12.11.2014 Views

Guidelines for the management of community ... - Brit Thoracic

Guidelines for the management of community ... - Brit Thoracic

Guidelines for the management of community ... - Brit Thoracic

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

BTS guidelines<br />

Appendix 3<br />

Types <strong>of</strong> study and levels <strong>of</strong> evidence used to illuminate specific clinical questions<br />

Type <strong>of</strong> clinical question Evidence level Brief definition Types <strong>of</strong> study providing this level <strong>of</strong> evidence<br />

Treatment Ia A good recent systematic review Systematic review <strong>of</strong> randomised trials<br />

Ib A rigorous study designed to answer <strong>the</strong> question A rigorous randomised trial comparing T with best alternative<br />

Is <strong>the</strong>rapy T effective? II One or more prospective clinical studies A cohort study or faulty randomised trial<br />

III One or more retrospective clinical studies A case-control study<br />

IVa Formal expert consensus Delphi study <strong>of</strong> expert practice<br />

IVb O<strong>the</strong>r in<strong>for</strong>mation Study <strong>of</strong> pharmacology <strong>of</strong> T<br />

Aetiology or harm Ia A good recent systematic review Systematic review <strong>of</strong> cohort studies<br />

Does A cause disease D? Ib A rigorous study designed to answer <strong>the</strong> question A large well-designed cohort study<br />

Does drug D cause side effect S? II One or more prospective clinical studies A faulty cohort study<br />

III One or more retrospective clinical studies A case-control study<br />

IVa Formal expert consensus Delphi study <strong>of</strong> expert opinion<br />

IVb O<strong>the</strong>r in<strong>for</strong>mation Study <strong>of</strong> pathophysiology <strong>of</strong> D<br />

Diagnosis or prognosis Ia A good recent systematic review Systematic review <strong>of</strong> blind comparisons <strong>of</strong> T with gold standard<br />

Is T an accurate test <strong>for</strong> diagnosis<br />

<strong>of</strong> D?<br />

Is finding F an accurate predictor<br />

<strong>of</strong> event E?<br />

Does severity measure M<br />

accurately predict event E?<br />

Ib A rigorous study designed to answer <strong>the</strong> question Blind prospective comparison <strong>of</strong> T, F or M with gold standard <strong>for</strong> D or E<br />

(eg, response to specific <strong>the</strong>rapy) with multivariate analysis<br />

II One or more prospective clinical studies Analysis <strong>of</strong> prospective test results in patients enrolled in a randomised<br />

clinical trial <strong>of</strong> <strong>the</strong>rapy <strong>for</strong> varying stages <strong>of</strong> D. Prospective validation<br />

study with univariate analysis<br />

III One or more retrospective clinical studies Retrospective study <strong>of</strong> test results or findings in a database <strong>of</strong> patients<br />

with univariate or multivariate analysis<br />

IVa Formal expert consensus Delphi study <strong>of</strong> expert opinion about T<br />

IVb O<strong>the</strong>r in<strong>for</strong>mation Study <strong>of</strong> pathophysiology <strong>of</strong> D<br />

Public health, health policy Ia Economic and policy analysis based on good<br />

recent systematic reviews<br />

Is policy P cost effective in <strong>the</strong><br />

NHS?<br />

Ib<br />

Economic and policy analysis based on a rigorous<br />

study designed to answer <strong>the</strong> question<br />

Economic and policy analysis with modelling and sensitivity analysis<br />

using data from systematic reviews <strong>of</strong> effectiveness and <strong>of</strong> cost studies<br />

in <strong>the</strong> same routine clinical settings<br />

Economic and policy analysis with modelling and sensitivity analysis<br />

using data from a randomised clinical trial <strong>of</strong> effectiveness and a cost<br />

study in <strong>the</strong> same routine clinical setting<br />

Economic and policy analysis with modelling and sensitivity analysis<br />

using o<strong>the</strong>r prospective data in various settings<br />

Economic and policy analysis with modelling and sensitivity analysis<br />

using retrospective data<br />

II<br />

Economic and policy analysis based on one or<br />

more prospective clinical studies<br />

III<br />

Economic and policy analysis based on one or<br />

more retrospective clinical studies<br />

IVa Formal expert consensus Delphi study <strong>of</strong> national expert opinion about P<br />

IVb O<strong>the</strong>r in<strong>for</strong>mation Local opinion about P<br />

Appendix 4<br />

Generic levels <strong>of</strong> evidence and guideline statement grades, appropriate across all types <strong>of</strong> clinical questions<br />

Evidence<br />

level Definition Example <strong>of</strong> study providing this level <strong>of</strong> evidence <strong>for</strong> a <strong>the</strong>rapy question<br />

Ia<br />

Ib<br />

A good recent systematic review <strong>of</strong> studies designed to<br />

answer <strong>the</strong> question <strong>of</strong> interest<br />

One or more rigorous studies designed to answer <strong>the</strong><br />

question, but not <strong>for</strong>mally combined<br />

One or more prospective clinical studies which illuminate, but<br />

do not rigorously answer, <strong>the</strong> question<br />

One or more retrospective clinical studies which illuminate<br />

but do not rigorously answer <strong>the</strong> question<br />

Cochrane systematic review <strong>of</strong> randomised controlled trials studying <strong>the</strong><br />

effectiveness <strong>of</strong> flu vaccines<br />

Randomised controlled trial <strong>of</strong> effectiveness <strong>of</strong> a flu vaccine<br />

II*<br />

Prospective cohort study comparing pneumonia rates in patients who are and B+<br />

are not vaccinated against flu; non-randomised controlled trial<br />

III{<br />

Audit or retrospective case control study, comparing flu vaccination history in B2<br />

patients who did and did not present with pneumonia<br />

IVa{ Formal combination <strong>of</strong> expert views Delphi study <strong>of</strong> UK expert recommendations <strong>for</strong> flu vaccination C<br />

IVb O<strong>the</strong>r in<strong>for</strong>mation Expert opinion, in<strong>for</strong>mal consensus; in vitro or in vivo studies on related topics D<br />

Guideline<br />

statement grade<br />

*Hard to differentiate Agency <strong>for</strong> Health Care Policy and Research’s ‘‘well designed controlled study without randomisation’’ (level IIa) from ‘‘o<strong>the</strong>r type <strong>of</strong> well-designed<br />

experimental study’’ (level IIb).<br />

{Major criterion is retrospective versus prospective data collection, since non-experimental designs are better suited than even randomised clinical trials <strong>for</strong> answering certain<br />

questions.<br />

{Distinguish <strong>for</strong>mal consensus from in<strong>for</strong>mal consensus methods according to <strong>the</strong> Health Technology Assessment 1998 systematic review.<br />

A+<br />

A2<br />

Thorax 2009;64(Suppl III):iii1–iii55. doi:10.1136/thx.2009.121434<br />

iii55

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!