Our objective is to study the efficiency of a modified assessment strategy which will counter the negative consequences of an increased referral rate.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Borstkanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter is the negative predictive value of preselection,
which is interrelated to secondary outcome parameters such as hospital referral
rate, detection rate, false-positive rate and the ultimate outcome survival
(estimated through a microsimulation model).
Secondary outcome
Additional outcome parameters are quality of life, anxiety, satisfaction,
productivity losses, patient time costs and volumes of care. The
cost-effectiveness analysis will estimate the cost per QALY gained and cost per
percentage increase in satisfaction with screening, or, if effects differ, the
incremental cost per QALY gained as the long run modelling outcome.
Background summary
Evaluation of the Dutch breast cancer screening programme showed that the
number of cancers detected could be increased by increasing the referral rate.
However, this would lead to a corresponding increase of false-positives,
resulting in an increased workload for GPs and hospital specialists, additional
financial costs and increased patient anxiety.
Study objective
Our objective is to study the efficiency of a modified assessment strategy
which will counter the negative consequences of an increased referral rate.
Study design
The study adopts a randomized clinical trial design with randomization before
consent.
Intervention
Women who are randomized into the intervention group that are assessed with a
BI-RADS code 4 or 5 (suspicious for malignancy) will directly be referred to
full hospital assessment, as in current screening practice. Non-invasive
pre-assessment will not be sufficient to reach a decision on diagnosis.
Women who are randomized into the intervention group with a BI-RADS code 0
(more information needed) will be referred to non-invasive pre-assessment in
the screening setting. The pre-assessment consists of an additional mammogram
and/or a breast ultrasound. The results of pre-assessment will either: increase
the suspicion that a malignant lesion is present (upgrade to BI-RADS 3, 4, 5),
in which case the woman will be referred for full hospital assessment; or
virtually exclude this possibility (downgrade to BI-RADS 1, 2), in which case
the woman will be classified as *definite benign* and go home reassured.
Study burden and risks
Women who participate in the study have to pay one extra visit to the
pre-assessment centre. In addition, the women are requested to fill in a
questionnaire that measures the quality of life, psychological consequences of
an abnormal screening mammography and satisfaction. A representative sample of
200 women in both arms is requested to fill a diary to register the use of
volumes of care, productivity losses and costs. The intervention is not a
treatment. It does not differ from the current practice in the type of
diagnostic techniques. It only differs in the workflow. Therefore, the risks
are negligible.
PO Box 9101
6500 HB Nijmegen
NL
PO Box 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
All women referred to hospital on basis of a positive screening mammography.
Exclusion criteria
Women who don*t understand the Dutch language, as well as women who are in a state of diminished responsibility or mentally disabled. they are not able to fill in the questionnaire and will not understand the information provided by the research assistant. They are therefore excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25266.091.08 |
| Other | nummer NTR 1480 |