Validation of an original questionnaire for patients with
psoriatic arthritis: The Psoriatic Arthritis Impact Prole (PAIP) S. Coaccioli, A.A. Bruno, G. Celi, M.E. Crapa, V.R. Ferri, F. Masia, M. Papini Internal Medicine and Rheumatology, and Dermatology Unit. Perugia University School of Medicine, Santa Maria General Hospital, Terni, Italy Original article Clin Ter 2014; 165 (2):e100-108. doi: 10.7471/CT.2014.1691 Correspondence: Prof. Stefano Coaccioli, MD, PhD. Chief, Internal Medicine and Rheumatology, Perugia University School of Medicine, Santa Maria General Hospital, via T. di Joannuccio 1, 05100 Terni, Italy. E-mail: stefano.coaccioli@unipg.it Copyright Societ Editrice Universo (SEU) ISSN 1972-6007 Introduction Psoriatic Arthritis (PsA) and Psoriasis (Ps) are associated to multiple health problems and considerably interfere with the quality of Life (QoL). These problems include physical symptoms linked both to the articular and cutaneous disea- ses, difculties in performing daily activities and social in- teractions, along with work problems. A study performed by the National Survey of Functional Health Status has revealed that patients with Ps refer of a worsened QoL compared to patients with arthritis, cancer, chronic lung disease, hyper- Abstract Background and Aims. There is a wide evidence that Psoriatic Arthritis (PsA) as well as Psoriasis (Ps) lead to signicant health pro- blems and interfere with the patient quality of life (QoL). Even though a validated questionnaire for Ps is available, no questionnaire for PsA is currently present in literature. The aim of our work has been to con- rm the efcacy of our original questionnaire as well as to validate it, through the comparison with other existing recognised and accepted questionnaires, such as MOF-SF36, HAQ, McGill Pain Questionnaire, and Zeung Self-Rating Depression and Anxiety Scales. Materials and Methods. We have realized a questionnaire for PsA (Psoriatic Arthritis Impact Questionnaire, PAIP), in terms of psychological and rheumatological evaluation, QoL, social and eco- nomic assets. Results. The statistical comparisons between PAIP and the accepted questionnaires (see above) conrm that PAIP is widely validated and represents a useful tool suitable for clinical evaluation and management of patients with PsA. Conclusions. The indexes of the correlation among the different parts of PAIP and the other questionnaires have shown positive correla- tions. Moreover, PAIP presents a dedicated unit for the economical and therapeutic parameters, The short time for compilation (15 minutes), the easy of comprehension of the questions, and above all the validation of PAIP, make our questionnaire a useful tool, suitable for the clinical management of the patients with PsA. Clin Ter 2014; 165(2):e100-108. doi: 10.7417/CT.2014.1691 Key words: psoriasis, psoriatic arthritis, pain, quality of life, que- stionnaire, validation tension, myocardial infarction, diabetes and depression (1). Qualitative studies evaluating the conditions of life of the patients affected by Ps, have targeted that the most recurrent issue is the feeling of discrimination (2), then the loss of self-esteem, failure of the interpersonal relations, anxiety and depression (3). Suicidal death happens, in fact, in the 5.5% of the cases in the patients with Ps, against the 0.12% of the population in general (3). According to many studies, the severity of Ps (4) is associated to a worsened status of the mental health, both in the patients with Ps and in the patients with PsA (5). Until a few years ago, PsA was considered as a less severe rheumatic pathology compared to the other inam- matory arthritis, as common belief was that this would affect a lower number of joints, and that only in rare ca- ses this disease would have a destructive growth. On the contrary, it is now clear that PsA can be as destructive for joints, generating disability and worsening the QoL. The term impact, as meant as for weighting the disease, is relatively bad dened and it has been, recently, suggested that personal impact in this approach is of fundamental im- portance in order to understand the patients point of view (6), at the point that this would suggest that it is necessary to substitute the actual outcomes referred to the patient with some totally new parameters that would better describe the individual perception of the patient himself, considering that the severity of his condition has to be evaluated also in the light of a social perspective. The international Classication of Functioning Disability and Health (ICF) has recently given a useful framework to evaluate the overall impact of Ps (7). The ICF holds that the impact of this disease can be seen as the expression of the indispositions and its consequently malfunctioning of the body. As for a body to operate correctly, in fact, this is seen to be working on three levels: the organic level (bodys structures or physiological functions, for instance the range of motion, i.e., articular), the personal level (limitation of activities; as getting dressed for example), and the social level (restrictions in participating to the activities of the com- munity; as going to work, for example). In addition, the ICF model claims that the functional expression of the disease is inuenced not only by the disease in itself, but also by some e101 Questionnaire for Psoriatic Arthritis personal dynamics, as could be the age range, the genre and also some psychological features. It can also be inuenced by the environmental setting, including the possibility, or not, to easily access the treatments and the social responses to the individual suffering. This model seems to offer signicant help to evaluate as the individual is affected by PsA (7). Although, many qualitative studies have conrmed that PsA is associated to many daily challenges, it does not currently exist a standard questionnaire able to cover every area of problems. At the moment we do have only questionnaires for each separated area, or different questionnaires for the same area of issues to be explored. The purposes of our work are substantially two: 1) give an overall framework of the QoL of the patients with PsA and Ps through the use of standard questionnaires validated and normally used in the clinical trials; 2) conrm the ef- cacy of an original questionnaire (PAIP, Psoriatic Arthritis Impact Prole) elaborated by us with the intent of validate it, through the use along with the other existing recognised questionnaires. We aim our questionnaire to become a uni- fying tool to assess the overall experience and perceptions of the patients with PsA and Ps (8), especially because it has been expressly formulated to discriminate what value the patient bestows to the PsA and to the Ps. Materials and Methods The sample of our study was constituted by 123 patients (of an average age of 49.63 years, ranging 22-82, 58 males, 65 females). All the patients were affected by Ps (medium duration, 16.5 years). More than a third of the patients (82) presented also a diagnosis of PsA, given in the majority of the cases after (39) or simultaneously (31) with the diagno- sis of Ps; only in 12 cases (10%) PsA appeared before the onset of Ps. To evaluate the entity of cutaneous involvement, all the patients were assessed with PASI (Psoriasis Area Severity Index, 9). Dermatological manifestations resulted to be low in 71 patients, moderate in 22 and severe in 25. All the patients have been enrolled, after they have signed an informed consent agreement, by the Internal Medicine and Rheumatology, and Dermatology Unit of the Perugia University School of Medicine in the Santa Maria General Hospital. The parameter that has been used for the patients to be admitted was that they had already to be clinically dia- gnosed as affected by PsA and/or by Ps by a rheumatologist, a dermatologist and by a general practitioner. Other than the PASI, for all the patients we have used other questionnaires aimed to evaluate the impact of the disease on QoL (PAIP, MOS SF-32, MPQ, S-HAQ, ZSAS e ZSDS). Nevertheless, our research is largely based on the Psoriasis Arthritis Impact Prole (PAIP) (8). We have divided the PAIP in ve parts: a general part and a share of four special parts. In the general part (Table 1) are addressed: the patients personal details, the duration of PsA and Ps, possible hospitalizations for both pathologies, the undergone therapies, an evaluation of the percentage of the extension of the cutaneous disease (0 = 0-5%, 1 = 5-10%, 2 = 10-30%, 3 = >30%) and its loca- lization, an evaluation of the pain as perceived by the patient in the VAS pain scale (0: 0-10%, 1: 10-30%, 2: 3070%, 3: >70%) and its localization. The special parts are composed by multiple answers tests, and the possibility to give to each answer a value between 0 and 3, depending on severity. To some of the questions, it is possible to answer giving a specic connection to PsA or Ps. Special Part I (Table 2) gives a psychological evaluation of the patient and is based on 6 items, with a maximum average of 27 points (21 for Ps). Special Part II (Table 3) gives a social dimension asses- sment of the patient and it is composed by 4 items, with a maximum average of 18 points (12 for Ps). Special Part III (Table 4) gives a rheumatologic evalua- tion of the patient exploring the possible disabilities and the inability to the normal daily activities, and is based on 7 items with a maximum average of 21. Special Part IV (Table 5) gives information on the socio- economic and therapeutic aspects, including the range value of the annual expenses afforded by the patient, except for the free services given by the National Health Care Servi- ce, and is based on 6 items with a maximum average of 18 points. The total score of PAIP is given by the sum of the points given in the 4 special parts and can have an overall result ranging between 0 and 84 for the patients with PsA, and between 0 and 52 for the patients with Ps. The PAIP is available also in the English version and it takes about 15 minutes to be completed. For the clinical evaluation of Ps severity, we have used the PASI (9). In order to evaluate the impact of QoL and to validate our questionnaire, the PAIP has been assessed in comparison of 4 validated tests, largely recognised and used in the clinical practice and statistical analyses: the Medical Outcome Scale Short Form 36 items (MOS SF-36) (10, 11), the McGill Pain Questionnaire (MPQ) (12, 13), the Zeung Self-Rating Depression Scale (ZSDS) (14) and the Zeung Self-Rating Anxiety Scale (ZSAS) (15). Patients affected by PsA have been assessed also with the Health Assessment Questionnaire (HAQ) (16,17), modied to evaluate spon- dyloarthritis (18). Results The data sprung from our study have been calculated using the Spearman coefcient of correlation formula and elaborating the data with the Statistical Package for Social Science (SPSS
Statistics di IBM v21, 2012). Moreover,
some correlations have been examined between the severity of Ps and some factors like age, genre and duration of the disease. The PASI score has not resulted linked with any factor as age or genre; rather it seems to be related with the duration of Ps (Table 6). Some other correspondences have been observed to look for links among the areas explored through the diffe- rent questionnaires used, and the variables of age, genre, duration of disease and severity of Ps. For the outcome of the patient, valued with the MOS SF-36, we have observed that physical activity (PA) is linked with age, while social activities (SA) are mostly related with the severity of Ps (PASI). Also, vitality (VT) could be associated with the PASI score (Table 7). Putting pain into the picture (test MPQ), we have seen some correlations with the severity of Ps (PASI), both in the e102 S. Coaccioli et al. total score and in the different classes of MPQ (Table 8). The subjective evaluation of pain has resulted to be, on the contrary, independent from the parameters like the age and the duration of disease (Table 8). The level of disability has been evaluated with the HAQ questionnaire. Results show that disability is independent from the age factor, but is linked to the duration of PsA (Table 9). Finally, we have observed the distribution of the anxiety and depression symptomatology (respectively through the ZSAS and the ZSDS questionnaires) without nding any signicant correlation with the variables taken into consi- deration (Table 10). To be able to evaluate the efcacy of PAIP as the lonely and unique tool for the overall evaluation of the patient conditions, we have examined the distribution of the values of the sample survey. Later, we evaluated the convergent validity through the determination of the Spearman Index between the PAIP and the correlated scales. The psycholo- gical dimension (PAIP I) resulted to be signicantly corre- lated with the duration of PsA; the social Impact (PAIP II) seems to be, instead, mostly inuenced by the severity of Ps (PASI). Finally, the rheumatologic evaluation (PAIP III) has resulted to be strictly correlated with the duration of Ps (Table 11). Among the questionnaires we have used, we have taken into consideration the MOS SF-2, as one of the most and universally used among the evaluation tools. As we expected, our work has shown some strict correlations with the subscales that are conceptually alike to the two tests. The rst section of PAIP has been confronted with the subscales e103 Questionnaire for Psoriatic Arthritis ER (emotional role and status) and MH (mental health); the second section with the subscales RP (Role and Physical HEALTH) and SA (social activities); the third section has been confronted with PA (Physical activity), PP (physical pain) and VT (vitality). Also, the nal score of the two tests resulted to be highly correlated, both in the sample survey and in the group of patients affected only by arthritis (Table 12 and Table 13). In the subjective evaluation of pain (MPQ), we have found signicant correlations both with the total value of PAIP and with the different subscales (Table 14). For disability level, we have found strong correlations with the third dimension of PAIP (rheumatologic evaluation) and with the total score of the test (Table 15). Finally, the tests ZSDS and ZSAS confronted with the 2 rst sections of the PAIP regarding the psychological and social evaluation of the patient with Ps, have shown the positive correlations presented in Table 16. Discussion From the analysis of the results shown in our study, some considerations can be drawn as follows: the severity of Ps (score PASI) is not linked with the parameter of age nor with the gender, but appears to be linked with the duration of the disease, bringing out the evolutive character of Ps; social activities (subclass AS of MOS SF-36) result mostly com- promised in the patients with a sever cutaneous involvement; regarding the feeling of stigmatization frequently shown in the patients with Ps, it does not surprise that the severity e104 S. Coaccioli et al. of skin damages is the factor properly and mostly correlated with the social participation; the subjective evaluation of pain (score MPQ) results more severe in the patients with PASI high scores. This outcome can be justied from the fact that, in our sample survey, patients with PsA have obtained an average of higher PASI scores compared to the patients with Ps (12.9 against 10.4 of the patients with PsA). Disability (questionnaire HAQ) has resulted strongly correlated with the duration of the disease. Also, this result is justied by the development and disposition of the disease, which in some cases can have a progressive elapse towards disability. The presence of psychological symptoms, as anxiety and depres- sion (score ZSAS and ZSDS) is resulted to be independent from the age, from the severity of the cutaneous involvement and from the duration of the pathology. In this eld, the individual parameters are most probably to play a role of primary importance, as long as with the psychological and the distinctive individual responses of the patient, similarly with the different ways of patients to deal with the disease and the familiar and social environment they are involved with. Regarding the dimensions evaluated with the PAIP, we have observed that the psychological dimension (PAIP I) appears to be independent from the age, duration of disease (Ps) and from the severity of the cutaneous involvement, accordingly with what we have observed through the use of the questionnaires ZSAS and ZSDS; considering only the patients with PsA, the psychological discomfort is resulted to be linked instead with the duration of the disease; the social dimension (PAIP II) seems to be directly related with the severity of the cutaneous manifestations, accordingly with e105 Questionnaire for Psoriatic Arthritis what we have observed through the subscale AS of MOS SF-36; accordingly with what we have observed through the use of the questionnaire HAQ, the rheumatologic dimension (PAIP III) results to be strongly correlated to the duration of PsA. About the ratio between the PAIP dimensions and the correlated scales with other evaluation tools, our study has conrmed that there are strict correlations with all the scales conceptually alike. Total score of PAIP is strictly correlated with the total score of MOS SF-36: the rst part of PAIP, i.e. the one that explores the psychological aspect of the disease, is resulted to be correlated with the MOS SF-36 role and emotional status (RE) and mental health (MH); the second part of PAIP, exploring the social impact of the disease, is correlated to the scales role and physical health (RP) and social activities (SA); third part of PAIP, strictly exploring the rheuma- tologic area, results strictly correlated with the scales physical as well as the scores of its single parts, result to be correlated with the score of MPQ. This result conrms that pain, and in particular how patients feel and ex- perience pain, does give an inuence on all the areas of the patients life, starting from the psychological and social dimension, to the economi- cal dimension. Especially relevant have been resulted the correlations among the emotional aspect of pain (PRI-A) and the psychological dimension (PAIP I) and the total score of MPQ, the economical dimension (PAIP V). In the patients with PsA, the rheumatologic dimension (PAIP III), has resulted to be strictly correla- ted with the severity of the disability, explored with HAQ and S-HAQ. Finally, the psychological (PAIP I) and the social (PAIP II) dimensions have resulted to be correlated with the level of anxiety and depression explored respectively with ZSAS and ZSDS. As conclusive conside- rations, we can afrm that PAIP has conrmed to be for us a valid tool for the evaluation of the patients with PsA and Ps. The PAIP questionnaire, both in its entireness and in its single parts, has shown a distribution of the sample studied substantially similar to the one in the other test, all widely validated by the literature, as well as by the clinical practice. Moreover, the indexes of the correlation among the different parts of PAIP and the scales conceptually alike of the other que- stionnaires have shown their positive correlation. Moreover, PAIP presents a dedicated unit for the economical and therapeutic parameters, an area scarcely explored by the other available questionnaires, nonetheless extremely important to be evaluated, both on the practical-clinical and statistical-epidemiological level. To our opinion, the time for compilation (15 minutes), the easy of comprehension of the questions, and above all the validation of PAIP, make our questionnaire a useful tool, suitable for the clinical management of the patients with PsA. Aknowledgments The Authors would like to thank Ms. Marta Di Felice for her excellent secretarial assistance in the revision of the e106 S. Coaccioli et al. Table 6. Correlation between PASI, age, gender, and duration of Psoriasis (Ps). PASI Age Rho = -0.012 Gender Rho = 0.251 Duration of Ps Rho = 0.503 * *signicant correlation at 0.01 Table 8. Correlation between MPQ scales (S, sensorial; A, affective; V, valutative), PASI, age, and duration of Psoriasis (Ps). PRI-S PRI-A PRI-V PRI-total PASI Rho = 0.551 ** Rho = 0.386 * Rho = 0.433 ** Rho = 0.543 Age Rho = 0.041 Rho = -0.004 Rho = -0.118 Rho = -0.007 Duration of Ps Rho = -0.232 Rho = 0.160 Rho = -0.277 Rho = -0.287 * signicant correlation at 0.05; ** signicant correlation at 0.01 Table 7. Correlation between subscores of MOS SF-32, age, PASI, and duration of Psoriasis (Ps). MOS-AF MOS-VT MOS-AS Age Rho = 0.371 * Rho = 0.032 Rho = 0.034 PASI Rho = 0.112 Rho = 0.437 ** Rho = 0.437 ** Duration of Ps Rho = 0.017 Rho = 0.118 Rho = 0.273 * signicant correlation at 0.05; ** signicant correlation at 0.01 e107 Questionnaire for Psoriatic Arthritis Table 9. Correlation between HAQ, age, and duration of Psoriatic Arthritis (PsA). HAQ S-HAQ Age Rho = 0.253 Rho = 0.221 Duration of PsA Rho = 0.634 * Rho = 0.615 * * Signicant correlation at 0.01 Table 11. Correlation between PAIP and age, PASI, duration of Psoriasis (Ps), duration of Psoriatic Arthritis (PsA). PAIP-I PAIP-II PAIP-III PAIP-IV Age Rho = 0.161 Rho = -0.040 Rho = 0.258 Rho = 0.012 PASI Rho = 0.270 Rho = 0.461 * Rho = 0.138 Rho = 0.303 Duration of Ps Rho = 0.209 Rho = 0.301 Rho = 0.025 Rho = 0.288 Duration of PsA Rho = 0.496 * Rho= 0.153 Rho = 0.679 * Rho = 0.024 * Signicant correlation at 0.01 Table 12. Correlation between PAIP and subscores of MOF SF-32. PAIP I PAIP II PAIP III PAIP IV PAIP total MOS AF - - Rho = 0.802 * - - MOS DF - - Rho = 0.553 * - - MOS RF - Rho = 0.520 * - - - MOS VT - - Rho = 0.528 * - - MOS SM Rho = 0.602 * - - - - MOS AS - Rho = 0.830 * - - - MOS RE Rho = 0.573 * - - - - MOS total - - - - Rho= 0.843 *
* Signicant correlation at 0.01 Table 13. Correlation between PAIP and subscores of MOF SF-32 in patients with Psoriatic Arthritis (PsA) PAIP I PAIP II PAIP III PAIP IV PAIP total MOS AF - - Rho = 0.773 ** - - MOS DF - - Rho = 0.568 ** - - MOS RF - Rho = 0.496 * - - - MOS VT - - Rho = 0.531 ** - - MOS SM Rho = 0.424 * - - - - MOS AS - Rho = 0.816 * - - - MOS RE Rho = 0.487 * - - - - MOS total - - - - Rho = 0.818 ** * Signicant correlation at 0.05; ** signicant correlation at 0.01 Table 14. Correlation between PAIP and subscores of MPQ. PAIP I PAIP II PAIP III PAIP IV PAIP total PRI S Rho = 0.583 * Rho = 0.601 * Rho = 0.506 * Rho = 0.520 * Rho = 0.690 * PRI A Rho = 0.636 * Rho = 0.517 * Rho = 0.593 * Rho = 0.535 * Rho = 0.732 * PRI V Rho = 0.567 * Rho = 0.531 * Rho = 0.461 * Rho = 0.546 * Rho = 0.632 * PRI total Rho = 0.624 * Rho = 0.618 * Rho = 0.554 * Rho = 0.562 * Rho = 0.737 * * Signicant correlation at 0.01 Table 10. Correlation between ZSAS and ZSDS, and age, duration of Psoriasis (Ps), duration of Psoriatic Arthritis (PsA), PASI. ZSAS ZSDS Age Rho = -0.062 Rho = -0.046 Duration of Ps Rho = 0.084 Rho = 0.084 Duration of PsA Rho = 0.130 Rho = 0.181 PASI Rho = 0.249 Rho = 0.291 e108 S. Coaccioli et al. manuscript. This study has been realized under the auspices of the Italian Association for the Study of Pain (AISD), the Paolo Procacci Foundation (PPF), and the Lions Interna- tional Association (108L District of I.T.A.L.Y) of behalf of Club of San Gemini-Terni dei Naharti. References 1. Taylor WJ. Impact of psoriatic arthritis on the patient: through the lens of the WHO International Classication of Functioning, Health, and Disability. Curr Rheumatol Rep 2012; 14(4):369-74 2. Uttjek M, Nygren L, Stenberg B, et al. Marked by visibility of psoriasis in everyday life. Qual Health Res 2007; 17(3):364- 72 3. Feldman S, Behnam SM, Behnam SE, et al. Involving the pa- tient: impact of inammatory skin disease and patient-focused care. J Am Acad Dermatol 2005; 53(1 Suppl 1):S78-85 4. Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic der- matitis and psoriasis. Br J Dermatol 1998; 139(5):846-50 5. Salaf F, Carotti M, Gasparini S, et al. The health-related quality of life in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis: a comparison with a selected sample of healthy people. Health Qual Life Outcomes 2009; 7:25-31 6. Sanderson T, Kirwan J. Patient-reported outcomes for arthri- tis: time to focus on personal life impact measures? Arthritis Rheum 2009; 61(1):1-3 7. The world Health Organization. International Classication of Functioning, Disability and Health: ICF: WHO; 2001 8. Coaccioli S, Di Cato L, Bruni PL, et al. A proposal of que- stionnaire for evaluation of the quality of life in patients with psoriatic arthritis. Rec Prog Med 2003; 94(9):380-6 9. Fredriksson T, Pettersson U. Severe psoriasis: oral therapy with a new retinoid. Dermatologica 1978; 157:238-44 10. McHorney CA, Ware JE Jr, Lu JF, et al. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 1994; 32(1):40-66 11. Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol 1998; 51(11):1025-36 12. Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain, 1985; 1:85-92 13. Salaf F, Nolli M, Cavalieri F, et al. Confronto tra indici algometrici nellesperienza algica in Reumatologia. Utilit della versione italiana del questionario analogico McGill. Reumatismo 1990; 42:198-31 14. Zung WWK. A rating instrument for anxiety disorders. Psychosomatics 1971; 12(6):371-9 15. Zung WWK. A Self-Rating Depression Scale. Arch Gen Psychiatry 1965; 12:63-70 16. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum 1980; 23(2):137- 45 17. Daltroy LH, Larson MG, Roberts NW, Liang MH. A mo- dication of the Health Assessment Questionnaire for the spondyloarthropathies. J Rheumatol 1990; 17(7):946-50 18. Salaf F, Carotti M, Cervini C. Health Assessment Question- naire: la versione italiana di uno strumento di valutazione della qualit della vita del paziente con artrite reumatoide. Adria Med 1997; 19:5-11 Table 15. Correlation between PAIP and HAQ, and S-HAQ. PAIP III PAIP total HAQ Rho = 0.979 * Rho = 0.689 * S-HAQ Rho = 0.940 * Rho = 0.620 * * Signicant correlation at 0.01 Table 16. Correlation between PAIP and ZSAS e ZSDS. PAIP I PAIP II ZSDS Rho = 0.593 * Rho = 0.495 * ZSAS Rho = 0.574 * Rho = 0.597 * * Signicant correlation at 0.01
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