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Tabla de contenido
  1. 1. Ensayo clínico
  2. 2. Documentación de rutina
  3. 3. Estudio de registro / cohorte
  4. 4. Seguro de calidad
  5. 5. Estándar de datos
  6. 6. Resultado reportado por el paciente
  7. 7. Especialidad médica
Modelos de datos seleccionados

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- 20/9/21 - 16 formularios, 4 itemgroups, 17 items, 1 idioma
Itemgroups: Visit overview, Quality of life assessment, Surrogate Markers, Comment

Registration

4 itemgroups 39 items

Therapy and toxicity cycle 10-13

16 itemgroups 68 items

Therapy and toxicity cycle > 13

16 itemgroups 68 items

Therapy and toxicity cycle 1-3

16 itemgroups 68 items

Therapy and toxicity cycle 4-6

16 itemgroups 68 items

Therapy and toxicity cycle 7-9

16 itemgroups 68 items
- 19/12/17 - 1 formulario, 14 itemgroups, 149 items, 2 idiomas
Itemgroups: 15 year follow up, Demography, Community Outreach, School, leisure / free time, Medical background data, Additional handicap, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, General self-assessed health, Background issues regarding socio-emotional and practical support to Parents / Guardians
- 19/12/17 - 1 formulario, 14 itemgroups, 149 items, 2 idiomas
Itemgroups: 18 year follow up, Demography, Community Outreach, School, leisure / free time, Medical background data, Additional handicap, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, General self-assessed health, Background issues regarding socio-emotional and practical support to Parents / Guardians
- 19/12/17 - 1 formulario, 18 itemgroups, 210 items, 2 idiomas
Itemgroups: 12 year follow up, Demography, Community Outreach, School, leisure / free time, Medical background data, Additional handicap, Cognitive functions, WPPSI-III scale, WISC-IV scale, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, General self-assessed health, Communication - Language - Eating, Background issues regarding socio-emotional and practical support to Parents / Guardians
- 19/12/17 - 1 formulario, 18 itemgroups, 206 items, 2 idiomas
Itemgroups: 6 year follow up, Demography, Community Outreach, Preschool/School, leisure / free time, Medical background data, Additional handicap, Cognitive functions, WPPSI-III scale, WISC-IV scale, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, General self-assessed health, Communication - Language - Eating, Background issues regarding socio-emotional and practical support to Parents / Guardians
- 18/12/17 - 1 formulario, 14 itemgroups, 147 items, 2 idiomas
Itemgroups: 9 year follow up, Demography, Community Outreach, School, leisure / free time, Medical background data, Additional handicap, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, General self-assessed health, Background issues regarding socio-emotional and practical support to Parents / Guardians
- 18/12/17 - 1 formulario, 13 itemgroups, 173 items, 2 idiomas
Itemgroups: 3 year follow up, Demography, Community Outreach, Preschool / School, Medical background data, Additional handicap, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, Communication - Language - Eating, Background issues regarding socio-emotional and practical support to Parents / Guardians
- 3/8/21 - 1 formulario, 10 itemgroups, 188 items, 1 idioma
Itemgroups: Participant Identification, Demographics, Onset of current illness and vital signs, Possible signs and symptoms of multisystem inflammatory syndrome, Other signs and symptoms of multisystem inflammatory syndrome, Recent history, Co-morbidities, past history, Pre-admission and chronic medication, Laboratory results, Imaging and pathogen testing
Based on CRF on https://isaric.org/research/covid-19-clinical-research-resources/multisystem-inflammatory-syndrome-mis-c/ This Case Report Form (CRF) has been developed by ISARIC in cooperation with WHO's working group (https://www.who.int/news-room/commentaries/detail/multisystem-inflammatory-syndrome-in-children-and-adolescents-with-covid-19) to use as a standalone CRF for children and adolescents presenting with syndrome of suspected Multisystem Inflammatory Syndrome (MIS-C). Preliminary case definition Children and adolescents 0–19 years of age with measured or self-reported fever ≥ 3 days AND two or more of the following: a) Rash or bilateral non-purulent conjunctivitis or muco-cutaneous inflammation signs (oral, hands or feet) b) Hypotension or shock c) Features of myocardial dysfunction, or pericarditis, or valvulitis, or coronary abnormalities (clinical features, ECHO findings, or laboratory markers such as elevated Troponin/NT-proBNP) d) Evidence of coagulopathy (such as abnormal PT, PTT, elevated d-Dimers) e) Acute gastrointestinal problems (such as diarrhoea, vomiting or abdominal pain) AND Elevated markers of inflammation such as ESR, C-reactive protein or procalcitonin AND No other obvious microbial cause of inflammation, including bacterial sepsis, staphylococcal or streptococcal shock syndromes AND Evidence of current or previous COVID-19 (RT-PCR, antigen test or serology positive) or likely contact with patients with COVID NB Consider this syndrome in children with features of typical or atypical Kawasaki disease or toxic shock syndrome. This Module is to be completed when multisystem inflammatory syndrome is suspected, on admission or in-patients.
- 7/4/22 - 1 formulario, 21 itemgroups, 60 items, 1 idioma
Itemgroups: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG)

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