notes: critical appraisal i: how to read a rct. chris...

25
Notes: Critical Appraisal I: How to read a RCT. Chris Gale May 2014 Deck Title http://strut.io/editor/preview_export/handouts.html 1 of 25 28/05/14 3:12 pm

Upload: nguyenhanh

Post on 10-Aug-2018

217 views

Category:

Documents


0 download

TRANSCRIPT

Notes:

Critical Appraisal I:

How to read a RCT.

Chris GaleMay 2014

Deck Title http://strut.io/editor/preview_export/handouts.html

1 of 25 28/05/14 3:12 pm

Notes:

How to ask a clinical question

How to search for a paperOvidPubmed

Tools for analysis.

Deck Title http://strut.io/editor/preview_export/handouts.html

2 of 25 28/05/14 3:12 pm

Notes:

Clinical Questions arise:

Seeing patientsConsultant ward roundsSupervision.

Deck Title http://strut.io/editor/preview_export/handouts.html

3 of 25 28/05/14 3:12 pm

Notes:

Epidemiology -- prevalence,risk factorsAetiology, mechanismsDiagnosisDisability, Recovery.Treatment: efficacy,effectiveness.

Deck Title http://strut.io/editor/preview_export/handouts.html

4 of 25 28/05/14 3:12 pm

Notes:

PECOT

In this population:Does this experimental conditionCompared to this control condtionProduce a better OutcomeOver this time period.

Deck Title http://strut.io/editor/preview_export/handouts.html

5 of 25 28/05/14 3:12 pm

Notes:

Systematic review of multiple meta analyses1.Meta analysis of good quality RCTs2.A large, high quality RCT3.Systematic review of RCTs4.High quality RCT(s)5.Open label trials6.Case reports7.Scholarly reviews8.Consensus expert opinion.9.Textbooks.10.

Deck Title http://strut.io/editor/preview_export/handouts.html

6 of 25 28/05/14 3:12 pm

Notes:

Traps for the unwary.

The reanalysis of a subset of datapresented as a meta analysis

Combining data from multiple RCTs andstating one trial

Underpowering a trial and saying thereis no significant difference ie equivelance.

Deck Title http://strut.io/editor/preview_export/handouts.html

7 of 25 28/05/14 3:12 pm

Notes:

Search engines.

Google scholar

Pubmed (Use clinical queries)

Deck Title http://strut.io/editor/preview_export/handouts.html

8 of 25 28/05/14 3:12 pm

Notes:Resources How To

Category:

Scope:

Clinical Study CategoriesTherapy

Broad

Systematic ReviewsTopic:

Medical Genetics

All

PubMed Clinical QueriesResults of searches on this page are limited to specific clinical research areas. For comprehensive searches, use PubMed directly.

Search

Sign in to NCBI

Schizophrenia Benzoate

Results: 5 of 750Case report of a patient presenting bothschizophrenia and Charcot-Marie-Tooth disease.Rafrafi R, Abdelaghaffar W, Ouanes S, Bekri I, Melki W, ElHechmi Z.Tunis Med. 2013 Dec; 91(12):740-1.

Add-on treatment of benzoate for schizophrenia: arandomized, double-blind, placebo-controlled trialof D-amino acid oxidase inhibitor.Lane HY, Lin CH, Green MF, Hellemann G, Huang CC,Chen PW, Tun R, Chang YC, Tsai GE.JAMA Psychiatry. 2013 Dec; 70(12):1267-75.

[Effect of antipsychotic amisulpride on immunereactivity].Idova GV, Al'perina EL, Lobacheva OA, Zhukova EN,Cheĭdo MA, Meniavtseva TA, Vetlugina TP.Eksp Klin Farmakol. 2013; 76(5):14-7.

Effects of cabergoline on hyperprolactinemia,psychopathology, and sexual functioning inschizophrenic patients.Kalkavoura CS, Michopoulos I, Arvanitakis P,Theodoropoulou P, Dimopoulou K, Tzebelikos E, LykourasL.Exp Clin Psychopharmacol. 2013 Aug; 21(4):332-41. Epub2013 Jul 8.

Antipsychotic combination using low-dose

Results: 5 of 28Delayed- and early-onset hypotheses ofantipsychotic drug action in the negativesymptoms of schizophrenia.Levine SZ, Leucht S.Eur Neuropsychopharmacol. 2012 Nov; 22(11):812-7. Epub2012 Apr 14.

Effects of drop-out on efficacy estimates in fiveCochrane reviews of popular antipsychotics forschizophrenia.Hutton P, Morrison AP, Yung AR, Taylor PJ, French P, DunnG.Acta Psychiatr Scand. 2012 Jul; 126(1):1-11. Epub 2012Apr 6.

Onset of action of atypical and typicalantipsychotics in the treatment of adolescentschizophrenic psychoses.Zedkova I, Dudova I, Urbanek T, Hrdlicka M.Neuro Endocrinol Lett. 2011; 32(5):667-70.

Pharmacological augmentation strategies forschizophrenia patients with insufficient responseto clozapine: a quantitative literature review.Sommer IE, Begemann MJ, Temmerman A, Leucht S.Schizophr Bull. 2012 Sep; 38(5):1003-11. Epub 2011 Mar21.

Risperidone versus other atypical antipsychotics

Results: 5 of 49A selective HDAC 1/2 inhibitor modulateschromatin and gene expression in brain and altersmouse behavior in two mood-related tests.Schroeder FA, Lewis MC, Fass DM, Wagner FF, Zhang YL,Hennig KM, Gale J, Zhao WN, Reis S, Barker DD, et al.PLoS One. 2013; 8(8):e71323. Epub 2013 Aug 14.

Dopamine D2 receptor signaling dynamics ofdopamine D2-neurotensin 1 receptor heteromers.Borroto-Escuela DO, Ravani A, Tarakanov AO, Brito I,Narvaez M, Romero-Fernandez W, Corrales F, Agnati LF,Tanganelli S, Ferraro L, et al.Biochem Biophys Res Commun. 2013 May 24;435(1):140-6. Epub 2013 Apr 25.

Reduction in phencyclidine induced sensorimotorgating deficits in the rat following increasedsystem xc⁻ activity in the medial prefrontal cortex.Lutgen V, Qualmann K, Resch J, Kong L, Choi S, BakerDA.Psychopharmacology (Berl). 2013 Apr; 226(3):531-40.Epub 2012 Nov 29.

Vulnerability to psychotogenic effects of ketamineis associated with elevated D2/3-receptoravailability.Vernaleken I, Klomp M, Moeller O, Raptis M, Nagels A,Rösch F, Schaefer WM, Cumming P, Gründer G.

Deck Title http://strut.io/editor/preview_export/handouts.html

9 of 25 28/05/14 3:12 pm

Notes:

OvidNeed to use library1.Each part of PECOT is a search2.Combine serially3.If multiple, add in search stringsfor

4.

meta analysis and RCTs.

Deck Title http://strut.io/editor/preview_export/handouts.html

10 of 25 28/05/14 3:12 pm

Notes:

Cochrane

Look for RCTs and reviews by topic andintervention.

[Need to do in library]

Deck Title http://strut.io/editor/preview_export/handouts.html

11 of 25 28/05/14 3:12 pm

Notes:

How to approach.

Introduction.

Methods

Results

What now.

Deck Title http://strut.io/editor/preview_export/handouts.html

12 of 25 28/05/14 3:12 pm

Notes:

Introduction.

Is the discussion of the condition sensible?1.Is there a clear clinical question?2.Does it answer the question you are interested in?3.Is the approach sensible and appropriate.4.

Consider the use of tools

EPIQ (Auckland) CATOxford CASP

Deck Title http://strut.io/editor/preview_export/handouts.html

13 of 25 28/05/14 3:12 pm

Notes:School of Population Health

Evidence-Based Practice and Critical Appraisal (updated May 2013)

Presentations and papers

In this section we provide a series of downloadable presentations on the EPIQ approach to evidence-based practice and critical appraisal anda paper we have published on the GATE approach to critical appraisal.

Presentation: An introduction to evidence-based practice by Rod Jackson (February 2013)(2.5MB PPT)

Presentation: The GATE approach to critical appraisal and EBP by Rod Jackson (February 2013)(1.8MB PPT)

Paper: The GATE approach to critical appraisal (published 2006)(1.7MB PDF)

Critically appraised topics (CATs) checklists for quantitative studies (updated February2013):

In this section we provide updated (2013) versions of our CAT checklists. The old versions and a brief history of their development can befound on the next page.

The new GATE CAT forms are now presented as MS Word documents rather than MS Excel documents, however the original calculator in theExcel version has been retained as a 1-page GATE Calculator. Each GATE CAT (MS Word) has an accompanying GATE calculator (MS Excel).We are also developing 1-page GATE CATs as writeable pdfs for rapid critical appraisals. To date we have completed one for RCTs/Cohort/Cross-sectional Studies and one for Diagnostic test Accuracy Studies.

GATE CATs and GATE calculators are designed to enable users to model the five steps of evidence-based practice and the electronic formsmake it easy to keep a record of the process. Users fill in the yellow-coloured fields of the CATs. Most of yellow fields have prompt questionsthat should be deleted after addressing the questions. The format of each GATE CAT is as follows:

Page 1 documents the clinical /practice scenario, the question asked (Step 1) and the search strategy and search results (Step 2).

Page 2 documents the first part of critical appraisal (Step 3a) which involves hanging the study on the GATE frame. Theaccompanying GATE Calculators should be completed with Page 2 of the GATE CAT. If you key the main study numbers into the GATEcalculator, it automatically calculates the relevant outputs including: risk, risk ratios, risk differences and NNTs, sensitivity, specificityas well as 95% confidence intervals for all estimates (note: the systematic review checklist does not include a calculator).

Pages 3-5 document the second part of critical appraisal (Step 3b) which is to assess the quality of the study (internal & externalvalidity, precision and power).

Page 6 documents the integration and application of evidence (Step 4) and personal and clinical audit (Step 5).

1. Evidence about Interventions (from RCTs, Cohort & Cross-sectional Studies)

GATE CAT for Intervention Studies: this MS Word form is designed for using evidence from RCTs and non-randomised cohort andcross-sectional studies to inform questions about the effectiveness of interventions.

Deck Title http://strut.io/editor/preview_export/handouts.html

14 of 25 28/05/14 3:12 pm

Notes:

Population.

From where?

Inpatient, outpatient, community?

How diagnosed?

How severe?

Who is excluded?

Deck Title http://strut.io/editor/preview_export/handouts.html

15 of 25 28/05/14 3:12 pm

Notes:

Describe when & from whereparticipants recruited

Define eligible population &inclusion and exclusion) criteria.

Describe recruitment process

What percentage of the invitedeligibles participated?What reasons were given fornon-participation among thoseotherwise eligible?

From EPIQ tool....Deck Title http://strut.io/editor/preview_export/handouts.html

16 of 25 28/05/14 3:12 pm

Notes:

Methods.

How robust is the randomization?1.How is allocation concealed?2.Are the two groups treated equivelantly?3.How reliable is the assessment? training? reliability measured?4.Are the assessors blinded?5.How is adherence measured (medications? Therapist (to manual?)6.How are dropouts accounted for (ITT LOCF)7.Is there a power calcuation?8.Does the statistical approach make sense?9.

Deck Title http://strut.io/editor/preview_export/handouts.html

17 of 25 28/05/14 3:12 pm

Notes:

HOME CRITICAL APPRAISAL WORKSHOPS CASP TOOLS & CHECKLISTS ABOUT US CONTACT US NEWS

CRITICAL APPRAISAL SKILLS PROGRAMME Making sense of evidence

Follow Follow @CASPUK@CASPUK 650 followers

CASP WorkshopsCASP offers critical appraisal skills workshops. Training can be in-house, or on ascheduled course.

3/3

We offer critical appraisalskills training, workshops andtools. These help you find andcheck research fortrustworthiness, results &relevance.

CASP CHECKLISTS

WORKSHOPS

NEWS

Sign up here to

Deck Title http://strut.io/editor/preview_export/handouts.html

18 of 25 28/05/14 3:12 pm

Notes:

HOME CRITICAL APPRAISAL WORKSHOPS CASP TOOLS & CHECKLISTS ABOUT US CONTACT US NEWS

CRITICAL APPRAISAL SKILLS PROGRAMME Making sense of evidence

Follow Follow @CASPUK@CASPUK 650 followers

This set of eight critical appraisal tools are designed to be used when reading research, these include tools for Systematic Reviews,Randomised Controlled Trials, Cohort Studies, Case Control Studies, Economic Evaluations, Diagnostic Studies, Qualitative studies andClinical Prediction Rule. These are free to download and can be used by anyone under the Creative Commons License.

CASP CHECKLISTS

Randomised Controlled Trial

Systematic Review

Qualitative

CASP Checklists (click to download)

Diagnostic

Cohort

Economic Evaluation

TweetTweet 173

Deck Title http://strut.io/editor/preview_export/handouts.html

19 of 25 28/05/14 3:12 pm

Notes:

Home CONSORT 2010 Extensions Downloads Examples Resources

DownloadsYou will find several collections of documents avaialable for download on this website,including translations of the CONSORT statement, extensions to CONSORT, and otherpublications, instruments, and resources. However the key document that we have madeavailable is the 2010 CONSORT statement checklist, which is available for download below inMicrosoft Word and Adobe .pdf format. We have also made the CONSORT flow diagram andthe CONSORT endorsement survey available to site visitors.

If you are looking for a particular document, and are not able to find it, please contact us, andwe'll do our best to make it available.

Downloads

CONSORT 2010 Checklist.doc (216 KB)

CONSORT 2010 Checklist.pdf (50.21 KB)

CONSORT 2010 Explanation and Elaboration (BMJ).pdf (636.65 KB)

CONSORT 2010 Flow Diagram.doc (47.5 KB)

Sign In

CONSORT 2010 Statement CONSORT Translations CONSORT Extensions

Deck Title http://strut.io/editor/preview_export/handouts.html

20 of 25 28/05/14 3:12 pm

Notes:

Results.Are all outcomes reported?1.Are all participants accounted for?2.Are the results of clincial importance.3.

Deck Title http://strut.io/editor/preview_export/handouts.html

21 of 25 28/05/14 3:12 pm

Notes:

Measurements of effect.

Effect size = change in normalized mean[derived from formulae]0.2 small, 0.5 moderate, 0.8 big.

Mean difference == Change mean difftx LESS Change mean diff controlDepends on scales.

Deck Title http://strut.io/editor/preview_export/handouts.html

22 of 25 28/05/14 3:12 pm

Notes:

Dichotamous variables

Risk ratio is the ratio recovered TxDIVIDED by ratio recovered control

[Odds Ratios generally not used RCTs]

Risk difference is the ratio recovered TxLESS ratio recovered control.

NNT = inverse risk difference.

Deck Title http://strut.io/editor/preview_export/handouts.html

23 of 25 28/05/14 3:12 pm

Notes:Deck Title http://strut.io/editor/preview_export/handouts.html

24 of 25 28/05/14 3:12 pm

Notes:

If in doubt.

Use the EPIQ spreadsheet.

Or use Revman. to Cochrane.orgto Archie

RevMan

Review Manager (RevMan) is the software used for preparing and maintainingCochrane Reviews.

You can use RevMan for protocols and full reviews. It is most useful when you haveformulated the question for the review, and allows you to prepare the text, build thetables showing the characteristics of studies and the comparisons in the review, and addstudy data. It can perform meta-analyses and present the results graphically.

Together with Archie (/archie) , RevMan forms the Cochrane Information ManagementSystem (IMS), which is designed to enable contributors to the Cochrane Collaboration tomeet the demands of producing high quality systematic reviews of the evidence of theeffects of healthcare and deliver these for publication in The Cochrane Library(http://www.thecochranelibrary.com/) and elsewhere.

RevMan continues to be developed through an ongoing process of consultation with itsusers and if you have any suggestions for improvements, please let us know. (/revman

/new-releases/revman-suggestion-form)

The latest major version, RevMan 5.2, was released on 8 November 2012.

Content available for RevManAmong other things, in this section you can find the following information:

What's New (/revman/new-releases/whats-new-in-revman-5) - List of changes made in updates to RevMan 5

Wish List (/revman/new-releases/revman-wish-list) - Suggestions that have not yet been scheduled forimplementationWe use cookies on this site to enhance your user experience.

By clicking 'Yes, I agree' you are giving your consent for us to set cookies.For more information, please see our disclaimer page.

Yes, I agreeYes, I agree Tell me moreTell me more

Deck Title http://strut.io/editor/preview_export/handouts.html

25 of 25 28/05/14 3:12 pm