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Health related quality of life assessment in the routine clinical practice of a dermatology unit


European Journal of Dermatology. Volume 16, Numéro 4, 409-15, July-August 2006, Clinical report


Summary  

Auteur(s) : Stefano Tabolli, Giannandrea Baliva, Giuseppe Alfonso Lombardo, Francesca Sampogna, Cristina Di Pietro, TJ Mannooranparampil, Gabriele Alvetreti, Damiano Abeni , Health Services Research Unit, Istituto Dermopatico dell’Immacolata (IDI-IRCCS), via dei Monti di Creta 104, 00167 Rome, ItalyFax: (+39) 06 6646 4329, 3 rd Clinical Dermatology Unit, Istituto Dermopatico dell’Immacolata (IDI-IRCCS), via dei Monti di Creta 104, 00167 Rome, Italy.

Illustrations

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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