CONFIDENTIAL CASE REPORT FORM AMITRIPTYLINE/NORTRIPTYLINE … · 6/3/2016 Survey Preview -...

6/3/2016 Survey Preview - Pharmacovigilance Survey - Amitriptyline/Nortriptyline

https://checkbox.caresearch.com.au/Forms/Surveys/preview.aspx?print=default&s=6404&loc=EN-US 1/38

*Patient ID

Site identifier / Medication number / Patient number

Initials of person entering data

CONFIDENTIAL

CASE REPORT FORM

AMITRIPTYLINE/NORTRIPTYLINE

Palliative Care Clinical Studies Collaborative

Rapid Pharmacovigilance in Palliative Care

The case report form is to be completed in compliance with PaCCSC Standard

Operating Procedures

V ers ion 1 .4 June 2016

Your participation in the RAPID program might be considered one element of your organisations locally adopted

continuous quality improvement strategy and assist your local accreditation program. In Australia this participation

may provide evidence to demonstrate meeting of the National Safety and Quality Health Service (NSQHS)

Standards.

If you wish to stop email reminders being sent to you for a patient who has died, follow this link and enter the

patient ID in the space provided. Remember to come back to this page, click next at the bottom of the screen to

save the death date (otherwise it wont be recorded) it, then you can close the page using the X at top right.

NOTE: During data entry, you must navigate a l l the way to the end of the survey by cl i cking on Next at the bottom of each page and cl ickFinish otherwise the data wi l l not be saved.

http://www.caresearch.com.au/caresearch/tabid/2149/Default.aspx



*Gender Male Female

Age

Years

Patient Reported

Weight (kg)

Height (cm)

NA

Serum albumin

International normalised ratio (INR)

C-Reactive Protein (CRP)

Calculated creatinine clearance (CCr) or eGFR

Haemoglobin (Hb)

Demographics

*Primary life limiting illness

Tick one

Advanced cancer AIDS

End stage renal failure Cardiac failure

Hepatic failure Respiratory failure

Neurodegenerative disease Other (please specify)

Palliative Care Phase

Stable Unstable Deteriorating Terminal

Cl ick here to download the Palliative Care Phase definitions listed above.

Laboratory tests1

Only if available

http://www.caresearch.com.au/caresearch/Portals/0/PaCCSC/Phase%20Definitions.pdf



Charlson Comorbidity IndexConditions

Myocardial infarct

Congestive cardiac failure

Peripheral vascular disease

Cerebrovascular disease

Dementia

Chronic pulmonary disease

Connective tissue disease

Ulcer disease

Mild liver disease

Diabetes

Hemiplegia

Moderate or severe renal disease

Diabetes with end organ damage

Any tumour

Leukaemia

Lymphoma

Moderate or severe liver disease

Metastatic solid tumour

AIDS

* Australian Modified Karnofsky Performance Scale (AKPS)2

100 = Normal; no complaints; no evidence of disease.

90 = Able to carry on normal activity; minor signs or symptoms.

80 = Normal activity with effort; some signs of symptoms or disease.

70 = Cares for self; unable to carry on normal activity or to do active work.

60 = Requires occasional assistance but is able to care for most of his needs.

50 = Requires considerable assistance and frequent medical care.

40 = In bed more than 50% of the time.

30 = Almost completely bedfast.

20 = Totally bedfast and requiring extensive nursing care by professionals and/or family.

10 = Comatose or barely rousable.

0 = Dead

Not able to determine



Data Points

*

Date of Medication Commencement (Baseline)

dd/mm/yyyy (please use date-picker)

*

Day 7 Assessment

7 days after baseline (dd/mm/yyyy - please use date-picker)

*

Day 14 Assessment

14 Days after baseline - (dd/mm/yyyy - please use date-picker)

*Reminders will be sent to this email address 7 days or 14 days after baselinePlease take care to type your email address correctly otherwise the reminders cannot be sent to you.

@@Email

*

Cease ad hoc adverse event reporting 4 weeks after

baseline

4 weeks after baseline (dd/mm/yyyy - please use date-picker)

Email Reminder content

This email is to remind you to record Rapid amitriptyline/nortriptyline data for patient [PID]

To complete the next section of the survey, go to the RDMS in CareSearch and search for the date you started entering data matching the patient ID number.



*Baseline Assessment DatePlease use date-picker dd/mm/yyyy

Total dose given in last 24 hours (mg)

Time of last dose (in 24-hour clock e.g. 2200)

T0 Baseline Assessment(The day baseline undertaken)

*Medication of Interest

Amitriptyline

Nortriptyline

*What is the underlying etiology of the pain?

Spinal Cord Injury

Diabetes (diabetic neuropathy)

Post-herpetic neuralgia

Nerve compression or invasion by tumour

Chemotherapy

Other:

*Symptom Severity Score

Grade Neuropathic Pain according to NCI criteria

1 2 3 Un-gradable

NCI Criteria:

1. Mild pain

2. Moderate pain; limiting instrumental ADL

3. Severe pain; limiting self care ADL

*Medication of interest dosing



1 2 3 4 5 Ungradable

No

symptom

Somnolence

Hallucinations

Delirium

Confusion

Urinary retention

Constipation

Supraventricular tachycardia

Other

Other

Other

1 2 3 Ungradable

No

symptom

Dry Mouth

Dizziness

Palpitations (only grade as 1-2)

Syncope (only grade as 3)

If "Other", please specify here



*Baseline Symptoms of interest (prior to commencement of medication)(Grade according to NCI criteria)

*Which toxicity is the most troublesome?

Select:

NCI Criteria:

Somnolence

1. Mild but more than usual drowsiness or sleepiness

2. Moderate sedation; limiting instrumental ADL

3. Obtundation or stupor

4. Life-threatening consequences; urgent intervention indicated

5. Death

Hallucinations

1. Mild hallucinations (e.g., perceptual distortions)

2. Moderate hallucinations

3. Severe hallucinations; hospitalization not indicated

4. Life-threatening consequences, threats of harm to self or others; hospitalization indicated

5. Death

Delirium

1. Mild acute confusional state

2. Moderate and acute confusional state; limited instrumental ADL

3. Severe and acute confusional state; limiting self-care ADL; hospitalization indicated

4. Life-threatening consequences, threats of harm to self or others; hospitalization indicated

5. Death



5. Death

Confusion

1. Mild disorientation

2. Moderate disorientation; limiting instrumental ADL

3. Severe disorientation; limiting self care ADL

4. Life-threatening consequences, urgent intervention indicated

5. Death

Urinary retention

1. Urinary, suprapubic or intermittent catheter placement not indicated; able to void with some residual

2. Placement of urinary suprapubic or intermittent catheter placement indicated; medication indicated

3. Elective operative or radiologic intervention indicated; substantial loss of affected kidney function or mass

4. Life-threatening consequences; organ failure; urgent operative intervention indicated

5. Death

Constipation

1. Occasional or intermittent symptoms; occasional use of stool softeners, laxatives, dietary modification, or

enema

2. Persistent symptoms with regular use of laxatives or enemas; limiting instrumental ADL

3. Obstipation with manual evacuation indicated; limiting self-care ADL

4. Life-threatening consequences; urgent intervention indicated

5. Death


1. Asymptomatic, intervention not indicated

2. Non-urgent medical intervention indicated

3. Medical intervention indicated

4. Life-threatening consequences, urgent intervention indicated

5. Death

Dry Mouth

1. Symptomatic (e.g., dry or thick saliva) without significant dietary alteration; unstimulated saliva flow

>0.2ml/min

2. Moderate symptoms; oral intake alterations (e.g., copious water, other lubricants, diet limited to purees

and/or soft, moist foods); unstimulated saliva 0.1 to 0.2 ml/min

3. Inability to adequately aliment orally; tube feeding or TPN indicated; unstimulated saliva <0.1ml/min

Dizziness

1. Mild unsteadiness or sensation of movement

2. Moderate unsteadiness or sensation of movement; limiting instrumental ADL

3. Severe unsteadiness or sensation of movement; limiting self-care ADL

Palpitations

1. Mild symptoms; intervention not indicated

2. Intervention indicated

Syncope

3. Fainting, orthostatic collapse



Page 7

*Do you have data for the next timepoint to be entered at this time?

Yes (continue to next timepoint)

No (Finish & close survey for now)



Page 8

Day 7 Assessment

Symptomatic Benefit Assessment - (Day 1 - Day 7)

*Assessed / Not assessed reason

Assessed today (continue)

Died (date of death required on final page)

Not able to be contacted / located

Too unwell

Other



*Date of assessment (Day 7 Assessment)(dd/mm/yyyy - please use date-picker)

Total dose given in the last 24 hours (mg)

Page 9

*How long has the patient been on this dose (days)

Select:

*Was there any benefit?

Yes

No

*Medication Changes

Medication of interest dose maintained/continue current dose

Medication of interest dose increased (please specify below)

Medication of interest dose decreased

Medication of interest dose ceased

New medication added (please specify below)

If "new medication added" above, please specify here

If "medication of interest dose increased" above, please specify new dose



1 2 3 Un-gradable No symptom




No

symptom

Somnolence

Hallucinations

Delirium

Confusion

Urinary retention

Constipation


Other

Other

Other

1 2 3 Ungradable

No

symptom

Dry Mouth

Dizziness






Page 10

Symptomatic Adverse Event Assessment - (Day 1 - Day 7)

Please list any symptomatic adverse events that occur (regardless of whether they are attributable to the medication of

interest or not)

*Were there any symptomatic adverse events?

Yes

No

*ToxicitiesSpecify any adverse drug event and grade it according to NCI criteria


Select:

*Consequences of ToxicitiesHas this medication contributed to:

Emergency Department presentation

Primary care presentation

Hospitalization

Prolongation of a hospitalization

Other:

*If there were toxicities, were any given a grade of 3 or more?

Yes No Not applicable



Page 11

Key questions derived from the Naranjo check list

(only complete this section if any toxicity on the previous page is 3 or greater)

*1. Did the adverse reaction appear after the suspected drug was given?

Yes

No

Don't know

*2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given?

Yes

No

*3. Are there alternative causes (other than the drug) that could on their own have caused the reaction?

Yes

No

Don't know

*4. Did the patient have a similar reaction to the same or similar drug in any previous exposure?

Yes

No

Don't know

*5. Was the adverse event confirmed by any objective evidence?

Yes

No

Don't know



If "yes" to "has a medication been added to treat a specific toxicity" above, please specify here

Page 12

*What is the intended treatment based on the assessment today?

No change to medication of interest/continue current dose

Medication of interest ceased

Medication of interest reduced

Medication of interest dose increased (please specify new dose)

Has a medication been added to treat a specific toxicity?

Yes No

Based on the assessment today has toxicity resolved?

Yes No

*Do you have data for the next timepoint to be entered at this time?

Yes (continue to next timepoint)

No (Finish & close survey for now)



Page 13

Day 14 Assessment

Symptomatic Benefit Assessment - (Day 8 - Day 14)

*Assessed / Not assessed reason

Assessed today (continue)

Died (date of death required on final page)

Not able to be contacted / located

Too unwell

Other



*Date of assessment (Day 14 Assessment)(dd/mm/yyyy - please use date-picker)

Total dose given in the last 24 hours (mg)

Page 14

*How long has the patient been on this dose (days)

Select:

*Was there any benefit?

Yes

No

*Medication Changes

Medication of interest dose maintained/continue current dose

Medication of interest dose increased (please specify below)

Medication of interest dose decreased

Medication of interest dose ceased

New medication added (please specify below)

If "new medication added" above, please specify here

If "medication of interest dose increased" above, please specify new dose



1 2 3 Un-gradable No symptom




No

symptom

Somnolence

Hallucinations

Delirium

Confusion

Urinary retention

Constipation

Supraventricular Tachycardia

Other

Other

Other

1 2 3 Ungradable

No

symptom

Dry Mouth

Dizziness






Page 15

Symptomatic Adverse Event Assessment - (Day 8 - Day 14)

Please list any symptomatic adverse events that occur (regardless of whether they are attributable to the medication of

interest or not)


Yes

No

*ToxicitiesSpecify any adverse drug event and grade it according to NCI criteria


Select:

Consequences of ToxicitiesHas this medication contributed to:

Emergency Department presentation

Primary care presentation

Hospitalization

Prolongation of a hospitalization

Other:


Yes No Not applicable



Page 16

Key questions derived from the Naranjo check list



Yes

No

Don't know


Yes

No


Yes

No

Don't know


Yes

No

Don't know


Yes

No

Don't know




Page 17

What is the intended treatment based on the assessment today?






Yes No

Based on the assessment today has toxicity resolved?

Yes No



*Date of assessment (medication cessation)Please use date-picker dd/mm/yyyy

Page 18

Medication Cessation

(complete this page at any time the medication of interest is ceased)

Medication was ceased (related to indication of interest):

Symptom resolved (provide date on next page, question a)

Symptom continued unchanged

Symptom worsened (please specify on next page, question b)

Medication was ceased (related to other reasons):

Toxicity - refer to unscheduled toxicity assessment

Patient unable to take medication (go to page 19 question c)

Other - please specify

What treatment did you subsequently initiate following cessation of the medication of interest?



a) Symptom resolved - date of resolution(dd/mm/yyyy - please use date-picker)

Page 19

b) Symptom worsened - Grade (NCI)

c) Patient unable to take medication please specify



Page 20

*Were there any ad hoc toxicities?

Yes No



*Date of assessment (ad hoc a)(dd/mm/yyyy - please use date-picker)


No

symptom

Somnolence

Hallucinations

Delirium

Confusion

Urinary retention

Constipation


Other

Other

Other

1 2 3 Ungradable

No

symptom

Dry Mouth

Dizziness






Page 21

Unscheduled Adverse Event Assessment (a)

Please list any symptomatic adverse events that occur at any time regardless of whether they are attributable to the

medication of interest or not.


Yes

No



1 2 3 Un-gradable

Toxicities

Specify any adverse drug event and grade it according to NCI criteria


Select:


Yes

No

Not applicable











Yes No



Page 22

Key questions derived from the Naranjo check list (a)



Yes

No

Don't know


Yes

No


Yes

No

Don't know


Yes

No

Don't know


Yes

No

Don't know



Page 23

*Were there any further ad hoc adverse events?

Yes

No



*Date of assessment (ad hoc b)

(dd/mm/yyyy - please use date-picker)


No

symptom

Somnolence

Hallucinations

Delirium

Confusion

Urinary retention

Constipation


Other

Other

Other

1 2 3 Ungradable

No

symptom

Dry Mouth

Dizziness






Page 24

Unscheduled Adverse Event Assessment (b)




Yes

No



1 2 3 Un-gradable

ToxicitiesSpecify any adverse drug event and grade it according to NCI criteria


Select:


Yes

No

Not applicable











Yes No



Page 25

Key questions derived from the Naranjo check list (b)



Yes

No

Don't know


Yes

No


Yes

No

Don't know


Yes

No

Don't know


Yes

No

Don't know



Page 26

*Were there any further ad hoc adverse events?

Yes

No



*Date of assessment (ad hoc c)(dd/mm/yyyy - please use date-picker)


No

symptom

Somnolence

Hallucinations

Delirium

Confusion

Urinary retention

Constipation


Other

Other

Other

1 2 3 Ungradable

No

symptom

Dry Mouth

Dizziness






Page 27

Unscheduled Adverse Event Assessment (c)




Yes

No



1 2 3 Un-gradable

Toxicities

Specify any adverse drug event and grade it according to NCI criteria


Select:


Yes

No

Not applicable











Yes No



Page 28

Key questions derived from the Naranjo check list (c)



Yes

No

Don't know


Yes

No


Yes

No

Don't know


Yes

No

Don't know


Yes

No

Don't know



Page 29

*Date of deathPlease use date-picker



Message Format:

From Email Address:

[email protected]

To Email Address:

@@Email

Bcc:

[email protected]

Subject:

Rapid Response - Amitriptyline: @@396798

Body:

Reminder emails will be sent to @@396849, @@396850 to complete the survey again:

At 7 days after commencement : @@396847

At 14 days after commencement : @@396848

CONFIDENTIAL CASE REPORT FORM AMITRIPTYLINE/NORTRIPTYLINE … · 6/3/2016 Survey Preview -...

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Transcript of CONFIDENTIAL CASE REPORT FORM AMITRIPTYLINE/NORTRIPTYLINE … · 6/3/2016 Survey Preview -...