SOS STOOLBOX

SOS STOOLBOX1

Simple One Step (SOS) stool processing method and Xpert MTB/RIF (Ultra) testing for the detection of Mycobacterium tuberculosis complex and rifampicin resistance

VARIABLES AND DATA COLLECTION FORMS

SOS STOOLBOX

SOS STOOLBOX2

Minimum set of variables

Example participant enrollment form

Example laboratory form

Example diagnosis form

TABLE OF CONTENTS

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Minimum set of variables

In the table below, the minimum set of variables are listed that should be collected during the pilot implementation period of the SOS stool method for the detection of tuberculosis and rifampicin resistance. Note that pilot implementation is meant to test the SOS stool method in the country’s routine setting to learn more about the performance of the method in the context in which it will be used after scaling up to national level when the pilot has ended. A pilot implementation phase usually includes a limited number of health facilities and patients, and runs for a limited period of time.

Unique participant code

Date of enrollment (or: date of firstdiagnostic visit)

Participant date of birth

Participant sex

HIV status

Type of samples collected for laboratory diagnostic assessment

Date of sample collection

Appearance of stool sample

Stool Xpert test date

Numerical

Date

Date

Categorical

Categorical

Categorical

Date

Categorical

Date

A numerical code that uniquely identifies each participant. In multicenter studies, this code should contain information about the center. E.g., first digit for the center, last three digits for the participant – the 5th participant in center 8 gets code 8005.

This is the date that the clinician assessed the participants because of his/her TB suggestive complaints.

If this date is not available, then alternatively age in months (for participants aged <1 year) or years (for older participants) can be collected.

Male/female.

Positive/negative/unknown.

Preferably pre-coded for most common types, e.g. 1=sputum 2= nasogastric aspirate 3=induced sputum 4=stool, etc.

Ideally to be collected for each sample type.

The Bristol stool chart can be followed to described the appearance of the stool. Otherwise, at least a differentiation should be made between solid (formed) and liquid (unformed).

Date that the stool sample was tested with Xpert.

To be assigned by the study/pilot team

Patient register

Patient register

Patient register

Patient register

Laboratory request form

Laboratoryrequest form

Laboratory request form?

Laboratory register, or obtained from the Xpert machine

Variable Data type Explanation Data source

SOS STOOLBOX4

Stool Xpert test result

Repeat stool Xpert test result (in case the first test was unsuccessful)

Date of Xpert testing of sample types other than stool

Other Xpert test result

Repeat other Xpert test result (if first test was unsuccessful)

Diagnosis

TB treatment

Date of starting TB treatment

Categorical

Categorical

Date

Categorical

Categorical

Categorical

Categorical

Date

Ideally not only detected/not detected/unsuccessful should be collected, but also specific test results; i.e., including bacterial load (trace/very low/low/medium/high) and rifampicin result for positive test results, and error codes.


Should be added in case any other sample (than stool) from the same participant was tested.



Should contain information about the final diagnosis: TB, or not TB; ideally should also specify whether the TB was bacteriologically confirmed or not (in accordance with national guidelines)

Specify whether TB treatment was started, ideally with TB treatment registration number.

Laboratory register, or obtained from Xpert machine





Patient register

TB register

TB register

Variable Data type Explanation Data source

SOS STOOLBOX5

<<LOGO’SCANBEINSERTEDHERE>>

Exampleparticipantenrollmentform-SOSStoolbox

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Explanation:Thisisanexampleofanenrollmentformtobefilledbytheclinicianatenrollmentoftheparticipant.Questionsmarkedwith*areconsideredtobe“musthave”.

Participantidentification(Uniqueidentificationcode,preferablyaspreprintedsticker)

Detailsofenrollmentandpatientdemographics1 Nameofclinician

2* Dateofenrollment __/__/____dd/mm/yyyy

3 Nameofparticipant1

4 DateofbirthIfunknown!! skiptoQ5

__/__/____ Afterfilling!! skiptoQ6dd/mm/yyyy

5* AgeFillageinmonthsif<1year

___Years__Months

6* Sex !Male !FemaleReason(s)forbeingregardedapresumptiveTBpatientatinitialassessment7a Coughof>2weeks !Yes !No7b Poorweightgainorlossofweight !Yes !No7c Reducedplayfulness !Yes !No7d Unexplainedfever !Yes !No7e Drenchingnightsweats !Yes !No7f Lymphnodesinneckenlarged !Yes !No7g ContacthistorywithinfectiousTBpatient !Yes !NoHealth-relatedconditions8* HIVstatus !Positive !Negative !Unknown9 Otherimmunosuppressingdiseases? !Yes,specify:____________________________

_________________________________________!No

10 Otherrelevantdisease/medicalcondition !Yes,specify:_____________________________________________________________________!No

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1 While a patient name should not be essential if a unique patient identification code is consistently used,experiencelearnsthatitmaystillbeneededtolinkdifferentformsandsolveissueswiththepatientidentificationcode.Ideally,patientnameshouldnotbeenteredinthedatabase.Paperformswithpatientnamesshouldbekeptinasavelocationthatisonlyaccessibletotheresearch/pilotimplementationteam,e.g.inalockedcabinet.

Logo’s can be inserted here

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Exampleparticipantenrollmentform-SOSStoolbox

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Samplescollected11a* Wasarespiratorysamplecollected? !Yes,spontaneouslyexpectoratedsputum

!Yes,nasogastricaspirate(NGA)!Notcollected!skiptoQ12a

11b* Dateofrespiratorysamplecollection __/__/____dd/mm/yyyy

12a* Wasastoolsamplerequested? !Yes !No!skiptoQ13

12b* Dateofstoolsamplecollection __/__/____dd/mm/yyyy

13 Wereanyotherdiagnosticsamplesrequested?TickallthatapplyandfilldateforeachsampletickedIfnoothersampleswerecollected!skiptoQ14

Sample Collectiondatedd/mm/yyyy

"Pleuralfluid"Cerebralspinalfluid(CSF)"Peritonealfluid"Pericardialfluid"Lymphnodeaspirate"Other,specify:________________________

__/__/______/__/______/__/______/__/______/__/______/__/____

14 WaschestX-rayrequested? !Yes!No


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Examplelaboratoryform–SOSStoolbox

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Explanation:Thisisanexampleofalaboratoryformthatcapturesresultsofdiagnostictestsfromthelaboratory.Questionsmarkedwith*areconsideredas“musthave”;(*)asmusthaveifapplicable.


Generalinformation1a Nameoflaboratory/clinic 1b Thisformwascompletedby

(name)

2a Nameofparticipant 2b Dateofbirth

Ifunknown!! skiptoQ5__/__/____ Afterfilling!! skiptoQ2ddd/mm/yyyy

2c* AgeIfage<1year,fillageinmonths

___Years__Months

2d* Sex !Male !FemaleRespiratorysample3* Isarespiratorysample

available?!Yes!No,reason: Afterfilling!! skiptoQ13!samplelost!leakingcontainer!other,specify:______________________________

4(*) Datesamplecollected __/__/____dd/mm/yyyy

5 Datesamplereceivedinthelaboratory

__/__/____dd/mm/yyyy

6 Typeofrespiratorysamplereceived

!NGA!Sputum

7 Appearance !Watery/salivary!Mucoid!Purulent!Bloody

8 Approximatevolumesample __mL



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Respiratorysample,continued9(*) DateXperttestconducted __/__/____

dd/mm/yyyy10a(*) XpertMTB/RIFtestresult MTB

!notdetected!detected,trace!detected,verylow!detected,low!detected,medium!detected,high!invalid!error,code ___!noresult,specify:_______________

RIFresistance!notdetected!detected!indeterminate

10b SampleProcessingControl(SPC)Cyclethreshold(Ct)value

___ !noSPC-Ctvalue(notestresult2)

11(*) Ifnotestresult2wasobtained,wasthetestrepeated?IftestresultwasMTB(not)detected!! skiptoQ13

!Yes,date:__/__/____ dd/mm/yyyy!No,reason: Afterfilling#skiptoQ13!samplelost!notenoughsampleleft!other,specify:______________________________

12a(*) RepeatXpertMTB/RIFtestresult

MTB!notdetected!detected,trace!detected,verylow!detected,low!detected,medium!detected,high!invalid!error,code: ___!noresult,specify:______________


12b SPC-Ctvalue ___ !noSPC-Ctvalue(notestresult2)


2I.e.,testresultwasinvalid,error,ortherewasnotestresult


2 l.e., test result was invalid, error, or there was no test reult

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Stoolsample13* Isastoolsampleavailable? !Yes

!No,reason: Afterfilling#skiptoQ23!samplelost!leakingcontainer!other,specify:______________________________

14(*) Dateofsamplecollection __/__/____dd/mm/yyyy

15 Timeofsamplecollection __/__hh/mm

16 Datesamplereceivedinlaboratory


17 Timesamplereceivedinlaboratory

__/__hh/mm

18(*) Appearance !Formed(solid)!Unformed(soft)!Takingtheshapeofthecontainer(liquid)

19(*) DateXperttestconducted __/__/____dd/mm/yyyy

20a(*) XpertMTB/RIFtestresult MTB!notdetected!detected,trace!detected,verylow!detected,low!detected,medium!detected,high!invalid!error,code: ___!noresult,specify:______________


20b SPC-Ctvalue ___ !noSPC-Ctvalue(notestresult2)21(*) Ifnotestresult2wasobtained,

wasthetestrepeated?IftestresultwasMTB(not)detected!! skiptoQ23






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Stoolsample13* Isastoolsampleavailable? !Yes

!No,reason: Afterfilling#skiptoQ23!samplelost!leakingcontainer!other,specify:______________________________

14(*) Dateofsamplecollection __/__/____dd/mm/yyyy

15 Timeofsamplecollection __/__hh/mm

16 Datesamplereceivedinlaboratory


17 Timesamplereceivedinlaboratory

__/__hh/mm

18(*) Appearance !Formed(solid)!Unformed(soft)!Takingtheshapeofthecontainer(liquid)

19(*) DateXperttestconducted __/__/____dd/mm/yyyy

20a(*) XpertMTB/RIFtestresult MTB!notdetected!detected,trace!detected,verylow!detected,low!detected,medium!detected,high!invalid!error,code: ___!noresult,specify:______________


20b SPC-Ctvalue ___ !noSPC-Ctvalue(notestresult2)21(*) Ifnotestresult2wasobtained,

wasthetestrepeated?IftestresultwasMTB(not)detected!! skiptoQ23



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Stoolsample,continued22a(*) RepeatXpertMTB/RIFtest

resultMTB!notdetected!detected,trace!detected,verylow!detected,low!detected,medium!detected,high!invalid!error,code: ___!noresult,specify:_______________


22b SPC-Ctvalue ___ !noSPC-Ctvalue(notestresult2)Otherdiagnostictestsdoneforthisparticipant23 Sampletype Test(s)conducted(circleappropriate): Testresult23a Sputum !Culture MGIT/LJ

!Smearmicroscopy directZN/FM!MODS!Other:______________________

!positive!negative!noresult!positive!negative!noresult!positive!negative!noresult!positive!negative!noresult

23b Urine !UrineLAM!Culture MGIT/LJ!Other:______________________

!positive!negative!noresult!positive!negative!noresult!positive!negative!noresult

23c Lymphnodeaspirate

!Culture MGIT/LJ!Other:______________________

!positive!negative!noresult!positive!negative!noresult

23d Cerebralspinalfluid(CSF)


!positive!negative!noresult!positive!negative !noresult

23f Bronchoalveolarlavage(BAL)


!positive!negative!noresult!positive!negative!noresult

23g Other,specify:______________

Specify:______________________ !positive!negative!noresult

24 Anyremarksonanyofthelaboratoryproceduresabove

____________________________________________________________________________________________________________


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Examplediagnosisform–SOSstoolbox

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Explanation:Thisisanexampleofaformthatcapturesthefinaldiagnosisoftheparticipant.Questionsmarkedwith*areconsideredas“musthave”.Participantidentification(Uniqueidentificationcode,preferablyaspreprintedsticker)

Generalinformation1 Nameofclinician

2 Nameofparticipant

3 DateofbirthIfunknown!! skiptoQ4

__/__/____ Afterfilling!! skiptoQ5dd/mm/yyyy

4* AgeIfage<1year,fillageinmonths

___Years__Months

5* Sex !Male !FemaleFinaldiagnosis6* WasaTBdiagnosismade? !Yes

!No!! Endofquestionnaire7* HowwastheTBdiagnosis

made?!Basedonclinicalsignsandsymptomsonly!! skiptoQ9!Basedacombinationofsigns,symptomsandbacteriology!Other,specify:___________________________________

8 Onwhattestresult(s)wasthebacteriologicaldiagnosisbased?TickallthatapplyandfilldateforeachtesttickedAfterfilling,!! skiptoQ10

Positivetestresult:Dateresultreceivedbyclinician:dd/mm/yyyy

�Xpertonsputum/NGA:�Xpertonstool:�Othertest(s),specify: 1._________________ 2._________________

__/__/______/__/______/__/______/__/____

9 IncaseTBwasdiagnosedclinically,basedonwhatinformationwasthediagnosismade?Tickallthatapply

�Chroniccough�ChestX-rayabnormal,suggestiveofTB�ContacthistorywithinfectiousTBpatient�Weightlossorfailuretogainweight�Fever�Drenchingnightsweats�Other,specify:___________________________________

TBtreatment10* WasTBtreatmentstarted? !Yes,treatmentstartdate: __/__/____

dd/mm/yyyy!Patientreferredfortreatmentto: (Namehealthfacility):_____________________________!Notstarted,becauseTBwasnotdiagnosed!Notstarted,reason(specify):_______________________


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SOS STOOLBOX

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