<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03230435</url>
  </required_header>
  <id_info>
    <org_study_id>QOLAN-DK 10226757</org_study_id>
    <nct_id>NCT03230435</nct_id>
  </id_info>
  <brief_title>Health Related Quality of Life for Patients With Anorexia Nervosa in Denmark.</brief_title>
  <acronym>QOLAN-DK</acronym>
  <official_title>Health Related Quality of Life for Patients With Anorexia Nervosa in Denmark.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>René Klinkby Støving</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Psychiatric Services in the Region of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Eating disorders (ED) comprise a multitude of symptoms involving a disturbed body image and a&#xD;
      preoccupation with food or bodyweight. EDs are often difficult to treat, in part due to the&#xD;
      lack of motivation for improvement. Anorexia nervosa (AN) has the highest mortality rate of&#xD;
      any psychiatric disease, and less than half of patients will recover from the disease.&#xD;
      Studies have found that patients suffering from AN have impaired health-related quality of&#xD;
      life (HRQoL) compared to the general population. It has also been suggested that despite&#xD;
      improvement in clinical parameters, patients report deterioration in HRQoL, which is in line&#xD;
      with a study finding low agreement between patient perceived outcome and clinician assessed&#xD;
      characteristics. To evaluate the patients' perception of their disease, it is important to&#xD;
      develop reliable and valid assessment tools. Previously generic questionnaires have been used&#xD;
      to assess HRQoL in Danish ED patients, as no disease-specific questionnaires have been&#xD;
      developed. Translating and validating a disease-specific questionnaire would provide a useful&#xD;
      tool in assessing current treatment and in developing new treatment options. This study aimed&#xD;
      to develop a Danish version of an internationally disease-specific HRQoL questionnaire.&#xD;
      Furthermore, HRQoL is assessed in patients who have gone through shorter or longer treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION Anorexia nervosa (AN) is an eating disorder of unknown etiology. The evidence&#xD;
      base for treatment is still very limited considering the extent to which this disorder erodes&#xD;
      lives and still carries the highest fatality rate of any psychiatric disease as well as any&#xD;
      other chronic disease in adolescence.&#xD;
&#xD;
      There is no consensus on appropriate effect goals in AN. Assessment of biomedical parameters&#xD;
      alone is not sufficient, why evaluation tools that consider the patient's own perception of&#xD;
      their health and well-being are essential. However, patients with AN characteristically have&#xD;
      a different opinion of their needs to that of the health professionals, which can lead to&#xD;
      differences in treatment goals, ambivalence towards treatment, and immense compliance&#xD;
      difficulties.&#xD;
&#xD;
      Health-related quality of life (HRQOL) can be defined as the overall effect of a medical&#xD;
      condition and/or its consequent therapy upon a patient. HRQOL is subjective and&#xD;
      multidimensional, encompassing physical and occupational function, psychological state,&#xD;
      social interaction and somatic sensation. Discrepancy between one's current level of function&#xD;
      and one's ideals or expectations can result in lower self-rated HRQOL, while cognitive&#xD;
      flexibility is believed to contribute to good HRQOL. Patients with AN typically have&#xD;
      unrealistically high expectations of themselves, are often rigid and usually do not consider&#xD;
      weight gain to be a necessity for a positive outcome. Therefore, treatment may potentially&#xD;
      lead to further reduction of HRQOL (for example due to coerced hospitalization), despite&#xD;
      significant positive improvements in biomedical parameters.&#xD;
&#xD;
      In a recently published meta-analysis examining the HRQOL of patients with eating disorders,&#xD;
      several methodological challenges were identified such as variations in study design,&#xD;
      diagnostic criteria and health outcome measurement. It is essential that HRQOL measures are&#xD;
      valid and reliable for the patient group in question. These measures can be either generic&#xD;
      (applicable to all patient groups) or disease-specific (designed to detect HRQOL changes&#xD;
      specific to a disease).&#xD;
&#xD;
      Only a few disease-specific HRQOL measures for AN have been developed. The Eating Disorder&#xD;
      Quality of Life (EDQLS) questionnaire was published by a Canadian research group and consists&#xD;
      of 40 items on selected topics including relationships with family and others, physical and&#xD;
      psychological health and eating. Subsequent studies have shown that the EDQLS demonstrates&#xD;
      excellent psychometric properties in terms of validity, reliability and responsiveness to&#xD;
      change.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
        1. To validate a Danish version of the Eating Disorder Quality of Life questionnaire in two&#xD;
           age ranges, 13-17 years and +18 years in patients with AN.&#xD;
&#xD;
        2. To assess age-specific HRQoL in patients with AN in different treatment settings.&#xD;
&#xD;
      DESIGN Preparatory study: Testing and adaptation of the Danish version of the EDQLS for use&#xD;
      by 13-17 year olds with anorexia nervosa.&#xD;
&#xD;
      Study 1: Concurrent validity and internal consistency. EDQLS, ED symptomatology, distress,&#xD;
      social function and generic HRQOL assessed in different clinical samples of AN patients aged&#xD;
      13-17 &amp; +18 years and in a sample of age-matched healthy controls within a normal weight&#xD;
      range.&#xD;
&#xD;
      Study 2: Test-retest reliability. EDQLS completed twice with a 2-4-week interval in a sample&#xD;
      of weight- and treatment-stable outpatients and controls aged 13-17 &amp; +18 years.&#xD;
&#xD;
      Study 3: Sensitivity to change. EDQLS applied three times over a 4-6-week interval in a&#xD;
      sample of AN inpatients aged 13-17 &amp; +18 years.&#xD;
&#xD;
      Study 4: Patients outside the established treatment. EDQLS, ED symptomatology, distress,&#xD;
      social function and generic HRQoL score among members and followers with BMI&lt;18 recruited&#xD;
      from the official website for the national patient organizations.&#xD;
&#xD;
      METHODS&#xD;
&#xD;
      TRANSLATION Prior to this study, the initial translations of the EDQLS was carried out using&#xD;
      the method recommended by WHO World Mental Health Initiative Translation Guidelines. After&#xD;
      permission from the Canadian authors, an expert panel of bilingual staff from an ED&#xD;
      outpatient clinic worked on the translation from English to Danish, aiming for conceptual&#xD;
      equivalence between the versions (i.e. similar relevance and meaning in the two&#xD;
      languages/cultures). After panel discussions to create a consensus version the Danish draft&#xD;
      questionnaire was completed individually by 18 adult women with AN, who in subsequent&#xD;
      qualitative interviews commented on their understanding of the items and any difficulties&#xD;
      they had with the wording. The linguistic comments and suggestions from the patients were&#xD;
      used to further improve the translation, which was then approved by the expert panel. This&#xD;
      draft was back-translated and the back-translation was reviewed by the Canadian authors of&#xD;
      the scale. After the refinement of a single word, it was accepted as the official Danish&#xD;
      EDQLS translation. Both the Danish version and the original EDQLS are licensed.&#xD;
&#xD;
      In the present study, the original EDQLS will be tested and adjusted as necessary for use&#xD;
      patients aged 13-17 years. This will be done by repeating the qualitative interviews with six&#xD;
      adolescents AN patients (13-17 years) to investigate whether the questionnaire should be&#xD;
      linguistically modified for this age group. Any modifications will be discussed with the&#xD;
      Canadian developers of EDQLS.&#xD;
&#xD;
      MEASURES Screening questionnaire: Patients will be asked to fill out a questionnaire&#xD;
      regarding current weight, height and information regarding current medication.&#xD;
&#xD;
      Disease-specific quality of life (EDQLS). WHO-5 Well-being Index (WHO-5). Generic health&#xD;
      related quality of life: Short Form-36 (SF-36). Eating disorder symptomatology: Eating&#xD;
      Disorder Inventory-3. Depression: The Beck Depression Inventory II (BDI-II). Impairment in&#xD;
      functioning: Work and Social Adjustment Scale (WSAS). Total item burden: Total amount of&#xD;
      measures is 201 items. Estimated time for administration is about two hours. The&#xD;
      questionnaires are stored in RedCap, automatically uploading the answers as the patients fill&#xD;
      them out.&#xD;
&#xD;
      DATA ANALYSES AND STATISTICS&#xD;
&#xD;
      POWER CALCULATIONS The sample size is based on the validation work of the original language&#xD;
      version in Canada. A high response rate of at least 80% is expected because there is a high&#xD;
      participatory interest in the subject and purpose of the study, and because the participants&#xD;
      receive a small fee.&#xD;
&#xD;
      MULTIVARIATE ANALYSES Description of the subsamples is presented as means and standard&#xD;
      deviations and frequencies. Inter-item correlations and confirmatory factor analyses are&#xD;
      performed on the full sample across age-groups and health status and in sub-populations.&#xD;
      Pearson correlations are produced for the included symptom and HRQOL scores.&#xD;
&#xD;
      ETHICAL CONSIDERATIONS According to Danish legislation, surveys are exempt from ethical board&#xD;
      review. However, a formal enquiry was made and the ethical board determined that the project&#xD;
      was approved without further application to the ethical committee. Participants will be&#xD;
      informed that study participation is voluntary, and will have no effect on their treatment&#xD;
      and management. There are no risks associated with participating in the study.&#xD;
&#xD;
      All questionnaires and tests used in the study are validated, recommended and widely&#xD;
      distributed clinically for diagnosing in psychiatry.&#xD;
&#xD;
      To facilitate a high proportion of completion, all participants (patients and controls) who&#xD;
      complete the test are honored with Danish kroner (DDK) 150.&#xD;
&#xD;
      ANONYMITY The project is approved by the Data Protection Agency, File no. 17/3218. The data&#xD;
      will be stored in a data sheet, REDCap.&#xD;
&#xD;
      FINANCE The study is a 100 % non-commercial study. The Jascha Fund has supported the post doc&#xD;
      salary for 18 months. There will be applied for licenses, participation fees, and operating&#xD;
      expenses.&#xD;
&#xD;
      DISSEMINATION AND TENTATIVE PUBLICATIONS&#xD;
&#xD;
      The study findings, both positive and negative results, will be disseminated through&#xD;
      communication at congresses and written scientific publications. Publications will be made&#xD;
      according to the Vancouver criteria with the tentative titles:&#xD;
&#xD;
        -  Health-related quality of life in anorexia nervosa: Validation of a Danish language&#xD;
           version in young and adult patients.&#xD;
&#xD;
        -  In-patients treatment of anorexia nervosa: Does it improve health related quality of&#xD;
           life?&#xD;
&#xD;
        -  Patients with anorexia nervosa, not seeking established treatment: specific health&#xD;
           related quality of life.&#xD;
&#xD;
        -  Gender differences in health-related quality of life in patients with anorexia nervosa.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EDQLS</measure>
    <time_frame>through a hospitalization, an average of 5 weeks</time_frame>
    <description>Disease specific health related quality of life</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">496</enrollment>
  <condition>Anorexia Nervosa</condition>
  <condition>Health-Related Quality Of Life</condition>
  <arm_group>
    <arm_group_label>Anorexia nervosa</arm_group_label>
    <description>Treatment settings as usual.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>No interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment settings as usual.</intervention_name>
    <description>Treatment according to guidelines and the local instructions (psychotherapy and dietary guidance).</description>
    <arm_group_label>Anorexia nervosa</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        PATIENTS will be recruited through specialized centres in Denmark and through contact to&#xD;
        Patient Association's network.&#xD;
&#xD;
        CONTROLS will be identified through public call for proposals. The proposals will be posted&#xD;
        at institutions of further education and public schools in Odense with students in the&#xD;
        appropriate age range.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
        1. Patients fulfilling Diagnostic and Statistical Manual of Mental Disorders, version 5&#xD;
        (DSM-5) criteria for anorexia nervosa.&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          1. Patients and controls who are unable to complete a Danish language questionnaire.&#xD;
&#xD;
          2. Controls: Any medication, except vitamins or oral contraceptives.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>90-95% female can be expected among patients with AN. The controls are matched on gender.</gender_description>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>René K Støving, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Eating Disorders, Odense University Hospital, &amp; Psychiatric survived in Southern Denmark</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura AD Winkler, PhD</last_name>
    <phone>65415307</phone>
    <phone_ext>+45</phone_ext>
    <email>laura.vad.winkler@rsyd.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>René K Støving, PhD</last_name>
    <phone>65411710</phone>
    <phone_ext>+45</phone_ext>
    <email>rene.k.stoving@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Endocrinology, Center for Eating Disorders, Odense UH</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura AD Winkler, PhD</last_name>
      <email>laura.vad.winkler@rsyd.dk</email>
    </contact>
    <contact_backup>
      <last_name>René K Støving, PhD</last_name>
      <phone>65411710</phone>
      <phone_ext>+45</phone_ext>
      <email>rene.stoeving@rsyd.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Winkler LA, Frolich JS, Gudex C, Horder K, Bilenberg N, Stoving RK. Patient- and clinician- reported outcome in eating disorders. Psychiatry Res. 2017 Jan;247:230-235. doi: 10.1016/j.psychres.2016.11.047. Epub 2016 Nov 30.</citation>
    <PMID>27923148</PMID>
  </reference>
  <reference>
    <citation>Winkler LA, Christiansen E, Lichtenstein MB, Hansen NB, Bilenberg N, Stoving RK. Quality of life in eating disorders: a meta-analysis. Psychiatry Res. 2014 Sep 30;219(1):1-9. doi: 10.1016/j.psychres.2014.05.002. Epub 2014 May 14.</citation>
    <PMID>24857566</PMID>
  </reference>
  <reference>
    <citation>Winkler LA, Bilenberg N, Horder K, Stoving RK. Does specialization of treatment influence mortality in eating disorders?--A comparison of two retrospective cohorts. Psychiatry Res. 2015 Dec 15;230(2):165-71. doi: 10.1016/j.psychres.2015.08.032. Epub 2015 Aug 28.</citation>
    <PMID>26391650</PMID>
  </reference>
  <reference>
    <citation>Adair CE, Marcoux GC, Cram BS, Ewashen CJ, Chafe J, Cassin SE, Pinzon J, Gusella JL, Geller J, Scattolon Y, Fergusson P, Styles L, Brown KE. Development and multi-site validation of a new condition-specific quality of life measure for eating disorders. Health Qual Life Outcomes. 2007 Apr 30;5:23. doi: 10.1186/1477-7525-5-23.</citation>
    <PMID>17470290</PMID>
  </reference>
  <reference>
    <citation>Adair CE, Marcoux GC, Bischoff TF, Cram BS, Ewashen CJ, Pinzon J, Gusella JL, Geller J, Scattolon Y, Fergusson P, Styles L, Brown KE. Responsiveness of the Eating Disorders Quality of Life Scale (EDQLS) in a longitudinal multi-site sample. Health Qual Life Outcomes. 2010 Aug 11;8:83. doi: 10.1186/1477-7525-8-83.</citation>
    <PMID>20701776</PMID>
  </reference>
  <reference>
    <citation>Winkler LA, Hemmingsen SD, Gudex C, Blegvad AC, Stoving RK, Arnfred SMH. A Danish translation of the eating disorder quality of life scale (EDQLS). J Eat Disord. 2019 May 1;7:11. doi: 10.1186/s40337-019-0241-7. eCollection 2019.</citation>
    <PMID>31069077</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>September 24, 2022</last_update_submitted>
  <last_update_submitted_qc>September 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>René Klinkby Støving</investigator_full_name>
    <investigator_title>Professor, PhD</investigator_title>
  </responsible_party>
  <keyword>anorexia nervosa, health-related quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Anorexia Nervosa</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be stored at Odense patient Data Explorative Network (OPEN).</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03230435
org study id: QOLAN-DK 10226757
nct id: NCT03230435
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Eating disorders (ED) comprise a multitude of symptoms involving a disturbed body image and a
      preoccupation with food or bodyweight. EDs are often difficult to treat, in part due to the
      lack of motivation for improvement. Anorexia nervosa (AN) has the highest mortality rate of
      any psychiatric disease, and less than half of patients will recover from the disease.
      Studies have found that patients suffering from AN have impaired health-related quality of
      life (HRQoL) compared to the general population. It has also been suggested that despite
      improvement in clinical parameters, patients report deterioration in HRQoL, which is in line
      with a study finding low agreement between patient perceived outcome and clinician assessed
      characteristics. To evaluate the patients' perception of their disease, it is important to
      develop reliable and valid assessment tools. Previously generic questionnaires have been used
      to assess HRQoL in Danish ED patients, as no disease-specific questionnaires have been
      developed. Translating and validating a disease-specific questionnaire would provide a useful
      tool in assessing current treatment and in developing new treatment options. This study aimed
      to develop a Danish version of an internationally disease-specific HRQoL questionnaire.
      Furthermore, HRQoL is assessed in patients who have gone through shorter or longer treatment.
INTRODUCTION Anorexia nervosa (AN) is an eating disorder of unknown etiology. The evidence
      base for treatment is still very limited considering the extent to which this disorder erodes
      lives and still carries the highest fatality rate of any psychiatric disease as well as any
      other chronic disease in adolescence.

      There is no consensus on appropriate effect goals in AN. Assessment of biomedical parameters
      alone is not sufficient, why evaluation tools that consider the patient's own perception of
      their health and well-being are essential. However, patients with AN characteristically have
      a different opinion of their needs to that of the health professionals, which can lead to
      differences in treatment goals, ambivalence towards treatment, and immense compliance
      difficulties.

      Health-related quality of life (HRQOL) can be defined as the overall effect of a medical
      condition and/or its consequent therapy upon a patient. HRQOL is subjective and
      multidimensional, encompassing physical and occupational function, psychological state,
      social interaction and somatic sensation. Discrepancy between one's current level of function
      and one's ideals or expectations can result in lower self-rated HRQOL, while cognitive
      flexibility is believed to contribute to good HRQOL. Patients with AN typically have
      unrealistically high expectations of themselves, are often rigid and usually do not consider
      weight gain to be a necessity for a positive outcome. Therefore, treatment may potentially
      lead to further reduction of HRQOL (for example due to coerced hospitalization), despite
      significant positive improvements in biomedical parameters.

      In a recently published meta-analysis examining the HRQOL of patients with eating disorders,
      several methodological challenges were identified such as variations in study design,
      diagnostic criteria and health outcome measurement. It is essential that HRQOL measures are
      valid and reliable for the patient group in question. These measures can be either generic
      (applicable to all patient groups) or disease-specific (designed to detect HRQOL changes
      specific to a disease).

      Only a few disease-specific HRQOL measures for AN have been developed. The Eating Disorder
      Quality of Life (EDQLS) questionnaire was published by a Canadian research group and consists
      of 40 items on selected topics including relationships with family and others, physical and
      psychological health and eating. Subsequent studies have shown that the EDQLS demonstrates
      excellent psychometric properties in terms of validity, reliability and responsiveness to
      change.

      OBJECTIVES

        1. To validate a Danish version of the Eating Disorder Quality of Life questionnaire in two
           age ranges, 13-17 years and +18 years in patients with AN.

        2. To assess age-specific HRQoL in patients with AN in different treatment settings.

      DESIGN Preparatory study: Testing and adaptation of the Danish version of the EDQLS for use
      by 13-17 year olds with anorexia nervosa.

      Study 1: Concurrent validity and internal consistency. EDQLS, ED symptomatology, distress,
      social function and generic HRQOL assessed in different clinical samples of AN patients aged
      13-17 & +18 years and in a sample of age-matched healthy controls within a normal weight
      range.

      Study 2: Test-retest reliability. EDQLS completed twice with a 2-4-week interval in a sample
      of weight- and treatment-stable outpatients and controls aged 13-17 & +18 years.

      Study 3: Sensitivity to change. EDQLS applied three times over a 4-6-week interval in a
      sample of AN inpatients aged 13-17 & +18 years.

      Study 4: Patients outside the established treatment. EDQLS, ED symptomatology, distress,
      social function and generic HRQoL score among members and followers with BMI<18 recruited
      from the official website for the national patient organizations.

      METHODS

      TRANSLATION Prior to this study, the initial translations of the EDQLS was carried out using
      the method recommended by WHO World Mental Health Initiative Translation Guidelines. After
      permission from the Canadian authors, an expert panel of bilingual staff from an ED
      outpatient clinic worked on the translation from English to Danish, aiming for conceptual
      equivalence between the versions (i.e. similar relevance and meaning in the two
      languages/cultures). After panel discussions to create a consensus version the Danish draft
      questionnaire was completed individually by 18 adult women with AN, who in subsequent
      qualitative interviews commented on their understanding of the items and any difficulties
      they had with the wording. The linguistic comments and suggestions from the patients were
      used to further improve the translation, which was then approved by the expert panel. This
      draft was back-translated and the back-translation was reviewed by the Canadian authors of
      the scale. After the refinement of a single word, it was accepted as the official Danish
      EDQLS translation. Both the Danish version and the original EDQLS are licensed.

      In the present study, the original EDQLS will be tested and adjusted as necessary for use
      patients aged 13-17 years. This will be done by repeating the qualitative interviews with six
      adolescents AN patients (13-17 years) to investigate whether the questionnaire should be
      linguistically modified for this age group. Any modifications will be discussed with the
      Canadian developers of EDQLS.

      MEASURES Screening questionnaire: Patients will be asked to fill out a questionnaire
      regarding current weight, height and information regarding current medication.

      Disease-specific quality of life (EDQLS). WHO-5 Well-being Index (WHO-5). Generic health
      related quality of life: Short Form-36 (SF-36). Eating disorder symptomatology: Eating
      Disorder Inventory-3. Depression: The Beck Depression Inventory II (BDI-II). Impairment in
      functioning: Work and Social Adjustment Scale (WSAS). Total item burden: Total amount of
      measures is 201 items. Estimated time for administration is about two hours. The
      questionnaires are stored in RedCap, automatically uploading the answers as the patients fill
      them out.

      DATA ANALYSES AND STATISTICS

      POWER CALCULATIONS The sample size is based on the validation work of the original language
      version in Canada. A high response rate of at least 80% is expected because there is a high
      participatory interest in the subject and purpose of the study, and because the participants
      receive a small fee.

      MULTIVARIATE ANALYSES Description of the subsamples is presented as means and standard
      deviations and frequencies. Inter-item correlations and confirmatory factor analyses are
      performed on the full sample across age-groups and health status and in sub-populations.
      Pearson correlations are produced for the included symptom and HRQOL scores.

      ETHICAL CONSIDERATIONS According to Danish legislation, surveys are exempt from ethical board
      review. However, a formal enquiry was made and the ethical board determined that the project
      was approved without further application to the ethical committee. Participants will be
      informed that study participation is voluntary, and will have no effect on their treatment
      and management. There are no risks associated with participating in the study.

      All questionnaires and tests used in the study are validated, recommended and widely
      distributed clinically for diagnosing in psychiatry.

      To facilitate a high proportion of completion, all participants (patients and controls) who
      complete the test are honored with Danish kroner (DDK) 150.

      ANONYMITY The project is approved by the Data Protection Agency, File no. 17/3218. The data
      will be stored in a data sheet, REDCap.

      FINANCE The study is a 100 % non-commercial study. The Jascha Fund has supported the post doc
      salary for 18 months. There will be applied for licenses, participation fees, and operating
      expenses.

      DISSEMINATION AND TENTATIVE PUBLICATIONS

      The study findings, both positive and negative results, will be disseminated through
      communication at congresses and written scientific publications. Publications will be made
      according to the Vancouver criteria with the tentative titles:

        -  Health-related quality of life in anorexia nervosa: Validation of a Danish language
           version in young and adult patients.

        -  In-patients treatment of anorexia nervosa: Does it improve health related quality of
           life?

        -  Patients with anorexia nervosa, not seeking established treatment: specific health
           related quality of life.

        -  Gender differences in health-related quality of life in patients with anorexia nervosa.
observational model: Case-Control
time perspective: Cross-Sectional
measure: EDQLS
time frame: through a hospitalization, an average of 5 weeks
description: Disease specific health related quality of life
arm group label: Anorexia nervosa
description: Treatment settings as usual.
arm group label: Healthy controls
description: No interventions.
intervention type: Other
intervention name: Treatment settings as usual.
description: Treatment according to guidelines and the local instructions (psychotherapy and dietary guidance).
arm group label: Anorexia nervosa
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: 90-95% female can be expected among patients with AN. The controls are matched on gender.
minimum age: 13 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: René K Støving, PhD
role: Principal Investigator
affiliation: Center for Eating Disorders, Odense University Hospital, & Psychiatric survived in Southern Denmark
last name: Laura AD Winkler, PhD
phone: 65415307
phone ext: +45
email: laura.vad.winkler@rsyd.dk
last name: René K Støving, PhD
phone: 65411710
phone ext: +45
email: rene.k.stoving@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
citation: Winkler LA, Frolich JS, Gudex C, Horder K, Bilenberg N, Stoving RK. Patient- and clinician- reported outcome in eating disorders. Psychiatry Res. 2017 Jan;247:230-235. doi: 10.1016/j.psychres.2016.11.047. Epub 2016 Nov 30.
PMID: 27923148
citation: Winkler LA, Christiansen E, Lichtenstein MB, Hansen NB, Bilenberg N, Stoving RK. Quality of life in eating disorders: a meta-analysis. Psychiatry Res. 2014 Sep 30;219(1):1-9. doi: 10.1016/j.psychres.2014.05.002. Epub 2014 May 14.
PMID: 24857566
citation: Winkler LA, Bilenberg N, Horder K, Stoving RK. Does specialization of treatment influence mortality in eating disorders?--A comparison of two retrospective cohorts. Psychiatry Res. 2015 Dec 15;230(2):165-71. doi: 10.1016/j.psychres.2015.08.032. Epub 2015 Aug 28.
PMID: 26391650
citation: Adair CE, Marcoux GC, Cram BS, Ewashen CJ, Chafe J, Cassin SE, Pinzon J, Gusella JL, Geller J, Scattolon Y, Fergusson P, Styles L, Brown KE. Development and multi-site validation of a new condition-specific quality of life measure for eating disorders. Health Qual Life Outcomes. 2007 Apr 30;5:23. doi: 10.1186/1477-7525-5-23.
PMID: 17470290
citation: Adair CE, Marcoux GC, Bischoff TF, Cram BS, Ewashen CJ, Pinzon J, Gusella JL, Geller J, Scattolon Y, Fergusson P, Styles L, Brown KE. Responsiveness of the Eating Disorders Quality of Life Scale (EDQLS) in a longitudinal multi-site sample. Health Qual Life Outcomes. 2010 Aug 11;8:83. doi: 10.1186/1477-7525-8-83.
PMID: 20701776
citation: Winkler LA, Hemmingsen SD, Gudex C, Blegvad AC, Stoving RK, Arnfred SMH. A Danish translation of the eating disorder quality of life scale (EDQLS). J Eat Disord. 2019 May 1;7:11. doi: 10.1186/s40337-019-0241-7. eCollection 2019.
PMID: 31069077
responsible party type: Sponsor-Investigator
investigator affiliation: Odense University Hospital
investigator full name: René Klinkby Støving
investigator title: Professor, PhD
mesh term: Anorexia
mesh term: Anorexia Nervosa
sharing ipd: Undecided
ipd description: Data will be stored at Odense patient Data Explorative Network (OPEN).