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Study Title and Description

Prevalence and associated factors for episodic and chronic daily headache in the Colombian population.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on behavior*?
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Primary Publication Information
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TitleData
Title Prevalence and associated factors for episodic and chronic daily headache in the Colombian population.
Author M Rueda-Sánchez,LA Díaz-Martínez,
Country
Year 2008
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Behavior - Design Details - INCLUDED Studies
Arms
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 18254892
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What outcome is being evaluated in this paper? Behavior
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What is the objective of the study (as reported by the authors)? The objective was to show the simultaneous evaluation of associated factors with CDH or episodic headache in the population of Bucaramanga.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) This was a cross-sectional survey made in the urban area of Bucaramanga, Colombia, which was previously approved by the Review Board of the Universidad Autónoma de Bucaramanga. The sample was selected in two simple random stages. In the first one, 1841 households were selected among the 64 206 registered in the Municipality Territorial Arrangement Plan (32). In a second stage, in each household, all 18–65-year-olds were identified, one of whom was selected by simple randomization. It was hypothesized that CDH had an annual prevalence of 3+/-1%, for which a sample of 1473 people was required, previewing a 95% confidence and an extra 20% for non-answers. All literate people accepted to participate in the study were included, except those who had some major disability inhibiting their ability to complete the survey (e.g. blindness, mental retardation). Each individual was personally contacted and asked to complete a self-report survey designed to inquire about headaches and CDH, emphasizing clinical characteristics of primary headache (if applicable), family history of CDH, personal clinical background of arterial hypertension, overuse of analgesics, caffeine consumption, alcoholism, depression, vital stressor events, insomnia symptoms, snoring, and use of hypnotics. To evaluate if primary headache had migraine characteristics, the validated Spanish version of the Diagnostic Questionnaire for Migraine (33) was applied, whereas to test for depression the validated Spanish version for Zung’s Self-rating Depression Scale (34) was used. CDH was considered when the inhabitant reported to have any type of headache for >15 days a month during at least the previous 3 months; episodic headache was considered if the headache was less frequent than 15 days a month or had an evolution <3 months (35). Medication overuse was considered, according to the International Headache Society classification (35), if a patient took simple analgesics >3 days a week, or ergotamine, triptans, or a combination of analgesics >2 days a week during the last 6 months. Alcoholism was defined as the consumption of any alcoholic drink regularly and a history of problems produced by alcohol intake. The vital stressor events considered were to have had a recent loss, difficulties at work, economic difficulties, relationship problems, family difficulties and any other problems that people in the study considered to have affected them in the last 3 months. The population was described in proportions; a confidence interval of 95% (95% CI), means and SD and interquartile range (IQR) according to the variable type used. These estimates and the statistical tests were adjusted by sampling effect in the ‘Svy’ module of STATA 9.0 (36), and were considered significant when differences showed a type I error <0.05. The association between independent variables and episodic headache or CDH was determined initially by comparing each patient group (without headache, with episodic headache, and with CDH) with the other two; a multinomial logistic regression model was then developed, following Greenland’s recommendations (37). Briefly, to develop this model, all variables with any significant association or a P-value <0.2 were included, beginning by gender and the most significant one. If the second variable had significant association or changed the gender odds ratio in >10%, this second variable was accepted into the model, but was otherwise rejected. This process was repeated sequentially until all variables were analysed.
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How many outcome-specific endpoints are evaluated? 1
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) headache
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes both chronic daily headache and episodic headache were evaluated
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Clinical Clinical
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Physiological
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Other
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What is the study design? Cross-sectional
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Randomized or Non-Randomized?
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What were the diagnostics or methods used to measure the outcome? Subjective
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Optional: Name of Method or short description To evaluate if primary headache had migraine characteristics, the validated Spanish version of the Diagnostic Questionnaire for Migraine
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Caffeine (general)
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Coffee Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda
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Tea
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Measured
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Self-report Self-report
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Children
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Adolescents
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Adults Adults
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Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) comparison of population without headache to those with either episodic or chronic daily headaches
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) N/A, caffeine was not selected for the multivariable model
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Provide a general description of results (as reported by the authors). Consumption of coffee Daily cups - No headache (A): 1.36 (1.19–1.52); Episodic headache (B): 1.36 (1.20–1.52); Chronic daily headache (C): 1.67 (1.26–2.07). Significance: A vs B: 0.758; A vs C: 0.768
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Did the authors perform a dose-response analysis (or trend/related analysis)? No
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What were the authors's observations re: trend analysis?
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What were the author's conclusions? In the other hand, caffeine consumption has been reported as a risk factor for CDH (10, 69); however, we have found no such association in our study. Nonetheless, it is not possible to discard caffeine given the great quantity of variables. The size of our sample is not large enough to demonstrate differences in some of these variables on multinomial analysis.
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What were the sources of funding? none reported
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What conflicts of interest were reported? N/A
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Does the exposure (dose) need to be standardized to the SR? Yes
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest). Episodic headache subject consumption: 1.36 cups of coffee/day x 95 mg/cup = 129.2 mg/day chronic daily headache subject consumption: 1.67 cups of coffee/day x 95 mg/cup = 158.7 mg/day
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  Episodic headache subject consumption: NOAEL = 129.2 mg/day chronic daily headache subject consumption: NOAEL = 158.7 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. no effects seen at levels below Nawrot.
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What is the importance of the study with respect to the adverseness of the outcome? Important
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