To Document Pneumonia Case Management Practices in Selected Communities in Pakistan; A Qualitative Study
Conditions: Pneumonia, Childhood Pneumonia, Infectious Disease, Acute Respiratory Infection
Sponsor: University of Edinburgh

<PCM-PK> 
<V1- 12112017> 
 
 
CR007-T02 v1.0 
1 of 27 
 
 
 
 
Non-CTIMP Study Protocol 
To document pneumonia case management practices in selected 
communities in Pakistan; A qualitative study 
 
The University of Edinburgh and/or Lothian Health Board 
ACCORD 
The Queen’s Medical Research Institute 
47 Little France Crescent 
Edinburgh 
EH16 4TJ 
Protocol authors 
 
Funder 
NIHR 
Funding Reference Number 
16/136/609 
Chief Investigator 
 
Sponsor number 
AC18006 
Version Number and Date 
V1- 12112017 
23-01-2018 
 
 
 
 
 
 
 

<PCM-PK> 
<V1 - 12112017> 
 
 
 
 
CR007-T02 v1.0 
4 of 27 
 
 
CONTENTS 
 
1 
INTRODUCTION ............................................................................................................. 8 
1.1 
BACKGROUND ...................................................................................................... 8 
1.2 
1.2. RATIONALE FOR STUDY .............................................................................. 8 
2 
STUDY OBJECTIVES ................................................................................................... 10 
2.1 
OBJECTIVES ........................................................................................................ 10 
2.1.1 
Primary Objective ............................................................................................... 10 
2.1.2 
Secondary Objectives ........................................................................................ 10 
2.2 
ENDPOINTS ......................................................................................................... 10 
2.2.1 
Primary Endpoint ............................................................................................... 10 
3 
STUDY DESIGN ............................................................................................................ 10 
3.1 
Methodology: ......................................................................................................... 10 
3.2 
Observation Sites: ................................................................................................. 11 
3.3 
Type of Observations: ........................................................................................... 11 
3.4 
Data Collectors:..................................................................................................... 11 
3.5 
Recruitment of Disguised Patients’ Caregiver and Conduction of 
Observations: ........................................................................................................ 12 
3.6 
Project work-plan: ................................................................................................. 12 
4 
STUDY POPULATION .................................................................................................. 13 
4.1 
NUMBER OF PARTICIPANTS ............................................................................. 13 
4.2 
INCLUSION CRITERIA......................................................................................... 13 
4.2.1 
INCLUSION CRITERIA OF DISGUISED CAREGIVER: ................................... 13 
4.2.2 
INCLUSION CRITERIA OF HEALTHCARE PROFESSIONALS 
UNDER OBSERVATION ................................................................................... 13 
4.2.3 
EXCLUSION CRITERIA .................................................................................... 14 
5 
PARTICIPANT SELECTION AND ENROLMENT ........................................................ 14 
5.1 
IDENTIFYING PARTICIPANTS ............................................................................ 14 
5.2 
CONSENTING PARTICIPANTS .......................................................................... 14 
5.2.1 
Withdrawal of Study Participants ....................................................................... 15 
6 
STUDY ASSESSMENTS .............................................................................................. 15 
6.1 
STUDY ASSESSMENTS ...................................................................................... 15 
7 
DATA COLLECTION..................................................................................................... 16 
7.1 
Source Data Documentation................................................................................. 17 
7.2 
Case Report Forms ............................................................................................... 17 
8 
STATISTICS AND DATA ANALYSIS .......................................................................... 18 
8.1 
SAMPLE SIZE CALCULATION ............................................................................ 18 
8.2 
PROPOSED ANALYSES ..................................................................................... 18 
9 
OVERSIGHT ARRANGEMENTS .................................................................................. 19 
9.1 
INSPECTION OF RECORDS ............................................................................... 19 
9.2 
RISK ASSESSMENT ............................................................................................ 19 

<PCM-PK> 
<V1 - 12112017> 
 
 
 
 
CR007-T02 v1.0 
5 of 27 
 
 
9.3 
STUDY MONITORING AND AUDIT..................................................................... 19 
The ACCORD Sponsor Representative will assess the study to determine if 
an independent risk assessment is required.  If required, the 
independent risk assessment will be carried out by the ACCORD 
Quality Assurance Group to determine if an audit should be performed 
before/during/after the study. ................................................................................ 19 
10 
GOOD CLINICAL PRACTICE....................................................................................... 19 
10.1 
ETHICAL CONDUCT ............................................................................................ 19 
Before the study can commence, all required approvals will be obtained and 
any conditions of approvals will be met. ............................................................... 20 
10.2 
INVESTIGATOR RESPONSIBILITIES ................................................................. 20 
10.2.1 Informed Consent .............................................................................................. 20 
10.2.2 Study Site Staff .................................................................................................. 20 
10.2.3 Data Recording .................................................................................................. 20 
10.2.4 Investigator Documentation ............................................................................... 20 
10.2.5 Confidentiality ..................................................................................................... 20 
10.2.6 Data Protection .................................................................................................. 21 
11 
STUDY CONDUCT RESPONSIBILITIES ..................................................................... 21 
11.1 
PROTOCOL AMENDMENTS ............................................................................... 21 
11.2 
MANAGEMENT OF PROTOCOL NON COMPLIANCE ...................................... 21 
11.3 
SERIOUS BREACH REQUIREMENTS ............................................................... 22 
11.4 
STUDY RECORD RETENTION ........................................................................... 22 
11.5 
END OF STUDY ................................................................................................... 22 
11.6 
INSURANCE AND INDEMNITY ........................................................................... 22 
12 
REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS ........................ 23 
12.1 
AUTHORSHIP POLICY ........................................................................................ 23 
13 
REFERENCES............................................................................................................... 23 
 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
6 of 27 
 
 
 
LIST OF ABBREVIATIONS 
.  
 
ACCORD 
Academic and Clinical Central Office for Research & Development - Joint office 
for The University of Edinburgh and Lothian Health Board 
AE 
Adverse Event 
AR 
Adverse Reaction 
CI 
Chief Investigator 
CRF 
Case Report Form 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonization 
PI 
Principal Investigator 
QA 
Quality Assurance 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SAR 
Serious Adverse Reaction 
SOP 
Standard Operating Procedure 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
HIV 
Human Influenza Virus 
LHWs 
Lady Health Workers 
BHU 
Basic Health Unit 
RHC 
Rural Health Centre 
GDP 
Gross Domestic Product 
WHO 
World Health Organization 
UNICEF 
United Nations International Children's Emergency Fund 
ARI 
Acute Respiratory Illness 
USAID 
U.S. Agency for International Development 
AKU 
Agha Khan University 
IMCI 
Integrated Management of Childhood Illnesses 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
7 of 27 
 
 
PAIMAN Pakistan Initiative for Mothers and New-borns 
MNCH 
Maternal, Neonatal and Child Health 
SP 
Standardized Patients 
KPK 
Khyber Pakhtun Khwah 
Y 
Yes 
N 
No 
eCRF 
Electronic Case Report Forms 
FLCF 
First Level Care Facility 
DFID 
Department for International Development 
ID 
Identification 
GPS 
Global positioning system 
ISF 
Investigator Site File 
 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
8 of 27 
 
 
1 
INTRODUCTION 
1.1 
BACKGROUND 
Pneumonia is an acute respiratory infection that affects the lungs [1]. In this disease, 
the alveoli (small sacs within lungs) get filled up with pus and fluid making it difficult 
to breathe [1]. In children under five, the most common presenting features of 
pneumonia are cough and /or difficult breathing/ lower chest in-drawing with or 
without fever [1]. Risk factors leading to pneumonia include lack of immunization, air 
pollution, overcrowding, parental smoking, under nutrition, non-hygienic practices, 
and pre-existing illnesses such as HIV and measles [2]. Early pneumonia 
identification and treatment saves lives as in severe cases, it can lead to death [3]. 
Initiating use of antibiotics upon onset of disease can hamper progression whereas 
absence of early intervention can have limited impacts even with intravenous 
antibiotics [4]. 
Despite the availability of standard pneumonia management guidelines and multiple 
global efforts, pneumonia continues to be the leading killer of children under five, 
accounting to around 17% of the total under five deaths globally [5-8]. It has been 
estimated that annually there are around 120 million episodes of pneumonia among 
children with around 14 million progressing to severe episodes. Out of these cases, 
close to 1.3 million children die with 81% of these deaths occurring in children under 
2 years of age [6]. 52% of these deaths occur in the Sub-Saharan region and South 
Asia with main contributions from India, Nigeria, Congo, Pakistan and Afghanistan 
[9].  In Pakistan, pneumonia contributes to 16% of under-five mortality in the country 
having a well-defined yet poorly functional healthcare system [10-12].  
Healthcare in Pakistan is provided through two sectors; Public and private. The 
public sector includes community health workers, referred to as Lady Health Workers 
(LHWs) working under the National Program for Family planning and Primary Health 
Care. It also includes the First Level Care Facilities referred to as Basic Health Units 
(BHUs) and Rural Health Centres(RHCs)  and district/tertiary care hospitals. The 
private sector includes the private clinic and private hospitals. The public sector 
provides healthcare free of cost or with minimal charges whereas the private sector is 
expensive as patients spend out-of-pocket for health service in this sector. This 
accounts to the wide difference of quality of care across both the sectors as the 
public sector is not funded adequately by the government to provide high quality 
services, due to only 2% of the GDP assigned to healthcare.  Irrespective of the 
public and private sector, case management of pneumonia in children under five is 
supposed to be followed uniformly across all sectors as training of the healthcare 
providers is standard across all cadres of care under various programs in the 
country. Despite that fact, the mortality and morbidity rate due to pneumonia in 
children under five remains unchanged in the country. 
 
1.2 
1.2. RATIONALE FOR STUDY 
 
WHO and UNICEF have developed multiple action/ intervention plans to curb 
pneumonia related morbidity and mortality in children under five and based on those 
plans Pakistan has launched multiple national programs. These programs include the 
National ARI control program which was launched in 1989 with the main objectives of 
reducing severity and mortality due to pneumonia and rationalize the use of 
 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
9 of 27 
 
 
 
 antimicrobials and other drugs for treatment of ARI [13]. It was supported by WHO, 
UNICEF and USAID. While the program was ongoing, in 1990, in a National 
workshop on policy related research action plan,  organized by the Ministry of Health, 
the Ministry of Planning and Development and the Aga Khan University (AKU), ARI 
was ranked sixth of fifteen priority areas for national policy-linked research [13]. The 
National ARI Control program continued but WHO soon realized that this disease 
centric narrow approach has not been able to achieve its desired objectives. 
Therefore, it developed a more integrated approach and launched it globally as 
Integrated Management of Childhood Illnesses (IMCI) launched in Pakistan in 
1998[14]. The approach in IMCI focused on improving case management skills of 
health workers, strengthening the health system, and addressing family and 
community practices. Concerns were raised that this is yet another attempt to launch 
a child health intervention vertically. Duplicity was very much evident from the fact 
that ARI existed as an independent program and was also part of the IMCI package. 
Between 2004-2010 PAIMAN, a USAID funded project was undertaken which 
focused on improving the status of maternal and newborn health in 10 districts (19% 
of the national population), which later expanded to 24 districts across the four 
provinces and Azad Jammu and Kashmir in Pakistan. ARI was an important 
component in that project [15]. The national Maternal, Neonatal and Child Health 
program (MNCH) was then launched in 2010 funded mainly by DFID implemented in 
36 districts and ended after 5 years [16]. It was focused on strengthening of 
management and organization mechanism of healthcare delivery systems. Under all 
these programs, selected health care professionals, both community and facility 
based, were trained on WHO standard of ARI case management out of the 18,029 
specialist doctors, 100,131 general physicians, 27,677 working nurses, 6,741 Lady 
Health Visitors and over 95,600 Lady Health Workers. Looking at the unchanged 
mortality statistics, there is a concern that these trainings might have failed to change 
the case management practices within the community. It is perhaps due to the fact 
that the monitoring and evaluation was not a strong point of these programs [15-18]. 
There is limited data within Pakistan which reflects the status of the quality of current 
pneumonia case management practices throughout the three tiered health system 
(primary health facilities, secondary care hospitals, and tertiary care hospitals) as 
well as the private sector. There are a number of approaches which can be used to 
assess standard case management including recall based patient surveys, 
questionnaire surveys of knowledge, prescription/chart analysis and use of 
standardized patients or disguised patients to assess actual practice[19]. 
Standardized patients (SP) are simulated patients who do not suffer from any 
disease per se but pretend to have those symptoms. They present in the designated 
clinics/hospitals and use a pre learnt script to provide a history of illness. The 
healthcare providers are unaware of the simulation of the cases. Upon taking the 
visit, the SP is then interviewed on the entire experience and in certain cases a 
recorder is used to audio record the visit. A disguised patient is one who although 
suffers from a particular disease but acts as a disguised observer as well and works 
the same way as a simulated patient. Considering the use of standardized patients 
(SPs) or disguised patients provides an actual picture of practice, therefore, it has 
been used extensively most recently [20]. This process provides an assessment of 
the practitioners’ knowledge of appropriate care and the actual care delivered, i.e., 
adherence to standard treatment guidelines [21].  
Such an approach in Pakistan can identify current pneumonia case management 
practices across the country because to-date no such study has been conducted in 
this field. The results of this study can help in informing design of future policies and 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
10 of 27 
 
 
 interventions that can in turn assist in 
reducing pneumonia related morbidity and mortality. 
2 
STUDY OBJECTIVES 
2.1 
OBJECTIVES 
2.1.1 Primary Objective 
To assess the standard practices of pneumonia case management at three levels of 
health care; community level, first level care facility and practitioner level, across 
Pakistan. 
To assess the standard practices of pneumonia case management in the private 
sector across Pakistan. 
 
2.1.2 Secondary Objectives 
To determine the differences in pneumonia case management observed across the 
provinces of Pakistan in both public and private sector.  
2.2 
ENDPOINTS 
2.2.1 Primary Endpoint 
1. 
Correct history taking of case of pneumonia 
2. 
Correct examination of case of pneumonia 
3. 
Correct diagnosis of case of pneumonia 
4. 
Correct treatment of case of pneumonia 
 
3 
STUDY DESIGN 
3.1 
Methodology: 
This will be a qualitative study which will be conducted through participant 
observations over a period of 13 months across randomly selected sites in four 
provinces of Pakistan in addition to the federal capital. The provinces are 
Baluchistan, Khyber Pakhtun Khwah (KPK), Punjab and Sindh.  
After obtaining ethical clearance, an observation tool will be developed based on 
standard WHO guidelines and input from field experts. This tool will be pretested 
upon finalization. At the same time an advisory committee will also be formulated 
composed of expert paediatricians and public health professionals who will provide 
their input into the implementation protocol and the tool. Once the tool is finalized 
trainings will be conducted on the tool and then observations will be conducted. 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
11 of 27 
 
 
 
 
3.2 
Observation Sites: 
 
Observations sites will be randomly selected from each of the four provinces and the 
capital through our specialized sampling software. Upon site selection, observations 
will be made across the following levels of healthcare: community level, first level 
care facility (FLCF) and practitioner level both in the public and private sector. The 
community level observations will include observation of the pneumonia case 
management by the LHWs. LHWs are the primary care givers at the community level  
who cover around 60% of Pakistan. Their basic duties include education, counselling 
and basic management of the common maternal and child ailments. Each LHW 
covers around 100-120 household and visits each household once a month. The 
observations will be made either at the health house of the LHW or she will be 
requested to visit the household of the disguised patient.  
The FLCF level will include observations made at the primary health care facilities 
which are the Basic Health Units (BHUs) and Rural Health Centres (RHCs). A basic 
health unit is located within a union council which is the smallest administrative unit in 
the Pakistani administrative system. Each basic health unit covers a catchment area 
of 25,000 households. Pakistan has around 5,290 BHUs although not all are 
functional. Services provided at BHU are promotive, preventive, curative and referral 
.LHWs refer patients usually to BHUs. RHCs provide in-patient service as compared 
to BHUs. They usually have 10-20 beds and cover a catchment area of 100,000 
people. The RHC provides promotive, preventive, curative, diagnostics and referral 
services apart from the in-patient services. It also provides clinical, logistical and 
managerial support to the BHUs, LHWs, and dispensaries that fall within its 
geographical limits. RHC also provides medico-legal, basic surgical, dental and 
ambulance services. There are around 552 RHCs in Pakistan. 
 The practitioner level observations will include those of practitioners at both the 
private and public sector. The public sector will include observations made in 
outpatient departments of selected tertiary care hospitals across the study sites. 
Observations made at the private practitioner level will include selected solitary 
private clinics or clinics within private hospitals. The community and FLCF level will 
represent practices within the rural community and the practitioner level will represent 
practices within the semi urban/urban communities.  
3.3 
Type of Observations: 
These will be participant, structured, disguised observations which will be done using 
a validated observation tool based on standard WHO pneumonia case management 
guidelines, developed in close collaboration with experts from University of 
Edinburgh. This tool will be pretested and translated into Urdu. 
3.4 
Data Collectors: 
A team of data collectors, who will be healthcare professionals, will be trained on 
appropriate administration of the observation tool upon recruitment.  The training will 
also include an introduction to pneumonia, its signs and symptoms, diagnosis and 
management according to WHO guidelines. A 3 day interactive training workshop will 
be conducted whereby mock excesses will also be conducted.  A total of three 
trainings will be conducted whereby data collectors from Islamabad (capital), Punjab  

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
12 of 27 
 
 
and KPK will have one training as their 
participants can be managed to be brought in one location due to close proximity. 
Sindh and Baluchistan participants will have two separate trainings.  
3.5 
Recruitment of Disguised Patients’ Caregiver and Conduction of 
Observations: 
Each data collector will be provided a pre-defined list of addresses whereby the 
observations will be made. He/she will go to the location and will search the nearby 
community for cases of pneumonia in children under five. Once the cases have been 
identified, their caregivers will be sought. These caregivers are the primary 
individuals providing direct care to the child. Usually, these are the mothers, fathers, 
grandmothers or guardians of the child. They will explained the purpose of the study 
and will be requested to participate in the study by acting as disguised caregivers to 
accompany the data collector to the health facilities and upon agreement will sign a 
consent form. This means that they will disguise as an acquaintance of the data 
collector who will take them to the healthcare professional to be observed. They will 
take the ill child along, give the history of that child to the healthcare professional and 
answer any relevant questions which will be asked by him/her and get the child 
examined and treated. In the meantime, the data collector will make the relevant 
observations based on the observation tool which will be filled after the visit.  The 
data collector will not reveal that he/she is a healthcare professional. Additionally, the 
data collector will also take an audio recorder along to record the entire conversation 
which will help in filling up the observation tool later and also validate the visit. Once 
the visit is completed, the data collector will take the caregiver back to their premises 
and fill up the observation tool in tablets within one hour of the visit. 
3.6 
Project work-plan: 
PROJECT ACTIVITIES 
YEAR 1(Months) 
YEAR 2 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 11 12 
1 
Ethical Clearance 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Staff Recruitment 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Tool Development 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Inception Meetings for 
development of 
implementation 
strategies 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Pretesting and 
Finalization of the tool 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
Data Collections 
(Trainings, identification 
of study site/centers, 
observations) 
 
 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
Data Analysis & 
Reporting 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
13 of 27 
 
 
4 
STUDY POPULATION 
4.1 
NUMBER OF PARTICIPANTS 
 
Two data collectors per province will be recruited to make the observations making a 
total of 10 data collectors for all the locations. Additionally, one caregiver per 
observation will be recruited by the data collectors to accompany them. Meaning 160 
caregivers will be recruited. This is to avoid inconvenience to the caregiver and their 
affected under five children. In case, a community is encountered whereby the cases 
of pneumonia are very few, then the same caregiver will be accompanied for 
observation of an LHW, BHU and RHC of that locality as these facilities are closely 
located. If despite this practice, number of observations are not achievable per site 
than an additional site will be provided to the data collector to visit. 
 
4.2 
INCLUSION CRITERIA 
4.2.1 INCLUSION CRITERIA OF DISGUISED CAREGIVERS: 
 
Caregivers of children under five years of age. These are those individuals 
who provide direct care to the child. These could either be a mother, father, 
grandmother or guardian. 
 
The child under five under that caregiver’s household must have symptoms of 
pneumonia/severe pneumonia as indicated in section 6.1 
 
Caregivers consenting to be a part of the study. 
 
4.2.2 INCLUSION CRITERIA OF HEALTHCARE PROFESSIONALS UNDER 
OBSERVATION 
4.2.2.1 LHWs: 
 
Those who have been practicing as LHWs for more than one year as 
identified by talking to the community. 
 
Those who belong to the catchment area of the selected study sites 
 
4.2.2.2 BHUs: 
Functional BHUs with at least one licensed healthcare provider. 
 
4.2.2.3 RHC: 
Functional RHCs with at least one licensed healthcare provider. 
 
4.2.2.4 Public Practitioners: 
Paediatricians working in a government tertiary healthcare facility as a full time 
employee. 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
14 of 27 
 
 
In case the facility/location does not have 
specialist paediatricians, then general physicians working full time within that facility.  
 
4.2.2.5  
4.2.2.6 Private Practitioners: 
Full time/part time  private paediatric practitioners working in either their private 
clinics or in private hospitals. 
In case the facility/location does not have specialist paediatricians, then general 
physicians working within that facility. 
4.2.3 EXCLUSION CRITERIA 
4.2.3.1 EXCLUSION CRITERIA FOR DISGUISED CAREGIVERS: 
Caregivers of children under five suffering from comorbidity with pneumonia. 
 
4.2.3.2 EXCLSUIONCRITERIA FOR HEALTHCARE PROFESSIONALS UNDER 
OBSERVATION 
BHUs or RHCs run by non -licensed healthcare professionals as there are certain 
locations whereby due to lack of licensed healthcare professional’s facility 
technicians tend to attend to the patients based on their experience. 
 
5 
PARTICIPANT SELECTION AND ENROLMENT 
5.1 
IDENTIFYING PARTICIPANTS 
 
Data collectors will be licensed healthcare professionals (doctors or nurses) with at 
least one 6-12 months of experience working in the field of paediatrics. They will be 
recruited after interviews with the selection team (Investigators and project manager) 
upon giving advertisements for posts of data collectors. 
For selection of the LHWs to observe them, a randomly selected rural community 
through our computerized system will be generated from where the caregivers will be 
selected to act as disguised ones. Additionally, a complete list of functional RHCs 
and BHUs will be obtained from the corresponding district health office (DHO) which 
is the administrative authority for these centres. From that list, four BHUs and four 
RHCs per province will be randomly selected using a lottery method. For sampling of 
the practitioners, a list of tertiary care facilities will be obtained from the health 
department of each province and a list of private clinic and private hospitals from 
their corresponding directories. These lists will be used to randomly select five 
practitioners each from public and private sector. Once the BHU, RHC, private and 
public practitioner sites have been selected, disguised caregiver will be recruited and 
observations made. In case a healthcare provider is not available or if a facility has 
been closed down, the caregiver will be provided an alternate address.  
 
5.2 
CONSENTING PARTICIPANTS 
A written and signed consent form will be obtained from the recruited disguised 
caregivers of children under five. A detailed consent form will be developed and will 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
15 of 27 
 
 
be translated into Urdu. It will include 
statements on voluntary participation with refusal  to continue at any point of the 
study with no penalty to the participants .Any queries of the caregivers regarding the 
study will be resolved prior to signing the  
 
consent form. Those caregivers who will be able to read will be given the opportunity 
to do so and sign the form and those who will not be able to read will have the 
consent form read out to them by the data collector in the presence of a witness and 
thereafter have their thumb impression on the form.  The witness will be any other 
household member over the age of 18 years. The witness will also be asked to sign 
the form in such a case.  In case a caregiver accepts to be a part of the study but 
refuses to sign the document, he/she will be requested to have a decision maker of 
the household to sign the form.  
No consent will be taken from the observed LHWs and healthcare providers of BHUs, 
RHCs, private and public healthcare facilities as we shall be conducting disguised 
observations. This is because if they are taken consent from, prior to the study, they 
will become cautious and chances are that the observations will not reflect their 
actual practice as they will change their practices. And considering there will be no 
harm generated on the part of the researchers and recruited caregivers therefore the 
benefit of not taking the consent outweighs the risk of taking consent.  
5.2.1 Withdrawal of Study Participants 
 
Caregivers will be free to withdraw from the study at any point in time or he/she can 
be withdrawn from the study by the investigator in case it is felt that the caregiver is 
not able to contribute to the observation making effectively. In any case, if a 
withdrawal occurs, the reason will be mentioned in the case report form.  Efforts will 
however be made to ensure maximum retention of participants by providing them 
financial incentives (that will also cover the transportation and consultation costs).   
6 
STUDY ASSESSMENTS 
6.1 
STUDY ASSESSMENTS 
The following assessments will be done while doing one time observations using the 
observation tool (Annex A): 
1. 
History taking: (Did the healthcare provider inquire about the presenting 
complaints and the predisposing factors which might have led to the 
complaints) 
 Cough (presenting complaint) 
 Fast breathing (presenting complaint) 
 Laboured breathing (presenting complaint) 
 Fever (presenting complaint) 
 Immunization history (Predisposing factor) 
 Breastfeeding history  (Predisposing factor) 
 Overcrowding  (Predisposing factor) 
 Parental smoking  (Predisposing factor) 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
16 of 27 
 
 
 Air pollution  (Predisposing 
factor) 
 Nutritional history (Predisposing factor) 
 Hygienic practices  (Predisposing factor) 
 Family history of HIV  (Predisposing factor) 
2. 
Examination: 
 Temperature (For fever) 
 Respiratory rate for 1 minute (For fast breathing) 
 Pallor (for anemia indicating malnutrition) 
 Skin rash (for measles) 
 Lower chest indrawing  
 Ausculation for wheeze and/or crepts 
3. 
Diagnosis: 
 Cough with no fast breathing/chest in drawing: No pneumonia 
 With fast breathing  and/or chest in drawing : Pneumonia 
 Pneumonia with any danger signs : Severe Pneumonia 
 
4. 
Management: 
 No Pneumonia: Symptomatic treatment 
 Pneumonia: Oral amoxicillin 40mg/kg/dose twice daily  for three days 
 Severe Pneumonia: For LHWs: First dose of oral antibiotic 
(amoxicillin) and referral to health facility and for health facilities , 
parenteral ampicillin 50mg/kg IV 6 hourly for five days along with 
gentamicin 7.5mg/kg/ IM or IV for five days. 
7 
DATA COLLECTION 
Data will be collected in the form of observations and then entered upon leaving the 
facility within one hour of the observation. For the purpose of ensuring accurate data 
entry, the data collector will use the audio recording and the prescription, the copy of 
which will be kept with them.  
A detailed checklist will be used to assess the adherence of the healthcare providers 
to standard guidelines. This checklist will include all aspects covered in section 6.1: 
 History taking 
 Examination 
 Diagnosis 
 Treatment/management  
These areas encompass the guidelines of essential care for pneumonia. Here 
essential care refers to the questions providers must ask the caregiver and 
examinations provider must conduct to accomplish correct diagnosis. 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
17 of 27 
 
 
7.1 
Source Data Documentation 
The checklist will be developed in the form of a structured Urdu questionnaire which 
will be pretested. It will then be transformed into a soft version using our online 
questionnaire development dashboard. The questionnaire will then be installed into 
tablets.  
Data will be collected in tablets to avoid errors of skips and logic. It will have an 
essential component of not accepting incomplete forms which will ensure that 
complete data is being collected on site. This data will be sent to our headquarters 
from all over the country via online server. This will ensure rapid access to data and 
data confidentiality as it will only be accessed by our data manager located in the 
headquarters through a password restricted data dashboard.  
Each data collector will be provided a tablet, its charging cable and a power-bank to 
ensure that the tablet is charged all the time. In case any technical error is faced in 
any of the tablets, he/she will inform the supervisor who will arrange an alternate 
tablet to enter data. Additionally, the data collector will also have extra hard copies of 
the questionnaires to enter data in case a technical error occurs in the tablet and if 
there is a delay in delivery of an alternate one. These hard copies will be sent to the 
project manager via courier on the same of completion of data collection to avoid 
delay in data entry. The data collector will also maintain a contact sheet which will 
include information on the location, date and time of the observation, name of the 
child and caregiver, phone number, observed health professional’s name and level of 
health facility/care. 
In order to ensure that data is provided timely, the data collector will be asserted on 
sending the entered data as soon as the form in the tablet is filled. Therefore, each 
tablet will have a network enabled sim with an internet connectivity which will ensure 
that the data is transferred timely. In case there is decreased network coverage, the 
data collector will send the form as soon as an area of strong connectivity is reached. 
Additionally, if he/she reaches a location which has Wi-Fi connectivity then it will be 
used to send the forms. In case a tablet gets lost as soon as the observation is 
made, then the data collector will inform the supervisor who will arrange an alternate 
tablet and will check whether all data has reached the server or not. In case partial 
data is obtained, then those cases will be identified and the data collector will be 
asked to fill another observation form (using the recordings and recall)  in the 
replaced tablet and ensure that data has been obtained by the supervisor. Tablets 
will be password enabled such that no one can gain access into the data except for 
the data collector. Considering all data will be sent to the server immediately after 
collection and will not be saved within the tablets, therefore even on being lost no 
one will be able to access the data. 
 
7.2 
Case Report Forms 
.  
Electronic CRFS (eCRFs) will be used for improved data quality, avoidance of 
manual data entry errors and confidentiality etc. It will include the following key 
points: 
 
Protocol ID 
 
Site code 
 
Subject ID 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
18 of 27 
 
 
 
Respondent Initials 
 
Respondent demographics (age, gender, educational level) 
 
Age of the youngest child 
 
Phone number  
 
Alternate phone number 
 
Prescription picture 
 
GPS location 
 
Date of visit 
 
Place of visit (LHW/BHU/RHC/Private clinic/Public tertiary hospital) 
 
Name of the healthcare provider 
 
Data collector initials/ID 
 
Time spent in consultation 
 
Visit checklist (as indicated by section 6.1) 
 
Reason of withdrawal from the study 
 
8 
STATISTICS AND DATA ANALYSIS 
8.1 
SAMPLE SIZE CALCULATION 
Considering this is a qualitative study therefore an approximate estimate of the 
sample will be provided. Event sampling will be employed whereby a pre-defined 
checklist of behaviours will be developed to record all occurrences. The sample size 
is based on point of theoretical saturation although we plan to conduct at least 32 
observations from each of the four provinces and the federal capital (LHWS; 6, BHU 
Medical officer; 4, RHC medical officer; 4, private practitioner; 9, and public 
practitioner; 9). Thus a minimum of 160 observations will be conducted. Data will be 
collected over a period of six months.  
8.2 
PROPOSED ANALYSES 
Behavioural coding will be employed to prepare the data for analysis. This means 
that a predetermined code will be given to each variable against each category of 
observations (History, examination, diagnosis and treatment). Each variable will be 
answered as ―Y’ meaning yes, the task was accomplished and ―N‖ meaning no, the 
task was not accomplished (section 6.1). Additionally, the responses will be labelled 
as correct, partially correct and incorrect for history taking and examination. If on 
history taking, the healthcare provider asks questions on all variables, then the 
responses will be labelled as correct and if any one variable is missed then the 
response is indicated as partially correct and in case less than 50% of the variables 
are asked about, then the responses will be labelled as incorrect. The same labels 
will be specified for the examination. In case of diagnosis and treatment, the labels 
will be specified as correct and incorrect only as there is no partially correct diagnosis 
and treatment regimens. The overall frequencies and percentages of these 
responses will be calculated and cross tabulated across the provinces.  

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
19 of 27 
 
 
 
9 
OVERSIGHT ARRANGEMENTS 
9.1 
INSPECTION OF RECORDS 
Investigators and institutions involved in the study permit trial related monitoring and 
audits on behalf of the sponsor, REC review, and regulatory inspection(s).  In the 
event of audit or monitoring, the Investigator agrees to allow the representatives of 
the sponsor direct access to all study records and source documentation. In the 
event of regulatory inspection, the Investigator agrees to allow inspectors direct 
access to all study records and source documentation. 
9.2 
RISK ASSESSMENT 
A study specific risk assessment will be performed by representatives of the co-
sponsors, ACCORD monitors and the QA group, in accordance with ACCORD 
governance and sponsorship SOPs. Input will be sought from the Chief Investigator 
or designee. The outcomes of the risk assessment will form the basis of the 
monitoring plans and audit plans. The risk assessment outcomes will also indicate 
which risk adaptions (delete if no adaptations were possible) could be incorporated 
into to trial design. 
9.3 
STUDY MONITORING AND AUDIT 
The ACCORD Sponsor Representative will assess the study to determine if an 
independent risk assessment is required.  If required, the independent risk 
assessment will be carried out by the ACCORD Quality Assurance Group to 
determine if an audit should be performed before/during/after the study. 
 
Risk assessment, if required, will determine if audit by the ACCORD QA group is 
required. Should audit be required, details will be captured in an audit plan. Audit of 
Investigator sites, study management activities and study collaborative units, facilities 
and 3rd parties may be performed. 
10 
GOOD CLINICAL PRACTICE 
10.1 ETHICAL CONDUCT 
The study will be conducted in accordance with the principles of the International 
Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH 
GCP). 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
20 of 27 
 
 
Before the study can commence, all 
required approvals will be obtained and any conditions of approvals will be met. 
10.2 INVESTIGATOR RESPONSIBILITIES 
The Investigator is responsible for the overall conduct of the study at the site and 
compliance with the protocol and any protocol amendments.  In accordance with the 
principles of ICH GCP, the following areas listed in this section are also the 
responsibility of the Investigator.  Responsibilities may be delegated to an 
appropriate member of study site staff.   
10.2.1 Informed Consent 
The Investigator is responsible for ensuring informed consent is obtained before any 
protocol specific procedures are carried out.  
Participant Information and Informed Consent Forms will be provided. The oral 
explanation to the participant will be performed by the Investigator or qualified 
delegated person, and will cover all the elements specified in the Participant 
Information Sheet and Consent Form. 
The participant will be given every opportunity to clarify any points they do not 
understand and, if necessary, ask for more information. The participant will be given 
sufficient time to consider the information provided.  It will be emphasized that the 
participant may withdraw their consent to participate at any time without loss of 
benefits to which they otherwise would be entitled. 
The participant will be informed and agree to their records being inspected by 
regulatory authorities and representatives of the sponsor(s). 
The Investigator or delegated member of the trial team and the participant will sign 
and date the Informed Consent Form(s) to confirm that consent has been obtained.  
The participant will receive a copy of this document and a copy filed in the 
Investigator Site File (ISF). 
10.2.2 Study Site Staff 
The Investigator is familiar with the protocol and the study requirements.  It will be the 
Investigator’s responsibility to ensure that all staff assisting with the study is 
adequately informed about the protocol and their trial related duties. 
10.2.3 Data Recording 
The Principal Investigator is responsible for the quality of the data recorded in the 
CRF at each Investigator Site.  
10.2.4  Investigator Documentation 
The Principal Investigator will ensure that the required documentation is available in 
local Investigator Site files ISFs.  
10.2.5 Confidentiality 
All evaluation forms, reports, and other records will be identified in a manner 
designed to maintain participant confidentiality.  All records will be kept in a secure 
storage area with limited access.  Clinical information will not be released without the 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
21 of 27 
 
 
written permission of the participant.  The 
Investigator and study site staff involved with this study will not disclose or use for 
any purpose other than performance of the study, any data, record, or other 
unpublished, confidential information disclosed to those individuals for the purpose of 
the study.  Prior written agreement from the sponsor or its designee must be 
obtained for the disclosure of any said confidential information to other parties. 
10.2.6 Data Protection 
All Investigators and study site staff involved with this study will comply with the 
requirements of the Data Protection Act 1998 with regard to the collection, storage, 
processing and disclosure of personal information and will uphold the Act’s core 
principles. Access to collated participant data will be restricted to individuals from the 
research team treating the participants, representatives of the sponsor(s) and 
representatives of regulatory authorities. 
Computers used to collate the data will have limited access measures via user 
names and passwords. 
Published results will not contain any personal data that could allow identification of 
individual participants. 
11 
STUDY CONDUCT RESPONSIBILITIES 
11.1 PROTOCOL AMENDMENTS 
Any changes in research activity, except those necessary to remove an apparent, 
immediate hazard to the participant in the case of an urgent safety measure, will be 
reviewed and approved by the Chief Investigator.   
Amendments will be submitted to a sponsor representative for review and 
authorisation before being submitted in writing to the appropriate REC, and local 
R&D for approval prior to participants being enrolled into an amended protocol. 
11.2 MANAGEMENT OF PROTOCOL NON COMPLIANCE 
Prospective protocol deviations, i.e. protocol waivers, will not be approved by the 
sponsors and therefore will not be implemented, except where necessary to eliminate 
an immediate hazard to study participants. If this necessitates a subsequent protocol 
amendment, this should be submitted to the REC, and local R&D for review and 
approval if appropriate. 
Protocol deviations will be recorded in a protocol deviation log and logs will be 
submitted to the sponsors every 3 months. Each protocol violation will be reported to 
the sponsor within 3 days of becoming aware of the violation.  All protocol deviation 
logs and violation forms should be emailed to QA@accord.scot 
Deviations and violations are non-compliance events discovered after the event has 
occurred.  Deviation logs will be maintained for each site in multi-centre studies.  An 
alternative frequency of deviation log submission to the sponsors may be agreed in 
writing with the sponsors. 
 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
22 of 27 
 
 
11.3 SERIOUS BREACH 
REQUIREMENTS 
A serious breach is a breach which is likely to effect to a significant degree: 
(a) the safety or physical or mental integrity of the participants of the trial; or 
(b) the scientific value of the trial. 
If a potential serious breach is identified by the Chief investigator, Principal 
Investigator or delegates, the co-sponsors (seriousbreach@accord.scot) will be 
notified within 24 hours.  It is the responsibility of the co-sponsors to assess the 
impact of the breach on the scientific value of the trial, to determine whether the 
incident constitutes a serious breach and report to research ethics committees as 
necessary.  
11.4 STUDY RECORD RETENTION 
All study documentation will be kept for a minimum of 3 years from the protocol 
defined end of study point. When the minimum retention period has elapsed, study 
documentation will not be destroyed without permission from the sponsor. All data 
will be stored in both hard and soft files. Hard files will include audio recording DVDs, 
any notes, consent forms and incentive acceptance sheets. This data will be saved in 
locked cupboards in the office premises with the key kept safe with the project 
manager. Soft files will include audio recordings, exel sheet observation data, 
analysis results and report. These files will be saved in password enables computer 
system with limited access. 
 
11.5 END OF STUDY 
The end of study is defined as the submission of the study report.   
The Investigators or the co-sponsor(s) have the right at any time to terminate the 
study for clinical or administrative reasons.  
The end of the study will be reported to the REC, and R+D Office(s) and co-sponsors 
within 90 days, or 15 days if the study is terminated prematurely. The Investigators 
will inform participants of the premature study closure and ensure that the 
appropriate follow up is arranged for all participants involved. End of study 
notification will be reported to the co-sponsors via email to resgov@accord.scot.  
A summary report of the study will be provided to the REC within 1 year of the end of 
the study. 
 
11.6 INSURANCE AND INDEMNITY 
The co-sponsors are responsible for ensuring proper provision has been made for 
insurance or indemnity to cover their liability and the liability of the Chief Investigator 
and staff. 
The following arrangements are in place to fulfil the co-sponsors' responsibilities: 
 
The Protocol has been designed by the Chief Investigator and researchers 
employed by the University and collaborators.  The University has insurance 
in place (which includes no-fault compensation) for negligent harm caused 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
23 of 27 
 
 
by poor protocol design by the 
Chief Investigator and researchers employed by the University. 
 
Sites participating in the study will be liable for clinical negligence and other 
negligent harm to individuals taking part in the study and covered by the 
duty of care owed to them by the sites concerned.  The co-sponsors require 
individual sites participating in the study to arrange for their own insurance 
or indemnity in respect of these liabilities. 
 
Sites which are part of the United Kingdom's National Health Service will 
have the benefit of NHS Indemnity. 
 
Sites out with the United Kingdom will be responsible for arranging their own 
indemnity or insurance for their participation in the study, as well as for 
compliance with local law applicable to their participation in the study. 
12 
REPORTING, PUBLICATIONS AND NOTIFICATION OF 
RESULTS 
12.1 AUTHORSHIP POLICY 
Ownership of the data arising from this study resides with the study team.   
13 
REFERENCES 
1. World Health Organization. (2016). Pneumonia. Available at: 
http://www.who.int/mediacentre/factsheets/fs331/en/ 
2. Rudan, I., O’brien, K. L., Nair, H., Liu, L., Theodoratou, E., Qazi, S., ... & Child 
Health Epidemiology Reference Group. (2013). Epidemiology and etiology of 
childhood pneumonia in 2010: estimates of incidence, severe morbidity, 
mortality, underlying risk factors and causative pathogens for 192 
countries. Journal of global health, 3(1). 
3. Kallander, K., Burgess, D. H., & Qazi, S. A. (2016). Early identification and 
treatment of pneumonia: a call to action. The Lancet. Global Health, 4(1), 
e12. 
4. Ghimire M, Pradhan YV, Maskey MK. Community-based interventions for 
diarrhoeal diseases and acute respiratory infections in Nepal. Bull World 
Health Organ. 2010;88:216–221 
 
5. Liu L, Johnson HL, Cousens S, et al. Global, regional, and national causes of 
child mortality: an updated systematic analysis for 2010 with time trends 
since 2000. Lancet 2012; 379: 2151–61. 
6. Walker, C. L. F., Rudan, I., Liu, L., Nair, H., Theodoratou, E., Bhutta, Z. A., ... 
& Black, R. E. (2013). Global burden of childhood pneumonia and 
diarrhoea. The Lancet, 381(9875), 1405-1416. 
7. Rabbani, F., Mukhi, A. A. A., Perveen, S., Gul, X., Iqbal, S. P., Qazi, S. A., & 
Aftab, W. (2014). Improving community case management of diarrhoea and 
pneumonia in district Badin, Pakistan through a cluster randomised study—
the NIGRAAN trial protocol. Implementation Science, 9(1), 186.. 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
24 of 27 
 
 
8. Das, J. K., & Salam, R. A. (2016). 
Improving Access and Reducing Childhood Deaths due to Pneumonia. 
9. Thomas, K. (2016). Global burden of pneumonia. International Journal of 
Infectious Diseases, 45, 1. 
10. National Institute of Population Studies, Macro International (2008). Pakistan 
Demographic and Health Survey 2006-07. Islamabad (Pakistan): National 
Institute of Population Studies, Macro International. 
 
11. 
National Institute of Population Studies, Macro International (2013). Pakistan 
Demographic and Health Survey 2012-13. Islamabad (Pakistan): National 
Institute of Population Studies, Macro International. 
 
12. Punjani, N. S., Shams, S., & Bhanji, S. M. (2014). Analysis of health care 
delivery systems: pakistan versus united states. Int J Endorsing Health Sci 
Res, 2(1), 38-41. 
 
13. David R. Marsh Inam-ul-Haq, Asma Fozia Qureshi, Qayyum Noorani, 
Rozona Noorali. (1993). Childhood acute respiratory infection in Pakistan. 
JPMA,pg 14-20. 
14. World Health Organization. (2014).Implementation of IMCI in Pakistan. 
Availabl at: 
http://www.emro.who.int/child-health/strategy-implementation/implementation-
of-imci-in-pakistan.html 
15. USAID. (2008). Mid-term evaluation of the usaid/pakistan maternal, newborn 
and child health program(PAIMAN Project). Available at: 
http://pdf.usaid.gov/pdf_docs/Pdacm873.pdf 
16. USAID. (2010). Usaid/pakistan: maternal newborn and child health program 
final evaluation.  
Available at: 
http://ghpro.dexisonline.com/sites/default/files/resources/legacy/sites/default/fi
les/1.394%20Pakistan%20Maternal%20Newborn%20and%20Child%20Healt
h%20Program%20%28Final%20Evaluation%29%20Report%20-%20508.pdf 
17. Technical Resource Facility .(2017). Pakistan National Maternal and Child 
Health Programme Mid Term Evaluation. Available at: 
http://www.trfpakistan.org/Portals/18/Resources/1.%20MNCH%20Evaluation.
pdf?ver=2017-03-22-181031-467 
18. Habib Ahmed Afsar, Muhammad Younus. (2002). Recommendations to 
strengthen the role of lady health workers in the national program for family 
planning and primary health care in  

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
25 of 27 
 
 
Pakistan: the health workers 
perspective. Available at:  
http://ayubmed.edu.pk/JAMC/PAST/17-1/HabibYounus.html 
19. Das, J., Kwan, A., Daniels, B., Satyanarayana, S., Subbaraman, R., 
Bergkvist, S.,& Pai, M. (2015). Use of standardised patients to assess quality 
of tuberculosis care: a pilot, cross-sectional study. The Lancet infectious 
diseases, 15(11), 1305-1313. 
20. Dholakia, Y., Mistry, N., Lobo, E., & Rangan, S. (2016). Use of standardised 
patients to assess quality of tuberculosis care. The Lancet Infectious 
Diseases, 16(1), 23. 
21. Mohanan, M., Vera-Hernández, M., Das, V., Giardili, S., Goldhaber-Fiebert, 
J. D., Rabin, T. L., ... & Seth, A. (2015). The know-do gap in quality of health 
care for childhood diarrhea and pneumonia in rural India. JAMA 
pediatrics, 169(4), 349-357. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
26 of 27 
 
 
 
 
 
 
 
ANNEX B- PARTICIPANT INFORMATION SHEET/CONTACT SHEET 
 
 
*”Professional observed” code: 
LHW = 1 
BHU = 2 
RHC = 3 
Public practitioner = 4 
Private practitioner = 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
S
r. 
N
o 
LOCA
TION 
Na
me 
of 
Chil
d 
und
er 
five 
Ag
e 
of 
chil
d 
Name 
of 
caregi
ver 
Addre
ss of 
child 
Phone 
numbe
r of 
caregi
ver 
Consented/
Did not 
consent 
Professio
nal 
observed 
(Enter 
code)* 
Name 
of the 
facility 
Contact Result 
(observation 
accomplished/not 
acched 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
27 of 27 
 
 
 
 
ANNEX C- OBSERVATION TOOL 
 
CLINICAL OBSERVATIONS (were the following 
parameters followed) 
 
1. 
History taking  
Y/N 
Cough 
 
Fast breathing 
 
Laboured breathing 
 
Fever 
 
Immunization 
 
Breastfeeding history 
 
Overcrowding 
 
Parental smoking/Household member smoking 
 
Air pollution (indoor cooking stove) 
 
Nutritional history 
 
Hygienic practices 
 
Family history of HIV 
 
2. 
Examination (Did the healthcare provider 
make the following necessary examinations 
apart from others) 
 
Temperature  
 
Respiratory rate counting for 1 minute 
 
Pallor  
 
Skin rash  
 
Examine lower chest in drawing 
 
Auscultate for wheeze or crepts 
 
3. 
Diagnosis (Did the healthcare provider make 
the 
correct 
diagnosis 
based 
on 
WHO 
guidelines) 
 
Cough with no fast breathing/chest in drawing: No 
pneumonia 
 
With fast breathing  and/or chest in drawing : 
Pneumonia 
 
Pneumonia with any danger signs : Severe 
Pneumonia 
 
4. 
Management (Did the healthcare provider 
manage the case per the guidelines) 
 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
28 of 27 
 
 
No Pneumonia: Symptomatic treatment 
 
Pneumonia: Oral amoxicillin 40mg/kg/dose twice 
daily  for three days 
 
Severe Pneumonia:  
For LHWs: First dose of oral antibiotic (amoxicillin) 
and referral to health facility and  
For BHUs: First dose of oral antibiotic (amoxicillin) 
and referral to rural health centre or tertiary care 
hospital 
For health facilities (public and private) : Parenteral 
ampicillin 50mg/kg IV 6 hourly for five days along 
with gentamicin 7.5mg/kg/ IM or IV for five days. 
 
 
SCORE: (Count the total number of Y and enter the value in the table 
below) 
ACTIVITY OBSERVED 
“ Y” SCORED 
TOTAL 
History Taking 
 
12 
Examination 
 
6 
Diagnosis 
 
1 
Management  
 
1 
 
OBSERVATION RESULT*: 
ACTIVITY OBSERVED 
SELECT THE APPRORIATE RESPONSE 
History Taking 
Correct/partially correct/ incorrect 
Examination 
Correct/partially correct/ incorrect 
Diagnosis 
Correct/ Incorrect 
Management  
Correct/ Incorrect 
 
*RESULT CRITERIA: 
For history taking: 
Correct: Score of 12 
Partially correct: Score of <12 but >6 
Incorrect: Score of <6 
 
For Examination: 
Correct: Score of 6 
Partially correct: Score of <6 but >3 
Incorrect: Score of <3 
 
For Diagnosis: 
Correct: 1 
Incorrect: 0 

<PCM-PK>                                      
<V1-12112017> 
 
CR007-T02 v1.0 
29 of 27 
 
 
 
For Management: 
Correct: 1 
Incorrect: 0 
 
Any other pertinent information: 
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________