Clinical trial NCT06103929: Adult Eating Disorder Assessment Study
Official title: Evaluation of Eating Difficulties Assessment Measures in Clinical Practice and in Epidemiological Surveys
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eating Disorders
Keywords: Eating disorders
Adult psychiatry
Epidemiology
Calibration
Public health
Anorexia nervosa
Bulimia nervosa
Binge eating disorder
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: Leicestershire Partnership NHS Trust
name: City, University of London
name: National Centre for Social Research, London, UK
name: University of London
First posted: 2023-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults resident in the UK who have been referred to NHS Leicestershire Partnership Trust. The study aims to collect data on accepted referrals, which will represent the clinical population, and referrals not accepted into treatment which will represent people more likely to describe eating difficulties in community surveys.

Brief summary: The hypothesis of the study is that low-cost self-completion questionnaires relating to eating disorder symptoms will predict the subsequent results of a detailed, semi-structured interview assessment of eating disorder symptoms that has been calibrated according to expert clinical diagnostic case thresholds. Eating disorders are recognised as a research priority among healthcare professionals, adults with lived experience, and their carers alike. There is a need for measurement methods that can reliably and systematically identify symptoms of common forms of eating disorder, including those fulfilling agreed diagnostic criteria for anorexia nervosa, bulimia nervosa, and binge-eating disorder. Effective diagnostic interview tools can facilitate early detection of eating disorders. To develop rules for determining whether diagnostic criteria for eating disorders are met, a study involving adults referred to specialist eating disorder services is required. In this study, assessments by eating disorder clinicians will be compared with researcher assessments using a semi-structured interview assessment, the Schedules for Clinical Assessment in Neuropsychiatry version 3 section 9 (SCANv3s9). The study population will consist of 100 adult patients referred to specialist eating disorder services, including patients whose referrals are accepted by these services, as well as those who are not. Clinical assessments and structured interview assessment findings will also be compared with those from widely used screening tools for eating disorders, the Eating Disorder Examination Questionnaire short-form and the SCOFF (Sick, Control, One, Fat, Food) questionnaire. The aim of this study is to evaluate the accuracy of the Eating Disorder Examination Questionnaire Short-Form (EDE-QS) and the SCOFF (Sick, Control, One, Fat, Food) questionnaire in adults referred to specialist eating disorder services, in a comparison with the Schedules for Clinical Assessment in Neuropsychiatry subsection on eating disorders and specialist NHS clinician assessments of the probability of eating disorder. This will help develop appropriate and accurate benchmarks for estimating the prevalence of eating disorder symptoms and clinical diagnoses, in adults referred to specialist eating disorder services, as well as the wider population (through combining the findings from this study with those of the community 2023 Adult Psychiatric Morbidity Survey).

Detailed description: Study Analysis Plan

Work Package 1 (WP1) relates to assessment of the entire study clinical population (n = 100). For WP1, the threshold for diagnosis of common forms of eating disorders (anorexia nervosa, bulimia nervosa, binge-eating disorder, and any eating disorder) by clinicians will be used as the reference (criterion) standard, and 95% confidence intervals will be performed for all estimates. Receiver-operating characteristic (ROC) curves and areas under the curve (AUC) will be calculated for all measurement tools (SCANv3s9, EDE-QS, and SCOFF), with reference to the criterion standard, as well as sensitivity, specificity, positive predictive value, and negative predictive values for a range of cut-off scores for these tools. Additionally, correlation coefficients will be calculated with respect to SCANv3s9, EDE-QS, and SCOFF findings, relative to those of the reference standard.

To calibrate the SCANv3s9 interview, symptom findings from the researcher-assessed SCANv3s9 will be compared with NHS clinician's diagnostic thresholds. However, the research team may modify the SCANv3s9 diagnostic algorithms in the event that they diverge substantially from clinician judgment, an approach that has previously been employed when calibrating the Autism Diagnostic Observation Schedule (ADOS) against clinical opinion. Work Package 2 (WP2) relates to retesting of a subsample of the WP1 population (n = 25). For WP2, test-retest reliability will be assessed using Cohen's kappa coefficient (κ), as well as simple percentage agreement calculations.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 16 years or older (on the date of referral to specialist eating disorder services)
* Individuals referred to specialist adult eating disorder services during the study period

Exclusion Criteria:

* Patients under 16 years old and having not been referred to specialist eating disorder services.
* Patients with a clinical diagnosis of intellectual disability will be excluded on the basis that the SCAN is not intended for use in this patient group.
* Patients lacking capacity to consent to take part.
* Participants who lose capacity during their participation will be withdrawn from the study (with data collected up until the point of withdrawal being retained).
* Participants who are unable to understand written and verbal English.

Primary outcomes:
measure: The threshold on the questionnaires and SCAN examination output algorithm scores calibrated against the clinician diagnostic thresholds for eating disorder, taking account of the level of agreement between the questionnaires and SCAN
timeFrame: The WP1 SCAN interview battery (60-84 minutes)
Secondary outcomes:
measure: The threshold on the EDE-QS examination output algorithm scores calibrated against the clinician diagnostic thresholds for eating disorder, taking account of the level of agreement between the EDE-QS and SCAN
timeFrame: The EDE-QS will take about 2.7 minutes to be completed
measure: The threshold on the SCOFF examination output algorithm scores calibrated against the clinician diagnostic thresholds for eating disorder, taking account of the level of agreement between the SCOFF and SCAN
timeFrame: The SCOFF (1.3 minutes) and basic demographic details form (3.7 minutes), completed by each participant
measure: A retest comparison of findings from the SCAN among a subgroup of participants subject to repeated assessment
timeFrame: The reduced time of assessment due to repeat SCAN testing with SCANv3s0 and SCANv3s9, will take 20-28 minutes.
measure: A retest comparison of findings from the EDE-QS among a subgroup of participants subject to repeated assessment
timeFrame: The EDE-QS will take about 2.7 minutes to be completed
measure: A retest comparison of findings from the SCOFF among a subgroup of participants subject to repeated assessment
timeFrame: The SCOFF (1.3 minutes) and basic demographic details form (3.7 minutes), completed by each participant
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicestershire Partnership NHS Trust
Study officials:
affiliation: University of Leicester
name: Samuel J. Tromans
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lord C, Risi S, Lambrecht L, Cook EH Jr, Leventhal BL, DiLavore PC, Pickles A, Rutter M. The autism diagnostic observation schedule-generic: a standard measure of social and communication deficits associated with the spectrum of autism. J Autism Dev Disord. 2000 Jun;30(3):205-23.
citation: Brugha TS, McManus S, Smith J, Scott FJ, Meltzer H, Purdon S, Berney T, Tantam D, Robinson J, Radley J, Bankart J. Validating two survey methods for identifying cases of autism spectrum disorder among adults in the community. Psychol Med. 2012 Mar;42(3):647-56. doi: 10.1017/S0033291711001292. Epub 2011 Jul 29.
citation: Fairburn CG, Cooper Z, O'Connor M. The eating disorder examination. 1993;6:1-8.
citation: McManus S, Bebbington PE, Jenkins R, Morgan Z, Brown L, Collinson D, Brugha T. Data Resource Profile: Adult Psychiatric Morbidity Survey (APMS). Int J Epidemiol. 2020 Apr 1;49(2):361-362e. doi: 10.1093/ije/dyz224. No abstract available.
citation: Gideon N, Hawkes N, Mond J, Saunders R, Tchanturia K, Serpell L. Development and Psychometric Validation of the EDE-QS, a 12 Item Short Form of the Eating Disorder Examination Questionnaire (EDE-Q). PLoS One. 2016 May 3;11(5):e0152744. doi: 10.1371/journal.pone.0152744. eCollection 2016.
citation: Morgan JF, Reid F, Lacey JH. The SCOFF questionnaire: a new screening tool for eating disorders. West J Med. 2000 Mar;172(3):164-5. doi: 10.1136/ewjm.172.3.164. No abstract available.
citation: American Psychiatric Association D, Association AP. Diagnostic and statistical manual of mental disorders: DSM-5. American psychiatric association Washington, DC; 2013.
citation: Hill LS, Reid F, Morgan JF, Lacey JH. SCOFF, the development of an eating disorder screening questionnaire. Int J Eat Disord. 2010 May;43(4):344-51. doi: 10.1002/eat.20679.