Research Methodology for MSc Students

Berihun Megabiaw (MD,MPH) April, 2012 Epid & Biostat Dep`t, UoG

Learning Objectives
At the end of this session the student will be able to: Define health research, research design, and research methods Understand the differences between research and audit Understand the different types of research Develop research objectives of different
forms

Research?

The systematic collection, analysis, and interpretation of data to answer a certain question or solve a problem
3

Health Research?
Health research is the process of obtaining systematic knowledge and technology which can be used for the improvement of the health of individual groups. It provides the basic information on the state of health and diseases of the population; it aims to develop tools to prevent and cure illness and mitigate its effects and it attempts to devise better approaches to health care for the individual and community (Davies 1991)

What is Health Research? Cont..

Health Research is a systematic collection, analysis and interpretation of data to solve a health problem.

Purpose of Health Research

- To generate knowledge essential to effectively promote the health of the population. - Without that knowledge, effective action is impossible because it has no logical or empirical basis.

Research must be:

Purposeful: what do you want to be able to contribute? Targeted: Who are the audiences? Credible: consider sources information, method of data collection, personnel involved Timely: Is the information needed?

Research is done to find solutions to health problems.

2) Research and audit

Although research and audit have a great deal to offer each other and should be inextricably linked, it is important to recognise their distinct roles. Otherwise there is a danger of audit masquerading as research but without the necessary rigour, or research pretending to be audit, but without any attempts to improve the quality of care given. (Black, 1992)

Research and audit cont..

Research aims to find the value of health care (Is an intervention effective/humane/costeffective?) should be generalizable to other places and times (if properly carried out) 4

Research and audit cont..

Audit Audit consists of reviewing and monitoring current practice, and evaluation (comparison of performance) against agreed predefined standards Audit is directed at the maintenance and achievement of quality in health care.

Research and audit cont..

Audit - aims to assess and monitor the provision of health care to ensure its quality (Quality = effectiveness, humanity, equity, efficiency) - is an ongoing activity to monitor, institute changes then reassess - is essentially a local activity, results being of primary value at the specific time and place

Ways in which Research and Audit are linked

Research as a basis for audit Research often makes a vital contribution to audit by: defining good quality care (Treatment of malaria by coartem) produce accurate outcome measures Audit as a basis for research Audit data can be used as a non-experimental basis for evaluating health care by: detecting dramatic effects of an intervention or rare side effects investigating differences in use of and access to services (equity) optimal approach is to collect together audit data with large audit databases

Criteria for undertaking audit

The issue should be a common, significant or serious problem Any changes following audit should be likely to benefit patients and to lead to greater effectiveness The issue is relevant to professional practice and development There is realistic potential for improvement The end result is likely to justify the investment of time and effort involved

Types of research
Level of Analysis
Conditions

Object of Analysis
Responses Clinical Research (Efficacy of preventive, diagnostic, and therapeutic procedures, natural history of diseases) Health Systems research (Effectiveness, quality, and costs of services: development and distribution of resources for care )

Individual and subindividual Population

Biomedical Research (Basic biological processes, structure and function of the human body, pathological mechanisms) Epidemiologic Research (Frequency, distribution, and determinants of health)

Types of research cont

Biomedical Research Example: Experiments in cell culture and in vivo demonstrate that treatment with statins reduces production of Abeta, the main component of senile plaques, a feature of Alzheimers Disease.

Epidemiological Research Example: Prevalence and risk factors of cigarette smoking and khat chewing

Types of research cont

Clinical Research Example: studying the effectiveness of coartem in treating malaria Health Systems Research Example: Study of the underlying reasons for emergency hospital admission of patients with diabetes.

Basic Vs Applied Research

Basic research (also called fundamental or pure research) -has as its primary objective the advancement of knowledge and the theoretical understanding of the relations among variables The terms basic or fundamental indicate that, through theory generation, basic research provides the foundation for further, sometimes applied research.

Basic Vs Applied Research cont..

It consists of pure basic research and strategic basic research. Pure basic research is carried out without looking for long-term benefits other than the advancement of knowledge.

Basic Vs Applied Research cont..

Strategic basic research - is directed to specified broad areas in the expectation of useful discoveries. It provides the broad base of knowledge necessary for the solution of recognized practical problems.

Basic Vs Applied Research cont..

Basic research is conducted to address fundamental questions about the biological, Behavioral, and social mechanisms, which underlie wellness and disease

Basic Vs Applied Research cont..

Applied research Is original work undertaken in order to acquire new knowledge with a specific application in view.

Is a research that seeks to solve practical problems

Research Methods
Refers to: The practices and techniques used to collect, process and analyze the data (e.g What type of experiment or survey); The sample size and methods of sampling In the case of experiments and analytical studies, of assignment to experimental and control groups The research proposal will need to present and justify the appropriateness of the chosen research methods

Overview of research process

What is the problem? Define your initial objective Search literature Modify your objective based on the information you get from literature Write the full proposal guided by the objective

Where are we?

You must be a researcher

Yes. How did you know?

Youre 30 metres above the ground in a balloon.

24

Because what Yes, we you told us is are. How absolutely did you correct but it is know? completely useless.

Because you dont know where you are, you dont know where youre going, and now youre You must blaming me for be policyanswering your makers. question precisely.

25

What is A Problem?
What is

What should be!

Ideal Exist

Situation: In District X (pop. 145,000) sanitary conditions are poor (5% of households have latrines) and diseases connected with poor sanitation, such as hepatitis, gastroenteritis and worms, are very common. The Ministry of Health has therefore initiated a sanitation project which aims at increasing the percentage of households with latrines by 15% each year. The project provides materials, and the population should provide labour. Two years later, less than half of the target has been reached.

Discrepancy:
35% of the households should have latrines, but only 15% do have them.

Possible answers????

Research Problem or not?

Problem situation: District A: 125 HIV-positive adults were coming to the hospital every day as part of a DOTS programme to take medication for TB; last month for one entire week, none of the 125 patients received any medication Discrepancy? Problem question? What are the factors responsible for 125 patients failing to receive any treatment? Possible answer: During the week a very heavy rainstorm caused flooding that washed out several roads a resupply truck could not reach the hospital for one week

Research Problem or not?

Whether a problem requires research or not

The reasons for this difference is unclear More than one possible answer to the question or solution to the problem

? ? ?

7 Criteria for selection of a research problem

Relevance (widespread, who is affected, severity) Avoidance of duplication Feasibility (available resources) Political acceptability Applicability Urgency Ethical applicability Prioritization: 1= LOW ; 2= MEDIUM; 3= HIGH

1. Relevance How large or widespread is the problem? Who is affected? How severe is the problem?

2. Avoidance of duplication find out whether the suggested topic has been investigated before either within the proposed study area or in another area with similar conditions

3. Urgency of data needed (timeliness) How urgently are the results needed for making a decision or developing interventions at various levels (from community to policy)? Consider which research should be done first and which can be done later 4. Political acceptability research a topic which has the interest and support of the local/national authorities

5. Feasibility Think about the resources required to conduct the study manpower, time, equipment and money that are locally available possibility of obtaining technical and financial assistance from external sources 6. Applicability of possible results/recommendations Is it likely that the recommendations from the study will be applied?

7. Ethical acceptability the possibility that we may inflict harm on others while carrying out research

Problem Analysis
Identify factors that may have contributed to the problem Clarify the relationship between problem and the contributory factors

FACTOR PROBLEM FACTOR

Prolonged duration for culture & sensitivity (6-10 weeks)

Availability of anti-TB drugs in market

Patients take care at GP Misuse of anti-TB drugs

X Ray or smear microscopy is inadequate for use in D &T Delay in diagnosis Attempts to develop rapid diagnosis procedure

Self medication

Delay in treatment

Growing resistance of Mycobacterium species to anti TB drugs Failure of anti TB drugs to control TB in recent years
Poor compliance of patients Not providing HE

Problem statement

Constitutes the scientific justification for the study; Gives an empirical basis to describe the situation Clearly specifies the gaps (in existing knowledge and/or controversy and inconclusive evidence) Defines the objective of study and conveys the questions or broader issues

A logical sequence for presenting the statement Magnitude, frequency and distribution: Affected geographical areas & population groups affected by the problem Probable causes of the problem: What is the current knowledge of the problem and its causes? Is there consensus? controversy? conclusive evidence? Possible solutions: In what ways have solutions to the problem been attempted? What has been proposed? What are the results? Unanswered questions: What remains to be answered? What areas have not been possible to understand, determine, verify, or test?

Formulation of the Problem Statement

Context Socio-economic and cultural characteristics and an overview of health status and the health care system Nature of the problem

An analysis of major factors and convincing argument

Any solution that have been tried in the past, how well

they have worked, and why further research is needed.

Type of information expected to result from the project and how this information will be used to solve problem.

NATURE OF PROBLEM

ANALYSI S
SOLUTION TRIED & JUSTIFICATI ON

Growing resistance of Mycobacterium species to anti TB drugs Failure of anti TB drugs to control TB in recent years Prolonged In adequate X Ray or duration for C smear microscopy &S Unsuccessful attempts to develop rapid diagnosis procedure

Microscopy and culture techniques remain the primary methods

A need for a rapid culture technique A simple, reliable and cheap method of culture in 6 days

EXPECTED RESULT

RESEARC H QUESTION

What will be the ways and means to develop rapid culture technique for tubercle bacilli ? Sample for INTRODUCTION

4/25/2012

Berihun M.

41

Formulation of Research Objectives

Berihun Megabiaw (MD, MPH) Dep`t of Epid and Biostat UoG March 2012

A Research Question
Uncertainty about something in the hospital/treatment procedure/population that the investigator wants to resolve by making measurements on his/her study subjects
Medical Articles

Research Question

Observations

Conference s

Applying new concepts to old issues

Research questions:
- Formulated when insight into the problem being studied is not sufficient.

5 CRITERIA for A Good Research Question

F Feasible : Adequate no. of subjects, adequate technical
expertise; afford in time and money

Interesting to the investigator

N Novel : Previous findings - confirm or refute, extend New

findings

E Ethical : Autonomy, Benefits and Risks, Justice R Relevant : To scientific knowledge, clinical & health policy
future research directions

Examples of Research Questions

(Articles, Research Reports, Congress Abstracts)

What are the patterns of antimalarial prescriptions at referral Hospitals?

What are the socioeconomic background and behavior of adolescent pregnancy? What are the traditional birth practices of rural Ethiopian women?

What formats can be used for stating research objectives?

Research objectives can be stated as: A) Questions: The objectives of this study are to answer the following questions B) Positive sentence: The objectives of this study are to assess C) Hypothesis: The objective of this study is to verify the following hypothesis...

Formulating Objectives cont..

A good question includes the following elements: The patient or client in question (the Problem) The Intervention (or exposure) being considered A Comparison - an alternative intervention or group The Outcome of interest This format (PICO) does not fit with all questions

Formulating Objectives
Example: Imagine you are a member of National Cigarette Smoking Cessation Group. One issue that the group considers is nicotine replacement therapy for people who want to stop smoking. The other group says advising people to stop smoking will suffice. The debate continued but they couldnt agree. Formulate a research question for the above problem

Formulating Objectives cont..

Answer
Problem For smokers who want to give up smoking, Intervention Comparison Outcome does nicotine when replacement compared therapy, with individuals relying on advice only, increase their chance of giving up smoking?

 It summarizes what is to be achieved by the research / study

 To focus the study (Narrow the scope) To avoid collection of unnecessary data
Facilitate the development of research methodology Help to orient the collection, analysis, interpretation and utilization of data.

If you are not

certain of where you are going, you may well end up somewhere else (and not even know it!).
WHERE ARE YOU GOING?
Set objective

Evaluate performance

 General Objective

What is expected to be achieved by the study in general terms

Specific Objectives

Breaking down the general objective into smaller, logically connected parts

Objective should be closely related to problem statement

Example problem:

Low utilization of Antenatal Care(ANC)

General Objective:

To assess the reasons for low utilization of ANC services in District X.

CHOOSING OF RESEARCH AREA

PROBLEM IDENTIFICATION, ANALYSIS AND STATEMENT OF THE PROBLEM

 Should address various aspect of problem and factors influencing/associated with/determining the problems. The first specific objective usually focuses on quantifying or specifying the problem Should specify What will do in the study Where For what purposes

1. Determine the level of utilization of ANC in District X over the years 1998 and 1999. 2. Identify whether there are variations in utilization of ANC service, related to the season and type of clinic.

3. Identify socioeconomic & cultural factors that may influence the mothers' utilization of ANC services

 Cover the different aspects of problem and its contributing factors in a coherent way and logical sequence

Clearly phrased in operational terms by specifying what you are going to do, where and for what purpose
Considering local conditions to be realistic Use action verbs

-determine -verify -describe - find calculate - establish

-identify - compare - explore

To compare: the level of utilization of ANC services among various S.E groups. To establish: the pattern of utilization of ANC services in various seasons of the year.

Avoid use of non-action verbs

Vague Examples:

to appreciate to study to understand to know

 Specific Measurable Achievable Realistic Time bound

 Clear and comprehensive objective is critical

To the dev`t of all other components of a research design, subsequent data collection, analysis, reporting & utilization of data.

 The evaluation of your research project

The results of the study/research will be compared to the research objectives.

Group work! Research Question and Objectives

1. Formulate research questions (03) 2. Write general and specific objectives for them

66