http://informahealthcare.com/jdt ISSN: 0954-6634 (print), 1471-1753 (electronic) J Dermatolog Treat, Early Online: 1–5 ! 2015 Informa UK Ltd. DOI: 10.3109/09546634.2014.992385
ORIGINAL ARTICLE
Treatment refusal among patients with psoriasis Bruno Halioua1, Agathe Maury Le Breton2, Anouk de Fontaubert2, Marie-Emilie Roussel2, and Jean-Franc¸ois Stalder3
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1
Dermatology Department, Institut Alfred Fournier, Paris, France, 2LEO Pharma, Voisins-le-Bretonneux, France, and 3Dermatology Department, CHU Hoˆtel-Dieu, Nantes, France Abstract
Keywords
Background: Treatment refusal, which is defined as a patient actively refusing to take treatment despite physician recommendations, has never been evaluated in psoriasis. Objective: To investigate refusal of topical treatments by patients living with psoriasis in France. Methods: Using responses to an internet study, participants who refused topical treatment (n ¼ 50) were compared to those who applied topical treatment (n ¼ 205). Participants undergoing phototherapy, biotherapy, and oral treatment were excluded. Spearman rank correlations completed by Fisher’s exact tests and Student’s t-tests were performed. Results: Comorbidities, localization of lesions, and symptoms associated with psoriasis were not significant predictors of treatment refusal. Compared to patients who accepted treatment, more patients who refused treatment believed that psoriasis is not manageable (80.0% versus 61.5%; p ¼ 0.01), that psoriasis treatments never work (58.0% versus 27.5%; OR: 2.09 p50.0001), and that all creams have the same effects (54.0% versus 31.7%; OR: 1.7, p ¼ 0.003). Among patients who reported seeking medical attention from physicians, more patients in the treatment refusal group reported some level of dissatisfaction with their relationship with their physician than in the treatment acceptance group. Limitations: The validity of the self-reported treatment refusal could not be evaluated. Conclusion: Treatment refusal is an important element to be taken into consideration in the management of psoriasis.
Adherence treatment, management, psoriasis, topical treatment, treatment refusal, treatment rejection
Introduction The incidence of psoriasis varies depending on the region of the world. It is estimated to affect 4.5 million people in the United States of America with a prevalence ranging from 2.9% in France to 6.5% in Canada (1,2). Although there is a little correlation between severity of disease and discomfort, the burden of disease is considered to be high (1). Many studies have documented the negative impact of psoriasis on quality of life due to physical discomfort, psychosocial stress, negative self-image, social stigmatization, and employment problems (3,4). In the United States of America, for example, 40% of patients describe their psoriasis as being a problem in their lives (1). Topical treatments are the cornerstone of psoriasis treatment (5,6). In a recently published, international study of 1884 psoriasis patients, most patients reported taking topical treatments (92%), followed by oral therapies (23%), phototherapies (10%), and injected therapies (7%) (5). The efficacy of topical treatments, which has been well documented in clinical trials, however, is hampered by poor adherence to treatment with respect both to frequency of application and amount of product applied (6,7). Reasons for non-adherence to topical treatments are numerous and include product specific factors such as low efficacy, messiness of treatment, and convenience of application (6,7). Correspondence: Bruno Halioua, 56, Boulevard Saint-Marcel, 75005 Paris, France. Tel: 33 1 43360025. Fax: 33 1 43371770. E-mail: [email protected]
History Received 3 September 2014 Revised 24 October 2014 Accepted 24 October 2014 Published online 2 February 2015
Another barrier to successful treatment, which has not been previously described in psoriasis research but is often included in adherence data, is treatment refusal. Treatment refusal is a more complex phenomenon than non-adherence as it requires an affirmative act that goes beyond more passive acts of not filling prescriptions, taking medication sporadically, or forgetting to take medication (8,9). Treatment refusal has been documented in patients suffering from atopic dermatitis, but not in patients with psoriasis (10). In the current study, we evaluated the incidence of topical treatment refusal as well as the factors that influence such refusal.
Methods A subanalysis of a previously published international internet survey of psoriasis patients was performed to investigate refusal of topical treatments in France (5). As previously described, participants were recruited from pre-existing databases and asked to fill out the French version of an online survey, which was delivered to patients via a secured website. The survey, which included 68 parts and took approximately 40 min to complete, included demographic questions, clinical questionnaires, and questions pertaining to patient attitudes towards treatment and physicians. The survey was developed and administered in accordance with the recommendations of the European Pharmaceutical Market Research Association. Participants provided informed consent. Participants were included/excluded from the analysis based on their responses to the survey. To be included in the analysis,
2
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J Dermatolog Treat, Early Online: 1–5
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Table 1. Patient demographics.
Age, years Male sex Family history of psoriasis Living alone or widow/er Comorbidities Anxiety Depression Diabetes Hypertension Insomnia Obesity Psoriatic rheumatism Disease characteristics Surface area, number of palmsz Nail psoriasis Age of onset of psoriasis, years Episodes per year Severe itching Crevasses/cutaneous bleeding Burning
Topical* treatment refused N ¼ 50
Topical* treatment accepted N ¼ 205
p valuey
39.8 ± 15.2 20 (40.0%) 17 (34.0%) 15 (30.0%)
42.7 ± 12.3 86 (42.0%) 77 (37.6%) 37 (18.0%)
0.2 0.8 0.6 0.06
21 11 3 5 16 9 4
(42.0%) (22.0%) (6.0%) (10.0%) (32.0%) (18.0%) (8.0%)
2.3 ± 1.8 7 (14.0%) 25.2 ± 14.8 4.9 ± 7.5 11 (22.0%) 12 (24.0%) 2 (4.0%)
92 44 11 34 62 33 8
(44.9%) (21.5%) (5.4%) (16.6%) (30.2%) (16.1%) (3.9%)
2.7 ± 3.0 12 (5.9%) 28.6 ± 13.5 8.3 ± 10.5 65 (31.7%) 53 (25.9%) 12 (5.9%)
0.7 0.9 0.9 0.2 0.8 0.7 0.2 0.3 0.04 0.2 0.01 0.2 0.8 0.6
Quantitative variables are expressed as means ± standard deviation. Qualitative variables are expressed as number and percentage of patients: n (%). *All patients undergoing phototherapy, biotherapy and oral treatment were excluded from the analysis. ySignificance was set at p50.05. zEstimated by number of palm prints needed to cover affected areas.
participants had to have psoriasis, be at least 18 years of age, and be living in France. Patients undergoing phototherapy, biotherapy, or oral treatment were excluded from the analysis. Topical treatment was defined as any prescribed cream, ointment, solution or foam applied externally to the skin (defined in question 29b). Statistics Descriptive statistics were used to summarize data. Quantitative variables are expressed as means ± standard deviation. Qualitative variables are expressed as n (%). Patients were divided into three groups based on their responses to survey questions. Patients who refused treatment were defined as patients who responded ‘‘I do not treat my psoriasis’’ to question 9b ‘‘and, when you treat your psoriasis, how long do the flare-ups usually last?’’ Patients who were not taking treatment and patients who accepted treatment were identified through their responses to question 29b ‘‘How many topical treatments are you currently being prescribed’’ and 30 ‘‘Which topical prescription medications are you currently taking for you psoriasis?’’ If the number topical medications being applied matched the number of prescribed medications reported in question 29b, patients were categorized as patients who accepted treatment. If the number did not match, patients were categorized as patients not taking their medication. Patients who refused treatment and those who accepted treatment were compared. Spearman rank correlations completed by Fisher’s exact tests and Student’s t-tests were performed to identify risk factors for topical treatment refusal within the last month. Significance was set at p50.05.
224 patients reported using no topical treatment (46.8%), and 205 patients reported using topical treatments (42.8%). Demographic variables (age, gender, living alone, family history of psoriasis) and self-reported comorbidities were not significantly different between groups (Table 1). No differences between groups were found for impact of psoriasis on every-day life or for impact of psoriasis on work and social activities (data not shown). No differences between groups were found for localization of lesions (data not shown) or for symptoms (Table 1). However, patients who refused treatment presented more often with nail psoriasis (14.0% versus 5.9% in the treatment acceptance group; p ¼ 0.04) and reported significantly fewer episodes per year (4.9 ± 7.5 versus 8.3 ± 10.5 in the treatment acceptance group; p ¼ 0.01). Patient attitude towards treatment In the treatment refusal group, significantly fewer patients reported believing that psoriasis can be managed (20.0% versus 38.5% in the treatment acceptance group; p50.01), significantly more patients reported believing that topical psoriasis treatments never work (58.0% versus 27.8% in the treatment acceptance group; OR: 2.09, p50.001), significantly fewer patients were willing to stay on prescription medications long-term (30.0% versus 77.6% in the treatment acceptance group; p50.001), and significantly more patients believed that all creams (prescription or over the counter) work the same (54.0% versus 31.7% in the treatment acceptance group; OR:1.07, p ¼ 0.003) (Table 2). Patient relationship with physician
Results Five-hundred and seventy-one patients suffering from psoriasis completed the online survey between 20 December 2010 and 7 January 2011. A total of 479 participants met the inclusion criteria. Fifty patients (10.4%) reported refusing topical treatment,
Most patients reported having seen a dermatologist (57%), a generalist (13%), a homeopath or acupuncturist (11%), or a rheumatologist (5%). In the treatment refusal group, 60% of patients (n ¼ 30) reported no longer consulting physicians. The main reasons for medical care cessation were absence of
Treatment refusal among patients with psoriasis
DOI: 10.3109/09546634.2014.992385
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Table 2. Patient attitudes towards treatment.
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Topical* treatment refused N ¼ 50 My psoriasis is very manageable (Q-45.43), yes I am willing to stay on prescription medication for extended periods of time for my psoriasis (Q-46.1), yes I avoid taking prescription medication for my psoriasis unless absolutely necessary (Q-46.3), yes I prefer to take natural supplements or remedies (i.e. herbal medicines and supplements, homeopathic medicine etc.) instead of prescription medications for my psoriasis (Q-46.4), yes I am eager to try new treatments or medications for my psoriasis (Q-46.6), yes All creams work the same, it does not matter if it is prescribed by the doctor or not (Q-46.17), yes Psoriasis treatments never work (Q-46.21), yes I always expect a new psoriasis treatment to work (Q-46.23), yes I expect treatments to work quickly (Q-46.25), yes
Topical* treatment accepted N ¼ 205
p valuey
79 (38.5%)
0.007
15 (30.0%)
159 (77.6%)
50.0001
27 (54.0%)
78 (38.0%)
0.04
26 (52.0%)
67 (32.7%)
0.01
20 (40.0%)
133 (64.9%)
0.001
27 (54.0%)
65 (31.7%)
0.003
29 (58.0%)
57 (27.8%)
50.0001
25 (50.0%)
142 (69.3%)
0.01
35 (70.0%)
182 (88.8%)
0.0008
10 (20%)
Original survey questions were provided in French. Variables are expressed as number and percentage of patients: n (%). Q, question. *All patients undergoing phototherapy, biotherapy and oral treatment were excluded from the analysis. ySignificance was set at p50.05.
Table 3. Patient perception of interactions with physicians regarding psoriasis.
My doctor has helped me a lot with my psoriasis (Q-47.4), yes My doctor and I collaborate well on the management of my psoriasis (Q-47.9), yes I always follow my doctor’s recommendations about my psoriasis (Q-47.13), yes My doctor takes his/her time listening to me about my psoriasis (Q-47.14), yes My doctor does consider which treatment would best fit my lifestyle and wishes (Q-47.22), yes My doctor does give me clear instructions on how to use my psoriasis treatment (Q-47.23), yes I fully trust my doctor about the management of my psoriasis (Q-47.26), yes
Topical* treatment refused N ¼ 20
Topical* treatment accepted N ¼ 185
10 (50.0%)
135 (73.0%)
0.03
10 (50.0%)
140 (75.7%)
0.01
13 (65.0%)
158 (85.4%)
0.02
13 (65.0%)
159 (85.9%)
0.02
11 (55.0%)
144 (77.8%)
0.02
13 (65.0%)
154 (83.2%)
0.0461
13 (65.0%)
154 (83.2%)
0.0461
p valuey
Original survey questions were provided in French. Variables are expressed as number and percentage of patients: n (%). Q, question. *All patients undergoing phototherapy, biotherapy and oral treatment were excluded from the analysis. ySignificance was set at p50.05.
improvement of psoriasis (40%) and feeling that the physician did not take psoriasis seriously (20%). Whereas in the treatment acceptance group, only 10% of patients reported no longer consulting physicians. Among patients who continued to consult their physician for their psoriasis (n ¼ 20 for the treatment refusal group and n ¼ 185 for the treatment acceptance group) (Table 3), significantly fewer patients in the treatment refusal group reported that they were helped significantly by their physician (50.0% versus 73.0% in the treatment acceptance group; p ¼ 0.03) and that they always followed recommendations from physicians (65.0% versus 85.4% in the treatment acceptance group; p ¼ 0.02). In addition,
significantly fewer patients in the treatment refusal group considered that their physician took the time to listen what he/ she had to say (65.0% versus 85.9% in the treatment acceptance group; p ¼ 0.02) and that their physician had given them clear instructions on how to use the treatment (65.0% versus 83.2% in the treatment acceptance group; p ¼ 0.046).
Discussion Treatment refusal, which is defined as a patient affirming his/her right not to take a treatment (8,9), is an important yet poorly described phenomenon in psoriasis. In this study, 10% of patients
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refused topical prescription treatment despite physician recommendations. Compared to patients who accepted treatment, patients who refused treatment reported a negative attitude towards the effectiveness of topical treatments, less involvement in the management of their psoriasis, and more dissatisfaction with their relationship with their physician. Demographic variables, comorbidities, and self-reported characteristics of psoriasis, however, were not significantly different between the two groups. This survey was designed to identify treatment refusal, which was defined as patients who received no prescriptions for the treatment of their psoriasis. This notion needs to be distinguished from the broader category of primary non-adherence, which describes patients who do not collect their medication after prescription and which has been shown, in at least one dermatology study, to affect 50% of psoriasis patients (11). The data presented herein identify a subset of patients who actively refuse topical treatments and who may need to be considered as a separate group by physicians. Our data show that indicators for treatment refusal fall into two broad categories: negative preconceptions about treatment efficacy and negative feelings about patient-physician relationship and communication. These data are consistent with what is generally known about the gaps in psoriasis treatment, the need for improvement in the doctor-patient relationship and in communication of treatment related instructions (12–14). Indeed, primary and secondary non-adherence have been shown to occur when patient preferences are not taken into consideration, when the patient-physician relationship is poor, and when the patient is not optimistic about efficacy or tolerability of treatment (13–15). Our data are also consistent with what is known about the decision to seek non-conventional health care providers. We found that significantly more patients in the treatment refusal group reported a preference for natural supplements or remedies, which is consistent with the recently reported study by Nelson et al. which showed that psoriasis patients perceiving lack of support from their general practitioner are most likely to withdraw from conventional medical providers and adopt alternative medicines (16). Treatment refusal in other therapeutic areas such as mental disorders and terminal diseases is well recognized and has been extensively documented and discussed as it raises ethical and legal concerns due to the uneasy balance between the patient’s inherent right to refuse treatment, questions about whether a patient’s competence to make such a decision has been compromised by the condition, and the physician’s obligation to provide care (8,9,17). In dermatology, the competence considerations are less relevant, but the study of treatment refusal remains important as it implies an affirmation of intent that needs to be respected by the physician and at the same time addressed in order to help the patient get the care he or she needs. We would like to suggest an approach based on communication in which physicians clearly explain the risks and benefits of the proposed treatment, describe the consequences of treatment refusal, respect the patient’s preferences, and encourage the patient to express specific concerns about topical treatments. Long-term studies would be needed to determine if such an approach is effective. Study limitations As with all surveys of this type, a certain amount of discrepancy between patient responses occurs from one question to the next. In this study, for example, 65% of patients who refused topical treatment considered that they always followed their physician’s recommendations. As refusing treatment, by definition, implies that the patient is not following the physician’s recommendations, these data reflect the limitations and the subjectivity of data
J Dermatolog Treat, Early Online: 1–5
collection through surveys. Multiple explanations for such discrepancies could be proposed, but in particular, it is important to note that the validity of the self-reported treatment refusal described herein cannot be evaluated. For this reason, the conclusions from this study have been derived from multiple questions and should be considered to reflect trends in the behaviors and attitudes of patients refusing topical treatment.
Conclusions In this study of treatment refusal in psoriasis, 10% of patients reported refusing topical treatment. Treatment refusal should therefore be taken into consideration by doctors in the management of patients with psoriasis. An approach based on communication could allow physicians to encourage treatment acceptance while respecting the patient’s right to refuse treatment.
Acknowledgements We thank Galien Health Publishing for providing medical writing assistance.
Declaration of interest This work was funded by LEO Pharma, France. Bruno Halioua received honoraria for consultancy for Leo Pharma France; Jean-Franc¸ois Stalder received honoraria for consultancy for Leo Pharma France, Agathe Maury Le Breton is an employee of Leo Pharma France, Anouk De Fontaubert is an employee of Leo Pharma France and Marie-Emilie Roussel is an employee of Leo Pharma France.
References 1. Stern RS, Nijsten T, Feldman SR, et al. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. J Investig Dermatol Symp Proc. 2004;9:136–9. 2. Lebwohl MG, Bachelez H, Barker J, et al. Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. J Am Acad Dermatol. 2014;70:871–81. 3. de Korte J, Sprangers MA, Mombers FM, Bos JD. Quality of life in patients with psoriasis: a systematic literature review. J Investig Dermatol Symp Proc. 2004;9:140–7. 4. Kimball AB, Jacobson C, Weiss S, et al. The psychosocial burden of psoriasis. Am J Clin Dermatol. 2005;6:383–92. 5. Bewley A, Burrage DM, Ersser SJ, et al. Identifying individual psychosocial and adherence support needs in patients with psoriasis: a multinational two-stage qualitative and quantitative study. J Eur Acad Dermatol Venereol. 2014;28:763–70. 6. Chan SA, Hussain F, Lawson LG, Ormerod AD. Factors affecting adherence to treatment of psoriasis: comparing biologic therapy to other modalities. J Dermatolog Treat. 2013;24:64–9. 7. Devaux S, Castela A, Archier E, et al. Adherence to topical treatment in psoriasis: a systematic literature review. J Eur Acad Dermatol Venereol. 2012;26:61–7. 8. Appelbaum PS, Gutheil TG. Drug refusal: a study of psychiatric inpatients. Am J Psychiatry. 1980;137:340–6. 9. Owiti JA, Bowers L. A narrative review of studies of refusal of psychotropic medication in acute inpatient psychiatric care. J Psychiatr Ment Health Nurs. 2011;18:637–47. 10. Fukaya M. Why do patients with atopic dermatitis refuse to apply topical corticosteroids? Dermatology. 2000;201:242–5. 11. Storm A, Andersen SE, Benfeldt E, Serup J. One in 3 prescriptions are never redeemed: primary nonadherence in an outpatient clinic. J Am Acad Dermatol. 2008;59:27–33. 12. Nelson PA, Barker Z, Griffiths CE, et al. ‘On the surface’: a qualitative study of GPs’ and patients’ perspectives on psoriasis. BMC Fam Pract. 2013;14:158.
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13. Puig L, Carrascosa JM, Belinchon I, et al. Adherence and patient satisfaction with topical treatment in psoriasis, and the use, and organoleptic properties of such treatments: a Delphi study with an expert panel and members of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology. Actas Dermosifiliogr. 2013;104:488–96. 14. Richards HL, Fortune DG, Griffiths CE. Adherence to treatment in patients with psoriasis. J Eur Acad Dermatol Venereol. 2006;20: 370–9.
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15. Bewley A, Page B. Maximizing patient adherence for optimal outcomes in psoriasis. J Eur Acad Dermatol Venereol. 2011;25: 9–14. 16. Nelson PA, Chew-Graham CA, Griffiths CE, Cordingley L. Recognition of need in health care consultations: a qualitative study of people with psoriasis. Br J Dermatol. 2013;168: 354–61. 17. Huchcroft SA, Snodgrass T. Cancer patients who refuse treatment. Cancer Causes Control. 1993;4:179–85.
ORIGINAL ARTICLE
Treatment refusal among patients with psoriasis Bruno Halioua1, Agathe Maury Le Breton2, Anouk de Fontaubert2, Marie-Emilie Roussel2, and Jean-Franc¸ois Stalder3
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1
Dermatology Department, Institut Alfred Fournier, Paris, France, 2LEO Pharma, Voisins-le-Bretonneux, France, and 3Dermatology Department, CHU Hoˆtel-Dieu, Nantes, France Abstract
Keywords
Background: Treatment refusal, which is defined as a patient actively refusing to take treatment despite physician recommendations, has never been evaluated in psoriasis. Objective: To investigate refusal of topical treatments by patients living with psoriasis in France. Methods: Using responses to an internet study, participants who refused topical treatment (n ¼ 50) were compared to those who applied topical treatment (n ¼ 205). Participants undergoing phototherapy, biotherapy, and oral treatment were excluded. Spearman rank correlations completed by Fisher’s exact tests and Student’s t-tests were performed. Results: Comorbidities, localization of lesions, and symptoms associated with psoriasis were not significant predictors of treatment refusal. Compared to patients who accepted treatment, more patients who refused treatment believed that psoriasis is not manageable (80.0% versus 61.5%; p ¼ 0.01), that psoriasis treatments never work (58.0% versus 27.5%; OR: 2.09 p50.0001), and that all creams have the same effects (54.0% versus 31.7%; OR: 1.7, p ¼ 0.003). Among patients who reported seeking medical attention from physicians, more patients in the treatment refusal group reported some level of dissatisfaction with their relationship with their physician than in the treatment acceptance group. Limitations: The validity of the self-reported treatment refusal could not be evaluated. Conclusion: Treatment refusal is an important element to be taken into consideration in the management of psoriasis.
Adherence treatment, management, psoriasis, topical treatment, treatment refusal, treatment rejection
Introduction The incidence of psoriasis varies depending on the region of the world. It is estimated to affect 4.5 million people in the United States of America with a prevalence ranging from 2.9% in France to 6.5% in Canada (1,2). Although there is a little correlation between severity of disease and discomfort, the burden of disease is considered to be high (1). Many studies have documented the negative impact of psoriasis on quality of life due to physical discomfort, psychosocial stress, negative self-image, social stigmatization, and employment problems (3,4). In the United States of America, for example, 40% of patients describe their psoriasis as being a problem in their lives (1). Topical treatments are the cornerstone of psoriasis treatment (5,6). In a recently published, international study of 1884 psoriasis patients, most patients reported taking topical treatments (92%), followed by oral therapies (23%), phototherapies (10%), and injected therapies (7%) (5). The efficacy of topical treatments, which has been well documented in clinical trials, however, is hampered by poor adherence to treatment with respect both to frequency of application and amount of product applied (6,7). Reasons for non-adherence to topical treatments are numerous and include product specific factors such as low efficacy, messiness of treatment, and convenience of application (6,7). Correspondence: Bruno Halioua, 56, Boulevard Saint-Marcel, 75005 Paris, France. Tel: 33 1 43360025. Fax: 33 1 43371770. E-mail: [email protected]
History Received 3 September 2014 Revised 24 October 2014 Accepted 24 October 2014 Published online 2 February 2015
Another barrier to successful treatment, which has not been previously described in psoriasis research but is often included in adherence data, is treatment refusal. Treatment refusal is a more complex phenomenon than non-adherence as it requires an affirmative act that goes beyond more passive acts of not filling prescriptions, taking medication sporadically, or forgetting to take medication (8,9). Treatment refusal has been documented in patients suffering from atopic dermatitis, but not in patients with psoriasis (10). In the current study, we evaluated the incidence of topical treatment refusal as well as the factors that influence such refusal.
Methods A subanalysis of a previously published international internet survey of psoriasis patients was performed to investigate refusal of topical treatments in France (5). As previously described, participants were recruited from pre-existing databases and asked to fill out the French version of an online survey, which was delivered to patients via a secured website. The survey, which included 68 parts and took approximately 40 min to complete, included demographic questions, clinical questionnaires, and questions pertaining to patient attitudes towards treatment and physicians. The survey was developed and administered in accordance with the recommendations of the European Pharmaceutical Market Research Association. Participants provided informed consent. Participants were included/excluded from the analysis based on their responses to the survey. To be included in the analysis,
2
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J Dermatolog Treat, Early Online: 1–5
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Table 1. Patient demographics.
Age, years Male sex Family history of psoriasis Living alone or widow/er Comorbidities Anxiety Depression Diabetes Hypertension Insomnia Obesity Psoriatic rheumatism Disease characteristics Surface area, number of palmsz Nail psoriasis Age of onset of psoriasis, years Episodes per year Severe itching Crevasses/cutaneous bleeding Burning
Topical* treatment refused N ¼ 50
Topical* treatment accepted N ¼ 205
p valuey
39.8 ± 15.2 20 (40.0%) 17 (34.0%) 15 (30.0%)
42.7 ± 12.3 86 (42.0%) 77 (37.6%) 37 (18.0%)
0.2 0.8 0.6 0.06
21 11 3 5 16 9 4
(42.0%) (22.0%) (6.0%) (10.0%) (32.0%) (18.0%) (8.0%)
2.3 ± 1.8 7 (14.0%) 25.2 ± 14.8 4.9 ± 7.5 11 (22.0%) 12 (24.0%) 2 (4.0%)
92 44 11 34 62 33 8
(44.9%) (21.5%) (5.4%) (16.6%) (30.2%) (16.1%) (3.9%)
2.7 ± 3.0 12 (5.9%) 28.6 ± 13.5 8.3 ± 10.5 65 (31.7%) 53 (25.9%) 12 (5.9%)
0.7 0.9 0.9 0.2 0.8 0.7 0.2 0.3 0.04 0.2 0.01 0.2 0.8 0.6
Quantitative variables are expressed as means ± standard deviation. Qualitative variables are expressed as number and percentage of patients: n (%). *All patients undergoing phototherapy, biotherapy and oral treatment were excluded from the analysis. ySignificance was set at p50.05. zEstimated by number of palm prints needed to cover affected areas.
participants had to have psoriasis, be at least 18 years of age, and be living in France. Patients undergoing phototherapy, biotherapy, or oral treatment were excluded from the analysis. Topical treatment was defined as any prescribed cream, ointment, solution or foam applied externally to the skin (defined in question 29b). Statistics Descriptive statistics were used to summarize data. Quantitative variables are expressed as means ± standard deviation. Qualitative variables are expressed as n (%). Patients were divided into three groups based on their responses to survey questions. Patients who refused treatment were defined as patients who responded ‘‘I do not treat my psoriasis’’ to question 9b ‘‘and, when you treat your psoriasis, how long do the flare-ups usually last?’’ Patients who were not taking treatment and patients who accepted treatment were identified through their responses to question 29b ‘‘How many topical treatments are you currently being prescribed’’ and 30 ‘‘Which topical prescription medications are you currently taking for you psoriasis?’’ If the number topical medications being applied matched the number of prescribed medications reported in question 29b, patients were categorized as patients who accepted treatment. If the number did not match, patients were categorized as patients not taking their medication. Patients who refused treatment and those who accepted treatment were compared. Spearman rank correlations completed by Fisher’s exact tests and Student’s t-tests were performed to identify risk factors for topical treatment refusal within the last month. Significance was set at p50.05.
224 patients reported using no topical treatment (46.8%), and 205 patients reported using topical treatments (42.8%). Demographic variables (age, gender, living alone, family history of psoriasis) and self-reported comorbidities were not significantly different between groups (Table 1). No differences between groups were found for impact of psoriasis on every-day life or for impact of psoriasis on work and social activities (data not shown). No differences between groups were found for localization of lesions (data not shown) or for symptoms (Table 1). However, patients who refused treatment presented more often with nail psoriasis (14.0% versus 5.9% in the treatment acceptance group; p ¼ 0.04) and reported significantly fewer episodes per year (4.9 ± 7.5 versus 8.3 ± 10.5 in the treatment acceptance group; p ¼ 0.01). Patient attitude towards treatment In the treatment refusal group, significantly fewer patients reported believing that psoriasis can be managed (20.0% versus 38.5% in the treatment acceptance group; p50.01), significantly more patients reported believing that topical psoriasis treatments never work (58.0% versus 27.8% in the treatment acceptance group; OR: 2.09, p50.001), significantly fewer patients were willing to stay on prescription medications long-term (30.0% versus 77.6% in the treatment acceptance group; p50.001), and significantly more patients believed that all creams (prescription or over the counter) work the same (54.0% versus 31.7% in the treatment acceptance group; OR:1.07, p ¼ 0.003) (Table 2). Patient relationship with physician
Results Five-hundred and seventy-one patients suffering from psoriasis completed the online survey between 20 December 2010 and 7 January 2011. A total of 479 participants met the inclusion criteria. Fifty patients (10.4%) reported refusing topical treatment,
Most patients reported having seen a dermatologist (57%), a generalist (13%), a homeopath or acupuncturist (11%), or a rheumatologist (5%). In the treatment refusal group, 60% of patients (n ¼ 30) reported no longer consulting physicians. The main reasons for medical care cessation were absence of
Treatment refusal among patients with psoriasis
DOI: 10.3109/09546634.2014.992385
3
Table 2. Patient attitudes towards treatment.
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Topical* treatment refused N ¼ 50 My psoriasis is very manageable (Q-45.43), yes I am willing to stay on prescription medication for extended periods of time for my psoriasis (Q-46.1), yes I avoid taking prescription medication for my psoriasis unless absolutely necessary (Q-46.3), yes I prefer to take natural supplements or remedies (i.e. herbal medicines and supplements, homeopathic medicine etc.) instead of prescription medications for my psoriasis (Q-46.4), yes I am eager to try new treatments or medications for my psoriasis (Q-46.6), yes All creams work the same, it does not matter if it is prescribed by the doctor or not (Q-46.17), yes Psoriasis treatments never work (Q-46.21), yes I always expect a new psoriasis treatment to work (Q-46.23), yes I expect treatments to work quickly (Q-46.25), yes
Topical* treatment accepted N ¼ 205
p valuey
79 (38.5%)
0.007
15 (30.0%)
159 (77.6%)
50.0001
27 (54.0%)
78 (38.0%)
0.04
26 (52.0%)
67 (32.7%)
0.01
20 (40.0%)
133 (64.9%)
0.001
27 (54.0%)
65 (31.7%)
0.003
29 (58.0%)
57 (27.8%)
50.0001
25 (50.0%)
142 (69.3%)
0.01
35 (70.0%)
182 (88.8%)
0.0008
10 (20%)
Original survey questions were provided in French. Variables are expressed as number and percentage of patients: n (%). Q, question. *All patients undergoing phototherapy, biotherapy and oral treatment were excluded from the analysis. ySignificance was set at p50.05.
Table 3. Patient perception of interactions with physicians regarding psoriasis.
My doctor has helped me a lot with my psoriasis (Q-47.4), yes My doctor and I collaborate well on the management of my psoriasis (Q-47.9), yes I always follow my doctor’s recommendations about my psoriasis (Q-47.13), yes My doctor takes his/her time listening to me about my psoriasis (Q-47.14), yes My doctor does consider which treatment would best fit my lifestyle and wishes (Q-47.22), yes My doctor does give me clear instructions on how to use my psoriasis treatment (Q-47.23), yes I fully trust my doctor about the management of my psoriasis (Q-47.26), yes
Topical* treatment refused N ¼ 20
Topical* treatment accepted N ¼ 185
10 (50.0%)
135 (73.0%)
0.03
10 (50.0%)
140 (75.7%)
0.01
13 (65.0%)
158 (85.4%)
0.02
13 (65.0%)
159 (85.9%)
0.02
11 (55.0%)
144 (77.8%)
0.02
13 (65.0%)
154 (83.2%)
0.0461
13 (65.0%)
154 (83.2%)
0.0461
p valuey
Original survey questions were provided in French. Variables are expressed as number and percentage of patients: n (%). Q, question. *All patients undergoing phototherapy, biotherapy and oral treatment were excluded from the analysis. ySignificance was set at p50.05.
improvement of psoriasis (40%) and feeling that the physician did not take psoriasis seriously (20%). Whereas in the treatment acceptance group, only 10% of patients reported no longer consulting physicians. Among patients who continued to consult their physician for their psoriasis (n ¼ 20 for the treatment refusal group and n ¼ 185 for the treatment acceptance group) (Table 3), significantly fewer patients in the treatment refusal group reported that they were helped significantly by their physician (50.0% versus 73.0% in the treatment acceptance group; p ¼ 0.03) and that they always followed recommendations from physicians (65.0% versus 85.4% in the treatment acceptance group; p ¼ 0.02). In addition,
significantly fewer patients in the treatment refusal group considered that their physician took the time to listen what he/ she had to say (65.0% versus 85.9% in the treatment acceptance group; p ¼ 0.02) and that their physician had given them clear instructions on how to use the treatment (65.0% versus 83.2% in the treatment acceptance group; p ¼ 0.046).
Discussion Treatment refusal, which is defined as a patient affirming his/her right not to take a treatment (8,9), is an important yet poorly described phenomenon in psoriasis. In this study, 10% of patients
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B. Halioua et al.
refused topical prescription treatment despite physician recommendations. Compared to patients who accepted treatment, patients who refused treatment reported a negative attitude towards the effectiveness of topical treatments, less involvement in the management of their psoriasis, and more dissatisfaction with their relationship with their physician. Demographic variables, comorbidities, and self-reported characteristics of psoriasis, however, were not significantly different between the two groups. This survey was designed to identify treatment refusal, which was defined as patients who received no prescriptions for the treatment of their psoriasis. This notion needs to be distinguished from the broader category of primary non-adherence, which describes patients who do not collect their medication after prescription and which has been shown, in at least one dermatology study, to affect 50% of psoriasis patients (11). The data presented herein identify a subset of patients who actively refuse topical treatments and who may need to be considered as a separate group by physicians. Our data show that indicators for treatment refusal fall into two broad categories: negative preconceptions about treatment efficacy and negative feelings about patient-physician relationship and communication. These data are consistent with what is generally known about the gaps in psoriasis treatment, the need for improvement in the doctor-patient relationship and in communication of treatment related instructions (12–14). Indeed, primary and secondary non-adherence have been shown to occur when patient preferences are not taken into consideration, when the patient-physician relationship is poor, and when the patient is not optimistic about efficacy or tolerability of treatment (13–15). Our data are also consistent with what is known about the decision to seek non-conventional health care providers. We found that significantly more patients in the treatment refusal group reported a preference for natural supplements or remedies, which is consistent with the recently reported study by Nelson et al. which showed that psoriasis patients perceiving lack of support from their general practitioner are most likely to withdraw from conventional medical providers and adopt alternative medicines (16). Treatment refusal in other therapeutic areas such as mental disorders and terminal diseases is well recognized and has been extensively documented and discussed as it raises ethical and legal concerns due to the uneasy balance between the patient’s inherent right to refuse treatment, questions about whether a patient’s competence to make such a decision has been compromised by the condition, and the physician’s obligation to provide care (8,9,17). In dermatology, the competence considerations are less relevant, but the study of treatment refusal remains important as it implies an affirmation of intent that needs to be respected by the physician and at the same time addressed in order to help the patient get the care he or she needs. We would like to suggest an approach based on communication in which physicians clearly explain the risks and benefits of the proposed treatment, describe the consequences of treatment refusal, respect the patient’s preferences, and encourage the patient to express specific concerns about topical treatments. Long-term studies would be needed to determine if such an approach is effective. Study limitations As with all surveys of this type, a certain amount of discrepancy between patient responses occurs from one question to the next. In this study, for example, 65% of patients who refused topical treatment considered that they always followed their physician’s recommendations. As refusing treatment, by definition, implies that the patient is not following the physician’s recommendations, these data reflect the limitations and the subjectivity of data
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collection through surveys. Multiple explanations for such discrepancies could be proposed, but in particular, it is important to note that the validity of the self-reported treatment refusal described herein cannot be evaluated. For this reason, the conclusions from this study have been derived from multiple questions and should be considered to reflect trends in the behaviors and attitudes of patients refusing topical treatment.
Conclusions In this study of treatment refusal in psoriasis, 10% of patients reported refusing topical treatment. Treatment refusal should therefore be taken into consideration by doctors in the management of patients with psoriasis. An approach based on communication could allow physicians to encourage treatment acceptance while respecting the patient’s right to refuse treatment.
Acknowledgements We thank Galien Health Publishing for providing medical writing assistance.
Declaration of interest This work was funded by LEO Pharma, France. Bruno Halioua received honoraria for consultancy for Leo Pharma France; Jean-Franc¸ois Stalder received honoraria for consultancy for Leo Pharma France, Agathe Maury Le Breton is an employee of Leo Pharma France, Anouk De Fontaubert is an employee of Leo Pharma France and Marie-Emilie Roussel is an employee of Leo Pharma France.
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