Clinical drug trials in general practice: how well are external validity issues reported?

BMC Primary Care

Table 2 External validity items reported in 134 drug trials in general practice

	Trials reporting data		Change in reporting over time
	n	%	p-value*
Total	134	100
Setting of the trial
Country	106	79.1	0.12
Clinical setting	30	22.4	0.82
Trial sites	122	91.0	0.05
Number reported	109	81.3
Names/affiliations listed	55	41.0
Selection of patients
Number of patients screened	61	45.5	0.005
Number of individuals who declined	24	17.9	0.12
Number of patients enrolled	134	100.0
Number of patients completed	125	93.3	0.34
Eligibility criteria reported	125	93.3	0.03
Characteristics of randomised patients
Comorbidity of included patients	54	40.3	0.002
Co-medication of included patients	27	20.1	0.002
Race/ethnicity of included patients	78	58.2	0.05
Outcome measures
Primary outcome
clinical	39	29.1
patient reported	25	18.7
surrogate	60	44.8
cost	1	0.7
other	7	5.2
not clearly defined	2	1.5
Surrogate outcomes only^a	47	35.1	0.72
Adverse effects of treatment
Details of adverse events	124	92.5	0.20

ISSN: 2731-4553