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Voortgangsverslag

Samenvatting
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Met veel enthousiasme zijn wij in september 2017 van start gegaan met onze studie in het Radboudumc te Nijmegen. In tweede instantie werd de studie vlot opgepakt door de twee andere ziekenhuizen (St. Antoniusziekenhuis locatie Leidsche Rijn en Noordwestziekengroep te Alkmaar). De snelle stijging van het inclusie-aantal was boven verwachting! Veel participerende vrouwen moedigden ons aan om onderzoek te doen naar het nut van mammogram, gezien veel vrouwen het als pijnlijk ervaren. Anderzijds werden ook kritische vragen gesteld door het team of we in de toekomst geen borstkanker zouden missen.

Naar aanleiding van een tussentijdse evaluatie hebben we de vragenlijsten iets verkort, zodat het de deelnemers minder tijd kost om het vragenformulier in te vullen en daarnaast bleek na de 1000+ inclusies dat bepaalde vragen (zoals "Hoe ervaart u het mammogram?") geen nieuwe inzichten meer zou opleveren.

 

Inmiddels hebben wij ruim 80% van het beoogd aantal te includeren patiënten reeds geincludeerd. Wij verwachten nog ongeveer vier maanden nodig te hebben om de rest van de patiënten te includeren. Dan hebben we weer een mijlpaal bereikt!~

 

Onze ervaring is dat de meeste patiënten deze studie aanmoedigen.

Resultaten
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Op dit moment zijn er nog geen resultaten.

Samenvatting van de aanvraag

Samenvatting
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OBJECTIVE(S)/RESEARCH QUESTION(S)

Is starting with ultrasound an accurate and cost-effective strategy for the evaluation of women with symptomatic breast disease?

 

HYPOTHESIS

It is expected that ultrasound only (with or without biopsy) will yield a definitive diagnosis in virtually all women with localized symptomatic breast disease. Mammography/tomosynthesis (DBT) in these women, the regular first line modality, could thus be avoided, yielding a potential cost-reduction of 5.2 M€ yearly.

 

STUDY DESIGN

Prospective diagnostic cohort study with intra-individual comparison.

 

STUDY POPULATION(S)/DATASETS

Women presenting with symptomatic localized breast disease

 

INTERVENTION

Initial targeted ultrasound and if necessary biopsy

 

USUAL CARE /COMPARISON

After initial work-up DBT will be performed. If required based upon additional findings on these images, ultrasound will be repeated, thus mimicking regular care.

 

OUTCOME MEASURES

Loss of sensitivity due to the omission of DBT

 

SAMPLE SIZE CALCULATION/DATA ANALYSIS

A sample size of 1951 patients is required to show that it is safe to implement the new approach in clinical practice in the Netherlands. This is based upon the expected breast cancer frequency away from the localized complaint in this population detected by DBT alone. As this is in fact screening, based upon extensive recent literature, we expect 0.8 cancers per 1000 women screened to appear in this population. Using a very narrow 95% confidence interval of 1%.

We will subsequently assess the actual frequency of breast cancer not detected by initial ultrasound will be assessed, and how often the radiologists still deem DBT necessary. Subgroup- analysis will be performed to identify women who, based on personal characteristics, symptoms and US features (e.g. BIRADS descriptors), might be at higher risk for cancer outside the symptomatic area, and for whom initial DBT may thus still be of more value.

 

 

COST-EFFECTIVENESS ANALYSIS/ BUDGET IMPACT ANALYSIS

Cost analysis will be performed from a societal perspective. Societal costs and quality-adjusted life years are measured alongside the trial. Resource use will be derived from hospital records. Relevant unit costs, of for example US and DBT examinations will be calculated according to the Dutch guidelines for costing research. Effectiveness is assessed in terms of breast cancers detected and quality-adjusted life years. A budget impact analysis is performed to assess the financial consequences of implementing the most cost-effective technique in patients with localized breast complaints, over different scenarios.

 

TIME SCHEDULE

48 months.

 

 

INTERVENTION

Initial targeted ultrasound and if necessary biopsy.

 

COMPARISON.

After initial work-up DBT will be performed. If required based upon additional findings on these images, ultrasound will be repeated, thus mimicking regular care.

 

OUTCOME MEASURES

Loss of sensitivity due to the omission of DBT

 

SAMPLE SIZE / DATA ANALYSIS:

1951 patients

 

 

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