WP1 Justification Guideline Development Keith Horner.

WP1 Justification & Guideline Development

Keith Horner

Work package 1 objectives:

1. to perform a systematic review of CBCT based on ‘dose and risk’, ‘diagnostic accuracy’ and ‘quality assurance’

2. to develop provisional guidelines to input into WP6.

3. to incorporate knowledge obtained from the results of SEDENTEXCT study

4. to develop definitive referral criteria and guidelines on quality assurance, optimization etc. to input into WP6.

Objectives for Year 2:Due Date Status

D1.1 (M1.4)Systematic review complete

31 Jan 2009* Completed

M1.5Second Guideline Development Panel (GDP) meeting

31 Mar 2009* Completed12/13 March 2009

D1.2Provisional guidelines developed

31 Mar 2009* Completed6 April 2009

* Deferred deadlines agreed with EC through Annual Report process

Scientific Progress Report:

Systematic Review process

Scientific Progress Report:

Systematic Review process

Critical appraisal using standard forms

Scientific Progress Report:

Guideline development process: evidence tables

Scientific Progress Report:

Guideline development

Panel meeting (March 2009)

Each topic addressed by two assessors

Asked to consider evidence tables and formulate recommendations, taking into account:

•Volume of evidence •Applicability of the findings to clinical practice •Generalisibility of the results presented to the guideline’s target population •Consistency of the results (highlighting any major inconsistencies) •Clinical impact (e.g resource implications, balance of risk/benefit)

Scientific Progress Report:

Provisional Guideline document

•Internal/ external review pre-release (v1.0)

•Feedback after release of v1.1

•Dissemination

Scientific Progress Report:

Systematic Review process: problems encountered

•Some allocation of studies into wrong categories

•Some papers for review fitted several categories, not just one.

•The review form design for “diagnostic accuracy” studies could have been better

Forward Planning: 1 January 2010 – 31 December 2010

Date Milestones Deliverable June 2010 (Month 30)

M1.6 Start of definitive guideline development

October 2010 (Month 34)

M1.7 Systematic review updated

December 2010 (Month 36)

M2.6 M3.7 M4.7 M5.8

Completion of WP 2, 3, 4 and 5 work

January 2011 (Month 37)

M1.8 “Pre-definitive” guideline delivery

February 2011 (Month 38)

M1.9 First Delphi round: EADMFR

April 2011 (Month 40)

M1.10 Completion of WP1 work. Delivery of definitive guidelines

D1.3 Definitive Guidelines developed

Start earlier

Forward Planning:Finalise the revised proformas for systematic review and data extraction (UNIMAN/MAHOD)Set up intranet pages for posting of papers for review (UNIMAN)

Analyse feedback on Provisional Guidelines document (UNIMAN)

Continue with literature searches and collection of national guideline documentation (UNIMAN)

Confirmation of membership of Guideline Development Panel (all partners except LTO)

TITLE/ABSTRACT REVIEW

CLASSIFICATION INTO: EXCLUDE NON-RELEVANT

1. RADIATION AND DOSE RISK

2. EQUIPMENT FACTORS IN REDUCING RISK TO

PATIENT

3. QUALITY STANDARDS/QA

4. STAFF PROTECTION

5. ECONOMIC EVALUATION

6. JUSTIFICATION AND REFERRAL CRITERIA

(to be assessed using Protocol 1)

Diagnostic accuracy

or

“Studies of diagnostic relevance”

PROTOCOL 1. SCREENING OF STUDIES CLASSIFIED UNDER

“JUSTIFICATION AND REFERRAL CRITERIA”

PLEASE ANSWER ALL THREE QUESTIONS

1. Is this a diagnostic accuracy study? (typical outcome measures for accuracy studies include yield of abnormal/normal diagnoses, percentage correct diagnoses in case series, positive/negative predictive value, sensitivity/specificity in defined clinical setting, ROC curve or area under curve)

YES If YES please tick all clinical areas covered: Localised applications of CBCT for the developing dentition Generalized application of CBCT for the developing dentition Dental caries diagnosis Periodontal assessment Assessment of periapical disease Endodontics Dental trauma Exodontia Implant dentistry Bony pathosis Facial trauma Orthognathic surgery Temporomandibular joint

NO If No, does the study assess outcomes associated with therapeutic efficacy (e.g. CBCT changed management of case) or patient outcome efficacy (e.g CBCT improved patient outcome)?

Yes (To be considered for further assessment at later stage)

No (For reclassification)

Protocol 1

2. Is CBCT used as an index test? YES

NO

3. Is CBCT compared to a reference standard? YES

NO

If NO, is the paper an ‘observer study’?

YES (To be considered for further assessment at later stage)

NO

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For a study to be included in the section on ”Justification and referral critieria” you

must be able to answer YES to questions 1, 2 and 3.

INCLUDE EXCLUDE UNSURE (please provide comments)

Protocol 1

PROTOCOL 2. ASSESSMENT OF ”JUSTIFICATION AND REFERRAL

CRITERIA” PAPERS USING QUADAS

CBCT equipment used:

Manufacturer………………………………………

Name of equipment………………………………..

FOV………………………………………………. kV……………………………………

Reference standard:……………………………………………………………………….

1. Was the spectrum of participants

representative of the patients who will receive

the test in practice?

Yes No Unclear N/A

2. Were selection criteria clearly described? Yes No Unclear N/A

3. Was the reference standard likely to classify

the target condition correctly?

Yes No Unclear N/A

4. Was the period between performance of the

reference standard and the index test short

enough to be reasonably sure that the target

condition did not change between the two

tests?

Yes No Unclear N/A

5. Did the whole sample or a random selection of

the sample receive verification using the

reference standard?

Yes No Unclear N/A

6. Did participants receive the same reference

standard regardless of the index test result?

Yes No Unclear N/A

Protocol 2

7. Was the reference standard independent of

the index test? (that is, the index test did not form

part of the reference standard)

Yes No Unclear N/A

8. Was the execution of the index test described

in sufficient detail to permit its replication?

Yes No Unclear N/A

9. Was the execution of the reference standard

described in sufficient detail to permit its

replication?

Yes No Unclear N/A

10. Were the index test results interpreted

without knowledge of the results of the reference

standard?

Yes No Unclear N/A

11. Were the reference standard results

interpreted without knowledge of the results of

the index test?

Yes No Unclear N/A

12. Were the same clinical data available when

the test results were interpreted as would be

available when the test is used in practice?

Yes No Unclear N/A

13. Were uninterpretable, indeterminate or

intermediate test results reported?

Yes No Unclear N/A

14. Were withdrawals from the study explained? Yes No Unclear N/A

Protocol 2

REFERENCE STANDARD

+ve -ve

TP FP CBCT +ve

-ve FN TN

Which of the following does the study report? (in each case please state value and 95%CI when available) Sensitivity of CBCT ………………………………… Specificity of CBCT ………………………………… Positive predictive value ………………………………… Negative predictive value ………………………………… Likelihood ratios ………………………………… ROC analysis ………………………………… Other ………………………… …………………………………

OVERALL ASSESSMENT Do you trust the results of this study?

Fully (++)

Partially (+) No (-)

Additional comments

Protocol 2

Forward Planning: 1 January 2010 – 31 December 2010

Date Milestones Deliverable June 2010 (Month 30)

M1.6 Start of definitive guideline development

October 2010 (Month 34)

M1.7 Systematic review updated

December 2010 (Month 36)

M2.6 M3.7 M4.7 M5.8

Completion of WP 2, 3, 4 and 5 work

January 2011 (Month 37)

M1.8 “Pre-definitive” guideline delivery

February 2011 (Month 38)

M1.9 First Delphi round: EADMFR

April 2011 (Month 40)

M1.10 Completion of WP1 work. Delivery of definitive guidelines

D1.3 Definitive Guidelines developed