Data Assessment Forms

Level 1 Screening

Objective 1:

1. Does this refer to determining the sensitivity or specificity of one of the following tests for celiac disease? (biopsy, anti-htTG, anti-endomysial, anti-gliadin antibody, anti-gliadin antibody, HLA DQ2/DQ8).

   1. This citation refers to another objective and should be moved or copied
   2. No (move on to next citation)
   3. Yes
   4. Can't tell

Objective 2:

1. Does this refer to the prevalence or incidence of celiac disease?

   1. This citation refers to another objective and should be moved or copied
   2. No (move on to next citation)
   3. Yes
   4. Can't tell

Objective 3:

1. Does this refer to an association between celiac and GI lymphoma?
   1. This citation refers to another objective and should be moved or copied
   2. No (move on to next citation)
   3. Yes
   4. Can't tell

Objective 4:

1. Does this refer to expected consequences of testing for celiac disease
   1. This citation refers to another objective and should be moved or copied
   2. No (move on to next citation)
   3. Yes
   4. Can't tell

Objective 5:

1. Does this refer to identifying or assessing interventions for promoting or monitoring adherence to a gluten free diet?
   1. This citation refers to another objective and should be moved or copied
   2. No (move on to next citation)
   3. Yes
   4. Can't tell

Level 2 Screening

Objective 1:

1. Does this refer specifically to determining the sensitivity or specificity of one of the identified tests for celiac disease? Note: for biopsy and HLA, we may not see sensitivity or specificity - keep if you can get data on use as diagnostic test or accuracy as a test or if it distinguishes celiac from other diseases etc.
   1. Yes. If this citation also refers to another objective(s), please state objective number(s):
   2. No. If this citation refers to another objective(s), please state objective number(s): (move on to next citation)
2. Is this a review article?
   1. Yes (keep for references)
   2. No
3. What is the test(s) being studied? (Note: we are not interested in any other type of test!)
   1. Biopsy
   2. Anti-htTG
   3. Anti-endomysial antibody (EMA)
   4. Anti-gliadin antibody (AGA)
   5. HLA DQ2/DQ8 (note: we are not interested in pathophysiology does the article give data using HLA to distinguish celiac from non celiac)
   6. If none of above then - reject citation
4. What is the “gold standard” the test(s) is compared to?
   1. Biopsy
   2. Anti-htTG
   3. Anti-endomysial antibody (EMA)
   4. Anti-gliadin antibody (AGA)
   5. HLA DQ2/DQ8
   6. Other (list in box)
5. What is the patient population?
   1. Adults
   2. Paediatric
   3. General unselected
   4. Specific ethnic groups (fill in box)
   5. Patients with suspected celiac (symptomatic)
   6. Patients at risk of celiac disease (asymptomatic - relatives of celiac, diabetes, Fe Diff, infertility, osteoporosis, short stature)
   7. Other (fill in box)

Objective 2:

1. Does this refer specifically to the prevalence or incidence of celiac disease? Please remember we are only really interested in the incidence / prevalence of celiac in population X or disease X NOT vice verse.
   1. Yes.
   2. No. Exclude
   3. No. But this referrers to an association between celiac and another disease to state in background /discussion
2. Is this a review article?
   1. Yes (keep for references)
   2. No
3. Does the prevalence or incidence refer to:
   1. Classical celiac
   2. Atypical celiac (i.e., Fe diff, infertility, short stature, osteoporosis)
   3. Asymptomatic celiac
   4. Other or (fill in box)
4. What is the patient population that was tested?
   1. Unselected - general population (e.g., blood donors, routine physical etc)
   2. Patients with suspected celiac
   3. Relatives of celiac patients
   4. Iron deficiency
   5. Osteoporosis
   6. Short stature
   7. Infertility
   8. Other (fill in box)
5. What was the screening test(s) used?
   1. Biopsy
   2. Anti-htTG
   3. Anti-endomysial antibody (EMA)
   4. Anti-gliadin antibody (AGA)
   5. HLA DQ2/DQ8
   6. Other (fill in box)
6. What is the country/region of origin of the study (fill in box)?

Objective 3:

1. Does this refer specifically to an association between celiac and GI lymphoma?
   1. Yes
   2. No. Exclude
2. Is this a review article?
   1. Yes (keep for references)
   2. No
3. Does this give data on the risk of developing GI lymphoma in celiac?
   1. Yes
   2. No
4. What is the country/region of origin of the study? (fill in box)
5. What celiac population was evaluated?
   1. Classical celiac
   2. Atypical celiac (i.e., fe dif, infertility, short stature, osteoporosis)
   3. Asymptomatic celiac
   4. Other (fill in box)

Objective 4:

1. Does this refer specifically to expected consequences of testing for celiac disease?
   1. Yes
   2. No. Exclude
2. Is this a review article?
   1. Yes (keep for references)
   2. No
3. What consequences were assessed:
   1. False-positive results
   2. Follow-up testing
   3. Invasive procedures (biopsy)
   4. Costs
   5. Cases diagnosed
   6. Patients complying with treatment
   7. Response to treatment
   8. Clinical outcome (reduced risk of complication etc)
   9. Other (fill in box)
4. What is the country/region of origin of the study? (fill in box)
5. What is the patient population that was tested?
   1. Unselected - general population (e.g., blood donors, routine physical, etc.)
   2. Patients with symptoms suggestive of celiac.
   3. Asymptomatic at risk populations (relatives of celiac patients, iron deficiency, osteoporosis, infertility short, stature)
   4. Other (fill in box).

Objective 5:

1. Does this specifically refer to identifying or assessing an intervention(s) for promoting or monitoring adherence to a gluten free diet?
   1. Yes
   2. No. Exclude
2. Is this a review article?
   1. Yes (keep for references)
   2. No
3. Does this refer to:
   1. Promoting adherence
   2. Monitoring adherence
   3. Both
4. What intervention was assessed? (If monitoring adherence)
   1. Biopsy
   2. Antibody testing
5. What intervention was used? (If promoting adherence) - fill in box

Level 3 Screening

Celiac 1: Sensitivity and specificity of screening tests:

Inclusion criteria: (a No answer to any of the below excludes the article)

1. For serology - the study publication date is 1990 or more recent (biopsy studies can be earlier)
   1. Yes (include)
   2. No (exclude)
2. For AGA - the studies uses a standardized commercial ELISA kit (or this study is testing such a kit or technique)
   1. Yes (include)
   2. No (exclude)
3. For EMA - the substrate is monkey esophagus or human umbilical cord
   1. Yes (include)
   2. No (exclude)
4. For tTG - study uses ELISA with the substrate for tTG being guinea pig or human recombinant tTG.
   1. Yes (include)
   2. No (exclude)
5. For any serology and HLA studies - the control group(s) are appropriate and controls evaluated with the reference test (i.e., biopsy)?
   1. Yes (include)
   2. No (exclude)
6. The paper allows for the extraction of the sensitivity or specificity of the test in question (AGA, EMA, tTG, HLA DQ2/8, biopsy)?
   1. Yes (include)
   2. No (exclude)
7. Was the diagnosis of celiac disease appropriate in the celiac disease group
   1. Yes (include)
   2. No (exclude)

Celiac 2: Prevalence and incidence of celiac disease:

Inclusion Criteria: (a No answer to any of the below excludes the article)

1. The country of origin must be Western Europe, North America, Australia, New Zealand.
   1. Yes (include)
   2. No (exclude)
2. The publication date was >= 1990 if serology was used to screen (but can be earlier for biopsy)
   1. Yes (include)
   2. No (exclude)
3. The screening test was biopsy, standardized ELISA AGA, EMA (monkey esophagus or human umbilical cord), tTG (guinea pig, or human recombinant)
   1. Yes (include)
   2. No (exclude)
4. The screened population must belong to one of these groups:
   1. Unselected - General population (e.g. Blood donors, routine physical etc)
   2. Patients with suspected celiac
   3. Relatives of celiac patients
   4. Iron deficiency
   5. Osteoporosis
   6. Diabetes
   1. Yes (include)
   2. No (exclude)

Celiac 3: Prevalence/incidence of lymphoma in celiac disease

1. Does this study specifically give the incidence, prevalence or a measure of risk of GI lymphoma (Includes malignant histiocytosis) in a population of celiac patients? (Note: we are not interested in other cancers, and we are not interested in how many lymphoma patients have celiac disease)
   OR
   Does this study discuss ulcerative jejuno-ileitis or refractory sprue as a precursor or marker for GI lymphoma in patients with celiac disease?
   1. Yes (include lymphoma)
   2. Yes (include jejuno-ileitis/refractory sprue)
   3. No (exclude)

Celiac 4: Consequences of testing for celiac disease

1. Does this paper report a consequence of testing for celiac listed below: (note: false positive, and negative results, follow-up testing and need for invasive testing is obtained from Celiac 1 objective)
   1. Costs
   2. Patients complying with treatment
   3. Response to treatment - i.e., clinical outcome (reduced risk of complication - osteoporosis, lymphoma, anemia, symptoms)
      1. Yes (include)
      2. No (exclude)
2. Did the population include one of the following (note: nothing more than listed):
   1. Patients with symptoms suggestive of celiac disease
   2. Asymptomatic, at-risk populations (affected family members, patients with type 1 diabetes, osteoporosis, Fe Diff)
   3. General population
      1. Yes (include)
      2. No (exclude)

a No to either question excludes the study

Celiac 5: Monitoring or promoting adherence to a GFD

If a monitoring question:

Does this paper report monitoring adherence based on serology (standardized ELISA AGA publication date >= 1990, EMA (monkey esophagus or human umbilical cord), tTG (guinea pig, or human recombinant) or biopsy?

If this is a study of sensitivity or specificity - it must include actual extractable follow-up data (like drop in titre or improvement in biopsy)

OR

If a promoting adherence question:

Does this paper report on an intervention that was used to promote adherence to Gluten free diet?

1. Yes (include promoting)
2. Yes (include Monitoring)
3. No (exclude)

Data Abstraction Forms

Celiac 1: Serology

1. Paper #:
2. Title:
3. Author/year:
4. Reference:
5. Reviewer:
6. Publication type:
   1. Journal
   2. Conference abstract
   3. Other:
7. Is this a duplicate publication (state refid of duplicate):
8. Study type:
   1. Relevant clinical population: (cases and controls defined from the population based on the results of the test under study)
   2. Case Control: (groups are predefined and may come from different populations):
   3. Other: (list)
9. Country:
10. Racial Groups and % if different from country: list in box
11. Group demographics

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    	Celiac		Control
    	Group 1	Group 2	Group 1	group 2	group 3	group 4
    Group name
    Age groups
    Mean age
    Age range
    % female
    Gluten intake

12. Type of population (applies to 8 a): (from level 2 database)
    1. Unselected - general population (e.g., blood donors, routine physical, etc.)
    2. Patients with suspected celiac
    3. Relatives of celiac patients
    4. Diabetes
    5. Iron deficiency
    6. Osteoporosis
    7. Other (fill in box): not part of extraction - background / discussion only
13. Case and control group types (applies to 8 b):
    1. Celiac group 1
       1. Untreated
          1. Classic
          2. Silent celiac
          3. Atypical celiac
          4. Other
       2. Treated On GFD
       3. Refractory (implies on GFD) / ulcerative jejuno-ileitis
       4. Other/can't tell: text box
    2. Celiac group 2 - if applicable
       1. Untreated
          1. Classic
          2. Silent celiac
          3. Atypical celiac
          4. Other
       2. Treated on GFD
       3. Refractory (implies on GFD) / ulcerative jejuno-ileitis
       4. Other/can't tell: text box
          Note: Control groups must have had a negative biopsy otherwise should have been excluded at level 3
    3. Control group 1:
       1. Unselected - general population (e.g., blood donors, routine physical, etc.)
       2. Patients with suspected celiac
       3. Relatives of celiac patients
       4. Diabetes
       5. Iron deficiency
       6. Osteoporosis
       7. Other disease controls
       8. Other (fill in box):
    4. Control group 2 (if applicable):
       1. Unselected - general population (e.g., blood donors, routine physical, etc.)
       2. Patients with suspected celiac
       3. Relatives of celiac patients
       4. Diabetes
       5. Iron deficiency
       6. Osteoporosis
       7. Other disease controls
       8. Other (fill in box):
    5. Control group 3 (if applicable):
       1. Unselected - general population (e.g., blood donors, routine physical, etc)
       2. Patients with suspected celiac
       3. Relatives of celiac patients
       4. Diabetes
       5. Iron deficiency
       6. Osteoporosis
       7. Other disease controls
       8. Other (fill in box):
    6. Control group 4 (if applicable):
       1. Unselected - general population (e.g., blood donors, routine physical, etc.)
       2. Patients with suspected celiac
       3. Relatives of celiac patients
       4. Diabetes
       5. Iron deficiency
       6. Osteoporosis
       7. Other disease controls
       8. Other (fill in box):
14. Reference test(s) for cases (i.e., how was celiac diagnosed):
    1. Biopsy (required):
       1. endoscopic
       2. capsule
          1. list type: text box
       3. how many samples taken (text box)
    2. Serology (check as many as applicable)
       1. AGA (date >1990)
       2. EMA
       3. tTG
    3. Comments:
15. What test was conducted first
    1. Biopsy
    2. Serology
    3. Simultaneous
    4. Mixed
    5. Unsure/other: comment in box
16. Reference test for control (s) 1-----2-----3-----4
    1. Include biopsy (required)
    2. Otherwise excluded
17. Detail biopsy criteria used to define celiac (ESPGAN, Marsh, Rostami) and state what grades were used (i.e., Marsh I and above? etc.)
18. Was IgA deficiency assessed (if applicable):
    1. Yes
    2. No
    3. N/A
    4. Comments: text box)
19. Overall number:
20. Number of:
    1. Cases 1
    2. Cases 2 (if applicable):
    3. Control group 1:
    4. Control group 2 (if applicable):
    5. Control group 3 (if applicable):
    6. Control group 4 (if applicable):
21. Intervention: ( may be up to 8+ tests studied - distinguish IgG from IgA )

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    				Results (4×4 table)
    Test name	Methodology	Cut-off (criteria)	Group	a	b	c	d

22. Stated results if raw data not given:

    View in own window

    Test name	Sensitivity	Specificity	PPV	NPV	Prevalence

23. Comments regarding study: test box

Notes for reference:

Test name can be:

1. Anti-htTG
2. Anti-endomysial antibody (EMA)
3. Anti-gliadin antibody (AGA)

Calculate automatically

• Prevalence: (a+c)/(a+b+c+d)
• Sensitivity: (a/(a+c));
• Specificity: d/(b+d);
• PPV: a/(a+b)
• NPV: d/(c+d)

Celiac 1: HLA

1. Paper #:
2. Title:
3. Author/year:
4. Reference:
5. Reviewer:
6. Publication type:
   1. Journal
   2. Conference abstract
   3. Other:
7. Is this a duplicate publication (state refid of duplicate):
8. Country:
9. Racial groups and % if different from country: list in box
10. Age groups (ped, adult, both):
11. Mean age:
12. Range of age:
13. Percent female:
14. Study type:
    • d. Relevant clinical population: (cases and controls defined from the population based on the results of the test under study)
    • e. Case control: (groups are predefined and may come from different populations:
    • f. Cross-sectional screening study
    • g. Other: (list)
15. Type of population (applies to 14 a, c):
    1. Unselected - general population (e.g., blood donors, routine physical etc)
    2. Patients with suspected celiac
    3. Relatives of celiac patients
    4. Diabetes
    5. Iron deficiency
    6. Osteoporosis
    7. Other (fill in box): not part of extraction - background / discussion only
16. Case and control group types (applies to 14b):
    • h. Celiac group 1
      1. Untreated
         1. Classic
         2. Silent celiac
         3. Atypical celiac
         4. Other
      2. Treated on GFD
      3. Refractory (implies on GFD) / ulcerative jejuno-ileitis
      4. Other/can't tell: text box Celiac group 2
    • i. Celiac group 2 - if applicable
      1. Untreated
         1. Classic
         2. Silent celiac
         3. Atypical celiac
         4. Other
      2. Treated on GFD
      3. Refractory (implies on GFD) / ulcerative jejuno-ileitis
      4. Other/can't tell: text box
         Note: Control groups must have had a negative biopsy otherwise should have been excluded at level 3
    • j. Control group 1:
      1. Unselected - general population (e.g., blood donors, routine physical, etc.)
      2. Patients with suspected celiac
      3. Relatives of celiac patients
      4. Diabetes
      5. Iron deficiency
      6. Osteoporosis
      7. Other disease controls
      8. Other (fill in box):
    • k. Control group 2 (if applicable):
      1. Unselected - general population (e.g., blood donors, routine physical, etc.)
      2. Patients with suspected celiac
      3. Relatives of celiac patients
      4. Diabetes
      5. Iron deficiency
      6. Osteoporosis
      7. Other disease controls
      8. Other (fill in box):
    • l. Control group 3 (if applicable):
      1. Unselected - general population (e.g., blood donors, routine physical, etc.)
      2. Patients with suspected celiac
      3. Relatives of celiac patients
      4. Diabetes
      5. Iron deficiency
      6. Osteoporosis
      7. Other disease controls
      8. Other (fill in box):
    • m. Control group 4 (if applicable):
      1. Unselected - general population (e.g., blood donors, routine physical, etc.)
      2. Patients with suspected celiac
      3. Relatives of celiac patients
      4. Diabetes
      5. Iron deficiency
      6. Osteoporosis
      7. Other disease controls
      8. Other (fill in box):
17. Reference test for cases
    • n. Biopsy:
      1. endoscopic
      2. capsule
         1. list type: text box
    • o. Serology (check as many as applicable)
      1. AGA (date >1990)
      2. EMA
      3. tTG
18. Reference test for control 1-----2------3-----4
    • p. Biopsy
    • q. Serology (list)
    • r. Can't tell
19. Overall number:
20. Number of:
    • s. Cases 1
    • t. Cases 2 (if applicable):
    • u. Control group 1:
    • v. Control group 2 (if applicable):
    • w. Control group 3 (if applicable):
    • x. Control group 4 (if applicable):
21. HLA tested

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    				Results (4×4 table)
    Test name	Methodology	Cut-off (criteria)	Group	a	b	c	d

22. Stated results if raw data not given:

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    Test name	Sensitivity	Specificity	PPV	NPV	Prevalence

23. Narrative result if data not extractable: text box
24. Comments regarding study: text box

Celiac 2: Prevalence and Incidence of Celiac Disease

1. Paper #:
2. Title:
3. Author/year:
4. Reference:
5. Reviewer:
   Patient population:
6. Publication type:
   1. Journal
   2. Conference abstract
   3. Etc (your list)
7. Is this a duplicated: list refid
8. Study type:
   1. Cross-sectional prevalence
   2. Cohort
   3. Case control
   4. Incidence study
   5. Other: (list)
9. Country:
10. Racial groups and % if different from country: list in box
11. Type of patients screened:
    1. Unselected - general population (e.g., blood donors, routine physical etc)
    2. Patients with suspected celiac
    3. Relatives of celiac patients
    4. Diabetes
    5. Iron deficiency
    6. Osteoporosis
    7. Other (fill in box): not part of extraction - background / discussion only
12. Age groups (ped, adult or both): from level 2 database
13. Mean age:
14. Range of age:
15. Percent female:
    Intervention:

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    				Results
    Test name	Methodology	# screened	Cases detected	Incidence (time period)	Prevalence

    Note: distinguish IgG from IgA. Also the screen may be single test, or combination of tests. So list each strategy used as a “test name”
16. State control reference and methodology of incidence study: (fill in box)
17. Confirmatory test
    1. None
    2. Biopsy
    3. Other serology
    4. Other: fill in box
18. Was IgA deficiency assessed (if applicable):
    1. Yes
    2. No
    3. N/A
    4. Comments: (text box)
19. Comments about study: text box

Celiac 3: Lymphoma

1. Paper #:
2. Title:
3. Author/year:
4. Reference:
5. Reviewer:
6. Publication type:
   1. Journal
   2. Conference abstract
   3. Etc (your list)
7. Study type:
   1. Cross-sectional prevalence
   2. Case series
   3. Cohort
      1. Prospective
      2. Retrospective
   4. Case control
   5. Other: (list)
8. Country: from level 2 database
9. Racial groups and % if different from country: list in box
10. Study population type(s) - this is the population of “lymphoma” in case control OR the overall population in a screening/prevalence study and cohort studies: Check multiple if study included different populations
    1. Classic celiac:
       1. Treated celiac
       2. Untreated celiac
       3. Non-compliant
       4. Unclear about treatment
    2. Asymptomatic (silent celiac)
    3. Atypical celiac (found on basis of
    4. Latent celiac (normal histology)
    5. Refractory celiac
    6. Ulcerative jejuno-ileitis
    7. Other celiac complications
    8. Patients on Immunosuppression:
    9. Other:
11. How were celiac patients identified (text box)
12. How were cases of lymphoma identified? (i.e., registry, administrative database, etc.) text box
13. Group demographics

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    	Overall population study type a, b, c	Case group	Control group
    Age groups
    Mean age
    Age range
    % female
    Disease duration

14. For case control study:
    1. Control population type (those without lymphoma)
       1. Unselected general population
       2. Other disease controls: state disease(s)
       3. A celiac population
          1. Classic celiac:
             1. Treated celiac
             2. Untreated celiac
             3. Non-compliant
             4. Unclear about treatment
          2. Asymptomatic (silent celiac)
          3. Atypical celiac (found on basis of
          4. Latent celiac (normal histology)
          5. Refractory celiac
          6. Ulcerative jejuno-ileitis
          7. Other celiac complications
       4. Patients on immunosuppression:
    2. # of cases:
    3. # of controls:
    4. Risk factor used to calculate odds ratio
       1. Celiac itself
          1. classic
          2. refractory
          3. ulcerative jejuno-ileitis
       2. Compliance with diet
       3. Disease duration
       4. Other: state in text box
    5. Raw data (if possible)
       Table for case control study

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       Risk factor	Lymphoma present	Lymphoma absent
       Present
       Absent

15. For cohort study
    • f. Length of F/U of cohort:
    • g. Timeline:
      • iii. Prospective cohort
      • iv. Retrospective cohort:
    • h. Risk factor used to calculate Relative Risk if one population used
      • v. Celiac itself
        1. classic
        2. atypical
        3. silent
        4. refractory
        5. ulcerative jejuno-ileitis
      • vi. Compliance with diet
      • vii. Disease duration
      • viii. Other: state in text box
    • i. If a celiac cohort was compared to another population to obtain another risk estimate (i.e., standardized mortality or morbidity ratios). Describe control population.
      • ix. Unselected general population
      • x. Other disease controls: state disease(s)
      • xi. A celiac population
        1. Classic celiac:
           1. Treated celiac
           2. Untreated celiac
           3. Non-compliant
           4. Unclear about treatment
        2. Asymptomatic (silent celiac)
        3. Atypical celiac (found on basis of
        4. Latent celiac (normal histology)
        5. Refractory celiac
        6. Ulcerative jejuno-ileitis
        7. Other celiac complications
      • xii. Patients on immunosuppression
      • xiii. Other: (fill in text box)
    • j. Overall number in cohort:
      • xiv. Number of cases identified:
    • k. Number in control population (if applicable)
      • xv. Number of lymphomas identified
      • xvi. Raw data if available:
16. Table for classic cohort study

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    Risk factor	Lymphoma present	Lymphoma absent
    Present
    Absent

17. For cross sectional studies: study population in Q #10
    • l. Overall number screened:
    • m. Number of cases identified:
18. Results (text boxes)
    • n. Lymphoma type
    • o. Prevalence of lymphoma in celiac:
    • p. Incidence of lymphoma in celiac:
    • q. Odds ratio (95% confidence interval)
    • r. Relative risk (95% confidence interval):
    • s. Standardized mortality ratio
    • t. Standardized morbidity ratio
    • u. Other risk estimate:
19. Study comments:

Celiac 4: Consequences of Testing

1. Paper #:
2. Title:
3. Author/year:
4. Reference:
5. Reviewer:
   Patient population:
6. Publication type:
   1. Journal
   2. Conference abstract
   3. Etc (your list)
7. Study type:
   1. Diagnostic test
   2. Cross-sectional prevalence
   3. Cohort
   4. Case control
   5. Other: (list)
8. Country: from level 2 database
9. Racial groups and % if different from country: list in box
10. Type of patients tested (from level 2 database)
    1. Unselected - general population (e.g., blood donors, routine physical, etc.)
    2. Patients with suspected celiac
    3. Relatives of celiac patients
    4. Diabetes
    5. Iron deficiency
    6. Osteoporosis
    7. Other (fill in box):
11. Type of celiac patients identified:
    1. Classic celiac
    2. Asymptomatic
    3. Atypical celiac
       1. Fe deficiency
       2. Osteoporosis
       3. Other
    4. Complicated celiac
       1. Refractory
       2. Jejuno-ileitis
       3. Lymphoma)
    5. Other
12. Intervention:
    1. Test(s) used to identify celiac patients:
       1. Biopsy
       2. AGA ELISA (publication date >1990)
       3. AMA
       4. tTG:
13. Was IgA deficiency assessed (if applicable):
    1. Yes
    2. No
    3. N/A
    4. Comments: text box)
14. Length of F/U:
15. How were patients followed (if applicable): test box
16. Outcomes:

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    Outcome	Result	Notes
    Costs
    Cases diagnosed
    Patients complying with treatment
    Response to treatment
    Clinical outcome (reduced risk of complication, etc)
    Other (fill in box)

17. Comments regarding study: Fill in text box

Celiac 5: Promoting and Monitoring Adherence to Gluten-Free Diet

1. Paper #:
2. Title:
3. Author/year:
4. Reference:
5. Reviewer:
   Patient population:
6. Publication type:
   1. Journal
   2. Conference abstract
   3. Etc (your list)
7. Study type:
   1. Diagnostic test
   2. Cross-sectional prevalence
   3. Cohort
   4. Case control
   5. Other: (list)
8. Country: from level 2 database
9. Racial groups and % if different from country: list in box
10. Age groups (ped, adult, both): from level 2 database
11. Mean age:
12. Range of age:
13. Percent female:
14. Disease duration: state in box
15. Type of celiac studied
    1. Classic celiac
    2. Asymptomatic celiac
    3. Atypical celiac (Fe deficiency, osteoporosis, etc.)
    4. Refractory celiac
    5. Ulcerative jejuno-ileitis
    6. IgA deficient celiac
    7. Other:
16. Does this refer to:
    1. Promoting adherence
    2. Monitoring adherence
    3. Both
17. What intervention was assessed? (if monitoring adherence)

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    	Result (normalization of biopsy or drop in antibody titres - list result details)
    Biopsy
    Antibody testing (state test used)
    Other:

18. Did this study determine the sensitivity/specificity of the intervention during follow-up or with different histologic grades:
    1. No
    2. Yes: detail in text box
19. Was IgA deficiency assessed (if applicable):
    1. Yes
    2. No
    3. N/A
    4. Comments: text box
20. What intervention was used? (if promoting adherence) - fill in box

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    Intervention	Result

    Comments about the study: fill in text box