Table 1

Collection of patient characteristics, outcome measures and explanatory variables   

VariablePreWeek 14–16
Clinical data*
 Gender (F, M)X
 Age (years)X
 Diagnosis (disease)X
 Onset of diagnosis (year)†X
 Education (level)‡X
 Menopause (year)X
 Comorbidity (diseases, Charlson index)X
 Medication (predefined choices)XX
 Diet (FFQ) (predefined choices)X
 Changes in diet (predefined choices)X
 Non-dietary lifestyle factors‡ (predefined choices)XX
Investigations:
 Height (cm)X
 Weight (kg)XX
  Body mass index (kg/m2)XX
 Routine blood analyses§XX
 Endoscopy¶XX
Biological samples**
 Fasting blood samplesXX
 Faeces samplesXX
 Urine samplesXX
 Biopsies¶XX
CD
 Disease location (predefined choices)X
 Prior operations (y/n, description)X
 Disease behaviour (fistulising, luminal)X
 Perianal involvement (y/n)X
 STRIDE—(y/n)NAX
  Abdominal pain (y/n)XX
  Diarrhoea (y/n)XX
  Altered bowel habit (y/n)XX
  SES-CD (score)XX
   Presence of ulcers (score)XX
   Ulcerated surface (score)XX
   Affected surface (score)XX
   Presence of narrowing (score)XX
   Number of affected segments (score)XX
  Alterations of cross-sectional imaging (MR, CT, UL) (y/n)††XX
 HBI index (score)XX
 HBI of 4 or less (y/n)‡‡XX
  General well-being (score)XX
  Abdominal pain (score)XX
  No of liquid stools per day (N)XX
  Abdominal mass (score)XX
  Manifestations (abscess, fistulas, fissures, arthralgia, uveitis, erythema nodosum, pyoderma gangrenosum, mouth ulcers, one point for each) (N)XX
 Physician global assessment (score)XX
 Physician global assessment (0–100 mm VAS)XX
 Patient global assessment (0–100 mm VAS)XX
 Corticosteroid-free remission§§ (y/n)X
 Concomitant medication (y/n, predefined choices)XX
 Number of draining fistulas (fistulising CD)XX
UC
 Disease location (predefined choices)X
 Prior operations (y/n, description)X
 STRIDE criteria (y/n)NAX
  Rectal bleeding (y/n)XX
  Altered bowel habit (y/n)XX
  Endoscopic remission (Mayo endoscopic subscore of 0–1)XX
 Mayo clinical score of 2 or less with no individual subscore of >1‡‡XX
 Mayo ‘normal mucosal appearance’ (y/n)XX
 Mayo clinical response§§ (y/n)¶¶XX
 Mayo clinical score (score)XX
  Mayo endoscopic subscore (score)XX
  Stools (score)XX
  Rectal bleeding (score)XX
  Physician global assessment (score)XX
 SCCAI (score)XX
  Bowel frequency (day) (score)XX
  Bowel frequency (night) (score)XX
  Urgency of defecation (score)XX
  Blood in stool (score)XX
  General well-being (score)XX
  Extracolonic features (one per manifestation)XX
 Physician global assessment (0–100 mm VAS)XX
 Patient global assessment (0–100 mm VAS)XX
 Corticosteroid-free remission§§ (y/n)X
 Concomitant medication (y/n, predefined choices)XX
Rheumatoid arthritis
 Positive for anti-CCP/RF (y/n)X
 Swollen joint count (of 28/66 joints examined)XX
 Tender joint count (of 28/68 joints examined)XX
 DAS28-CRP (score)XX
 SDAI (score)XX
 ACR20 (y/n)‡‡NAX
 ACR50 (y/n)NAX
 ACR70 (y/n)NAX
 EULAR good or moderate response (y/n)NAX
 Low disease activity (DAS28<3.2)NAX
 DAS28 remission (DAS28<2.6)NAX
 Physician global assessment (0–100 mm VAS)XX
 Patient global assessment (0–100 mm VAS)XX
 Patient assessment of pain (0–100 mm VAS)XX
 HAQ (score)XX
axSpA
 Positive for HLA-B27 (y/n)X
 BASDAI (score)XX
 BASFI (score)XX
 BASMI (score)
 Total score for back pain (0–100 mm VAS)XX
 Patient global assessment of disease activity (0–100 mm VAS)XX
 Patient assessment of pain (0–100 mm VAS)XX
 Physician global assessment (0–100 mm VAS)XX
 ASAS20 (y/n)‡‡NAX
 ASAS40 (y/n)NAX
 ASAS partial response (y/n)NAX
 ASAS5/6 response (y/n)NAX
PsA
 Dactylitis (y/n)XX
 Enthesitis (y/n)XX
 PASI (score)XX
 PASI 75 response (y/n)NAX
 PASI 90 response (y/n)NAX
 ACR20††NAX
 Swollen joint count (of 28/66 joints examined)XX
 Tender joint count (of 28/68 joints examined)XX
 DAS28-CRP (score)XX
 Patient global assessment of disease activity (0–100 mm VAS)XX
 Patient assessment of PsA pain (0–100 mm VAS)XX
 Physician global assessment (0–100 mm VAS)XX
 SDAIXX
 HAQ (score)XX
PsO
 Psoriatic arthritis (y/n)XX
 PASI (score)XX
 PASI75 response (y/n)‡‡NAX
 PASI90 response (y/n)NAX
 Patient global assessment of disease activity (0–100 mm VAS)XX
 Patient assessment of PsA pain (0–100 mm VAS)XX
 Physician global assessment (0–100 mm VAS)XX
 DLQI (score)XX
Hidradenitis suppurativa
 HiSCR response‡‡NAX
 Hurley stage*** (score)XX
 Previous systemic treatment (y/n, description)X
 Prior surgery (y/n, description)X
 Lesion counts (N)XX
 Total no. of abscesses and inflammatory nodules (N)XX
 No. of abscesses (N)XX
 No. of inflammatory nodules (N)XX
 No. of draining fistulas (N)XX
 Modified Sartorius score (score)XX
 Percentage of participants who achieve abscess and inflammatory nodule (AN) count of 0, 1 and 2, respectivelyXX
 Patient global assessment of skin pain (score)XX
 DLQI (score)XX
NiU
 SUN (score)XX
 Uveitis treatment failure (y/n)‡‡NAX
 New active, inflammatory chorioretinal or retinal vascular lesions relative to baseline (y/n)XX
 Inability to achieve ≤0.5+  or a two-step increase relative to best state achieved at all visits in anterior chamber cell grade or vitreous haze grade (y/n)XX
 Worsening of best-corrected visual acuity by ≥15 letters relative to best state achieved (y/n)XX
Health-related quality of life††† X X
 SF12 (score)XX
 SHS (score)XX
 Physician global assessment (0–100 mm VAS)XX
 Patient global assessment (0–100 mm VAS)XX
 Rome-III (score)XX
 NYHA (score)XX
 Continuation of anti-TNF treatment (y/n, predefined choices for stopping if no)XX
Adverse events
 Discontinuation due to adverse events (y/n)X
 Serious adverse event (y/n)X
  Death (y/n)X
  Occurrence of surgery (y/n)X
  Occurrence of hospital admission (y/n)X
 Occurrence of disease-related complication (y/n)X
Laboratory§
 CRP (mg/L)‡‡‡XX
  • *Data will be collected using a questionnaire as well as local and national registries.

  • †Registry data will be retrieved from the Danish registries using the Danish individual civil registration number (CPR) including BIO-IBD,116 DANBIO,117 DERMBIO118 (database on IBD, RA, HS, axSpA, PsA and PsO patients on biological therapy), the National Patient Registry (eg, comorbidity), registries on medication and use of receipts, local laboratory databases (laboratory data) and the electronic patient records (side effects).

  • ‡Lifestyle (dietary and non-dietary) will be registered using a validated FFQ that includes food items and a photographic food atlas of picture series of portion sizes will be used to assess intake of food groups, such as meat and dairy, and calculate total energy, fibre, protein, fat, sugar and carbohydrate intakes as well as glycaemic index and load. In addition, questions on non-diet lifestyle factors (smoking, physical activity, alcohol consumption and use of over-the-counter medicine (use of probiotics, prebiotics, painkillers, laxative and antidiarrhoea agents)) as well as educational level and year of menopause (female) are included.63 The follow-up questionnaire is identical to the initial questionnaire apart from the questions on food items that only contain questions on changes of diet since the last questionnaire.

  • §Routine blood analyses include CRP, haemoglobin, erythrocyte count, haematocrit, erythrocyte mean cell volume, mean cell haemoglobin and mean cell haemoglobin concentration, leucocyte count, differential count, thrombocytes, K+, Na+, creatinine, coagulation factor II+VII+X, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, haemoglobin glycation, lipids (cholesterol, high-density, low-density cholesterol) and transglutaminase.

  • ¶Only patients with IBD.

  • **From all participants, blood, urine and faeces are sampled. In addition, from patients with IBD, intestinal biopsies are sampled. In selected cases, the additional biological material on participants from this study may be retrieved from the Patobank and the Danish Biobank. The samples will be collected adhering to the Sample PRE-analytical Code and Biospecimen Reporting for Improved Study Quality guidelines, using standard operational procedures describing and logging primary container, centrifugation conditions, centrifugation parameters and storage conditions.120 121 The biological material will be stored at Odense Patient data Explorative Network (OPEN) (biological material from Odense University Hospital) or at SHS (biological material from the other hospitals).

  • ††Only patients with CD when endoscopy cannot adequately evaluate inflammation.

  • ‡‡Primary endpoint for the individual diseases

  • §§Corticosteroid-free remission. Clinical remission in patients using oral corticosteroids at baseline (pre) that have discontinued corticosteroids and in clinical remission at first follow-up.

  • ¶¶A reduction in complete Mayo score of ≥3 points and ≥30% from baseline (or a partial Mayo score of ≥2 points and ≥25% from baseline, if the complete Mayo score was not performed at the visit) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point.

  • ***Data for the Hurley stage reflect actual assessment. A patient’s overall Hurley stage is the highest stage across all affected anatomical sites. Stage I is defined as the localised formation of single or multiple abscesses without sinus tracts or scarring, stage II as recurrent abscesses (single or multiple) with sinus tract formation and scarring and stage III as multiple abscesses with extensive, interconnected sinus tracts and scarring.

  • †††All participants will be asked whether they have any complaints regarding or are known with diseases affecting the bowel, the skin, rheumatic complaints and so on, and if no to both questions they will not be asked to complete the relevant questionnaire.

  • ‡‡‡Biological response defined as a drop in CRP level of more than 25% or to the normal level among patients with an elevated CRP before treatment (higher than normal range).119

  • ACR, American College of Rheumatology; ASAS, Assessment of Spondyloarthritis International Society; axSpA, axial spondyloarthropathy; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CCP/RF, cyclic citrullinated peptide/rheumatoid factor; CD, Crohn’s disease; CRP, C-reactive protein; DAS, Disease Activity Score; DLQI, Dermatology Life Quality Index; EULAR, European League Against Rheumatism; FFQ, Food Frequency Questionnaire; HAQ, Health Assessment Questionnaire; HBI, Harvey-Bradshaw Index; HiSCR, Hidradenitis Suppurativa Clinical Response; HLA-B27, human leucocyte antigen; IBD, inflammatory bowel disease; K+, potassium; NA, not applicable; N+ sodium; NiU, non-infectious uveitis; NYHA, New York Heart Association; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, psoriasis; SCCAI, Simple Clinical Colitis Activity Index; SDAI, Simplified Disease Activity Index; SES-CD, Simple Endoscopic Score for Crohn’s Disease; SF12, Short Form Health Survey; SHS, Short Health Scale; STRIDE, Selecting Therapeutic Targets in Inflammatory Bowel Disease; SUN, Standardization of Uveitis Nomenclature for Reporting Clinical Data; TNF, tumour necrosis factor; UC, ulcerative colitis; UL, ultrasound; VAS, Visual Analogue Scale; y/n, yes/no.