CHAPTER FIVE

STRUCTURED OBSERVATION

Structured Observation is potentially one of the most

useful field methods in drug use studies. This
chapter is devoted to a brief overview of the method
and a detailed description of the main steps involved
in conducting an observational drug use study.

5.10: Overview

5.11: What is Structured Observation

Observation is a technique that involves directly observing behaviour with

the purpose of describing it. To observe means to examine an object, or an
individual, or group of people, or an event with all of the senses. Recording
of observations may take many forms, from simple and casual to exact and
sophisticated. For example, an observer may observe an event and then
complete a checklist on whether or not key behaviours occurred. Or the
observer may write notes on everything that happens in his or her presence.
More sophisticated recording may involve audio-visual devices.

The technique can be classified into participant and non-participant

observations. Participant observation takes place when an observer
participates with the people and in the events he or she is observing. Non-
participant observation occurs when an observer observes events without
interacting with the person(s) being observed.

Non-participant observation may further be classified as structured or

unstructured. The aim of unstructured observation is to observe and record
behaviour in a holistic way without the use of a pre-determined guide.
Structured observation, on the other hand, refers to a technique in which an
observer observes events using a guide that has been planned in advance.
The focus of this chapter is on structured observation.

Events in structured observation are recorded according to an observation

guide. The observer is not involved in the activities being observed, but
records them as inconspicuously as possible. However, it must be pointed
out that the presence of even a "neutral" and non-interacting observer may
influence the behaviors of the person(s) or events being observed.

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Although structured observation may seem simple, obtaining useful data
requires reliable observers, an informative observational guide, and the
cooperation of those being observed. This presents the issue of bias in the
observation process in both the observer and the person being observed.
The observer's bias includes his or her subjective judgment regarding events
being observed. For example, if the observer has a positive attitude
towards the person being observed, he or she may record positive
observations and ignore negative behaviours. To overcome this bias, an
observer must be trained to be neutral and non-judgmental towards persons
being observed.

From the perspective of the person being observed, bias occurs when the
person being observed alters his or her usual performance of an activity in
order to impress the observer. In a diarrhoea study in one country for
example, when prescribers were informed that the observation concerned
diarrhea, they examined infants who had diarrhea longer than they did other
patients. The examination took about 5-7 minutes for diarrhea cases,
whereas the examination for other patients took only 1-2 minutes.

Surrogate Patient Technique

To overcome certain problems of bias, some studies employ the use of

surrogate patients. In this technique a client suitably dressed and prepared
presents at a health facility or dispensing/drug sale outlet with a complaint
requiring treatment. The complaint may concern the same individual or the
treatment may be for another person, such as a child. When combined with
direct interviews, the method affords an investigator the opportunity to
contrast what providers say they do with what they actually do. The reasons
for the discrepancies can then be ascertained using in-depth interviews or
focus groups.

5.12: Use of Structured Observation in Drug Use Studies

In drug use studies structured observation can be used independently or as

supplement to other methods. As an independent method, it can be used to
observe situations in health facilities. This will involve part or all the
sequence of events commencing when a patient comes to register until he
or she leaves the health center. In general, the goal for using the
observational method in drug use studies involves one or more of the
following:

! To generate research hypotheses in pilot studies where very little is

known about the problem.

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! To collect information not available in any other way, such as
communication patterns during a provider-patient encounter.

! To supplement other data as part of a multiple assessment

approach where observation may aid in the interpretation of data.

As a supplementary method, structured observation can also be made

during focus group discussions (FGDs), in-depth interviews, or interviews
using a structured questionnaire. It can also be used to supplement
quantitative methods of data collection, such as prescribing surveys.

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5.20: Key Steps in Conducting Structured Observations

The steps listed in Table 5.1. can be followed in applying the structured
observational method to study drug use problems. The list is followed by a
more detailed discussion of each step.

TABLE 5.1:Key Steps in Conducting Structured Observations

Step 1. Decide if a resource person is needed.

Step 2. Determine what is to be observed.

Step 3. Choose the observers.

Step 4. Develop observation guides.

Step 5. Select the setting for the observations.

Step 6. Train observers and pre test observations.

Step 7. Conduct the observations.

Step 8. Analyze and interpret the observational findings.

5.21. STEP 1: Decide If a Resource Person Is Needed

Use of structured observations in a drug use study requires certain skills

which those involved in the clinical aspects of health may lack. One of the
first decisions to make is whether the assistance of a resource person is
needed. The following are some points to consider.

a. Assessing the Need for a Resource Person

The assistance of a resource person is very helpful, but whether you need
one or not will depend on a number of factors. These include size of the
study, the resources available for it, and the experience of the investigator
and others on the study team.

If the study is small, you may rely on the services of someone who can
consult for brief periods when you need his/her services. However, if it is a
large study you may need to look for someone who can devote sufficient
time to the study. The use of a resource person can be very important to
the success of the study, particularly if you have no experience with
observational methods.
b. Who to consider as a Resource Person

The role of a resource person is to assist in planning the observation

protocol and preparing for subsequent stages of the study. The first choice
for a resource person would be a social scientist who has the knowledge,
skills, and actual field experience in using structured observational methods.
Where it is difficult to find a social scientists to assist, others whose jobs are
behaviourally oriented and who have actually done some work using
observations such as colleagues in public health or community development
officers, can be equally useful. In any case, the resource person needs to
have knowledge about the health care system and the context of drug use
in the locality.

5.22. STEP 2: Determine What Is to Be Observed

The beginning of preparing an observation protocol is to determine what

behaviours or encounters will be observed on the field. The following
describes some guidelines.

a. Selection Criteria

As with all applied qualitative methods, the purpose of the study will
determine who and what is to be observed. Since structured observation is
often used to validate data obtained from other methods, appropriate
sources of information must be identified. For example, suppose the
purpose of an observation encounter is to verify a claim by providers that
they give antibiotics to children who present with ARI because their
accompanying parents ask for them. Since you cannot observe all patients
in the targeted population, you will need to develop a method to select
encounters to represent this group.

Most clinic-based observational studies use a convenience sample of

patients who happen to be available at the time of data collection. Thus, all
patients who report with cough on a particular day at a certain health center
might be observed. A random sample of patients with cough in the
community during a given period would be impractical to obtain.

b. Sources of Information

An investigator using structured observations must decide beforehand what

the target of attention of the study will be. Pertinent issues to consider
before designing the observation protocol include:

! Is the emphasis to be on drug prescribing habits, adequate

patient care, patient behaviour, the health system context, or all
of these?

! Will the focus of attention be the health provider, the patient, or

 the prescribing encounter?

! Will the observation take place in hospitals, health centers,

private drug outlets, or some other place?
 ! Will the observation cover the interaction of prescriber and
patient, or the whole situation at the health facility or drug
outlet?

! What are the possible opportunities in the observing

environment for the observer to blend in and become less
obtrusive?

! What is the most appropriate recording system for this

situation?

The final decisions must be based upon the aims and goals of the study and
the practical aspects of collecting the data. Remember to narrow attention
to data that are useful in designing an intervention, and not other
interesting but possibly unnecessary information.

5.23. STEP 3: Choose the Observers

In preparing for data collection, you need to select the most appropriate
field staff to carry out the observations. The following are essential
prerequisites to consider when recruiting field staff.

a. Qualities to Consider When Selecting Observers

The following observer qualities are helpful in ensuring accurate data:

! Familiarity with the cultural background of the people being

observed and ability to understand their language is a key
qualification.

! Familiarity with pharmaceutical and general medical terms is a

benefit, and may be an absolute prerequisite for certain
studies..

! Knowledge about social research techniques is an advantage.

! A secondary or high school education may be sufficient if the

medical aspects of the behaviour being observed are not
complex..

! Observers must be able to sit quietly and observe without

interfering.
 Ideally, structured observation would use two observers to ensure
reliable information.

However, it may not always be possible to have two observers for every
situation. Besides, it may be more difficult for two observers to stay
"unnoticed" than one person. With adequate training, a single observer
should be able to produce high-quality and consistent data.

b. Observer's Role in Structured Observation

In structured observations, the observer watches events unfold without

affecting them and records these events in appropriate categories (on an
already prepared checklist). The observer is like a video recorder. He or she
should record as objectively as possible all relevant events, situations, and
behaviours.

To minimize bias, the observer tries to be as unobtrusive as possible so that

subjects feel at ease and comfortable in carrying out their daily activities.
The best way is to "sit quietly as a fly on the wall in the corner" so that the
subject forgets that the observer is in the same room. The observer must
maintain interest in the events being observed. Otherwise he or she will
carry out the observation mechanically and risk failing to notice some
important events.

5.24. STEP 4: Develop Observation Guides

The basis for structured observations is the observation guide. A

preliminary list of issues to be observed, and the categories in which to
record them, must be prepared in advance based on the objectives of the
study. A list of common items that can be observed during clinical
encounters at a health facility is included in Table 5.2.

a. Who Prepares the Guide?

Usually the investigator(s) and/or the resource person directing the study
is/are the appropriate persons responsible for writing the guide. However, it
is advisable and helpful to involve the observers to enable them have input
and familiarize themselves with the study. Useful input might also be
obtained from people who would have special insight into the interactions
being observed (e.g., experienced clinicians, community leaders), or
administrators who will be involved in later interventions.

b. Structure and Contents of Guide

Since it is difficult to predict observable behavior in advance, a draft protocol

can initially be partially structured. More attention should be paid to
specific aspects that appear central to the problem as the study proceeds,
and a final observation guide prepared.

The guide should be prepared to suit local situations; the input of the field
team is particularly useful. You may also find it useful to begin with the
instruments and protocols presented in the annex, and adapt them to the
local environment and problem of interest.
Table 5.2 Items That Can Be Observed During Clinical
Encounters in a Health Facility

1. REGISTRATION:
! impressions
!0 payment

2. SCREENING:
! does it occur?
! who does it?
! content

3. WAITING:
! what do parents and patients do?
! any health education opportunities?
! how long?

4. CLINICAL CONSULTATION:
! physical environment: private, others present, place for patient to sit, exam.
bed,
greeting ritual
! medical history: duration, associated symptoms (fever, chills, chest pain,
cough, yellowish sputum in cough), appetite (eating, drinking), previous
treatment
! clinical exam: temperature, pulse, breathing (rate, in-drawing of space
between the ribs), touching, listening to the chest.
! use of instruments(stethoscope, BP machine, etc.)
! interaction: warm, cold, patient encouraged to speak, type of language
(technical vs. non-technical, local vs. non-local)
! explanation of illness: causes, prognosis
! advice: about prevention (environment, hand washing, food storage, clean
water, latrines),
! about feeding (fluids, breast feeding), explanation about drugs
! length of time
! how encounter is terminated: prescribing on termination, reassurance,
warm, abrupt
! prescriber washes hands after examination.

5. WAIT FOR DRUGS:

! how long?
! what happens during the waiting period?

6. DISPENSING ENCOUNTER:
! physical environment: private, possible to talk with dispenser
! how are drugs dispensed: packaging, sterile technique for injection, labeling
! communication: instructions about how to take, side effects/precautions,
prevention and care, patient asks questions
c. Useful Events to Observe During Clinical Encounters

The most frequent target of observation in drug use studies is the clinical
encounter between health provider and patient. The following are key
events that can be observed during the clinical encounter:

1. Aspects of Clinical Process

Polypharmacy

The focus of the observation is on how many drugs a provider

prescribes for a patient and why. Observation can take place in a
health center, or in clinical examination areas during a working day.
The observer can sit quietly close by the prescriber and record the
drugs being given to the patient and any discussion about reasons for
multiple drug therapy.

Non-pharmaceutical therapy

The focus of the observation is on any instances in which a provider

consults with a patient without prescribing any drugs, and why. In
drug use studies, the observation usually takes place in the consulting
room, although observing interactions between patients and nurses or
dispensers may also be informative..

Selection of Drugs

The focus of the observation is on the choice of drugs, and reasons for
specific choices. Many different aspects of the decision-making
process can be covered: adequacy of history taking and examination;
discussion of alternatives with patients; patient requests for particular
drugs; the use of generic names; stock availability; and so forth.

Two prescribing choices that have received particular attention are use
of antibiotics and injections. Which antibiotics are being given to
patients, and for what diagnoses? What are the opportunities for
laboratory investigation, and are they used appropriately? For
injections, in addition to why they are given and whether they are
necessary, observation can also focus on adequacy of sterile practice.

Information about use, risks, side effects

 The focus of the observation is on the information communicated to
the patient about prescribed drugs, on both whether communication
takes place at all and whether it is adequate. Issues addressed can
include how and when to take the drugs prescribed, possible side
effects and what to do if they occur, as well as responses to patient
questions or concerns. These interactions can be observed in the
consultation room as well as in the dispensing room.
2. Features of provider-patient interaction

In addition to the more clinical aspects of the encounters between

patients and health providers, the observational method can be used
to study the nature of the interaction between them. It is often non-
clinical aspects of the encounter that determine the overall quality of
care from the patient=s perspective. The following aspects of the
encounter can be included in the observation guide.

! exchange of greetings between provider and patient;

! verbal expressions of concern by the provider;

! conversation between provider and patient;

! nonverbal expressions such as smile, touch, tone of voice;

! eye contact between provider and patient;

! duration of the encounter;

! language used during the encounter;

! advice given by the provider;

! questions posed by the patient;

! how provider ends the interaction.

5.25. STEP 5: Select the Setting for the Observations

Before beginning the field work, you need to decide the sites, days, times,
and other related issues for the observations. The following steps outline
the preparations that need to be made.

a. Site Selection and Permission

Some days or weeks before the field work, the investigator should visit the
location of the study to learn about the setting and people in order to make
a final selection of study sites. When this visit is made, it is possible to
obtain permission to carry out the observations from relevant authorities.
The meeting can be used to inform local leaders about the purpose of the
study, and how it is intended to benefit them, and how many observers will
be involved.

Before deciding on the specific site, date, and time of the study, discuss the
issues with the local authorities. This could ensure their support and
cooperation. Sometimes the places and times offered by local authorities
require compromise in the intended study plans. Time constraints can often
be overcome by doing the observations over several days, rather than on
only one working day.

b. Date and Time

The availability of cases for observation depends on local patterns of health

service use. The investigators and the contact personnel at the observation
sites must decide the days on which it is best to collect the data. Remember
to schedule observations at the time of day and week when an appreciable
number of cases can be obtained.

For health centres, it is usually best to conduct observations in the morning

between 8:00 and 1:00. Attendances are likely to be low at week-ends and
holidays. For observations in households and private retail outlets, early
mornings before work and late evenings after work are optimum in most
communities.

c. Decide on Observation Sites

The number of observation sites will be influenced by the objectives of the

study, the number of available and accessible sites, and the need to
adequately represent the target population. Difference in attendance at
various sites must also be considered. The decision about how many sites
to include will therefore vary from place to place. If the study aims to assess
practice in a large group of health facilities, a minimum of 10 randomly
selected sites would generally be needed.

d. Determine Number of Observations per Site

The number of observations per site is again dependent upon the study
objectives, logistics, attendance, and so forth. Usually observations can be
made at the place of registration, the waiting room, the consultation room or
at the dispensary. There is no rule for deciding how many observations per
site, but at least 20-30 would be recommended to adequately describe
practices at each site.

5.26. STEP 6: Train Observers and Pilot Test Observations

Structured observation may not appear as complicated as other applied

qualitative methods such as FGD and in-depth interview. However,
observable behavior may be so complex and rapid that observers may fail
to detect interesting and important aspects if they are not properly trained.
Observers need to be well trained to enable them take note of interesting
unforeseen events which may not be indicated in their guides.
a. Useful Hints for the Trainer

The following are some useful hints to guide the training:

!0 Find a suitable location for the training that allows participants

to be comfortable and removed from their usual work setting;

!0 Involve the entire field team in all aspects of the training;

!0 Allot sufficient time for each session, especially the practical

sessions like role plays and pilot observations;

!0 Use simple materials for the training;

!0 Use appropriate language, i.e., local language, for the training

sessions;

!0 Set sufficient time aside for discussions, and questions from the
trainees;

!0 Evaluate the sessions in a formal way to allow improvement

over time.

b. Training Agenda

Theoretical issues that must be covered in the training include the following:

!0 What is structured observation and why is the method useful?

!0 What are the objectives of the study?

!0 Why is structured observation appropriate for the study?

!0 How are unstructured observations conducted?

!0 How will structured observations be conducted in this study?

!0 How are field problems to be dealt with?

!0 How will field data be handled and summarized in the daily

report?

c. Practical Aspects of Training

Role play is a very effective practical approach for training observers how
to observe. In role play, the observers play scenes to depict the activities
and roles at a health facility. Models could include registration clerks/nurses,
a doctor, a dispenser, other paramedics, and patients. While some of the
observers act the scene, others observe the activity. They record events
according to items in the guide as well as those that they observe
themselves.

During the role play, the trainer observes the observers, and later
comments on their performance. For example: observer busily writing
instead of paying close attention to an event.

When beginning training, it can be most useful to start with exercises

in unstructured observation. Create hypothetical events/situations and
let trainees describe them. This helps to bring out the observational
strengths and weaknesses of trainees for the trainer. This might be done by
having two trainees observe the same events during a role play, after which
they would each write one paragraph to describe the key aspects of what
they observed. Discussing their descriptions with the trainer and the other
observers can help them to focus on important issues.

After they become comfortable with unstructured observation, trainees can

be introduced to the structured observation guide and taught the meaning
of each item in the protocol. They can then role play again, and use the
structured form to record data.

After the role play sessions, it is important to pilot test and revise the
guide before beginning actual field work. The uses of the pilot test include
the following:

! to check whether the observational guide is suited to actual

situations;

! allows observers to become familiar with the guide;

! spot which parts of the guide need to be revised.

5.27. STEP 7: Conduct the Observations

After pilot testing and revising the guide as needed, you are now ready to
begin the field work.

a. Preparing for Field Work

Ensure that the following are available for use by observers before they
move into the field.
 !0 Latest version of the observation guide and data collection
forms
!0 Notebook for making notes

!0 Pens/Pencils

!0 Any other recording equipment such as tape recorder that will

be used

It is of utmost importance that observers dress appropriately for the field.

Appropriate dress will vary from group to group and from community to
community, but the guiding criterion is that dress should be chosen to be
unobtrusive. For example, an observer wearing a suit to collect data in a
village health post would stand out and interfere with normal activities. On
the other hand, an observer wearing a lab coat in a consultancy area in a
health center can often blend most easily into the background.

b. Conduct the Observations

On the day of the observation, observers should arrive early at the health
facility to make the necessary preparations before the health facility
commences work. Such preparations will include locating observation
positions. Being in position as patients arrive can help observers appear
more natural. When everything is set the observation can proceed as
follows:

1. Getting Started

It may sometimes be necessary to inform and explain your presence

to those being observed. How this is done depends on the setting
and people involved. It is best to have your host at a health facility
(usually the officer in charge) do this introduction. At this very first
stage, display friendliness and show interest.

A prospective observer must gain the trust, confidence and

cooperation of subjects. However, even after achieving this, the
observer's presence may sometimes influence behaviour and events
being observed. The observer must be aware of this possibility and
try to prevent it by positioning himself/herself away from the center of
activity, and by writing as inconspicuously as possible. It may also
reduce bias if the first few encounters observed are not included in the
sample, giving time for everyone to become used to the observer=s
presence.
2. Observing

Remain reasonably detached yet attentive. Observers must

record observations as systematically and accurately as possible. The
use of observational guides or forms should enable them to record
events easily. It is also important to write notes about events that are
not included in the guides or forms. These qualitative data will add
flavor to the interpretation of the more structured items and could
provide unexpected, but relevant information. For example, the fact
that female patients are not touched by male health workers may not
have been captured by the observation protocol, but could be a key
finding for developing an intervention.

Observers may also make sketches of observation situations and note

other non-verbal communication.
3. Wrap-Up

At the end of the session remember to thank the health facility staff
and your host. In some situations, it may be appropriate to thank
patients or their accompanying person immediately after the
encounter. On the other hand, it is best to wait until the end of a day's
field work before you say thank you to health facility staff. Sort out
any problems you might have encountered with your host if it is within
his/her means to help before the next observations begin.

c. Regular Review of Data

During the field work, there must be a regular review of the data by the
investigator with the observers. This is very helpful for ensuring the
accuracy of recordings especially at the early stages of the study. Such a
review also provides an opportunity for the investigator to discuss any
problems encountered by observers in the field.

d. Recording Information in Structured Observations

An observation protocol must strike the correct balance between brevity and
comprehensiveness in recording data during the observations. Generally,
relying on the observer's memory is ideal but risky because notes made
after the observation can be distorted. However, making extensive notes
during the observation may also distract subjects and cause the observer to
miss some important events while occupied with note taking.

Observation guides with which observers have been familiarized through

training are an effective means of recording data. The observers can check
appropriate categories in the guides and write notes in available space for
comments and other observations. Normally, because events are itemized
in the guide, structured observation may not always need extensive
supplementary notes. Nonetheless, notes of unexpected events not
included in the guide should be recorded.

5.28. STEP 8: Analyze and Interpret the Observational Findings

The final stages of the observational study involve analyzing and

interpreting the data from the field. This can be done manually or with the
aid of a computer depending upon local capability, as well as the objectives
and size of the study.

a. When does Analysis Begin?

The analysis of structured observational data begins the moment the data
collection begins. The exercise involve a number of activities which include;
 !0 Routine debriefing sessions involving observers and
investigators. This aspect of data management can
improve the quality of the final results.

!0 Comparing notes of observers from daily field trips. This

makes it possible to compare the performance of different
observers, and to spot and remove irrelevant parts of their
field notes. It also provides an opportunity to add new
themes or topics which are found useful while the data
collection lasts.

b. How much Analysis is Required?

Since structured observation is partly quantitative and partly qualitative, the

analysis involves procedures for both types of data. Whether it is done
manually or with the aid of a computer, the analysis involves the following:

!0 Categorization of data: This is the first formal stage of the

analysis. The qualitative part of the data comprising
descriptions of behaviours of people, events, and
situations recorded as free text must first be categorized.
This begins by reading through the raw data and placing
similar responses in identifiable categories.

Usually, the data collected with structured observation forms

about planned events are already categorized. If the data are to
be analyzed by computer, some software requires that numeric
codes be assigned to different categories (e.g., A0" assigned to
ANo,@ and A1" to AYes@ responses. The qualitative data that has
been categorized previously may also need to be coded with
numbers.

!0 Summarizing the data: This stage involves analyzing the

coded information in order to describe the frequency of
responses for each item or theme. Report percentages for
each response category for pre-planned observations. You
may also describe the qualitative aspects in a narrative
style, although certain qualitative issues could equally be
quantified and presented as percentages. The data
summaries should present the key quantitative and
qualitative findings from the observations that would
guide the design of an intervention.

c. Doing Analysis with a Computer

Using a computer to analyze data from structured observation can be more
costly and time consuming than manual analysis. If the data set is small, it
is advisable to avoid computerization. If a computer analysis is to be used,
the following steps can be followed after coding the data:

!0 Choose appropriate software: Various computer software

programs are available; two of the most popular are Epi
Info and dBase. It is suggested you see a resource person
for assistance before you choose a program.
!1
!0 Enter the data: Before entering data, you need to develop a
data entry format to allow transfer of coded data into the
computer. Data entry needs to be validated, often by
entering data twice and comparing the entries. Data entry
errors must be thoroughly edited out before analyzing the
data. .

!0 Run the analysis: After editing the data, you are now ready to
run the desired analyses. You can analyze the contents of
each response under various sub-themes using frequency
distributions, and compare responses in different
categories of the target population using two-way or
three-way tables..

d. Writing the Report

Writing the report is the responsibility of the investigators, but involving the
entire study team will ensure that all important aspects are covered.
Discussion of findings by the team will often trigger unexpected insights
about the reasons for problems or ways of improving them. The report
should focus on recommendations for policy changes or specific
interventions to solve the problem being studied.

The major sections of the report of an observational study are:

Introduction: Statement of problem, research objectives, rationale,

scope, operational definition,
outline of the chapter.

Methodology: Research approach and method, instruments, study

setting, sampling, personnel, field work organization and
supervision, mode of data analysis.

Findings: This embodies tabulating and deascribing the study

results.
Discussion: Underlying reasons and explanations of the main
findings.

Conclusion and
Recommendations: Inferences, suggestions, and likely follow-up
interventions.

Interpreting the findings involves drawing conclusions about intervention

design based on both quantitative summaries and the qualitative data
analysis. Other data which can help in interpreting findings include
observers= notes from the field, existing research findings, as well as
educated opinion on the subject. The conclusions and recommendations
should stay primarily focused on the issues that will contribute to the design
of an intervention.