class CareModelMixin(models.Model):
care = models.CharField(
verbose_name="Is the patient in care?",
choices=YES_NO_UNKNOWN,
max_length=25,
)
care_not_in_reason = models.CharField(verbose_name="If not in care, why?",
max_length=25,
null=True,
blank=True)
care_facility_location = models.CharField(
verbose_name="Does the patient receive care in this facility",
max_length=25,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
help_text="Either integrated care or vertical care",
)
icc_since_mocca = models.CharField(
verbose_name=("Has the patient received integrated care "
"since the leaving the MOCCA (orig) trial until now?"),
max_length=25,
choices=CARE_SINCE_MOCCA,
)
icc_since_mocca_comment = OtherCharField(
verbose_name="If some interruption in integrated care, please explain")
icc = models.CharField(
verbose_name="Does the patient currently receive integrated care",
max_length=25,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
help_text="Either at this facility or elsewhere",
)
icc_not_in_reason = models.CharField(
verbose_name="If not receiving integrated care, why not?",
max_length=25,
choices=NOT_ICC_REASONS,
default=NOT_APPLICABLE,
)
care_comment = models.TextField(
verbose_name="Additional comments relevant to this patient's care",
null=True,
blank=True,
)
class Meta:
abstract = True
class InteDeathReportModelMixin(models.Model):
death_location_type = models.CharField(
verbose_name="Where did the participant die?",
max_length=50,
choices=DEATH_LOCATIONS,
)
death_location_name = models.CharField(
verbose_name=(
"If death occurred at hospital / clinic, please give name of the facility"
),
max_length=150,
null=True,
blank=True,
)
informant_contacts = EncryptedTextField(null=True, blank=True)
informant_relationship = models.CharField(
max_length=50,
choices=INFORMANT_RELATIONSHIP,
verbose_name="Informants relationship to the participant?",
)
other_informant_relationship = OtherCharField()
death_certificate = models.CharField(
verbose_name="Is a death certificate is available?",
max_length=15,
choices=YES_NO,
)
secondary_cause_of_death = models.ForeignKey(
CauseOfDeath,
on_delete=models.PROTECT,
related_name="secondary_cause_of_death",
verbose_name="Secondary cause of death",
help_text=(
"Secondary cause of death in the opinion of the "
"local study doctor and local PI"
),
)
secondary_cause_of_death_other = models.CharField(
max_length=100,
blank=True,
null=True,
verbose_name='If "Other" above, please specify',
)
class Meta:
abstract = True
class OffstudyModelMixin(UniqueSubjectIdentifierFieldMixin, models.Model):
"""Model mixin for the Off-study model.
Override in admin like this:
def formfield_for_choice_field(self, db_field, request, **kwargs):
if db_field.name == "offstudy_reason":
kwargs['choices'] = OFF_STUDY_REASONS
return super().formfield_for_choice_field(db_field, request, **kwargs)
"""
offstudy_reason_choices = OFF_STUDY_REASONS
offstudy_datetime = models.DateTimeField(
verbose_name="Off-study date and time",
validators=[datetime_not_before_study_start, datetime_not_future],
default=get_utcnow,
)
offstudy_reason = models.CharField(
verbose_name=
"Please code the primary reason participant taken off-study",
choices=offstudy_reason_choices,
max_length=125,
)
offstudy_reason_other = OtherCharField()
def __str__(self):
local = timezone.localtime(self.offstudy_datetime)
return f"{self.subject_identifier} {formatted_datetime(local)}"
def save(self, *args, **kwargs):
off_all_schedules_or_raise(
subject_identifier=self.subject_identifier,
offstudy_datetime=self.offstudy_datetime,
)
super().save(*args, **kwargs)
def natural_key(self):
return (self.subject_identifier, )
@property
def report_datetime(self):
return self.offstudy_datetime
class Meta:
abstract = True
class MissedDosesModelMixin(models.Model):
week2 = models.ForeignKey(Week2, on_delete=models.PROTECT)
day_missed = models.IntegerField(verbose_name="Day missed:",
choices=DAYS_MISSED)
missed_reason = models.CharField(verbose_name="Reason:",
max_length=25,
blank=True,
choices=REASON_DRUG_MISSED)
missed_reason_other = OtherCharField()
class Meta:
abstract = True
class Week4(ClinicalAssessmentModelMixin, CrfModelMixin):
fluconazole_dose = models.CharField(
verbose_name="Fluconazole dose (day prior to visit)",
max_length=25,
choices=FLUCONAZOLE_DOSE,
)
fluconazole_dose_other = OtherCharField(max_length=25)
rifampicin_started = models.CharField(
verbose_name="Rifampicin started since last visit?",
max_length=25,
choices=YES_NO_ALREADY_ND,
)
rifampicin_start_date = models.DateField(
verbose_name="Date Rifampicin started",
validators=[date_not_future],
null=True,
blank=True,
)
lp_done = models.CharField(
verbose_name="LP done?",
max_length=5,
choices=YES_NO,
help_text="If yes, ensure LP CRF completed.",
)
other_significant_dx = models.CharField(
verbose_name="Other significant diagnosis since last visit?",
max_length=5,
choices=YES_NO_NA,
)
on_site = CurrentSiteManager()
objects = CrfModelManager()
history = HistoricalRecords()
class Meta(CrfModelMixin.Meta):
verbose_name = "Week 4"
verbose_name_plural = "Week 4"
class MissedDosesModelMixin(models.Model):
study_termination_conclusion = models.ForeignKey(
StudyTerminationConclusion, on_delete=models.PROTECT)
day_missed = models.IntegerField(verbose_name="Day missed:",
choices=DAYS_MISSED)
missed_reason = models.CharField(verbose_name="Reason:",
max_length=25,
blank=True,
choices=REASON_DRUG_MISSED)
missed_reason_other = OtherCharField()
def __str__(self):
return (f"{self.study_termination_conclusion}: "
f"Missed {self.get_day_missed_display()}")
class Meta:
abstract = True
class Microbiology(CrfModelMixin):
urine_culture_performed = models.CharField(
max_length=5,
choices=YES_NO,
help_text="only for patients with >50 white cells in urine",
)
urine_taken_date = models.DateField(
validators=[date_not_before_study_start, date_not_future],
null=True,
blank=True)
urine_culture_results = models.CharField(
verbose_name="Urine culture results, if completed",
max_length=10,
choices=CULTURE_RESULTS,
default=NOT_APPLICABLE,
)
urine_culture_organism = models.CharField(
verbose_name="If positive, organism",
max_length=25,
choices=URINE_CULTURE_RESULTS_ORGANISM,
default=NOT_APPLICABLE,
)
urine_culture_organism_other = OtherCharField(max_length=50,
null=True,
blank=True)
blood_culture_performed = models.CharField(max_length=5, choices=YES_NO)
blood_culture_results = models.CharField(
verbose_name="Blood culture results, if completed",
max_length=10,
choices=CULTURE_RESULTS,
default=NOT_APPLICABLE,
)
blood_taken_date = models.DateField(
validators=[date_not_before_study_start, date_not_future],
null=True,
blank=True)
day_blood_taken = models.IntegerField(
verbose_name="If positive, study day positive culture sample taken",
validators=[MinValueValidator(1)],
null=True,
blank=True,
)
blood_culture_organism = models.CharField(
verbose_name="If growth positive, organism",
max_length=50,
choices=BLOOD_CULTURE_RESULTS_ORGANISM,
default=NOT_APPLICABLE,
)
blood_culture_organism_other = OtherCharField(max_length=50,
null=True,
blank=True)
bacteria_identified = models.CharField(
verbose_name="If bacteria, type",
max_length=50,
choices=BACTERIA_TYPE,
default=NOT_APPLICABLE,
)
bacteria_identified_other = OtherCharField(max_length=100,
null=True,
blank=True)
sputum_afb_performed = models.CharField(
verbose_name="AFB microscopy performed?",
max_length=5,
choices=YES_NO,
help_text="Was sputum AFB done?",
)
sputum_afb_date = models.DateField(
validators=[date_not_before_study_start, date_not_future],
null=True,
blank=True)
sputum_results_afb = models.CharField(
verbose_name="AFB results",
max_length=10,
choices=POS_NEG_NA,
default=NOT_APPLICABLE,
)
sputum_performed = models.CharField(
verbose_name="Culture performed?",
max_length=15,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
sputum_taken_date = models.DateField(
validators=[date_not_before_study_start, date_not_future],
null=True,
blank=True)
sputum_results_culture = models.CharField(
verbose_name="Culture results",
max_length=10,
choices=POS_NEG_NA,
default=NOT_APPLICABLE,
)
sputum_results_positive = models.CharField(
verbose_name="If culture is positive, please specify:",
max_length=50,
null=True,
blank=True,
)
sputum_genexpert_performed = models.CharField(
verbose_name="Sputum Gene-Xpert performed?",
max_length=15,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
sputum_genexpert_date = models.DateField(
verbose_name="Date sputum Gene-Xpert taken",
validators=[date_not_before_study_start, date_not_future],
null=True,
blank=True,
)
sputum_result_genexpert = models.CharField(
verbose_name="Sputum Gene-Xpert results",
max_length=45,
choices=SPUTUM_GENEXPERT,
default=NOT_APPLICABLE,
)
tissue_biopsy_taken = models.CharField(max_length=5, choices=YES_NO)
tissue_biopsy_results = models.CharField(
verbose_name="If YES, results",
max_length=10,
choices=CULTURE_RESULTS,
default=NOT_APPLICABLE,
)
biopsy_date = models.DateField(
validators=[date_not_before_study_start, date_not_future],
null=True,
blank=True)
day_biopsy_taken = models.IntegerField(
verbose_name="If positive, Study day positive culture sample taken",
validators=[MinValueValidator(1)],
null=True,
blank=True,
)
tissue_biopsy_organism = models.CharField(
verbose_name="If growth positive, organism",
max_length=50,
choices=BIOPSY_RESULTS_ORGANISM,
default=NOT_APPLICABLE,
)
tissue_biopsy_organism_other = OtherCharField(max_length=50,
null=True,
blank=True)
histopathology_report = models.TextField(null=True, blank=True)
csf_genexpert_performed = models.CharField(
verbose_name="CSF Gene-Xpert performed?",
max_length=15,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
csf_genexpert_date = models.DateField(
verbose_name="Date CSF Gene-Xpert taken",
validators=[date_not_before_study_start, date_not_future],
null=True,
blank=True,
)
csf_result_genexpert = models.CharField(
verbose_name="CSF Gene-Xpert results",
max_length=45,
choices=SPUTUM_GENEXPERT,
default=NOT_APPLICABLE,
)
on_site = CurrentSiteManager()
objects = CrfModelManager()
history = HistoricalRecords()
class Meta(CrfModelMixin.Meta):
verbose_name = "Microbiology"
verbose_name_plural = "Microbiology"
class PatientHistory(CrfModelMixin, BaseUuidModel):
symptoms = models.ManyToManyField(
Symptoms, verbose_name="Do you have any of the following symptoms?"
)
other_symptoms = OtherCharField(null=True, blank=True)
hiv_diagnosis_date = models.DateField(
verbose_name="When was the diagnosis of HIV made?", null=True, blank=True
)
arv_initiation_date = models.DateField(
verbose_name="Date of start of antiretroviral therapy (ART)",
null=True,
blank=True,
)
viral_load = models.IntegerField(
verbose_name="Last viral load",
validators=[MinValueValidator(0), MaxValueValidator(999999)],
null=True,
blank=True,
help_text=COPIES_PER_MILLILITER,
)
viral_load_date = models.DateField(
verbose_name="Date of last viral load", null=True, blank=True
)
cd4 = models.IntegerField(
verbose_name="Last CD4",
validators=[MinValueValidator(0), MaxValueValidator(3000)],
null=True,
blank=True,
help_text=CELLS_PER_MILLIMETER_CUBED_DISPLAY,
)
cd4_date = models.DateField(verbose_name="Date of last CD4", null=True, blank=True)
current_arv_regimen = models.ForeignKey(
ArvRegimens,
on_delete=models.PROTECT,
related_name="current_arv_regimen",
verbose_name=(
"Which antiretroviral therapy regimen is the patient currently on?"
),
null=True,
blank=False,
)
other_current_arv_regimen = OtherCharField(null=True, blank=True)
current_arv_regimen_start_date = models.DateField(
verbose_name=(
"When did the patient start this current antiretroviral therapy regimen?"
),
null=True,
blank=True,
)
has_previous_arv_regimen = models.CharField(
verbose_name="Has the patient been on any previous regimen?",
max_length=15,
choices=YES_NO,
)
previous_arv_regimen = models.ForeignKey(
ArvRegimens,
on_delete=models.PROTECT,
related_name="previous_arv_regimen",
verbose_name=(
"Which antiretroviral therapy regimen was the patient previously on?"
),
null=True,
blank=True,
)
other_previous_arv_regimen = OtherCharField(null=True, blank=True)
on_oi_prophylaxis = models.CharField(
verbose_name=(
"Is the patient on any prophylaxis against opportunistic infections?"
),
max_length=15,
choices=YES_NO,
)
oi_prophylaxis = models.ManyToManyField(
OiProphylaxis,
verbose_name="If YES, which prophylaxis is the patient on?",
blank=True,
)
other_oi_prophylaxis = OtherCharField(null=True, blank=True)
hypertension_diagnosis = models.CharField(
verbose_name="Has the patient been diagnosed with hypertension?",
max_length=15,
choices=YES_NO,
)
on_hypertension_treatment = models.CharField(
verbose_name="Is the patient on treatment for hypertension?",
max_length=15,
choices=YES_NO,
)
hypertension_treatment = models.ManyToManyField(
HypertensionMedications,
verbose_name=(
"What medications is the patient currently taking for hypertension?"
),
blank=True,
)
other_hypertension_treatment = OtherCharField(
verbose_name=mark_safe("If other medication(s), please specify ..."),
null=True,
blank=True,
)
taking_statins = models.CharField(
verbose_name="Is the patient currently taking any statins?",
max_length=15,
choices=YES_NO,
)
current_smoker = models.CharField(
verbose_name=mark_safe("Is the patient a <u>current</u> smoker?"),
max_length=15,
choices=YES_NO,
)
former_smoker = models.CharField(
verbose_name=mark_safe("Is the patient a <u>previous</u> smoker?"),
max_length=15,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
diabetes_symptoms = models.ManyToManyField(
DiabetesSymptoms,
verbose_name=mark_safe(
"In the <u>past year</u>, have you had any of the following symptoms?"
),
)
other_diabetes_symptoms = OtherCharField(
verbose_name=mark_safe(
"If other symptom in the <u>past year</u>, please specify ..."
),
null=True,
blank=True,
)
diabetes_in_family = models.CharField(
verbose_name=(
"Has anyone in your immediate family " "ever been diagnosed with diabetes?"
),
max_length=15,
choices=YES_NO,
help_text="Immediate family is parents, siblings, and children",
)
class Meta(CrfModelMixin.Meta):
verbose_name = "Patient History"
verbose_name_plural = "Patient History"
class FollowupExamination(CrfStatusModelMixin, CrfWithActionModelMixin,
edc_models.BaseUuidModel):
action_name = FOLLOWUP_EXAMINATION_ACTION
tracking_identifier_prefix = "FU"
action_identifier = models.CharField(max_length=50, unique=True, null=True)
tracking_identifier = models.CharField(max_length=30,
unique=True,
null=True)
# 4a
symptoms = models.ManyToManyField(
Symptoms,
related_name="symptoms",
verbose_name=(
"Since the participant's last appointment have they experienced "
"any of the following symptoms"),
help_text="either at this hospital or at a different clinic",
)
# 4b
symptoms_sought_care = models.ManyToManyField(
Symptoms,
related_name="symptoms_sought_care",
verbose_name=
"Did they seek care from any health worker for these symptoms",
)
# 4a
symptoms_g3 = models.ManyToManyField(
Symptoms,
related_name="symptoms_g3",
verbose_name="For these symptoms, were any grade 3 events",
help_text=("Refer to DAIDS toxicity table. "
"Please complete Serious Adverse Event form"),
)
symptoms_g3_detail = models.TextField(
verbose_name=
"Please provide details on any of the Grade 3 symptoms above.",
null=True,
blank=True,
)
# 4a
symptoms_g4 = models.ManyToManyField(
Symptoms,
related_name="symptoms_g4",
verbose_name="For these symptoms, were any grade 4 events",
help_text=("Refer to DAIDS toxicity table. "
"Please complete Serious Adverse Event form"),
)
symptoms_g4_detail = models.TextField(
verbose_name=
"Please provide details on any of the Grade 4 symptoms above.",
null=True,
blank=True,
)
# 4c
symptoms_detail = models.TextField(
verbose_name="Please provide details on any of the symptoms above.",
null=True,
blank=True,
)
# 5a
attended_clinic = models.CharField(
verbose_name=
("Since the participant's last visit did they attend any other clinic or hospital "
"for care for any reason"),
max_length=25,
choices=YES_NO,
help_text=
("Includes other routine appointments, e.g. BP check or family planning"
),
)
# 5b
admitted_hospital = models.CharField(
verbose_name="If YES, were they admitted to hospital?",
max_length=25,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
# 5c
attended_clinic_detail = models.TextField(
verbose_name=("If YES, attend other clinic or hospital, "
"please provide details of this event"),
help_text=("If the participant was given a referral letter or "
"discharge summary record details here"),
null=True,
blank=True,
)
attended_clinic_sae = models.CharField(
verbose_name=mark_safe(
"Does the event constitute a <u>Serious Adverse Event</u>"),
max_length=25,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
help_text="If YES, submit a <u>Serious Adverse Event</u> Form",
)
# 5d
prescribed_medication = models.CharField(
verbose_name=("Was the participant prescribed any other medication at "
"this clinic or hospital visit?"),
max_length=25,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
# 5d
prescribed_medication_detail = models.TextField(
verbose_name=("If YES, prescribed any other medication, "
"please provide details of this visit"),
null=True,
blank=True,
)
# 6a
any_other_problems = models.CharField(
verbose_name=(
"Since your last visit has the participant experienced any other "
"medical or health problems NOT listed above"),
max_length=25,
choices=YES_NO,
)
# 6a
any_other_problems_detail = models.TextField(
verbose_name="If YES, please provide details of the event",
null=True,
blank=True,
)
any_other_problems_sae = models.CharField(
verbose_name="Does this event constitute an Adverse Event?",
max_length=25,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
any_other_problems_sae_grade = models.CharField(
verbose_name="If YES, what grade?",
choices=GRADE34_CHOICES,
max_length=25,
default=NOT_APPLICABLE,
help_text="If YES, grade 3 or 4, submit Serious Adverse Event form",
)
# 7a
art_change = models.CharField(
verbose_name=("Since the participant's last visit has there "
"been any change in their HIV medication?"),
max_length=25,
choices=YES_NO,
)
# 7b
art_change_reason = models.TextField(
verbose_name="If YES, please provide reason for change",
null=True,
blank=True)
# 7c
art_new_regimen = models.ForeignKey(
ArvRegimens,
on_delete=PROTECT,
verbose_name="Please indicate new regimen",
related_name="art_new_regimen",
null=True,
blank=True,
)
art_new_regimen_other = OtherCharField()
abdominal_tenderness = models.CharField(
verbose_name="Abdominal tenderness", max_length=25, choices=YES_NO)
enlarged_liver = models.CharField(verbose_name="Enlarged liver",
max_length=25,
choices=YES_NO)
jaundice = models.CharField(verbose_name="Jaundice",
max_length=25,
choices=YES_NO)
comment = models.TextField(verbose_name=(
"Comment on the clinical course, any other symptoms present, "
"assessment and management plan"))
lactic_acidosis = models.CharField(
verbose_name="Do you think the participant has lactic acidosis?",
max_length=25,
choices=YES_NO,
help_text=
("Classical signs of lactic acidosis include: abdominal or stomach "
"discomfort, decreased appetite, diarrhoea, fast or shallow breathing, "
"a general feeling of discomfort, muscle pain or cramping; and "
"unusual sleepiness, fatigue, or weakness."),
)
hepatomegaly = models.CharField(
verbose_name=
"Do you think the participant has hepatomegaly with steatosis?",
max_length=25,
choices=YES_NO,
help_text=
("This condition often does not have any clinical signs and symptoms, "
"it may present with an enlarge liver on examination, and symptoms "
"of fatigue and right upper abdominal pain. The risk of developing "
"this condition is higher in patients who are obese and who have "
"type 2 diabetes or metabolic syndrome"),
)
referral = models.CharField(
verbose_name="Is the participant being referred",
max_length=25,
choices=YES_NO)
referral_reason = models.TextField(
verbose_name="If YES, where are they being referred to",
null=True,
blank=True,
help_text=(
"Note: remind participant that admission or discharge information "
"will be needed at the next follow up visit."),
)
class Meta(CrfWithActionModelMixin.Meta, edc_models.BaseUuidModel.Meta):
verbose_name = "Clinic follow up: Examination"
verbose_name_plural = "Clinic follow up: Examination"
class StudyTerminationConclusion(
NonUniqueSubjectIdentifierFieldMixin,
BaseStudyTerminationConclusion,
OffScheduleModelMixin,
StudyMedicationModelMixin,
MedAndDrugInterventionModelMixin,
BloodTransfusionModelMixin,
ActionModelMixin,
TrackingModelMixin,
BaseUuidModel,
):
action_name = STUDY_TERMINATION_CONCLUSION_ACTION
tracking_identifier_prefix = "ST"
subject_identifier = models.CharField(max_length=50, unique=True)
discharged_after_initial_admission = models.CharField(
verbose_name="Was the patient discharged after initial admission?",
max_length=6,
choices=YES_NO,
)
initial_discharge_date = models.DateField(
verbose_name="Date of initial discharge",
validators=[date_not_future],
blank=True,
null=True,
)
readmission_after_initial_discharge = models.CharField(
verbose_name="Was the patient re-admitted following initial discharge?",
max_length=7,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
readmission_date = models.DateField(
verbose_name="Date of readmission",
validators=[date_not_future],
blank=True,
null=True,
)
discharged_date = models.DateField(
verbose_name="Date discharged",
validators=[date_not_future],
blank=True,
null=True,
)
termination_reason = models.CharField(
verbose_name="Reason for study termination",
max_length=75,
choices=REASON_STUDY_TERMINATED,
help_text=(
"If included in error, be sure to fill in protocol deviation form."
),
)
willing_to_complete_10w = models.CharField(
verbose_name=("Is the patient willing to complete the W10 "
"and W16 FU visit only?"),
max_length=12,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
willing_to_complete_centre = models.CharField(
verbose_name=("Is the patient willing to complete the W10"
"and W16 FU visit only at their new care centre?"),
max_length=17,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
willing_to_complete_date = models.DateField(
verbose_name="Date the 10W FU due",
validators=[date_not_future],
editable=False,
null=True,
help_text="get value from Ambition visit schedule",
)
protocol_exclusion_criterion = models.CharField(
verbose_name="Late protocol exclusion met?",
max_length=12,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
included_in_error_date = models.DateField(
verbose_name="If included in error, date",
validators=[date_not_future],
blank=True,
null=True,
)
included_in_error = models.TextField(
verbose_name="If included in error, narrative:",
max_length=300,
blank=True,
null=True,
)
rifampicin_started = models.CharField(
verbose_name="Rifampicin started since week 4?",
max_length=30,
choices=YES_NO_ALREADY,
)
first_line_regimen = models.CharField(
verbose_name=("ART regimen started for naive patients (or regimen"
" switched for those already on ARVs)"),
max_length=75,
choices=FIRST_ARV_REGIMEN,
default=NOT_APPLICABLE,
)
first_line_regimen_other = OtherCharField()
second_line_regimen = models.CharField(
verbose_name="Second line / second switch ARV regimen",
max_length=50,
choices=SECOND_ARV_REGIMEN,
default=NOT_APPLICABLE,
)
second_line_regimen_other = OtherCharField()
arvs_switch_date = models.DateField(
verbose_name="ARV start/switch date",
blank=True,
null=True,
validators=[date_not_future],
)
first_line_choice = models.CharField(
verbose_name="If first line:",
max_length=5,
choices=FIRST_LINE_REGIMEN,
default=NOT_APPLICABLE,
)
arvs_delay_reason = models.CharField(
verbose_name="Reason ARVs not started",
max_length=75,
blank=True,
null=True)
medicines = models.ManyToManyField(
Day14Medication, verbose_name="Medicines on study termination day:")
on_study_drug = models.CharField(
verbose_name="Has the patient started 'study' drug",
max_length=25,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
def save(self, *args, **kwargs):
if not self.last_study_fu_date:
self.last_study_fu_date = self.offschedule_datetime.date()
super().save(*args, **kwargs)
class Meta(OffScheduleModelMixin.Meta):
verbose_name = "Study Termination/Conclusion"
verbose_name_plural = "Study Terminations/Conclusions"
class PatientHistory(CrfModelMixin):
symptom = models.ManyToManyField(
Symptom,
blank=True,
related_name="symptoms",
verbose_name="What are your current symptoms?",
)
headache_duration = models.IntegerField(
verbose_name="If headache, how many days did it last?",
validators=[MinValueValidator(1)],
null=True,
blank=True,
)
visual_loss_duration = models.IntegerField(
verbose_name="If visual loss, how many days did it last?",
validators=[MinValueValidator(1)],
null=True,
blank=True,
)
tb_history = models.CharField(
verbose_name="Previous medical history of Tuberculosis?",
max_length=5,
choices=YES_NO,
)
tb_site = models.CharField(
verbose_name="If YES, site of TB?",
max_length=15,
choices=TB_SITE,
default=NOT_APPLICABLE,
)
tb_treatment = models.CharField(
verbose_name="Are you currently taking TB treatment?",
max_length=5,
choices=YES_NO,
)
taking_rifampicin = models.CharField(
verbose_name="If YES, are you currently also taking Rifampicin?",
max_length=5,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
rifampicin_started_date = models.DateField(
verbose_name="If YES, when did you first start taking Rifampicin?",
validators=[date_not_future],
null=True,
blank=True,
)
new_hiv_diagnosis = models.CharField(
verbose_name="Is this a new HIV diagnosis?", max_length=5, choices=YES_NO
)
taking_arv = models.CharField(
verbose_name="If NO, has the patient ever been on ART?",
max_length=5,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
# retired
first_arv_regimen = models.CharField(
verbose_name="If YES, which drugs were prescribed for their first ART regimen?",
max_length=50,
choices=FIRST_ARV_REGIMEN_RETIRED,
default=QUESTION_RETIRED,
editable=False,
)
# retired
first_arv_regimen_other = OtherCharField(editable=False)
# retired
first_line_choice = models.CharField(
verbose_name="If first line:",
max_length=25,
choices=FIRST_LINE_REGIMEN_RETIRED,
default=QUESTION_RETIRED,
editable=False,
)
initial_arv_date = models.DateField(
verbose_name=mark_safe(
"If YES, when did the patient <u>start</u> ART for the first time."
),
validators=[date_not_future],
null=True,
blank=True,
)
initial_arv_date_estimated = IsDateEstimatedFieldNa(
verbose_name="If YES, is this ART date estimated?", default=NOT_APPLICABLE
)
initial_arv_regimen = models.ManyToManyField(
ArvRegimens,
verbose_name=mark_safe(
"If YES, which drugs were prescribed for their first ART regimen?"
),
related_name="initial_arv",
)
initial_arv_regimen_other = OtherCharField()
has_switched_regimen = models.CharField(
verbose_name="Has the patient ever switched ART regimen?",
max_length=5,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
current_arv_date = models.DateField(
verbose_name=mark_safe(
"If YES, when was their <u>current or most recent</u> "
"ART regimen started?"
),
validators=[date_not_future],
null=True,
blank=True,
)
current_arv_date_estimated = IsDateEstimatedFieldNa(
verbose_name="If YES, is this ART date estimated?", default=NOT_APPLICABLE
)
current_arv_regimen = models.ManyToManyField(
ArvRegimens,
verbose_name=mark_safe(
"If YES, what is their current or most recent ART regimen?"
),
related_name="current_arv",
)
current_arv_regimen_other = OtherCharField()
current_arv_is_defaulted = models.CharField(
verbose_name=mark_safe(
"Has the patient <u>now</u> defaulted from their ART regimen?"
),
max_length=5,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
help_text="'DEFAULTED' means no ART for at least one month.",
)
current_arv_defaulted_date = models.DateField(
verbose_name=mark_safe(
"If the patient has DEFAULTED, on what date did they default "
"from their <u>most recent</u> ART regimen?"
),
validators=[date_not_future],
null=True,
blank=True,
)
current_arv_defaulted_date_estimated = IsDateEstimatedFieldNa(
verbose_name="If DEFAULTED, is this date estimated?", default=NOT_APPLICABLE
)
current_arv_is_adherent = models.CharField(
verbose_name=mark_safe(
"If the patient is currently on ART, are they ADHERENT to "
"their <u>current</u> ART regimen?"
),
max_length=5,
choices=YES_NO_NA,
default=NOT_APPLICABLE,
)
current_arv_tablets_missed = models.IntegerField(
verbose_name=("If not ADHERENT, how many doses missed in the last month?"),
validators=[MinValueValidator(0), MaxValueValidator(31)],
null=True,
blank=True,
)
current_arv_decision = models.CharField(
verbose_name=mark_safe(
"What decision was made at admission regarding their "
"<u>current</u> ART regimen?"
),
max_length=25,
choices=ARV_DECISION,
default=NOT_APPLICABLE,
)
# retired
second_arv_regimen = models.CharField(
verbose_name="Second line ARV regimen",
max_length=50,
choices=SECOND_ARV_REGIMEN_RETIRED,
default=QUESTION_RETIRED,
editable=False,
)
# retired
second_arv_regimen_other = OtherCharField(editable=False)
# retired
patient_adherence = models.CharField(
verbose_name="Is the patient reportedly adherent?",
max_length=25,
choices=YES_NO_NA_RETIRED,
default=QUESTION_RETIRED,
editable=False,
)
# retired
last_dose = models.IntegerField(
verbose_name=(
"If no tablets taken this month, how many months "
"since the last dose taken?"
),
validators=[MinValueValidator(0)],
null=True,
blank=True,
editable=False,
)
last_viral_load = models.DecimalField(
verbose_name="Last Viral Load, if known?",
decimal_places=3,
max_digits=10,
null=True,
blank=True,
help_text="copies/mL",
)
viral_load_date = models.DateField(
verbose_name="Viral Load date",
validators=[date_not_future],
null=True,
blank=True,
)
vl_date_estimated = IsDateEstimatedFieldNa(
verbose_name=("Is the subject's Viral Load date estimated?"),
default=NOT_APPLICABLE,
)
last_cd4 = models.IntegerField(
verbose_name="Last CD4, if known?",
validators=[MinValueValidator(1), MaxValueValidator(2500)],
null=True,
blank=True,
help_text=mark_safe("acceptable units are mm<sup>3</sup>"),
)
cd4_date = models.DateField(
verbose_name="CD4 date", validators=[date_not_future], null=True, blank=True
)
cd4_date_estimated = IsDateEstimatedFieldNa(
verbose_name=("Is the subject's CD4 date estimated?"), default=NOT_APPLICABLE
)
temp = models.DecimalField(
verbose_name="Temperature:",
validators=[MinValueValidator(30), MaxValueValidator(45)],
decimal_places=1,
max_digits=3,
help_text="in degrees Celcius",
)
heart_rate = models.IntegerField(
verbose_name="Heart rate:",
validators=[MinValueValidator(30), MaxValueValidator(200)],
help_text="bpm",
)
sys_blood_pressure = models.IntegerField(
verbose_name="Blood pressure: systolic",
validators=[MinValueValidator(50), MaxValueValidator(220)],
help_text="in mm. format SYS, e.g. 120",
)
dia_blood_pressure = models.IntegerField(
verbose_name="Blood pressure: diastolic",
validators=[MinValueValidator(20), MaxValueValidator(150)],
help_text="in Hg. format DIA, e.g. 80",
)
respiratory_rate = models.IntegerField(
verbose_name="Respiratory rate:",
validators=[MinValueValidator(6), MaxValueValidator(50)],
help_text="breaths/min",
)
weight = models.DecimalField(
verbose_name="Weight:",
validators=[MinValueValidator(20), MaxValueValidator(150)],
decimal_places=1,
max_digits=4,
help_text="kg",
)
weight_determination = models.CharField(
verbose_name="Is weight estimated or measured?",
max_length=15,
choices=WEIGHT_DETERMINATION,
)
glasgow_coma_score = models.IntegerField(
verbose_name="Glasgow Coma Score:",
validators=[MinValueValidator(3), MaxValueValidator(15)],
help_text="/15",
)
neurological = models.ManyToManyField(Neurological, blank=True)
neurological_other = OtherCharField(
verbose_name='If "Other CN palsy", specify',
max_length=250,
blank=True,
null=True,
)
focal_neurologic_deficit = models.TextField(
verbose_name='If "Focal neurologic deficit" chosen, please specify details:',
null=True,
blank=True,
)
visual_acuity_day = models.DateField(
verbose_name="Study day visual acuity recorded?",
validators=[date_not_future],
null=True,
blank=True,
)
left_acuity = models.DecimalField(
verbose_name="Visual acuity left eye:",
decimal_places=3,
max_digits=4,
null=True,
blank=True,
)
right_acuity = models.DecimalField(
verbose_name="Visual acuity right eye",
decimal_places=3,
max_digits=4,
null=True,
blank=True,
)
ecog_score = models.CharField(
verbose_name="ECOG Disability Score", max_length=15, choices=ECOG_SCORE
)
ecog_score_value = models.CharField(
verbose_name="ECOG Score", max_length=15, choices=ECOG_SCORE
)
lung_exam = models.CharField(
verbose_name="Abnormal lung exam:", max_length=5, choices=YES_NO
)
cryptococcal_lesions = models.CharField(
verbose_name="Cryptococcal related skin lesions:", max_length=5, choices=YES_NO
)
specify_medications = models.ManyToManyField(Medication, blank=True)
specify_medications_other = models.TextField(max_length=150, blank=True, null=True)
previous_oi = models.CharField(
verbose_name="Previous opportunistic infection other than TB?",
max_length=5,
choices=YES_NO,
)
on_site = CurrentSiteManager()
objects = CrfModelManager()
history = HistoricalRecords()
class Meta(CrfModelMixin.Meta):
verbose_name = "Patient's History"
verbose_name_plural = "Patient's History"
class MedicalExpenses(CrfModelMixin):
info_source = models.CharField(
verbose_name="What is the main source of this information?",
max_length=25,
choices=PATIENT_REL,
)
currency = models.CharField(verbose_name="Which currency do you use?",
max_length=20,
choices=CURRENCY)
food_spend = models.DecimalField(
verbose_name="How much do you/your family spend on food in a week?",
decimal_places=2,
max_digits=15,
null=True,
validators=[MinValueValidator(0)],
)
utilities_spend = models.DecimalField(
verbose_name=
"How much do you/your family spent on rent and utilities a month?",
decimal_places=2,
max_digits=15,
null=True,
validators=[MinValueValidator(0)],
)
item_spend = models.DecimalField(
verbose_name=
("How much have you spent on large items (e.g. furniture, electrical "
"items, cars) in the last year?"),
decimal_places=2,
max_digits=15,
null=True,
validators=[MinValueValidator(0)],
)
subject_spent_last_4wks = models.DecimalField(
verbose_name=("Over the last 4/10 weeks, how much have you "
"spent on activities relating to your health?"),
decimal_places=2,
max_digits=15,
null=True,
validators=[MinValueValidator(0)],
help_text=(
"On D1 record data for the four weeks prior to recruitment. "
"On W10 record data for the ten weeks since recruitment."),
)
someone_spent_last_4wks = models.DecimalField(
verbose_name=("Over the last 4/10 weeks, how much has someone else "
"spent on activities relating to your health?"),
decimal_places=2,
max_digits=15,
null=True,
validators=[MinValueValidator(0)],
help_text=(
"On D1 record data for the four weeks prior to recruitment. "
"On W10 record data for the ten weeks since recruitment."),
)
total_spent_last_4wks = models.DecimalField(
verbose_name=
("How much in total has been spent on your healthcare in the last 4/10 weeks?"
),
decimal_places=2,
max_digits=16,
null=True,
validators=[MinValueValidator(0)],
help_text=(
"On D1 record data for the four weeks prior to recruitment. "
"On W10 record data for the ten weeks since recruitment."),
)
care_before_hospital = models.CharField(
verbose_name=(
"Have you received any treatment or care "
"for your present condition, before coming to the hospital?"),
max_length=5,
choices=YES_NO,
help_text="If YES, please complete medical expenses part 2",
)
duration_present_condition = models.IntegerField(
verbose_name="How long have you been sick with your current condition?",
validators=[MinValueValidator(0)],
null=True,
help_text="in days",
)
activities_missed = models.CharField(
verbose_name=("What would you have been doing if you were not sick "
"with your present condition"),
max_length=25,
null=True,
choices=ACTIVITIES_MISSED,
)
activities_missed_other = OtherCharField(max_length=25,
blank=True,
null=True)
time_off_work = models.DecimalField(
verbose_name="How much time did you take off work?",
max_digits=4,
decimal_places=1,
validators=[MinValueValidator(0)],
blank=True,
null=True,
help_text="in days",
)
carer_time_off = models.IntegerField(
verbose_name=("How much time did a caring family member "
"take to accompany you to the hospital?"),
validators=[MinValueValidator(0)],
blank=True,
null=True,
help_text="in days",
)
loss_of_earnings = models.CharField(
verbose_name="Did you lose earnings as a result?",
max_length=5,
choices=YES_NO_NA,
)
earnings_lost_amount = models.DecimalField(
verbose_name="How much did you lose?",
decimal_places=2,
max_digits=15,
validators=[MinValueValidator(0)],
null=True,
blank=True,
)
form_of_transport = models.CharField(
verbose_name="Which form of transport did you take to get here today?",
max_length=25,
default=NOT_APPLICABLE,
choices=TRANSPORT,
)
transport_fare = models.DecimalField(
verbose_name="How much did you spend on the transport (in total)?",
decimal_places=2,
max_digits=15,
validators=[MinValueValidator(0)],
blank=True,
null=True,
)
travel_time = models.CharField(
verbose_name="How long did it take you to reach there?",
validators=[hm_validator],
max_length=8,
help_text="Specify as hours:minutes (format HH:MM)",
null=True,
blank=True,
)
loans = models.CharField(
verbose_name="Did you take out any loans to pay for your healthcare?",
max_length=5,
choices=YES_NO,
)
sold_anything = models.CharField(
verbose_name="Did you sell anything to pay for your healthcare?",
max_length=5,
choices=YES_NO,
)
private_healthcare = models.CharField(
verbose_name="Do you have private healthcare insurance?",
max_length=5,
choices=YES_NO,
)
healthcare_insurance = models.CharField(
verbose_name="Did you use it to help pay for your healthcare?",
max_length=5,
choices=YES_NO_NA,
)
welfare = models.CharField(
verbose_name="Do you receive any welfare or social service support?",
max_length=5,
choices=YES_NO,
)
on_site = CurrentSiteManager()
objects = CrfModelManager()
history = HistoricalRecords()
class Meta(CrfModelMixin.Meta):
verbose_name = "Health Economics: Medical Expenses"
verbose_name_plural = "Health Economics: Medical Expenses"
class MedicalExpensesTwoDetail(BaseUuidModel):
medical_expenses_two = models.ForeignKey(MedicalExpensesTwo, on_delete=PROTECT)
location_care = models.CharField(
verbose_name="Where did you receive treatment or care?",
max_length=35,
choices=LOCATION_CARE,
)
location_care_other = OtherCharField()
transport_form = models.CharField(
verbose_name="Which form of transport did you take to reach there?",
max_length=20,
choices=TRANSPORT,
default=NOT_APPLICABLE,
)
transport_cost = models.DecimalField(
verbose_name="How much did you spend on the transport (return)?",
decimal_places=2,
max_digits=15,
validators=[MinValueValidator(0)],
null=True,
blank=True,
)
transport_duration = models.CharField(
verbose_name="How long did it take you to reach there?",
validators=[hm_validator],
max_length=8,
help_text="Specify as hours:minutes (format HH:MM)",
null=True,
blank=True,
)
care_provider = models.CharField(
verbose_name="Who provided treatment or care during that visit?",
max_length=35,
choices=CARE_PROVIDER,
)
care_provider_other = OtherCharField(max_length=25, blank=True, null=True)
paid_treatment = models.CharField(
verbose_name=(
"Did you pay for the consultation you received during that visit"
),
max_length=15,
choices=YES_NO,
)
paid_treatment_amount = models.DecimalField(
verbose_name=("How much did you pay for this visit?"),
decimal_places=2,
max_digits=15,
validators=[MinValueValidator(0)],
null=True,
blank=True,
)
medication_bought = models.CharField(
verbose_name="Did you buy other medication for relief?",
max_length=15,
choices=YES_NO,
)
medication_payment = models.DecimalField(
verbose_name="How much did you pay?",
decimal_places=2,
max_digits=15,
validators=[MinValueValidator(0)],
null=True,
blank=True,
)
other_place_visited = models.CharField(
verbose_name="Before this, did you go to another place "
"for the treatment of the present situation?",
max_length=15,
choices=YES_NO,
help_text='If YES, click "Add another Medical Expenses Part 2: Detail" below.',
)
objects = ModelManager()
history = HistoricalRecords()
def __str__(self):
return self.medical_expenses_two.visit.subject_identifier
def natural_key(self):
return (self.location_care,) + self.medical_expenses_two.natural_key()
natural_key.dependencies = ["ambition_subject.medicalexpensestwo"]
class Meta:
verbose_name = "Medical Expenses Part 2: Detail"
verbose_name_plural = "Medical Expenses Part 2: Detail"
class FollowUp(ClinicalAssessmentModelMixin, CrfModelMixin):
fluconazole_dose = models.CharField(
verbose_name="Fluconazole dose (day prior to visit)",
max_length=25,
choices=FLUCONAZOLE_DOSE,
)
fluconazole_dose_other = OtherCharField(
verbose_name="If other, specify dose:", max_length=25)
rifampicin_started = models.CharField(
verbose_name="Rifampicin started since last visit?",
max_length=25,
choices=YES_NO_ALREADY_ND,
)
rifampicin_start_date = models.DateField(
verbose_name="Date Rifampicin started",
validators=[date_not_future],
null=True,
blank=True,
)
days_hospitalized = models.DecimalField(
verbose_name=("Over the ten weeks spent in the study how "
"many days did the patient spend in hospital?"),
decimal_places=3,
max_digits=5,
null=True,
)
antibiotic = models.ManyToManyField(
Antibiotic,
blank=True,
verbose_name="Were any of the following antibiotics given?",
)
antibiotic_other = models.CharField(
verbose_name="If other antibiotics, please specify:",
max_length=50,
null=True,
blank=True,
)
blood_transfusions = models.CharField(
verbose_name=
"Has the patient had any blood transfusions since week two? ",
max_length=5,
choices=YES_NO,
null=True,
)
blood_transfusions_units = models.DecimalField(
verbose_name="If YES, no. of units? ",
decimal_places=3,
max_digits=5,
null=True,
blank=True,
)
patient_help = models.CharField(
verbose_name=("Does the patient require help from"
" anybody for everyday activities? "),
max_length=10,
choices=YES_NO_ND,
help_text=("For example eating, drinking, washing,"
" brushing teeth, going to the toilet"),
)
patient_problems = models.CharField(
verbose_name=
"Has the illness left the patient with any other problems?",
max_length=10,
choices=YES_NO_ND,
)
rankin_score = models.CharField(
verbose_name="Modified Rankin score",
choices=RANKIN_SCORE,
max_length=10,
null=True,
)
other_significant_dx = models.CharField(
verbose_name="Other significant diagnosis since last visit?",
max_length=5,
choices=YES_NO_NA,
)
on_site = CurrentSiteManager()
objects = CrfModelManager()
history = HistoricalRecords()
class Meta(CrfModelMixin.Meta):
verbose_name = "Follow-up"
verbose_name_plural = "Follow-up"
class VisitModelFieldsMixin(models.Model):
report_datetime = models.DateTimeField(
verbose_name="Report date and time",
validators=[datetime_not_before_study_start, datetime_not_future],
default=get_utcnow,
help_text="Date and time of this report",
)
reason = models.CharField(
verbose_name="What is the reason for this report?",
max_length=25,
)
reason_unscheduled = models.CharField(
verbose_name="If 'unscheduled', provide the reason for " "the unscheduled visit",
max_length=25,
choices=VISIT_REASON_UNSCHEDULED,
default=NOT_APPLICABLE,
)
reason_unscheduled_other = OtherCharField(
verbose_name='If the reason for the unscheduled visit is "other", specify',
max_length=25,
blank=True,
null=True,
)
reason_missed = models.CharField(
verbose_name="If 'missed', provide the reason for the missed visit",
max_length=35,
blank=True,
null=True,
)
reason_missed_other = OtherCharField(
verbose_name='If the reason for the missed visit is "other", specify',
max_length=25,
blank=True,
null=True,
)
study_status = models.CharField(
verbose_name="What is the participant's current study status",
max_length=50,
null=True,
)
require_crfs = models.CharField(
max_length=10,
verbose_name="Are scheduled data being submitted with this visit?",
choices=YES_NO,
default=YES,
)
info_source = models.CharField(
verbose_name="What is the main source of this information?", max_length=25
)
info_source_other = OtherCharField(
verbose_name='If "Other" source of information, specify'
)
survival_status = models.CharField(
max_length=10,
verbose_name="Participant's survival status",
choices=ALIVE_DEAD_UNKNOWN,
null=True,
default=ALIVE,
)
last_alive_date = models.DateField(
verbose_name="Date participant last known alive",
validators=[date_not_before_study_start, date_not_future],
null=True,
blank=True,
)
comments = models.TextField(
verbose_name=(
"Comment if any additional pertinent information " "about the participant"
),
max_length=250,
blank=True,
null=True,
)
class Meta:
abstract = True