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* From the Niehoff School of Nursing (Dr. Lanuza and Ms. Lefaiver), Loyola University of Chicago; and Loyola University Medical Center (Dr. Garrity and Mss. Mc Cabe and Farcas), Maywood, IL.
Correspondence to: Dorothy M. Lanuza, PhD, RN, Loyola University Medical Center, Niehoff School of Nursing, McGuire Building, Room 2859, 2160 South First Ave, Maywood, IL 60153; e-mail: dlanuza{at}luc.edu
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Abstract |
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 TOP Abstract IntroductionMaterials and MethodsResultsDiscussionConclusionReferences |
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Design: A longitudinal, small-group, repeated-measures design.
Setting: A large Midwest university medical center.
Measurements and results: Several instruments were used to measure perceived health, QOL, functional status, and respiratory function. The perceived improvement in physical function after transplantation was accompanied by increased satisfaction with physical strength, current health, and QOL. In addition, dramatic improvements in pulmonary function were seen after transplantation (FVC, FEV1, and forced expiratory flow at 25 to 75% of FVC); however, only the FEV1 values significantly improved between 1 and 3 months after transplantation. For example, the FEV1 (mean ± SD) increased from 22 ± 11% of predicted before transplantation to 46 ± 12% and 55 ± 14% of predicted at 1 month and 3 months after transplantation, respectively. Although the total number of psychological symptoms did not decrease significantly over time, the intensity and distress associated with the symptoms did. Psychological function scores did not change significantly. Ninety percent of the subjects reported being very satisfied with their transplant decision.
Conclusions: Lung transplantation significantly improved the subjects’ overall function and their satisfaction with their QOL and health status. However, since this report only addressed data for the first 3 months after transplantation, additional longitudinal research is needed to further elucidate the experiences and outcomes associated with lung transplantation.
Key Words: functional status • health status • lung transplant • psychological status • quality of life • respiratory status
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Introduction |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionReferences |
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This pilot study was part of a larger project, and its overall goals were to test our instruments and procedures, and to follow, prospectively, from pretransplant to 3 months posttransplant, a subsample of 10 subjects from our larger project of 35 LT candidates. Using a multidimensional approach, the purposes of this study were to determine the impact of lung transplantation on patients’ function, moods, and overall satisfaction with their health and QOL both before and up to 3 months after transplantation. More specifically, changes were examined in the following: (1) perceived functional status, as determined by the Sickness Impact Profile (SIP); (2) respiratory function, as determined by pulmonary function tests; (3) moods, as determined by the Brief Symptom Inventory (BSI); (4) satisfaction with their overall QOL and current health, as determined by a satisfaction rating scale; and (5) thoughts about their decision to undergo lung transplantation, as determined by a satisfaction rating scale and an open-ended question.
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Materials and Methods |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionReferences |
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18 years of age;
(2) on the waiting list for single LT or bilateral, sequential LT; (3)
able to read and understand English; and (4) willing to sign a written
informed consent. Each subject served as her/his own control. The
setting for this study was a Midwest university medical center.
Procedure
After approval was obtained from the Institutional Review Board
for the study, a letter was sent to potential subjects on the waiting
list for lung transplantation. Next, a member of the research team
contacted eligible patients, explained the purpose of the study, and
obtained written informed consents from patients willing to
participate. The subjects were then given a study packet that included
the questionnaires and a stamped, addressed envelope for returning
them. The subjects were given verbal instructions for completing the
questionnaires. Codes rather than names were used on the questionnaires
to ensure confidentiality of the responses. A follow-up telephone call
was made the next day, as previously arranged, to see if the subject
had any questions or problems with the tools. Chart audits were
conducted to collect demographic and respiratory data. Data were
collected before transplantation (time 1), within 1 month after
transplantation (time 2), and at 3 months after transplantation (time
3). Instrument internal consistency, test-retest reliability, and
concurrent validity were determined using the LT candidates’
pretransplant data from the larger project (n = 35), of which the 10
participants were part.
Instruments
SIP:
The SIP is a 136-item instrument used to measure
health-related functional status. Subjects respond to each question
(eg, I laugh or cry suddenly) by checking if that behavior
applies to them. SIP scores are reported for the total tool, for
physical and psychological dimensions, and for 12 functional
categories. The 12 categories of function include the following: sleep
and rest, emotion, body care, home management, mobility, social
interaction, ambulation, alertness, communication, recreation, eating,
and work. High scores reflect high levels of dysfunction, and low
scores are indicative of better functioning. Reliability and validity
data have been reported.10
11
12
In this study, Cronbach 
correlations for the total tool, physical, and psychological dimensions
were 0.92, 0.69, and 0.86, respectively. The test-retest reliabilities
for the total tool and dimensions were 0.83, 0.77, and 0.86,
respectively.
BSI:
The BSI, a 53-item multidimensional, psychological
symptom inventory that includes three global indexes and nine primary
symptom dimensions, is used to determine an individual’s
psychopathologic status and general level of well being. A 5-point
scale ranging from 0 (not at all distressed) to 4 (extremely
distressed) is used to answer each question. The three global indexes
of distress are as follows: the Global Severity Index (GSI), the
positive symptom total (PST), and the Positive Symptom Distress Index
(PSDI). The nine primary symptom dimensions are as follows:
somatization, obsessive-compulsive, interpersonal sensitivity,
depression, anxiety, hostility, phobic anxiety, paranoid ideation, and
psychosis. Similar to the SIP, high scores on the BSI are indicative of
greater symptomatology. Good reliability and validity data have been
reported for the BSI.13
In this study, the Cronbach
correlation was 0.92, and the test-retest reliability correlations for
pretransplant data for the GSI, PSDI, and PST subscales were 0.80,
0.73, and 0.74, respectively. Concurrent validity scores between the
BSI and SIP were good, ranging from 0.53 to 0.96.
The General Health/QOL Rating Scale:
The general health/QOL
rating scale is a five-item instrument, using a 6-point rating scale.
It was developed by the investigators to ascertain subjects’ overall
satisfaction with the following: (1) QOL; (2) current health; (3)
psychological/emotional strength; (4) physical strength; and (5)
satisfaction with the outcome of their transplant. Thus, only four
items are answered pretransplant and five items are answered
posttransplant. The instrument also includes a yes-or-no question
asking subjects after transplantation whether they would have undergone
the LT, knowing what they know now. The subjects were also asked to
explain their response to that question. In contrast to the previous
scales, high scores on the general health/QOL rating scale indicate
greater satisfaction. The Cronbach correlation for the overall tool
was 0.82. The pretransplant, test-retest reliability data suggested low
stability for satisfaction ratings of current health status and
physical strength (ie, - 0.03 and 0.28, respectively),
while stronger stability was found for satisfaction ratings for
psychological/emotional strength and overall QOL (r = 0.73
and r = 0.53, respectively). The pretransplant concurrent
validity between the items in the general health/QOL rating scale and
the total and dimension scores for the SIP ranged from
r = - 0.30 to r = - 0.94.
Respiratory Function:
A remote spirometry device (Medi-Facts
Remote Spirometry; San Clemente, CA) was used to obtain the following
pulmonary function measurements: FVC, FEV1, and
forced expiratory flow at 25 to 75% of FVC
(FEF25–75). This device allowed subjects to
perform their own pulmonary function testing at home, and then transmit
the data to the pulmonary function laboratory at the study site via
telephone modem. Once the data were received and logged into a
database, a comprehensive summary of the results, including graphs, was
printed out and interpreted.14
The Medi-Facts spirometry
device has been shown to meet the standards of accuracy of the American
Thoracic Society for 24 standard waveforms, and the peak flow
measurements of this device have been reported to be ± 10% of the
value recommended by the National Asthma Education Project for portable
peak flowmeters (R.O. Crapo, MD, and R.L. Jenson, PhD; unpublished
data; August, 1993).
Statistical Analysis:
Total and subscale scores were
derived, as appropriate, for each tool. Data were analyzed using
descriptive statistics, Pearson correlation, and analysis of variance
with repeated measures. The level of significance was set at
p 
0.05.
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Results |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionReferences |
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0.02) improved from pretransplant values (time 1;
Fig 1
). In addition, the FEV1 also improved
significantly from time 2 to time 3. Mean FVC increased from
37 ± 8% of predicted at time 1, to 51 ± 17% and 58 ± 18% of
predicted at time 2 and time 3, respectively. Mean
FEV1 increased from 22 ± 11% of predicted at
time 1, to 46 ± 12% and 55 ± 14% of predicted at time 2 and
time 3, respectively. Mean FEF25–75 increased
from 14 ± 23% of predicted at time 1, to 54 ± 30% and
68 ± 56% of predicted at time 2 and time 3, respectively.
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BSI
In general, between time 1 and time 2, there were no significant
changes in any of the BSI scores (ie, GSI, PSDI, and PST).
However, between time 2 and time 3, marked (p < 0.05) improvements,
as indicated by lower scores, were seen in symptom intensity (GSI) and
symptom distress (PSDI) scores (Table 2)
. Yet, no significant changes
over time were found for the total number of symptoms (PST scores). An
examination of primary symptoms showed that only the somatization
(ie, body distress) scores changed greatly over time,
decreasing significantly (p < 0.05) from time 2 to time 3.
General Health/QOL Rating Scale
The most dramatic improvement in subjects’ satisfaction was in
relation to their physical strength/energy. The subjects were "very
dissatisfied" with their physical strength/energy at time 1; their
satisfaction ratings increased significantly (p < 0.05) at time 2 to
"slightly dissatisfied"; and by time 3, the satisfaction
ratings increased to "moderately satisfied" and were significantly
(p < 0.05) higher than both time 1 and time 2. The patterns of
change for the subjects’ satisfaction ratings for their QOL and
current health status were similar, being very low before transplant
and significantly (p < 0.05) higher after transplant. Before
transplantation, the subjects indicated that they were "moderately
dissatisfied" with their QOL; at time 2, they were "slightly
satisfied"; and by time 3, they were "moderately satisfied" with
their QOL. In relation to their satisfaction with their current health,
the subjects reported they were moderately dissatisfied at time 1 and
time 2, and "very satisfied" at time 3. Unlike the preceding
satisfaction ratings, there were no significant changes over time in
the subjects’ ratings of their satisfaction with their
psychological/emotional strength. The subjects were slightly
dissatisfied with their psychological strength at time 1, and by time
3, they were moderately satisfied.
Patients’ Feelings About LT Decision
While 9 of the 10 LT recipients reported that they were very
satisfied with their decision to undergo transplantation, the remaining
recipient commented that he believed it was too soon to tell (even at 3
months after transplantation). At time 2, some of the explanations the
subjects gave for their satisfaction with their transplant decision
included the following: an increase in strength and energy, more
independence, and the ability to breathe without supplemental
oxygen. At 3 months after transplantation, some of the comments
suggested more reflection. For example, one subject reported, "I feel
happy and lucky, because without the transplant, I would not be
here." Another stated, "It was my only chance at life, but I am
discouraged by my diaphragm injury and its associated problems."
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Discussion |
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TOPAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionReferences |
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The pretransplant total score, as well as the physical and psychological dimension scores of the SIP, indicated levels of dysfunction slightly higher than those reported for subjects with chronic COPD.19 This is understandable since the subjects had end-stage respiratory conditions. The SIP total and category scores were fairly comparable to the pre- and posttransplant scores reported by Ramsey et al,15 and, in a similar manner, indicated that improvement did not occur equally in all aspects of function. Since only one previous lung transplant study15 reported SIP total and category data, the pre- and post-SIP total, dimension, and category scores in this study were also compared with data from other solid-organ transplant studies. For example, our pretransplant SIP total and physical dimension scores were lower (indicating better function) than those of heart transplant subjects,17 but higher than scores of kidney transplant subjects.16 Although different instruments were used, Littlefield et al20 also showed that posttransplant functioning was better in lung transplant recipients than in heart transplant recipients. Including this study, an examination of SIP data across lung,15 heart,17 and kidney16 21 transplant populations revealed that the following were the top ranked areas of pretransplant dysfunction: recreation and pastimes, sleep, and home management. An examination of early (ie, within a couple of weeks) posttransplant SIP scores revealed that kidney transplant subjects21 indicated less dysfunction in categories related to self-care (eg, body care and movement, home management, mobility, ambulation, etc.) than our subjects, who did not demonstrate a marked improvement in self-care function until between 1 month and 3 months posttransplant. This length of time for marked improvement demonstrated by our lung transplant recipients is in keeping with Littlefield et al,20 who reported that improvements for the heart, lung, and liver transplant subjects were found to be most evident between 3 months and 6 months posttransplant.
As with the physical dimension scores, in this study, the pretransplant SIP psychological dimension scores were also slightly higher than those reported for subjects with chronic COPD.19 Similar to COPD patients,19 22 23 LT candidates face many uncertainties, a progressive deterioration of their respiratory status, as well as some anxiety and/or depression. Thus, it would not be surprising if the SIP psychological dimension scores indicated some dysfunction. Such was the case in this study; however, there was a great deal of interindividual variability. The subjects were only slightly unsatisfied with their psychological/emotional strength prior to the transplant, and while some improvements occurred posttransplant, the changes were not significant.
An examination of the BSI primary symptoms revealed that only the somatization symptom scores changed significantly over time. Somatization scores reflect distress related to the perception of general body dysfunction, and it is not limited to just the cardiovascular and respiratory systems.13 23 The pretransplant mean somatization scores for the entire sample reflected dysfunction scores that were high, but lower than the scores reported for chronic COPD subjects with high dyspnea.23 Yet, this comparison could be misleading, since only 5 of our 10 subjects had a diagnosis of COPD, and differences in pretransplant diagnoses could skew the comparisons. When data from our five COPD subjects were compared with those of chronic COPD subjects with high dyspnea,23 the data were comparable. (This tool has not been used with CF or idiopathic pulmonary fibrosis patients.) Since data collection at time 2 occurred after the transplant procedure and early in the patient’s recovery process (ie, within 1 month posttransplant), it was not surprising that subjects reported more distress with body dysfunction. By 3 months posttransplant (time 3), however, there was a dramatic decrease in somatization scores.
Although the subjects’ satisfaction ratings with their current health, physical strength, and QOL increased significantly immediately posttransplant, similar improvements in functional status (as determined by the SIP and BSI) were not seen. There are a couple of plausible explanations for this discrepancy. First, the satisfaction ratings may have improved simply because the subjects were grateful and relieved that they received a LT, which most subjects believed was their only chance of survival. Second, their respiratory function improved immediately posttransplant, and this marked improvement in their ability to breathe may have influenced their ratings of improved satisfaction with QOL, physical strength, and health status in spite of little perceived change in other aspects of their physical and functional status.
As indicated above, respiratory function improved dramatically posttransplant for all the subjects. Since differences in respiratory function may exist due to underlying diagnoses, mean pulmonary function values of our subjects were examined in two diagnostic groups: COPD (n = 5) and CF (n = 4) patients. The pretransplant FVC and FEV1 values of our COPD subjects differed from the pretransplant values reported for COPD subjects in other studies, being slightly higher than one study24 and slightly lower than another.25 The 3-month posttransplant FVC, FEV1, and FEF25–75 percent predicted measurements, however, were fairly similar to those reported by Bando et al,25 with the exception of greater variability in the FEF25–75 values of our COPD subjects. This variability in the FEF25–75 measurements in our COPD population may have played a role in not detecting a significant change between time 2 and time 3.
As reported by Kerem et al,26 CF patients with a FEV1 < 30% of predicted have a 50% mortality within 2 years and should be evaluated for lung transplantation. The mean pretransplant FEV1 values of our CF patients were 24% of predicted, similar to pretransplant values reported for other CF patients.27 28 29 The posttransplant FVC and FEV1 values for our CF patients appear to be slightly lower than other posttransplant values reported for CF patients.27 28 This may have been due to such factors as differences in posttransplant timing, sample size, and age composition (eg, our sample was limited to adult CF patients).
It has been reported that improvements in pulmonary function achieve peak levels within 3 to 6 months after transplantation.30 While in this study dramatic improvements in pulmonary function (FVC, FEV1, and FEF25–75) were seen between pre- and posttransplant measurements, only the FEV1 values continued to significantly improve between 1 month and 3 months posttransplant. Very likely this was because FEV1 is not as dependent on respiratory muscle strength as FVC, nor is it as affected by altered chest wall mechanics, both of which may not have completely recovered yet. These findings are supported by reports that peak posttransplant respiratory improvement occurs after the pain and tissue trauma associated with the surgical procedure (eg, edema, inflammation, etc.) have abated, usually between 3 months and 6 months postoperatively.30 31 In addition to the variability found in the data, insufficient recovery time may be another possible explanation for not finding a significant postoperative change between 1 month and 3 months in the very sensitive FEF25–75 measurements. This is thought to be a result of the new airway being prone to inflammation, edema, and/or potential problems with the anastomosis during this early postoperative period. Thus, a longer time period may be necessary to detect significant posttransplant improvement in FEF25–75. If complications occur, however, there may be subsequent deterioration of respiratory function, which will be reflected in changes in FEF25–75 levels31 and FEV1 levels32 earlier than in other pulmonary values.
In keeping with the improvement in respiratory function measurements, it was not surprising that 90% of the subjects did not need supplemental oxygen shortly after the transplant, and none needed supplemental oxygen 3 months posttransplant. A rapid return to normal levels is seen in arterial oxygenation following an uncomplicated lung transplantation.30 On the other hand, if hypercapnia with an attenuated ventilatory response to carbon dioxide was present in patients with emphysema prior to transplantation, this condition usually persisted for several weeks posttransplant.30 33 The one subject who believed that she needed supplemental oxygen following her transplantation did have emphysema, with hypercapnia and phrenic nerve damage, as well as anxiety about no longer using supplemental oxygen. Thus, her need for supplemental oxygen may have been due to both physiologic and psychological factors.
Similar to the studies of Lanuza et al34 and Gross et al,6 almost 90% of the subjects were satisfied with their decision to undergo the transplant even if they had experienced complications. Likewise, the subjects in this study reported being moderately satisfied with their current health status and QOL at 3 months posttransplant.
Study Limitations
Limitations of this study include the relatively small sample size
(although large enough to detect pre- to posttransplant differences in
some outcome variables) and short follow-up time. Three months after
transplantation may be too soon to determine optimal pulmonary
recovery, as evidenced by a lack of significant change in the FVC or
FEF25–75 from 1 month to 3 months
posttransplant. Since few prospective, longitudinal studies
investigating QOL in patients before and after lung transplantation are
available, the ability to compare the findings of this study to similar
research in this patient population is limited.
While the findings of this study help to elucidate the QOL and functional changes of LT patients, further investigation is needed. Since this is a longitudinal study, we will have the opportunity to follow our subjects throughout their first year after transplantation, which may lend greater clarity to understanding the recovery trajectory of LT recipients, as well as the changes they experience (both psychosocial and functional).
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Footnotes |
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This study was supported with funding from the National Institutes of Health, Shannon Award NR04283–01.
The study was conducted at the Loyola University Medical Center Hospital and Outpatient Clinic Facilities.
Received for publication August 2, 1999. Accepted for publication January 14, 2000.
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