Conducting Your Research Project I: The Protocol: the preparation and planning stages Mayyada...

Conducting Your Research Project

I: The Protocol: the preparation and planning stages

Mayyada Wazaify,PhD

We’ll be talking about….

Literature Review & Preliminary fieldwork Specifying Aims and Objectives Ethical Approval and research governance Pilot Studies Project Management, conduct and a

professional approach Working with others & Group projects

Research Process

Phase I: Identify the research question Identify the research problem Review of the literature Identify variables State hypothesis

Phase II: Design the study Phase III: Methods Phase IV: Data Analysis

Analyze data Interpret findings

Phase V: Communication

Research Proposal

Establishing area of inquiry

Out of:Personal interest or experienceA desire to help solve a problemIn response to a request from a

stakeholder or donor

Why is the research question important?

Features of Research Questions:

The Question should be important – The “so what?” How often this clinical problem occurs in practice? Will this findings provide useful information for clinical decision

making?The Question should be Answerable-objective The Question should be feasible

Researcher knowledge and background Time ,money, human and physical resources Availability of subjects Protection of subject’s rights (Risk and benefits)

Exercise-1:

Consider which elements of the following questions are too vague and subjective. Suggest how each might be made more objective.

a. Are Aspirin tablets better than Paracetamol tablets at relieving pain?

b. With regards to wheelchairs, is Manufacturer’s A product superior to Manufacturer’s B product?

c. How can we improve general public’s motivation to exercise?

Exercise-2:

In 5 minutes: Write down three questions concerning your practice which you would like the answer to.

1.

2.

3.

Literature Review & Preliminary Fieldwork

Literature Review: the first major task

Often Concurrent

Together: background of the study

Together: lead to the development of the research protocol

O'Leary, Z. (2004) The Essential Guide to Doing Research. London: Sage. Chapter Three

Cycles of ResearchQuestion Development

The Research Protocol

The end result of planning process Should be completed before data collection

commences. Available later in the project as a map to

remind you exactly what you planned to do. Makes you define and refine your research

design Time invested at this stage will mean fewer

problems later in the project.

Research Protocol comprises of:

Introduction

Aims and Objectives

Methodology

Details of the programme of work e.g. time scales, project milestones, management processes, financial issues

Introduction

A statement of background to:explain how your aims and objectives

build on existing knowledge, Provide the rational of the studyJustify the need to investigation of the

problemProvide theoretical framework to

interpret your results

Literature Review

Literature Review

What is already known about the subject?

“Do not reinvent the wheel”

Look for both: Research or Anecdotal

Reports

Not only peer-reviewed articles

Acknowledge your sources avoid

plagiarism

Literature Review

Aids in:

1. the development of aims and objectives of the study

2. Devising a suitable methodology for meeting the objectives

3. Later: interpret your results

SHOULD BE AS COMPREHENSIVE AS POSSIBLE!

Critical Appraisal

A very important step when reviewing the literature;

When reviewing the literature, the findings and conclusions of a study must be interpreted in the context of the methods used.

Methodology: all studies have strengths and weaknesses

What is critical appraisal?

• This is the term given to describe the skills used when reading a paper to enable one to assess the validity (i.e. how close to truth) and usefulness (i.e. can the results be applied to your practice) of the results.

• Forms an integral part of evidence based medicine (EBM).

Critical Appraisal

Compromises are inevitable and they arise for all sorts of reasons:

e.g. limited time or resources, ethical constraints, low response rate, poor judgment on the part of the researchers, or unforeseen difficulties that arise during the execution of the study

Formulating hypotheses and aims

A Hypothesis: is a proposition about the relationship between variables or differences between groups.

e.g. There is support for the pharmacist’s extended role”

Exercise-3:

Turn the 3 research questions that you formulated in exercise-1 into hypotheses

a.

b.

c.

Some research projects will not have an hypothesis in the formal sense but will have an aim or objective instead.

e.g. measuring health needs in the community

Specifying the aims and objectives

Aims: more global statements

Objectives: specific and measurable- they describe how the aim is to be achieved

Example:

Study aim: to evaluate the effectiveness of a new pharmacy service

Specific objectives of the study:Specific Objectives of the study:

Example-cont.

Exercise-4:

For the research questions you have put earlier, specify the aims and objectives of each.

Aim:

Objectives:1.2.3.

Outcome Measures:

How each objective will be addressed?

Literature review robust very helpful

Example

Example:

Methodology

Explanation of the approach, methods and procedures with some justification for their selection and comments on how potential problems will be addressed.

Details of research design: sampling, recruitment, data collection, research instrument and other documentation (e.g. questionnaires, data collection forms, information leaflets, consent forms), how bias can be eliminated, ethical aspects, analysis of data

Research Design:

The researcher defines the population of interest;

Selects the cases to be studied;

Then, observes or studies individuals within the population of interest and, in doing so, generate data.

“The Hawthorne Effect”

Hawthorne Effect

PILOT STUDIES

A mini-version of the definitive (main) study

Conducted to test the methods, procedures, instruments and documentation of a study

Essential for the success of the study

The purpose of pilot studies:

To check that methods and procedures are acceptable and feasible in the research settings

To ensure that the chosen methods provide the data required (in terms of completeness, reliability and validity) to meet the study objectives

Examples:

In a questionnaire or interview pilot-part you may find:

Inconsistencies in responses suggest ambiguity in the questions

Content of the data obtained sufficient details to enable you to address each study objective?

Missing data may indicate that respondents had difficulty providing some information

or that there were some questions that were sensitive and which they did not want to answer

The results of pilot study may lead to some modifications to the study procedures:

Modify the recruitment process, e.g. information provided to potential participants or change the location of recruitment

Reduce or extend a period of observation Amend an interview schedule, e.g. question order,

reduce the length of an interview Rephrase questions in a questionnaire to ensure

clarity Modify the layout of data collection form in an

observation study Include additional questions on certain topics and/or

omit others

Example: wrong place of recruitment!

Project Management: Time scales

A time plan covering the duration of the project and

including all stages of the work should be prepared at the start of the work.

Researchers are often over-ambitious

Examples:

Lengthy steps: the preparation of applications for ethics committees and waiting for approval, recruitment of participants, and receipt of completed questionnaires, arranging interviews to suit the availability of others YOU HAVE ONLY LIMITED CONTROL!

Following up non-respondents to questionnaires, transcribing audio-recorded data, checking data for accuracy and coding and analyzing qualitative data sets can be very time-consuming

Project Management: Organization

Conducting a project requires good organization

Detailed notes should be kept of all your notes and decisions at all stages (with reasoning)

A system to record details of all contacts relating to the project (personal, telephone etc)

Follow-up system for others involved in study conduction.

Project Management: Conduct & professional Approach

People who take part in your research are doing you a favor!

If you are a student: they may see this value as limited to educational objectives

People will often be agreeable only if they can see that the work is relevant to aspect of service development or patient care, carefully planned and professionally conducted and that their rights are being observed

Goodwill vs. nominal payment

Maintaining a professional approach:

Good time-keeping Appropriate self-presentation Adherence to agreed study procedures Forethought: procedures result in minimum

inconvenience e.g. data-show, computer, spare batteries

As a researcher-you must be willing to accommodate the commitments of participants

Provide participants with a summary of findings/ the published paper/ a ‘Thank You’ letter.

Remember!

An unprofessional approach could both jeopardize your work and discourage individuals from participating in future research

Weekend Homework:

For each group, write down a proposal draft of the project you’re thinking to conduct.

Must be submitted/discussed after Eid holiday.

Take Home Glossary…

Conflict of interest Bias Hawthorne effect Plagiarism Critical appraisal Peer review

Parameter Variable Statistic