FoodNet Hemolytic Uremic Syndrome (HUS) Surveillance

Emerging Infections Program

Att A - FoodNet_HUS_CRF_Data Dictionary_Redcap_VAR KEY_2016

FoodNet Hemolytic Uremic Syndrome (HUS)

OMB: 0920-0978

Document [pdf]
Download: pdf | pdf
Case ID_____________p1

A

A

CDC’s FoodNet Hemolytic Uremic Syndrome (HUS) Surveillance
Case Report Form

1A. Case ID [caseid]

YYYYYearXXFipscode001Record

___________________________________________

2A. State ID [stateid]

___________________________________________

3A. FoodNet Person ID (if applicable) [personid]

___________________________________________

4A. Site [site]

___________________________________________

5A. Date entered [denter]

____/____/____

Demographic Information
Instructions: Complete the following demographic information as it pertains to the patient diagnosed with HUS.
6A. Date of Birth [dob]

____/____/____

7A. State of Residence [state]

_______________________________________________

8A. County of residence [county]

_______________________________________________

9A. Sex [sex]

 Male (1)  Female (2)  Unknown (9)

10A. Ethnicity [ethnicity]

 Hispanic (1)

11A. Race [race]

 Black (1)

 Non-Hispanic (2)

 White (2)

 Unknown (9)

 Asian (3)

 American Indian / Alaska Native (4)
 Pacific Islander / Native Hawaiian (5)
 Multi-Racial (6)  Other (12)  Unknown (9)
Clinical Information
Instructions: Complete the following by interviewing the attending physician and/or reviewing patient's medical record.
12A. Is the date of HUS diagnosis known? [dhusunk]

 yes(1)  no(0)

13A. Date of HUS diagnosis? [dhus]

____/____/____

14A. Did the patient have diarrhea in the 3 weeks before HUS diagnosis? [diarrhea]

 yes (1)  no (0)  unknown (9)

if yes

17A.

15A.

Date of diarrhea onset [donset]

____/____/____

16A.

Did stools contain visible blood at the time? [stoolblood]

 yes (1)  no (0)  unknown (9)

Was diarrhea treated with antimicrobial medications? [abxdiar]
if yes

18A.

Types of antimicrobials used to treat diarrhea: (check all that apply)

(0,1)













 yes (1)  no (0)  unknown (9)

Azithromycin (Zithromax, Z-Pak) [abxd_azithromycin]
Ceftriaxone (Rocephin)[abxd_ceftriaxone]
Ciprofloxin (Cipro) [abxd_cirpofloxin]
Levofloxacin (Levaquin) [abxd_levofloxacin]
Metronidazole (Flagyl) [abxd_metronidazole]
Piperacillin [abxd_piperacillin]
Tazobactam [abxd_tazobactam]
Trimethoprim Sulfamethoxazole (Bactrim, Septra) [abxd_trimethoprimsul]
Vancomycin (Vancocin) [abxd_vancomycin]
Other (specify in comments) [abxd_other] __________________________________[abxdoth]
Unknown [abxd_unknown]

Last updated 6/13/2016

Case ID_____________p2

A

A
Clinical Information Continued
19A. Did the patient have contact with another person with
diarrhea or HUS during the 3 weeks before HUS diagnosis
(include daycare, household, etc)? [contact]

 yes (1)  no (0)  unknown (9)

20A. Was the patient treated with an antimicrobial medication
(ANY antibiotic) for any other reason than diarrhea during
the 3 weeks before HUS diagnosis? [abxnotdiar]

 yes (1)  no (0)  unknown (9)

if yes

21A. Reason treated with antimicrobial [abxndreason]

22A.

Types of antimicrobials used to treat conditions other than diarrhea: (check all that apply)
(0,1)













_______________________________

Azithromycin (Zithromax, Z-Pak) [abxnd_azithromycin]
Ceftriaxone (Rocephin)[abxnd_ceftriaxone]
Ciprofloxin (Cipro) [abxnd_cirpofloxin]
Levofloxacin (Levaquin) [abxnd_levofloxacin]
Metronidazole (Flagyl) [abxnd_metronidazole]
Piperacillin [abxnd_piperacillin]
Tazobactam [abxnd_tazobactam]
Trimethoprim Sulfamethoxazole (Bactrim, Septra) [abxnd_trimethoprimsul]
Vancomycin (Vancocin) [abxnd_vancomycin]
Other (specify in comments) [abxnd_other]
___________________________[abxndoth]
Unknown [abxnd_unknown]

Other medical conditions present during 3 weeks before HUS diagnosis:
23A.

Other gastrointestinal illness [gastro]

 yes (1)  no (0)  unknown (9)

24A.

Urinary tract infection [uti]

 yes (1)  no (0)  unknown (9)

25A.

Respiratory tract infection [rti]

 yes (1)  no (0)  unknown (9)

26A.

Other acute illness[acute]

 yes (1)  no (0)  unknown (9)

if yes

______________________________

Describe [acutedesc]

27A.

Pregnancy [preg]

 yes (1)  no (0)  unknown (9)

28A.

Kidney disease [kidn]

 yes (1)  no (0)  unknown (9)

29A.

Immune compromising condition or medication [immcomp]

 yes (1)  no (0)  unknown (9)

if yes

30A. Malignancy [malig]

 yes (1)  no (0)  unknown (9)

31A. Transplanted organ or bone marrow [transpl]

 yes (1)  no (0)  unknown (9)

32A. HIV infection [hiv]

 yes (1)  no (0)  unknown (9)

33A. Steroid Use (parenteral or oral) [ster]

 yes (1)  no (0)  unknown (9)

Other, describe [immother]

 yes (1)  no (0)  unknown (9)
______________________[immotherdesc]

Laboratory values within 7 days before and 3 days after HUS diagnosis
Instructions: Record the correct unites or convert to the correct units before entering into the HUS database, especially for platelet
count (e.g., enter a platelet count of 33,700/mm3 as 33.7)
34A.

Highest serum creatinine

[cre]

______ mg/dL (suggested range: 0.10-30.00)

35A.

Highest serum BUN

[bun]

______ mg/dL (suggested range: 4.0-100.0)

36A.

Highest WBC

[wbc]

______K/mm3 (suggested range: 0.50-125.00)

37A.

Lowest hemoglobin

[hgb]

______ g/dL

(suggested range: 2.0-30.0)

Last updated 6/13/2016

Case ID_____________p3

A

A

Laboratory Values Continued
38A.

Lowest hematocrit

[hct]

______ %

(suggested range: 0.0-100.0)
3

(suggested range: 3.0-600.0)

39A.

Lowest platelet count

[plt]

______ K/mm

40A.

Microangiopathic changes

[rcfrag]

 yes (1)  no (0)  unknown (9)  not tested (7)

Other laboratory findings within 7 days before and 3 days after HUS diagnosis:
41A. Blood (or heme) in urine [burine]

 yes (1)  no (0)  unknown (9)  not tested (7)

42A. Protein in urine [purine]

 yes (1)  no (0)  unknown (9)  not tested (7)

43A. RBC in urine by microscopy [rburine]

 yes (1)  no (0)  unknown (9)  not tested (7)
Epi Information

Instructions for Hospital Discharge Data: All records meeting the ICD9-or ICD10-CM codes specified in the surveillance protocol should
be reviewed even if the case had already been identified through Active Surveillance in order to obtain potentially missing information.
If a case is captured through HDD and was previously identified through the network of practitioners, sites should check that the
abstracted information from active surveillance is current and complete. In the event that additional information is available, this should
be included in the FoodNet HUS surveillance system. If a discrepancy is identified, the most current information should be used.
44A. How was patient’s illness first identified by public health (state or local health department or EIP)? [firstident]













Report of HUS case by a physician or service participating in the FoodNet HUS active surveillance network (1)
Report of HUS case by a non-participating physician or service (2)
Routine STEC infection active surveillance (3)
Retrospective review of hospital discharge data (4)
Other (specify in comments) (7) _____________________________[fidentothdesc]
Unknown (9)

45A. Date reported to public health or identified
by hospital discharge data review [dphreport]

____/____/____

46A. Was hospital discharge data review completed
for this case (to verify or supplement information)? [hddrev]

 yes (1)  no (0)  unknown (9)

47A. Date of HDD (hospital discharge data) review [dhdd]

____/____/____

48A. Is this case epidemiologically linked to a confirmed
or probable Shiga toxin-producing E.coli (STEC) case?[epilink]

 yes (1)  no (0)  unknown (9)

49A. Is this case outbreak related? [outbreak]

 yes (1)  no (0)  unknown (9)

Form A Comments, Composite Variables, and Status
50A. Completed by (initials): [aby]

_______________________________

51A. Comments [commentsa]

_______________________________

52A. Age at HUS Diagnosis

[age]

Number in years (round-up)

53A. Is the patient a resident of the FoodNet catchment area [fncatch]

1(in catchment), 0 (not in catchment), blank (incomplete)

54A. Is this a FoodNet pediatric post diarrheal case [postdiarrheal]

1(Yes), 0 (No), blank (incomplete)

55A. Year reported? [reportedyear]

____________ (e.g. 2016)

56A. Complete? [a_case_report_form_complete]

 incomplete (0)  unverified (1)  complete (2)

Last updated 6/13/2016

Case ID_____________p4

B

B
CDC’s Foodnet Hemolytic Uremic Syndrome Surveillance
Microbiology Report Form

Instructions: Enter the most relevant microbiology tests associated with this HUS case by specimen source. If multiple positive stool specimens were
tested, prioritize specimens tested by the SPHL or CDC. Include positive stool with any evidence of STEC, and, if applicable, serum sent to CDC for
testing of abxbodies against STEC and/or one other positive specimen if additional results are available. In addition, you will be prompted to enter
negative results (if applicable) only for evidence of STEC.

Stool Specimen
1B. Was stool collected?

 yes (1)  no (0)  unknown (9)

[stoolspec]

2B. Date stool specimen collected [dstoolspec]

____/____/____

3B. State Lab ID: [stoolslabsid]

_____________________________

Instructions: Answer below questions as they pertain to the stool specimen collected at each lab. You will be asked about other specimens in the other
pathogens section.

4B. Questions
Was this specimen forwarded
to the lab?
Was testing performed at lab?
Was a Shiga toxin test
performed? (e.g. PCR, EIA)
Shiga toxin test result
Shiga toxin type

Was a CIDT for E. coli O157
performed? (e.g. Immunocard Stat)
CIDT result?
Did the test include H7?
Was a culture for E.coli O157
performed?
Was E.coli O157 isolated?
Was a culture for E.coli nonO157 performed?
Was E.coli non-O157
isolated?
O Antigen

Clinical Lab
 yes (1)  no (0)  unk (9)
[sspecsent]
 yes (1)  no (0)  unk (9)
[ctest]
 yes (1)  no (0)  unk (9)
[cstxtest]
 positive (1)  negative (2)
[cstxresult]
 stx1 (1)  stx2 (2)  stx1
& stx2 (3) undifferentiated(9)
[cstxgene]
 yes (1)  no (0)  unk (9)
[co157cidt]
 positive (1)  negative (2)
[co157cidtresult]
 yes (1)  no (0)  unk (9)
[cidth7]
 yes (1)  no (0)  unk (9)
[co157cult]
 yes (1)  no (0)  unk (9)
[co157isol]
N/A
N/A
N/A

State or Local PHL
 yes (1)  no (0)  unk (9)
[fspecsent]
 yes (1)  no (0)  unk (9)
[stest]
 yes (1)  no (0)  unk (9)
[sstxtest]
 positive (1)  negative (2)
[sstxresult]
 stx1 (1)  stx2 (2)  stx1
& stx2 (3) undifferentiated(9)
[sstxgene]
 yes (1)  no (0)  unk (9)
[so157cidt]
 positive (1)  negative (2)
[so157cidtresult]
N/A

 yes (1)  no (0)  unk (9)
[so157cult]
 yes (1)  no (0)  unk (9)
[so157isol]
 yes (1)  no (0)  unk (9)
[snono157cult]
 yes (1)  no (0)  unk (9)
[snono157isol]
O26(1) O111(2)
O103(3)  O121 (4) O45(5)
 O145(6) rough(-2) und (-3)
not found(-1)

CDC Lab (Federal)
N/A

 yes (1)  no (0)  unk (9)
[ftest]
N/A

 positive (1)  negative (2)
[fstxresult]

 stx1 (1)  stx2 (2)  stx1
& stx2 (3) undifferentiated(9)
[fstxgene]
N/A
N/A
N/A
N/A

 yes (1)  no (0)  unk (9)
[fo157isol]

 yes (1)  no (0)  unk (9)
[fnono157cult]

 yes (1)  no (0)  unk (9)
[fnono157isol]
[foant]
[foantoth]

[soant]
H Antigen

 H7 pos (1)  H7 neg (2)
 non-motile(3) not

tested(4)
[chant]
5B. Was immunomagnetic separation (IMS) used to
identify common STEC serogroups? [ims]

[shant]
[shantoth]

[fhant]
[fhantoth]

 yes (1)  no (0)  unknown (9)

O157 [imssero_O157] O26 [imssero_O26]
O45 [imssero_O45] O103 [imssero_O103]
O111 [imssero_O111] O121 [imssero_O121] O145 [imssero_O145]
7B. Was whole genome sequencing (WGS) performed on this isolate? (at state or CDC) [wgs]
 yes (1)  no (0)  unknown (9)
8B. Sequencing ID: [wgsid]
_____________________________
6B. What serogroup(s) did the IMS procedure target?
(check all that apply) (0,1)

Last updated 6/13/2016

Case ID_____________p5

B

B
CDC Serology Tests
 yes (1)  no (0)  unknown (9)

9B. Has patient serum or plasma been sent to CDC for testing
for antibodies to O157 or other STEC? [antio157]
10B. Date serology specimen collected? [dserum]

____/____/____

11B. State laboratory ID for serum [serumslabsid]

_____________________________

12B. Was there more than one serology result for this case? [multiserol]

 yes (1)  no (0)  unknown (9)

13B. Questions
LPS type

Titer IgG

 O157(1)  O111(2)

[igg1]

Interpretation of IgG
Positive
Negative
[igginterp1] (1)
(2)

[igm1]

Interpretation of IgM
Positive
Negative
[igminterp1] (1)
(2)

[lpstype1]
[lsptype2]

[igg2]

[igginterp2] (1)

(2)

[igm2]

[igminterp2] (1)

(2)

[lpstype3]

[igg3]

[igginterp3] (1)

(2)

[igm3]

[igminterp3] (1)

(2)

Titer IgM

Other Pathogens (co-infections) and Other Specimens
14B. Questions
Were any other pathogens
identified?
Specimen source
Test type
Pathogen

Clinical Lab

State or Local PHL

CDC Lab (federal)

yes(1) no(0)  unk(9)

yes(1) no(0)  unk(9)
[cothpath]
[sothpath]
Same stool used for STEC
Same stool used for STEC
testing
testing
culture(1) CIDT(2)
culture(1) CIDT(2)
[cothpathttyp]
[sothpathttyp]
[cpath]
[spath]
Other Specimens (second specimen)

yes(1) no(0)  unk(9)
[fothpath]
Same stool used for STEC
testing
culture(1) CIDT(2)
[fothpathttyp1]
[fpath]

yes(1) no(0)  unk(9)

Was any other specimen
collected?
Date other specimen
collection
Specimen source

[othspec]
____/____/____
[dothspec]
[specsrc]
culture(1) non-culture (CIDT)(2)
[othspecttyp1]
[othspecpath1]
culture(1) non-culture (CIDT)(2)
[othspecttyp2]
[othspecpath2]

Test type 1
Pathogen 1
Test type 2
Pathogen 2


Where positive? (check
all that apply) (0,1)
Other specimen
State lab id

clinic [osp_clinic] 

State or local [osp_phl] 

CDC [osp_cdc]

[osslabsid]

Form B Comments, Composite Variables, and Status
15B. Completed by (initials): [bby]

_______________________________

16B. Comments [commentsb]

_______________________________

17B. Is there an STEC isolate? [stecisolate]

1(Yes), 0 (No), blank (incomplete)

18B. Is there evidence of STEC by serology [stecbyserology]

1(Yes), 0 (No), blank (incomplete)

19B. Is there any evidence of Shiga toxin? [anystx]

1(Yes), 0 (No), blank (incomplete)

20B. Complete? [b_microbiology_form_complete]

 incomplete (0)  unverified (1)  complete (2)
Last updated 6/13/2016

Case ID_____________p6

C

C
CDC’s Foodnet Hemolytic Uremic Syndrome Surveillance
Chart Review Form

Instructions: Complete after patient has been discharged; use hospital discharge summary, consultation notes and DRG coding sheet.
Complete one composite form for all institution where hospitalized.

Hospitals
1C. Was patient hospitalized? [hospital]

 yes(1)  no(0)  unknown(9)

2C. Date of first admission: [dadmis]

___/____/___

3C. Date of last discharge: [ddisch]

___/____/___

Complications
Did any of the following complications occur during this admission:
4C.
6C.
8C.
10C.
12C.

Pneumonia
[pne]
Seizure
[szr]
Paralysis or hemiparesis [par]
Blindness
[bln]
Other major neurologic
sequelae
[ner]
if yes, Describe: [nerdesc]

 yes (1)  no (0)
 yes (1)  no (0)
 yes (1)  no (0)
 yes (1)  no (0)
 yes (1)  no (0)

 unknown (9)
 unknown (9)
 unknown (9)
 unknown (9)
 unknown (9)

Date of onset
if yes
5C. [dpne]
If yes
7C. [dszr]
If yes 9C. [dpar]
if yes 11C. [dbln]
if yes 13C. [dner]

_____________________________

Were any of the following procedures performed during this admission:
14C.
15C.

19C.
20C.

Peritoneal dialysis [pdial]
Hemodialysis [hdial]

 yes (1)  no (0)  unknown (9)
 yes (1)  no (0)  unknown (9)

Transfusion with:
16C. packed RBC or whole blood [prbc]
17C. platelets [pltt]
18C. fresh frozen plasma [ffpl]

 yes (1)  no (0)  unknown (9)
 yes (1)  no (0)  unknown (9)
 yes (1)  no (0)  unknown (9)

Plasmapheresis [phres]
Laparotomy or other abdominal surgery* [surg]
(*other than insertion of dialysis catheter)
if yes Describe: [surgdesc]

 yes (1)  no (0)  unknown (9)
 yes (1)  no (0)  unknown (9)
_____________________________

Discharge
21C. Condition at discharge

[conddc]

 dead (1) alive (0)

if dead

22C. Date deceased [ddead]

____/____/____

if alive

23C. Requiring dialysis [reqdial]

 yes (1)  no (0)  unknown (9)

24C. With neurologic deficits [neurodef]

 yes (1)  no (0)  unknown (9)

Form C Comments, Composite Variables, and Status
25C. Completed by (initials): [cby]

_______________________________

26C. Comments [commentsc]

_______________________________

27C. Length of Stay? (Days) [los]

Number in Days

28C. Complete? [c_chart_review_form_complete]

 incomplete (0)  unverified (1)  complete (2)
Last updated 6/13/2016


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