Skindex-29 Questionnaire Research Articles

Qol-O-05 - An update on health-related quality of life from the PROCLIPI study

Background: Health-related quality of life (HRQoL) is a multi-dimensional concept that focuses on the impact of health status on quality of life. Mycosis fungoides/Sézary syndrome (MF/SS), the prototypical forms of cutaneous T cell lymphoma, are visible cutaneous malignancies with a profound effect of HRQoL. The PROCLIPI study is a multi-national prospective study collecting pre-defined clinical, treatment and quality of life data and began recruiting 2015. Objectives: To provide an update of HRQoL data captured in the PROCLIPI study to date. Methods: HRQoL per study visit was assessed using the Skindex-29 questionnaire and data obtained from the PROCLIPI database together with demographic, clinical, and histologic information. The data was analysed using a combination of descriptive and inferential statistics. Results: To date, 1594 Skindex-29 questionnaires (median 1, min–max 1–9) have been collected from 812 individuals from 33 centres across 16 countries. Respondents included 518 males and 294 females (male:fmale ratio 1.8:1) with a median (IQR) age of 61 (48–71 years). CTCL subtypes included 75.5% with classical MF, 13.2% folliculotropic MF, 0.6% with pagetoid reticulosis and 10.7% Sézary syndrome. 76.3% had early-stage disease and 23.6% had late-stage disease. The number of skindex-29 questionnaires collected per visit included: visit 1 = 569, visit 2 = 325, visit 3 = 254, visit 4 = 186, visit 5 = 109 and visit 6+ = 150. The number of paired observations between visit 1 and visit 2 was 188. Median skindex-29 scores improved between visit 1 and visit 2 for symptoms (p=0.002), emotions (p=0.002) and global scores (p=0.007) but not for functioning (p=0.41). No significant differences were identified in Skindex-29 scores beyond visit 2. Conclusion: The PROCLIPI registry is the most extensive study to date to examine HRQoL in patients with MF/SS. Preliminary analysis of this data has shown an improved HRQoL between visit 1 and visit 2 and for both symptoms and emotions possibly due to effective treatment and education on their disease but plateaus after that. Longitudinal analysis of this data will help to identify individual, disease and treatment characteristics that influence HRQoL changes over time. Health-related quality of life (HRQoL) is a multi-dimensional concept that focuses on the impact of health status on quality of life. Mycosis fungoides/Sézary syndrome (MF/SS), the prototypical forms of cutaneous T cell lymphoma, are visible cutaneous malignancies with a profound effect of HRQoL. The PROCLIPI study is a multi-national prospective study collecting pre-defined clinical, treatment and quality of life data and began recruiting 2015. To provide an update of HRQoL data captured in the PROCLIPI study to date. HRQoL per study visit was assessed using the Skindex-29 questionnaire and data obtained from the PROCLIPI database together with demographic, clinical, and histologic information. The data was analysed using a combination of descriptive and inferential statistics. To date, 1594 Skindex-29 questionnaires (median 1, min–max 1–9) have been collected from 812 individuals from 33 centres across 16 countries. Respondents included 518 males and 294 females (male:fmale ratio 1.8:1) with a median (IQR) age of 61 (48–71 years). CTCL subtypes included 75.5% with classical MF, 13.2% folliculotropic MF, 0.6% with pagetoid reticulosis and 10.7% Sézary syndrome. 76.3% had early-stage disease and 23.6% had late-stage disease. The number of skindex-29 questionnaires collected per visit included: visit 1 = 569, visit 2 = 325, visit 3 = 254, visit 4 = 186, visit 5 = 109 and visit 6+ = 150. The number of paired observations between visit 1 and visit 2 was 188. Median skindex-29 scores improved between visit 1 and visit 2 for symptoms (p=0.002), emotions (p=0.002) and global scores (p=0.007) but not for functioning (p=0.41). No significant differences were identified in Skindex-29 scores beyond visit 2. The PROCLIPI registry is the most extensive study to date to examine HRQoL in patients with MF/SS. Preliminary analysis of this data has shown an improved HRQoL between visit 1 and visit 2 and for both symptoms and emotions possibly due to effective treatment and education on their disease but plateaus after that. Longitudinal analysis of this data will help to identify individual, disease and treatment characteristics that influence HRQoL changes over time.

Tre-O1-02 - Real world data shows that chlormethine gel is efficient and safe in mycosis fungoides skin lesions

<h3>Background:</h3> Chlormethine gel is a skin-directed therapy used for patients with mycosis fungoides (MF) that has shown promising results in a randomized clinical trial. Currently, data on chlormethine gel use in real-world settings is limited. <h3>Objectives:</h3> To assess safety and efficacy of chlormethine gel treatment in patients treated during daily clinical practice, and investigate associations between response and disease stage, lesion type, mono- or combination therapy, and occurrence of dermatitis. <h3>Methods:</h3> A retrospective chart review of patients using chlormethine gel from 3 sites in Greece was performed. Efficacy was assessed through modified Severity-Weighted Assessment Tool (mSWAT) scores. Safety assessments included analysis of the occurrence and severity of dermatitis. The Skindex-29 questionnaire was used to evaluate quality of life. <h3>Results:</h3> A total of 58 patients were included. The overall response rate (ORR) increased from 37.9% at month 1 to 80.8% at month 9. For 64.2% of patients, response was maintained for at least 4 months (ORR4). At month 3, a higher ORR was seen for patients with patches (69.7%) than patients with plaques/tumors (both 15.2%). A higher ORR4 was observed for patients with early-stage vs late-stage disease (71.4% vs 36.4%) and patients on mono- vs combination therapy (75% vs 47.6%). Dermatitis was observed in the majority of patients (72.4%), but the presence or severity of dermatitis was not directly correlated with treatment response. Both mSWAT and Skindex-29 scores decreased significantly during treatment, and changes in these scores from baseline to month 6 showed a positive correlation (r=0.55, p=0.026). <h3>Conclusions:</h3> Chlormethine gel treatment was effective for patients with all stages of MF in clinical practice, although patients with patch-stage or early-stage disease may have higher response rates or more durable responses compared with patients with more-advanced disease. Response rates increased over time, indicating that continued treatment with the gel is important. Dermatitis may be managed by reducing the treatment frequency, and the occurrence of dermatitis did not affect the response to CL gel treatment.

Psychological assessment of atopic dermatitis in Asia: a systematic review

ABSTRACT Atopic dermatitis (AD) is a frequently occurring skin disorder in Asia that substantially impacts the social, financial, and psychological lives of individuals. However, there is uncertainty regarding the psychological instruments for this domain. Hence, this review systematically assessed the existing measurement instruments used, developed, and/or validated for the measurement of psychological outcomes in Asian adult patients with AD as well as the scope of those assessment tools (e.g. validity and reliability). Electronic searches were performed using six databases (inception to February 2020) to identify studies. Thematic analysis of 44 included studies revealed that the commonly employed tools to assess the quality of life were the Dermatology Life Quality Index followed by the Skindex-16 questionnaire, the European Quality of Life-5 Dimensions, and the Quality of Life Hand Eczema Questionnaire. Similarly, the Patient Health Questionnaire, Self-rating depression scale (SDS), and Hospital Anxiety and Depression Scale were frequently employed to assess depressive symptoms. Additionally, symptoms of anxiety were frequently assessed through Interaction Anxiousness Scale and the Spielberger State-Trait Anxiety Inventory. Although a variety of psychological assessment measures have been used in research, data on their reliability and validity is limited. Also, information on the cultural applicability of these instruments is scantier. More research is needed to ascertain the suitability of tools for use in clinical practice.

Investigating bacterial decolonization for the prevention of radiation dermatitis: A randomized controlled trial and quality of life assessment.

TPS12137 Background: Radiation dermatitis (RD) can be therapy-limiting and detrimental to quality of life for cancer patients receiving radiation therapy (RT). Bacteria play an important role in many inflammatory dermatoses. In an observational clinical study, our group discovered that nasal colonization with bacteria, specifically with Staphylococcus aureus (SA), prior to RT was an independent predictor of higher-grade RD (grade ≥2). Higher-grade RD patients were also found to have more SA on the irradiated skin after treatment. If successful, bacterial decolonization could be a safe and cost-effective method to prevent RD. Methods: This is a randomized controlled trial assessing the efficacy of universal bacterial decolonization in preventing RD. Subject inclusion criteria include patients who are aged ≥ 18 years with a diagnosis of a solid tumor of the breast or head and neck with plans for fractionated RT (≥ 15 fractions) with curative intent. Based on previous studies and power analyses, we plan to recruit a total of 80 patients. Patients in the control arm will be treated according to standard of care, including daily application of emollients and gentle bathing. In addition to standard of care, patients in the intervention arm will receive a decolonization regimen consisting of intranasal mupirocin ointment used twice daily and chlorhexidine wash used daily for 5 days prior to the initiation of RT and repeated for 5 days every other week throughout RT. Study evaluations for both groups will include bacterial cultures obtained via superficial swab from the nares, irradiated skin, and contralateral non-radiated skin performed at the beginning, middle, and end of RT. Additionally, standardized photographs of the skin at the radiated site will be performed prior to and at the completion of RT, which will be graded by a dermatologist blinded to study arm. Lastly, at identical timepoints, each patient will complete the SKINDEX-16 questionnaire, a validated quality of life (QoL) assessment. The primary endpoint is development of grade ≥ 2 RD, as compared to low-grade RD (grade 0-1), during RT. The secondary endpoint includes the impact of bacterial decolonization on QoL. Pearson’s chi square or Fisher’s exact tests will be used to compare the incidence rates of higher-grade RD between the interventional arm and control arm to assess if the intervention is associated with a lower incidence rate of higher-grade RD. Paired t-tests will be used to compare the QoL score change from baseline to after RT between the two arms. Linear regression models will be used in both analyses to adjust for covariates. Clinical trial information: NCT03883828.

Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial)

Background and purposeThe purpose of this study was to investigate the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) in head and neck cancer (HNC) patients. Materials and methodsA randomised, placebo-controlled trial (RCT) with 46 HNC patients who underwent radiotherapy (RT) with or without concomitant chemotherapy was set up (DERMISHEAD trial). Patients were randomised to receive PBM or placebo treatments from the first day of RT (2×/week) alongside the institutional skincare. The severity of skin reactions was assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v4.03) and the Radiotherapy-Induced Skin Reaction Assessment Scale (RISRAS). Quality of life (QoL) was evaluated using the Skindex-16 questionnaire. ResultsPBMT significantly reduced NCI-CTCAE grade 2–3 ARD with 49% at the end of RT. ConclusionThe results of the first RCT in HNC patients showed that PBMT is an effective method to prevent the development of severe ARD. These results support the implementation of PBM in the clinical oncology – radiotherapy practice.

The Effect of Four Approaches to Treat Actinic Keratosis on the Health-Related QOL, as Assessed by the Skindex-29 and Actinic Keratosis QOL

To evaluate the impact of actinic keratosis (AK) and the effect of four AK treatments on the health-related QOL (HRQOL), the Skindex-29 and AK QOL (AKQOL) questionnaires were completed by 624 patients with AK participating in a randomized controlled trial comparing 5% fluorouracil cream (Efudix, Meda Pharma B.V., Amstelveen, the Netherlands), 5% imiquimod cream (Aldara, Meda Pharma B.V., Solna, Sweden), methyl aminolevulinate (Metvix, Galderma SA, Penn Pharmaceutical Services, Gwent, UK) photodynamic therapy (MAL-PDT), and 0.015% ingenol mebutate gel (Picato, LEO Pharma A/S, Bellerup, Denmark) (Jansen et al., 2019).

Hair Loss Severity and its Impact on Quality of Life in Patients Suffering from Androgenic Alopecia

Background: Androgenic alopecia (AGA) is a common form of nonscarring alopecia encountered in daily dermatology practice. Both apparent and imperceptible AGA has a significant impact on an individual's personality, where physical appearance plays an important role in the probable prospects for marriage as well as other social aspects. Hair loss, thus, can severely hamper them for both men and women with clinical severity of alopecia not necessarily correlating with the quality of life (QoL) of the patient. Objectives: The objective is to assess the QoL in patients with AGA attending a tertiary care hospital in western India and compare QoL with hair loss severity (HLS), rated by both dermatologist and patient. Materials and Methods: One hundred and four patients, clinically diagnosed with AGA, consenting for the study over a period of 1 year were included. Demographic data of the patients were recorded. QoL was assessed using skindex-16 questionnaire; HLS was assessed through self-administered questionnaires completed by patients and dermatologists. Data were analyzed using Wilcoxon signed-rank test, Kendall's tau correlation coefficients, and Chi-square test. Results: The mean global score of Skindex–16 was 45.75 ± 16.90, with highest scores from emotions (64.93 ± 23.26). A positive correlation was found between the patients' HLS rating (r = 0.33, P &lt; 0.0001) and the clinical HLS rating. However, patient rated the extent of their hair loss as more severe than the dermatologist. Patient-related HLS significantly correlated with the mean global score of Skindex–16 (P &lt; 0.0001) as well as with all the subdomain scores (P &lt; 0.0001), whereas dermatologist-rated HLS only significantly correlated with the global score of Skindex–16 (P = 0.04) but not with the subdomain scores. Limitations: As Skindex-16 is a self-reported questionnaire, there may be a recall bias. Another limitation of our study is the sample size; a study with a bigger sample size is required to vindicate our findings. Conclusion: The study demonstrates that AGA patients perceived their HLS as more severe than the dermatologist. Both patient-related HLS and dermatologist-rated HLS showed statistical correlation with the total global Skindex-16 score. Hence, dermatologists need to be more alert and should address the psychosocial and QOL issues, when treating patients with AGA.

Reliability and validity of the Chinese version of the vitiligo specific quality of life instrument (VitiQoL)

Background: Vitiligo is an acquired, idiopathic skin disorder that can significantly affect the health-related quality of life (QoL). The vitiligo-specific QoL instrument (VitiQoL), recently developed by an American group, was found to be a reliable patient-reported outcome measure in both Brazilian and Iranian patients. Methods: The VitiQoL was initially cross-culturally adapted to Chinese through forward-backward translation. The Chinese version of the VitiQoL was then distributed to 182 vitiligo patients together with the dermatology life quality index (DLQI) and Skindex-16 questionnaire. Then, the reliability and validity of the Chinese version of the VitiQoL was assessed by statistical analysis. Results: The Chinese version of the VitiQoL showed high internal consistency (Cronbach alpha = 0.958) and test–retest reliability (intraclass correlation coefficient = 0.887). Convergent validity testing showed that the correlation coefficient for the Chinese VitiQoL and DLQI was 0.70 (P &lt; 0.01), the Chinese VitiQoL and Skindex-16 each was 0.84 (P &lt; 0.01), and for the Chinese VitiQoL (questions 1–15 and 16) was 0.62 (P &lt; 0.01). Confirmatory factor analysis revealed two important factors within the VitiQoL: Participation limitation and stigma. Conclusion: The Chinese version of the VitiQoL questionnaire has sufficient reliability and validity to be used to evaluate Chinese vitiligo patients' QoL.

Acute and sub-acute toxicity profile of ultra-hypofractionated low-dose total skin electron beam with two 4 Gy fractions for cutaneous T cell lymphoma

PurposeLow-dose total skin electron beam therapy (TSEBT) over 3 weeks has proved to be a safe and effective treatment for cutaneous T cell lymphomas (CTCL). In this prospective trial, we examined the feasibility of ultra-hypofractionated low-dose TSEBT regimen in two fractions with 4 Gy combined with systemic therapy to minimize the number of visits to radiation centers.Patients and methodsSix patients with mycosis fungoides (MF) or Sézary syndrome (SS) received TSEBT with a total radiation dose of 8 Gy in two fractions between April 2020 and June 2020. Patient and treatment characteristics, tumor burden, the impact on the quality of life using Skindex-29 questionnaires, and acute toxicities were analyzed.ResultsDuring TSEBT, all patients developed grade 1 toxicities while two patients developed grade 2 toxicities. One patient experienced sepsis. The most common adverse effects were erythema and edema. All grade 2 toxicities regressed after 4 weeks following TSEBT. Based on the reported symptoms measured by Skindex-29, we detected a significant reduction in total Skindex-29 score after 8 weeks of radiation (P = 0.03), particularly in the symptoms (P = 0.01) and emotional domains (P = 0.04).ConclusionUltra-hypofractionated low-dose TSEBT followed by systemic therapy seems to be a safe and feasible alternative to conventional fractionated TSEBT for patients with MF/SS. The skin tumor burden and the health-related quality of life have been significantly improved within 8 weeks following radiotherapy.

A study of quality of life in people with mycosis fungoides and Sézary syndrome

Mycosis fungoides (MF) is the commonest type of skin lymphoma and is part of a group of conditions known as cutaneous T-cell lymphomas (CTCL). MF can appear as flat/raised, smooth/scaly red lesions known as patches and plaques, making it difficult to tell apart from eczema or psoriasis. Raised “lumps” called tumours can appear and the disease can become more serious. Sézary syndrome (SS) is a leukaemic form of CTCL and has an extensive red, itchy rash over most of the body, the presence of cancerous cells in the blood, and enlarged lymph glands. MF/SS can reduce patient quality of life (QoL) due to symptoms including itch and pain, poor self-esteem secondary to cosmetic disfigurement, and can impair interpersonal relationships. In this article, we examine QoL in patients with MF/SS in a large international research study called PROCLIPI, using a questionnaire called Skindex-29 which asks patients to comment on skin related questions which may affect their life enjoyment. We identified a number of important determinants of worse QoL in MF/SS including: female gender, patients diagnosed with SS and those with more widespread disease. Disease features which were associated with more impaired QoL included alopecia (hair loss) and confluent erythema (red patches and plaques merging together to form larger areas of affected skin). Combining all these factors together, we found that female patients, alopecia and confluent erythema were the most important. Given that females had worse QoL, we examined more closely which items in the Skindex-29 questionnaire differed between males and females. Female patients experienced more burning, stinging, itch and irritation on their skin and greater feelings of depression, shame, embarrassment and annoyance with their diagnosis of MF/SS. Our research study has highlighted important aspects of QoL in MF/SS and emphasizes the urgent need for a more comprehensive QoL questionnaire to address not only the skin related aspects of the disease, but also the effects of cancer and its treatment on patient QoL. This is a summary of the study: Characteristics associated with significantly worse quality of life in mycosis fungoides/Sézary syndrome from the Prospective Cutaneous Lymphoma International Prognostic Index (PROCLIPI) study

Skin Changes in Patients with Diabetes Melitus Type 2 and their Impact on Quality of Life.

Introduction:Changes in the skin can occur as part of a diabetic, metabolic disorder or diabetic complications. Studies have shown that diabetes has an extremely strong negative impact on quality of life, especially diabetes with complications.Aim:Examine the impact of skin changes in patients with type 2 diabetes mellitus on quality of life.Methods:A prospective study analysed the quality of life in 200 respondents with type 2 diabetes mellitus which had diabetes-related skin changes. Subjects were divided into four groups according to the type of skin changes associated with diabetes mellitus. Group 1 consisted of patients which had skin changes with a greater or lesser association with diabetes mellitus, group 2 patients with infections, group 3 patients with cutaneous manifestations of diabetic complications and group 4 patients with allergic reactions to antidiabetic therapy. Quality of life assessment was performed using the Skindex-29 questionnaire, and the Nijsten categorization was used to assess the impact of skin changes in patients with type 2 diabetes mellitus on quality of life.Results:There were (51.95%) respondents in group 1, group 2 (24.02%), group 3 (22.22%) and group 4 (1.8%) respondents. In the scale of emotions in 84 respondents (43.0%) the impact on quality of life was serious, in the scale of symptoms in 96 (48%) was moderate, and in the scale of social and physical functioning 106 (55%) also had a moderate impact on quality of life, as well as in the total score of 94 respondents (47%). There was a statistically significant difference in the scale of social and physical functioning in the presence of skin changes in group 1 (x2 = 7.95; df = 3, p = 0.045) and group 3 (x2 = 12.48, df = 3; p = 0.006), and in the total score of Skindex-29 when it comes to changes in the skin of group 3 (x2 = 7.26, df = 3, p = 0.05).Conclusion:the quality of life in patients with type 2 diabetes mellitus which have skin changes is significantly reduced.

A Study of Quality of Life in Patients with Facial Melanoses.

Context:Facial melanoses decreases the quality of life (QoL). Melasma is the commonest cause but there are various other etiologies for facial pigmentation.Aims:To study the clinical profile of patients with facial melanoses and the psychological burden in these patients.Settings and Design:All patients having patchy or diffuse facial pigmentation attending the OPD in a tertiary care hospital for a period of 1 year were included in this hospital based cross-sectional study.Subjects and Methods:The type, extent, and distribution of the pigmentation was noted and tabulated in all patients. All patients were explained about Skindex-16 questionnaire and asked to complete it.Statistical Analysis Used:Student t-test (two tailed, independent) was used to find the significance of study parameters on continuous scale between two groups. Chi-square/Fisher Exact test was used to find the significance of study parameters on categorical scale between two or more groups. Correlation was performed using Spearman corrélation.Results:The total number of cases studied was 238 of which 186 (78.2%) were females and 52 (21.8%) were males. The most common diagnosis was melasma seen in 73% of cases. Other conditions noted were phototanning (5.8%), post-inflammatory hyperpigmentation (5.8%), Lichen planus pigmentosus (4.2%), freckles (3.7%), and Nevus of Ota (1.6%). Skindex-16 score against different grades of pigmentation showed that the mean Skindex-16 score was higher in severe cases but there was no statistically significant difference between the groups.Conclusions:The extent and severity of facial pigmentation and the decrease in the QoL are not proportional.

Current approaches to the treatment of frequently recurrent urticaria.

The article presents summarized materials on etiology, pathogenesis, classification, clinical manifestations and treatment of chronic urticuria, The management of patients with this pathology at Dniprovsky Allergological Center was analyzed. For assessment of quality of life SKINDEX-29 questionnaire was used. The questionnaire includes three sections: symptoms, emotions and functions. Physical symptoms include six points: tenderness, heartburn or tingling, itching unpleasant sensations when cotacting with water, skin irritation, sensitivity. The emotional sphere is characterized by such ten points as: concern about the condition of the skin; deppression; feeling of shame; concern that scars can remain after skin disease; feelings about worsening of the skin; anxious mood; embarrassment, feeling of humiliation; skin irritation; rejection of oneself. “Features” section has twelve items: sleep quality; work and hobbies; social activity; sex life; solitude; fatigue; unwillingness to leave home; limiting intimacy with others; complexity in carrying out daily activities; difficulty in expressing feelings; obstruction to create relationships with others; limiting close communication with relatives. Gastrointestinal system was also examined: fibrogastroduodenoscopy with determination of Helicobacter Pylori, ultrasound diagnosis of abdominal organs, the intensity of clinical symptoms was determined on a UAS7 scale. Fifteen patients (including eight women and seven men) were successfully treated with omalizumab. The mean age was 39.1 ± 3.6 years. The average duration of the disease in patients was 5.1 ± 0.9 years. The intensity of symptoms was determined before treatment after the first and second injection of Omalizumab. After the first injection, there was a positive trend. The clinical effect occurred in seventy-two hours. Statistical processing of the study results was performed using Statistica v.6.1® software. (StatSoft, USA). The inclusion of omalizumab is an effective treatment for chronic urticaria in the absence of an effect from antihistamines.

Final Phase in the Validation of the Cross-Cultural Adaptation of the Hair-Specific Skindex-29 Questionnaire Into Spanish: Sensitivity to Change and Correlation With the 12-Item Short-Form Health Survey

Background and objectiveWork has already been done on validating the cross-cultural adaptation of the hair-specific Skindex-29 questionnaire (HSS-29) into Spanish. This questionnaire measures the impact of female-pattern hair loss on health-related quality of life (HRQoL). The aim of this study was to complete the validation process by testing the questionnaire’s sensitivity to change and assessing its correlation with the generic 12-item Short-Form Health Survey (SF-12). Materials and methodsPatients who started treatment with a nutritional supplement that blocks the activity of 5 alpha-reductase were seen at 2 visits: a baseline visit and a follow-up visit at 6 months. At each visit, hair loss severity was assessed by both investigators and patients via the Sinclair scale, evaluation of hair condition, and administration of HSS-29 and SF-12. ResultsIn total, 983 women with female-pattern hair loss participated in the study. The mean (SD) HSS-29 score decreased from 25.7 (18.7) at baseline to 19.3 (15.7) at follow-up and significant changes were also observed in the functioning, emotions, and symptoms domains. Changes in overall and subscale HSS-29 scores from baseline to follow-up were all significantly correlated with changes in SF-12 subscale scores. The Pearson correlation coefficients ranged from -0.1 to -0.4 and were all significant at P<.001. ConclusionsThe Spanish version of HSS-29 is sensitive to change, as it detected changes in objective measurements of HRQoL. Correlations between HSS-29 and SF-12 scores were also observed.

Low-dose total skin electron beam therapy: Quality of life improvement and clinical impact of maintenance and adjuvant treatment in patients with mycosis fungoides or Sezary syndrome.

Total skin electron beam therapy (TSEBT) has proved to be asafe and effective treatment for cutaneous T‑cell lymphomas. Here, we examined the impact of this treatment on patient quality of life and outcome. Forty-four patients with mycosis fungoides (MF) or Sezary syndrome (SS) received 48TSEBT courses with amedian dose of 12 Gy within the past 8years at our institute. Patient and treatment characteristics for these cases as well as the impact of TSEBT on quality of life and duration of response were retrospectively analyzed and compared. The median modified Severity-Weighted Assessment Tool score before the start of TSEBT was 44. The overall response rate was 88%, with acomplete response (CR) rate of 33%. The median follow-up period was 13months. The median duration of response (DOR) and progression-free survival (PFS) for the entire cohort were 10months and 9months, respectively. Patient-reported symptom burden was measured with the Dermatological Life Quality Index and Skindex-29 questionnaires. The mean symptom reductions were 6 ± 8 (P = 0.005) and 21 ± 24 (P = 0.002), respectively. In the Functional Assessment of Cancer Therapy-General Assessment, significant improvements in the emotional (P = 0.03) domains were observed after TSEBT. Patients who received maintenance or adjuvant treatments had alonger PFS (P = 0.01). TSEBT improved disease symptoms and significantly improved emotional domains of patients' quality of life in patients with MF or SS. In addition, our results indicate that maintenance or adjuvant therapy after TSEBT may improve the PFS.

Quality of Life Improvement Following Low-Dose Total Skin Electron Beam Therapy in Patients with Mycosis Fungoides or Sezary Syndrome

Total skin electron beam therapy (TSEBT) has proved to be a safe and effective treatment for cutaneous T-cell lymphomas. Here, we report our experience applying low-dose TSEBT to patients with mycosis fungoides (MF) or Sezary syndrome (SS). We examined the impact of this treatment on patient quality of life and outcome. Forty-four patients with MF or SS received 48 TSEBT courses with a median dose of 12 Gy (range, 12–24) within the past eight years at our institute. Patient and treatment characteristics for these cases, as well as the impact of TSEBT on quality of life and duration of response, were retrospectively analyzed and compared. The median modified Severity Weighted Assessment Tool score before the start of TSEB was 44 (mean: 57, range: 7–160). The overall response rate was 88%, with a complete response (CR) rate of 33%. Five patients (10%) had near CR (< 1% body surface area). Pruritus improved significantly in 84% of the patients treated (CR rate, 35%). The median follow-up period was 13 months. The median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) for the entire cohort were 10 months, 9 months, and 20 months, respectively. Patients who received maintenance treatments had a longer DOR (13 months vs. 6 months, respectively; P = 0.1), PFS (9 months vs. 3 months, respectively; P = 0.01), and OS (51 months vs. 18 months, respectively; P = 0.15). Meanwhile, patients presenting CR had a noticeably longer PFS (13 months vs. 7 months, respectively; P = 0.05). Patient-reported symptom burden was measured with Dermatological Life Quality Index and Skindex-29 questionnaires. The mean symptom reductions were 6 ± 8 (P = 0.005) and 21 ± 24 (P = 0.002), respectively. In the Functional Assessment of Cancer Therapy-General assessment, significant improvements in both the emotional (P = 0.03) and social (P = 0.08) domains were observed after TSEBT. In univariate analyses, various clinical and hematological parameters were found to be significant. In a multivariate analysis, only CD30+ MF was associated with improved DOR (P = 0.05) and PFS (P = 0.05), while disease stage appears to potentially impact OS (P = 0.06). Taken together, these results indicate that maintenance of TSEBT improves the PFS of patients with MF or SS. In addition, TSEBT improved disease symptoms and significantly improved emotional and social domains of patients’ quality of life.

Fase final de la validación transcultural al español de la escala Hair Specific Skindex-29: sensibilidad al cambio y correlación con la escala SF-12

Background and objectiveWork has already been done on validating the cross-cultural adaptation of the Hair-Specific Skindex-29 questionnaire (HSS-29) into Spanish. This questionnaire measures the impact of female-pattern hair loss on health-related quality of life (HRQoL). The aim of this study was to complete the validation process by testing the questionnaire's sensitivity to change and assessing its correlation with the generic 12-item Short-Form Health Survey (SF-12). Material and methodPatients who started treatment with a nutritional supplement that blocks the activity of 5-alpha-reductase were seen in two visits: a baseline visit and a follow-up visit at 6months. At each visit, hair loss severity was assessed by both investigators and patients via the Sinclair scale, evaluation of hair condition, and administration of HSS-29 and SF-12. ResultsIn total, 983 women with female-pattern hair loss participated in the study. The mean HSS-29 score decreased from 25.7±18.7 at baseline to 19.3±15.7 at follow-up and significant changes were also observed in the functioning, emotions, and symptoms domains. Changes in overall and subscale HSS-29 scores from baseline to follow-up were all significantly correlated with changes in SF-12 subscale scores. The Pearson correlation coefficients ranged from −0.1 to −0.4 and were all significant at P<.001. ConclusionsThe Spanish version of HSS-29 is sensitive to change, as it detected changes in objective measurements of HRQoL. Correlations between HSS-29 and SF-12 scores were also observed.

Characteristics associated with significantly worse quality of life in mycosis fungoides/Sézary syndrome from the Prospective Cutaneous Lymphoma International Prognostic Index (PROCLIPI) study.

Mycosis fungoides (MF) and Sézary Syndrome (SS) are the most common cutaneous T-cell lymphomas. MF/SS is accompanied by considerable morbidity from pain, itching and disfigurement. To identify factors associated with poorer health-related quality of life (HRQoL) in patients newly diagnosed with MF/SS. Patients enrolled into Prospective Cutaneous Lymphoma International Prognostic Index (PROCLIPI; an international observational study in MF/SS) had their HRQoL assessed using the Skindex-29 questionnaire. Skindex-29 scores were analysed in relation to patient- and disease-specific characteristics. The study population consisted of 237 patients [60·3% male; median age 60 years, (interquartile range 49-70)], of whom 179 had early MF and 58 had advanced MF/SS. In univariate analysis, HRQoL, as measured by Skindex-29, was worse in women, SS, late-stage MF, those with elevated lactate dehydrogenase, alopecia, high modified Severity Weighted Assessment Tool and confluent erythema. Linear regression models only identified female gender (β = 8·61; P = 0·003) and alopecia (β = 9·71, P = 0·02) as independent predictors of worse global HRQoL. Item-level analysis showed that the severe impairment in symptoms [odds ratio (OR) 2·14, 95% confidence interval (CI) 1·19-3·89] and emotions (OR 1·88, 95% CI 1·09-3·27) subscale scores seen in women was caused by more burning/stinging, pruritus, irritation and greater feelings of depression, shame, embarrassment and annoyance with their diagnosis of MF/SS. HRQoL is significantly more impaired in newly diagnosed women with MF/SS and in those with alopecia. As Skindex-29 does not include existential questions on cancer, which may cause additional worry and distress, a comprehensive validated cutaneous T-cell lymphoma-specific questionnaire is urgently needed to more accurately assess disease-specific HRQoL in these patients. What's already known about this topic? Cross-sectional studies of mixed populations of known and newly diagnosed patients with mycosis fungoides (MF)/Sézary syndrome (SS) have shown significant impairment in health-related quality of life (HRQoL). Previous studies on assessing gender-specific differences in HRQoL in MF/SS are conflicting. More advanced-stage disease and pruritus is associated with poorer HRQoL in patients with MF/SS. What does this study add? This is the first prospective study to investigate HRQoL in a homogenous group of newly diagnosed patients with MF/SS. In patients newly diagnosed with MF/SS, HRQoL is worse in women and in those with alopecia and confluent erythema. MF/SS diagnosis has a multidimensional impact on patient HRQoL, including a large burden of cutaneous symptoms, as well as a negative impact on emotional well-being.

The effect of striae gravidarum on quality of life in a sample of Turkish pregnant woman population

Background: Striae gravidarum is a commonly occurred physiological change among women with pregnancy. Although these changes are accepted as physiological, the lack of therapeutical and preventive techniques led to impaired quality of life of women. The aim of this study is to evaluate the effect of striae gravidarum on quality of life in a sample of Turkish pregnant woman population and the usage of cream/lotion to prevent the striae. Methods: Women with pregnancy whose completed 36 weeks of their pregnancy and admitted to the Obstetrics and Gynecology outpatient unit between March 2017 and August 2017 were included in the study. The severity of striae was assessed using Davey's score. The effects of striae on patient's quality of life were evaluated by Skindex-29 questionnaire. The usage of cream/lotion whether or not was also asked and recorded. Results: A total of 153 women with pregnancy were included in the study. Of those 43.1% (n = 66) was primiparae and 56.9% (n = 87) was multiparae. The prevalence of striae gravidarum in total, primiparae and multiparae was 75.8%, 66.7%, and 82.7%, respectively. There was a weak positive correlation found between the parity and severity of striae (ρ =0.190, P = 0.018). The emotion and symptom score of primiparae women with severe striae were higher than women without striae (P = 0.001; P = 0.028, respectively). The usage of cream/lotion was significantly higher in primiparae compared to multiparae (P

Under-Reporting of Patient Reported Outcome (PRO) in Clinical Trials

Introduction: Clinically relevant outcomes as improvements in overall survival (OS) or quality of life (QOL) should guide decision-making. The FDA encourages the implementation of patient-centric PRO measures in clinical trials. In the recent decade there have been a growing number of protocols including PROs in their outcome measures, and an increase in pre-market submissions including those measures. We aimed to evaluate the frequency at which PRO measures, incorporated into clinical trials, are made publicly available, when trial results are published.Methods: We searched Citeline® Trialtrove database, a registry of clinical trials, for randomized phase 2/3 and 3 clinical trials including patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL), initiated between the years 2005-2015, with PRO endpoints listed. We excluded trials involving patients with acute leukemia or involving stem cell transplantation. For these trials we recorded the following data: indication, treatment and comparator, phase, primary endpoint, type of scale or questionnaire used for PRO endpoint. We then identified all available publications associated with the trial, and recoded type of publication (abstract or full text), year, number of randomized patients, reported outcomes.Results: 120 CLL and NHL trials were identified through our search. 44 trials (23 CLL, 21 NHL) were listed with at least one PRO endpoint. Eleven trials were excluded (1 extension of an included trial, 4 not completed, 4 not published, 2 cancelled with little or no recruitment). PRO endpoints were assessed utilizing - EORTC-QLQ30 QoL, QLQ-CLL16, FACIT-fatigue, FACT-leu, FACT-lym, EQ-5D, Skindex-29, and Rituximab Administration Satisfaction Questionnaire as relevant per indication. PRO was the primary outcome in two trials, and secondary in the other 31. Study sponsor was industry-only in 27 trials, and industry-academic in five. Of the 33 trials analyzed, 14 (42%) published results of the PRO endpoint - 6/17 (35%) of CLL trials, and 8/16 (50%) of NHL trials. 26/33 of the trials were published as full-text, 6/33 as abstract, and 1 published on clinicaltrials.gov. Of the 26 full text publications, 12 (46%) reported PRO. In 8 of full-text PRO were reported as part of the primary publication or published within 6 months. Nine of all trials provided a comprehensive report of PRO endpoints. Of the 33 trials, only 2 provided information about missing PRO data. 54% of trials in which primary endpoint was reached, and 12.5% of trials in which it was not reached, were published listing PRO results. Of the trials that showed PFS benefit, with no OS benefit, 9/15 (60%) published the results of the PRO endpoints.Conclusions: Despite a growing emphasis on QOL and use of PROs in oncology clinical trials, and despite patient and health provider efforts to record PRO data, most CLL and NHL randomized trials still do not report the PRO endpoints. In several cases they were published later and in a partial manner, minimizing their impact on treatment decisions. This may indicate a disregard to PRO data collected, incomplete collection or methodological flaws in data analysis. Regardless of the reason, PRO data should be routinely included in study publications to allow for a complete assessment of investigational treatment outcome - including disease related outcomes, as well as those reported by the patients themselves. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.