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2	European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis
3	European Guidelines for Quality Assurance in Cervical Cancer Screening
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5	Chapter: 11 Communication (J.Austoker, L.Giordano, P.Villain and P. Hewitson )
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13	Methods for the guidelines on quality assurance on CRC screening For each point of the outline the available scientific evidence, if any, is reported: 1. clinical questions, based on PICOS drive the literature search 2. the available scientific literature is summarised and the LEVEL OF EVIDENCE is scored
14	"DATA BASES" DATA BASES: Embase, Medline, Cochrane collaboration METHOD: Mesh terms if available, free text otherwise No language restriction
15	"STUDIES" STUDIES: published since 2000 previously published studies considered, if relevant, or proposed by working group
16	"SYSTEMATIC REVIEWS" SYSTEMATIC REVIEWS: QUOROM DIAGNOSTIC ACCURACY: QUADAS COHORT / CASE CONTROL: NEWCASTLE-OTTAWA
17	"EVIDENCE TABLE FOR EACH STUDY" EVIDENCE TABLE FOR EACH STUDY SUMMARY DOCUMENT INCLUDING LEVEL OF EVIDENCE DESCRIPTIVE REPORT IF NO CLEAR EVIDENCE RECOMMENDATION TO BE DRAWN BY WORKING GROUP
18	FORMULATING QUESTIONS P ATIENT I NTERVENTION C ONDITION O UTCOME S TUDY DESIGN
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20	2. Level of evidence supporting the recommendations I: many RCTs or SRs of RCTs II: one RCT III: prospective cohort studies or SRs of cohort studies IV: retrospective case-controls studies or SRs of case controls studies V: case series; studies without control group VI: expert opinion
21	"In presence of" In presence of DISAGREEMENT the LEVEL OF EVIDENCE should be DISCUSSED
22	Example of evidence table
23	Chapters’ structure-I For each sub point of the index: starting from clinical questions based on PICOS (1) the available scientific literature and the LEVEL OF EVIDENCE (2) are reported EVIDENCE BASED RECOMMENDATION and their STRENGHT (3) are formulated by the working group
24	Chapters’ structure-II When scientific literature is not available the working groups should INTEGRATE the sub points APPENDIX: PICOS SEARCH STRATEGY EVIDENCE TABLES
25	3. Grading for strength of recommendations A: intervention strongly recommended for all patients B: intervention recommended C: intervention to be considered but with uncertainty about its impact D: intervention not recommended E: intervention strongly not recommended
26	"This grading doesn’t request a..." This grading doesn’t request a rigid correspondence with the levels of evidence. For example a grade A is given to intervention for which there are evidence level I (many RCTs or Sr of RCTs) but also to interventions that can’t be assessed by RCTs, e.g. psychological aspects, the importance of an accurate information to the patients, etc). A grade B is given to intervention for which there are lower evidence level (II or III) but also for intervention for which there are level evidence I but there is uncertainty about the impact of the intervention in the population or about its practical implementation (e.g. no resource availability , social barriers , supposed lack of acceptability by the target population). A grade C level is given to intervention for which there are no evidence and are not considered very important from other points of view. A grade D and E are given to intervention for which there are evidence of no benefit for the patients or for which the harm outweighs the benefits.
27	Evidence retrieved-I
28	Evidence retrieved-II
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30	"EACH GROUP TRANSLATES THE CHAPTER..." EACH GROUP TRANSLATES THE CHAPTER INDEX INTO SPECIFIC QUESTIONS FOR LITERATURE SEARCH A PRIORITY LEVEL WILL BE ASSIGNED TO EACH QUESTION.
31	"IS FOBT SCREENING OFFERED TO..." IS FOBT SCREENING OFFERED TO GENERAL POPULATION AGED 50 AND OLDER EFFECTIVE IN REDUCING COLORECTAL CANCER MORTALITY AND OVERALL MORTALITY?
32	"P" P: General population at average risk of colorectal cancer aged 50 years and older I: FOBT screening test; control intervention: no screening C: colorectal cancer O: colorectal mortality, overall mortality after at least 5 (10) years of follow up S: RCTs, systematic reviews of RCTs
33	"Medline" Medline: Search date 15th October 2007 Search Terms: (("Colorectal Neoplasms"[Mesh]) AND ("Mass Screening"[Mesh]) AND ("Occult Blood"[Mesh])) Systematic reviews only (no date restriction) – 42 results – most recent review (Kerr et. al.) and Cochrane review (Hewitson et. al.) selected for guideline evidence. 2007 only – 39 results – no relevant articles published after Kerr et. al. Systematic review
34	"Embase" Embase: Search date 15th October 2007 Search Terms: (exp Mass Screening AND exp Large Intestine Tumour AND exp Occult Blood) AND (systematic review$ OR metaanalys$ OR meta-analys$) – 8 results – most recent from 2005, i.e. before Kerr et. al. and therefore not included (exp Mass Screening AND exp Large Intestine Tumour AND exp Occult Blood) limit to yr=“2007” 47 results – no relevant articles published after Kerr et. al. systematic review
35	"GUAIAC TEST BIENNIAL INTERVAL" GUAIAC TEST BIENNIAL INTERVAL 4 studies, 329.642 participants: RR:0.84 (CI95%0.78 -0.90) GUAIAC TEST ANNUAL INTERVAL 3 studies, 245.764 participants: RR: 0.85 (CI95% 0.78 – 0.92)
36	"GUAIAC TEST ANNUAL AND BIENNIAL..." GUAIAC TEST ANNUAL AND BIENNIAL INTERVAL RR 0.85 (CI95%0.79-0.93)
37	"There is good evidence that..." There is good evidence that FOBT screening using the Guaiac test reduces mortality for colorectal cancer of invited participants by 16%. The reduction in colorectal cancer mortality has no impact on overall mortality because colorectal cancer is a disease which causes only a small proportion of the overall mortality. (LEVEL OF EVIDENCE I)
38	"1" 1. Which are patient-related criteria for postponing polypectomy in patients undergoing CRC screening primary FS screening b) colonoscopic assessment for positive screening test 2. Which are polyp-related criteria for performing immediate polypectomy in patients undergoing CRC screening primary FS screening b) colonoscopic assessment for positive screening test 3. Which is the appropriate and safe excision technique in patients eligible for polypectomy in CRC screening?
39	"4" 4. Which are polyp-related criteria indicating referral to surgery in patients detected with polyps at CRC screening 5. Which information should always be provided in the pathological report to orient further assessment, treatment and surveillance of patients detected with polyps at CRC screening 6. Which are appropriate quality indicators and standards to monitor and evaluate management of patients detected with polyps at CRC screening
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41	PROPOSED METHOD FOR QUESTIONS FORMULATION PICO(S) method; this is the method proposed by the Evidence Based Medicine Working Group and is also the method followed to define the objective and the inclusion criteria of studies by researchers who perform a systematic review. P: patients characteristics I: experimental intervention and control intervention on which the question is focused C: condition: pathology , illness O: outcome measure on which we are interested S: study design Example from chapter one Chapter 1.1 Evidence for efficacy of FOBt screening Chapter 1.2 Evidence for efficacy and Status of flexisig and colonoscopy screening Some specific questions derived from this general questions could be: Is FOBT screening offered to general population aged 50 and older effective in reducing colorectal cancer mortality and overall mortality? P: general population at average risk of colorectal cancer aged 50 years and older I: FOBT screening test; control intervention: no screening C: colorectal cancer O: colorectal mortality, overall mortality at least at 5 (10) years of follow up S: RCTs, systematic reviews of RCTs
42	Adopted methology
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46	Definition of members and functions of Editorial board Chapters authors Contributors Reviewers Literature group Colorectal cancer screening network Project steering committee
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