clinical-research-guide

Clinical Research Guide

A skill for designing clinical studies and reporting results according to established guidelines. Covers randomized controlled trials (CONSORT), observational studies (STROBE), diagnostic studies (STARD), and systematic reviews (PRISMA).

Study Design Selection

Hierarchy of Evidence

Systematic Reviews / Meta-analyses
       |
Randomized Controlled Trials (RCTs)
       |
Cohort Studies (prospective)
       |
Case-Control Studies
       |
Cross-Sectional Studies
       |
Case Reports / Case Series
       |
Expert Opinion

Choose the design that best answers your research question
given ethical, practical, and resource constraints.

Design Decision Framework

def select_study_design(research_question: str,
                        can_randomize: bool,
                        outcome_prevalence: str,
                        time_constraint: str) -> dict:
    """
    Guide selection of clinical study design.

    Args:
        research_question: The clinical question
        can_randomize: Whether randomization is ethical and feasible
        outcome_prevalence: 'common' or 'rare'
        time_constraint: 'short', 'medium', or 'long'
    """
    if can_randomize:
        design = {
            "recommended": "Randomized Controlled Trial (RCT)",
            "reporting": "CONSORT 2010",
            "strengths": "Strongest causal inference",
            "considerations": [
                "Need equipoise (genuine uncertainty about which is better)",
                "Blinding may or may not be feasible",
                "Intent-to-treat analysis is the primary approach",
                "Pre-register at ClinicalTrials.gov or ISRCTN"
            ]
        }
    elif outcome_prevalence == "rare":
        design = {
            "recommended": "Case-Control Study",
            "reporting": "STROBE",
            "strengths": "Efficient for rare outcomes",
            "considerations": [
                "Select controls carefully (matching, population-based)",
                "Recall bias is a major threat",
                "Can only calculate odds ratios, not incidence"
            ]
        }
    elif time_constraint == "short":
        design = {
            "recommended": "Cross-Sectional Study",
            "reporting": "STROBE (cross-sectional extension)",
            "strengths": "Quick, inexpensive, good for prevalence",
            "considerations": [
                "Cannot establish temporal sequence",
                "Prevalence bias (overrepresents chronic conditions)",
                "Useful for hypothesis generation"
            ]
        }
    else:
        design = {
            "recommended": "Prospective Cohort Study",
            "reporting": "STROBE",
            "strengths": "Can establish temporal sequence, multiple outcomes",
            "considerations": [
                "Loss to follow-up is the main threat",
                "Confounding must be addressed analytically",
                "Expensive and time-consuming"
            ]
        }

    return design