Form Approved
OMB# 0920-1011
expires 03/31/2017
Data Abstraction Form :
Investigation of Mucormycosis Disease among Bone Marrow Transplant Patients
Initials: ________
Case #: ________
Medical Record #: ____________
Reviewers Initials: ________
Review Date: ________
Case of Mucormycosis Infection of Interest
Bone marrow transplant patients with stays in unit 41 and 42 with any presentation of a mucormycosal infection excluding gastrointestinal
WITH
Histopathological or cytopathological examination showing hyphae from needle aspiration or biopsy specimen with evidence of associated tissue damage (either microscopically or as an infiltrate or lesion by imaging)
OR
Positive culture result for a sample obtained by sterile procedure from normally sterile and clinically or radiologically abnormal site consistent with mucormycosal infection.
Matched Controls
Bone marrow transplant patients (Preferred) with stays in unit 41 and 42:
a date of birth is within five years of the matched mucormycosis case’s birthday
with matched hematologic malignancy (See section II)
Other major risk factors we will assess for and enough controls present, we can consider matching for diabetes status, diabetic ketoacidosis, blood iron overload condition, chronic high-dose corticosteroids use. If necessary we can also expand the control group to hematopoietic stem cell transplant from unit 41, or from unit 41 and 42.
Case-Case Abstraction Form
Section I: Demographic and Admission Data
Age at diagnosis (years): __________
Gender: __________(0= Male, 1= Female)
Race (Select all that apply): __________
(0=white/Caucasian, 1=black/African-American, 2=Asian, 3=American Indian/Alaskan, 4=Hawaiian/Pacific Islander, 5=not known)
Ethnicity: __________(0=not Hispanic, 1=Hispanic, 2=not known)
County: ___________________
City: ___________________ State: _____ Zip: ______________
Phone #: --
Date of admission (mm/dd/yy): //
Admit diagnosis: _____________________________________________________________________
Section II: Underlying Medical Conditions and Risk Factors (at time of admission or before onsets, check all that apply)
General Medical Conditions:
None
Bone Marrow Transplant
Other
hematopoietic stem cell transplant
Diabetes [not Diabetic Ketoacidosis (DKA)]
Last Hemoglobin A1C level ____________
Diabetic Ketoacidosis (DKA) during stay on unit
Hemochromatosis
Thalassemia
Transfusion-induced iron overload in the 14 days before or during say on unit
Iron overload for any other reason and/or iron chelation therapy within 14 days prior to exposure to the unit (Desferrioxamine therapy)
Immunocompromised State: None
Solid organ transplant (ever)
renal liver lung heart other (specify) _______________________
If transplant recipient, date of most recent transplant (mm/dd/yy): ____/____/____
Solid tumor malignancy (specify type): __________________________
If history of solid tumor, on or had been on chemotx in the 14 days before culture?
Yes No Unknown
History of stem cell transplant
Neutropenia (< 500 neutrophils per mm3) within 14 days prior to onset (or admission?)
Total number of neutropenic days within 14 day period: ___________or Unknown
Systemic corticosteroids at avg dose ≥0.3 mg/kg/day prednisone (or equivalent) for > 3 weeks
Chronic Granulomatous Disease
Other __________________________________ (specify)
Hematologic malignancy
Leukemia
Acute myeloid leukemia (AML) (e.g. M0-M7)
Chronic myeloid leukemia (CML) (e.g. Chronic phase, Accelerated phase, Blast crisis)
Acute lymphocytic leukemia (ALL) (e.g. L1-L3)
Chronic lymphocytic leukemia (CLL) (e.g. B cell origin, T cell
origin, Adult T cell leukemia, Sezary
syndrome,
Unclassified)
Hodgkin’s disease (e.g. Lymphocyte predominant, Lymphocyte
rich, Nodular sclerosis, Hairy cell leukemia,
Mixed
cellularity, Lymphocyte depleted, Large, granular lymphocyte
leukemia)
Non-Hodgkin’s lymphoma (e.g. B cell origin, T cell origin)
Aplastic anemia
Multiple myeloma
Myelodysplastic syndrome (e.g. RA, RARS, RAEB-1, RAEB-2, RCMD, RCMD/RS, 5q syndrome, CMML)
Sickle cell anemia
Other _______________________________________________
If history of heme malignancy, on or had been on chemotx in the 14 days before culture?
Yes No Unknown
Graft-versus-host disease:
Acute; if yes, record grade (I-IV) __________
Chronic; if yes, check one: limited extensive unknown
None
Unknown
Section III: Location
Did this patient have any prior INPATIENT hospitalizations within 30 days prior to the current admission?
(Include ALL hospitalizations, including those not at Hospital A)
Yes (fill out table below, with most recent hospital admissions) No Unknown
Facility Name |
Admission Dates (mm/dd/yy)-(mm/dd/yy) |
Ward/Bed (complete for each location) |
First date at location |
Last date at location |
|
|
|
// Unk |
// Unk |
|
|
|
// Unk |
//
|
Where was patient admitted from?
Home
Nursing home/subacute care facility
Other acute care hospital
Rehabilitation
Other (specify): ________________________________________
Unknown
Room history during current admission:
Ward/Room |
First date at location |
Last date at location (or Unk) |
|
// Unk |
// Unk |
|
// Unk |
// Unk |
|
// Unk |
// Unk |
|
// Unk |
// Unk |
Section IV: Laboratory
Did patient have a positive Mucor culture? Yes No Unknown
Culture Date (mm/dd/yy) |
Specimen Site/Type (blood, sputum, pleural fluid, CSF, etc) |
Organism |
// |
|
|
// |
|
|
Did patient have a positive Mucor pathology finding? Yes No Unknown
If yes, please complete table:
Date (mm/dd/yy) |
Anatomical site |
Organism/Description of Fungal Elements |
// |
|
|
// |
|
|
If patient had a head CT, please list date: //
Cavernous sinus thrombosis
Changes to the orbit
Semiacute right frontal lobe infarct
Diffuse sinusitis
Describe other findings: ___________________________________________________________________
If patient had a head MRI, please list date: //
Cavernous sinus thrombosis
Changes to the orbit
Semiacute right frontal lobe infarct
Diffuse sinusitis
Describe other findings: ___________________________________________________________________
Does the patient have a history of positive cultures for Mucor? Yes No Unknown
If yes, date of previous culture : //
Section V: Medications/Procedures
Has patient received immunosuppressive medications (including chemotherapy) within 30 days of the index culture date? Yes No Unknown
If yes, please list: 1) __________________________
2) __________________________
3) __________________________
4) __________________________
5) __________________________
Did the patient receive systemic antifungal medication in the 30 days prior to the date of index culture that were given for reasons other than treatment of the current infection (i.e. prophylaxis or treatment of another fungal infection)? DO NOT include drugs given to treat the current infection.
Yes (fill out the table below) No Unknown
Antifungal drug |
Given? |
Total days of therapy in 30-day period |
Date of last dose prior to first culture (mm/dd/yy) |
Amphotericin B (Polyene Antifungal) Fungizone, (Lipid-based Polyene Antifungal) Amphotec Abelcet
AmBisome Amphocil, |
Yes No Unknown |
|
// Unk |
Anidulafungin (Eraxis) (an Echinocandin) |
Yes No Unknown |
|
// Unk |
Caspofungin (Cancidas) (an Echinocandin) |
Yes No Unknown |
|
// Unk |
Fluconazole (Diflucan) (an Azole) |
Yes No Unknown |
|
// Unk |
Flucytosine (5FC) (a Nucleoside Analog Antifungal) |
Yes No Unknown |
|
// Unk |
Micafungin (Mycamine) (an Echinocandin) |
Yes No Unknown |
|
// Unk |
Posaconazole (Noxafil) (an Azole) |
Yes No Unknown |
|
// Unk |
Itraconazole (Sporanox) (an Azole) |
Yes No Unknown |
|
// Unk |
Voriconazole (Vfend) (a Triazole) |
Yes No Unknown |
|
// Unk |
Was the patient intubated? Yes No Unknown
If yes, complete the following questions:
Where was the patient intubated? (ER, floor, ICU, field): ____________________________
Type of intubation: Oral Nasal
List dates of intubation: ____________________________________________________
Did index culture date occur prior to or after intubation? Prior After
Did the patient have a tracheostomy? Yes No Unknown
If yes, date of tracheostomy? //
If yes, did index culture date occur prior to or after tracheostomy? Prior After
Did the patient have any inpatient respiratory therapies in the 30 days before the index culture date?
Yes No Unknown
If yes, check below:
NC O2 NC O2 w/ humidified air Nebulized meds (SVN) MDIs
CPAP/BIPAP Other ____________ None Unknown
If ‘yes’ to SVN or MDI, fill in the table below:
Drug |
Mode of Administration (SVN or MDI) |
|
|
|
|
|
|
Did patient have any procedures within 30 days prior to the index culture date?
Yes No Unknown
If yes, please check all that apply:
Thoracentesis Date: //
Bronchoscopy Date: //
Date: //
Date: //
Thoracotomy (Chest tube insertion) Date: //
Endoscopy Date: //
Transesophageal echocardiogram Date: //
Surgery (1)__________________________ Date: //
OR #:______________
(2)__________________________ Date: //
OR #:______________
Percutaneous/interventional radiology
procedure: ___________________________________________
(specify)
Date: //
Other _________________________(specify) Date: //
Section VI: Symptoms
Was the onset of symptoms more chronic, over the course of several weeks? Yes No Unknown
Manifested as an acute sinus infection? Yes No Unknown
Nasal congestion? Yes No Unknown
Fever? Yes No Unknown
Headache? Yes No Unknown
Facial pain? Yes No Unknown
Tinnitus? Yes No Unknown
Reddish and swollen skin over nose and sinuses? Yes No Unknown
Periorbital edema and erythema (Reddish and swollen skin around the eye)? Yes No Unknown
Ptosis of the eyelid? Yes No Unknown
Visual problems? Yes No Unknown
Edema and hypertrophy of the nasal turbinates? Yes No Unknown
Edema and hypertrophy of the posterior pharynx? Yes No Unknown
Altered mental status? Yes No Unknown
Blindness of the eye? Yes No Unknown
Dilated pupil? Yes No Unknown
Nonreactive pupil? Yes No Unknown
Cavernous sinus thrombosis? Yes No Unknown
Evidence of spread to the brain? Yes No Unknown
Spread to the orbits? Yes No Unknown
Section VII: Treatment
Did the patient undergo debridment? Yes No Unknown
Myringotomy with insertion of a tympanostomy? Yes No Unknown
Hyperbaric oxygen therapy (HBO)? Yes No Unknown
Did the patient undergo surgery for treatment (not diagnosis) of rhinocerebral mucormycosis?
Yes No Unknown
If yes, what was the name of the procedure? __________________________
(e.g. Frontal lobectomy, Ethmoidectomy, Maxillary sinus antrostomy, Frontal sinusotomy, Sphenoidectomy)
Was the patient treated with an antifungal after the infection was diagnosed? Yes No Unknown
If yes, complete table:
Antifungal drug |
Given? |
Total days of therapy in 30-day period |
Date of last dose prior to first culture (mm/dd/yy) |
Amphotericin B (Polyene Antifungal) Fungizone, (Lipid-based Polyene Antifungal) Amphotec Abelcet
AmBisome Amphocil, |
Yes No Unknown |
|
// Unk |
Anidulafungin (Eraxis) (an Echinocandin) |
Yes No Unknown |
|
// Unk |
Caspofungin (Cancidas) (an Echinocandin) |
Yes No Unknown |
|
// Unk |
Fluconazole (Diflucan) (an Azole) |
Yes No Unknown |
|
// Unk |
Flucytosine (5FC) (a Nucleoside Analog Antifungal) |
Yes No Unknown |
|
// Unk |
Micafungin (Mycamine) (an Echinocandin) |
Yes No Unknown |
|
// Unk |
Posaconazole (Noxafil) (an Azole) |
Yes No Unknown |
|
// Unk |
Itraconazole (Sporanox) (an Azole) |
Yes No Unknown |
|
// Unk |
Voriconazole (Vfend) (a Triazole) |
Yes No Unknown |
|
// Unk |
Renal indices monitored during therapy? Yes No Unknown
Nephrotoxicity levels during treatment______
Iron chelator therapy? Yes No Unknown
Deferasirox? Yes No Unknown
Deferiprone? Yes No Unknown
Section VII: Outcomes
Was infected sinus tissue or sinus tissue destruction visibly observed? Yes No Unknown
Significant devitalized mucous membranes? Yes No Unknown
Significant devitalized mucous membranes? Yes No Unknown
Necrotic lesions in the:
Nasal mucosa? Yes No Unknown
Turbinates? Yes No Unknown
Hard palate? Yes No Unknown
Extension of the disease into the:
Maxillary sinus? Yes No Unknown
Invasion of the surrounding vasculature? Yes No Unknown
Spread into the cribriform plate or the orbital apex? Yes No Unknown
Did the patient require enucleation? Yes No Unknown
Occlusion of the carotid
artery, causing an internal carotid artery pseudoaneurysm?
Yes No
Unknown
Infarction and necrosis of
tissues in other structures? Yes
No Unknown
Other structures
involved?____________________________________________________________________
Was patient diagnosed with
rhinocerebral mucormycosis in the medical record?
Yes No
Unknown Not applicable
Date of discharge (mm/dd/yy): //
Status at discharge:
Alive Deceased Unknown
If deceased, date of death: //
If patient is deceased, is death certificate available?
Yes No Unknown Not applicable
If yes, is invasive fungal infection (IFI) listed as cause of death?
Yes No Unknown Not applicable
If yes, is IFI listed as primary or secondary cause of death? Primary Secondary
If patient is deceased, was an autopsy performed?
Yes No Unknown Not applicable
If yes, was evidence of invasive fungal infection (IFI) present?
Yes No Unknown Not applicable
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File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Rachel Mann Smith |
File Modified | 0000-00-00 |
File Created | 2021-01-26 |