Whoever Could Get Rid of the Context of Discovery/Context of Justification Dichotomy? A Proposal Based on Recent Developments in Clinical Research

Figures & data

FIGURE 1 Villard de Honnecourt: Lion et Porcupine. C. 1235. Pen and ink. (From Gombrich, E. H. [2000]. Art and Illusion. Princeton, NJ: Princeton University Press; pp. 176–177.)

FIGURE 2 Constable: Cloud Study. 5 Sept. 1822. (From Gombrich, E. H. [2000]. Art and Illusion. Princeton, NJ: Princeton University Press; pp. 176–177.)

FIGURE 3 Cozens: Sky template 1785. (From Gombrich, E. H. [2000]. Art and Illusion. Princeton, NJ: Princeton University Press; pp. 176–177.)

FIGURE 4 Constable: Drawing according to Cozens. (From Gombrich, E. H. [2000]. Art and Illusion. Princeton, NJ: Princeton University Press; pp. 176–177.)

FIGURE 5 Constable: Drawing according to Cozens. (From Gombrich, E. H. [2000]. Art and Illusion. Princeton, NJ: Princeton University Press; pp. 176–177.)

FIGURE 6 Constable: Drawing according to Cozens. (From Gombrich, E. H. [2000]. Art and Illusion. Princeton, NJ: Princeton University Press; pp. 176–177.)

TABLE 1 Excerpt from CONSORT Statement

Heading	Subheading	Descriptor
Title		Identify the study as a randomized trial
Abstract		Use a structured format
Introduction		State prospectively defined hypothesis, clinical objectives, and planned subgroup or covariate analyses
Methods	Protocol	Describe
		Planned study population, together with inclusion or exclusion criteria
		Planned interventions and their timing
		Primary and secondary outcome measure(s) and the minimum important difference(s), and indicate how the target sample size was projected
		Rationale and methods for statistical analyses, detailing main comparative analyses and whether they were completed on an intention-to-treat basis
		Prospectively defined stopping rules (if warranted)
	Assignment	Describe
		Unit of randomization (for example, individual, cluster, geographic)
		Method used to generate the allocation schedule
		Method of allocation concealment and timing of assignment
		Method to separate the generator from the executor of assignment
	Masking (blinding)	Describe
		Mechanism (for example, capsules, tablets)
		Similarity of treatment characteristics (for example, appearance, taste)
		Allocation schedule control (location of code during trial and when broken)
		Evidence for successful blinding among participants, person doing intervention, outcome assessors, and data analysts
Results	Participant flow and follow up	Provide a trial profile [ . . . ] summarizing participant flow, numbers and timing of randomization assignment, interventions, and measurements for each randomized group
	Analysis	State estimated effect of intervention on primary and secondary outcome measures, including a point estimate and measure of precision (confidence interval)
		State results in absolute numbers when feasible (for example, 10/20, not 50%)
		Present summary data and appropriate descriptive and interferential statistics in sufficient detail to permit alternative analyses and replication
		Describe prognostic variables by treatment group and any attempt to adjust for them
		Describe protocol deviations from the study as planned, together with the reasons
	Discussion	State specific interpretations of study findings, including sources of bias and imprecision (internal validity) and discussion of external validity, including appropriate quantitative measures when possible
		State general interpretation of the data in light of the totality of the available evidence
Source: Moher, D., Schulz, K. F., & Altman, D. G. (2001). ‘The CONSORT statement: Revised recommendations for improving the quality of reports of parallel group randomized trials,’ BMC Medical Research Methodology, 1(2).