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Table 1 Patient data collected and instruments used at baseline and 12-month follow-up

From: Dual guidance structure for evaluation of patients with unclear diagnosis in centers for rare diseases (ZSE-DUO): study protocol for a controlled multi-center cohort study

 

T0

Prior to first clinic visit

T1

At first clinic visit

T2

At 12 month follow-up

Socio-demographic data

CRD patient questionnaire

Socio-demographic history (family status, education)

Employment status (includes unemployment and disability)

CRD patient questionnaire

Social history (employment status, salaries), ZSE-DUO health economics questionnaire (changes in employment status, salaries)

ZSE-DUO health economics questionnaire (changes in employment status, salaries)

Signs and symptoms

CRD patient questionnaire, medical summary from referring physician, medical letters

Medical history, physical examination, psychopathological statusa, diagnostic procedures

Prior diagnoses

medical summary by referring physician, medical letters

Medical history

New diagnoses / symptomatology explained

Medical history, physical examination, mental disordersa, diagnostic procedures

Medical information available after clinic visit

Successful transition to standard care delivered by other health care providers

Medical information available after clinic visit

Quality of life (QoL)

EQ-5D-5L, SF-12 (adults), Kidscreen-10 (youth) a, qualitative telephone interviews

EQ-5D-5L, SF-12 (adults), life satisfaction, Kidscreen-10 (youth)

EQ-5D-5L, SF-12 (adults), life satisfaction, Kidscreen-10 (youth), qualitative telephone interviews

Mental status

PHQ-15, GAD-7, DSS-4, SCL-K-9, SDQ (youth) a

PHQ-15, GAD-7, DSS-4, SCL-K-9, SDQ (youth), MINI-DIPSa, PSS-Ka

PHQ-9, GAD-7, SDQ (youth)

Health economics data

ZSE-DUO health economic questionnaire (adaption of FIMA-questionnaire)

ZSE-DUO health economic questionnaire (adaption of FIMA-questionnaire)

Expectationsb

qualitative telephone interviewsb

Satisfaction

ZUF-8, qualitative telephone interviewsb

Health insurance data

Selected items

Selected items

  1. Abbreviations of instruments used: EQ-5D-5L, 5 dimensions 5 level quality of life (QoL) questionnaire of the EuroQol group; SF-12, Short Form Health questionnaire [12, 13]; PHQ-9, PHQ-15, Patient Health Questionnaire-9 and -15 [14,15,16]; GAD-7, General Anxiety Disorder-7 questionnaire [17, 18]; DSS-4, Dissociation Tension Scale [19]; SCL-K-9, Symptom Checklist [20]; SDQ, Strengths and Difficulties Questionnaire [21]; Mini-DIPS, standardized diagnostic interview for mental disorders [8, 9]; PSS-K, screening measure for the assessment of personality disorders [10]; FIMA, questionnaire for health-related resource use in the elderly population [22]
  2. ain innovative care group only
  3. b10% of patients only