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Association of Dissatisfaction With Care and Psychiatric Morbidity With Poor Treatment Compliance
Cristina Renzi, MD, MSc;
Angelo Picardi, MD;
Damiano Abeni, MD, MPH;
Elisabetta Agostini, BD;
Giannandrea Baliva, MD;
Paolo Pasquini, MD, MPH;
Pietro Puddu, MD;
Mario Braga, MD, MSc
Arch Dermatol. 2002;138:337-342.
ABSTRACT
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Objectives To examine factors associated with compliance with dermatologic treatment.
Design Longitudinal study. Quality of life and psychological well-being were
measured before the dermatologic visit with a self-completed questionnaire.
Telephone interviews were performed 3 days and 4 weeks after the visit to
evaluate patient satisfaction and medication adherence, respectively.
Setting Outpatient clinics of a large dermatologic hospital in Rome, Italy.
Patients A total of 1389 outpatients were contacted and 722 (52%) agreed to participate.
Among them, 424 responded to the inclusion criteria and were enrolled in the
study. Of these, 396 (93%) completed the telephone interviews.
Main Outcome Measure Self-reported compliance with dermatologic treatment.
Results The dermatologists' prescriptions were not exactly followed by 44% of
patients. In multiple logistic regression analysis, treatment adherence was
strongly associated with complete satisfaction. Poor quality of life on the
emotions scale (indicating mainly high levels of shame and embarrassment)
was also associated with medication adherence. On the contrary, a strong negative
association was observed between psychiatric morbidity and compliance.
Conclusions This is the first longitudinal study on dermatologic patients showing
that dissatisfaction with care and psychiatric morbidity are significantly
and independently associated with poor medication adherence. To improve medication
adherence, particular attention should be dedicated to the physician's interpersonal
skills, which emerged as a major component of patient satisfaction. Moreover,
our results highlight the need for a timely identification and appropriate
management of psychiatric disorders in everyday dermatologic practice.
INTRODUCTION
UNDERSTANDING and enhancing patient compliance with physician-prescribed
treatments are relevant aspects of medical care. In fact, poor compliance
with medications may lead not only to negative health outcomes for the patient
but also to wasting of economic resources. Previous studies have shown that
30% to 70% of patients affected by a long-standing diagnosis of a chronic
disease have poor medication adherence.1-2
Richards and colleagues2 have reported that
among patients with a chronic skin disease, such as psoriasis, 39% had not
complied with treatment regimens prescribed by the dermatologist.
Numerous factors have been suggested to be associated with compliance,
for example, the patient-physician relationship,3
satisfaction with various aspects of care,4
and medication adverse effects.5 In dermatology,
most surveys on medication adherence are cross-sectional and address single
diseases, such as psoriasis2, 6-7
and acne.8 Moreover, these surveys mainly describe
compliance in relation to type of treatment (topical or systemic)6 or report compliance with specific treatments.9-10 Some studies on dermatologic patients
have examined the importance of the patient-physician relationship in improving
medication adherence.8
Medication adherence might be related not only to the clinical severity
of the disease and quality of life but also to the psychological or psychiatric
well-being of the patient. Including measures of psychological or psychiatric
well-being appears particularly important among individuals with skin diseases,
because high prevalence of psychiatric disorders have been reported among
dermatologic patients.11-13
A recent study14 conducted in our dermatologic
outpatient clinics has shown a prevalence of psychiatric morbidity of 25%.
Patient satisfaction with various aspects of care has also been reported
to influence treatment compliance.3-4
Estimating the independent effects of specific factors on medication adherence
allows us to have a greater insight into the determinants of poor compliance.
This information could be useful for developing strategies aimed at improving
compliance.
To the best of our knowledge, this is the first longitudinal study on
dermatologic outpatients using multivariate analysis to evaluate the association
between patient characteristics (sociodemographic factors, psychiatric morbidity,
health-related quality of life, and severity of skin disease), patient satisfaction
with dermatologic care, and self-reported compliance with prescribed medical
therapy.
PARTICIPANTS, MATERIALS, AND METHODS
STUDY DESIGN
The study is based on a sample of outpatients seeking dermatologic care
at the Istituto Dermopatico dell' Immacolata (IDI) of Rome, Italy. The IDI
is the largest dermatologic treatment and research facility in Italy, with
approximately 160 000 dermatologic outpatient visits during 1999.
From January 18, 2000, to March 6, 2000, all patients in the waiting
rooms of the dermatologic outpatient clinics between 8 and 10 AM were given
a letter explaining the study and a questionnaire collecting information on
sociodemographic characteristics, the patient's quality of life, and potential
minor psychiatric problems. Patients willing to participate were invited to
sign the informed consent form, complete the questionnaire before being visited,
and return the questionnaire to their dermatologist during the visit. The
dermatologists were asked to record diagnoses and location of skin lesions.
They were also requested to score the severity of the disease on a 5-point
scale, answering the following question: "In your experience, among all patients
you have seen with this condition, how severe is this patient's condition?"15
Inclusion criteria for participating in the subsequent steps of the
study were as follows: (1) written informed consent, (2) age of 18 years or
older, (3) Italian nationality (foreign patients were excluded because of
potential language problems), and (4) no visits made to IDI during the previous
year. The last criterion aims at avoiding selection bias, because patients
returning to IDI after a relatively short time probably represent a "more
satisfied with care" subgroup.
Participants were contacted by telephone within 3 days from the visit
to collect information on satisfaction with care. The 10- to 15-minute telephone
interviews have been performed using the Computer Aided Telephone Interview
system. Telephone interviews have been preferred to other methods of data
collection because of their ability to obtain a sufficiently high response
rate.
Four weeks after the visit, a second telephone interview was performed
on the same sample. This interview collected information on self-reported
compliance.
Absolute confidentiality has been guaranteed for all participants, and
the study protocol had been approved by the institutional ethical committee.
ASSESSMENT TOOLS
The self-completed questionnaires used to assess patients' health-related
quality of life and to detect psychiatric disorders were the Italian versions
of the Skindex-29 and the 12-item General Health Questionnaire (GHQ-12). The
Skindex-29 has been shown to be a valid tool for measuring health-related
quality of life of dermatologic patients.15
The Italian version of the Skindex-29 has been developed by one of us (D.A.)
following the guidelines for the cross-cultural adaptation of health-related
quality-of-life measures16 and has been used
in a previous survey14; higher scores indicate
a poorer quality of life. Quality of life is measured on 3 scales: the emotions,
symptoms, and social functioning scales.15
The GHQ-12 has been translated into Italian and is considered a valid
and reliable instrument for detecting current, nonpsychotic psychiatric disorders
in both general practice settings and the community.17-19
The patient satisfaction questionnaire has been designed using as reference
some questionnaires already validated in the United States and Great Britain.20-22 However, we have
modified the questions to make them more specific for patients attending a
dermatologic outpatient clinic in Italy. Patients were invited to choose their
answer on a 5-point scale, ranging from totally positive to totally negative
opinions. For example, "What is your opinion on the doctor's answers to your
questions?" Possible answers were excellent, very good, good, fair, and poor.
The questionnaire used neutrally worded questions and response formats to
minimize acquiescence response bias and unreliability in satisfaction measures.20
Dermatologists have been asked for comments and suggestions on the preliminary
version of the questionnaire, and a pilot study has been conducted on a sample
of 70 dermatologic outpatients. The final version of the questionnaire includes
27 questions on perceived quality of care, with items on access to care (eg,
office hours), infrastructures, assistance and information given by administrative
staff, waiting times, physicians' interpersonal attitude, and overall satisfaction
with care.
The questionnaire collecting information on patient self-reported compliance
with medication was specifically designed for the present study. It includes
15 questions concerning type of prescribed treatment (medical or surgical
treatment or cryotherapy; the medical treatments include pills, creams, shampoos,
etc); time of treatment commencement; if never started treatment, reasons
for not having started; patient's estimate of overall compliance ("How would
you describe your behavior regarding the medical treatment prescribed by the
dermatologist at IDI?" Answers could be chosen on a 5-point scale, ranging
from totally positive to totally negative opinions: "I have exactly followed
the dermatologist's prescriptions," "I have almost exactly followed the dermatologist's
prescriptions," etc). Moreover, 5 questions examined in depth different aspects
of medication (timing of medication, doses, etc). Comparing patients' answers
to these questions with answers on overall compliance shows internal consistency
of self-reported compliance with prescribed treatment (data not shown).
Previous studies have suggested that there is not a perfect measure
of compliance,23 and comparing patient-reported
adherence with electronic monitoring records in patients with hypertension
has shown that patient reports are qualitatively informative and may be useful
in interpreting the reasons for lack of physiologic response.24
Self-reported compliance of patients affected by chronic nondermatologic diseases
had higher sensitivity and specificity when compared with other measures of
compliance.25-26 In dermatology,
2 previous studies2, 6 on patients
with psoriasis have used self-reported compliance.
VARIABLE DEFINITIONS AND STATISTICAL ANALYSIS
Self-reported overall compliance with medical therapy was considered
as the outcome variable. Patients prescribed a medical therapy who reported
that they had followed exactly the dermatologist's prescription were classified
as compliant with medication. Patients prescribed a medical therapy but who
never started the therapy or patients who started the therapy but reported
to have not followed exactly the dermatologist's prescription were classified
as poorly compliant. Analyses are limited to compliance with medical therapy.
We have opted for a strict definition of adherence to reduce the overestimation
of compliance. In fact, previous studies have shown that patient reports usually
overestimate compliance,25, 27
whereas nonadherence is generally accurately reported by patients.24, 26
Patient satisfaction with care, sociodemographic data (current age,
sex, and educational level), dermatologist-rated severity of disease, health-related
quality of life, and psychiatric morbidity were considered as independent
variables. The GHQ-12 scores were computed in the conventional way with the
binary scoring method, that is, collapsing adjacent responses to obtain a
dichotomous score (0-0-1-1). Individuals with a score of 5 or higher have
been considered to have significant psychiatric morbidity. This threshold
has been used in previous studies14, 19
and has been shown to increase positive predictive value as much as possible,
leaving sensitivity at an acceptable level.19
A score of 5 or higher is obtained if at least 5 of the following problems
have been experienced by the respondent during the last weeks: lost sleep,
felt under strain, could not concentrate, felt not to play a useful part,
could not face problems, could not make decisions, could not overcome difficulties,
did not enjoy everyday activities, felt unhappy and depressed, lost confidence,
or felt worthless. The Skindex-29 was scored as previously described.15 The Skindex-29 has 3 quality-of-life scales: the
emotions, symptoms, and social functioning scales. Each scale has been divided
into tertiles. For each of the 3 scales, the lower, intermediate, and upper
tertiles have been defined respectively as good, fair, and poor quality of
life.
Concerning disease severity, we have transformed the 5-point scale into
3 categories: mild (including the very low and low severity cases), moderate,
and severe (including the severe and very severe cases).
The 13 variables concerning patient satisfaction with specific aspects
of care (office hours, access procedures, communication skills of physician)
have been examined by means of principal component analysis with promax rotation
to identify items relating to similar aspects of care.28
The Eigenvalue limit for the principal component analysis was set at 1. For
each factor extracted, we then calculated scores by scoring questions from
1 to 5, with 5 always representing maximum satisfaction. The factor scores
were standardized and transformed into 3 binary variables, thus classifying
participants for each factor into 2 groups, those with scores above the mean
and those with scores below or equal to the mean.
Multiple logistic regression has been used to evaluate the association
between self-reported compliance with medical therapy and overall satisfaction
with care and patient characteristics (sex, age, education, disease severity,
health-related quality of life, and presence of psychiatric disorders).
Overall satisfaction with care was evaluated asking patients the following
question: "Overall, what is your opinion on the quality of care received at
IDI?" Patients have been classified as completely satisfied if they reported
having received "excellent" or "very good" care at IDI, whereas those reporting
"good," "average," or "bad" care have been classified as not completely satisfied.
A similar definition has been used in previous studies.29
Sample size calculations showed that if the proportion of treatment
adherence was 60% among satisfied patients and 40% among dissatisfied patients,
we would have needed 330 patients (66 dissatisfied and 264 satisfied patients)
to have 80% power to detect a risk ratio of 1.50 at the .05 level of significance.
Statistical analysis was performed using the computer package Stata
Statistical Software, release 6.0 (Stata Corp, College Station, Tex).
RESULTS
A total of 1389 people were contacted, and 722 patients (52%) agreed
to participate. Of these, 215 did not meet the inclusion criteria, mainly
because they had recently sought care at IDI. The other 83 patients were excluded
because the dermatologist had not reported diagnosis, location, or severity
of the skin disease. Thus, 424 patients were eligible for the telephone interviews.
Among them, 396 (93%) completed both telephone interviews, with each interview
taking approximately 10 to 15 minutes to complete.
Of the 396 participants, 158 (40%) were men and 238 (60%) were women.
The mean age was 37 years (SD, ±15 years; range, 18-80 years). To verify
the representativeness of our study sample, we have compared it to the total
population of patients attending the dermatologic outpatient clinics at IDI
from January 18, 2000, to March 6, 2000, who met the inclusion criteria of
our study. The administrative registries were used for this purpose. The mean
age of the patients attending IDI was 43 years (SD, ±17 years), with
42% of patients being men and 58% women.
The most frequent diagnoses in our sample were dermatitis (25%), acne
(11%), and nevi (10%). The dermatologist-rated severity of the skin disease
was mild for 48% of patients, moderate for 39%, and severe for 9%. Information
on disease severity was not available for 4% of patients.
Psychiatric disorders were detected in 21% of the sample (95% confidence
interval, 17.1%-25.3%).
Sixty percent of the participants rated the care received at IDI as
excellent or very good, 36% as good, and 4% as average or bad. Patients having
rated care received at IDI as average or bad were similar to the fully satisfied
patients concerning age, sex, disease severity, and psychiatric morbidity.
Patients' opinions on specific aspects of care have been examined by
means of factor analysis, and 3 factors have emerged with Eigenvalues greater
than unity. The first factor relates to the physician's interpersonal skills
and includes the patient's opinion on quality of physician listening, thoroughness
of the visit, and quality of explanations given about the skin problem and
the therapy. The second factor regards access to care and includes patient's
opinions on convenience of office hours, access modalities, infrastructures,
and helpfulness of administrative staff. The third factor includes items concerning
the time spent at IDI (time physician spent with patient, and time patient
spent in the waiting room and in the physician's office waiting for the physician
to arrive). Details on patient satisfaction are reported elsewhere.30
A treatment (either surgical or medical or both) was prescribed to 351
patients (89%), and the distribution of type of prescribed treatment is as
follows: surgical, 38 (10%); medical, 300 (76%); surgical and medical, 13
(3%); and none, 45 (11%). Among the 313 patients who were prescribed a medical
therapy, 94% started the treatment. Overall, 139 patients (44%) who were prescribed
a medical therapy were poorly compliant, whereas 174 (56%) were compliant
(ie, followed exactly the dermatologist's advice). Compliance with medical
treatment varied only slightly according to dermatologic diagnosis. In particular,
the proportion of compliant patients was 49% in dermatitis, 60% in acne, and
50% in psoriasis. Table 1 shows
self-reported compliance with medical therapy by patients' characteristics
and satisfaction with dermatologic care.
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Table 1. Self-reported Compliance With Medical Therapy by Patient Characteristics
and Satisfaction With Care
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In multiple logistic regression analysis (Table 2), treatment adherence was strongly associated with complete
satisfaction. Poor quality of life on the emotions scale and age of 60 years
or older were also associated with medication adherence, although the latter
association fell slightly short of statistical significance. On the contrary,
a strong negative association was observed between compliance and psychiatric
morbidity.
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Table 2. Multiple Logistic Regression Risk Ratios (RRs) for the Association
Between Self-reported Compliance With Medical Therapy and Patient Overall
Satisfaction With Care and Patient Characteristics*
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COMMENT
Poor compliance with medical therapy was relatively frequent in our
sample of dermatologic patients, since 44% of patients did not adhere fully
to the dermatologist's prescription. These results are in agreement with previous
surveys, reporting 39% of poor compliance among patients with psoriasis2 and adherence rates of 50% among patients affected
by a variety of other medical conditions.31
The domains of patient satisfaction identified in our study by means of factor
analysis (ie, satisfaction with physician's interpersonal skills and with
access to care) are in line with those reported in previous studies on patients
affected by nondermatologic diseases.21, 29
In our study, medication adherence was strongly associated with overall
satisfaction with care. Poor quality of life on the emotions scale was also
associated with medication adherence. In addition, a borderline significant
association was observed between compliance and older age. On the contrary,
psychiatric morbidity was negatively associated with compliance with dermatologic
treatment.
Previous studies on nondermatologic patients reported an association
between patient satisfaction and compliance with treatment.4, 22
Some authors have highlighted the importance of patient-physician communication
for effective treatment of specific dermatologic diseases, such as psoriasis6 and acne.8 Our study
is the first longitudinal study, to our knowledge, on dermatologic patients
showing that patient satisfaction has a significant and independent effect
on medication adherence. Moreover, factor analysis showed that satisfaction
with a physician's interpersonal skills is a major component of overall satisfaction.
Qualitative data collected in our study on patients' explanations for
not having followed the dermatologist's prescriptions showed that there were
2 main categories of reasons for poor compliance: problems in the patient-physician
relationship (ie, patients were not sufficiently convinced about the appropriateness,
usefulness, or effectiveness of treatment) or problems related to the treatment
itself (ie, patients believed that the treatment was excessively complicated
or long or had caused adverse effects).
Some authors6, 8 have formulated
specific recommendations for dermatologists aimed at improving the patient-physician
communication. However, clinical trials would be necessary to examine in greater
detail what kind of information provided by the dermatologist (eg, on treatment
safety, potential adverse effects) might be most effective in increasing compliance
with medication or whether other approaches (eg, simplified dosing, topical
or systemic treatments, automated remainders) could have a greater impact
on compliance. In fact, many different interventions to improve medication
adherence have been studied, but mainly among patients affected by nondermatologic
disorders, such as psychiatric disorders, hypertension, and asthma. Moreover,
only very few of these studies are rigorous trials, and, until now, very little
evidence has been produced on methods that can be implemented in usual clinical
settings to effectively improve compliance and treatment outcomes.31 Recently, increasing attention is being devoted to
issues of patient involvement in treatment decisions, because it has been
recognized that an individual's opinions, expectations, and values cannot
be neglected in patient-centered health care. In dermatologic care, some authors2, 6, 32 have highlighted that
patient involvement in treatment planning should also include a continuous
assessment of patients' quality of life, a measure that we have found to be
associated with treatment adherence. In particular, high levels of shame and
embarrassment, as measured by the Skindex-29 emotions scale, were found to
be associated with increased compliance, probably mediated by high motivation
for treatment.
It should be emphasized that psychiatric morbidity was the strongest
predictor of poor compliance in our sample. This finding has particular relevance
if one considers that psychiatric morbidity is frequent among dermatologic
outpatients, with epidemiologic studies reporting a prevalence ranging from
25.2% to 42.7%.11-14
In this sample, 21% of patients were identified by the GHQ-12 as having significant
psychiatric morbidity. Such prevalence estimates are 2 to 3 times higher than
1-month or point prevalence estimates of psychiatric disorders in the general
population of Western countries33-34
and are comparable to prevalence estimates observed in Italian general practice
settings.17, 19 Given that the
GHQ-12 is mainly aimed at detecting nonpsychotic disorders, it is reasonable
to assume that most patients identified as "psychiatric cases" by the GHQ-12
have a depressive disorder or an anxiety disorder, and some would not receive
any formal psychiatric diagnosis despite experiencing substantial psychological
distress. The strong association found in our study between psychiatric morbidity
and noncompliance with dermatologic treatment highlights the need for a timely
identification and appropriate management of anxiety disorders and depressive
disorders in everyday dermatologic practice. It is important for dermatologists
to be aware of this issue.
Finally, some potential limitations of our study should be discussed.
Our prevalence estimates of overall satisfaction, psychiatric morbidity, and
compliance with treatment could have been influenced by the fairly high nonparticipation
rate. However, we have compared the demographic characteristics of our study
sample with those of all patients attending the dermatologic clinics at IDI,
and we have found that responders are similar to the total population of IDI
patients. Moreover, it is somewhat reassuring that our results are in agreement
with previous studies. It should also be noted that other factors, not included
in this study, might affect compliance with treatment. In particular, further
studies would be necessary to evaluate the effect of a patient's ability to
pay for medications on treatment adherence.
AUTHOR INFORMATION
Accepted for publication August 7, 2001.
The study was financially supported in part by the Italian Ministry
of Health, Rome.
We thank Luciano Sobrino (Hospital Information System) for providing
administrative data and Simone Bolli and Valentina Salvatori for assisting
in data collection and data entry.
Corresponding author and reprints: Damiano Abeni, MD, MPH, Clinical
Epidemiology Unit, Istituto Dermopatico dell'Immacolata–Istituto di
Ricovero e Cura a Carattere Scientifico, Via dei Monti di Creta, 104, 00167
Rome, Italy (e-mail: d.abeni{at}idi.it).
From the Health Care Quality Research Unit (Drs Renzi and Braga and
Ms Agostini), Clinical Epidemiology Unit (Drs Picardi, Abeni, and Pasquini),
III Dermatological Clinic (Dr Baliva), and Dermatoimmunology Department (Dr
Puddu), Istituto Dermopatico dell'Immacolata–Istituto di Ricovero e
Cura a Carattere Scientifico, Rome, Italy.
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