Conceiving a Research

Noel R. Juban, MD, MSc Epidemiology
Department of Clinical Epidemiology

UP College of Medicine


What is Research?

Research is the systematic
– collection,
– analysis, and
– interpretation of data


to answer a certain question or

to solve a problem

People Interested in Research 5/28/14 ◆ Investigator ◆ Evaluators of research ◆ Prioritizing authorities ◆ Consumers of research .

graduation. recognition .Reasons for Doing Research ◆ ◆ 5/28/14 Pure interest Pre-requisite for promotion.

Origins of a Research Question ◆Medical articles and conferences ◆Critical thinking about clinical practices and problems ◆Discussions with colleagues ◆Applying new concepts or methods to old issues ◆Ideas that emerge from teaching ◆Top 10 causes of morbidity and mortality 5/28/14 .

A sample research question Is fexofenadine (FEX) as effective as desloratidine (DL) in the relief of nasal symptoms and increasing the peak nasal inspiratory flow (PNIF) among patients with seasonal allergic rhinitis? 5/28/14 .

P: adults with seasonal rhinitis I: FEX C: DL O: nasal symptoms M: 8 .

Feasible ◆ ◆ ◆ ◆ 5/28/14 Adequate number of subjects Adequate technical expertise Affordable in time and money Manageable in scope .

Interesting ◆ 5/28/14 To the investigator .

Novel ◆ ◆ ◆ 5/28/14 Confirms or refutes previous findings Extends previous findings Provides new findings .

Ethical ◆ 5/28/14 Apply for institutional review board approval .

Relevant ◆ ◆ ◆ 5/28/14 To scientific knowledge To clinical and health policy To future research directions .

FINER Criteria for a Good Research Question ◆ ◆ ◆ ◆ ◆ 5/28/14 Feasible Interesting Novel Ethical Relevant .

The Research Question Format ◆ ◆ ◆ ◆ ◆ ◆ Biologic/ theoretical rationale Study population Maneuver or exposure under study Primary outcome Comparative maneuver or exposure Study design 5/28/14 A Research Question ◆ Is fexofenadine (FEX) as effective as desloratidine (DL) in the relief of nasal symptoms and increasing the peak nasal inspiratory flow (PNIF) among patients with seasonal allergic rhinitis? 9/3/2005 .

5/28/14 ◆ P -population ◆ I / E – intervention/exposure ◆ C – comparison/control ◆ O – outcome measures ◆ M – methods (study design) .


Example 1 P – middle-aged woman A 40 year old woman hospitalized with severe is hospitalized with depression severe depression. ◆ I – Group psychotherapy ◆ ◆ Might the addition of group psychotherapy ◆ C – Usual care improve her (pharmacotherapy) outcomes? 
 5/28/14 ◆ O – improve symptoms and shorten hospital stay .

Research question 1 ◆ Among middle-aged women with severe depression admitted at MMC. will group psychotherapy improve clinical symptoms (???) and decrease length of hospital day as compared to pharmacotherapy (usual care)? 5/28/14 .

Example 2 ◆ A 30 year old man has been taking Zoloft for mild depression for 6 months with good results. sildenafil=Viagra) effective in treating sexual dysfunction associated with SSRIs? ◆ ◆ ◆ ◆ 5/28/14 P – male with mild depression on Zoloft I – viagra C – no viagra /placebo O – improved sexual functions .g. however about the sexual side effects of the drug. Are phosphodiesterase inhibitors (e. He’s concerned.

Research question 2 5/28/14 .

You confirm a diagnosis of ADHD without co-morbid conditions. Would treatment with stimulants alone be as effective as combined medication and psychosocial intervention? 5/28/14 .Example 3 ◆ A 9 year old boy is referred by his school for symptoms of hyperactivity and inattention.

Example 4 ◆ What is the percentage of patients with ruptured appendicitis who developed complications after an exploratory lap? 5/28/14 .

Example 5 5/28/14 .

The Research Question and Study Plan: Problems and Solutions 5/28/14 .

The research question is not FINER ! Not feasible 5/28/14 • Too broad Specify a smaller set of variables Narrow the question • Not enough subjects Expand inclusion criteria Modify exclusion criteria Add other sources Lengthen the time frame • Methods beyond the skills of investigator Collaborate with colleagues Consult experts / review literature Learn the skills • Too expensive Modify study design .

or relevant Consult with mentor Modify the research question ! Uncertain ethical suitability Consult with the IRB Modify the research question 5/28/14 .The research question is not FINER ! Not interesting. novel.

The study plan is vague ! Write the research question at an early stage ! Get specific in the 1-2 page study plan How the subjects will be sampled How the variables will be measured 5/28/14 .

Where is your research question falling into the research loop? 5/28/14 .

Is the treatment effective in reducing the problem? EFFICIENCY What procedure is more cost effective? .BURDEN OF ILLNESS How grave is the burden of illness? REASSESSMENT Did the mortality rate decrease significantly? MONITORING PROGRAM Is implementation operating well in the field? SYNTHESIS AND IMPLEMENTATION How will the program be implemented? 5/28/14 ETIOLOGY OR CAUSATION MEASUREMENT ITERATIVE LOOP What are the causes or risk factors/ predictors of the disease? COMMUNITY EFFECTIVENESS .

Goal: Find an important one that can be developed into a feasible and valid study plan Key ingredients: scholarship and experience Sources of research questions FINER criteria of a good research question Develop the research question into a brief written study plan .Summary ◆ ◆ ◆ ◆ ◆ ◆ 5/28/14 All studies should start with a research question that addresses what the investigator would like to know.

familiarity with the literature. pilot studies. Qualities needed: judgment.Summary ◆ ◆ 5/28/14 Developing the research question and study plan is an iterative process that includes consultations. creativity Focus on a single primary question . tenacity.

Next Steps . Start writing the protocol outline 5/28/14 . . .

Outline of the Study Protocol ! ! ! ! 5/28/14 Research Question Significance (Background) General and specific objectives Methodology ! Study Design .predictor variables outcome variables !Statistical issues – hypothesis sample size analytic approach ! Ethical considerations and issues .time frame epidemiologic approach ! Subjects .selection criteria sampling design ! Variables .

Formulation of Research Objectives ◆ ◆ 5/28/14 General Objectives Specific Objectives .

Why should research objectives be developed? ◆ ◆ ◆ ◆ 5/28/14 Focus the study Avoid collection of unnecessary data Organize the study Facilitate development of the research methodology .

to validate . to determine.How should objectives be stated? ◆ ◆ ◆ ◆ 5/28/14 Cover the different aspects of the problem in a coherent and logical sequence Clearly phrased in operational terms Realistic Use action verbs e. to compare.g.

attainable R .realistic T – time bound 5/28/14 .Guide for Assessing Objectives S – simple and specific M – measurable A .SMART .

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