD, MA, RN

Author Information
Journal of Cardiopulmonary Rehabilitation and Prevention: March 2019 - Volume 39 - Issue 2 - p 73-84
doi: 10.1097/HCR.0000000000000405

Chronic obstructive pulmonary disease is a common condition, with 19% of Australians >40 yr of age estimated to be affected. People with this condition have poor quality of life (QoL) with cardinal symptoms of dyspnea and exercise intolerance. Pulmonary rehabilitation (PR) programs have been shown to help reduce these symptoms and reduce health care utilization.1

Coronary heart disease remains the most frequent cause of death worldwide; however, with improved medical technology and interventions, people are living longer with symptomatic coronary heart disease. Cardiac rehabilitation (CR) programs have been shown to reduce the risk of reinfarction as well as reduce cardiovascular and all-cause mortality.2

Patients with chronic cardiac and chronic respiratory illness have been found to benefit from an integrated self-management plan that is initially put together for them within a rehabilitation program.3,4 The concept of QoL is integral to rehabilitation and its measurement in this setting summarizes the overall value placed on life at any given time. Health-related quality of life measures to what extent disease limits the capacity to lead a normal life.5

In rehabilitation, function of patients is the result of a dynamic interaction between health conditions (disease) and contextual factors (environmental and personal factors) that describe the milieu in which individuals live.6 Disability is defined as a loss of function in a person and CR and PR programs are designed to limit the disabling consequences of disease.

To ensure CR and PR programs continue to provide clinically valuable services, it is essential to evaluate the efficacy of these programs. Therefore, patient outcome measures (POMs) are essential to determine treatment effectiveness.

In response to worldwide endorsement of CR and PR programs, the Cochrane Review committee has undertaken literature reviews of both types of programs. There have been 6 reviews of CR programs and 3 reviews of PR programs. Both sets of reviews have endorsed the success of these rehabilitation programs; however, there are some methodological issues with the initial studies.

To measure the effectiveness of such programs, POMs are used to assess a patient's response and should reflect a direction of perceived health change. Measuring change in POMs in this setting is in part a reflection of the reliability of an instrument and the ongoing process of construct validity (learning more about the construct, making new predictions, and then testing them).7,8

Responsiveness, or the process of measuring change in a patient's response in relation to POMs, is a key issue in this review and it is why validation of these instruments is important and, as such, needs to be fully explained. Responsiveness is related to sensitivity.9 Responsiveness is the ability of POMs to detect changes when a patient's condition improves or deteriorates. Responsiveness is the measurement of the change an instrument detects over time among patients. The concept of responsiveness is context specific, that is, a POM may be responsive in a certain setting with a certain population but that same tool may not perform as well in another population.7

The concept of responsiveness determines the effectiveness of both CR and PR programs. A POM such as a health-related quality of life measure may be sensitive to the disease process and give information in this area but may not necessarily give information as to whether the rehabilitation program brings about an improvement, a deterioration, or no change in the health status of the patient.

Studies relating to rehabilitation as an intervention, studies that involve a pre- and post-rehabilitation measurement regime, are essentially of 2 types. First, the “within” patient trial is a longitudinal study with rehabilitation as an intervention that measures change of health status over time in patients within a group (eg, a prospective trial). The “between” patient trial is a longitudinal study with rehabilitation as an intervention but also compares patient groups (eg, randomized controlled trials [RCTs]).10

Significance tests are conducted (t test or equivalent) to determine whether the change in score of a POM within a patient over time is most likely due to chance or to an intervention. To estimate the magnitude of change over time (or whether that change is meaningful), the effect size index will supplement the statistical testing (Figure 1).10

Figure 1.
Figure 1.:
A summary of how to assess the responsiveness of HRQoL questionnaires in pre- to post-studies of pulmonary and cardiac rehabilitation. HRQoL indicates health-related quality of life; QoL, quality of life; RCTs, randomized controlled trials.

METHODOLOGY

The purpose of this comparative effectiveness review was to determine whether community-based CR and PR programs bring about a measurable change in health status as shown by POMs pre- to post-rehabilitation. The 3 main objectives of this review were to (1) list the articles under review and provide a checklist of items included in each study; (2) provide a qualitative analysis of research papers; and (3) provide a qualitative analysis of POMs utilized in these review studies.

A search was undertaken of current databases (Figure 2), including MEDLINE, PyschINFO, Cochrane, CINAHL, Ovid, BMJ, AMED, BioMed Central, and Open Access journals, with articles restricted to published research in English (1995-2015). One thousand five hundred fifty-seven articles were found that satisfied the inclusion criteria. Exclusion criteria were then applied to this group, and it was found that 83 studies matched the selection criteria applicable for this literature review. Table 1 provides a comprehensive list of articles in date order with a description of the population, the type of trial under review, the POMs and other tests that were undertaken, a short description of the intervention, and a short summary of conclusions for each study.11

Figure 2.
Figure 2.:
Flow diagram of search criteria and included publications. COAD indicates chronic obstructive airway disease; COPD, chronic obstructive pulmonary disease; QoL, quality of life.
Table 1 - Quality Assessment of Included Studies
Author (Year), Type of Rehabilitation Selection Bias: Random Sequence Generation Selection Bias: Allocation Concealment Performance Bias: QoL Tools Responsiveness Assessed in Previous Studies Attrition Bias: Incomplete Outcome Data Selective Reporting Other Sources of Bias Overall Quality Assessment
1. Nilesh et al (2013), PR No No Yes No No COPD patients only Low
2. Chair et al (2013), CR Yes Yes Yes Yes Yes Results may be affected by cultural issues High
3. Stauber et al (2013), CR No No Yes No Yes Unequal sample size of groups Moderately low
4. Berton et al (2013), PR No No Yes No Yes Power calculations show that study is underpowered for this HRQoL Moderately low
5. Janssen et al (2012), CR No No Yes No Yes Conclusions not consistent with results Moderately low
6. Gurgun et al (2012), PR Yes No No No No Small sample sizes Low
7. Sagar et al (2012), CR No No Yes No Yes No power equation Moderately low
8. Yoshimi et al (2012), PR No No No No No ... Very low
9. Dodd et al (2012), PR No No No Yes Yes Baseline characteristics were of T3 patients Moderately low
10. Shah et al (2012), PR No No No No No No follow-up results Very low
11. Ringbaek et al (2012), PR No No Yes No Yes Problems completing HRQoL Moderately low
12. Bratas et al (2011), PR No No Yes Yes Yes Some issues with recall bias Moderate
13. Puhan et al (2010), PR Yes Yes Yes Yes Yes Small sample size High
14. van Gestel et al (2010), PR Yes No No Yes No Patients had difficulty with the breathing technique Moderately low
15. Mosayebi et al (2011), CR No No Yes No No Results inconclusive due to no follow-up Low
16. Beauchamp et al (2010), PR No No Yes Yes Yes Some questionnaires may have had ceiling effects Moderate
17. Yohannes et al (2010), CR No No Yes Yes Yes ... Moderate
18. Beckie et al (2010), CR Yes Yes Yes Yes Yes A randomized clinical trial comparing a tailored CR program with conventional CR
Only women used in this study and demographic data reported were limited
High
19. Izawa et al (2010), CR No No No No No Nonrandomized longitudinal observational trial
Numbers for follow-up not reported
Low
20. Fast et al (2009), CR No No Yes Yes No Nonrandomized descriptive prospective trial
QoL forms filled in by spouses for patients, this was not controlled, which allows for bias in reporting
Moderately low
21. Jones et al (2009), PR No No No Yes No Nonrandomized prospective trial
There were only 8 patients out of 100 diagnosed with PTSD. Conclusions concerning QoL in a PR setting for these patients must be conservative as these numbers are very small
Low
22. McGrady et al (2009), CR No No No Yes Yes Nonrandomized retrospective study
QoL responsiveness assumed for instruments used in this study
Assumptions regarding QoL and depression in CR patients are limited within this context
Moderately low
23. McKee et al (2009), CR No No Yes Yes Yes Nonrandomized longitudinal prospective trial
No demographic data available on patients
Moderate
24. Riaz et al (2009), CR No No No Yes No Nonrandomized prospective longitudinal trial
Assumptions made concerning patients' mental health pre- to post-CR may be unfounded due to the lack of responsiveness of the SF-36 MCS in this setting
Low
25. Bailey et al (2008), PR No No Yes Yes Yes Retrospective study
Findings are limited due to study design
Moderate
26. Jeger et al (2008), CR No No Yes No Yes Prospective study
High dropout rate post-rehabilitation
Moderately low
27. Maes et al (2008), CR No No Yes Yes Yes Prospective nonrandomized cohort study
High dropout rate of patients by end of study
Moderate
28. Maltais et al (2008), PR Yes No Yes Yes Yes Randomized multicenter clinical trial
Self-report with home exercise may have caused some bias in reporting
Moderately high
29. Benzer et al (2007), CR No No Yes No No Nonrandomized comparison trial
Inpatient ExCR group more likely to have had an MI
Low
30. Gunstad et al (2007), CR No No No No No Nonrandomized retrospective study
Selection bias of completed charts with no comparison of patients who had not completed
Very low
31. Haugen et al (2007), PR Yes Yes Yes Yes Yes Nonrandomized comparative trial
Exercise programs were different in the 2 groups, so this could not be excluded as a reason for increase in patient QoL
High
32. Hevey et al (2007), CR No No Yes Yes Yes Nonrandomized comparison trial
Patients were not randomized and not adjusted by matching or statistically adjusted for potential confounders
Moderate
33. Lotshaw et al (2007), PR No No No No Yes Retrospective case-controlled study
Difficulty drawing conclusions as sample participants were different at start of study
Low
34. Mandel et al (2007), CR Yes Yes Yes Yes Yes Randomized controlled trial
Large dropout rates at follow-up
High
35. Mildestvedt et al (2007), CR Yes No No Yes Yes Prospective nonrandomized trial
Patients self-selected to participate in study
Moderate
36. Paz-Diaz et al (2007), PR Yes No
No No No Prospective nonrandomized trial
Small patient numbers make generalizability difficult
Low
37. Puhan et al (2007), PR Yes No Yes Yes Yes Multicenter randomized trial
PR patients taken as a homogenous group rather than separate disease entities
Moderately high
38. Sanderson et al (2007), CR No No No No Yes Retrospective nonrandomized trial
Conclusions did not consider differences in sex and socioeconomic status
Low
39. Vizza et al (2007), CR No No No No Yes Prospective nonrandomized trial
Stated 1-y follow-up data not reported
Low
40. Yohannes et al (2007), CR No No No Yes Yes Prospective nonrandomized trial
Generalizability of results questionable due to nonrandomization
Moderately low
41. Aldana et al (2006), CR No No No Yes Yes Nonrandomized comparison trial
Patients self-selected which group they would participate in and the Ornish group incurred a fee for the program; this brings into question the generalizability of the results
Moderately low
42. Alexander et al (2006), CR No No No Yes Yes Retrospective nonrandomized trial
Profile of nonparticipants will determine whether there is a difference between participants and nonparticipants
Moderately low
43. Aude et al (2005), CR No No No Yes Yes Retrospective nonrandomized trial
Profile of nonparticipants determined whether there is a difference between participants and nonparticipants
Moderately low
44. Belza et al (2005), PR No No Yes Yes Yes Prospective nonrandomized trial
Sample included only men and PR patients taken as a homogenous group rather than separate disease entities
Moderate
45. Chan et al (2005), CR No No No Yes Yes Prospective nonrandomized trial
Gender, socioeconomic, and educational distributions were very unequal in this population
Moderately low
46. Leal et al (2005), CR No No Yes Yes Yes Prospective nonrandomized trial
Needs a comparison of nonparticipant's demographic data for completeness
Moderate
47. Puhan et al (2005), PR Yes No Yes Yes Yes Prospective nonrandomized trial
Limited population; elderly with severe disease
Moderately high
48. Ries et al (2005), PR No No No Yes Yes Prospective multicenter nonrandomized trial
Applicable only to patients with emphysema
Moderately low
49. Verrill et al (2005), PR No No No Yes Yes Prospective nonrandomized multicenter trial
All PR programs in this multicenter trial were not the same
Moderately low
50. Aoun et al (2004), CR No No No Yes Yes Prospective nonrandomized trial
Post-program questionnaires were posted, resulting in a 50% dropout
Moderately low
51. California PR Collaborative Group (2004), PR No No Yes Yes Yes Prospective multicenter nonrandomized trial
Population taken as a homogeneous group rather than stratifying for different disease populations
Moderate
52. Focht et al (2004), CR Yes No Yes Yes Yes Randomized controlled trial
The CBT group had a longer period of contact with staff for up to 9 mo
Moderately high
53. Hevey et al (2004), CR No No Yes Yes Yes Nonrandomized comparative trial
Large dropout rate
Moderate
54. Izawa et al (2004), CR No No No Yes Yes Prospective nonrandomized trial
QoL instruments distributed in 3 groups: disease-specific domain; specific; and generic; however, group B had 2 domain-specific instruments
Moderately low
55. Sin et al (2004), CR No No Yes Yes Yes Retrospective nonrandomized trial
71% of patients completing outcomes were white
Moderate
56. Williams et al (2003), PR No No Yes No Yes Prospective nonrandomized trial
The interviewer-led version of the CRQ was administered first; thus, the responses to the CRQ-SR may have been biased
Moderately low
57. Verrill et al (2003), CR No No Yes No Yes Prospective nonrandomized trial
Small numbers of other ethnic minorities
Moderately low
58. de Torres et al (2002), PR No No No No Yes Prospective nonrandomized trial
Very limited mix of patients
Low
59. Glazer et al (2002), CR No No No Yes Yes Prospective nonrandomized trial
Limited sample mix with a high percentage of male patients
Moderately low
60. Goss et al (2002), CR No No No Yes Yes Prospective nonrandomized trial.
Multicenter trial; however, not all programs were the same
Moderately low
61. Jamieson et al (2002), CR No No Yes No Yes Prospective nonrandomized trial
No reported loss to follow-up
Moderately low
62. Stulbarg et al (2002), PR No No Yes Yes Yes Randomized controlled trial
Results limited to COPD patients
Moderate
63. Turner et al (2002), CR No No No Yes
Yes
Prospective nonrandomized trial
This study is dependent on HADS scores, which is a limited questionnaire as used in this context
Moderately low
64. White et al (2002), PR Yes Yes Yes Yes Yes Randomized controlled trial.
Heterogeneous group with varying degrees of disability not accounted for in statistical analysis
High
65. Finnerty et al (2001), PR Yes No No No No Randomized controlled trial.
No statistical evidence presented to back up statement regarding 6-mo maintenance improvement
Low
66. Singh et al (2001), PR No No Yes Yes Yes Retrospective trial
Only one-third of patients completed all questionnaires pre- to post-rehabilitation
Moderate
67. Verrill et al (2001), CR No No Yes Yes Yes Prospective nonrandomized trial
No statistical adjustment for different types of cardiac patients; all CR patients were studied as an homogenous group
Moderate
68. Bowen et al (2000), PR No No No No Yes Retrospective nonrandomized trial
There was variability in length of the PR programs
Low
69. Guell et al (2000), PR Yes No No Yes Yes Randomized controlled trial
Numbers of participants decreased significantly over time
Moderate
70. Marrin et al (2000), CR No No No Yes Yes Retrospective nonrandomized trial
This study cannot be generalized to all CR patients because the type of study and parameters do not allow for this
Moderately low
71. O'Farrell et al (2000), CR No No No Yes Yes Retrospective nonrandomized trial
This study cannot be generalized to all CR patients as the type of study and parameters do not allow for this
Moderately low
72. Sledge et al (2000), CR No No No No Yes Retrospective matched case-controlled study
No statistical adjustment for different types of cardiac patients; all CR patients were studied as a homogenous group
Low
73. Troosters et al (2000), PR No Yes No Yes Yes Randomized controlled trial
Initial patient selection was not randomized; rather randomization was the result of selection to control or treatment groups
Moderate
74. Ades et al (1999), CR No No No Yes Yes Prospective nonrandomized trial
No statistical adjustment for different types of cardiac patients; all CR patients were studied as a homogenous group
Moderately low
75. Berkhuysen et al (1999), CR Yes Yes Yes Yes Yes Randomized controlled trial
Patients were not representative of a typical CR group
High
Abbreviations: CBT, cognitive behavior therapy; COPD, chronic obstructive pulmonary disease; CR, cardiac rehabilitation; CRQ, Chronic Respiratory Disease Questionnaire; CRQ-SR, self-reported Chronic Respiratory Disease Questionnaire; ExCR, exercise-based cardiac rehabilitation; HADS, Hospital Anxiety Depression Scale; HRQoL, health-related quality of life; MI, myocardial infarction; PR, pulmonary rehabilitation; PTSD, post-traumatic stress disorder; QoL, quality of life; RAND SF-36 MCS, RAND Short Form-36 questionnaire mental component score; SF-36, 36-Item Short Form Health Survey.

RESULTS

Eighty-three articles were found that fit the selection criteria and 75 of those are listed in the Supplemental Digital Content 1, available at: http://links.lww.com/JCRP/A100, and supplemental reference list (see Supplemental Digital Content 2, available at: http://links.lww.com/JCRP/A101). Of these 75 articles, 14 were RCTs, 7 were nonrandomized parallel group trials or comparative trials, 38 were prospective observational trials, and 16 were retrospective trials.

The PR literature consisted of 32 studies: 9 were RCTs, 1 a comparative study, 14 were prospective longitudinal trials, and 8 were retrospective trials. The CR literature included 43 studies: 5 were RCTs, 6 were comparison trials, 24 were prospective longitudinal trials, and 8 were retrospective trials.

QUALITY ASSESSMENT OF THE LITERATURE

The bulk of articles in this review were observational studies and the main emphasis of this review is as an outcome-level assessment evaluating the performance of POMs. Therefore, several arguments can be put forward to include these studies in a quality assessment of the literature. The sample sizes for the existing RCTs are quite low while there are a number of community-based observational trials with large number of patients (eg, Ries et al12 with 1218 patients and Hevey et al13 with 1485 patients). Treatment providers and types of programs available for CR and PR in an outpatient setting can be inconsistent with staff ranging from nurses, allied health professionals, and other professionals assisting.

There are also several gaps in the RCT literature. These include the following: (1) none of the RCTs were able to blind for the outcome of interest (ie, health-related quality of life); (2) all the RCTs were efficacy studies14; (3) and not all of the important outcomes were captured in the RCTs (ie, the responsiveness of the POMs used in the studies).15

METHODOLOGY OF QUALITY ASSESSMENT

The quality assessment of the literature included all types of studies: RCTs; comparative studies; observational studies; and retrospective studies.14,15 The quality assessment tool used in this review was adapted from the graded Cochrane Collaboration system, which can be used to assess the quality of parallel group trials and observational trials, although it was specifically developed for RCTs. Articles were graded using 5 areas of bias: (1) random sequence generation; (2) allocation concealment, both sources of selection bias16; (3) the responsiveness of the POMs being assessed in previous studies, a source of performance bias17; (4) incomplete outcome data, a source of attrition bias; and (5) selective reporting which is a source of reporting bias. These areas of bias are important to this group of articles and, as such, affect the quality of the results of each study.

Blinding of the outcome assessments (ie, POMs) did not occur in any of the included studies featured, so it was eliminated as a source of selection bias due to redundancy. Attrition bias and reporting bias were interpreted using the usual Cochrane-based quality assessment.

Table 1 is the list of included articles. If bias was present in an area, it was designated as “-ve” and if no bias was present, it was marked as “+ve.” Once each article was examined for bias, it was graded from high, the likelihood of bias is very small to very low, which meant that the likelihood of bias in this study was high.

Table 2 is a summary of the quality assessment process, with 46 articles falling in the moderately low, low, and very low class, and 29 articles were grouped as above the moderate level. It is this second group of studies from which POMs were assessed more closely for responsiveness.16Table 3 is a compilation of the most commonly used POMs from the 29 studies listed at the moderate level and above in the quality assessment.

Table 2 - Summary of the Quality Review of Included Studies
Quality Rating Cardiac Rehabilitation (CR) Trials Total CR Trials Pulmonary Rehabilitation (PR) Trials Total PR Trials Grand Total of Trials
Retrospective Trials Prospective Trials Comparative Trials Randomized Controlled Trials Retrospective Trials Prospective Trials Comparative Trials Randomized Controlled Trials
High Chair et al (2013)
Beckie et al (2010)
Mandel et al (2007)
Berkhuysen et al (1999)
4 Haugen et al (2007) Puhan et al (2010)
White et al (2002)
3 7
Moderately High Focht et al (2004) 1 Puhan et al (2007) Puhan et al (2005) Maltais et al (2008) 3 4
Moderate Sin (2004) Yohannes et al (2010)
McKee et al (2009)
Maes et al (2008)
Mildesvelt et al (2007)
Leal et al (2005)
Verrill et al (2001)
Hevey et al (2007)
Hevey et al (2004)
9 Singh et al (2001)
Bailey et al (2008)
Bratas et al (2011)
Beauchamp et al (2010)
Belza et al (2005)
California PR Group (2004)
Stulbarg et al (2002)
Guell et al (2000)
Troosters et al (2000)
9 18
Moderately Low Alexander et al (2008)
Aule et al (2006)
Marrin et al (2000)
O'Farrell et al (2000)
Jannesen et al (2013)
McGrady et al (2009)
Fast et al (2009)
Jeger et al (2008)
Chan et al (2005)
Auon et al (2005)
Izawa et al (2004)
Verrill et al (2003)
Glazer et al (2002)
Goss et al (2002)
Jamieson et al (2002)
Turner et al (2002)
Yohannes et al (2000)
Ades et al (1999)
Stauber et al (2013)
Sagar et al (2012)
Aldana et al (2006)
21 Berton et al (2013) Dodd et al (2012)
Ringbaek et al (2012)
Verrill et al (2008)
Ries et al (2005)
William et al (2004)
Van Gestel et al (2010) 7 28
Low Sanderson et al (2007)
Sledge et al (2000)
Mosayebi et al (2011)
Izawa et al (2010)
Riaz et al (2009)
Vizza et al (2007)
Benzer et al (2007) 7 Jones et al (2009)
Lotshaw et al (2007)
Bowen et al (2000)
Nilesh et al (2013)
Paz-Diaz et al (2007)
de Torres et al (2002)
Gurgun et al (2012)
Finnerty et al (2001)
8 15
Very low Gunstad (2007) 1 Yoshimmi (2012) Shah (2012) 2 3
Totals 8 24 6 5 43 8 14 1 9 32 75

Table 3 - Most Commonly Used QoL Instruments in Studies Assessed as Moderate, Moderately High, and High Quality
HRQoL Domains/Items Articles Summary of Changes From Cardiac and Pulmonary Rehabilitation for Each HRQoL
Generic: Pulmonary
SF-36
Physical domain; 4 subscales:
Physical function (PF)
Role physical (RP)
Bodily pain (BP)
General health (GH)
Mental domain; 4 subscales:
Mental health (MH)
Role emotional (RE)
Social function (SF)
Vitality (V)
36 questions
Puhan et al (2007)
Ries et al (2005)
California PR Group (2004)
Stulbarg et al (2002)
White et al (2002)
1. Overall, there was a significant change in score pre- to post-rehabilitation program
2. Physical composite domain (PCS) had a greater significant change due to PR than the SF-36 MCS
3. PF subscale had the greatest significant change due to PR and BP subscale the least
4. The SF subscale had a significant change due to PR within a patient group but not between patient groups
Generic: Cardiac
SF-36
2 domains:
Mental
Physical
8 subscales
36 questions
Chair et al (2013)
McKee et al (2009)
Mandel et al (2007)
Leal et al (2005)
Hevey et al (2004)
Sin et al (2004)
1. Overall, there was a significant change due to CR
2. PCS had a greater significant change due to CR than SF-36 MCS
3. PF subscale had the greatest significant change due to CR and GH the least
4. SF and BP subscales also showed less significant treatment effect
Health-related QoL: Pulmonary
Chronic Respiratory Questionnaire
4 domains:
Dyspnea
Fatigue
Emotional
Mastery
Minimally important difference = 0.5
>0.5 improvement; −0.5 to +0.5 unchanged;
< −0.5 deterioration
20 items
Puhan et al (2010)
Beauchamp et al (2010)
Maltais et al (2008)
Puhan et al (2007)
Stulbarg et al (2002)
White et al (2002)
Singh et al (2001)
Troosters et al (2000)
1. No significant change due to PR with blinded RCT
2. There was a significant change due to PR in nonblinded RCTs, comparative trials, and prospective trials. In the domains of Dyspnea, Emotional, and Mastery, the degree of responsiveness was best in Dyspnea, less responsive in Emotional, less again in Mastery, and even less in Fatigue.
Health-related
QoL: Cardiac
QoL after myocardial infarction
MacNew
3 domains:
Emotional
Physical
Social
27 items
Yohannes et al (2010)
Leal et al (2005)
Hevey et al (2004)
1. Significant change due to CR except for sexual activity
2. Significant change due to CR in between patient comparisons
Purpose-specific: Pulmonary
Feeling thermometer
Visual Analog Scale
100 intervals
Puhan et al (2010)
Puhan et al (2007)
Puhan et al (2005)
1. Significant change due to PR
2. Significant difference between early and late starters in PR; this was greater in first 6 mo
Purpose-specific:
Cardiac
Hospital Anxiety and Depression Scale
2 domains:
Anxiety
Depression
Yohannes et al (2010)
Hevey et al (2007)
Leal et al (2005)
Hevey et al (2004)
1. Significant change due to CR reported in both anxiety and depression in 4 of 8 trials
2. No significant change due to CR reported in 2 trials particularly in the depression domain
Abbreviations: CR, cardiac rehabilitation; HRQoL, health-related quality of life; MCS, mental component score; PCS, Physical Component Score; PR, pulmonary rehabilitation; QoL, quality of life; RCT, randomized controlled trial; SF-36, Medical Outcomes Study Short Form 36-item questionnaire.

ASSESSMENT OF POMS

The 36-Item Short Form Health Survey (SF-36) was the most commonly used generic measurement tool in both CR and PR; in fact, it was the most commonly used POM in the cardiac literature. In the PR literature, the SF-36 ceased to be used after the study by Jones et al.18 Instead, the respiratory literature changed to using disease-specific instruments with the development of improved instruments, such as the COPD Assessment Test and the Clinical COPD Questionnaire. Compared with the disease-specific instruments in the CR and PR setting, the generic instruments and many domains of the generic instruments were less responsive to change in health status.

In the PR literature, the disease-specific Chronic Respiratory Questionnaire (CRQ) was the most frequently used instrument, with the consensus being that in the domain of dyspnea and fatigue, the CRQ (in particular, the self-administered form) is more responsive to change in health status than the St George's Respiratory Questionnaire.19,20 The most commonly used purpose-specific instrument in PR was the Feeling Thermometer.21

The most commonly used disease-specific tool in the CR literature was the MacNew QoL after Myocardial Infarction (MacNew). This instrument is responsive to CR in most domains; however, it shows a greater treatment effect in the short-term than in the long-term.13 The most commonly used purpose-specific instrument in CR is the Hospital Anxiety and Depression Scale (HADS). This instrument for patients with higher measured values in the domains of anxiety and depression shows good responsiveness; however, for patients whose measured values are in the lower ranges of anxiety and depression, this instrument shows little significant change and, therefore, is less responsive.

Eleven of the review articles specifically assessed and compared POMs in both CR and PR (see Supplemental Digital Content 1, available at: http://links.lww.com/JCRP/A100). Several studies performed correlations across instruments, but the most consistently significant correlations were in the dyspnea domains between the purpose-specific instruments, such as the Medical Research Council Scale and the CRQ and St George's Respiratory Questionnaire in PR and between the MacNew Physical domain and the SF-36 Physical Composite (PCS) domain in CR.

This group of articles found that the Global Mood Scale, a purpose-specific instrument based on a 2-factor model of mood with 10 negative and 10 positive mood terms was the most responsive instrument in the CR setting.22 The domain construct for this instrument is very different to that of the HADS since the Global Mood Scale provides information on global well-being whereas the HADS assesses clinical states and was developed in a hospital setting. The veteran's version of the SF-36 (SF-36V) was found to be more responsive than the usual version of the SF-36. The SF-36V uses a 5-point ordinal choice instead of the usual dichotomous yes/no answer.23

DISCUSSION

An overall assessment of the literature reveals that CR and PR in the outpatient setting bring about a change in health status for patients and that there is overall an improvement in the QoL for most patients in this setting. But the question that this review poses is how successfully existing POMs go about measuring this, and it is evident that there are many problems in this area.

Many of the review studies were not consistent in their determination of responsiveness or effect size and this made comparison of POMs across studies difficult. For each new set of circumstances (ie, population), it is important to test the POM for responsiveness. Even if an instrument is reliable, it remains to be shown that differences in response to treatment can be detected before the instrument can be used for the assessment of change.24

The literature revealed a range of recommendations of which instrument (generic, disease-specific, or purpose-specific) is best used in CR and PR.25 Generic instruments often provide a broad picture of health and allow comparison of trial patients to population norms.26 They are often more sensitive to comorbidities, an important consideration when choosing an instrument to use in CR and PR. An assessment of a global concept of QoL may be useful in population studies; however, they may be difficult to interpret at a clinical level. Highly standardized POMs such as the SF-36 may also omit aspects of QoL that are of great importance to the individual.27

Existing generic instruments may have more of a rehabilitation focus. The SF-36, created in the 1980s, is an example of this type of instrument and is a multipurpose health survey with 36 questions. The 8 health concepts for the SF-36 were selected from 40 included in the Medical Outcomes Study published by Stewart and Ware in 1992,28 although most of the items for the SF-36 were taken from concepts already in existence in POMs from the 1970s and the 1980s.

Rehabilitation has had a paradigm shift since the 1980s model, which was originally proposed by Nagi Wood for the World Health Organization. This model was based on a “consequences of disease” classification, which focused on the impact of diseases or other health conditions that may follow as a result.29 This model has since been superseded by the International Classification of Functioning, Disability and Health (ICF-2001), in which the patient is instead seen in terms of his or her function, especially at the person and societal levels.30

Disease-specific measures were more widely used in the pulmonary literature. These instruments are more sensitive to the disorder under consideration and are therefore more likely to reflect clinical changes. They appear to be more useful in RCTs as they detect small but significant change even though these studies often use smaller or more moderate sample sizes. They are also better used for the specific population for which they were created.

Purpose-specific instruments such as the HADS also have a role to play and are often used to supplement and fill the gaps between generic- and disease-specific instruments. To cover all the domains in CR or PR that the clinician or researcher requires, often a number of POMs are needed (ie, generic, disease-specific as well as purpose-specific instruments). An example of this is the MacNew, which loses some of its discriminatory power at the end of the CR period and, therefore, it is best to compliment the MacNew with other psychosocial assessment instruments.31

The purpose of the POM is the best determinant for which type of instrument to use. Patient outcome measures that are successful in a research setting may not always translate into a clinical setting and vice versa. Instruments that are clinically relevant and have a medical (organ function) focus, which emphasizes signs, symptoms, and diagnosis, may not translate to a rehabilitation focus (such as CR and PR), which emphasizes function at the person and societal level.32

Self-report or individualized POMs were not included in any of the review literature. They were, however, used with some success in 2 articles on generic chronic disease rehabilitation.25,33 A large number of POMs reflect the objective perspective of the outsider rather than the patient's subjective point of view. Individualized methods focus on uniqueness (ie, the QoL is determined by the person who lives it).27

CONCLUSION

In the search to find a “gold standard” POM for use in CR and PR, the surveyed literature instead revealed a diversity of opinions and several instruments were proposed with a preference for the disease-specific instruments. While most of these are sensitive to the disease process, not all domains or all instruments are responsive to longitudinal change in health status brought about by CR and PR.

Current studies of CR and PR programs utilize generic, disease-specific, and purpose-specific POMs or a combination of these instruments. In CR and PR programs, symptoms and signs of organ dysfunction may show very little related to mapping a patient's progress. These tools have some drawbacks but the main issue for the patient is that, for all these instruments, an external investigator has determined the domains. Instead, the patient's own perceptions of his or her health status may prove to be more meaningful.25 A tool that utilizes the patient's own perceptions and weights aspects of that life which are particular to the person may prove to be more responsive in this setting.27,32,33

ACKNOWLEDGMENT

This research was supported by an Australian Government Research Training Program (RTP) Scholarship.

References

1. Johnston M, Young M, Grimmer K, Antic R, Frith P. Frequency of referral and attendance at a pulmonary rehabilitation programme amongst patients admitted to a tertiary hospital with chronic obstructive pulmonary disease. Respirology. 2013;18:1089–1094.
2. Clark AM, Hartling L, Vandermeer B, Lissel SL, McAlister FA. Secondary prevention programmes for coronary heart disease: a meta-regression showing the merits of shorter, generalist, primary care-based interventions. Eur J Cardiovasc Prev Rehabil. 2007;14:538–546.
3. American Association of Cardiovascular and Pulmonary Rehabilitation. Guidelines for Pulmonary Rehabilitation Programs. 3rd ed. Champaign, IL: Human Kinetics; 2004.
4. American Association of Cardiovascular and Pulmonary Rehabilitation. Guidelines for Cardiac Rehabilitation and Secondary Prevention Programs. 4th ed. Champaign, IL: Human Kinetics; 2004.
5. Stineman M, Lollar D, Ustun T. The International Classification of Functioning, Disability and Health. In: DeLisa JA, et al, eds. Physical Medicine and Rehabilitation: Principles and Practices. 4th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:1096–1138.
6. World Health Organization. International Classification of Functioning, Disability and Health: ICF. Geneva, Switzerland: World Health Organization; 2001. http://www.who.int/iris/handle/10665/42407. Accessed 2015.
7. Streiner DL, Norman GR. Health Measurement Scales: A Practical Guide to Their Development and Use. 2nd ed. Toronto, Canada: Oxford Press; 1996.
8. Guyatt G, Kirshner B, Jaeschke R. Measuring health status: what are the necessary measurement properties? J Clin Epidemiol. 1992;45(12):1341–1345.
9. Fayers PM, Machin D. Quality of Life: The Assessment, Analysis and Interpretation of Patient-Reported Outcomes. 2nd ed. Chichester, West Sussex, England: John Wiley and Sons; 2007.
10. Middel B, van Sonderen E. Statistical significant change versus relevant or important change in (quasi) experimental design: some conceptual and methodological problems in estimating magnitude of intervention-related change in health services research. Int J Intergr Care. 2002;2:e12.
11. Hackett L, Anderson C. Predictors of depression after stroke: a systematic review of observational studies. Stroke. 2005;36:2296–2301.
12. Ries A, Make B, Lee S, et alThe effects of pulmonary rehabilitation in the National Emphysema Treatment Trial. Chest. 2005;128(6):3799–3809.
13. Hevey D, McGee H, Horgan J. Responsiveness of HRQoL outcome measures in cardiac rehabilitation: comparison of cardiac rehabilitation outcome measures. J Consult Clin Psychol. 2004;72(6):1175–1180.
14. Norris S, Atkins D, Bruening W, et al. Selecting observational studies for comparing medical interventions. Methods Guide for Effectiveness and Comparative Effectiveness Review [Internet]. Rockville, MD: Agency for Healthcare Research and Quality (US); 2008-2010. https://www.ncbi.nlm.nih.gov/books/NBK47095/. Accessed 2017.
15. Dreyer N, Tunis S, Berger M, Ollendorf D, Mattox P, Gliklich R. Why observational studies should be among the tools used in comparative effectiveness research. Health Aff. 2010;29(10):1818–1825.
16. Higgins JPT, Altman DG, Gotzsche PC, et alThe Cochrane Collaboration's Tool for assessing risk of bias. BMJ. 2011;343(7829):889–893.
17. Guyatt G, Naylor D, Juniper E, Heyland DK, Jaeschke R, Cook DJ. Users' guide to the medical literature. XII. How to use articles about health-related quality of life. JAMA. 1997;277:1232–1237.
18. Jones R, Harding S, Chung M, Campbell J. The prevalence of post-traumatic stress disorder in patients undergoing pulmonary rehabilitation and changes in PTSD symptoms following rehabilitation. J Cardiopulm Rehabil Prev. 2009;29:49–56.
19. Daudey L, Peters J, Molema J, et alHealth status in COPD cannot be measured by the St George's Respiratory Questionnaire alone: an evaluation of the underlying concepts of this questionnaire. Respir Res. 2010;11:98–104.
20. Puhan M, Guyatt G, Goldstein G, et alRelative responsiveness of the Chronic Respiratory Questionnaire, St Georges Respiratory Questionnaire and four other health-related QoL instruments for patients with chronic lung disease. Respir Med. 2007;101:308–316.
21. Lavrakas PJ, ed. Encyclopedia of Survey Research Methods. Thousand Oaks, CA: Sage Publications; 2008.
22. Vizza J, Neatrour D, Felton P, Ellsworth DL. Improvement in psychosocial functioning during an intensive cardiovascular lifestyle modification program. J Cardiopulm Rehabil Prev. 2007;27:376–383.
23. Belza B, Steele B, Cain K, Coppersmith J, Howard J, Lakshminarayan S. Seattle Obstructive Lung Disease questionnaire. J Cardiopulm Rehabil. 2005;25:107–114.
24. Verrill D, Barton C, Beasley W, Lippard WM. The effects of short-term and long-term pulmonary rehabilitation on functional capacity, perceived dyspnea and QoL. Chest. 2005;128:673–683.
25. Kennedy A, Reeves D, Bower P, et alThe effectiveness and cost- effectiveness of a national lay-led selfcare support programme for patients with long-term conditions: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2007;61:254–261.
26. McKee G. Are there meaningful longitudinal changes in health related quality of life-SF-36, in cardiac rehabilitation patients. Eur J Cardiovasc Nurs. 2009;2009:40–47.
27. Carr A, Thonpson P, Kirwan J. Quality of life measures. Br J Rheumatol. 1996;35:275–281.
28. Stewart AL, Ware JE. Measuring Functioning and Well-Being: The Medical Outcomes Study Approach. Durham, NC: Duke University Press; 1992.
29. Granger C. Quality and Outcome Measures for Medical Rehabilitation. Philadelphia, PA: WB Saunders; 2000.
30. Kaplan R. QoL as an outcome measure in pulmonary disease. J Cardiopulm Rehabil. 2005;25(6):321–331.
31. Maes S, de Gucht V, Goud R, Hellemans I, Peek N. Is the MacNew quality of life questionnaire a useful diagnostic and evaluation instrument for cardiac rehabilitation? Eur J Cardiovasc Prev Rehabil. 2008;15(5):516–520.
32. Kalra A. Measuring quality of life-who should measure quality of life? BMJ. 2001;322:1417–1420.
33. Pitkala K. The effectiveness of day hospital care on home care patients. J Am Geriatr Soc. 1998;46(9):1086–1095.
Keywords:

cardiac disease; quality of life; questionnaires; rehabilitation; respiratory tract disorders

Supplemental Digital Content

© 2019 Wolters Kluwer Health, Inc. All rights reserved.