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
SOS STOOLBOX3
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.
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.
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.
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 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
Laboratory register, or obtained from Xpert machine
Laboratory register, or obtained from Xpert machine
Laboratory register, or obtained from Xpert machine
Laboratory register, or obtained from Xpert machine
Patient register
TB register
TB register
Variable Data type Explanation Data source
SOS STOOLBOX5
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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.
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SOS STOOLBOX6
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Exampleparticipantenrollmentform-SOSStoolbox
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Participantidentification(Uniqueidentificationcode,preferablyaspreprintedsticker)
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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SOS STOOLBOX7
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Examplelaboratoryform–SOSStoolbox
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Explanation:Thisisanexampleofalaboratoryformthatcapturesresultsofdiagnostictestsfromthelaboratory.Questionsmarkedwith*areconsideredas“musthave”;(*)asmusthaveifapplicable.
Participantidentification(Uniqueidentificationcode,preferablyaspreprintedsticker)
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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SOS STOOLBOX8
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Examplelaboratoryform–SOSStoolbox
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Participantidentification(Uniqueidentificationcode,preferablyaspreprintedsticker)
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:______________
RIFresistance!notdetected!detected!indeterminate
12b SPC-Ctvalue ___ !noSPC-Ctvalue(notestresult2)
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2I.e.,testresultwasinvalid,error,ortherewasnotestresult
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2 l.e., test result was invalid, error, or there was no test reult
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SOS STOOLBOX9
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Examplelaboratoryform–SOSStoolbox
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Participantidentification(Uniqueidentificationcode,preferablyaspreprintedsticker)
Stoolsample13* Isastoolsampleavailable? !Yes
!No,reason: Afterfilling#skiptoQ23!samplelost!leakingcontainer!other,specify:______________________________
14(*) Dateofsamplecollection __/__/____dd/mm/yyyy
15 Timeofsamplecollection __/__hh/mm
16 Datesamplereceivedinlaboratory
__/__/____dd/mm/yyyy
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:______________
RIFresistance!notdetected!detected!indeterminate
20b SPC-Ctvalue ___ !noSPC-Ctvalue(notestresult2)21(*) Ifnotestresult2wasobtained,
wasthetestrepeated?IftestresultwasMTB(not)detected!! skiptoQ23
!Yes,date:__/__/____ dd/mm/yyyy!No,reason: Afterfilling#skiptoQ23!samplelost!notenoughsampleleft!other,specify:______________________________
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Examplelaboratoryform–SOSStoolbox
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Participantidentification(Uniqueidentificationcode,preferablyaspreprintedsticker)
Stoolsample13* Isastoolsampleavailable? !Yes
!No,reason: Afterfilling#skiptoQ23!samplelost!leakingcontainer!other,specify:______________________________
14(*) Dateofsamplecollection __/__/____dd/mm/yyyy
15 Timeofsamplecollection __/__hh/mm
16 Datesamplereceivedinlaboratory
__/__/____dd/mm/yyyy
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:______________
RIFresistance!notdetected!detected!indeterminate
20b SPC-Ctvalue ___ !noSPC-Ctvalue(notestresult2)21(*) Ifnotestresult2wasobtained,
wasthetestrepeated?IftestresultwasMTB(not)detected!! skiptoQ23
!Yes,date:__/__/____ dd/mm/yyyy!No,reason: Afterfilling#skiptoQ23!samplelost!notenoughsampleleft!other,specify:______________________________
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SOS STOOLBOX10
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Examplelaboratoryform–SOSStoolbox
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Participantidentification(Uniqueidentificationcode,preferablyaspreprintedsticker)
Stoolsample,continued22a(*) RepeatXpertMTB/RIFtest
resultMTB!notdetected!detected,trace!detected,verylow!detected,low!detected,medium!detected,high!invalid!error,code: ___!noresult,specify:_______________
RIFresistance!notdetected!detected!indeterminate
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)
!Culture MGIT/LJ!Other:______________________
!positive!negative!noresult!positive!negative !noresult
23f Bronchoalveolarlavage(BAL)
!Culture MGIT/LJ!Other:______________________
!positive!negative!noresult!positive!negative!noresult
23g Other,specify:______________
Specify:______________________ !positive!negative!noresult
24 Anyremarksonanyofthelaboratoryproceduresabove
____________________________________________________________________________________________________________
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SOS STOOLBOX11
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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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