3.1.

Data collection techniques and tools

1. Eligible patients presenting to OPD and ER:
- The initial patient interview:
The Initial Interview will be conducted with Eligible
patients when first presenting to the OPDs and ERs
o The interview will be conducted by the treating doctor
and a trained data collector.
o The Interview will be conducted with the eligible patient
him/herself, or with the accompanying person in case of
very ill or comatose patients and with children less than
fourteen years of age.
o The interviews will be conducted using the Patient
Initial Questionnaire (attached) adapted from the
WHO Initial Interview Questionnaire of Cases and Initial
Interview Questionnaire of Cases. The questionnaire will
be composed of a medical part and a non-medical part,
it will cover the following sections:
The participant unique identifier
Background information
Complains
Medical
Part
Past medical history
Risk factors
Non
- Initial patient Clinical, physical examination:
-Medical
o Clinical physical examination of Eligible
patients when
first presenting to the OPDs and ERs
o The examination will be conducted by the medical
doctors working in OPD and ER.
o The medical examination will be the standard
examination of a case suspected of MERS-CoV.
o The results of the examination will be recorded in
check-list sheet including the participant identifier.
- Patient Laboratory investigation:
The laboratory investigations that will be taken from eligible
patients when first presenting to the OPDs and ERs will
include only Upper respiratory tract specimens will be

collected due to difficulty in collecting lower respiratory

tract specimens. This will in the form of one of the following:
1. Nasopharyngeal AND oropharyngeal swabs
(NP/OP swabs
Nasopharyngeal swabs
2. Oropharyngeal swabs -- Swab the posterior
pharynx, avoiding the tongue.
3. Nasopharyngeal wash/aspirate or nasal
aspirates
The samples will be placed in containers labeled with the
patient unique identifier and transported according to the
standard guidelines (see laboratory procedure below) to the
National Public Health Laboratory Riyadh for
investigations.
All eligible patients who are RT-PCR positive will be classified
into the following categories based of the study case
definitions (see above):
Mild cases
Moderate cases
Severe cases
These will be followed for period of 4 weeks. On daily basis
these confirmed cased will subjected to follow-up interview
and follow-up examination.
Eligible patients who are RT-PCR negative will not be
investigated further.
Patient Follow-up interview:
o The follow-up interview will be conducted with eligible
participants from all categories who have a positive
result of RT-PCR.
o The interview will be conducted on daily basis for a
period of 4 weeks.

o The interview will be conducted using the Follow-up

Questionnaire that will be composed of the following
sections (attached):
Participants unique identifier
Symptoms
o The interview will be conducted by a nurse.
Patient Follow-up examination:
o The follow-up examination will be conducted for eligible
participants from all categories who have a positive
result of RT-PCR
o The follow-up examination will conducted by a medical
doctor on daily basis for a period of 4 weeks.
o The medical examination will be the standard
examination of a case suspected of MERS-CoV.
o The results of the examination will be recorded in a
check list sheet including the unique identifier of the
participant.
1. Household contacts of MERS-CoV confirmed cases.
- Contact initial interview:
The Initial contact Interview will be conducted with
contacts of confirmed cases of MERS-CoV.
o The interview will be conducted by a medical doctor
and a trained data collector.
o The Interview will be conducted with the contact
him/herself, or with the accompanying person in case of
very ill or comatose contacts and with children less
than fourteen years of age.
o The interviews will be conducted using the Initial
Contact Questionnaire (attached) adapted from the
WHO Questionnaire for Sero-epidemiological
Investigation of Contacts of MERS-CoV patients. The
questionnaire will be composed of a medical part and a
non-medical part, it will cover the following sections:
The participant unique identifier

 Background information
Medical
Complains
Part
Past medical history
Risk factors
Non
- Initial Contact Clinical, physical examination:
o Clinical physical examination of the-Medical
contact of
confirmed MERS-CoV.
o The examination will be conducted by a medical doctor.
o The medical examination will be the standard
examination of a case suspected of MERS-CoV.
o The results of the examination will be recorded in
check-list sheet including the participant identifier.
- Contact Laboratory investigation:
Symptomatic Contacts:
The laboratory investigations that will be performed for
symptomatic contacts will include:
1. Upper respiratory tract specimens for virologic
confirmation using RT-PCR:
1. Nasopharyngeal AND oropharyngeal swabs
(NP/OP swabs
Nasopharyngeal swabs
2. Oropharyngeal swabs -- Swab the posterior
pharynx, avoiding the tongue.
3. Nasopharyngeal wash/aspirate or nasal
aspirates.
2. Blood samples for serologic testing
Asymptomatic contacts:
Asymptomatic contacts will be followed for two weeks if no
symptoms develop during this period a blood samples for
serologic testing will be taken.

If at any time during the course of follow-up symptoms or

signs appear an upper respiratory tract specimen will be
collected for virologic confirmation using RT-PCR
All the samples will be placed in containers labeled with the
contact unique identifier and transported according to the
standard guidelines (see laboratory procedure below) to the
National Public Health Laboratory in Riyadh for
investigations.
All contacts who have a positive RT-PCR or serology test will
be classified into the following categories based of the study
case definitions (see above):
Mild cases
Moderate cases
Severe cases
All contacts with a positive RT-PCR or serological test results
will be followed for a period of 4 weeks. On daily basis they
will be subjected to follow-up interview and follow-up
examination (see above).
3. Eligible Health care workers at OPDs and ERs
and Health care workers involved in the
management of MERS-CoV confirmed cases
- Health care worker initial interview:
o The Initial health care worker Interview will be
conducted with Eligible Health care workers at OPDs
and ERs and Health care workers involved in the
management of MERS-CoV confirmed cases
o The interview will be conducted by a medical doctor
and a trained data collector.
o The Interview will be conducted with the health care
him/herself, or with the accompanying person in case of
very ill or comatose health care worker.

o The interviews will be conducted using the Initial HCW

Questionnaire (attached) adapted from the WHO
Questionnaire for Assessment of potential risk factors of
infection of MERS-CoV among health care personnel in
a health care setting. The questionnaire will be
composed of a medical part and a non-medical part, it
will cover the following sections:
The participant unique identifier
Background information
Complains
Medical
Part
Past medical history
Risk factors
- Initial Health Care Worker Clinical, Non
physical
-Medical
examination:
o Clinical physical examination of the Health care worker.
o The examination will be conducted by a medical doctor.
o The medical examination will be the standard
examination of a case suspected of MERS-CoV.
o The results of the examination will be recorded in
check-list sheet including the participant identifier.
- Health Care Worker Laboratory investigation:
The laboratory investigations that will be performed for
health care workers will include:
1. Upper respiratory tract specimens for virologic
confirmation using RT-PCR:
1. Nasopharyngeal AND oropharyngeal swabs
(NP/OP swabs
Nasopharyngeal swabs
2. Oropharyngeal swabs -- Swab the posterior
pharynx, avoiding the tongue.
3. Nasopharyngeal wash/aspirate or nasal
aspirates.
2. Blood samples for serologic testing

All the samples will be placed in containers labeled with the

Health Care Worker unique identifier and transported
according to the standard guidelines (see laboratory
procedure below) to the National Public Health Laboratory in
Riyadh for investigations.
All Health care workers who are positive for either RT-PCR or
serelogy will be classified into the following categories
based of the study case definitions (see above):
Mild cases
Moderate cases
Severe cases
These will be followed for period of 4 weeks. On daily basis
these confirmed cased will subjected to follow-up interview
and follow-up examination (see above).
Health care worker who are negative for both RT=PR and
serology will be followed for two weeks and second sample
for serology will be taken from them at the end of this
period if no symptoms develop. If symptoms develop during
this period a RT-PCR will be performed. If any of the two
tests is positive the health care workers will be followed for
a period of 4 weeks (see above)