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1.

Introduction

The use of multiparametric magnetic resonance imaging

(MRI) to inform the detection of prostate cancer (PCa) has

grown rapidly in the last few years. Numerous publications

have sought to standardise the conduct and reporting of

prostate MRI

[1–3]

. Most recently the European Society of

Uroradiology and the American College of Radiology

[4]

published the second version of the Prostate Imaging

Reporting and Data System (PI-RADS) outlining the conduct,

interpretation, and reporting of prostate MRI. These guide-

lines focus on PCa detection, and the questions asked are

‘‘How likely is it that this man has prostate cancer?’’ and

‘‘How can this best be biopsied?’’

The 2014 UK National Institute for Health and Care

Excellence (NICE) PCa guidelines

[5]

suggest a role for MRI

in the initial and repeat assessment of men on active

surveillance, although no guidance is offered on imaging

criteria for selection or continuation of surveillance. NICE

recommends MRI and/or biopsy for re-evaluation if there is

‘‘concern over prostate-specific antigen (PSA) kinetics or

clinical assessment.’’ The question asked of MRI is then ‘‘Has

there been any significant change?’’ To distinguish between

significant change, measurement error, and natural fluctua-

tions in tumour appearance, we need to understand the

natural history of MRI changes over time in men on active

surveillance in terms of change to MRI lesions and so-called

normal MRI findings. Once these data are established,

radiologic thresholds can be set that indicate significant

actionable, clinical change in disease.

Schoots et al reviewed the evidence for MRI in men on

active surveillance

[6]

. They found a lack of published data

in the use of MRI in active surveillance follow-up. The

European School of Oncology then convened the Prostate

Cancer Radiological Estimation of Change in Sequential

Evaluation (PRECISE) panel to develop recommendations

for MRI in men on active surveillance for PCa. Formal

consensus methodology, including the use of a face-to-face

meeting, was chosen. This technique is helpful to determine

the level of agreement amongst experts and to identify

areas that require further data before agreement can be

reached. The panel’s objective was to develop recommen-

dations for the reporting of individual MRI studies in men

on active surveillance (the PRECISE report form) and for

researchers reporting the outcomes of cohorts of men

having MRI on active surveillance (the PRECISE checklist).

2.

Materials and methods

2.1.

Study design

We used the RAND/UCLA Appropriateness Method

[7] .

A core group

(C.M.M., I.G.S., A.K., C.A., and F.G.) developed a draft set of 350 statements

and sent them to all panel members for modification. Statements could

be revised, removed, or added at this stage. A revised set of

394 statements was scored by each panel member on a scale of

agreement from 1 to 9, in which 1 indicated strongest disagreement and

9 indicated strongest agreement. These scores were collated, and a

summary of agreement, uncertainty, or disagreement (derived from the

group median score) was calculated for each statement. Calculations to

determine consensus or lack of consensus for each statement were

performed using the RAND/UCLA classical criteria that take into account

the proportion of panellists scoring within a given category of agreement

(7–9), uncertainty (4–6), or disagreement (1–3). For a statement to have

consensus, a clear majority scoring in that category is needed.

A chair (P.A.) who did not participate in scoring convened a panel

meeting. A graphic representation of the group response was presented

for each statement that included the group median score and the degree

of consensus

( Fig. 1

). Each statement was discussed. Some statements

were modified or removed; others were added as a result of the

discussions. Following discussion, each statement was rescored anony-

mously by each panel member. Following the meeting, the individual

panellist scores were collated, and the degree of agreement and

consensus was calculated for each statement. The collated scores and

the content of the discussion were used to develop the PRECISE checklist

of reporting criteria for studies of MRI in men on active surveillance and

was scored for agreement on a 9-point scale by each panellist prior to a panel meeting. Each

statement was discussed and rescored at the meeting.

Outcome measurements and statistical analysis:

Measures of agreement and consensus

were calculated for each statement. The most important statements, derived from both

group discussion and scores of agreement and consensus, were used to create the Prostate

Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) checklist and

case report form.

Results and limitations:

Key recommendations include reporting the index lesion size

using absolute values at baseline and at each subsequent MRI. Radiologists should assess

the likelihood of true change over time (ie, change in size or change in lesion characteristics

on one or more sequences) on a 1–5 scale. A checklist of items for reporting a cohort of men

on active surveillance was developed. These items were developed based on expert

consensus in many areas in which data are lacking, and they are expected to develop

and change as evidence is accrued.

Conclusions:

The PRECISE recommendations are designed to facilitate the development of a

robust evidence database for documenting changes in prostateMRI findings over time of men

on active surveillance. If used, they will facilitate data collection to distinguish measurement

error and natural variability in MRI appearances from true radiologic progression.

Patient summary:

Few published reports are available on how to use and interpret

magnetic resonance imaging for men on active surveillance for prostate cancer. The

PRECISE panel recommends that data should be collected in a standardised manner so

that natural variation in the appearance and measurement of cancer over time can be

distinguished from changes indicating significant tumour progression.

#

2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Please visit

www.eu-acme.org/ europeanurology

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