ARTICLE
Auteur(s) : Stefano
Tabolli1, Giannandrea Baliva2, Giuseppe
Alfonso Lombardo2, Francesca Sampogna1,
Cristina Di Pietro1, TJ Mannooranparampil1,
Gabriele Alvetreti2, Damiano Abeni1
1Health Services Research Unit, Istituto Dermopatico
dell’Immacolata (IDI-IRCCS), via dei Monti di Creta 104, 00167
Rome, ItalyFax: (+39) 06 6646 4329
23rd Clinical Dermatology Unit, Istituto
Dermopatico dell’Immacolata (IDI-IRCCS), via dei Monti di Creta
104, 00167 Rome, Italy
accepté le 27 Février 2006
Patient-reported outcome measures in clinical practice, in
particular those evaluating health-related quality of life (HRQoL),
have been proposed as a means of facilitating doctor-patient
communication, uncovering patients’ problems, as well as of
monitoring disease or treatment, and as a screening for functional
problems [1-3]. HRQoL measures ensure that treatment and
evaluations focus on the patient rather than on the disease, and
may be used as a way of capturing the personal and social context
of patients and of linking it to the classical clinical view of
disease [4, 5]. In addition, these measures can be used to increase
awareness of the clinical personnel about the complexity of the
negative effects of disease, thus giving the possibility to
prioritise problems, identify preferences, and train new
staff.However, while HRQoL measures are now quite commonly included
in the protocols of randomised controlled clinical trials and of
other clinical research studies, their use in routine clinical
practice is still quite limited, and – to the best of our knowledge
– no experiences exist in this field in dermatology. Several
barriers to the routine clinical use of HRQoL measures exist, and
they include concern about cost, feasibility, and clinical
relevance [6]. Also, given that most existing questionnaires were
specifically designed, developed and validated for use in clinical
research [7] and for group comparisons, it is a concern that the
available instruments for HRQoL measurement may not be suitable for
monitoring individual patients in clinical practice [8].Another
important aspect in the comprehensive evaluation of patients’
status is their psychological condition. Disorders such as anxiety
and depression are particularly prevalent in hospital settings and
yet often go unrecognised [9, 10], even if they can impact not only
on patients’ lives but also on the adherence to treatment,
treatment effectiveness, and patients’ satisfaction with care.
Self-completed instruments that are acceptable to patients have
adequate sensitivity and specificity in their ability to identify
problems such as anxiety and depression, and are sensitive to
changes, are available for use in clinical settings. The routine
use of these questionnaires might be a simple and cost-effective
mean of improving the recognition, management, and outcome of
psychological problems in non-psychiatric settings.We report here
our experience in the evaluation of the HRQoL and of the possible
presence of minor non-psychotic psychiatric disorders in the
routine clinical practice of a Dermatology Unit in our Institute in
Rome. This study aimed to verify whether the HRQoL measurements
were actually feasible in daily hospital routine and to see to what
degree the instruments were accepted by patients, dermatologists,
and nurses. Moreover, the study aims to evaluate if HRQoL
measurements could provide meaningful information in the monitoring
of the course of patients’ conditions over time.
Materials and methods
The study was carried out between February 21 and May 31, 2005. All
patients admitted in a Dermatology Unit at the IDI-IRCCS in Rome
(3rd Unit, 25 beds; mainly focused on treatment of
cutaneous T-cell lymphomas and Graft Versus Host Disease (GVHD))
were invited to participate in the study.
The study had been approved by the Ethical Committee of
IDI-IRCCS. Full information about the study methods and purposes
was provided, and patients who agreed to participate and signed a
written informed consent form received three research
questionnaires. Patients were invited to fill them out carefully
and taking their time, but if possible before any clinical
examination was performed and before any new treatment was
administered. On average, filling out the questionnaires took
approximately fifteen to twenty minutes. Patients re-hospitalised
during the study period were asked to fill out the questionnaires
again so that a few patients have reports of two or three
observations.
The questionnaires were then collected by a research
dermatologist, who checked them for completeness and passed them to
the research unit for data entry and processing. Within three hours
the questionnaire results were returned to the 3rd
Dermatology Unit on standardised forms (see ( figure 1 ) with a patient
profile), and included in the patient records together with all
other personal history, clinical and laboratory information
routinely collected.
The three questionnaires we used were the Skindex-29, the
12-item General Health Questionnaire (GHQ-12), and the 36-item
Short Form of the Medical Outcomes Study questionnaire (SF-36).
The Skindex-29 is a reliable and valid instrument that has been
specifically designed for measuring health-related quality of life
in dermatological patients [11]. It consists of three scales
assessing areas considered essential in any instrument purported to
assess quality of life: burden of symptoms, functioning and
emotional state. The Italian version of this self-administered
questionnaire has been recently validated [12, 13]. Patients
answered the 29 questions referring to the previous 4-week period,
on a five-point scale from ‘never’ (= 0) to ‘all the time’ (= 4).
The score of each scale ranges from 0 to 100 (as a percentage of
the maximum score obtainable on that scale), and higher scores
reflect a worse quality of life. In the feed-back form used in this
study, as a guide to interpretation of the three Skindex-29 scale
scores we gave ranges of scores identifying “categories” of quality
of life established using a mixed-population model analysis of the
data set originally used for the validation of the Italian version.
(D. Abeni personal communication). In addition, we also reported
what we called “warnings”, i.e., we pointed out items for which the
patient had answered that she/he experienced that problem “all the
time”.
The GHQ-12 is a self-administered questionnaire consisting of 12
items, designed to measure psychological distress and to detect
current non-psychotic psychiatric disorders [14], usually
depressive or anxiety disorders. The reliability and validity of
the Italian version has been documented in many types of patients,
including those with dermatological conditions [15, 16]. Answers
are given on a four-point scale: for instance, the answers to the
item “in the last weeks, did you feel under strain?” are “no”, “no
more than usual”, “more than usual”, and “much more than usual”.
When scored with the binary method (0-0-1-1), the GHQ-12 can be
used as a screening tool to detect minor non-psychotic psychiatric
disorders. For instance, to receive a score of 1 on the previously
described item, a subject should answer “more than usual” or “much
more than usual”. In this way, each subject obtains a score from 0
to 12: on the feed-back form we reported the patient score together
with a guide to interpretation of the score, based on a previous
validation study [17]. Operationally, patients scoring four or more
were considered as “GHQ-positive” (GHQ+).
The SF-36 was designed as a generic indicator of health status
for use in population surveys and evaluative studies of health
policy [18]. As a generic instrument, the SF-36 was designed to be
applicable to a wide range of types and severity of conditions. It
is a useful instrument for monitoring patients with multiple
conditions, for comparing the health status of patients with
different conditions, and for comparing patients to the general
population. The SF-36 includes 36 items, in a Likert-type or
forced-choice format, intended to measure the following eight
dimensions: physical functioning (PF, limitations in performing
physical activities such as bathing or dressing), role-physical
(RP, limitations with work and other daily activities as a result
of physical health), bodily pain (BP, how severe and limiting is
pain), general health (GH, how general personal health is evaluated
by the patient), vitality (VT, feeling tired and worn out vs.
feeling full of energy), social functioning (SF, interference with
normal social activities due to physical or emotional problems),
role-emotional (RE, limitations with work and other daily
activities as a result of emotional problems), mental health (MH,
feeling nervous and depressed vs. peaceful, happy and calm). Scores
for each domain range from 0 to 100, with high scores indicating a
better status. We used the Italian version of the SF-36 [19],
cross-culturally validated within the framework of the
International Quality of Life Assessment (IQOLA) Project. On the
feed-back form we reported the classical graph depicting the
patient’s “quality of life profile” and references for normal
Italian population (25th and 75th
percentiles).
At the beginning of the study, we trained physicians and nurses
about the study procedures (e.g., providing information to
patients, obtaining the informed consent, giving and collecting the
questionnaires, checking completeness of responses, results
interpretation), we told them to be aware that each patient’s
results were returned to the clinical unit within one day, and
recommended that they regularly use the information provided in the
feed-back form.
The knowledge of the clinical staff about HRQoL measures, and
their attitudes, behaviours and opinions about the study
instruments and procedures were surveyed using a standardised
questionnaire, which was administered during the last week of the
study (the questionnaire is available upon request).
The instrument scores were computed using electronic worksheets
and database programs (i.e., Microsoft Excel and Microsoft Access).
All other statistical analysis was performed using Stata 7.0.
StataCorp, College Station, TX, USA.
Results
During the study period, 232 hospitalisations of 197 patients were
recorded in the 3rd Dermatology Unit of IDI-IRCCS. Of
these patients, 12 (6%) refused to participate, and 15 (8%) were
excluded because of cognitive impairment or because it was deemed
that the clinical condition was so severe as to preclude completion
of the questionnaires. The daily number of patients enrolled in the
study ranged from 0 to 5 (median = 2).
Table 1( Table 1 ) shows the sex and
age distribution of the study population, as well as the mean of
Skindex-29 and of SF-36 scores, and the proportion of GHQ+ patients
in each group. As already observed in other samples [20, 21], women
had substantially worse quality of life compared to men. Also the
prevalence of GHQ+ was twice as high in women compared to men. As
expected, older patients had a poorer quality of life on the
physical scales of the SF-36, while on the psychosocial scales
differences were slight.
Table 1 also summarises the frequency of diseases observed
during the study period and the HRQoL scores for each condition. It
is of interest to note that the Skindex-29 symptoms scale
emphasises the impact of classical dermatological conditions (i.e.
dermatitis, psoriasis, skin ulcers), while the “physical” scales of
SF-36 indicate a greater impact of GVHD and pemphigus besides skin
ulcers. In the psychosocial scales, it is important to note that
the impact of inflammatory and bullous skin conditions is
comparable to, and often greater than that of GVHD and cutaneous
lymphomas. “Warning” items at Skindex-29 were present in almost 60%
of patients. 7.1% of patients reported two or three symptoms “all
the time”.
The overall prevalence of GHQ+ was 39.3%, with proportion of GHQ
positives ranging from 21.7% in cutaneous lymphomas to 55.6% in
GVHD. Despite the documented high prevalence of patients with GHQ+
results, indicating the probable presence of relevant psychological
problems, the number of liaison consultancies requested from the
3rd Clinical Dermatology Unit to the Clinical Psychology
Unit was very low during the study period.
In addition to the individual standardised response forms ((
figure 1 )),
whenever repeated hospitalisations occurred for the same patient,
we provided the clinical staff of the Dermatology Unit with graphs
comparing QoL and GHQ scores at the different time points of
hospitalisation. ( Figure 2 ) summarises the
Skindex-29 and SF-36 of different patients re-admitted to the
hospital for specific treatment protocols. Although the SF-36
offers more scale scores, the QoL pattern seemed more easily
interpretable from the Skindex-29 graphs. From ( figure 2 ), looking for
example at Skindex graphs of GVHD cases, we can readily see patient
A with no symptoms, progressively better functioning, and moderate
emotional problems in the second hospitalisations; patient B with a
slight worsening in symptoms, a stable emotional situation, and
increasing functioning problems. Also, patient C, suffering from
Sézary syndrome, shows a moderate but progressive improvement in
symptoms, and an earlier and greater improvement in the emotional
scores and especially in the functioning scale.
As for the clinical staff of the Dermatology Unit, 14 persons
were involved in this study (6 dermatologists and 8 nurses). During
the staff survey, 12 completed questionnaires were collected. Given
that questionnaires were completely anonymously it is not possible
to know whether non respondents were dermatologists or nurses.
The reported attitudes towards the study were quite positive:
9/12 responders considered as useful the measurement of QoL and of
psychological distress; 10/12 said that these measurements helped
them in taking care of their patients; 11/12 reported that they
were looking at “warnings” and that this helped in their practice;
8/12 said that these measurements should be introduced and
constantly used in the clinical practice routine of their Unit.
However, the correspondence between such positive attitudes and
actual behaviour was poor: no one of the 12 responders said he/she
had discussed QoL or psychological distress results with the
patients, and only 2/12 had even informed the patients of their
results; 1/12 was contacted by a patient’s relatives requesting
some kind of explanation for the meaning of those measurements.
Only 1 responder out of 12 reported he/she had modified his/her
practice based on the feed-back forms from this study.
Table 1 Skindex-29, Sf-36 mean values, and proportions
(%) of patients scorting (≥ 4) on Ghq-12 in all patients by sex,
age and disease
|
SKINDEX-29
|
SF-36
|
GHQ-12
|
|
|
n
|
%
|
Symptoms
|
Emotions
|
Social-funct.
|
PF
|
RP
|
BP
|
GH
|
VT
|
SF
|
RE
|
MH
|
% (≥ 4)
|
|
Total
|
|
170
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sex
|
Male
|
107
|
62.9
|
45.0
|
37.7
|
32.0
|
71.4
|
55.5
|
62.2
|
58.6
|
59.7
|
68.5
|
61.2
|
62.6
|
27.6
|
|
Female
|
63
|
37.1
|
54.5
|
51.3
|
40.2
|
71.1
|
40.7
|
45.7
|
49.2
|
44.1
|
53.0
|
45.5
|
49.3
|
58.7
|
|
Age (years)
|
< 45
|
54
|
31.8
|
41.6
|
38.9
|
29.5
|
83.1
|
64.2
|
65.4
|
59.6
|
57.7
|
63.9
|
60.1
|
63.1
|
37.7
|
|
45-64
|
56
|
32.9
|
48.2
|
44.7
|
34.0
|
73.4
|
48.5
|
54.7
|
55.8
|
52.6
|
65.7
|
60.3
|
53.5
|
41.8
|
|
≥ 65
|
60
|
35.3
|
55.0
|
44.5
|
41.0
|
58.5
|
37.9
|
48.8
|
50.5
|
50.7
|
59.0
|
47.0
|
55.4
|
38.3
|
|
Disease
|
|
Psoriasis
|
41
|
24.1
|
57.3
|
46.3
|
37.7
|
70.9
|
51.3
|
52.9
|
55.7
|
51.5
|
58.8
|
50.9
|
50.7
|
47.5
|
|
Gvhd
|
10
|
5.9
|
36.5
|
40.6
|
39.5
|
56.1
|
30.6
|
54.3
|
45.0
|
51.9
|
58.3
|
48.1
|
59.5
|
55.6
|
|
Connective tissue #
|
17
|
10.0
|
34.8
|
36.5
|
24.0
|
83.4
|
64.1
|
62.4
|
53.1
|
57.6
|
64.7
|
71.1
|
64.3
|
29.4
|
|
Dermatitis
|
32
|
18.8
|
59.7
|
47.3
|
38.0
|
82.8
|
51.7
|
52.9
|
60.8
|
55.9
|
65.2
|
50.0
|
59.5
|
34.4
|
|
Skin-ulcers
|
13
|
7.6
|
58.7
|
42.5
|
47.0
|
51.4
|
19.2
|
33.9
|
41.3
|
44.2
|
52.9
|
28.2
|
47.8
|
53.9
|
|
Pemphigus
|
13
|
7.6
|
47.3
|
46.7
|
40.5
|
57.7
|
34.1
|
55.8
|
51.0
|
55.0
|
52.9
|
60.6
|
50.8
|
38.5
|
|
Lymphomas
|
23
|
13.5
|
32.0
|
30.6
|
18.4
|
79.8
|
72.7
|
76.1
|
59.0
|
58.6
|
78.3
|
69.7
|
69.4
|
21.7
|
|
Other
|
21
|
12.5
|
42.8
|
46.5
|
40.1
|
63.3
|
54.1
|
54.1
|
59.7
|
52.5
|
61.9
|
63.0
|
57.8
|
42.9
|
Discussion
The training of health care professionals remains based, in
general, on the traditional biomedical model of health. As a
result, clinicians may be unprepared to respond appropriately to
their patients’ emotional and functional needs [22, 23]. The use of
standard HRQoL questionnaires in clinical practice is a potential
way of helping health care professionals to adapt to the increasing
requirements for the assessment of their patients’ functional and
psychological problems.
To the best of our knowledge, this is the first study in
dermatology introducing the routine assessment of HRQoL in
individual patients. In this study we showed that the introduction
of HRQoL measurements in the clinical routine of a busy Dermatology
Unit is feasible. We also collected information indicating a high
acceptance both from the patients and the clinical staff and the
observed refusal rate (6%) suggests that this intervention may be
unsuitable only for very few patients.
The systematic collection of HRQoL information allows for
comprehensive depiction of the characteristics of patients cared
for in a given clinical unit. This might allow comparisons over
time within the unit, but also with other units – and could guide
allocation of resources, based on the assumption that patients with
poor quality of life may request more time and more complex care
than patients with a lower degree of QoL impairment. Moreover, with
multiple longitudinal assessments each patient would serve as
his/her own reference, and changes in the scores over time will be
more informative than a single assessment [24]. This is
particularly true for chronic diseases, such as psoriasis and
connective tissue diseases, that have a prolonged course and thus
offer the possibility to perform repeated measurements. Also, how
the HRQoL scores change over time according to different treatment
approaches can be evaluated, and how they relate to “objective”
clinical severity measurements in individual patients.
The clear and user-friendly presentation of the HRQoL results is
essential to allow use in clinical practice. We designed and used
graphs presenting results for SF-36 and normative references for
Skindex-29, we reported the “warning” elements to alert clinicians
about possible specific problems, and we specified the GHQ-12 score
cut-offs. All this information was kept to a single page, and we
also used different colours to enhance readability and
interpretability. The format of HRQoL data and clinicians’
perception of criteria for identifying a clinically important
difference or change in HRQol are also likely to influence
clinicians’ use of data. Given that the current format of medical
records is essentially a tool for diagnosing disease but does not
easily support the monitoring of symptoms or functional problems,
the QoL assessment could be a feasible and effective approach for
enhancing the collection and recording of information relevant to a
possible improvement of the overall medical approach to a patient.
HRQoL assessment in daily clinical practice is an aid to detect
physical or psychological problems that otherwise might be
overlooked; it monitors disease and treatment and improves delivery
of care. In particular, it is well known that psychological
problems are very frequent among dermatological patients and that
QoL is strongly impaired even in non life threatening
dermatological conditions such as psoriasis or atopic
dermatitis.
Some studies reported benefits of the routine assessment of
HRQoL showing an improvement in patients’ overall and emotional
wellbeing. A larger proportion of patients exposed to the
assessment of their HRQoL showed clinically meaningful improvement
in HRQoL compared to patients in control groups. The explicit use
of HRQoL information during clinical encounters was associated with
a significant improvement in patient wellbeing [24]. Other studies,
on the contrary, reported little or no patient benefit [25-27]. In
a randomised controlled trial the only statistically significant
difference between the intervention and control groups in patient
satisfaction was observed in the perceived emotional support the
patient received from the physician [28]. There are studies that
indicated that patients are significantly more likely to disclose
information about their psychological functioning when their
physician exhibits such supportive behaviour [29]. Another study
suggested that the completion of the questionnaires itself may have
an effect on patient well-being, particularly on symptom control,
regardless of whether the results are fed back to physicians. These
results indicate that QoL assessment influences clinician-patient
relationship, but seems to play a modest role in treatment
decisions [30-32].
In respect to the use of General Health Questionnaire, we
confirm a high prevalence of minor psychiatric conditions in
dermatological diseases. However our clinicians seemed to be more
confident with their capability to identify psychological problems
and did not rely on this screening instrument so that psychological
consultancies remain low. Therefore we think that more detailed
information could be provided to our dermatologists about the
validity of the instrument and help to improve the use of the
GHQ-12 in requesting more appropriate liaisons with
psychologists.
In our study, the communication between patients and physician,
according to the results of the questionnaires completed by the
clinicians, did not seem to be improved but we observed an
increased discussion between clinicians about symptoms reported by
patients. We confirm what has been reported in other studies, that
the frequency with which HRQoL issues were discussed increases
especially for less observable aspects such as for functioning and
emotions [28, 33, 34]. This is particularly interesting in the
routine clinical practice, given that the administration of
self-reported HRQoL questionnaires requires only a modest
investment in time, material and personnel, and it is acceptable
both to patients and staff [35, 36].
We are conscious of a number of limitations present in our
study. First, we did not assess the patient’s satisfaction and we
did not collect data on the effects of such intervention on the
choice of treatment. The limited sample of clinicians is clearly
another limit but this pilot phase was essential before promoting
the implementation of this program in the whole hospital. With an
appropriate training aimed at motivating clinicians about
communication on patients’ problems highlighted by the
questionnaires, we intend to influence therapeutic approaches and
hence the clinical course of the disease and to increase patient
satisfaction. However, in our experience, it has been crucial to
start in a single clinical Unit in order to identify practical
obstacles and difficulties, before implementing the program on a
larger scale.
In conclusion, our results support the use of standardised HRQoL
assessments in dermatological inpatients as a mean to facilitate
the physicians’ awareness of patients’ unrecognised problems.
Future efforts should be directed at improving the precision of the
assessment, to generalise the implementation of such assessment and
to assist long-term treatment choices for patients with chronic
conditions by monitoring changes over time.
Above all, it seems crucial to devise strategies to improve
awareness of clinicians about the wealth of information provided by
HRQoL measurements, and about the potential benefits – both for
patients and providers – deriving from their proper use.
Acknowledgements
We thank all patients and all clinicians (nurses and physicians)
participating in the study. We thank Alessia Di Felice for
assisting in data collection and management.
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