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  string(146) "Evaluating the Cross-Cultural Equivalence of the DLQI for Asians in the U.S. and Asians in Asian Countries Who Have Psoriasis or Atopic Dermatitis"
  ["project_narrative_summary"]=>
  string(666) "Among multinational clinical trials that include Asian participants from both the U.S. and Asian countries, Asian individuals are considered a monolith and aggregated under a single Asian category regardless of country of residence or origin. However, some data suggest that Asian Americans and Asian individuals in or from Asia are culturally distinct enough to warrant disaggregation in studies of health-related QoL. The potential harm of aggregating Asian Americans and Asian individuals in or from Asia in the absence of cross-cultural equivalence of the DLQI is over- or under-estimation of the QoL impact of skin diseases among the culturally distinct groups."
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  string(254) "Pooled analysis of individual-level baseline data from Phase III clinical trials for psoriasis and atopic dermatitis using data from the YODA Project and other data sources to evaluate the cross-cultural equivalence of the Dermatology Life Quality Index."
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  ["project_date_type"]=>
  string(91) "Individual Participant-Level Data, which includes Full CSR and all supporting documentation"
  ["property_scientific_abstract"]=>
  string(3283) "Background: As clinical trials make increasing efforts to diversify participant populations to better reflect the general population and as they become increasingly multinational, it is critical to understand how the effects of skin diseases on QoL may differ by race, ethnicity, and culture. In prior work, we have found that the QoL impact of psoriasis and atopic dermatitis (AD) differs by race and ethnicity, independent of objective disease severity. On an international scale, however, little is known about the cross-cultural equivalence of dermatology-specific QoL instruments such as the DLQI and whether there are any differences in QoL impact due to psoriasis or AD especially among Asian populations. Notably, among multinational clinical trials that include Asian participants from both the U.S. and Asian countries, Asian individuals are considered a monolith and aggregated under a single Asian category regardless of country of residence or origin. Yet, some data suggest that Asian Americans and Asians in Asia are culturally distinct enough to warrant disaggregation in studies of health-related QoL. It remains unknown if skin disease specific QoL differs between Asian Americans and Asians in Asia. 

Objective: To evaluate and compare Dermatology Life Quality Index scores between Asians in the U.S. and Asians in Asia who have psoriasis or atopic dermatitis.

Study Design: Cross-sectional analysis of de-identified, participant-level, baseline data from phase 3 clinical trials for psoriasis and atopic dermatitis that measured QoL impact using the DLQI and were published between 2016 and 2021. Separate cross-sectional analyses will be performed among psoriasis and atopic dermatitis studies.

Participants: Asian individuals in the U.S. or an Asian country who participated in psoriasis or AD clinical trials that assessed QoL using the DLQI and were published between 2016 and 2021.

Main Outcome Measure: Dermatology Life Quality Index (DLQI). 

Statistical Analysis: We will analyze data from the adult and pediatric patient populations separately. We will use descriptive statistics to summarize demographic characteristics (including age, gender, country of participation), objective disease severity, and other variables of interest as listed previously. In an unadjusted analysis, we will use Student?s t-test or Wilcoxon rank-sum test (depending on the distribution of the data) to compare continuous DLQI scores between Asians in the U.S. and Asians in Asia. We will also perform multivariable mixed effects linear regression analysis with study included as random effect to evaluate the association between country of participation among Asian individuals and DLQI score, while adjusting for age, sex, objective disease severity, and other variables of interest that differ significantly between the two Asian groups. Depending on the distribution of DLQI scores, we may also dichotomize the scores as small to extremely large effect (2-30) versus no effect (0-1) on QoL. We will use the same statistical analysis techniques for the pediatric population using the CDLQI scores instead of the DLQI scores. Statistical significance will be defined by two-sided p-value < 0.05. Data analyses will be conducted using STATA 16."
  ["project_brief_bg"]=>
  string(2128) "Psoriasis and atopic dermatitis (AD) are common chronic inflammatory skin diseases. The prevalence of psoriasis is approximately 3%, affecting nearly 8 million Americans. The prevalence of atopic dermatitis is approximately 20% among children and 10% among adults, affecting 31.6 million Americans..1 Psoriasis and AD are each associated with significant negative impacts on the quality of life (QoL) of affected individuals.2,3 Just one example of the importance of measuring QoL as a health outcome for skin diseases is the inclusion of skin disease-specific QoL measures (e.g., the Dermatology Life Quality Index) as primary or secondary outcomes in most clinical trials of chronic inflammatory skin diseases. As clinical trials make increasing efforts to diversify participant populations to better reflect the general population and as they become increasingly multinational, it is critical to understand how the effects of skin diseases on QoL may differ by race, ethnicity, and culture. In fact, in prior work, we have found that the QoL impact of psoriasis and AD differs by race and ethnicity, independent of objective disease severity.4,5 On an international scale, however, little is known about the cross-cultural equivalence of dermatology-specific QoL instruments such as the DLQI and whether there are any differences in QoL impact due to psoriasis or AD especially among Asian populations. Notably, among multinational clinical trials that include Asian participants from both the U.S. and Asian countries, Asian individuals are considered a monolith and aggregated under a single Asian category regardless of country of residence or origin. However, some data suggest that Asian Americans and Asian individuals in or from Asia are culturally distinct enough to warrant disaggregation in studies of health-related QoL.6 The potential harm of aggregating Asian Americans and Asian individuals in or from Asia in the absence of cross-cultural equivalence of the DLQI or other dermatology-specific QoL instruments is over- or under-estimation of the QoL impact of skin diseases among the culturally distinct groups."
  ["project_specific_aims"]=>
  string(578) "The objective of this study is to evaluate the cross-cultural equivalence of the Dermatology Life Quality Index for Asian individuals in the U.S. and Asian individuals in Asia who have psoriasis or atopic dermatitis. Separate analyses will be performed among individuals with psoriasis and individuals with atopic dermatitis. We hypothesize that there will be clinically significant differences between the DLQI scores reported by Asians in the U.S. experiencing psoriasis or atopic dermatitis as compared to Asians in Asian countries, independent of objective disease severity."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(5) "other"
    ["label"]=>
    string(5) "Other"
  }
  ["project_study_design_exp"]=>
  string(0) ""
  ["project_purposes"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(5) "Other"
      ["label"]=>
      string(5) "Other"
    }
  }
  ["project_purposes_exp"]=>
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  ["project_software_used"]=>
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    ["value"]=>
    string(5) "STATA"
    ["label"]=>
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  ["project_software_used_exp"]=>
  string(0) ""
  ["project_research_methods"]=>
  string(1235) "We performed a literature search on PubMed for phase 3 psoriasis and AD clinical trials that were published between 2016 and 2021.

Inclusion criteria:

Phase 3 clinical trials for plaque psoriasis or atopic dermatitis

Clinical trials published between 2016 and 2021

Clinical trials that included sites in either the U.S. or an Asian country

Clinical trials that assessed quality of life using the DLQI

Exclusion criteria:

Clinical trials that did not assess quality of life using the DLQI

Extension studies

For psoriasis only: clinical trials for non-plaque psoriasis

For psoriasis only: clinical trials that involved children

We will be pooling data from the YODA Project with data shared through Vivli (NCT02118766, NCT02118792, NCT02260986, NCT02277743, NCT02277769, NCT03054428, NCT03345914, NCT03912259, NCT01646073, NCT02684370, NCT02684357, NCT02694523, NCT02672852, NCT01474512, NCT02513550, NCT03435081, NCT02203032, NCT02346240, NCT02326298, NCT02326272, NCT03131648, NCT03160885, NCT03363854, NCT02462070, NCT02462122). We are also trying to obtain data from Novartis (NCT01555125, NCT02748863, NCT02826603, NCT02016105) and Incyte (NCT03745638, NCT03745651)."
  ["project_main_outcome_measure"]=>
  string(406) "Outcome Elements Categorization / Definitions

Dermatology Life Quality Index (DLQI)

We request data only for Asian participants at U.S. study sites or Asian participants at a non-U.S. Asian country study site (China, Hong Kong, India, Japan, Malaysia, Singapore, South Korea, Taiwan, Vietnam) with different indicator variables for Asian participants in the U.S. and Asian participants in Asia."
  ["project_main_predictor_indep"]=>
  string(51) "Asians in the U.S. versus Asians in Asian countries"
  ["project_other_variables_interest"]=>
  string(1024) "Psoriasis: age, sex, disease duration, prior treatments for psoriasis, weight, body mass index, comorbid disease status, and objective disease severity measures (specifically Physician?s or Investigator's Global Assessment (PGA or IGA), Psoriasis Area and Severity Index (PASI), and body surface area involvement).

Atopic Dermatitis: age, sex, disease duration, prior treatments for atopic dermatitis, history of atopic comorbidity (food allergies, allergic rhinitis, asthma, allergic conjunctivitis, hives/urticaria, chronic rhinosinusitis, eosinophilic esophagitis, nasal polyps), objective disease severity measures (specifically Physician?s or Investigator's Global Assessment (PGA or IGA), Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and body surface area involvement), patient-reported severity measures (specifically Patient-Oriented Eczema Measure (POEM) and pruritus Numerical Rating Scale (NRS)), and Hospital Anxiety and Depression Scale (HADS) scores (total, HADS-A, HADS-D)."
  ["project_stat_analysis_plan"]=>
  string(2052) "We are requesting de-identified, participant-level, baseline data from phase 3 clinical trials for atopic dermatitis and psoriasis to evaluate the association between participant country of residence (U.S. versus Asian countries) and quality of life (as measured by the Dermatology Life Quality Index) among Asian participants. Separate analyses will be performed among individuals with atopic dermatitis and individuals with psoriasis. The primary outcome is the continuous DLQI/CDLQI score. The main independent variable is country of study participation (U.S. versus Asian country) among Asian individuals. It is anticipated that missing data will be minimal among baseline clinical trial data; individuals with missing data will be excluded from analysis. For our statistical analysis, we will analyze data from the adult and pediatric patient populations separately. We will use descriptive statistics to summarize demographic characteristics (including age, gender, country of participation), objective disease severity, and other variables of interest as listed previously. In an unadjusted analysis, we will use Student?s t-test or Wilcoxon rank-sum test (depending on the distribution of the data) to compare continuous DLQI scores between Asians in the U.S. and Asians in Asia. We will also perform multivariable mixed effects linear regression analysis with study included as random effect to evaluate the association between country of participation among Asian individuals and DLQI score, while adjusting for age, sex, objective disease severity, and other variables of interest that differ significantly between the two Asian groups. Depending on the distribution of DLQI scores, we may also dichotomize the scores as small to extremely large effect (2-30) versus no effect (0-1) on QoL. We will use the same statistical analysis techniques for the pediatric population using the CDLQI scores instead of the DLQI scores. Statistical significance will be defined by two-sided p-value < 0.05. Data analyses will be conducted using STATA 16."
  ["project_timeline"]=>
  string(74) "Target Start Date: Sept 1, 2022

Target Completion Date: June 1, 2023"
  ["project_dissemination_plan"]=>
  string(321) "The findings of this study will be published in a peer-reviewed journal (e.g., JAMA Dermatology, Journal of Investigative Dermatology, Journal of the American Academy of Dermatology) and/or presented at clinical or scientific conferences (e.g., American Academy of Dermatology, The Society for Investigative Dermatology)."
  ["project_bibliography"]=>
  string(1342) "
1. Armstrong AW, Mehta MD, Schupp CW, Gondo GC, Bell SJ, Griffiths CEM. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. 2021;157(8):940-946. doi:10.1001/jamadermatol.2021.2007

2. Rapp SR, Feldman SR, Exum ML, Fleischer AB, Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3 Pt 1):401-407. doi:10.1016/s0190-9622(99)70112-x

3. Silverberg JI, Gelfand JM, Margolis DJ, et al. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study. Ann Allergy Asthma Immunol Off Publ Am Coll Allergy Asthma Immunol. 2018;121(3):340-347. doi:10.1016/j.anai.2018.07.006

4. Takeshita J, Augustin M, Jong EMGJ de, et al. Health-related quality of life differs by race/ethnicity in North American patients with psoriasis: results from PSOLAR. J Invest Dermatol. 2022;0(0). doi:10.1016/j.jid.2022.02.013

5. Oluwole S, Barbieri JS, Chiesa Fuxench ZC, Shin DB, Takeshita J. Racial/Ethnic Differences in Quality-of-Life Among Adults with Atopic Dermatitis. J Invest Dermatol 141(5, Supplement): S98, May 2021.

6. Kim SY, Jeon EY, Sok SR, Oh HK, Kim KB. Quality of life of Korean and Korean American older adults: a comparison. J Gerontol Nurs. 2009;35(6):28-34. doi:10.3928/00989134-20090428-06
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  ["data_use_agreement_training"]=>
  bool(true)
  ["certification"]=>
  bool(true)
  ["project_send_email_updates"]=>
  bool(true)
  ["project_status"]=>
  string(30) "approved_pending_dua_signature"
  ["project_publ_available"]=>
  bool(true)
  ["project_year_access"]=>
  string(0) ""
  ["project_rep_publ"]=>
  array(1) {
    [0]=>
    array(1) {
      ["publication_link"]=>
      string(0) ""
    }
  }
  ["project_assoc_data"]=>
  array(0) {
  }
  ["project_due_dil_assessment"]=>
  bool(false)
  ["project_title_link"]=>
  array(21) {
    ["ID"]=>
    int(12090)
    ["id"]=>
    int(12090)
    ["title"]=>
    string(28) "data_request_approved_notice"
    ["filename"]=>
    string(32) "data_request_approved_notice.pdf"
    ["filesize"]=>
    int(195663)
    ["url"]=>
    string(81) "https://yoda.yale.edu/wp-content/uploads/2023/08/data_request_approved_notice.pdf"
    ["link"]=>
    string(74) "https://yoda.yale.edu/data-request/2023-5250/data_request_approved_notice/"
    ["alt"]=>
    string(0) ""
    ["author"]=>
    string(4) "1363"
    ["description"]=>
    string(0) ""
    ["caption"]=>
    string(0) ""
    ["name"]=>
    string(28) "data_request_approved_notice"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(8535)
    ["date"]=>
    string(19) "2023-08-09 18:11:47"
    ["modified"]=>
    string(19) "2023-08-09 19:07:57"
    ["menu_order"]=>
    int(0)
    ["mime_type"]=>
    string(15) "application/pdf"
    ["type"]=>
    string(11) "application"
    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_review_link"]=>
  bool(false)
  ["project_highlight_button"]=>
  string(0) ""
  ["search_order"]=>
  string(5) "-8280"
}
data partner
array(1) {
  [0]=>
  string(15) "johnson-johnson"
}


pi country
array(1) {
  [0]=>
  string(13) "United States"
}


pi affil
array(1) {
  [0]=>
  string(8) "Academia"
}


products
array(1) {
  [0]=>
  string(7) "tremfya"
}


num of trials
array(1) {
  [0]=>
  string(1) "4"
}


res
array(1) {
  [0]=>
  string(1) "3"
}