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Detmar SB, Muller MJ, Schornagel JH, Wever LDV, Aaronson NK. Health-Related Quality-of-Life Assessments and Patient-Physician Communication: A Randomized Controlled Trial. JAMA. 2002;288(23):3027–3034. doi:10.1001/jama.288.23.3027
Author Affiliations: Division of Psychosocial Research and Epidemiology (Drs Detmar and Aaronson, Mr Muller, and Ms Wever) and Department of Medical Oncology (Dr Schornagel), the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam.
The Patient-Physician Relationship Section Editor: Richard M. Glass, MD, Deputy Editor.
Context There has been increasing interest in the use of health-related quality-of-life
(HRQL) assessments in daily clinical practice, yet few empirical studies have
been conducted to evaluate the usefulness of such assessments.
Objective To evaluate the efficacy of standardized HRQL assessments in facilitating
patient-physician communication and increasing physicians' awareness of their
patients' HRQL-related problems.
Design Prospective, randomized crossover trial.
Setting Outpatient clinic of a cancer hospital in the Netherlands.
Participants Ten physicians and 214 patients (76% women; mean age, 57 years) undergoing
palliative chemotherapy who were invited to participate between June 1996
and June 1998.
Intervention At 3 successive outpatient visits, patients completed an HRQL questionnaire
(European Organization for Research and Treatment of Cancer Quality of Life
Questionnaire-Core 30). The responses were computer scored and transformed
into a graphic summary. Physicians and patients received a copy of the summary
before the consultation.
Main Outcome Measures Audiotapes of the consultations were content analyzed to evaluate patient-physician
communication. Physicians' awareness of their patients' health problems was
assessed by comparing physicians' and patients' ratings on the Dartmouth Primary
Care Cooperative Information Functional Health Assessment (COOP) and the World
Organisation Project of National Colleges and Academics (WONCA) charts.
Results The HRQL-related issues were discussed significantly more frequently
in the intervention than in the control group (mean [SD] communication composite
scores: 4.5 [2.3] vs 3.7 [1.9], respectively (P =
.01). Physicians in the intervention group identified a greater percentage
of patients with moderate-to-severe health problems in several HRQL domains
than did those in the control group. All physicians and 87% of the patients
believed that the intervention facilitated communication and expressed interest
in its continued use.
Conclusion Incorporating standardized HRQL assessments in daily clinical oncology
practice facilitates the discussion of HRQL issues and can heighten physicians'
awareness of their patients' HRQL.
In recent years, interest has been expressed in the use of health-related
quality-of-life (HRQL) assessments in daily clinical practice as an aid to
detect physical or psychosocial problems that otherwise might be overlooked,
monitor disease and treatment, and improve the delivery of care.1-4 Although
the literature enumerates the putative benefits of routine assessment of patients'
HRQL in clinical practice,3-6 relatively
few empirical studies have investigated the effect of such a procedure.
The results of feasibility studies are consistent and encouraging. Administration
of self-reported HRQL questionnaires in outpatient clinic settings requires
only a modest investment in material and personnel and is acceptable to both
patients and staff.7-11 The
randomized studies7,9,12-19 that
have investigated the value of routine HRQL assessments for patient management
and outcomes have yielded less consistent and generally less favorable results.
Although several studies have reported improved detection of patients' problems
(eg, depression),14,18,19 others
have not.12,20 No studies have
found a salutary effect on patient satisfaction or health status.
There are several possible explanations for the relative paucity of
positive findings. In some studies, the HRQL assessments were made at fixed
intervals, regardless of whether they coincided with specific medical visits12,17 or were made at a single time point,
thus precluding the possibility of monitoring changes in patients' HRQL.7,9,16,18,19 None
of the studies provided summaries of the patients' responses to the HRQL questionnaires
to the patients themselves. Most notable, however, is the lack of attention
paid to the rigorous evaluation of the effect of HRQL assessments on patient-physician
communication. Although in several of the studies the participating physicians
and/or patients reported that the availability of the HRQL data facilitated
self-reports need to be confirmed by direct behavioral measures.21
Given that effective communication is an early step in the care process,22 it seems only logical that patient-physician communication
be included as the most proximal outcome in studies that evaluate the effect
of standardized HRQL assessments in daily clinical practice. If no effect
on communication is found, it is unlikely that any effect on more distal outcomes,
such as patient satisfaction or HRQL, will be observed.
The current study was undertaken to investigate the potential value
of providing oncologists and their patients with timely, structured feedback
on the patients' HRQL during palliative chemotherapy treatment. Our primary
hypothesis was that such HRQL assessments would facilitate the frequency with
which HRQL issues were discussed during the consultations. Additional outcomes
included physicians' awareness of their patients' HRQL, clinical management
activities, patients' and physicians' satisfaction with their medical interactions,
and patients' self-reported HRQL over time.
The study was conducted at the Antoni van Leeuwenhoek Hospital, a specialized
cancer treatment center in Amsterdam, the Netherlands. The physician sample
consisted of the oncologists working in the Department of Medical Oncology.
The patient sample was a consecutive series of patients who were receiving
outpatient palliative chemotherapy. Patients were excluded if they lacked
basic proficiency in the Dutch language, were younger than 18 years, or were
participating in a concurrent HRQL study. Eligible patients were invited to
participate in the study after they had received 2 cycles of chemotherapy.
They were provided with both oral and written information about the study
prior to obtaining their informed consent. The institutional review board
of the hospital approved the study.
The study used a longitudinal, randomized, crossover design. The physicians
were initially assigned, at random, to either the intervention or control
condition. For each physician, a minimum of 10 consecutive patients were recruited
into the study. The first study medical visit served as a baseline assessment
for both groups. The intervention was introduced at the second study visit
and continued through the fourth study visit.
Midway through the study, the physicians originally assigned to the
control arm of the study were switched to the intervention arm and those originally
assigned to the intervention arm to the control arm. A second cohort of at
least 10 patients per physician was recruited and followed-up in a manner
identical to that in the first study period. A buffer period of 2 months was
introduced before starting recruitment of the second cohort of patients. This
crossover design was deemed the most appropriate means of testing the effect
of the intervention, given the relatively limited number of participating
physicians. With each physician serving as his/her own control, the potential
influence of between-physician differences in sociodemographics, professional
experience, and attitudes and behavior on key study outcomes could be neutralized.
The sample size was established to provide 80% power to detect a moderate
between-group difference (effect size = 0.40) in the frequency with which
patients' problems were discussed during the medical consultations (α
All patients had standard follow-up visits with their physician before
the start of each cycle of chemotherapy. Patients in the intervention arm
were asked to complete a standardized HRQL questionnaire, the 30-item European
Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core
30 (QLQ-C30) (version 3.0), in the waiting room immediately before each visit.
The QLQ-C30 is organized into 5 functional scales (physical, role, cognitive,
emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting),
a global HRQL scale, and a number of single items that assess additional symptoms.
The questions are posed in terms of the previous week. For most items, a 4-point
Likert-type response scale is used (ranging from "not at all" to "very much").
Following standard European Organization for Research on the Treatment of
Cancer procedures, all scores were linearly converted to a 0 to 100 scale,
with higher scores indicating a higher level of functioning and more severe
The patients' responses to the QLQ-C30 were optically scanned into a
desktop computer, scored, and printed as a graphic summary profile (Figure 1). Copies of the summary were given
to the patient and physician immediately before consultation. A copy was also
placed in the medical records. At the 2 subsequent outpatient visits, the
QLQ-C30 summary included both the patients' current scores and those elicited
at the previous visit(s).
Before the start of the intervention period, each physician received
a single, half-hour educational session on how to interpret the QLQ-C30 summary
scores. Patients in the intervention group received a similar explanation
in a pamphlet mailed to their home. If desired, a research assistant provided
further explanation of the summary. No specific guidelines were provided for
the use of the summary during the medical consultations.
Patients' Sociodemographic and Clinical Characteristics. At the time of the baseline visit, the patients completed a brief sociodemographic
questionnaire, and the physicians rated their patients' performance status
using the Eastern Cooperative Oncology Group scale.24 Clinical
information was extracted from the medical records.
Patient-Physician Communication. All of the medical consultations were audiotaped, transcribed, and content
analyzed with the aid of a checklist to determine whether the HRQL topics
included in the QLQ-C30 were discussed and to record the total length of the
consultations. Coding was performed directly from audiotape by 3 trained raters
(S.B.D. and L.D.V.W.) who were blinded to group assignment. All raters coded
a random sample of 15% of the audiotapes to assess interrater reliability.
A high level of agreement was reached (mean, 95%). A composite communication
score (range, 0-12) was calculated by summing all HRQL-related topics that
were discussed. This composite score served as the primary study outcome.
Physicians' Awareness of Patients' HRQL. At the first and fourth study visits, the physicians and patients were
asked to complete the Dartmouth Primary Care Cooperative Information Functional
Health Assessment (COOP) and the World Organisation Project of National Colleges
and Academics (WONCA) charts.25 These charts
assess physical fitness, feelings, daily and social activities, pain, and
overall health. An additional chart that assessed fatigue was also included.
A 5-point response scale is used, with 1 representing the best and 5 representing
the worst level of functioning. The charts were used to (1) determine the
physicians' awareness of their patients HRQL and (2) identify patients with
serious HRQL impairments.
Patient Management. Medical records and the audiotapes were used to abstract notations and
comments relating to HRQL-related patient management, including prescription
of medication, ordering of tests, referrals to other health care practitioners,
and counseling. A composite patient management score was calculated by summing
all HRQL-related actions taken by the physicians per patient.
Patient and Physician Satisfaction. Following the first and the fourth study visits, patients completed
the 5-item Patient Satisfaction Questionnaire C, which assessed satisfaction
with how their needs were addressed, their active involvement during the visit,
patient-physician interaction, and information and emotional support received.26 An overall satisfaction score was calculated by averaging
the responses to the 5 questions. At the same time points, the physicians
were asked to rate their global satisfaction by means of a single question:
"How satisfied were you with the communication with your patient during this
Patients' Self-Reported HRQL. At the first and fourth visits, the Medical Outcomes Study 36-Item Short-Form
Health Survey (SF-36)27,28 was
administered to all patients. The SF-36 is organized into 8 multi-item scales.
The questions referring to general health perceptions were omitted because
they had been shown to be upsetting to patients with advanced cancer.28
Patient and Physician Evaluation of the Intervention. Following the fourth study visit, patients in the intervention group
completed a questionnaire and a brief telephone interview regarding their
experience with the intervention. Similarly, all of the participating physicians
underwent a semistructured interview to obtain their views.
All statistical analyses relating to the effectiveness of the intervention
were performed on an intention-to-treat basis and were based on data obtained
from the fourth study visit. Patients' sex, the study period (precrossover
vs postcrossover), and, when possible, baseline (ie, first visit) values were
used as covariates. Stepwise linear regression analysis was used to test for
between-group differences in the mean scores on the composite communication
scale, and forward, unconditional logistic regression analysis was used to
compare the percentage of consultations in the intervention with the control
group in which the specific HRQL topics were discussed.
Physicians' awareness of patients' HRQL problems was assessed by calculating
the percentage of exact and global agreement between patient and physician
ratings for the COOP/WONCA charts. Exact agreement was defined as identical
patient and physician ratings, whereas global agreement was defined as agreement
within 1 response category in either direction.29 Logistic
regression analyses were performed for the total sample and for the subgroup
of patients experiencing moderate-to-severe problems (rating of 3 to 5 on
the COOP/WONCA charts) at the fourth visit. Additionally, within-group change
over time in physician awareness of patients with moderate-to-severe problems
was examined. For these latter analyses, no formal statistical testing could
be performed because the patients with moderate-to-severe problems at the
fourth visit were not necessarily the same patients as those at the first
visit. Rather, a within-group shift over time of at least 10% of cases in
which agreement was taken as an indication of improved physician recognition
of patients' problems.
Stepwise linear regression analysis was used to test for between-group
differences on the measures of patient management, patient and physician satisfaction,
and patients' self-reported HRQL as measured by the SF-36. Additionally, between-group
comparisons were made of the percentage of patients whose SF-36 scores improved
by at least 0.5 SD unit from the first to the fourth visit. All statistical
tests were 2-sided, with the significance level set at P = .05. All analyses were performed using SPSS version 10.1 (SPSS
Inc, Chicago, Ill).
Of the 12 physicians asked to participate in the study, 10 agreed to
do so. The 2 who declined objected to having their consultations audiotaped.
Four of the participating physicians were women. Their mean age was 44 years
(range, 35-53 years), with an average of 11 years of working experience in
oncology (range, 2-24 years).
Between June 1996 and June 1998, 382 patients were invited to participate
in the study, of whom 273 agreed (71% response rate). Of the 109 nonrespondents,
50 declined to participate because of poor physical or emotional condition,
43 indicated insufficient interest or lack of time, and 16 had objections
to the audiotaping. A nonrespondent analysis indicated that patients who declined
to participate were significantly less well educated than those who agreed
to participate (P<.001). No statistically significant
differences were found for other background characteristics. During the study,
31 patients in the intervention group and 28 in the control group were lost
to follow-up: 33% died, 30% changed physicians, and 37% transferred to another
hospital. There were no statistically significant differences between groups
in reasons for loss to follow-up (Figure 2).
The background characteristics of the remaining 214 patients are presented
in Table 1. The intervention and
control groups were well-balanced on variables except primary diagnosis, with
the control group having proportionally more breast cancer patients than the
intervention group (62% vs 41%, P = .03).
The mean (SD) composite communication score at the fourth visit was
4.5 (2.3) in the intervention group and 3.7 (1.9) in the control group (P = .01; effect size = .38). Ten of the 12 HRQL issues
were discussed more frequently in the intervention group compared with the
control group. These differences reached statistically significant levels
for social functioning, fatigue, and dyspnea (Table 2).
There were no statistically significant between-group differences at
the fourth visit in exact or global physician-patient agreement in ratings
on the COOP/WONCA charts. Similar results were obtained when limiting the
analysis to those patients who reported moderate-to-severe problems on one
or more of the COOP/WONCA charts. In this later case, the only statistically
significant group difference was in ratings of social functioning (83% agreement
in the intervention group vs 65% in the control group; P = .05). However, within the intervention group, an increase over
time of at least 10% in physician recognition of moderate-to-severe problems
was observed for daily activities, feelings, social activities, pain, and
fatigue. Within the control group, this was the case only for daily activities
and pain (Table 3).
The between-group difference in the mean number of HRQL-related patient
management actions taken per patient was negligible (0.6 for the intervention
group and 0.5 for the control group). No statistically significant between-group
differences were observed in the prescription of medications, ordering of
tests, or referrals to other health care practitioners. However, a significantly
greater percentage of patients in the intervention group (23%) received counseling
from their physician on how to manage their health problems than the control
group (16%) (P = .05).
Overall patient satisfaction with the fourth medical visit was high
in both groups. At the individual item level, the only statistically significant
between-group difference was with regard to the degree of emotional support
received (mean [SD], 4.3 [.72] vs 4.0 [.89] for the intervention and control
groups, respectively; P = .05). The level of physician
satisfaction with the medical encounter was similarly high in the intervention
and control conditions (mean score, 4.5 in both groups).
There were no statistically significant between-group differences at
the fourth visit for any of the SF-36 scales (Table 4). However, a significantly greater percentage of patients
in the intervention group compared with the control group exhibited improvement
over time (defined as a 0.5-SD unit or greater change) in mental health (43%
vs 30%; P = .04) and role functioning (22% vs 11%; P = .05).
No statistically significant between-group difference was found in the
mean duration of the visits (mean [SD], 19.8 [6.2] minutes for the intervention
group and 20.4 [6.8] minutes for the control groups). Ninety-seven percent
of the patients in the intervention group reported that the HRQL summary profile
provided an accurate picture of their functioning and well-being, 57% reported
that it was used explicitly during the medical visits, 79% believed that the
summary enhanced their physician's awareness of their health problems, and
87% believed that it would be useful to introduce the intervention as a standard
part of the outpatient clinic procedure. Approximately 25% of the patients
indicated that they had discussed the HRQL summary profile with family members
or close friends, and 6% had shared it with their family physician.
All physicians reported that the summary profile provided a useful,
overall impression of their patients' symptom experience and functional health
and indicated that it facilitated communication, especially with regard to
psychosocial topics and "unexpected" symptoms (eg, sleep disturbances). Although
all of the physicians indicated that they would like to continue use of the
HRQL summary profile in their daily practice, several suggested that the information
could be more tailored to the problems of specific patient groups (eg, site
of pain and use of pain medication for patients with bone metastases).
As hypothesized, the intervention resulted in a significant increase
in the frequency with which HRQL issues were discussed. The observed, salutary
effect of the intervention on patient-physician communication is particularly
encouraging in that the most notable increase was in the discussion of HRQL
issues that are less observable (ie, social functioning) or are of a more
diffuse and long-term nature (ie, fatigue) and thus are often left unaddressed
by health care practitioners.29,30
No statistically significant between-group differences were observed
in physicians' awareness of the level of functioning or symptom experience
of their patients. However, a series of within-group analyses indicated that,
over time, physicians in the intervention group improved in their recognition
of patients' with moderate or severe problems in 5 of the 7 HRQL domains covered
by the COOP and WONCA. Again, it is noteworthy that substantial improvement
was observed in the recognition of problems in areas that tend to be underestimated
by health care practitioners (eg, emotional and social health, fatigue, and
The intervention had only a modest effect on patient management activities,
primarily in terms of increased levels of patient counseling. The only statistically
significant difference between the intervention and control groups in patient
satisfaction was in the perceived emotional support received from the physician.
This is not trivial in that previous research has indicated that patients
are significantly more likely to disclose information about their psychosocial
functioning when their physician exhibits such supportive behavior.31 The failure to detect significant between-group differences
in other aspects of patient satisfaction and in physician satisfaction may
be because the levels of satisfaction tended to be high, leaving little room
for improvement. Such a "ceiling" effect has been reported in other studies.8,13,32
Most patients exposed to the intervention and all of the physicians
reported that the HRQL summary profile was useful in facilitating communication
and in enhancing physician awareness of patients' problems and favored continued
use of the intervention as a standard part of the outpatient clinic procedure.
An additional, unanticipated finding was that approximately 25% of the patients
shared the results of the summary profile with family members or with their
primary care physician. We consider this to be a positive spin-off, in that
previous studies have shown that patients' partners and formal caregivers
are often less than fully informed about the patients' HRQL33 and
that problem-oriented feedback (eg, letters and lists) from medical specialists
can be a useful means of keeping primary care physicians informed about their
patients' health status.34-36
The intervention had only a modest impact on patients' self-reported
HRQL over time as assessed by the SF-36. This was not unanticipated, given
the complex array of factors that can affect patients' health. Nevertheless,
the finding that significantly more patients in the intervention than the
control group improved by more than half an SD unit on the 2 SF-36 indicators
of emotional health is encouraging.
We are cognizant of a number of limitations of our study. First, the
results need to be interpreted with some caution because of the relatively
large number of statistical tests performed. When correcting for multiple
testing using the Hommel procedure,37 the between-group
differences noted in the percentage of consultations in which specific HRQL
topics were discussed no longer reached conventional levels of statistical
significance. Nevertheless, statistically significant between-group differences
were observed for the mean composite communication score and 10 of the 12
specific HRQL topics were discussed with greater frequency (in absolute terms)
in the intervention than in the control group. These 2 findings suggest that
the intervention had the intended, salutary effect on patient-physician communication.
Second, although the patient sample was large, the physician sample
was limited. However, we have no reason to believe that the results are in
any way atypical of what would be found with a larger group of physicians
in that the participating physicians varied substantially in age, sex, and
years of work experience.
Third, although the use of a crossover in the study design enabled us
to largely neutralize any effect that might be attributed to physicians' background
characteristics, it also carried with it the risk of a carryover or contamination
effect. In fact, some evidence was found suggesting that the physicians who
began in the experimental condition and subsequently crossed over to the control
condition may have been sensitized to HRQL issues and may have changed their
behavior during the period in which they were no longer exposed explicitly
to the intervention. This can be illustrated by the pattern of results pertaining
to the discussion of patients' emotional functioning (Figure 3). In the absence of a carryover effect, one would expect
that, both before and after the crossover, the percentage of baseline consultations
in which patients' emotional functioning was discussed would be similar for
the groups that included the same physicians. This was, in fact, the case
for those physicians who were first in the control group (36%) and then crossed
over to the intervention (41%). However, the percentage of baseline consultations
in which emotional functioning was discussed was considerably higher after
crossover when physicians were first exposed to the intervention (22%) and
then crossed over to the control group (39%) (P =
.06). A similar pattern of results was observed when exploring other HRQL
outcomes. Importantly, however, any such carryover effect would tend to have
a conservative effect, because it would tend to suppress between-group differences
in the principal study outcomes.
Finally, the study was conducted in a single hospital that specialized
in the treatment of patients with cancer. Future studies are needed to evaluate
the efficacy of the intervention in other treatment settings and with larger
and more diverse physician and patient samples.
In conclusion, our results support the use of standardized HRQL assessments
in the palliative cancer treatment setting as a means of facilitating the
discussion of HRQL issues and of heightening physicians' awareness of their
patients' problems. Future efforts should be directed at improving the flexibility
and precision of HRQL assessments and at linking patients' HRQL (change) scores
to specific treatment and care strategies.
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