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- remove 'Unblinding request' action linked PRN
- changes to Lumbar Puncture/CSF CRF:
- remove Q16: QC Requisition
- remove Q17: QC Result Report Date and Time
- remove Q18: Quantitative culture
- remove Q32: CSF CrAg done by IMMY CrAg LFA
- changes to Chest X-ray CRF:
- add 'Normal' option to results list
- add 'chest_xray_results_other' field
- remove MCV, MCH, MCHC and HCT from Full Blood Count CRF
- changes to Patient Treatment CRF:
- merge Patient Treatment and Patient Treatment Day 14 into single CRF
- remove Fluconazole dose question
- changes to Visit Schedule:
- D1
- Re-order baseline forms
- Move X-ray, LP CSF & Microbiology (TB Diagnostics) to PRN forms
- If yes to "Was an Xray/lumbar puncture/urinary LAM performed" on Signs and Symptoms, present relevant CRF
- Make renal function and liver function required at baseline
- Unscheduled:
- Add Health Economics CRF to be included for all unscheduled visits
- Schedule Significant Diagnoses CRF for all visits post baseline
- rename Microbiology CRF to TB Diagnostics
- changes to Consent form:
- remove "Guardian name" field (346)
- changes to Screening:
- move "willing to participate?" and "capacity to provide informed consent?" towards bottom of form (339, 340)
- remove all "Not answered" responses (341, 342)
- validate/prevent saving if CD4 count not < 100 (345)
- update verbose_name to ‘Is the patient CONFIRMED HIV sero-positive’
- Serum CrAg
- validate/prevent saving if serum CrAg result not positive (341)
- remove IND as option for CrAg results
- validate/prevent saving if serum CrAg date not within last 14 days (344)
- change to 'Was CM confirmed in CSF by any other method? etc' and add list of methods
- explicitly ask about/exclude protocol listed clinical symptoms/signs of symptomatic meningitis (343)
(i.e. a progressively severe headache, a headache and marked nuchal rigidity,
a headache and vomiting, seizures, a Glasgow Coma Scale (GCS) score of <15)
- separate pregnancy / breastfeeding questions to be like ambition, add preg date
- changes to Follow-up (formerly Clinical Assessment) form:
- rename/standardise 'Clinical Assessment' to be 'Follow-up' throughout
- add "Other" choice/"Other, please specify..." field to Q3 (Was this a telephone follow up or an in person visit?)
- add survival status help text, for 'Deceased' and 'Alive, but unwell' choices
- modify adherence_counselling to only be applicable if not 'Deceased'
- add AE_INITIAL_ACTION action item if yes answer to 'hospitalized'
- validate 'assessment_type' and 'info_source' against 'info_source' answer provided on Subject Visit CRF
- changes to Signs and Symptoms form:
- reorder fields based on feedback
- convert headache_duration to edc_models.DurationDHField
- use _sx in field names to be consistent ('current_sx', cm_sx')
- add new model fields: 'any_sx', 'current_sx_other', 'current_sx_gte_g3', 'current_sx_gte_g3_other', 'headache_duration_microseconds', 'xray_performed', 'lp_performed', 'urinary_lam_performed', 'cm_sx_lp_done', 'cm_sx_bloods_taken', 'cm_sx_bloods_taken_other'
- add N/A options for if no/unknown answer to 'any_sx'
- add validation
- add AE_INITIAL_ACTION action item if yes answer to any of: 'reportable_as_ae' or 'patient_admitted'
- merge in Neurological form fields
- changes to Mental Status form:
- expand Modified Rankin Score choices to include 0 and 6, and add descriptions
- make 'reportable_as_ae' and 'patient_admitted' not applicable at baseline
- changes to AE Initial Form:
- add new model fields: 'fluconazole_relation', 'flucytosine_relation', 'patient_admitted', 'date_admitted', 'inpatient_status' and 'date_discharged'
- added 'Hospitalization' section to form/admin
- reordered 'Cause and relationship to study' form/admin section
- rename Study Treatment form to Patient Treatment
- replace 'admission' with 'enrolment' in 'current_arv_decision' question
- remove:
- Neurological Symptoms form
- FocalNeurologicDeficits list model
- fix server error when trying to save “mental status” form