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.

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

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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.

! 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
! 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:

! Find a suitable location for the training that allows participants to be comfortable and
removed from their usual work setting;

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

! Allot sufficient time for each session, especially the practical sessions like role
plays and pilot observations;

! Use simple materials for the training;

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

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

! 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:

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

! What are the objectives of the study?

! Why is structured observation appropriate for the study?

! How are unstructured observations conducted?

! How will structured observations be conducted in this study?

! How are field problems to be dealt with?

! 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.

! Latest version of the observation guide and data collection forms

! Notebook for making notes

! Pens/Pencils

! 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;
 ! Routine debriefing sessions involving observers and investigators. This aspect
of data management can improve the quality of the final results.

! 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:

! 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.

! 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:

! 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.
 ! 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. .

! 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.