Mucormycosis Data Abstraction Form

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 #: ____________

Date of Birth: //

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

1. Age at diagnosis (years): __________

2. Gender: __________(0= Male, 1= Female)

3. 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)

4. Ethnicity: __________(0=not Hispanic, 1=Hispanic, 2=not known)

5. County: ___________________

City: ___________________ State: _____ Zip: ______________

6. Phone #: --

7. Date of admission (mm/dd/yy): //

8. Admit diagnosis: _____________________________________________________________________

Section II: Underlying Medical Conditions and Risk Factors (at time of admission or before onsets, check all that apply)

9. 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)

10. 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

11. 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	// Unk

12. Where was patient admitted from?

Home

Nursing home/subacute care facility

Other acute care hospital

Rehabilitation

Other (specify): ________________________________________

Unknown

13. 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

14. 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
//
//

15. 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
//
//

16. 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: ___________________________________________________________________

17. 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: ___________________________________________________________________

18. Does the patient have a history of positive cultures for Mucor? Yes No Unknown

If yes, date of previous culture : //

Section V: Medications/Procedures

19. 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) __________________________

20. 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, ABLC ABCD	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

21. Was the patient intubated? Yes No Unknown

If yes, complete the following questions:

1. Where was the patient intubated? (ER, floor, ICU, field): ____________________________

2. Type of intubation:  Oral  Nasal

3. List dates of intubation: ____________________________________________________

4. Did index culture date occur prior to or after intubation?  Prior  After

22. Did the patient have a tracheostomy? Yes No Unknown

    1. If yes, date of tracheostomy? //

    2. If yes, did index culture date occur prior to or after tracheostomy?  Prior  After

23. Did the patient have any inpatient respiratory therapies in the 30 days before the index culture date?

Yes No Unknown

5. If yes, check below:

 NC O2 NC O2 w/ humidified air  Nebulized meds (SVN) MDIs 

 CPAP/BIPAP Other ____________ None Unknown

1. If ‘yes’ to SVN or MDI, fill in the table below:

Drug	Mode of Administration (SVN or MDI)

24. 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

25. Was the onset of symptoms more chronic, over the course of several weeks? Yes No Unknown

26. Manifested as an acute sinus infection? Yes No Unknown

27. Nasal congestion? Yes No Unknown

28. Fever? Yes No Unknown

29. Headache? Yes No Unknown

30. Facial pain? Yes No Unknown

31. Tinnitus? Yes No Unknown

32. Reddish and swollen skin over nose and sinuses? Yes No Unknown

33. Periorbital edema and erythema (Reddish and swollen skin around the eye)? Yes No Unknown

34. Ptosis of the eyelid? Yes No Unknown

35. Visual problems? Yes No Unknown

36. Edema and hypertrophy of the nasal turbinates? Yes No Unknown

37. Edema and hypertrophy of the posterior pharynx? Yes No Unknown

38. Altered mental status? Yes No Unknown

39. Blindness of the eye? Yes No Unknown

40. Dilated pupil? Yes No Unknown

41. Nonreactive pupil? Yes No Unknown

42. Cavernous sinus thrombosis? Yes No Unknown

43. Evidence of spread to the brain? Yes No Unknown

44. Spread to the orbits? Yes No Unknown

Section VII: Treatment

45. Did the patient undergo debridment? Yes No Unknown

46. Myringotomy with insertion of a tympanostomy? Yes No Unknown

47. Hyperbaric oxygen therapy (HBO)? Yes No Unknown

48. Did the patient undergo surgery for treatment (not diagnosis) of rhinocerebral mucormycosis?

49. Yes No Unknown

50. If yes, what was the name of the procedure? __________________________

(e.g. Frontal lobectomy, Ethmoidectomy, Maxillary sinus antrostomy, Frontal sinusotomy, Sphenoidectomy)

51. 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, ABLC ABCD	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

52. Renal indices monitored during therapy? Yes No Unknown

53. Nephrotoxicity levels during treatment______

54. Iron chelator therapy? Yes No Unknown

55. Deferasirox? Yes No Unknown

56. Deferiprone? Yes No Unknown

Section VII: Outcomes

57. Was infected sinus tissue or sinus tissue destruction visibly observed? Yes No Unknown

58. Significant devitalized mucous membranes? Yes No Unknown

59. Significant devitalized mucous membranes? Yes No Unknown

60. Necrotic lesions in the:

1. Nasal mucosa? Yes No Unknown

2. Turbinates? Yes No Unknown

3. Hard palate? Yes No Unknown

61. Extension of the disease into the:

Maxillary sinus? Yes No Unknown

62. Invasion of the surrounding vasculature? Yes No Unknown

63. Spread into the cribriform plate or the orbital apex? Yes No Unknown

64. Did the patient require enucleation? Yes No Unknown

65. Occlusion of the carotid artery, causing an internal carotid artery pseudoaneurysm?
    Yes No Unknown

66. Infarction and necrosis of tissues in other structures? Yes No Unknown
    Other structures involved?____________________________________________________________________

67. Was patient diagnosed with rhinocerebral mucormycosis in the medical record?
    Yes No Unknown Not applicable

68. Date of discharge (mm/dd/yy): //

69. Status at discharge:

Alive Deceased Unknown

70. If deceased, date of death: //

71. If patient is deceased, is death certificate available?

Yes No Unknown Not applicable

72. 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

73. If patient is deceased, was an autopsy performed?

Yes No Unknown Not applicable

74. If yes, was evidence of invasive fungal infection (IFI) present?

Yes No Unknown Not applicable

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