Clinical Research Using PICO Framework

Lecture 03: Defining your research questions SoHP503 Project studies

• This lecture discusses defining research questions for SoHP503 project studies.
• The agenda covers using evidence for decision-making, formulating searchable questions, and finding relevant evidence.
• Intended learning outcomes include explaining PICO and PICOTE, applying the framework, formulating clinical questions, identifying research components, and creating viable research questions.
• Virtual meeting etiquette guidelines were mentioned, relating to phone use, keyboard, appropriate attire, awareness of surroundings, microphone use, and camera positioning.
• The anatomy of the research process was described, illustrating the journey from choosing a topic to developing a research project proposal and data collection/conclusion.

Decision Making Process

• According to Hastie and Dawes (2010), decision-making involves three parts:
  • Multiple courses of action
  • Consideration of outcomes/consequences
  • Assessment of consequences based on personal beliefs & goals

Use of Evidence to Decide

• Thomson & Stapley (2011) presented different types of decisions in clinical practice:
  • Decisions about interventions
  • Decisions on optimal patient selection for interventions
  • Decisions on timing of interventions
  • Decisions relating to delivery of information
  • Decisions on managing services and care delivery
  • Decisions on reassurance of patients

Consequences and Implications of Decisions

• Some decisions are more important than others based on potential for patient harm and costs.
• Clinicians need to identify areas of higher risk in their practice and assess the evidence base for treatments used in those high-risk areas.
• Practical consideration: Lack of research evidence for a specific treatment or area of concern

Types of Evidence

• Most appropriate evidence for general practice should be adopted and justified.
• Types include primary research, reviews of research, policy/guidelines/care pathways, clinical judgment, and patient experience/expertise.
• Additional types: statistical, testimonial, anecdotal, and analogical evidence.
• Anecdotal evidence shouldn't be relied upon unless absolutely necessary.

Examples - Evidence for Decisions

• Examples of clinical scenarios requiring evidence-based decisions were presented.
  • Patient with alcohol issues seeking self-discharge from hospital
  • Student colleague struggling emotionally
  • Patient seeking advice on vision therapy for a child
  • Patient with diabetes requiring specific treatment

Which Type of Evidence Do I Need?

• Evidence of effectiveness, patient experience, and practical application are important considerations for making decisions

Research that has not been conducted in your particular setting or patient group

• In some cases, there might not exist research for a particular set of patients or setting.
• Research that's conducted in related areas should be considered as a start
• Research from other disciplines could be a viable source of evidence.

Where can I get this from?

• List of resources to obtain high-quality information regarding drug, health services, and health statistics.
  • Clinical Trials.gov, Cochrane Library, NHS evidence, Google Scholar, MEDLINE, MedicalStudent.com, Merriam-Webster, NICE
  • Public Library of Science (PLOS), Plymouth Primo, PubMed, ScienceDirect, The British Library, Zetoc.
  • British National Formulary (bnf.org) and US Food and Drug Administration (fda.gov) for drug info
  • Medicines and Healthcare Products Regulatory Agency (mhra.gov.uk) etc for safety info

Key points

• Every decision demands evidence consideration.
• Various decision types and evidence types exist.
• Use research papers initially, and other rationales (like ethical considerations & clinical judgment) when no study exists
• Anecdotal evidence is a last resort.
• Always use the best available evidence.

Formulating Searchable Questions

• Searching for evidence begins with formulating clear questions.
• Questions can pertain to treatment methods, guidelines, policies, or research
• The structure of the question should be considered.
• Bad questions include those that are unanswerable or poorly focused.

Types of questions

• Clinical questions are categorized as background or foreground questions.
• Background questions address general knowledge. (Who, What, When)
• Foreground questions pertain to specific patient problems or scenarios.
  • Examples include interventions for myopia prevention in children, or the effectiveness of treatment based on patient demographics.

Type of foreground question

• Aetiology (cause of disease)
• Diagnosis (methods and interpretation of test results)
• Therapy (best interventions and harm reduction)
• Prognosis (likely outcome of disease and possibilities of complications)
• Magnitude (size of health problem in terms of patient numbers/costs)

Outlook: Research question and research design

• Research question types include descriptive, relational, and causal analyses.
• Descriptive research focuses on characteristics of a population/phenomenon
• Relational research examines relationships, or correlation, between variables.
• Causal research attempts to establish cause-and-effect relationships among variables.

Breaking down the clinical scenario

• The PICO framework provides a structure to phrase clinical questions.
• P = Patient/Population, I = Intervention, C = Comparison (interventions/placebos), O = Outcome

PICO Example 1

• Does hand washing reduce hospital-acquired infections in healthcare workers?

Identifying keywords

• Examples provided relating to patient scenarios.
• Example: A 72-year-old woman, with age-related macular disease, wants to know if antioxidant pills may slow down the progression of the disease, and the best ones to use

PICO Example 3

• 10-year-old patient with myopia, seeks to prevent further progression

Tips for writing a clinical question in practice

• Defining the person, patient, population, or problem (P). This involves listing specific qualities and characteristics for the patient or participant group.
• Identifying the intervention (I). Listing the procedure, treatment, or substance being used.
• Identifying the comparison intervention (C). Listing the alternative procedure, treatment, or substance to compare the intervention to.
• Identifying the outcome (O). Listing the result the study aims to achieve.

PICO Example 4

• For patient care workers, it relates to what method of hand-washing (medicated soap, alcohol-based solution) is most effective from an infection control perspective.

Common search frameworks

• PICO(S), PEO, SPIDER, ECLISSE, and SPICE are frameworks to guide searching, depending on the area under investigation

Finding evidence

• The phrasing of the question directly impacts the relevance and volume of search results.

How questions influence search results:

• Broad questions yield many results (often irrelevant)
• Narrow questions yield fewer results (often highly relevant)

Building a search strategy

• Identify the PICO, synonyms, resources.
• Apply truncations & wildcards in searches.
• Combine terms using Boolean operators (AND, OR, NOT).
• Combine terms using nesting.
• Refine search results using filters.

Identify synonyms

• Consider possible alternative terms for keywords to broaden and refine search.
• Recognize differences in spelling and terminology (UK vs US).

Terminology (database indexes, filters)

• Database-specific terms and filters should be considered while searching for evidence.
• (Database examples include Medline, CINAHL, Embase, PsychINFO, and the Cochrane library; their differences in content and terms)

Sources for synonyms

• Use medical encyclopaedia, dictionaries, and colleague’s expertise.

Identify Synonyms (Example)

• Example presented for an individual patient and potential use of the PICO framework

Combining final search strategy (example)

• Example of combining components for a complex search

Refine the search strategy - Filters

• Types of Evidence, background/foreground questions, along with patient/problem, intervention, comparison (interventions/ placebos), outcome.

Comparison - Answer

• Comparing common search strategies and EBP search strategies.

Summary search strategy

• Steps on how to proceed with a summary search strategy

Phrase your aims and objectives

• How to create clear aims & objectives for a research study

Terminology

• Definitions of research question, aim, objectives, and hypothesis

Research Aim

• Overview of the overall intention/goal of the research

Research Objectives

• How to formulate tangible and specific steps towards your research aim
• Steps must be SMART (Specific, Measurable, Achievable, Realistic, Time-constrained)

What is the difference between research aims and objectives?

• Explanation of the difference between aims & objectives

What not to do

• Mistakes to avoid when formulating aims & objectives

Table of words to be used

• Table providing terms related to understanding, applying, analysing, synthesising, and evaluating different types of research information

Example (Voluntary Counselling and Testing)

• Example provided to structure clinical research question, including aim, objectives

Example - SoHP503

• Example used to present research questions, aim, and objectives for a specific study

Please use the discussion board in case of questions. Thank you!

• Concluding remarks for the lecture