Blood test ordering for unexplained complaints in general practice: the VAMPIRE randomised clinical trial protocol.
Marloes A van Bokhoven1, Hèlen Koch, Trudy van der Weijden
1University 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
Insights
A watchful waiting strategy for unexplained complaints can reduce unnecessary blood tests and false positives. This study evaluated its accuracy and the impact of a quality improvement strategy on general practitioners' (GPs) testing behavior.
Area of Science:
- Clinical Epidemiology
- Health Services Research
- General Practice
Background:
- General practitioners (GPs) often order blood tests for unexplained complaints, leading to high false-positive rates.
- This can cause patient anxiety, increased costs, and morbidity due to unnecessary follow-up testing.
- Barriers exist for GPs in adopting a watchful waiting approach to postpone blood tests.
Purpose of the Study:
- To assess the accuracy of blood tests in detecting pathology in patients with unexplained complaints.
- To evaluate the diagnostic accuracy of a watchful waiting strategy.
- To determine the effectiveness of a quality improvement strategy in promoting the postponement of blood test ordering by GPs.
Main Methods:
- Randomized trial with three groups: immediate testing, watchful waiting, and watchful waiting with quality improvement.
- Includes a diagnostic study (patient level) and a quality improvement study (GP level).
- Follow-up of 12 months, assessing test accuracy, postponement effects, and secondary outcomes like patient quality of life and anxiety.
Main Results:
- The study aims to determine the accuracy and added value of blood tests and a watchful waiting strategy.
- It will assess the impact of a 4-week postponement on blood test characteristics and the number of tests ordered.
- The quality improvement strategy's effect on GP behavior will be evaluated.
Conclusions:
- This trial uniquely integrates clinical-epidemiological and quality of care research.
- Findings will inform strategies to optimize blood test utilization in primary care.
- The study seeks to reduce unnecessary testing while ensuring serious pathology is not missed.
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.
Design:
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.
Discussion:
The innovative aspect of this trial is that it combines a clinical-epidemiological study and a quality of care study.
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