Blood test ordering for unexplained complaints in general practice: the VAMPIRE randomised clinical trial protocol. [ISRCTN55755886].
BACKGROUND
General practitioners (GPs) frequently order blood tests when they see patients presenting with unexplained complaints. Due to the low prevalence of serious pathology in general practice, the risk of false-positive test results is relatively high. This may result in unnecessary further testing, leading to unfavourable effects such as patient anxiety, high costs, somatisation and morbidity. A policy of watchful waiting is expected to lower both the number of patients to be tested and the risk of false-positive test results, without missing serious pathology. However, many general practitioners experience barriers when trying to postpone blood testing by watchful waiting. The objectives of this study are (1) to determine the accuracy of blood tests in patients presenting with unexplained complaints in terms of detecting pathology, (2) to determine the accuracy of a watchful waiting strategy and (3) to determine the effects of a quality improvement strategy to promote the postponement of blood test ordering by GPs for patients with unexplained complaints.


METHODS
General practices are randomised over three groups. Group 1 is instructed to order blood tests immediately, group 2 to apply a watchful waiting policy and group 3 also to postpone testing, but supported by our quality improvement strategy. The trial consists of two sub-studies: a diagnostic study at patient level (group 1 versus groups 2 and 3) and a quality improvement study at GP level (group 2 versus group 3). The diagnostic strategy to be used involves of both customary and innovative tests. The quality improvement strategy consists of two small-group meetings and a practice outreach visit. Patient follow-up ends at 12 months after the initial consultation. Primary outcome measures are the accuracy and added value of blood tests for detecting pathology, the effect of a 4-week postponement of test ordering on the blood test characteristics and the quantity of tests ordered. Secondary outcome measures are the course of complaints, quality of life, satisfaction with care, anxiety of patients and practitioners, determinants of physicians' behaviour, health care utilisation and costs.


CONCLUSIONS
The innovative aspect of this trial is that it combines a clinical-epidemiological study and a quality of care study.
University of Maastricht, Care and Public Health Research Institute (CAPHRI), Department of General Practice/Centre for Quality of Care Research, PO Box 616, 6200 MD, Maastricht, The Netherlands. loes.vanbokhoven@hag.unimaas.nl
Marloes A
MA
van Bokhoven
Hèlen
H
Koch
Trudy
T
van der Weijden
Richard P T M
RP
Grol
Patrick J E
PJ
Bindels
Geert-Jan
GJ
Dinant
D000328:Adult; D002985:Clinical Protocols; D005194:Family Practice / Q000379:methods* / Q000592:standards; D005260:Female; D006403:Hematologic Tests / Q000592:standards* / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019370:Observation; D010043:Outcome and Process Assessment, Health Care; D010338:Pathology, Clinical; D011237:Predictive Value of Tests; D011785:Quality Assurance, Health Care; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D011795:Surveys and Questionnaires; D013997:Time Factors; D019564:Unnecessary Procedures