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www.wren.wisc.edu The PRECIS-2 tool: Matching Intent with Methods www.wren.wisc.edu The PRECIS-2 tool: Matching Intent with Methods

www.wren.wisc.edu The PRECIS-2 tool: Matching Intent with Methods - PowerPoint Presentation

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www.wren.wisc.edu The PRECIS-2 tool: Matching Intent with Methods - PPT Presentation

David Hahn MD MS WREN Director Department of Family Medicine amp Community Health University of Wisconsin School of Medicine amp Public Health DLHahnwiscedu wwwwrenwiscedu Agenda Explanatory and pragmatic trial ID: 633476

wisc wren azmatics www wren wisc www azmatics score trials precis guideline explanatory pragmatic trial usual study visits enrollment

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Slide1

www.wren.wisc.edu

The PRECIS-2 tool: Matching Intent with Methods

David Hahn, MD, MS, WREN Director

Department of Family Medicine & Community Health

University of Wisconsin School of Medicine & Public Health

DLHahn@wisc.eduSlide2

www.wren.wisc.edu

Agenda

Explanatory and pragmatic trial

concepts

Introduce the PRECIS-2 tool

Present an example from my research

You score, I score

Audience participation using your research

We all scoreSlide3

www.wren.wisc.edu

Definitions

Explanatory (~efficacy)

Can this intervention work under ideal conditions?

Pragmatic (~effectiveness)

Does this intervention work under usual conditions?Slide4

www.wren.wisc.edu

Why is it important

to distinguish?

To ensure that the trial results can indeed support end user decisions in the ways intended by the trial design team.Slide5

www.wren.wisc.edu

Common mismatch

R

esults of explanatory (efficacy) studies are

too often used in

guidelines for general patient populations that were not studied.

Poor external validity risks inefficiencies and/or unintended adverse consequences (i.e., less benefit, more harm).Slide6

www.wren.wisc.edu

Example for today

Asthma treatment guidelines

are based

mainly on explanatory

studies that

collectively exclude ~95%

of people with asthma

(

Herland

et al.

Respir

Med

2005;

Travers

et al.

,

Thorax 2007

)Slide7
Slide8

AZMATICSSlide9

AZMATICS

Randomized

75/304 (25%)

If PFTs not required

77/304 (25%)

Declined placebo

34/304 (11%)Slide10

www.wren.wisc.edu

Important note

PRECIS-2 is focused exclusively on APPLICABILITY (

external

validity)

Not a tool to gauge

internal

validitySlide11

The Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) wheelSlide12

www.wren.wisc.edu

Eligibility

As the similarity between people

in the trial and those in usual care decreases, then so would the PRECIS-2 score.

AZMATICS:

adult asthma

Dx

and RAO; 30% actual enrollment, 50% potential enrollment.

Guideline trials: average 5% enrollment.Slide13

www.wren.wisc.edu

Recruitment

Via usual appointments in multiple clinics receives a high (very pragmatic) score; via media with incentives receives a lower score.

AZMATICS: via usual care in multi-state practices; no financial incentives.

Guideline

trials

:

Often via media; large incentivesSlide14

www.wren.wisc.edu

Setting

Good

match between setting of trial and setting where the results will be applied receives a higher score.

AZMATICS: conducted in settings where results are applied.

Guideline

trials

: Often in academic

research units.Slide15

www.wren.wisc.edu

Organisation

The greater the e

ase

of implementation in usual

care the higher the PRECIS-2 score

AZMATICS: oral tablet with simple instructions.

Guideline trials: oral, inhaled or injectable medications.Slide16

www.wren.wisc.edu

Flexibility: delivery

The closer the resemblance between trial intervention and actual use, the higher the PRECIS-2

score.

AZMATICS:

flexible dosing and scheduling, particularly in open label (OL) group.

Guideline

trials

:

flexibility varies.Slide17

www.wren.wisc.edu

Flexibility: adherence

Trials with no special measures to enforce compliance will score near 5; protocols that measure and monitor compliance will score

at or close to 1

AZMATICS:

weekly self-report.

Guideline trials: daily diaries, pill counts, even metered dose inhaler electronic monitoring.Slide18

www.wren.wisc.edu

Follow-up

Outcome data obtained from routine visits with no study visits

is the most pragmatic; the more intense the study follow up, the more explanatory.

AZMATICS: no study visits; Internet self-report.

Guideline trials: often intense/rigorous study visits.Slide19

www.wren.wisc.edu

Primary outcome

The more patient-important, the more

pragmatic; the more disease-oriented the more explanatory.

AZMATICS:

symptoms, quality of life.

Guideline trials: in transition from disease-oriented (PFTs, biomarkers) to patient-oriented.Slide20

www.wren.wisc.edu

Primary analysis

“Intention-to-treat” is

the most pragmatic approach; “as treated analysis” is the most explanatory.

AZMATICS: intention to treat.

Guideline trials: varies; both may be reported.Slide21
Slide22

www.wren.wisc.edu

Now it’s your turn

Choose a completed trial or a new protocol.

Discuss for each domain.

Come to a consensus on PRECIS-2 scores for each domain.

Reconvene to discuss the process.Slide23

The Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) wheel