CD: Gastrointestinal Outcomes (2006)
Exclusion criteria included age < 18 years, age > 70 years, severe chronic liver disease, coronary heart disease, alcohol abuse, drug addiction, and use of corticosteroids, NSAIDs, antisecretory drugs, drugs affecting GI motility, or antibiotics in the past 4 weeks.
Recruitment
Retrospective review of patients referred for endoscopy for duodenal biopsy or upper GI symptoms, from 1996 - 2001.
Design
Case-Control Study.
Blinding used (if applicable)
Not applicable.
Intervention (if applicable)
Each patient given a questionnaire for evaluation of GORD symptoms prior to and 4-12 months after endoscopy.
Statistical Analysis
Significance of differences assessed by Fisher's exact test and ANOVA or Student's t test for unpaired observations, as appropriate. A p value of less than 0.05 was considered to be statistically significant.
Timing of Measurements
Patients completed questionnaire for evaluation of GORD symptoms prior to and 4-12 months after endoscopy. Patients re-evaluated for GORD symptoms at 4 month intervals up to 1 year.
Dependent Variables
- GORD symptom questionnaire, about heartburn, regurgitation, retrosternal pain, dysphagia, belching. Not shown to be valid or reliable measure.
- Endoscopy and severity of esophagitis assessed according to Los Angeles classification system
- 24 hour esophageal pH monitoring to detect acid pathological reflux
Independent Variables
- Celiac patients treated with gluten-free diet, not monitored or defined.
- Esophagitis patients in both groups treated with 8 week course of omeprazole
Control Variables
Initial N: 205 celiac patients (153 females, 52 males) and 400 non-celiac controls (244 females, 156 males)
Attrition (final N): See above
Age: Celiac patients median age 32 years, controls median age 37 years
Ethnicity: Not mentioned
Other relevant demographics:
Anthropometrics: Controls were similar but not matched
Location: Italy
Celiac Patients (n=205) | Non-Celiac Controls (n=400) | |
Epigastric Pain | 67 (32.7%) | 192 (48%) |
Postprandial Fullness |
85 (41.5%) |
153 (38.2%) |
Nausea | 25 (12.2%) | 34 (8.5%) |
Belching | 26 (12.7%) | 45 (11.2%) |
Dysphagia | 4 (1.9%) | 12 (3%) |
Heartburn | 77 (37.5%) | 121 (30.2%) |
Regurgitation |
38 (18.5%) |
54 (13.5%) |
Other Findings
Esophagitis was present in 39/205 (19%, 95% confidence interval 13.8 - 25.0%) celiac patients and in 32/400 (8%, 95% confidence interval 5.5 - 11.1%) dyspeptic subjects (p < 0.0001).
At the 1 year follow up, GORD symptoms relapsed in 10/39 (25.6%, 95% confidence interval 13 - 42.1%) celiacs with esophagitis and in 23/32 (71.8%, 95% confidence interval 53.2 - 86.2%) non-celiac subjects with esophagitis (p < 0.0001).
University/Hospital: | CIRANAD- Second University of Napoli (Italy); MIUR (Italy) |
Quality Criteria Checklist: Primary Research
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Relevance Questions | |||
1. | Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) | Yes | |
2. | Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? | Yes | |
3. | Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? | Yes | |
4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | Yes | |
Validity Questions | |||
1. | Was the research question clearly stated? | Yes | |
1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | Yes | |
1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
1.3. | Were the target population and setting specified? | Yes | |
2. | Was the selection of study subjects/patients free from bias? | Yes | |
2.1. | Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? | Yes | |
2.2. | Were criteria applied equally to all study groups? | Yes | |
2.3. | Were health, demographics, and other characteristics of subjects described? | Yes | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | Yes | |
3. | Were study groups comparable? | ??? | |
3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | Yes | |
3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | ??? | |
3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | Yes | |
3.4. | If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? | N/A | |
3.5. | If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) | ??? | |
3.6. | If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? | N/A | |
4. | Was method of handling withdrawals described? | Yes | |
4.1. | Were follow-up methods described and the same for all groups? | Yes | |
4.2. | Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) | Yes | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
4.4. | Were reasons for withdrawals similar across groups? | N/A | |
4.5. | If diagnostic test, was decision to perform reference test not dependent on results of test under study? | N/A | |
5. | Was blinding used to prevent introduction of bias? | Yes | |
5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | Yes | |
5.2. | Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) | Yes | |
5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | N/A | |
5.4. | In case control study, was case definition explicit and case ascertainment not influenced by exposure status? | Yes | |
5.5. | In diagnostic study, were test results blinded to patient history and other test results? | N/A | |
6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? | Yes | |
6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | Yes | |
6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | N/A | |
6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | Yes | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | ??? | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | Yes | |
6.6. | Were extra or unplanned treatments described? | Yes | |
6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | Yes | |
6.8. | In diagnostic study, were details of test administration and replication sufficient? | N/A | |
7. | Were outcomes clearly defined and the measurements valid and reliable? | ??? | |
7.1. | Were primary and secondary endpoints described and relevant to the question? | Yes | |
7.2. | Were nutrition measures appropriate to question and outcomes of concern? | Yes | |
7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | Yes | |
7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | No | |
7.5. | Was the measurement of effect at an appropriate level of precision? | ??? | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | ??? | |
7.7. | Were the measurements conducted consistently across groups? | Yes | |
8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | Yes | |
8.1. | Were statistical analyses adequately described and the results reported appropriately? | Yes | |
8.2. | Were correct statistical tests used and assumptions of test not violated? | Yes | |
8.3. | Were statistics reported with levels of significance and/or confidence intervals? | Yes | |
8.4. | Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? | N/A | |
8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | N/A | |
8.6. | Was clinical significance as well as statistical significance reported? | Yes | |
8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
9. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
9.1. | Is there a discussion of findings? | Yes | |
9.2. | Are biases and study limitations identified and discussed? | Yes | |
10. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |