Table 1.

Minimal and additional data elements recommended.

Minimal data elements

Study design Type of study (e.g. case-control; case-only; cross-sectional; longitudinal) Recruitment method, site and time-frame Dates and time intervals of data collection Randomization protocol (when employed) Primary and secondary outcomes Language(s) used to collect data Statistical methods Ethical review Demographics of study population Age, race, ethnicity, sex Educations, socioeconomic status Body mass index Marital status, children, living arrangements Employment/disability status Mode of onset of illness(e.g., acute, gradual; definition used to determine) Duration of illness Factors that exacerbate or trigger illness (desirable) Case definition Specify case definition used for enrollment and methods used to apply definition Cite reference for questionnaires and scoring, or provide copies and scoring algorithm in supplementary material Symptom inventory Include all case defining symptoms, frequency and severity Sleep Pain Include reference to questionnaire and scoring method, or provide copy in supplemental material Medical and psychiatric exclusions and co-morbidities Screening laboratory tests and cut-off values for exclusion Exclusionary medical and psychiatric conditions - method of ascertainment Methods used to evaluate controls for medical/psychiatric conditions List of co-morbid conditions in study population Current medications Self-reported functional impairment/levels of activity Specify instrument/questionnaire used, and method of scoring; validated options include: Medical Outcomes Survey Short Form-36 Short Form-12 Sickness Impact Profile International Physical Activity Questionnaire The Seven-Day Physical Activity Recall Questionnaire Time logs such as Activity Record (ACTRE) (Gerber and Furst, 1992)