Cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (the BICAT-NL study): study design of a prospective multicenter randomised controlled trial.

BACKGROUND: Cataract surgery is one of the most frequently performed types of surgery. Most patients suffer from bilateral cataract and while cataract surgery of only one eye is effective in restoring functional vision, second-eye surgery leads to further improvements in health-related quality of life, and is cost-effective. At present, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS). The aim of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to test the hypothesis that ISBCS is non-inferior to DSBCS in terms of effectiveness and superior to ISBCS in terms of cost-effectiveness. METHODS/DESIGN: Multicenter non-inferiority randomised controlled clinical trial. Patients (18 years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study. Patients are randomly assigned to either ISBCS or DSBCS. The primary endpoint is the proportion of patients with a refractive outcome in the second eye within 1.0 dioptre from the target refraction, at 4 weeks after surgery. Secondary outcomes include corrected and uncorrected distance visual acuity, complications, patient reported outcomes (PROMs), cost-effectiveness, and budget impact. Follow-up visits are planned at 1 week after first-eye surgery and 4 weeks after second-eye surgery. At 3 months after first-eye surgery, the occurrence of complications is checked and patients fill in a final questionnaire. DISCUSSION: This study protocol describes the design of a multicenter non-inferiority randomised controlled trial. Current studies on ISBCS often lack information on safety regarding refractive outcomes. In addition, there is a lack of well-designed cost-effectiveness studies using established methods. The BICAT-NL study will provide more insight in refractive and cost-effectiveness outcomes for ISBCS compared to DSBCS. TRIAL REGISTRATION: This study was prospectively registered at Clinicaltrials.gov on January 17th 2018. (Identifier: NCT03400124 .

Diagnostic performance of breast technologists in reading mammograms in a clinical patient population.

PURPOSE: In the setting of an increasing workload for radiologists, this study focuses on the feasibility of skill mixing in breast imaging in a hospital radiology department. METHODS: Two radiological technologists with more than 10 years of experience in performing mammograms were trained in prereading mammograms to select the cases that require further evaluation by a radiologist. Mammograms of consecutive patients were independently evaluated by the technologists, next to the standard clinical interpretation by the radiologist on duty. Mammographic findings were recorded and a BI-RADS classification was assigned for each breast. Different prereading scenarios were analysed using clinical decision rules. Two different cut-off points of BI-RADS classifications were applied to the data. Analysis was performed for the overall clinical patient population as well as for a subgroup of patients with no immediate indication for further work-up. RESULTS: Mammograms of 1994 patients were evaluated. In total, 93 breast cancers were found in 91 patients (prevalence 4.6%). Sensitivity and specificity in selecting mammographic findings (cut-off point between BI-RADS 1 and BI-RADS 0, 2-5 and the radiologist's diagnosis as reference standard) was 98% and 74% for technologist 1 and 98% and 78% for technologist 2. In distinguishing normal and benign mammograms from those with abnormalities that are probably benign, suspicious or highly suggestive for malignancy (cut-off point BI-RADS 1-2 and BI-RADS 0, 3-5 and pathology results as reference standard), sensitivity decreased to 89% and 91% respectively. Specificity increased to 82% for both technologists. In a subgroup of 1389 patients with no immediate indication for additional imaging with the involvement of a radiologist, technologists obtained a mean sensitivity and specificity of 98% and 77% in detecting mammographic findings, and a mean sensitivity and specificity of 78% and 88% in detecting suspicious abnormalities. CONCLUSIONS: The employment of technologists in prereading mammograms seems to be an effective working strategy in daily clinical practice. However, its position in clinical practice remains indistinct as a continuous availability of radiologists still needs to be guaranteed. Nevertheless, as a substantial proportion of mammograms could be evaluated without the attention of a radiologist, the employment of technologists in prereading mammograms seems a promising new working strategy.

Pre-reading mammograms by specialised breast technologists: legal implications for technologist and radiologist in The Netherlands.

This paper focuses on the legal implications in terms of duties and responsibilities for radiologists and radiologic technologists of independent pre-reading of mammograms by radiologic technologists, so patients could be discharged without being seen by a radiologist. Pre-reading could be effectuated when preconditions are met to perform reserved procedures by unauthorised professionals as stated in the Individual Health Care Professions (IHCP) Act. Furthermore, compliance with a protocol or code of conduct in combination with adequate training and supervision should be sufficient to disprove potential claims. For a wide implementation, pre-reading should be well-embedded in legal rules and should answer the professional standard of care.

Performance of radiographers in mammogram interpretation: a systematic review.

Radiologists may be relieved from work that could be performed by radiographers. This systematic literature review focuses on the performance of radiographers (also referring to technologists and physician assistants) compared with radiologists in the interpretation of mammograms; the effect of training; and the question whether there are any studies evaluating the effects of involving radiographers in the interpretation of diagnostic mammograms in daily clinical practice on the sensitivity and specificity of cancer detection in breast imaging. Six studies met the inclusion criteria (primary aim of the study has to be the evaluation of the performance of radiographers, sensitivity and specificity have to be reported or calculable and there has to be a sufficient gold standard). The results showed that, in a screening setting, radiographers scored higher false positive rates with a similar sensitivity in the detection of malignancies, compared with radiologists. Furthermore, results suggested that training could improve their performance. No studies were reported assessing the performance of radiographers interpreting diagnostic mammograms in a consecutive patient population in a daily clinical setting. This indicates a need for a well-designed diagnostic study using an adequate gold standard, in order to evaluate the feasibility of deploying radiographers in the interpretation of diagnostic mammograms in a clinical setting.