- Email: [email protected]
PSS30 USTEKINUMAB SIGNIFICANTLY IMPROVES QUALITY OF LIFE IN PATIENTS WITH PSORIASIS: RESULTS FROM A PHASE III STUDY
Abstracts cation possession was 28% and number of days covered was 131 using unadjusted days supply estimate. Compared to LAT, odds of achieving medication possession at year’s end were 26%–34% lower for BIM and 34%–36% lower for TRAV (p ⱕ 0.001 for all comparisons for each imputation). Days covered were 21–29 days lower for BIM and 33–42 days lower for TRAV (p ⱕ 0.001 for all comparisons). Failure to refill a 2.5 mL size bottle within the first 90 days had 90%–99% specificity for predicting < 75% days covered. CONCLUSION: Persistence with ocular prostaglandins remains a concern. LAT users were more likely to achieve medication possession and had more days covered during the first therapy year than those treated with BIM or TRAV. Failure to refill the index agent within the initial 90 days predicted poor persistence.
PSS28 DISTANCE VISUAL ACUITY AS A MEASURE OF VISION FUNCTION—INSIGHT INTO THE ASSOCIATION OF ETDRS LETTERS AND SELF-REPORT IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (NV-AMD)
Pleil A1, Buggage R2, Chen L2, Barsdorf A2, Zlateva G2 1 Pfizer Inc, San Diego, CA, USA, 2Pfizer Inc, New York, NY, USA OBJECTIVE: To examine the relationship between distance visual acuity (DVA) and self-reported vision-related quality of life in NV-AMD subjects. METHODS: Baseline data from 113 subjects completing 30 weeks in the PERSPECTIVES study, a multicenter, multi-national 102-week clinical trial for the treatment of NV-AMD, were reviewed. Vision function of the better-seeing eye based on DVA (ETDRS letters at 2m), near vision (BaileyLovie logMAR scores at 25cm), reading speed (words/minute at 25cm), and contrast sensitivity (Pelli-Robson logMAR score at 1m) were all measured. Vision-related quality of life (VR-QOL) was collected using the National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ). Correlations were tested using Pearson’s R, a = 0.05. RESULTS: Subject mean age was 74.0 years (⫾8.0); 67 (59%) were female; and 109 (97%) were white. DVA was significantly correlated with the three clinical measures of vision function (p < 0.001). DVA was also correlated with the NEI-VFQ Distance Vision domain (p = 0.011) but not significantly associated with the Near Vision domain (p = 0.057). With the exception of driving and color vision (p = 0.426 and p = 0.135), the remaining domain scores were significantly correlated with the DVA measure (range p = 0.029 to p = 0.001). CONCLUSION: Some differences in self-reported VR-QOL can be explained by DVA, while other effects on vision functioning are less clear. Therefore, it may be preferable to use more than one measure of vision function when assessing treatment effects.
PSS29 USTEKINUMAB IMPROVES DISEASE SPECIFIC HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH MODERATE TO SEVERE PSORIASIS: RESULTS WITH THE DERMATOLOGY LIFE QUALITY INDEX
Lebwohl M1, Papp K2, Schenkel B3, Eisenberg D3,Yeilding N4, Guzzo C4, Wang Y4, Li S4, Krueger GG5 1 Mount Sinai School of Medicine, New York, NY, USA, 2Probity Medical Research, Waterloo, ON, Canada, 3J&J Pharmaceutical Services L.L.C, Horsham, PA, USA, 4Centocor Research and Development, Inc, Malvern, PA, USA, 5University of Utah Health Sciences Center, Salt Lake City, UT, USA OBJECTIVE: To evaluate the effects of ustekinumab on disease specific HRQoL in psoriasis patients. METHODS: A total of 765 patients were enrolled in the PHOENIX I study. Patients were
A293 randomized 1:1:1 to receive placebo, ustekinumab 45 mg, or ustekinumab 90 mg. In the ustekinumab groups,patients received treatment at weeks 0,4,16, and every 12 weeks thereafter. Patients randomized to placebo at baseline crossed-over to receive either 45 mg or 90 mg of ustekinumab at week 12. Disease specific HRQoL was assessed using the Dermatology Life Quality Index (DLQI). RESULTS: Baseline DLQI scores were similar among treatment groups. The baseline mean (median) total DLQI score was 11.5 (10.0). At week 2, the combined ustekinumab group had significantly greater improvements (p < 0.001) from baseline in DLQI scores compared to the placebo group. All placebo-treated patients crossed over to receive ustekinumab at Week 12 and had comparable DLQI improvements to the groups originally randomized to receive ustekinumab. The mean (median) change from baseline score to week 12 was –8.0 (-6.0) for the 45 mg group and –8.7 (-7.0) for the 90 mg group, compared with –0.6 (0.0) for the placebo group. At week 12, the proportion of patients who achieved a clinically meaningful improvement (decrease of 5 or more points; Kimball et al, 2004) was 64.6% in the 45 mg group and 71.1% in the 90 mg group, compared to 17.9% in the placebo group. Improvements were also demonstrated by the statistically significant proportion of patients in the 45 and 90 mg ustekinumab groups who achieved a DLQI of 0 (32.7% and 34.0%, respectively), as compared to the proportion of patients in the placebo group (0.8%). CONCLUSION: Treatment with ustekinumab 45 mg or 90 mg resulted in significantly improved disease specific HRQoL compared with placebo in patients with moderate to severe psoriasis, as measured by the DLQI. PSS30 USTEKINUMAB SIGNIFICANTLY IMPROVES QUALITY OF LIFE IN PATIENTS WITH PSORIASIS: RESULTS FROM A PHASE III STUDY
Langley R1, Lebwohl M2, Krueger GG3,Yeilding N4, Guzzo C4, Wang Y4, Li S4, Schenkel B5, Reich K6, Leonardi C7 1 Dalhousie University, Halifax, NS, Canada, 2Mount Sinai School of Medicine, New York, NY, USA, 3University of Utah Health Sciences Center, Salt Lake City, UT, USA, 4Centocor Research and Development, Inc, Malvern, PA, USA, 5J&J Pharmaceutical Services L.L.C, Horsham, PA, USA, 6University Hospital, Gottingen, Germany, 7 St. Louis University Medical Hospital, St. Louis, MO, USA OBJECTIVE: To report the impact of ustekinumab on quality of life(QOL)in psoriasis. METHODS: PHOENIX 2 was a multicenter,randomized, double-blind, placebo-controlled, trial in which 1230 psoriasis patients were randomized to receive subcutaneously administered ustekinumab (45or 90 mg 4 weeks apart, then q12 weeks thereafter) or placebo. Patients changed to receive 45 or 90 mg ustekinumab at Weeks 12 and 16. Impact on QOL, anxiety, depression, job performance, and work productivity were assessed using the Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Scale (HADS), and Work Limitations Questionnaire(WLQ). RESULTS: DLQI improvements from baseline were apparent by Week 4 (6.9 for 45 mg and 7.0 for 90 mg versus 1.4 for placebo; each p < 0.001 versus placebo). At Week 12, improvement in DLQI was 9.3 and 10.0 in the 45 and 90 mg groups, compared to 0.5 for placebo(each p < 0.001 versus placebo). DLQI improvement was maintained through Week 24 (9.5 in 45 mg group and 10.3 in 90 mg group). Patients randomized to placebo experienced improvements in DLQI 12 weeks after changing to ustekinumab. At Week 12, 36.7%, and 39.1% of patients receiving 45 and 90mg, achieved a DLQI score of 0, indicating no impact of the disease on patients’ QOL, compared with 1.0% receiving placebo(each p < 0.001 versus placebo). At Week 12, 71.8% of
Abstracts
A294 patients receiving 45 mg and 76.9% of those receiving 90 mg experienced a reduction of 5 points in DLQI score, signifying an important difference, compared with 21.4% for placebo (each p < 0.001 versus placebo). All DLQI scores improved from baseline to Week 12 in each active treatment group compared with placebo (each p < 0.001 versus placebo). Improvements were observed in clinical parameters, HADS, and WLQ. CONCLUSION: Ustekinumab resulted in significant and clinically meaningful improvements in QOL within 1 month after starting treatment; improvements at Week 12 were maintained through Week 24. Improvements were also observed in anxiety, depression, and work limitations.
PSS31 ASSESSMENT OF QUALITY OF LIFE IN DAILY CLINICAL DERMATOLOGICAL ROUTINE: QUESTIONNAIRES AND CHECKLIST
Tabolli S1, Abeni D2, Di Pietro C2, Sampogna F2 1 IDI IRCCS, ROME, Italy, 2IDI IRCCS, Rome, Italy OBJECTIVE: Patient–reported outcome measures, in particular those evaluating health-related quality of life (HrQoL) , have been proposed as a mean of facilitating doctor-patient communication. While these measures are commonly included in clinical research studies, their use in clinical practice is still quite limited. Our objective is to assess HrQoL in a dermatological clinic daily routine and to develop an appropriate and effective reporting tool for health personnel. METHODS: First phase: patients were invited to complete the Skindex-29, GHQ-12, and SF-36 questionnaires. Scores were returned to the clinical staff. Second phase: the patients’ medical records were reviewed to verify which issues (e.g., pain, itch, bleeding, sleep loss, functional limitations, fatigue) highlighted by the questionnaires were recorded/neglected by physicians. Third phase: we developed a check list (presence/absence) of symptoms, emotions or functional problems to be filled by health personnel to complete the routine clinical records. RESULTS: For 170 participants (63% males, 35% age > 64 years), feedback forms were provided within three hours from data collection. We analyzed data for 126 patients with the most common conditions: psoriasis (n = 40), dermatitis (n = 30), leg ulcers (n = 13), pemphigus (n = 22), cutaneous lymphoma (n = 21). Overall, sensitivity of medical records in identifying patients’ problems ranged from zero for most issues (including sleep loss, sex life, bleeding), to 3% for burning, 10% for depression, 15% for pain, and 35% for itching. A 30-item checklist (a synthesis of the three questionnaires) was developed and tested in 100 patients who completed their Skindex-29 questionnaire. The sensitivity and specificity of physicians’ records increased for each issue, ranging from 7% (humiliation) to 81% (itching). CONCLUSION: The routine assessment of HrQoL in dermatology is feasible. The checklist induced the staff to report on medical records often-neglected patients’ problems. The checklist increased substantially the sensitivity of physicians in identifying patients’ problems.
PSS32 QUALITY OF LIFE AND PSYCOLOGICAL DISTRESS IN PATIENT WITH CUTANEUOS LYMPHOMA
Sampogna F1, Frontani M1, Baliva G1, Russo G1, Di Pietro C1, Abeni D1, Tabolli S2 1 IDI IRCCS, Rome, Italy, 2IDI IRCCS, ROME, Italy OBJECTIVE: Cutaneous lymphomas may have a profound impact on patients’ health-related quality of life (HRQoL) and psychological well-being. A detailed investigation of HRQoL, analyzing its correlation with clinical variables and biological
parameters, has not been done before. METHODS: The study population consisted of patients with cutaneous T- cell (CTCL) or B-cell lymphoma (CBCL), consecutively recruited in the outpatient and the inpatient clinics of an Italian hospital. Data was collected using a dermatology-specific questionnaire, the Skindex-29 (symptoms, emotions, and functioning scales), and an oncology-specific questionnaire, the EORTC QLQ-C30 (15 scales, concerning physical and emotional aspects). RESULTS: Of 95 patients, there were 24 patients with CBCL, 59 with mycosis fungoides (MF), and 12 with Sézary syndrome (SS). The most frequent problems appearing from the EORTC QLQ-C30 analysis were fatigue, pain, and insomnia. The differences among hystotypes were particularly high in the global health status and emotional functioning scales, with a worse HRQoL in patients with SS, followed by MF, and CBCL. HRQoL impairment in all hystotypes was higher in women than in men, in patients with probable anxiety or depression, and when the disease worsened. The multivariate analysis of the independent role of each variable confirmed these results. The highest prevalence of probable anxiety or depression was observed in patients treated with systemic steroids (60%) and interferon (50%). CONCLUSION: The detailed evaluation of HRQoL and psychological problems in patients with cutaneous lymphomas, and their relationship with clinical variables, may give important information on the course of the disease as well as the possible effect of treatment. PSS33 INTERNATIONAL DEVELOPMENT OF THE FIRST QUALITY OF LIFE INSTRUMENT SPECIFIC TO COSMETOLOGY AND PHYSICAL APPEARANCE:THE BEAUTYQOL INITIATIVE
Beresniak A1, Auquier P2, Duru G3, Krueger GG4, Talarico S5, Tsutani K6, De Linares Y7, Berger G8 1 Data Mining International, Geneva, Switzerland, 2Laboratoire de Santé Publique, Marseilles, France, 3National Centre of Scientific Research, Lyon, France, 4School of medicine, S.L.C, UT, USA, 5Federal University of Sao Paulo, Sao Paulo, Brazil, 6Tokyo University, Tokyo, Japan, 7L’Oréal International, Asnieres sur Seine, France, 8University Pierre&Marie Curie, Paris, France OBJECTIVE: To develop an internationally validated Quality of Life (QoL) instrument specific to cosmetology and personal appearance. This instrument will allow to measure the impact of the use of cosmetic products in various QoL dimensions. METHODS: Several studies have demonstrated the positive impact of cosmetic products in dimensions. However, no specific instrument exists to assess the main QoL dimensions in the general population of cosmetic users. The BeautQol questionnaire is designed to be a multi-dimensional, self-administered QoL questionnaire developed simultaneously in 13 countries. The questionnaire focuses on concerns identified by users using cosmetic products or cosmetic techniques. Semi directive interviews were carried out simultaneously in 10 countries with a total of 309 users by clinical psychologists in France (32), UK (18), Germany (46), Spain (27), Sweden (19), Russia (16), USA (53), Brazil (32), Japan (48), and China (18). Interviews have been audio or video recorded and reported in a standard format report. Interviews were analyzed both semantically and using text-mining techniques (Alceste software). RESULTS: From the analysis of the 10 interview country reports, 61 items were selected leading to 61 questions in the prototype questionnaire describing major domains such as well being, self esteem, social life, love life, sexual life, confidence, happiness, image, status, emotion, seduction, success, vitality, charisma, motivation, joy, fun, dignity, etc. Three additional countries joined the project (India, South Africa and Italy). The acceptability study is currently in progress with 650 users. The planned validation study
PSS28 DISTANCE VISUAL ACUITY AS A MEASURE OF VISION FUNCTION—INSIGHT INTO THE ASSOCIATION OF ETDRS LETTERS AND SELF-REPORT IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (NV-AMD)
Pleil A1, Buggage R2, Chen L2, Barsdorf A2, Zlateva G2 1 Pfizer Inc, San Diego, CA, USA, 2Pfizer Inc, New York, NY, USA OBJECTIVE: To examine the relationship between distance visual acuity (DVA) and self-reported vision-related quality of life in NV-AMD subjects. METHODS: Baseline data from 113 subjects completing 30 weeks in the PERSPECTIVES study, a multicenter, multi-national 102-week clinical trial for the treatment of NV-AMD, were reviewed. Vision function of the better-seeing eye based on DVA (ETDRS letters at 2m), near vision (BaileyLovie logMAR scores at 25cm), reading speed (words/minute at 25cm), and contrast sensitivity (Pelli-Robson logMAR score at 1m) were all measured. Vision-related quality of life (VR-QOL) was collected using the National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ). Correlations were tested using Pearson’s R, a = 0.05. RESULTS: Subject mean age was 74.0 years (⫾8.0); 67 (59%) were female; and 109 (97%) were white. DVA was significantly correlated with the three clinical measures of vision function (p < 0.001). DVA was also correlated with the NEI-VFQ Distance Vision domain (p = 0.011) but not significantly associated with the Near Vision domain (p = 0.057). With the exception of driving and color vision (p = 0.426 and p = 0.135), the remaining domain scores were significantly correlated with the DVA measure (range p = 0.029 to p = 0.001). CONCLUSION: Some differences in self-reported VR-QOL can be explained by DVA, while other effects on vision functioning are less clear. Therefore, it may be preferable to use more than one measure of vision function when assessing treatment effects.
PSS29 USTEKINUMAB IMPROVES DISEASE SPECIFIC HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH MODERATE TO SEVERE PSORIASIS: RESULTS WITH THE DERMATOLOGY LIFE QUALITY INDEX
Lebwohl M1, Papp K2, Schenkel B3, Eisenberg D3,Yeilding N4, Guzzo C4, Wang Y4, Li S4, Krueger GG5 1 Mount Sinai School of Medicine, New York, NY, USA, 2Probity Medical Research, Waterloo, ON, Canada, 3J&J Pharmaceutical Services L.L.C, Horsham, PA, USA, 4Centocor Research and Development, Inc, Malvern, PA, USA, 5University of Utah Health Sciences Center, Salt Lake City, UT, USA OBJECTIVE: To evaluate the effects of ustekinumab on disease specific HRQoL in psoriasis patients. METHODS: A total of 765 patients were enrolled in the PHOENIX I study. Patients were
A293 randomized 1:1:1 to receive placebo, ustekinumab 45 mg, or ustekinumab 90 mg. In the ustekinumab groups,patients received treatment at weeks 0,4,16, and every 12 weeks thereafter. Patients randomized to placebo at baseline crossed-over to receive either 45 mg or 90 mg of ustekinumab at week 12. Disease specific HRQoL was assessed using the Dermatology Life Quality Index (DLQI). RESULTS: Baseline DLQI scores were similar among treatment groups. The baseline mean (median) total DLQI score was 11.5 (10.0). At week 2, the combined ustekinumab group had significantly greater improvements (p < 0.001) from baseline in DLQI scores compared to the placebo group. All placebo-treated patients crossed over to receive ustekinumab at Week 12 and had comparable DLQI improvements to the groups originally randomized to receive ustekinumab. The mean (median) change from baseline score to week 12 was –8.0 (-6.0) for the 45 mg group and –8.7 (-7.0) for the 90 mg group, compared with –0.6 (0.0) for the placebo group. At week 12, the proportion of patients who achieved a clinically meaningful improvement (decrease of 5 or more points; Kimball et al, 2004) was 64.6% in the 45 mg group and 71.1% in the 90 mg group, compared to 17.9% in the placebo group. Improvements were also demonstrated by the statistically significant proportion of patients in the 45 and 90 mg ustekinumab groups who achieved a DLQI of 0 (32.7% and 34.0%, respectively), as compared to the proportion of patients in the placebo group (0.8%). CONCLUSION: Treatment with ustekinumab 45 mg or 90 mg resulted in significantly improved disease specific HRQoL compared with placebo in patients with moderate to severe psoriasis, as measured by the DLQI. PSS30 USTEKINUMAB SIGNIFICANTLY IMPROVES QUALITY OF LIFE IN PATIENTS WITH PSORIASIS: RESULTS FROM A PHASE III STUDY
Langley R1, Lebwohl M2, Krueger GG3,Yeilding N4, Guzzo C4, Wang Y4, Li S4, Schenkel B5, Reich K6, Leonardi C7 1 Dalhousie University, Halifax, NS, Canada, 2Mount Sinai School of Medicine, New York, NY, USA, 3University of Utah Health Sciences Center, Salt Lake City, UT, USA, 4Centocor Research and Development, Inc, Malvern, PA, USA, 5J&J Pharmaceutical Services L.L.C, Horsham, PA, USA, 6University Hospital, Gottingen, Germany, 7 St. Louis University Medical Hospital, St. Louis, MO, USA OBJECTIVE: To report the impact of ustekinumab on quality of life(QOL)in psoriasis. METHODS: PHOENIX 2 was a multicenter,randomized, double-blind, placebo-controlled, trial in which 1230 psoriasis patients were randomized to receive subcutaneously administered ustekinumab (45or 90 mg 4 weeks apart, then q12 weeks thereafter) or placebo. Patients changed to receive 45 or 90 mg ustekinumab at Weeks 12 and 16. Impact on QOL, anxiety, depression, job performance, and work productivity were assessed using the Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Scale (HADS), and Work Limitations Questionnaire(WLQ). RESULTS: DLQI improvements from baseline were apparent by Week 4 (6.9 for 45 mg and 7.0 for 90 mg versus 1.4 for placebo; each p < 0.001 versus placebo). At Week 12, improvement in DLQI was 9.3 and 10.0 in the 45 and 90 mg groups, compared to 0.5 for placebo(each p < 0.001 versus placebo). DLQI improvement was maintained through Week 24 (9.5 in 45 mg group and 10.3 in 90 mg group). Patients randomized to placebo experienced improvements in DLQI 12 weeks after changing to ustekinumab. At Week 12, 36.7%, and 39.1% of patients receiving 45 and 90mg, achieved a DLQI score of 0, indicating no impact of the disease on patients’ QOL, compared with 1.0% receiving placebo(each p < 0.001 versus placebo). At Week 12, 71.8% of
Abstracts
A294 patients receiving 45 mg and 76.9% of those receiving 90 mg experienced a reduction of 5 points in DLQI score, signifying an important difference, compared with 21.4% for placebo (each p < 0.001 versus placebo). All DLQI scores improved from baseline to Week 12 in each active treatment group compared with placebo (each p < 0.001 versus placebo). Improvements were observed in clinical parameters, HADS, and WLQ. CONCLUSION: Ustekinumab resulted in significant and clinically meaningful improvements in QOL within 1 month after starting treatment; improvements at Week 12 were maintained through Week 24. Improvements were also observed in anxiety, depression, and work limitations.
PSS31 ASSESSMENT OF QUALITY OF LIFE IN DAILY CLINICAL DERMATOLOGICAL ROUTINE: QUESTIONNAIRES AND CHECKLIST
Tabolli S1, Abeni D2, Di Pietro C2, Sampogna F2 1 IDI IRCCS, ROME, Italy, 2IDI IRCCS, Rome, Italy OBJECTIVE: Patient–reported outcome measures, in particular those evaluating health-related quality of life (HrQoL) , have been proposed as a mean of facilitating doctor-patient communication. While these measures are commonly included in clinical research studies, their use in clinical practice is still quite limited. Our objective is to assess HrQoL in a dermatological clinic daily routine and to develop an appropriate and effective reporting tool for health personnel. METHODS: First phase: patients were invited to complete the Skindex-29, GHQ-12, and SF-36 questionnaires. Scores were returned to the clinical staff. Second phase: the patients’ medical records were reviewed to verify which issues (e.g., pain, itch, bleeding, sleep loss, functional limitations, fatigue) highlighted by the questionnaires were recorded/neglected by physicians. Third phase: we developed a check list (presence/absence) of symptoms, emotions or functional problems to be filled by health personnel to complete the routine clinical records. RESULTS: For 170 participants (63% males, 35% age > 64 years), feedback forms were provided within three hours from data collection. We analyzed data for 126 patients with the most common conditions: psoriasis (n = 40), dermatitis (n = 30), leg ulcers (n = 13), pemphigus (n = 22), cutaneous lymphoma (n = 21). Overall, sensitivity of medical records in identifying patients’ problems ranged from zero for most issues (including sleep loss, sex life, bleeding), to 3% for burning, 10% for depression, 15% for pain, and 35% for itching. A 30-item checklist (a synthesis of the three questionnaires) was developed and tested in 100 patients who completed their Skindex-29 questionnaire. The sensitivity and specificity of physicians’ records increased for each issue, ranging from 7% (humiliation) to 81% (itching). CONCLUSION: The routine assessment of HrQoL in dermatology is feasible. The checklist induced the staff to report on medical records often-neglected patients’ problems. The checklist increased substantially the sensitivity of physicians in identifying patients’ problems.
PSS32 QUALITY OF LIFE AND PSYCOLOGICAL DISTRESS IN PATIENT WITH CUTANEUOS LYMPHOMA
Sampogna F1, Frontani M1, Baliva G1, Russo G1, Di Pietro C1, Abeni D1, Tabolli S2 1 IDI IRCCS, Rome, Italy, 2IDI IRCCS, ROME, Italy OBJECTIVE: Cutaneous lymphomas may have a profound impact on patients’ health-related quality of life (HRQoL) and psychological well-being. A detailed investigation of HRQoL, analyzing its correlation with clinical variables and biological
parameters, has not been done before. METHODS: The study population consisted of patients with cutaneous T- cell (CTCL) or B-cell lymphoma (CBCL), consecutively recruited in the outpatient and the inpatient clinics of an Italian hospital. Data was collected using a dermatology-specific questionnaire, the Skindex-29 (symptoms, emotions, and functioning scales), and an oncology-specific questionnaire, the EORTC QLQ-C30 (15 scales, concerning physical and emotional aspects). RESULTS: Of 95 patients, there were 24 patients with CBCL, 59 with mycosis fungoides (MF), and 12 with Sézary syndrome (SS). The most frequent problems appearing from the EORTC QLQ-C30 analysis were fatigue, pain, and insomnia. The differences among hystotypes were particularly high in the global health status and emotional functioning scales, with a worse HRQoL in patients with SS, followed by MF, and CBCL. HRQoL impairment in all hystotypes was higher in women than in men, in patients with probable anxiety or depression, and when the disease worsened. The multivariate analysis of the independent role of each variable confirmed these results. The highest prevalence of probable anxiety or depression was observed in patients treated with systemic steroids (60%) and interferon (50%). CONCLUSION: The detailed evaluation of HRQoL and psychological problems in patients with cutaneous lymphomas, and their relationship with clinical variables, may give important information on the course of the disease as well as the possible effect of treatment. PSS33 INTERNATIONAL DEVELOPMENT OF THE FIRST QUALITY OF LIFE INSTRUMENT SPECIFIC TO COSMETOLOGY AND PHYSICAL APPEARANCE:THE BEAUTYQOL INITIATIVE
Beresniak A1, Auquier P2, Duru G3, Krueger GG4, Talarico S5, Tsutani K6, De Linares Y7, Berger G8 1 Data Mining International, Geneva, Switzerland, 2Laboratoire de Santé Publique, Marseilles, France, 3National Centre of Scientific Research, Lyon, France, 4School of medicine, S.L.C, UT, USA, 5Federal University of Sao Paulo, Sao Paulo, Brazil, 6Tokyo University, Tokyo, Japan, 7L’Oréal International, Asnieres sur Seine, France, 8University Pierre&Marie Curie, Paris, France OBJECTIVE: To develop an internationally validated Quality of Life (QoL) instrument specific to cosmetology and personal appearance. This instrument will allow to measure the impact of the use of cosmetic products in various QoL dimensions. METHODS: Several studies have demonstrated the positive impact of cosmetic products in dimensions. However, no specific instrument exists to assess the main QoL dimensions in the general population of cosmetic users. The BeautQol questionnaire is designed to be a multi-dimensional, self-administered QoL questionnaire developed simultaneously in 13 countries. The questionnaire focuses on concerns identified by users using cosmetic products or cosmetic techniques. Semi directive interviews were carried out simultaneously in 10 countries with a total of 309 users by clinical psychologists in France (32), UK (18), Germany (46), Spain (27), Sweden (19), Russia (16), USA (53), Brazil (32), Japan (48), and China (18). Interviews have been audio or video recorded and reported in a standard format report. Interviews were analyzed both semantically and using text-mining techniques (Alceste software). RESULTS: From the analysis of the 10 interview country reports, 61 items were selected leading to 61 questions in the prototype questionnaire describing major domains such as well being, self esteem, social life, love life, sexual life, confidence, happiness, image, status, emotion, seduction, success, vitality, charisma, motivation, joy, fun, dignity, etc. Three additional countries joined the project (India, South Africa and Italy). The acceptability study is currently in progress with 650 users. The planned validation study