You are on page 1of 70

The Saudi Center for

Evidence Based Health Care

Breast Cancer

Clinical Practice Guideline
on the Use of Screening Strategies
for the Detection of Breast Cancer

April 2014

The Saudi Center for EBHC Clinical Practice Guideline 6

Antithrombotic Treatment of
Use of Screening
Allergic
Patients Rhinitis
with Strategies
in Asthma
Non-Valvular for
Atrial
Detection of Breast
Fibrillation Cancer i

Breast Cancer
Clinical Practice Guideline
on the Use of Screening Strategies
for the Detection of Breast Cancer

April 2014

Use of Screening Strategies for
Detection of Breast Cancer ii

Guideline Adaptation Panel Members

Saudi Expert Panel
Dr. Omalkhair Abualkhair
Dr. Ahmad Saadeddin
Dr. Bandar Al Harthy
Dr. Fatina Tahan
Dr. Iman Baroum

The Saudi Oncology Society

McMaster Working Group
Alonso Carrasco-Labra, Romina Brignardello-Petersen, Ignacio Neumann, Jan Brozek, and
Holger Schünemann on behalf of the McMaster Guideline Working Group

Acknowledgements
We acknowledge Dr. Abdulaziz Al Saif, Dr. Abdulmohsen Al Kushi, Dr. Abdulrahman
Al Naeem, Dr. Fatma Al Mulhim, Dr. Mushabbab Al Asiri, Dr. Sameerah Sulaimani, and Dr.
Ghada Farhat for their contribution to this work

Address for correspondence:
The Saudi Center for Evidence Based Health Care
E-mail: ebhc@moh.gov.sa
Web: http://www.moh.gov.sa/endepts/Proofs/Pages/home.aspx

Disclosure of potential conflict of interest:
Authors have no conflict of interest to declare.

Funding:
This clinical practice guideline was funded by the Ministry of Health, Saudi Arabia.

....................................................... 14 Appendices......................................................................................... 4 Scope and purpose........................................................................................................................................................................................................................................................................................................................................... 2 How to use these guidelines ............................................................................................................................................................................. 2 Methodology.................................................................. 5 Introduction ...................................................................................... 6 Key questions ............................................................................................... 16 Appendix 1: Evidence-to-Recommendation Tables and Evidence Profiles ......................................Use of Screening Strategies for Detection of Breast Cancer 1 Contents Executive summary .......................................................................................................................................................................................................................................................... 58 ................................................ 7 References ................. 5 How to use these guidelines ............................................................ 2 Introduction .................................................................................................................................................................................................................................................................................................................................................................. 6 Recommendations ........ 3 Recommendations ............................................................................................................................................................................... 5 Methodology........ 17 Appendix 2: Search Strategies and Results ............................................ 2 Key questions .......................................................................

8 Quality of evi- mography can identify early stage breast can.2% guideline panel to follow the structured con- of all morphological breast cancer variants. (Grading of Recommendations.5 We also conducted systematic occur in less developed countries. sensus process and transparently document all decisions made during the meeting (see Early detection of breast cancer in order to Appendix 1). On the other hand.2 According searches for information that was required to to the 2009 Cancer Incidence Report of the develop full guidelines for the KSA.1 There is widespread recommendations during this meeting. almost by the Canadian Task Force on Preventive 50% of breast cancer cases and 58% of deaths Health Care. Development and Evaluation) approach. Based on the In 2009 the age-specific incidence rate was updated systematic reviews we prepared 22. 8500) accounts for 78. directness. specific to the Saudi context. High quality This clinical practice guideline is a part of the evidence indicates that we are very confident larger initiative of the Ministry of Health of that the true effect lies close to that of the the Kingdom of Saudi Arabia (KSA) to establish estimate of the effect. the quality of the supporting evidence accord- examination can all identify tumors. For all selected questions we updat- world.7 mortality. Introduction The KSA guideline panel selected the topic of this guideline and all clinical questions ad- Breast cancer is the most common cancer in dressed herein using a formal prioritization women in both the developed and developing process. 2013 and formulated all breast cancer control.7/100. Poten- acceptance of the value of regular breast can.4 The guideline working group developed and Mammography. mate of the effect. Riyadh region (29. It is estimated that worldwide over ed existing systematic reviews that were used 508. Moderate quality evi- a program of rigorous adaptation and de novo dence indicates moderate confidence. low. the infiltrating duct to recommendation tables that served the carcinoma (ICD-O-3. Assessment.4/100. but there is a possibility .1/100. moderate.1 The reason for this is that breast cancer can be more effectively treated at an How to use these guidelines early stage.000).000.3 breast cancer is the searches for information about patients’ val- most common among women representing ues and preferences and cost (resource use) 25. The ultimate goals that the true effect is likely close to the esti- are to provide guidance for clinicians and re.6 We an age at diagnosis was 48 years (range 19 to used this information to prepare the evidence 99 years). Mam. ing to the GRADE approach. of treatment effects) is categorized as: high. and development of guidelines. and breast self.000 women died in 2011 due to breast for the 2010 “Screening for Breast Cancer in cancer. or very low based on consid- Methodology eration of risk of bias. The guideline panel met in Ri- improve survival remains the cornerstone of yadh on December 5.4/100.Use of Screening Strategies for Detection of Breast Cancer 2 duce variability in clinical practice across the Executive summary Kingdom.000). clinical breast examination by graded the recommendations and assessed a health care professional. consistency and precision of the estimates. tial conflicts of interests of all panel members cer screening as the single most important were managed according to the World Health public health strategy to reduce breast cancer Organization (WHO) rules. dence (confidence in the available estimates cer. In Saudi Arabia.000). including Kingdom of Saudi Arabia.1 Although breast cancer is thought to Average-risk Women Aged 40 to 74” guideline be a disease of the developed world. The medi. The three regions with the summaries of available evidence supporting highest incidence were Eastern region each recommendation following the GRADE (33.1% of all newly diagnosed female cancers. and Makkah region (26. it could also lead to over diagnosis and overtreatment.

the true effect is likely to be substan. Should screening for breast cancer among women all ages? with mammography (digital) vs. Adherence to this rec. Decision aids may be useful helping in- dividuals making decisions consistent with their values and preferences. with his or her values and preferences. proportion would not. Key questions 5. and that the true pressed as either strong (‘guideline panel rec- effect may be substantially different. For clinicians Most individuals should receive the Recognize that different choices will be intervention. The recommendation can be Policy making will require substantial ers adapted as policy in most situations debate and involvement of various stakeholders. ommends…’) or conditional (‘guideline panel very low quality evidence indicates that the suggests…’) and has explicit implications (see estimate of effect of interventions is very un. Finally. appropriate for individual patients and ommendation according to the that you must help each patient arrive guideline could be used as a quality at a management decision consistent criterion or performance indicator. Should breast self-examination be used to screen for breast cancer among women all ages? . no screening be used in women aged 40– 49 years? 2. further research is likely to have important potential for reducing the uncertainty. Should mammography (digital) be used to screen for breast cancer among women aged 50-69? 3. Should mammography (digital) be used to screen for breast cancer among women aged 70-74? 4. Low quality evidence indicates that our confidence in the The strength of recommendations is ex- effect estimate is limited. but many would not. these two grades is essential for sagacious tially different from the effect estimate and clinical decision making. Formal deci- sion aids are not likely to be needed to help individuals make decisions consistent with their values and preferences.Use of Screening Strategies for Detection of Breast Cancer 3 that it is substantially different. Should clinical breast examination be used to screen for breast cancer 1. Understanding the interpretation of certain. Table 1). Table 1: Interpretation of strong and conditional (weak) recommendations Implications Strong recommendation Conditional (weak) recommendation For patients Most individuals in this situation The majority of individuals in this situa- would want the recommended tion would want the suggested course course of action and only a small of action. For policy mak.

the inci. The panel determined that the strength of the recommendation should be weak/conditional Recommendation 3: based on the extensive level of uncertainty The Saudi Expert Panel suggests no screening and lack of evidence. (Conditional recommendation. scribed in this recommendation c vers only cal cancer registry data. the inci. Since the Remarks: guideline panel determined that there is a The panel determined that the strength of the close balance between desirable and undesir. . they also suggest imple. based on the extensive level of uncertainty menting shared-decision making strategies as and lack of evidence. (Conditional recommendation. this option should always be offered first to patients. screening with mammography seems to be tine physical examination. (Conditional recommen- dation. women between 70 to 74 years old. This fact may indi. The guideline panel also with mammography in women aged 70–74 highlighted that when mammography is avail- years. Based on lo. method of screening for breast cancer in cate that higher benefit on breast cancer mor. Remarks: Based on local cancer registry data. Clinical breast examination could be used as method for breast cancer screen- Remarks: ing only when mammography is unavailable. Remarks: quences in most settings. This recommendation does not relate to rou- es. low. In this regard. moderate-quality evidence) Recommendation 5: The Saudi Expert Panel suggests that clinical Remarks: breast examination by a health care profes- Based on local cancer registry data. In case this option is offered to years every 1 to 2 years. when mammography is spective into the decision. available. able. sional not be used as a single method of dence of breast cancer in the KSA for this age screening for breast cancer in women of all group is similar to the ones reported in the ages. breast self- Recommendation 2: examination plays a secondary role. the panel ommendation. especially The Saudi Expert Panel suggests screening in regions where mammography may not be with mammography in women aged 50–69 offered. The option de- not a priority for this age group. highlighted that. The guideline panel deter- Recommendation 1: mined that undesirable consequences proba- The Saudi Expert Panel suggests screening bly outweigh desirable consequences in most with mammography in women aged 40–49 settings. Giving the competing risks with other diseas. low-quality evidence) proposed that this should be done every 2 to3 years. The guideline panel also a way to incorporate actively patients’ per. (Conditional rec. very-low quality evidence) implementing breast cancer screening using mammography in this age group. the incidence of clinical breast examination in the context of breast cancer in the KSA for this age group is breast cancer screening. (Conditional recommen- tality justifies a recommendation in favor of dation. this option should always be offered first quality evidence) to patients. recommendation should be weak/conditional able consequences.Use of Screening Strategies for Detection of Breast Cancer 4 Recommendations similar to the ones reported in the literature in other countries. years every 2 years. no evi- literature in other countries. women of all ages. Recommendation 4: dence of breast cancer in the KSA seems to be The Saudi Expert Panel suggests that self- higher than in the other countries in which breast examination not be used as a single studies were conducted. The guideline dence) panel determined that desirable consequenc- es probably outweigh undesirable conse.

for the 2010 “Screening for breast cancer in tion strategies.1 There is methodological support of the McMaster Uni. these policies cannot elimi.7/100. The Saudi Expert Panel selected the topic of dence of breast cancer is increasing in the de. including According to the 2009 Cancer Incidence Re. the ultimate goal examination by a health care professional. The guidance about population-based screening three regions with the highest incidence were strategies to detect breast cancer in women. widespread acceptance of the value of regular versity working group produced clinical prac. ed existing systematic reviews that were used tion could be achieved implementing preven. For all selected questions we updat- western lifestyles. lines. and Makkah region cludes primary care physicians and specialists (26.2% of all morphologi- makers may also benefit from these guide.1 The reason for this is This clinical practice guideline is a part of the that breast cancer can be more effectively larger initiative of the Ministry of Health of treated at an early stage. searches for information that was required to develop full guidelines for the KSA. the infiltrating duct carcinoma (ICD-O- professionals.1 Although breast cancer is thought to present the details of the methodology in a be a disease of the developed world. by the Canadian Task Force on Preventive and middle-income countries where it is diag. we briefly describe the methodology we world.5 We also conducted systematic nosed in very late stages.000). due to the increase in dressed herein using a formal prioritization life expectancy. Although some risk reduc. stage breast cancer. Riyadh region The target audience of these guidelines in. breast cancer screening as the single most tice guidelines to assist health care providers important public health strategy to reduce in evidence-based clinical decision-making. The median age at diagnosis in medical oncology and radiology in the was 48 years (range 19 to 99 years). Saudi Arabia to establish a program of rigor. the Minis.000 women died in 2011 due to breast and quality of the supporting evidence. cancer outcome and survival remains the cor- try of Health (MoH) of Saudi Arabia with the nerstone of breast cancer control. in part. It is estimated that worldwide over used to develop and grade recommendations 508. Easter region (33. urbanization and adoption of process. Early detection in order to improve breast Given the importance of this topic.1/100. it could also lead to overdiagnosis and over- ous adaptation and de novo development of treatment. Other health care Arabia. 8500) accounts for 78.000. average-risk women aged 40 to 74” guideline nate the majority of breast cancers in low.Use of Screening Strategies for Detection of Breast Cancer 5 breast cancer is the most common among Scope and purpose women representing 25.3 . Mammography can identify early Kingdom. Health Care.000). this guideline and all clinical questions ad- veloping world.4/100.1% of all newly diag- nosed female cancers. searches for information about patients’ val- port of the Kingdom of Saudi Arabia (KSA). In Saudi Kingdom of Saudi Arabia. cal breast cancer variants. On the other hand. public health officers and policy 3. (29. We cancer. almost separate publication.2 The inci.4/100.4 Mammography.000). clinical breast guidelines in the Kingdom. breast cancer mortality.9 50% of breast cancer cases and 58% of deaths occur in less developed countries . In 2009 the age- The purpose of this document is to provide specific incidence rate was 22. being to provide guidance for clinicians and and breast self-examination can all identify reduce variability in clinical practice across the tumors. Introduction Methodology Breast cancer is the most common cancer in To facilitate the interpretation of these guide- women in both the developed and developing lines.

ion. The definition of for breast cancer in women. pa- each category is as follows: tients.9 Based on this information and the input of KSA panel members we prepared the evi. Based on the (see Appendix 1). or the courts  High: We are very confident that the should never view these recommendations as true effect lies close to that of the es. institutional review committees. but there is a pos- these guidelines by rote or in a blanket fash- sibility that it is substantially different. no the guideline panel to follow the structured screening be used in women aged 40– consensus process and transparently docu. 1. dictates. 49 years? . According to the GRADE approach. Assessment. mendations from these guidelines. Po- each recommendation following the GRADE tential conflicts of interests of all panel mem- (Grading of Recommendations. bers were managed according to the World Development and Evaluation) approach (see Health Organization (WHO) rules. companying each recommendation are its  Very low: We have very little confi- integral parts and serve to facilitate an accu- dence in the effect estimate: The true rate interpretation. The guideline panel met in updated systematic reviews we prepared Riyadh on December 5. How to use these We assessed the quality of evidence using the guidelines system described by the GRADE working group. For details on the process by decision-making.6 The guideline panel provided additional information. Should screening for breast cancer dence-to-recommendation tables that served with mammography (digital) vs. other stakeholders. 2013 and formulated summaries of available evidence supporting all recommendations during this meeting. Understanding the inter. can take into account all of the often- compelling unique features of individual clini-  Moderate: We are moderately confi- cal circumstances. particularly when lack of published evidence was identified. The following is a list of the clinical questions pretation of these two grades – either strong selected by the KSA guideline panel as rele- or conditional – of the strength of recom. or “very low” McMaster University Clinical Practice Guide- based on decisions about methodological lines provide clinicians and their patients with characteristics of the available evidence for a a basis for rational decisions about screening specific health care problem. the strength of a recommendation is either strong Key questions or conditional (weak) and has explicit implica- tions (see Table 1).7 Appendix 2). Therefore. third-party payers.Use of Screening Strategies for Detection of Breast Cancer 6 ues and preferences and cost (resource use) ment all decisions made during the meeting specific to the Saudi context. No guidelines and recommendations timate of the effect. which the questions were selected please re- fer to the separate methodology publication. vant for the Saudi context and addressed in mendations is essential for sagacious clinical this guideline.  Low: Our confidence in the effect es- timate is limited: The true effect may Statements about the underlying values and be substantially different from the es- preferences as well as qualifying remarks ac- timate of the effect. “moderate”.8 Quality of evidence is classified as The Ministry of Health of Saudi Arabia and “high”. They should never be effect is likely to be substantially dif- omitted when quoting or translating recom- ferent from the estimate of effect. “low”. Clinicians. no one charged dent in the effect estimate: The true with evaluating clinicians’ actions should at- effect is likely to be close to the esti- tempt to apply the recommendations from mate of the effect.

Should mammography (digital) be the option is implemented in intervals <24 used to screen for breast cancer months there is a reduction in the risk of among women aged 50-69? death from breast cancer of 18% (RR 0. Regarding screen. Should breast self-examination be benefit and considerable harm (RR 1. no judged to be “low”. High quality evidence). and therefore.94]. and the opinion of a below 50 years of age. this age group. mortality. There was disagreement within the panel about the rela- Recommendations tive importance of the outcome false positive results. in women bers’ clinical experience.50].72 – 0. In absolute positives in their decision-making. Use of digital mammography for breast attended the panel meeting. of the evidence for this recommendation was cer with mammography (digital) vs.100 women would Other women refuse breast cancer screening need to be screened every 2 to 3 years. Then. However. The panel agreed that there imaging be used as a strategy for breast can. fatalistic beliefs. Should mammography (digital) be [95%CI. The literature ascribed to breast cancer in 15% without sig. among women all ages? 5. phy in particular for perceived reduction of dence to recommendation table 1). three A recent Cochrane systematic review10 that sources of data informed this topic: literature included data from eight randomized con. about 2. However. the evidence shows that when providers. representative from the patients that partici- phy compared to no screening reduces deaths pated during the panel meeting. to save one additional life from breast many of the studies were done when partici- cancer over about 11 years of follow-up. absence of women would have an unnecessary breast symptoms. the use of mammogra. is considerable uncertainty regarding the cer screening”.11-13 panel mem- trolled trials (RCT) showed that. ther testing or harm arising from false- trieve any additional evidence. which was addressed in the baseline risk in this specify age subgroup. the overall quality Question 1: Should screening for breast can. Low quality evidence). After further input from a patient that I. reports that most women value mammogra- nificant effect on all-cause mortality (See evi. or work or family responsibilities biopsy. that do not allow for daytime appointments. in pants were already in screening programs.82 3. The sys. involved in decision making with their care ing interval. few women consider issues of fur- tematic search update conducted did not re. and 690 women will have a false posi. used to screen for breast cancer while the 95% confidence interval for screen- among women aged 70-74? ing ≥24 months includes both an important 4.04 used to screen for breast cancer [95%CI 0. er. the outcome of cancer screening false positive results was rated down from critical to important. but some would go for screening if . the absolute effect of mammography may also be higher. screening be used in women aged 40–49 years? Values and preferences: There are no local published data on women’s Summary of findings: values and preferences. existing in other countries. terms. The majority of women prefer to be jointly iety and follow-up testing. Canadian Task Force on Preventive Health Their experience and additional local evidence Care 2010 guideline was not considered as brought to the discussion3 suggest that the relevant for the KSA context by the guideline baseline risk in Saudi population may be high- panel. 75 because of fear. tive mammogram leading to unnecessary anx.Use of Screening Strategies for Detection of Breast Cancer 7 2. Should clinical breast examination be The guideline panel downgraded the quality used to screen for breast cancer of the evidence for the outcome breast cancer among women all ages? mortality from moderate to low due to seri- The question “Should magnetic resonance ous indirectness.72 – 1. 0.

the Resource use: panel recognized the necessity for educating Under lack of local evidence on costs. tion represents a good opportunity for shared this recommendation places higher value for decision-making. In addition. Availability of assessment clinics for false positive results. be higher than in the other countries in fits.500 using more accurate and direct evidence from per quality-adjusted life year (QALY) saved the local context. the cost per QALY gained for triennial screening those Remarks: aged 47 to 49 was about US$45.200 and $14. or used modelling techniques Research priority: to estimate cost-effectiveness ratios. using mammography in this age group. the inci- panel determined that probably the incre. tioned the need for closer monitoring via the a recent systematic review14 including 26 implementation of a mammography national studies from other regions that incorporated registry cost-effectiveness data alongside randomized controlled trials. therefore. will have a lower value compared to the per- ceived benefits on mortality. Centers Although there are no published or un. the the population on the importance of breast guideline panel agreed that the resources cancer screening strategies. of implementing breast cancer screening formed of previous initiatives for implement.000 US ommendation. deter. (Conditional rec- would cost between $24.000.000 to $65. this option is acceptable for all positive results and frequency of screening the stakeholders. point of view. low-quality evidence) dollars per QALY gained. the panel men- mammograms in the context of Saudi Arabia. The mammography national registry proposed mined that mammography and clinical breast by the panel also will inform further decisions examination cost an additional USD 35. In addition the review stated that the cost per life years Recommendation 1: saved.Use of Screening Strategies for Detection of Breast Cancer 8 recommended by their providers. from annual and biennial screening of women aged 40-49 was $26. the pa. and human resources. Implementation considerations: tient participating in the panel meeting cor. Among the costs related to this intervention can be listed: Monitoring and evaluation: equipment.16 From the panel’s decided that any psychological effect of false. The panel highlights that this recommenda- roborated panel’s perception and. compared with no screening. a also mentioned that all radiologists diagnosing higher number of well-trained radiologists are and reporting mammograms should be certi- needed. This fact may indicate that higher benefit on breast cancer Acceptability: mortality justifies a recommendation in favor Panel members mentioned that they are in. The Saudi Expert Panel suggests screening respectively. the guideline panel raphy in the Kingdom.000. which studies were conducted. Moreover. fied and be monitored periodically. needed to allocate are not small. Finally. The access for women with being alive and prevents death from breast disabilities should be guaranteed across the cancer irrespective of the consequences of Kingdom. A study mentioned that starting with mammography in women aged 40–49 the screening at the age of 40 instead of 50 years every 1 to 2 years. dence of breast cancer in the KSA seems to mental cost is small relative to the net bene. They available across regions in the Kingdom. Based on ing breast cancer screening using mammog- their clinical experience. women with positive (true & false) screening results should be guaranteed.15 The Based on local cancer registry data. In addition. Although The panel considered that control and audit digital mammogram equipment is widely the result of mammograms is important. Since . offering the service should also be regulated published data on the cost-effectiveness of and monitored.

therefore. However. The overall compared with no screening. Based on included data from seven randomized con. or used modeling techniques of 14% (RR 0. Regarding screening interval. Moreover. three would cost between $24. this age group. but some would go for screening if A recent Cochrane systematic review10 that recommended by their providers. phy in particular for perceived reduction of .88]. Moderate quality evidence). 26 women Resource use: would have an unnecessary breast biopsy. 204 Although there are no published or un- women will have a false positive mammogram published data on the cost-effectiveness of leading to unnecessary anxiety and follow-up mammograms in the context of Saudi Arabia. tients’ perspective into the decision. fatalistic beliefs. absence of Question 2: Should mammography (digital) symptoms. However. tematic search update conducted did not re. a recent systematic review14 including 26 dence shows that when the option is imple. In absolute being alive and prevents death from breast terms. the cost existing in other countries. or work or family responsibilities be used to screen for breast cancer among that do not allow for daytime appointments. A study mentioned that starting There are no local published data on women’s the screening at the age of 40 instead of 50 values and preferences. many of the studies were done when partici- gies as a way to incorporate actively pa. The sys.000.000 US sources of data informed this topic: literature dollars per QALY gained. from annual and biennial screening of women aged 40-49 was $26. Implementing screening mined that mammography and clinical breast ≥24 months also suggests a reduction in examination cost an additional USD 35. deter- quality evidence).67 [95%CI 0. 0. the pa- nificant effect on all-cause mortality (See evi.000. about 720 women would need to be screened every 2 to 3 years. to save one additional life from breast cancer irrespective of the consequences of cancer over about 11 years of follow-up. In addition the quality of the evidence for this recommenda. they also suggest im. Other women refuse breast cancer screening because of fear. the guideline panel trolled trials (RCT) showed that. and the opinion of a aged 47 to 49 was about US$45. in false positive results. saved. tient participating in the panel meeting cor- dence to recommendation table 2).86 [95%CI.98]. cost-effectiveness data alongside randomized duction in the risk of death from breast cancer controlled trials. positives in their decision-making. ceived benefits on mortality. positive results and frequency of screening phy compared to no screening reduces deaths will have a lower value compared to the per- ascribed to breast cancer in 12% without sig. this recommendation places higher value for trieve any additional evidence. plementing shared-decision making strate. Finally. testing. in women at decided that any psychological effect of false- least 50 years of age. panel determined that probably the incre- pated during the panel meeting. High to estimate cost-effectiveness ratios. per QALY gained for triennial screening those bers’ clinical experience. review stated that the cost per life years tion was judged to be “Moderate”. The literature mental cost is small relative to the net bene- reports that most women value mammogra. pants were already in screening programs.Use of Screening Strategies for Detection of Breast Cancer 9 the guideline panel determined that there is mortality.51 – per quality-adjusted life year (QALY) saved 0. the evi. 11-13 panel mem. their clinical experience. Values and preferences: respectively.75 – 0. ther testing or harm arising from false- sirable consequences.15 The representative from the patients that partici.000 to $65.500 breast cancer mortality (RR 0. studies from other regions that incorporated mented in intervals <24 months there is a re. women aged 50-69? The majority of women prefer to be jointly involved in decision making with their care Summary of findings: providers. roborated panel’s perception and.200 and $14. fits. few women consider issues of fur- a close balance between desirable and unde. the use of mammogra.

three dation. and monitored. In absolute terms. in this age group. representative from the patients that partici- dence of breast cancer in the KSA for this age pated during the panel meeting. In addition. values and preferences. the result of mammograms is important. Regarding screening interval. The systematic search cancer screening strategies. 0. 96 women will fied and be monitored periodically. 11 women would have an and reporting mammograms should be certi. They about 450 women would need to be screened also mentioned that all radiologists diagnosing every 2 to 3 years. and the opinion of a Based on local cancer registry data. women aged 70-74? Implementation considerations: The panel highlights that this recommenda. The Saudi Expert Panel suggests screening Values and preferences: with mammography in women aged 50–69 There are no local published data on women’s years every 2 years (Conditional recommen.45–1. Cost effectiveness studies be “low”. quences probably outweigh undesirable con- formed of previous initiatives for implement. The guideline phy in particular for perceived reduction of . breast cancer is not a priority or a main Recommendation 2: health problem. unnecessary breast biopsy. Low Research priority: quality evidence). The overall quality of the evi- using more accurate and direct evidence from dence for this recommendation was judged to the local context. Centers have a false positive mammogram leading to offering the service should also be regulated unnecessary anxiety and follow-up testing. Given other competing health risks. while the 95% confidence The mammography national registry proposed interval suggests an important benefit and a by the panel also will inform further decisions negligible harm.68.16 From the panel’s Question 3: Should mammography (digital) point of view. the reduction in breast cancer mortality (RR 0. The literature group is similar to the ones reported in the reports that most women value mammogra- literature in other countries. the inci. age group. sequences in most settings. sources of data informed this topic: literature existing in other countries. The access for women with meta-analysis of the two trials that reported disabilities should be guaranteed across the results for women aged ≥70 years (Swedish Kingdom. East and West) found that women with positive (true & false) screening screening led to a non-statistically significant results should be guaranteed.11-13 panel mem- Remarks: bers’ clinical experience. moderate-quality evidence).Use of Screening Strategies for Detection of Breast Cancer 10 Acceptability: panel determined that desirable conse- Panel members mentioned that they are in. to save Monitoring and evaluation: one additional life from breast cancer over The panel considered that control and audit about 11 years of follow-up. ing breast cancer screening using mammog- raphy in the Kingdom. Summary of findings: tion represents a good opportunity for shared A recent systematic review10 that conducted a decision-making. the evidence tioned the need for closer monitoring via the shows that when the option is implemented implementation of a mammography national in intervals ≥24 months there is a 32% reduc- registry tion in the risk of death ascribed to breast cancer (RR 0. However. Availability of assessment clinics for Two County.01]. update conducted did not retrieve any addi- tional evidence.68 [95%CI. In addition.45 – 1. panel recognized the necessity for educating 95% CI 0.01) (See evidence to recom- the population on the importance of breast mendation table 3). this option is acceptable for all be used to screen for breast cancer among the stakeholders. The panel considered that the op- are also needed to inform future guidelines tion might not be relevant for this particular and stakeholders. the panel men.

Panel members mentioned that they are in- positives in their decision-making. screening with mammography seems to be not a priority for this age group.000. tioned the need for closer monitoring via the a recent systematic review14 including 26 implementation of a mammography national studies from other regions that incorporated registry cost-effectiveness data alongside randomized controlled trials. the population on the importance of breast tient participating in the panel meeting cor.000 to $65. the pa. women with positive (true & false) screening positive results and frequency of screening results should be guaranteed. In addition. In addition the are also needed to inform future guidelines review stated that the cost per life years and stakeholders. the guideline panel Kingdom. offering the service should also be regulated published data on the cost-effectiveness of and monitored. Acceptability: ther testing or harm arising from false. deter. or used modeling techniques Research priority: to estimate cost-effectiveness ratios. this recommendation places higher value for Monitoring and evaluation: being alive and prevents death from breast The panel considered that control and audit cancer irrespective of the consequences of the result of mammograms is important. They false positive results. Availability of assessment clinics for decided that any psychological effect of false. Cost effectiveness studies compared with no screening. Finally. Based . or work or family responsibilities that do not allow for daytime appointments. the panel men- mammograms in the context of Saudi Arabia. cancer screening strategies. Based on disabilities should be guaranteed across the their clinical experience.200 and $14. raphy in the Kingdom. A study mentioned that starting the screening at the age of 40 instead of 50 The Saudi Expert Panel suggests no screening would cost between $24. from annual and biennial screening of women aged 40-49 was $26. also mentioned that all radiologists diagnosing and reporting mammograms should be certi- Resource use: fied and be monitored periodically. roborated panel’s perception and. the will have a lower value compared to the per.Use of Screening Strategies for Detection of Breast Cancer 11 mortality. Centers Although there are no published or un. In addition.000.000 US with mammography in women aged 70–74 dollars per QALY gained. Recommendation 3: respectively. symptoms.16 From the panel’s Other women refuse breast cancer screening point of view. Remarks: mental cost is not small relative to the net Giving the competing risks with other dis- benefits. low- per QALY gained for triennial screening those quality evidence) aged 47 to 49 was about US$45. therefore. panel recognized the necessity for educating ceived benefits on mortality.15 The panel determined that probably the incre. ing breast cancer screening using mammog- pants were already in screening programs.500 using more accurate and direct evidence from per quality-adjusted life year (QALY) saved the local context. formed of previous initiatives for implement- many of the studies were done when partici. but some would go for screening if decision-making. few women consider issues of fur. fatalistic beliefs. this option is acceptable for all because of fear. The access for women with recommended by their providers. Implementation considerations: The majority of women prefer to be jointly The panel highlights that this recommenda- involved in decision making with their care tion represents a good opportunity for shared providers. Moreover. However. The mammography national registry proposed mined that mammography and clinical breast by the panel also will inform further decisions examination cost an additional USD 35. saved. eases. absence of the stakeholders. the cost years (Conditional recommendation.

The panel determined that the strength of en refuse breast cancer screening because of the recommendation should be fear. Some wom. the and frequency of screening will have a lower panel proposed that this should be done value compared to the perceived benefits on every 2 to 3 years. This raises concern for the potential harms of Implementation considerations: breast self-examination with the subsequent The panel considered this option as feasible lack of evidence of their effectiveness in de.18 These trials reported that breast the relation between incremental cost and self-examination did not lead to significant relative to the net benefits is uncertain. therefore.2]) (See evidence to recommendation From the panel’s point of view. Based on their clinical ex- probably outweigh desirable consequences perience. weak/conditional based on the extensive or work or family responsibilities that do not level of uncertainty and lack of evidence. and easy to implement. The panel recognizes that more research in this area is The overall quality of the evidence for this needed in order to inform further recommen- recommendation was downgraded from dations on this regard. The . this option is table 4). In case this option is offered psychological effect of false-positive results to women between 70 to 74 years old. breast cancer mortality in the context of Saudi ings of two studies conducted in Russia17 and Arabia. the incidence allow for daytime appointments. Remarks: pated during the panel meeting. “moderate” to “very low” given that there is Recommendation 4: no data informing breast cancer mortality. However. this recommendation cancer screening places higher value for being alive and pre- vents death from breast cancer irrespective of Question 4: Should breast self-examination the consequences of false positive results. be used to screen for breast cancer among women all ages? Resource use: Given that there are no published or un- Summary of findings: published data on the cost-effectiveness of The evidence synthesis reported on the find.Use of Screening Strategies for Detection of Breast Cancer 12 on local cancer registry data.98 [95%CI Acceptability: 0. (Conditional recommen- existing in other countries. differences between the option and control groups in all-cause mortality (RR 0. very-low quality evidence) bers’ clinical experience. The cited studies also detected an acceptable for all the stakeholders. three method of screening for breast cancer in sources of data informed this topic: literature women of all ages. and the opinion of a representative from the patients that partici. Finally. increased harm for benign breast biopsy. Research priority: cer mortality or all-cause mortality were lo. The guideline panel some would go for screening if recommended determined that undesirable consequences by their providers. but ture in other countries. tiveness of breast self-examination.83-1.11-13 panel mem. creasing mortality. absence of symptoms. cision making with their care providers. the guideline panel decided that any in most settings. dation. There is very limited evidence on the effec- cated in the updated literature search. Use of breast self-examination for breast ception and. The majority of breast cancer in the KSA for this age group of women prefer to be jointly involved in de- is similar to the ones reported in the litera. No new studies on the im- pact of breast self-examination on breast can. fatalistic beliefs. Values and preferences: The Saudi Expert Panel suggests that self- There are no local published data on women’s breast examination not be used as a single values and preferences. the guideline panel determined that Shanghai. the patient participating in the panel meeting corroborated panel’s per- II. mortality.

should always be offered first to patients. In this regard. breast examination in the context of breast ception and. the patient participating in in this recommendation covers only clinical the panel meeting corroborated panel’s per. but mammography is available. this option some would go for screening if recommended should always be offered first to patients. three sional not be used as a single method of sources of data informed this topic: literature screening for breast cancer in women of all existing in other countries. especially in regions where Under lack of local evidence on costs for this mammography may not be offered. Question 5: Should clinical breast examina- tion be used to screen for breast cancer Research priority: among women all ages? There is very limited evidence on the effec- tiveness of clinical breast examination. This and frequency of screening will have a lower recommendation does not relate to routine value compared to the perceived benefits on physical examination. this recommendation cancer screening. Use of clinical breast examination for small. absence of symptoms. The option described mortality. guideline panel also highlighted that when cision making with their care providers. There are no published or unpublished breast cancer screening data on the cost effectiveness of clinical breast examination. The of women prefer to be jointly involved in de. this option the consequences of false positive results. (Conditional recommendation. the guideline panel decided that any method for breast cancer screening only psychological effect of false-positive results when mammography is unavailable. The Summary of findings: panel recognizes that more research in this No evidence was found indicating that Clinical area is needed in order to inform further rec- Breast Examination reduces breast cancer ommendations on this regard mortality or all-cause mortality. and the opinion of a dence). no evi- bers’ clinical experience. the guideline panel agreed that the resources needed to allocate probably are III. However. (See evidence to recommendation table 5). Clinical breast examination could be used as perience.Use of Screening Strategies for Detection of Breast Cancer 13 guideline panel also highlighted that.11-13 panel mem. The majority level of uncertainty and lack of evidence. breast self-examination plays a Resource use: secondary role. by their providers. places higher value for being alive and pre- . Some wom. representative from the patients that partici- pated during the panel meeting. Remarks: en refuse breast cancer screening because of The panel determined that the strength of fear. when vents death from breast cancer irrespective of mammography is available. Finally. therefore. the recommendation should be or work or family responsibilities that do not weak/conditional based on the extensive allow for daytime appointments. fatalistic beliefs. Recommendation 5: Values and preferences: The Saudi Expert Panel suggests that clinical There are no local published data on women’s breast examination by a health care profes- values and preferences. intervention. Based on their clinical ex. ages.

Marshall D. systematic review.CD001877. summary of findings tables. 11. al. 2011. canadienne. 2014. 7: Breast Cancer of mammography screening in Screening.64(4):401-406. WHO.: World Health 2014. 10. 3.iarc. Arabia. 2006. Results of a 9. Connor Gorber S. Journal of 2010. Methodology for the [Russia (St. Aust. Recommendations on screening theory perspective on why women do for breast cancer in average-risk or do not decide to have cancer women aged 40-74 years. Irwig LM. IARC. Hosseini H. national public breast cancer 8. The global burden of disease: University Clinical Practice Guidelines.0. Manikhas AG. France: Denmark based on discrete ranking International Agency for Research on data.42(4):347-357. 2012. World Health Organization. et al. DOI: 2013. Barfar E.64(4):383-394. Handbooks of Cancer 12. Introduction.pd Musaad SM. 2002. 5. Oxman AD. Int J Technol Assess Health Care. Gyrd-Hansen D. http://apps. Benefits. Preston SD. Sep-Oct the quality of evidence. Cost 2011. Saudi Cancer Walsh J.fr. Cancer.65(6):1130-1140. The first f. Apr 17.16(3):811-821.183(17):1991-2001. Schunemann screening program in Saudi Arabia. 2000. Cost-benefit analysis Prevention. Thabane L. McMaster University Guideline prospective randomized investigation Working Group. Ferlay J. Van Bebber S. vol. 4.Petersburg)/WHO] to Development of the Ministry of Health evaluate the significance of self- of Saudi Arabia and McMaster examination for the early detection of . Organization. Rating Annals of Saudi medicine. Saudi Arabia: Kingdom of Saudi for cancer screening. Barooti E. Ervik M. Med J Development. García AD. Moiseyenko VM. A review of Registry: Cancer Incidence Report studies examining stated preferences 2009. Soerjomataram I. Tonelli M.1002/14651858. a GRADE guidelines: 1. et al. 665/75146/1/9789241548441_eng. 2013. Jazieh AR. clinical epidemiology. Jørgensen KJ. GRADE guidelines: 3. Vol 7. 10. Ackerson K. harms and costs of screening 7. Nov 22 Nosratnejad S. Semiglazov VF.who. Accessed February 7. Art. Akl EA. Gøtzsche PC. Prev Chronic Dis. et for breast cancer with mammography.int/iris/bitstream/10 16. = journal de l'Association medicale 14.: IARC CancerBase No. Balshem H.30(5):350-357. screening using mammography. et al. Iranian journal of GRADE evidence profiles and public health.Use of Screening Strategies for Detection of Breast Cancer 14 References 1. Al Tahan FM. Issue 6. 2009. 2002.2008. Guyatt G. effectiveness of breast cancer 6. 2004 update.pub5. Abulkhair OA. HJ. Lyon. 2013. Joffres M. Barratt AL. Houssami N. WHO mammography in women 70 years Handbook for Guideline and over: a systematic review. Helfand M. Rashidian A. Al-Eid HS. Apr Salkeld GP. 11 [Internet] CD001877. CMAJ : screening: systematic review. Phillips KA. Ministry of Health.176(6):266-271. Journal of 15. Cancer Cochrane Database of Systematic Incidence and Mortality Worldwide: Reviews. Young SE. clinical epidemiology. Accessed December 2013. A decision et al. No. 2011. 2012. Screening 2. http://globocan. GLOBOCAN 2012 v1. Glasziou PP.3(3):A75. 13. J Adv Canadian Medical Association journal Nurs.

Use of Screening Strategies for
Detection of Breast Cancer 15

breast cancer. Vopr Onkol. examination in Shanghai: final results.
2003;49(4):431-441. Journal of the National Cancer
18. Thomas DB, Gao DL, Ray RM, et al. Institute. Oct 2 2002;94(19):1445-
Randomized trial of breast self 1457.

Use of Screening Strategies for
Detection of Breast Cancer 16

Appendices
1. Evidence-to-Recommendation Tables and Evidence Profiles
2. Search Strategies and Results

Use of Screening Strategies for
Detection of Breast Cancer 17

Appendix 1: Evidence-to-Recommendation Tables and Evidence Profiles

1. Should screening for breast cancer with mammography (digital) vs. no screening be used in women aged 40–49 years?

Problem: Women at average risk of disease (de- Background: Regular screening for breast cancer with mammography, breast self-examinations and clinical breast
fined as those with no previous breast cancer, no examination by a health care professional are widely recommended to reduce mortality due to breast cancer. Alt-
history of breast cancer in a first degree relative, hough controversy remains over which screening services should be provided and to whom (age groups), these
no known mutations in the BRCA1/BRCA2 genes or methods are frequently used in contemporary practice.
no previous exposure of the chest wall to radia-
tion).
Option: Screening for breast cancer using mam-
mography
Comparison: No screening
Setting: Outpatients
Perspective: Health system

it could also lead to overdiagnosis and overtreatment.2% of all morphologi- represents an earlier onset of the P RO B LE M Is the No Probably Uncertain Probably Yes Varies cal breast cancer variants.000).000).4/100. Ministry of Health. the Incidence of breast cancer is 25 per 100. Mammography. and breast self-examination can all identify tumours. and Makkah region 60 years. García AD. The median age at diagnosis was 48 years (range 19 to 99 years). In incidence has a bimodal 2009 the age-specific incidence rate was 22. examination by a health care professional. Mammography can identify early stage breast cancer. From the panel’s point (26. Saudi other hand. Cancer Registry: Cancer The reason for this is that breast cancer can be more effectively treated at an early stage. 8500) accounts for the 78.7/100. Saudi screening as the single most important public health strategy to reduce breast cancer mortality. clinical breast Arabia: Kingdom of Saudi Arabia. the pick at 45 years Arabia.4/100. The three regions with the highest inci- presentation with picks at 45 and dence were Easter region (33. breast cancer is determined that the age-specific the most common among women representing 25. priority? X Early detection in order to improve breast cancer outcome and survival remains the cornerstone of breast cancer control. the infiltrating duct carcinoma (ICD-O-3. the guideline panel According to the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. There is widespread acceptance of the value of regular breast cancer Al-Eid HS. .000).000 Based on the data described in the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia.Use of Screening Strategies for Detection of Breast Cancer 18 Evidence to recommendation framework 1 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Based on the data described in the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia.1/100.000. No Yes disease compared to statistics problem a reported in the literature. In Saudi of view. Riyadh region (29. On the Incidence Report 2009.1% of all newly diagnosed female cancers. 2012.

. Overdiagnosis Important Low much uncertainty uncertainty uncertainty uncertainty undesirable or variability or variability or variability or variability outcomes people Unnecessary biopsies or surgery Important Low value the X main Radiation exposure Important Low BENEFITS & HARMS OF THE OPTIONS outcomes? Anxiety.373 484 fewer RR 0. the outcome false uncertainty False positive results Important Low positve results was rated down Possibly Probably no No about how Important important important important No known from critical to important. two thought it was Breast cancer mortality Critical Low important.75 women would have an small? fewer) unnecessary breast biopsy .85 LOW No Yes . per 100.300 (115 fewer (0.615 unnecessary anxiety and follow- desirable fewer to 1.000.100 women would need to be anticipated mortality per 195.000) (RR) evidence cancer over about 11 years in this (95%CI) (95%CI) (GRADE) age group.172 per 79.098 (1.96) .388 1.97 HIGH positive mammogram leading to Are the mortality (0.690 women will have a false All cause 2.Use of Screening Strategies for Detection of Breast Cancer 19 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS What is the overall No The relative importance or values of the main outcomes of interest: included The opinion of guideline panel certainty of studies Very low Low Moderate High members was divided – 2 thought Outcome Relative Certainty of the this X the outcome false positives were evidence? importance evidence critical.700 LOW undesirable results .91 to per 132. § Overdiagnose: Any invasive or effects? noninvasive breast cancer .04) effects No Probably Closely Probably Yes Varies up testing 726 more) large No balanced Yes relative to X False positive 32.75 to screened every 2 to 3 years effects X to 792 0.000 .2. After further imput from Is there All cause mortality Critical High a patient that attended the panel important meeting. distress.919 per 152. or other psychological re- Important Low sponses Are the desirable No Probably Uncertain Probably Yes Varies Summary of findings: Screening for breast cancer with mammography (digital) vs no anticipated No Yes screening (40-49 years) effects X large? Outcome Without With mammography Difference Relative Certainty (follow-up: 11 screening (per effect of the To save one life from breast yr) 1. about: Are the undesirable No Probably Uncertain Probably Yes Varies Breast cancer 625 448 474 fewer RR 0.

18 – 0.04 – 0. distress. and feedback from a Most women value mammography in particular for perceived reduction of mortality. . .19) 0.17) Frequency of breast self examination 0.11 (0.14) Perceived benefits of mammography 0. Screening interval fatal breast cancer of 20 to 25 cases in - Screening with mammography on 100.82 (95%CI.94) High quality evidence Psychological Effects of False-Positive Mammograms ≥24 months: Increase effect size ¶ (95% CI) RR 1.27) 0.5 – Medium 0.000 not have been identified clinically or would not have resulted in Unnecessary .05 – 0.09 (0.2 – Small LOW Somatization 0. See table - old psychological below responses <24 months: RR 0.06 – 0. LOW cancer in women 40 to 49 years or other .72 – 0. 500 .04 (95%CI 0.04 – 0. 0.72 – 1. 500 .000 relative risk of death from breast Anxiety. .8 – Large Perceived likelihood of getting breast cancer 0. consider issues of further testing or harm arising from false-positives in their decision making.88 (0.50) Effect Certainty of the evidence Low quality evidence Distress 0.19) Summary of the evidence for patients’ values and preferences: Based on local literature.22 (0.14) ¶ Cohen’s effect size interpreta- tion Anxiety 0. few women representative from the patients. clinical experience. LOW detected by screening that would (organized BCS) per 100. the guideline panel decided that .22) Fear 0.Use of Screening Strategies for Detection of Breast Cancer 20 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Overdiagnose § .12 (0.16 (0. LOW symptoms or death in a person’s biopsies or Per 100.11 (0.03 – 0.10 – 0.000 lifetime is called overdiagnosis surgery Radiation Annual screening (digital) in women 40– LOW exposure 80 yr is associated with a lifetime risk of .

fatalistic beliefs. any psycological effect of false- Other women refuse breast cancer screening because of fear.Use of Screening Strategies for Detection of Breast Cancer 21 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS However. but benefits on mortality some would go for screening if recommended by their providers. The screening will have a lower value compared to the perceived majority of women prefer to be jointly involved in decision making with their care providers. or work or family responsibilities that do not allow for daytime appointments. . many of the studies were done when participants were already in screening programs. absence of positive results and frequency of symptoms.

respec- Compared to no screening.. X 3% discounted cost-effectiveness ratio for organized screening the net Rashidian.512 per life year gained while opportunistic screening benefits? Mammography. . No.200 and $14. Barratt et al had reported that starting the screening from breast cancer mortality (13%) during the lifespan of the popula- incremental age 40 instead of 50 would cost $24. and X 35. From the panel point of X stakeholders? X view. the cost per QALY gained for trien- No Yes mortality rate (25%) 20 years after the start of the program. a higher number In those aged less than 50. Moreover.000. Iranian J Publ Health. widely available across regions in the Kingdom. et al. the implementation of this recommenda- on health X tion would reduce inequity in a way that larger population would inequities? be benefited from this screening strategy. pp.671 to €24. this option is acceptable for all the stakeholders. both yielded a similar reduction in Is the tively. the guideline panel agreed No Probably Uncertain Probably Yes Varies resources No Yes that the resources needed to allocate are not small. Among the required Mammography and clinical breast examination cost an additional USD costs related to this intervention can be listed: equipment. The cost per life years saved. 347-357 gained Cost-effectiveness of opportunistic versus organized mam- mography screening for women aged 50 to 69 (Switzerland) The guideline panel agreed that since mammography for breast What would Increased Probably Uncertain Probably Reduced Varies cancer screening is not systematically offered and widely availa- E Q UIT Y be the impact increased reduced None identified ble across the Kingdom.4.Use of Screening Strategies for Detection of Breast Cancer 22 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS Are the Under lack of local evidence on costs. Vol. Although digital mammogram equipment is screening. The relative to nial screening those aged 47 to 49 was about US$45. a Systematic Review. identified. 42.000. from annual and biennial RE S O URCE US E screening of those aged 40-49 was $26. had twice the cost.000 US dollars tion screened and a similar reduction in predicted breast cancer cost small No Probably Uncertain Probably Yes Varies per QALY gained. with a ratio of €22.000 to$ 65. Cost Effectiveness of Breast Cancer Screening Using was €11. A.500 per quality-adjusted life year (QALY) saved compared with no small? human resources. two studies from the US and UK were of well-trained radiologists are needed. A CCE P T A B ILIT Y Is the option Panel members mentioned that they are informed of previous No Probably Uncertain Probably Yes Varies acceptable No Yes small-scale initiatives for implementing breast cancer screening None identified to key using mammography in the Kingdom.707 per life year Apr 2013.

Balance of Undesirable consequences Undesirable consequences probably The balance between Desirable consequences Desirable consequences clearly outweigh outweigh desirable and undesirable consequences probably outweigh clearly outweigh consequences desirable consequences desirable consequences is closely balanced undesirable consequences undesirable consequences in most settings in most settings in most settings in most settings X Type of We recommend against We suggest not offering We suggest offering We recommend offering recommendation offering this option this option this option this option X Recommendation (text) The Saudi Expert Panel suggests screening with mammography in women aged 40–49 years every 1 to 2 years. low-quality evidence) Justification Probably higher incidence than in the other countries in which studies were done.Use of Screening Strategies for Detection of Breast Cancer 23 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS The panel highlights that this recommendation would represent a good opportunity for implementing shared decision-making. implement? X Availability of assessment clinics for women with positive (true + false positive) screening results. F E A S IB ILIT Y Is the option No Probably Uncertain Probably Yes Varies No Yes The access for women with disabilities should be guaranteed feasible to None identified across the Kingdom. (Conditional recommendation. probably higher benefit on breast cancer mortality justifies a recommendation in favour of the option Subgroup None considerations .

Use of Screening Strategies for Detection of Breast Cancer 24 Implementation  The panel highlights that this recommendation represents a good opportunity for shared decision-making. Centres offering the service should also be regulated and monitored. Availability of assessment clinics for women with positive (true + false) screening results. the panel mentioned the need for closer monitoring via the implementation of a national registry Research priorities The national registry proposed by the panel also will inform further decisions using more accurate and direct evidence from the local context . Monitoring and The panel considered that control and audit the result of mammograms is important. They also mentioned that all radiologists diagnosing and reporting mammograms should be certified and be evaluation monitored periodically. In addition. The access for women with disabilities should be guaranteed considerations across the Kingdom.

p-value for testing heterogeneity is 0.7%) (1.96) (115 fewer to 792 fewer) All-cause mortality (follow-up: median 11 years) 2 Randomized None None2 None 6 None7 Undetected8 ⊕⊕⊕⊕ 1.04) (1. Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No.172 RR 0. Total sample size is large and the total number of events is >300 5. No serious heterogeneity.97 to 1. p-value for testing heterogeneity is 0.388/132.098 2. Insufficient number of studies to assess publication bias . They provided evidence suggesting that the baseline risk in Saudi population may be higher 3. Insufficient number of studies to assess publication bias 6. .373/79.65 and I2 =0% 7. High risk of bias.85 474 fewer CRITICAL trials Low (0.615 fewer to 726 more) False positive results 2 Observational None None None None Undetected9 ⊕⊕⊝⊝ 32.Use of Screening Strategies for Detection of Breast Cancer 25 Evidence profile: 1.300 625/195.700/100.75 to 0.97 484 fewer CRITICAL trials High (1. of Study Absolute per Risk of Publication Quality Relative Importance studies design Indirectness Inconsistency Imprecision Mammography Control 1.48 and I2 =0% 4.919 RR 0. Blinding and allocation concealment were unclear for five studies 2.8%) (0.000 bias bias (95% CI) (95% CI) Breast cancer mortality 8 Randomized Serious 1 Serious2 None 3 None4 Undetected5 ⊕⊕⊝⊝ 448/152. Should mammography vs.000 IMPORTANT Low . No serious heterogeneity.7%) 1.000. no intervention be used for breast cancer screening in women 40 to 49 years old? Author(s): Alonso Carrasco-Labra. The panel agreed that there is considerable uncertainty regarding the baseline risk in this subgroup. Sample size is large and total number of events is > 300 8. - studies (32.

75(10): 2507-17. 97(10): 2387-96. 359(9310): 909-19.Tabár L. Lancet. Eriksson O. The Gothenburg Breast Screening Trial. J Natl Cancer Inst. Frisell J. and Fletcher SW. 368(9552): 2053-60. Age-specific reduction in breast cancer mortality by screening: an analysis of the results of the Health Insurance Plan of Greater New York study. van Putten DJ. van Oortmarssen GJ. Effect of mammographic screening from age 40 years on breast cancer mortality at 10 years' follow-up: a randomised controlled trial. Cancer. J Natl Cancer Inst. Thoresen S. Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged 50-59 years. Nordenskjöld B. 101(7): 1501-7. Salander H. Baines CJ. .Miller AB. Moceri VM.Miller AB. Cahlin E. and Rutqvist LE. PM:15378474. To T. 92(18): 1490-9. 2006. and van der Maas PJ. To T. and Wall C. new results from the Swedish Two- County Trial. 2002. Ten-year risk of false positive screening mammograms and clinical breast examina- tions. Cancer. Ann Intern Med. Johns L. Nyström L. and Wahlin T.Hofvind S.Nyström L. Persson S. 1995. . and Smith RA. Waller M. PM:17161727 Habbema JD. Smart CR. Bjurstam N. Duffy SW. . PM:3461193 . Sala E. Arena PJ. Fagerberg G. Baines CJ. Duffy SW.Elmore JG. Mattsson J. . 2004. PM:12204013. The cumulative risk of a false-positive recall in the Norwegian Breast Cancer Screening Program. . Lancet. Andersson I. Säve-Söderbergh J. Rudenstam CM. and Tretli S. 77(2): 317-20. and Bobrow L. Warwick J. and Wall C. Gad A. Barton MB. 338(16): 1089-96. N Engl J Med.Use of Screening Strategies for Detection of Breast Cancer 26 REFERENCES . Evans A. PM:10995804. Björneld L. PM:12733136 . 1998. The Canadian National Breast Screening Study-1: breast cancer mortality after 11 to 16 years of follow-up. Cuckle H. Lingaas H. 2003.Bjurstam N. PM:9545356. Polk S. 2002. Cancer. A ran- domized screening trial of mammography in women age 40 to 49 years. 137(5 Part 1): 305-12.Moss SM. Chen HH. 2000. PM:7736395 . 1986. Long-term effects of mammography screening: updated overview of the Swedish randomised trials. Efficacy of breast cancer screening by age. Walker N. Lubbe JT.

described in the portant public health strategy to reduce breast cancer mortality. cancer.4/100. Incidence Report of Mammography.1/100. the No Probably Uncertain Probably Yes Varies region (29.7/100. Incidence Report of mon among women representing 25. BRCA1/BRCA2 genes or no previous exposure of the chest wall to radiation).000 priority? X Early detection in order to improve breast cancer outcome and survival remains the cornerstone of breast cancer Based on the data control.000).000. Mammography can identify early stage breast cancer Saudi Arabia. clinical breast examination by a health care professional. the infiltrating duct carcinoma (ICD-O-3. these degree relative. no history of breast cancer in a first controversy remains over which screening services should be provided and to whom (age groups).1% of all newly diagnosed female cancers.2% of all morpholog. the Kingdom of tify tumours. and breast self-examination can all iden.000). it could also lead to overdiagnosis and overtreatment. Should mammography (digital) be used to screen for breast cancer among women aged 50-69? Problem: Women at average risk of disease Background: Regular screening for breast cancer with mammography.000). the . Option: Screening for breast cancer using mammography Comparison: No screening Setting: Outpatients Perspective: Health system ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIO NS Based on the data described in the 2009 Cancer According to the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. 100. breast self-examinations and clin- (defined as those with no previous breast ical breast examinations are widely recommended to reduce mortality due to breast cancer. In Saudi Arabia. The three regions with the highest incidence were Easter region (33. and Makkah region (26. Riyadh Saudi Arabia. The reason for this is that breast cancer can be 2009 Cancer more effectively treated at an early stage. There is widespread acceptance of the value of regular breast cancer screening as the single most im.4/100. On the other hand.Use of Screening Strategies for Detection of Breast Cancer 27 Evidence to recommendation framework 2 2. no known mutations in the methods are frequently used in contemporary practice. cancer is 25 per problem a ical breast cancer variants. breast cancer is the most com. However. The median age at diagnosis was 48 years (range 19 to Incidence of breast P RO B LE M Is the No Yes 99 years). 8500) accounts for the 78. In 2009 the age-specific incidence the Kingdom of rate was 22.

. two thought it important Important important important important No known was important. Saudi Arabia: Kingdom of Saudi Arabia. the pick at 45 years represents an earlier onset of the disease compared to statistics reported in the literature. García AD. After uncertaint uncertainty uncertainty uncertainty uncertainty undesirable Overdiagnose Important Low y about or variability or variability or variability or variability outcomes further input from a how much Unnecessary biopsies or surgery Important High patient that attended X people the panel meeting. Saudi Cancer Registry: Cancer Incidence Report 2009. From the panel’s point of view. 2012. ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIO NS What is the overall No The relative importance or values of the main outcomes of interest: BENEFITS & HARMS OF THE OPTIONS included certainty studies Very low Low Moderate High The opinion of panel Outcome Relative importance Certainty of the evidence of this X members was evidence? Breast cancer mortality Critical Moderate divided – 2 thought All cause mortality Critical High the outcome false Is there positives were Possibly Probably no No False positive results Important Low critical.Use of Screening Strategies for Detection of Breast Cancer 28 guideline panel determined that the age-specific incidence has a bimodal presentation with picks at 45 and 60 years. Ministry of Health. Al-Eid HS.

identified clinically or relative to X breast cancer of 20 to 25 cases in 100. .530 more to (1. per 100.424 5.3 HIGH § Overdiagnose: Any biopsies or surgery per 66.206 per 135.050 fewer) 0.902 more) 1.68 to need to be screened 2. or LOW e effects? other psychological . symptoms or death responses in a person’s lifetime is called overdiagnosis (20 yrs period) Psychological Effects of False-Positive Mammograms Screening interval .000.387 fewer RR 0.000 . Summary of findings: Screening for breast cancer with mammography (digital) vs no screening (50-69 years) To save one life from breast cancer over Outcome Without With mammography Difference Relative Certainty of about 11 years in Are the (follow-up: 11 yr) screening (per 1.45) testing Unnecessary 1.000) effect evidence desirable No Probably Uncertain Probably Yes Varies this age group.96 to unnecessary breast anticipated 620 more) 1. distress.720 women would mortality per 115.000 (1. or other psychological responses Important Low rated down from ? critical to important.000 - would not have undesirabl resulted in Anxiety.204 women will small? False positive results 28. (95%CI) (RR) (GRADE) anticipate No Yes about: (95%CI) d effects X large? Breast cancer 743 639 1. 500 .200 LOW have a false positive .26 women would undesirabl All cause mortality 690 734 220 more RR 1.35 to 1.711 (140 fewer to (0.40 LOW anxiety and follow-up (organized BCS) per 100. RR 1.90) every 2 to 3 years Are the . mammogram leading to unnecessary Overdiagnose § . distress.694 per 19.167 (3.150 more RR 1. .06 HIGH have an No Probably Uncertain Probably Yes Varies e No Yes per 19. See table below .2 to invasive or 6.4) noninvasive breast Are the cancer detected by desirable screening that would Radiation exposure Annual screening (digital) in women 40–80 LOW effects No Probably Uncertain Probably Yes Varies not have been No Yes years old is associated with a lifetime risk of fatal large .2) biopsy X effects .Use of Screening Strategies for Detection of Breast Cancer 29 value the Radiation exposure Important Low the outcome false main positve results was outcomes Anxiety.154 per 66.083 1.78 MODERATE .068 (622 fewer to (0.

Other women refuse breast cancer ¶ Cohen’s effect size interpretation screening because of fear.09 (0.27) years old LOW Somatization 0. The majority of women prefer to be jointly involved in decision making 0.86 (95%CI.22) from breast cancer in Fear 0. or work or family responsibilities that do 0.17) High quality Frequency of breast self examination 0. 0.12 (0.11 (0.22 (0.14) RR 0. However.19) <24 months: Perceived likelihood of getting breast cancer 0.05 – 0. fatalistic beliefs.06 – 0. many of the studies were done when participants were already in screening programs.51 – 0.04 – 0. and feedback from a representative from the patients.10 – 0. absence of symptoms. few women consider issues of further testing or harm arising from false-positives in their decision making.19) evidence ≥24 months: RR 0.18 – 0.16 (0.5 – Medium with their care providers.14) women 50 to 69 Anxiety 0.88) Summary of the evidence for patients’ values and preferences: Moderate quality evidence Most women value mammography in particular for perceived reduction of mortality. the guideline panel decided that any psycological effect of false-positive results and frequency of screening will have a lower value compared to the perceived benefits on mortality .2 – Small not allow for daytime appointments. but some would go for screening if recommended by their providers.88 (0.04 – 0. clinical experience.8 – Large Based on local literature.75 – 0. 0.Use of Screening Strategies for Detection of Breast Cancer 30 Effect Increase effect size ¶ (95% CI) Certainty of the Screening with evidence mammography on relative risk of death Distress 0.67 (95%CI 0.03 – 0.98) Perceived benefits of mammography 0.11 (0.

512 per life year gained while opportunistic screening benefits? had twice the cost.000 to$ 65. 347-357 was €11. Apr 2013. Barratt et al RE S O URCE US E had reported that starting the screening from age 40 instead of 50 would cost $24. a Systematic Review.671 to €24. From the panel point of X stakeholders view. et al. 42.4. a higher number fied.. Cost Effectiveness of Breast Cancer Screening Using Mam- relative to 3% discounted cost-effectiveness ratio for organized screening X mography.707 per life year gained Cost-effectiveness of opportunistic versus organized mam- mography screening for women aged 50 to 69 (Switzerland) What would The guideline panel agreed that since mammography for breast be the Increased Probably Uncertain Probably Reduced Varies cancer screening is not systematically offered and widely availa- E Q UIT Y impact increased reduced None identified ble across the Kingdom. ? . the Compared to no screening. No. from annual and biennial screening of of well-trained radiologists are needed. Vol. The cost per life years saved. the implementation of this recommenda- on health X tion would reduce inequity in a way that larger population would inequities? be benefited from this screening strategy.000 US dollars per QALY gained.Use of Screening Strategies for Detection of Breast Cancer 31 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS Are the Under lack of local evidence on costs. costs related to this intervention can be listed: equipment. Is the A CCE P T A B ILIT Y option Panel members mentioned that they are informed of previous No Probably Uncertain Probably Yes Varies acceptable No Yes small-scale initiatives for implementing breast cancer screening None identified to key using mammography in the Kingdom. the guideline panel agreed No Probably Uncertain Probably Yes Varies resources No Yes Mammography and clinical breast examination cost an additional USD 35. respectively. The Rashidian. Among the required quality-adjusted life year (QALY) saved compared with no screening.500 per that the resources needed to allocate are not small.000. Iranian J Publ Health.000. Moreover. Although digital mammogram equipment is In those aged less than 50. two studies from the US and UK were identi- widely available across regions in the Kingdom. this option is acceptable for all the stakeholders. both yielded a similar reduction in Is the cost per QALY gained for triennial screening those aged 47 to 49 was breast cancer mortality (13%) during the lifespan of the popula- incremental about US$45. and X small? human resources. those aged 40-49 was $26.200 and $14. the net pp. A. with a ratio of €22. tion screened and a similar reduction in predicted breast cancer No Probably Uncertain Probably Yes Varies cost small No Yes mortality rate (25%) 20 years after the start of the program.

No Yes None identified option feasible to X The access for women with disabilities should be guaranteed implement? across the Kingdom. Availability of assessment clinics for women with positive (true + false positive) screening results. In addition.Use of Screening Strategies for Detection of Breast Cancer 32 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS The panel highlights that this recommendation would represent a good opportunity for implementing shared decision-making. . the panel recognized the necessity for educating the population on the importance of breast cancer screening strate- F E A S IB ILIT Y Is the No Probably Uncertain Probably Yes Varies gies.

the panel mentioned the need for closer monitoring via the implementation of a national registry Research priorities The national registry proposed by the panel also will inform further decisions using more accurate and direct evidence from the local context . The access for women with disabilities should be guaranteed across the Kingdom. moderate-quality evidence). Centres offering the service should also be regulate and monitor.Use of Screening Strategies for Detection of Breast Cancer 33 Balance of consequences Undesirable consequences Undesirable consequences probably The balance between Desirable consequences Desirable consequences clearly outweigh outweigh desirable and undesirable consequences probably outweigh clearly outweigh desirable consequences desirable consequences is closely balanced or uncertain undesirable consequences undesirable consequences in most settings in most settings in most settings in most settings X Type of recommendation We recommend against We suggest not offering We suggest offering We recommend offering offering this option this option this option this option X Recommendation (text) The Saudi Expert Panel suggests screening with mammography in women aged 50–69 years every 2 years (Conditional recommendation. They also mentioned that all radiologists diagnosing and reporting mammograms should be certified and be monitored periodically. considerations Availability of assessment clinics for women with positive (true + false) screening results. In addition. In addition. Justification - Subgroup considerations None Implementation  The panel considered that shared decision making is crucial for this recommendation. Monitoring and evaluation The panel considered that control and audit the result of mammograms is important. the panel recognized the necessity for educating the population on the importance of breast cancer screening strategies.

To T.65%) (0. Should mammography vs.711 690/19. p-value for testing heterogeneity is 0.2%) 1. Single study. . Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No.200/100. . Total sample size is large and the total number of events is >300 5.206 RR 0. To T. 2000. J Natl Cancer Inst.2) (140 fewer to 620 more) False positive results 2 Observational None None2 None None Undetected5 ⊕⊕⊝⊝ 28. Sample size is large and total number of events is > 300 REFERENCES .Miller AB. . 137(5 Part 1): 305-12.06 220 more CRITICAL trials High (3.000 IMPORTANT Low . Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged 50-59 years.12 and I2 =41% 4. Baines CJ. The Canadian National Breast Screening Study-1: breast cancer mortality after 11 to 16 years of follow-up.5%) (0.47%) (0. Insufficient number of studies to assess publication bias 6. No serious heterogeneity.90) (622 fewer to 2.7%) (3.000 bias bias (95% CI) (95% CI) Breast cancer mortality (follow-up: median 11 years) 7 Randomized Serious 1 None2 None 3 None4 Undetected5 ⊕⊕⊕⊝ 639/135. - studies (28.96 to 1. High risk of bias. and Wall C. Baines CJ.Use of Screening Strategies for Detection of Breast Cancer 34 Evidence profile: 2. 2002. PM:12204013. comparator and outcome 3. Blinding and allocation concealment were unclear for five studies 2. 92(18): 1490-9. PM:10995804.000.387 fewer CRITICAL trials Moderate (0. heterogeneity not applicable 7.050 fewer) All-cause mortality (follow-up: median 11 years) 1 Randomized None None2 None6 None7 Undetected5 ⊕⊕⊕⊕ 734/19.694 RR 1. Ann Intern Med. intervention. The question addressed is the same for the evidence regarding the population.78 1.Miller AB. and Wall C.68 to 0. A ran- domized screening trial of mammography in women age 40 to 49 years. no intervention be used for breast cancer screening in women 50 to 69 years old? Author(s): Alonso Carrasco-Labra.068 743/115. of Study Absolute per Risk of Publication Quality Relative Importance studies design Indirectness Inconsistency Imprecision Mammography Control 1.

Cancer.Hofvind S. 338(16): 1089-96.Miller AB.Use of Screening Strategies for Detection of Breast Cancer 35 . J Natl Cancer Inst.Tabár L. PM:10995804. van Oortmarssen GJ. Lancet. 77(2): 317-20. Arena PJ. Polk S. PM:9545356. PM:3461193. Waller M. Lubbe JT.Habbema JD. The cumulative risk of a false-positive recall in the Norwegian Breast Cancer Screening Program.Moss SM. Duffy SW. and Bobrow L. Evans A. Ten-year risk of false positive screening mammograms and clinical breast examina- tions. N Engl J Med. Efficacy of breast cancer screening by age. Johns L. Bjurstam N. Chen HH. . . Gad A. 368(9552): 2053-60.Elmore JG. and Rutqvist LE. Frisell J. . Smart CR. PM:15378474. 2000. Lancet. Thoresen S. 359(9310): 909-19. 1995. . . New results from the Swedish Two- County Trial. van Putten DJ. Moceri VM. and Tretli S. and van der Maas PJ. . 92(18): 1490-9. Nordenskjöld B. Baines CJ. Age-specific reduction in breast cancer mortality by screening: an analy- sis of the results of the Health Insurance Plan of Greater New York study. Barton MB. and Fletcher SW. To T. Cancer. J Natl Cancer Inst. Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged 50-59 years. and Smith RA. Andersson I. Nyström L. and Wall C. Effect of mammographic screening from age 40 years on breast cancer mortality at 10 years' follow-up: a randomised controlled trial. 2006. 1986. Cuckle H. Long-term effects of mammography screening: updated overview of the Swe- dish randomised trials. 2002. 101(7): 1501-7. 75(10): 2507-17. 2004. 1998. Fagerberg G.

Mammography. clinical breast examination by a health care disease compared to statistics reported in the professional. identify early stage breast cancer Al-Eid HS. There is widespread acceptance of the value of that the age-specific incidence has a bimodal regular breast cancer screening as the single most important public health strategy to presentation with picks at 45 and 60 years. P RO B LE M Is the No Probably Uncertain Probably Yes Based on the data described in the 2009 No Yes problem a Cancer Incidence Report of the Kingdom of Early detection in order to improve breast cancer outcome and survival remains the priority? X Saudi Arabia. Use of Screening Strategies for Detection of Breast Cancer 36 Evidence to recommendation framework 3 3. Ministry of Health. 201 . Should mammography (digital) be used to screen for breast cancer among women aged 70-74? Problem: Women at average risk of disease (defined as those with no previous breast cancer.2% of all morphological breast cancer variants. the infiltrating duct carcinoma (ICD-O- Varies 3. ing services should be provided and to whom (age groups). these methods are frequently used in contemporary practice. On the other hand.000).1% of all newly diagnosed Based on the data described in the 2009 female cancers. In 2009 the age-specific incidence rate was 22.000). no known mutations in the BRCA1/BRCA2tions are widely recommended to reduce mortality due to breast cancer. The reason for this is that breast cancer can be more From the panel’s point of view. reduce breast cancer mortality. Saudi Cancer Registry: Cancer Incidence Report 2009. García AD. it could also lead to overdiagno- years represents an earlier onset of the sis and overtreatment. 8500) accounts for the 78. In Saudi Arabia. and breast self-examination can all identify tumours.000. However.000).1/100. the guideline panel determined cornerstone of breast cancer control. According to the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. Option: Screening for breast cancer using mammography Comparison: No screening Setting: Outpatients Perspective: Health system CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS The panel considered that the intervention might not be relevant for this particular age group. Given other competing health risks. The three Cancer Incidence Report of the Kingdom of regions with the highest incidence were Easter region (33. and Makkah region (26.7/100. controversy remains over which screen- genes or no previous exposure of the chest wall to radiation). breast cancer is not a priority or a main health problem. Mammography can literature. the Incidence of breast cancer (29. breast self-examinations and clinical breast examina- no history of breast cancer in a first degree relative. Riyadh region Saudi Arabia. Saudi Arabia: Kingdom of Saudi Arabia. breast cancer is the most common among women representing 25. the pick at 45 effectively treated at an early stage.4/100.000 48 years (range 19 to 99 years).4/100. The median age at diagnosis was is 25 per 100. Background: Regular screening for breast cancer with mammography.

339 (3.01) No Yes age group.Use of Screening Strategies for Detection of Breast Cancer 37 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS What is the overall No The relative importance or values of the main outcomes of interest: included The opinion of panel certainty of studies Very low Low Moderate High members was divided – Outcome Relative importance Certainty of the evidence this X 2 thought the outcome evidence? Breast cancer mortality Critical Low false positives were All cause mortality Critical .68 LOW about 11 years in this undesirable No Probably Uncertain Probably Yes Varies mortality per 7.450 women would small? All cause mortality need to be screened . Anxiety. critical. about: anticipated 39 more) effects X .307 per 10. or other outcomes? Important Low psychological responses Are the Summary of findings: Screening for breast cancer with mammography (digital) vs no screening desirable No Probably Uncertain Probably Yes Varies (70-74 years) anticipated No Yes effects X Outcome Without With Difference Relative effect Certainty of large? (follow-up: 11 yr) screening mammography (per 1.734 fewer to (0. distress.218 fewer RR 0. the Unnecessary biopsies or BENEFITS & HARMS OF THE OPTIONS much uncertainty uncertainty uncertainty uncertainty undesirable Important Low outcome false positve or variability or variability or variability or variability outcomes surgery results was rated down people value the X Radiation exposure Important Low from critical to main important. two thnught it Is there was important.000. After important False positive results Important Low further input from a uncertainty Overdiagnose Important Low patient that attended the Possibly Probably no No about how Important important important important No known panel meeting.000) (RR) the (95%CI) (95%CI) evidence (GRADE) To save one life from breast cancer over Are the Breast cancer 50 49 2.45 to 1.

000 - - § Overdiagnose: Any Radiation exposure Annual screening (digital) in LOW invasive or noninvasive women 40–80 yr is associated breast cancer detected with a lifetime risk of fatal breast .27) Screening with LOW mammography on Somatization 0.09 LOW false positive (organized BCS) per 100.17) old Frequency of breast self examination 0.96 women will have a Overdiagnose § .Use of Screening Strategies for Detection of Breast Cancer 38 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS .12 (0.09 (0. .04 – 0.18 – 0.06 – 0. . person’s lifetime is effects large No ballanced Yes responses relative to called overdiagnosis (20 X yrs period) undesirable effects? Psychological Effects of False-Positive Mammograms Effect Increase effect size ¶ (95% CI) Certainty of the evidence Distress 0. See table below .22 (0.88 (0. distress.11 (0.14) Screening interval Anxiety 0.03 – 0. every 2 to 3 years .11 women would have False positive 21. .96) mammogram leading to unnecessary anxiety Unnecessary . .05 – 0. or LOW symptoms or death in a No Probably Closely Probably Yes Varies other psychological .19) <24 months: Not available . RR 0. biopsy . by screening that would cancer of 20 to 25 cases in not have been identified 100. 500 .22) Fear 0.000 (0.000 clinically or would not Are the have resulted in desirable Anxiety.11 (0. 500 LOW and follow-up testing biopsies or surgery per 100. . . per 100.19) relative risk of death Perceived likelihood of getting breast cancer 0.16 (0.88 to 0. .10 – 0.04 – 0.000 .14) from breast cancer in women 70 to 74 years Perceived benefits of mammography 0.200 LOW an unnecessary breast results .

but some would go for screening if recommended by 0.01) Most women value mammography in particular for perceived reduction of mortality. few women consider Low quality evidence issues of further testing or harm arising from false-positives in their decision making. fatalistic beliefs.45 – 1.2 – Small their providers. or work or family ¶ Cohen’s effect size responsibilities that do not allow for daytime appointments.8 – Large Based on local literature.Use of Screening Strategies for Detection of Breast Cancer 39 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Summary of the evidence for patients’ values and preferences: ≥24 months: RR 0.5 – Medium 0. Other women refuse breast cancer screening because of fear. and feedback from a representative from the patients. The majority of women prefer to be jointly interpretation involved in decision making with their care providers.68 (95%CI 0. However. absence of symptoms. clinical experience. 0. many of the studies were done when participants were already in screening programs. the guideline panel decided that any psycological effect of false-positive results and frequency of screening will have a lower value compared to the perceived benefits on mortality .

this option is acceptable for all the stakeholders. the implementation of this recommenda- on health X tion would reduce inequity in a way that larger population would inequities? be benefited from this screening strategy.671 to €24. 42. Moreover. benefits? had twice the cost. The relative to 3% discounted cost-effectiveness ratio for organized screening X Rashidian. respec- tively. and X small? screening. a higher number In those aged less than 50.512 per life year gained while opportunistic screening Mammography. tion screened and a similar reduction in predicted breast cancer No Probably Uncertain Probably Yes Varies cost small No Yes nial screening those aged 47 to 49 was about US$45. ? . with a ratio of €22.500 per quality-adjusted life year (QALY) saved compared with no costs related to this intervention can be listed: equipment. Barratt et al had reported that starting the screening from Compared to no screening. the guideline panel agreed No Probably Uncertain Probably Yes Varies resources No Yes that the resources needed to allocate are not small. Iranian J Publ Health.200 and $14.000 to$ 65. human resources. 347-357 gained Cost-effectiveness of opportunistic versus organized mam- mography screening for women aged 50 to 69 (Switzerland) What would The guideline panel agreed that since mammography for breast be the Increased Probably Uncertain Probably Reduced Varies cancer screening is not systematically offered and widely availa- E Q UIT Y impact increased reduced None identified ble across the Kingdom. From the panel point of X stakeholders view.000. Vol.4. pp. Cost Effectiveness of Breast Cancer Screening Using the net was €11.. a Systematic Review. two studies from the US and UK were of well-trained radiologists are needed.707 per life year Apr 2013. et al. Although digital mammogram equipment is widely available across regions in the Kingdom. identified. A. No. mortality rate (25%) 20 years after the start of the program.000 US dollars breast cancer mortality (13%) during the lifespan of the popula- incremental per QALY gained. from annual and biennial RE S O URCE US E screening of those aged 40-49 was $26. both yielded a similar reduction in Is the age 40 instead of 50 would cost $24.Use of Screening Strategies for Detection of Breast Cancer 40 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS Are the Under lack of local evidence on costs. Among the Mammography and clinical breast examination cost an additional USD required 35. the cost per QALY gained for trien.000. The cost per life years saved. Is the A CCE P T A B ILIT Y option Panel members mentioned that they are informed of previous No Probably Uncertain Probably Yes Varies acceptable No Yes small-scale initiatives for implementing breast cancer screening None identified to key using mammography in the Kingdom.

the panel guideline considered that given other competing health risks. Availability of assessment clinics for women with positive (true + false positive) screening results. option No Yes None identified feasible to X The access for women with disabilities should be guaranteed implement? across the Kingdom. the panel recognized the necessity for educating the population on the importance of breast cancer screening strate- Is the F E A S IB ILIT Y No Probably Uncertain Probably Yes Varies gies. breast cancer is not a priority or a main health problem In case this option is offered to women between 70 to 74 years old. the panel proposed that this should be done every 2 to 3 years Subgroup considerations None . low-quality evidence) Justification In this group. In addition.Use of Screening Strategies for Detection of Breast Cancer 41 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS The panel highlights that this recommendation would represent a good opportunity for implementing shared decision-making. Balance of consequences Undesirable consequences Undesirable consequences probably The balance between Desirable consequences Desirable consequences clearly outweigh outweigh desirable and undesirable consequences probably outweigh clearly outweigh desirable consequences desirable consequences is closely balanced or uncertain undesirable consequences undesirable consequences in most settings in most settings in most settings in most settings X Type of recommendation We recommend against We suggest not offering We suggest offering We recommend offering offering this option this option this option this option X Recommendation (text) The Saudi Expert Panel suggests no screening with mammography in women aged 70–74 years every 2 to 3 years (Conditional recommendation.

Use of Screening Strategies for Detection of Breast Cancer 42 Implementation  The access for women with disabilities should be guaranteed across the Kingdom. In addition. In addition. They also mentioned that all radiologists diagnosing and reporting mammograms should be certified and be monitored periodically. Centres offering the service should also be regulate and monitor. Availability of assessment clinics for women with positive (true + false) screening considerations results. the panel mentioned the need for closer monitoring via the implementation of a national registry Research priorities The national registry proposed by the panel also will inform further decisions using more accurate and direct evidence from the local context . Monitoring and evaluation The panel considered that control and audit the result of mammograms is important. the panel recognized the necessity for educating the population on the importance of breast cancer screening strategies.

Hofvind S. Age-specific reduction in breast cancer mortality by screening: an analysis of the results of the Health Insurance Plan of Greater New York study. 1998. No serious heterogeneity. The cumulative risk of a false-positive recall in the Norwegian Breast Cancer Screening Program. 75(10): 2507-17. Insufficient number of studies to assess publication bias REFERENCES . 1986. Polk S. High risk of bias.68 2. no intervention be used for breast cancer screening in women 70 to 74 years old? Author(s): Alonso Carrasco-Labra. Efficacy of breast cancer screening by age. J Natl Cancer Inst. of Study Risk of Inconsisten. CRITICAL ies report- .200/100. - ing this outcome False positive results 2 Observational None None2 None None Undetected ⊕⊕⊝⊝ 21. 101(7): 1501-7. Evidence to recommendation framework 4 . . 338(16): 1089-96. . Ten-year risk of false positive screening mammograms and clinical breast examina- tions. Total sample size is large. Moceri VM. Publica. p-value for testing heterogeneity is 0. . .Use of Screening Strategies for Detection of Breast Cancer 43 Evidence profile: 3.47%) (0.734 fewer to 39 more) All-cause mortality No stud.307 RR 0.Habbema JD.45 to 1. . PM:7736395 . .339 50/7. - studies (21. Quality Relative Absolute Importance studies design Indirectness Mammography Control bias cy sion tion bias (95% CI) (95% CI) Breast cancer mortality 2 Randomized Serious 1 None2 None 3 Serious4 Undetected5 ⊕⊕⊝⊝ 49/10. 2004. Gad A. Impreci. comparator and outcome 3. Lubbe JT.7%) (0. Should mammography vs. Smart CR. intervention. van Oortmarssen GJ. PM:15378474. Thoresen S.01) (3. . and van der Maas PJ. . . PM:9545356. Fagerberg G.Tabár L. van Putten DJ. Serious imprecision. Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. PM:3461193. Duffy SW. The question addressed is the same for the evidence regarding the population.2%) 1. 77(2): 317-20. Blinding and allocation concealment were unclear 2. . Barton MB. but the total number of events is <300 5. . and Tretli S. Cancer. Cancer.218 fewer CRITICAL trials Low (0. Chen HH. N Engl J Med. and Fletcher SW.000 IMPORTANT Low .Elmore JG. new results from the Swedish Two- County Trial. and Smith RA.75 and I2 =0% 4. Arena PJ. . 1995.

breast self-examinations and clini- (defined as those with no previous breast can. and breast self-examination can all identify tumours.000 (29. On the other hand. the Incidence of breast cancer is regions with the highest incidence were Easter region (33. Option: Screening for breast cancer using breast self-examination Comparison: No screening Setting: Outpatients Perspective: Health system CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS According to the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. the pick at 45 reduce breast cancer mortality.000). Ministry of Health. regular breast cancer screening as the single most important public health strategy to From the panel’s point of view. Saudi Cancer Registry: identify early stage breast cancer. the guideline panel determined problem a Early detection in order to improve breast cancer outcome and survival remains the that the age-specific incidence has a bimodal priority? X cornerstone of breast cancer control. However. Mammography. Based on the data described in the 2009 No Probably Uncertain Probably Yes Varies O-3. it could also lead to overdiag. no known mutations in the methods are frequently used in contemporary practice.000. clinical breast examination by a health care literature. breast Based on the data described in the 2009 cancer is the most common among women representing 25. 8500) accounts for the 78.4/100.1% of all newly diagnosed Cancer Incidence Report of the Kingdom of female cancers. The three Saudi Arabia. cer. In 2009 the age-specific incidence rate was 22. There is widespread acceptance of the value of presentation with picks at 45 and 60 years. . Riyadh region 25 per 100. cal breast examinations are widely recommended to reduce mortality due to breast cancer.1/100.Use of Screening Strategies for Detection of Breast Cancer 44 4. and Makkah region (26.000).000). García AD. Cancer Incidence Report 2009. these gree relative. Mammography can Al-Eid HS. professional. 2012.2% of all morphological breast cancer variants. BRCA1/BRCA2 genes or no previous exposure of the chest wall to radiation). Cancer Incidence Report of the Kingdom of P RO B LE M Is the No Yes Saudi Arabia. the infiltrating duct carcinoma (ICD. Saudi Arabia: Kingdom of Saudi Arabia. disease compared to statistics reported in the nosis and overtreatment. The reason for this is that breast cancer can be more years represents an earlier onset of the effectively treated at an early stage. controversy remains over which screening services should be provided and to whom (age groups). no history of breast cancer in a first de. The median age at diagnosis was 48 years (range 19 to 99 years). In Saudi Arabia.4/100. Should breast self-examination be used to screen for breast cancer among women all ages? Problem: Women at average risk of disease Background: Regular screening for breast cancer with mammography.7/100.

positives were critical.763 per 193.83 to 1.596 (254 fewer to (0. . the outcome Possibly Probably no No Overdiagnose Important - about how Important important important important No known false positve results was BENEFITS & HARMS OF THE OPTIONS much uncertainty uncertainty uncertainty uncertainty undesirable Unnecessary biopsies or rated down from critical to Important - people or variability or variability or variability or variability outcomes surgery important.2) associated with teaching effects X 234 more) Breast Self Exam to women small? aged 31 to 64.000) effect (RR) the effects X examination No evidence was found (95%CI) (95%CI) evidence large? indicating that Breast Self (GRADE) Exam reduces breast Breast cancer cancer mortality or all- mortality . distress. Two large Are the trials identified no reduction undesirable No Probably Uncertain Probably Yes Varies No Yes All cause mortality 289 292 30 fewer RR 0. . - cause mortality. value the X Anxiety. All cause mortality Critical MODERATE After further input from a Is there important False positive results Important . The overall quality of the psychological responses outcomes? evidence was considered as very low given that there Summary of findings: Screening for breast cancer with breast self-examination vs no screening is no data informing breast Are the (all ages) cancer mortality.98 MODERATE in breast cancer mortality anticipated per 193. .000. two thought it was important. but found .Use of Screening Strategies for Detection of Breast Cancer 45 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS What is the No The relative importance or values of the main outcomes of interest: overall included The opinion of panel certainty of studies Very low Low Moderate High members was divided – 2 this Outcome Relative importance Certainty of the evidence thought the outcome false X evidence? Breast cancer mortality Critical . desirable No Probably Uncertain Probably Yes Varies No Yes Outcome Without With clinical Difference Relative Certainty of anticipated (follow-up: 11 yr) screening breast (per 1. or other main Important . patient that attended the uncertainty panel meeting.

19) clinically or would not have resulted in symptoms or death in a person’s lifetime Summary of the evidence for patients’ values and preferences: is called overdiagnosis (20 yrs period) Most women value mammography in particular for perceived reduction of mortality.04 – 0. .Use of Screening Strategies for Detection of Breast Cancer 46 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS False positive evidence of increased harm results . . suggested as a monthly examination of the woman’s breasts.22 (0. This rise concern for the Overdiagnose § .18 – 0.09 (0. few women consider issues of further testing or harm arising from false-positives in their decision making.88 (0.04 – 0. for benign breast biopsy. .Specificity: range from undesirable X 66% and 81% Distress 0. . ¶ Cohen’s effect size inter- However. Anxiety.06 – 0.19) LOW § Overdiagnose: Any invasive or noninvasive Perceived likelihood of getting breast cancer 0.11 (0. - .05 – 0. distress. .12 (0.14) Anxiety 0.10 – 0.17) screening that would not have been identified Frequency of breast self examination 0. Breast self-exam has been responses . . Are the Accuracy estimates: Psychological Effects of False-Positive Mammograms . potential harms of Breast (organized BCS) Self Exam and the corresponding lack of Unnecessary .27) Somatization 0. many of the studies were done when participants were already in screening programs.03 – 0.Sensitivity: range from desirable effects large No Probably Uncertain Probably Yes Varies 12% to 41% No Yes Effect Increase effect size ¶ (95% CI) Certainty of the relative to evidence .22) effects? Fear 0. .14) breast cancer detected by Perceived benefits of mammography 0. evidence of their biopsies or surgery . effectiveness in decreasing mortality. .16 (0. or other psychological See table below . . .11 (0.

fatalistic beliefs.2 – Small majority of women prefer to be jointly involved in decision making with their care providers.Use of Screening Strategies for Detection of Breast Cancer 47 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Other women refuse breast cancer screening because of fear. The 0. but 0. the guideline panel decided that any psycological effect of false- positive results and frequency of screening will have a lower value compared to the perceived benefits on mortality .8 – Large some would go for screening if recommended by their providers. and feedback from a representative from the patients.5 – Medium 0. or work or family responsibilities that do not allow for daytime appointments. absence of pretation symptoms. clinical experience. Based on local literature.

X implement? . Among the required resources it can be listed: healthy Is the None identified women educational programs.Use of Screening Strategies for Detection of Breast Cancer 48 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS Are the No Probably Uncertain Probably Yes Varies resources No Yes required small? X Under lack of local evidence on costs for this intervention. educational material. X stakeholders ? Is the F E A S IB ILIT Y No Probably Uncertain Probably Yes Varies option No Yes The panel considered this option as feasible and easy to imple- None identified feasible to ment. inequities? Is the A CCE P T A B ILIT Y option No Probably Uncertain Probably Yes Varies acceptable No Yes The guideline panel thinks that the option is acceptable to all None identified to key stakeholders with no exceptions. location for incremental in-person sessions. as long as the on health X educational program is widely available across the Kingdom. the RE S O URCE US E guideline panel agreed that the resources needed to allocate are small. relative to X the net benefits? What would be the Increased Probably Uncertain Probably Reduced Varies The guideline panel considered that health inequities would be E Q UIT Y impact increased reduced None identified reduced if this intervention were implemented. health care professionals to deliver the mes- No Probably Uncertain Probably Yes Varies cost small No Yes sage.

breast self-examination plays a secondary role. The guideline panel also highlight- ed that when mammography is available. considerations Monitoring and evaluation - Research priorities There is very limited evidence on the effectiveness of breast self-examination. Subgroup considerations None Implementation  The panel considered this option as feasible and easy to implement. this option should always be offered first to patients. very-low quality evidence) Justification The panel determined that the strength of the recommendation should be weak/conditional based on the extensive level of uncertainty and lack of evidence. . The panel recognizes that more research in this area is needed in order to inform further recommendations on this regard. especially in regions where mammography may not be offered. (Conditional recommendation.Use of Screening Strategies for Detection of Breast Cancer 49 Balance of consequences Undesirable consequences Undesirable consequences probably The balance between Desirable consequences Desirable consequences clearly outweigh outweigh desirable and undesirable consequences probably outweigh clearly outweigh desirable consequences desirable consequences is uncertain undesirable consequences undesirable consequences in most settings in most settings in most settings in most settings X Type of recommendation We recommend against We suggest not offering We suggest offering We recommend offering offering this option this option this option this option X Recommendation (text) The Saudi Expert Panel suggests that self-breast examination is not used as a single method of screening for breast cancer in women of all ages. In this regard.

. . . . Zhao GL. High risk of bias. 1992.Use of Screening Strategies for Detection of Breast Cancer 50 Evidence profile: 4. PM:12359854. .Semiglazov VF. Randomized trial of breast self-examination in Shanghai: final results. 8(4): 498- 502. Allison CJ. Seleznyov NK. and Self SG.15%) (0. Chen FL. Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. . Wang WW. Eur J Epidemiol. Evans I. The question addressed is the same for the evidence regarding the population. . - this outcome 1. Bavli JL. comparator and outcome 3. - this outcome All-cause mortality 2 Randomized Serious1 None2 None3 None4 Undetected5 ⊕⊕⊕⊝ 292/193. Moiseyenko VM.596 298/193.Thomas DB. . Li W.84 to 1. Stalsberg H. .58 and I2 =0% 4. Blinding and allocation concealment were unclear 2. . . . Should breast self-examination vs. . Ray RM. Relative Absolute Importance studies design Indirectness Inconsistency Imprecision Control bias bias examination (95% CI) (95% CI) Breast cancer mortality No studies CRITICAL reporting .98 30 fewer CRITICAL trials Moderate (0. Ivanova OA. Hu YW. Lin MG. PM:1397215. Insufficient number of studies to assess publication bias REFERENCES . Gao DL. . p-value for testing heterogeneity is 0. and Barash NJ. J Natl Cancer Inst. No serious heterogeneity. . . 2002. . Wu C. of Study Risk of Publication Quality Breast self. no intervention be used for breast cancer screening in women of all ages? Author(s): Alonso Carrasco-Labra. 94(19): 1445-57. . Migmanova NS. Pan LD. The role of breast self-examination in early breast cancer detection (results of the 5-years USSR/WHO randomized study in Leningrad). . Popova RT. Orlov AA.15%) (0.763 RR 0. Porter P. Sample size is large and total number of events >300 5. . Chagunava OA.15) (254 fewer to 234 more) False positive No studies IMPORTANT reporting . Coriaty Z.

However. The median age at diagnosis was 48 years (range 19 to 99 years). the Early detection in order to improve breast cancer outcome and survival remains the cornerstone of guideline panel determined that the breast cancer control. the 2009 the age-specific incidence rate was 22. BRCA1/BRCA2 genes or no previous exposure of the chest wall to radiation). 8500) accounts for the 78. .Use of Screening Strategies for Detection of Breast Cancer 51 Evidence to Recommendation Framework 5 5.4/100. breast cancer is 2009 Cancer Incidence Report of the most common among women representing 25.000. ical breast examinations are widely recommended to reduce mortality due to breast cancer.1/100. There is widespread acceptance of the value of regular breast cancer age-specific incidence has a screening as the single most important public health strategy to reduce breast cancer mortality. controversy remains over which screening services should be provided and to whom (age groups).000). disease compared to statistics reported in the literature.000). Riyadh region (29. Mammography. it could also lead to overdiagnosis and overtreatment. these gree relative.1% of all newly diagnosed female cancers. and Makkah region 100.7/100. no history of breast cancer in a first de. bimodal presentation with picks at The reason for this is that breast cancer can be more effectively treated at an early stage. In the Kingdom of Saudi Arabia. Should clinical breast examination be used to screen for breast cancer among women all ages? Problem: Women at average risk of disease Background: Regular screening for breast cancer with mammography. breast self-examinations and clin- (defined as those with no previous breast can. Option: Screening for breast cancer using clin- ical breast examination Comparison: No screening Setting: Outpatients Perspective: Health system ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Based on the data described in the According to the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. and breast self-examination can all identify tumours. represents an earlier onset of the Mammography can identify early stage breast cancer. cer. In Saudi Ara- No Probably Uncertain Probably Yes Varies bia.2% of all morphological P RO B LE M Is the Based on the data described in the No Yes breast cancer variants. no known mutations in the methods are frequently used in contemporary practice. problem a 2009 Cancer Incidence Report of priority? X the Kingdom of Saudi Arabia. On the 45 and 60 years. the pick at 45 years examination by a health care professional. From the panel’s other hand. the infiltrating duct carcinoma (ICD-O-3. The three regions with the highest inci- Incidence of breast cancer is 25 per dence were Easter region (33.000).4/100.000 (26. clinical breast point of view.

García AD.Use of Screening Strategies for Detection of Breast Cancer 52 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Al-Eid HS. Saudi Arabia: Kingdom of Saudi Arabia. After uncertainty Possibly Probably no No False positive further input from a Important - about how Important important important important No known results patient that attended the much uncertainty uncertainty uncertainty uncertainty undesirable panel meeting. Ministry of Health. from critical to important. 2012. Saudi Cancer Registry: Cancer Incidence Report 2009. ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS What is the No The relative importance or values of the main outcomes of interest: overall included certainty of studies Very low Low Moderate High The opinion of panel this Outcome Relative importance Certainty of the evidence X members was divided – evidence? Breast cancer 2 thought the outcome Critical - mortality false positives were BENEFITS & HARMS OF THE OPTIONS Is there critical. sies or surgery outcomes? Anxiety. two thought it All cause mortality Critical - important was important. or other psychological Important - Are the responses desirable No Probably Uncertain Probably Yes Varies anticipated No Yes Summary of findings: Screening for breast cancer with clinical breast examination vs no screening effects X (all ages) large? No evidence was found . distress. the or variability or variability or variability or variability outcomes Overdiagnose Important - people outcome false positve value the X results was rated down Unnecessary biop- main Important .

.18 – 0.03 – 0. .17) ¶ Cohen’s effect size .positive predictive Overdiagnose § . .22) Fear 0. .88 (0.16 (0.11 (0.000) effect (RR) of the undesirable No Probably Uncertain Probably Yes Varies examination reduces breast cancer No Yes (95%CI) (95%CI) evidence anticipated mortality or all-cause effects X (GRADE) mortality.14) Perceived benefits of mammography 0. .12 (0.000. invasive or noninvasive Anxiety. - (organized BCS) value: 4% to 50% Unnecessary .10 – 0. .04 – 0. small? Breast cancer mortality . distress. .06 – 0.14) Anxiety 0.27) LOW Somatization 0.sensitivity: range from 40% to 69% False positive . . . - biopsies or surgery . 88% to 99% . by screening that would See table below - desirable responses not have been identified No Probably Uncertain Probably Yes Varies effects large No Yes clinically or would not relative to have resulted in X undesirable symptoms or death in a effects? person’s lifetime is called Psychological Effects of False-Positive Mammograms overdiagnosis (20 yrs period) Effect Increase effect size ¶ (95% CI) Certainty of the evidence Distress 0. .05 – 0.Use of Screening Strategies for Detection of Breast Cancer 53 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Outcome Without With clinical Difference Relative Certainty indicating that Clinical Are the Breast Examination (follow-up: 11 yr) screening breast (per 1. .09 (0. . - Accuracy of clinical All cause mortality breast examination: . or breast cancer detected Are the other psychological .19) Perceived likelihood of getting breast cancer 0. .22 (0. . . § Overdiagnose: Any .specificity: range from results . .

the guideline panel decided that any psycological effect of false-positive results and frequency of screening will have a lower value compared to the perceived benefits on mortality . or work or family responsibilities that do not allow for daytime appointments. Other women refuse breast cancer screening because of fear. clinical experience. but some would go for screening if recommended by their providers.8 – Large Summary of the evidence for patients’ values and preferences: Most women value mammography in particular for perceived reduction of mortality. However.11 (0. fatalistic beliefs. The majority of women prefer to be jointly involved in decision making with their care providers. and feedback from a representative from the patients. many of the studies were done when participants were already in screening programs.Use of Screening Strategies for Detection of Breast Cancer 54 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Frequency of breast self examination 0. Based on local literature.2 – Small 0.19) interpretation 0.5 – Medium 0.04 – 0. absence of symptoms. few women consider issues of further testing or harm arising from false-positives in their decision making.

X implement? . No Probably Uncertain Probably Yes Varies cost small No Yes relative to X the net benefits? What would be the Increased Probably Uncertain Probably Reduced Varies E Q UIT Y increased reduced The guideline panel considered that health inequities would be impact None identified reduced if this intervention were implemented. on health X inequities? Is the A CCE P T A B ILIT Y option No Probably Uncertain Probably Yes Varies acceptable No Yes The guideline panel determined that this option is acceptable to None identified to key key stakeholders X stakeholders ? Is the F E A S IB ILIT Y No Probably Uncertain Probably Yes Varies option No Yes The panel considered this option as feasible and easy to imple- None identified feasible to ment. the Is the None identified guideline panel agreed that the resources needed to allocate incremental probably are small.Use of Screening Strategies for Detection of Breast Cancer 55 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS Are the No Probably Uncertain Probably Yes Varies resources No Yes required X small? RE S O URCE US E Under lack of local evidence on costs for this intervention.

Clinical breast examination could be used as method for breast cancer screening only when mammography is unavailable. The guideline panel also highlight- ed that when mammography is available. The option described in this recommendation covers only clinical breast examination in the context of breast cancer screening. (Conditional recommendation. this option should always be offered first to patients. no evidence) Justification The panel determined that the strength of the recommendation should be weak/conditional based on the extensive level of uncertainty and lack of evidence. The panel recognizes that more research in this area is needed in order to inform further recommendations on this regard . Subgroup considerations None Implementation  - considerations Monitoring and evaluation - Research priorities There is very limited evidence on the effectiveness of clinical breast examination.Use of Screening Strategies for Detection of Breast Cancer 56 Balance of consequences Undesirable consequences Undesirable consequences probably The balance between Desirable consequences Desirable consequences clearly outweigh outweigh desirable and undesirable consequences probably outweigh clearly outweigh desirable consequences desirable consequences is uncertain undesirable consequences undesirable consequences in most settings in most settings in most settings in most settings X Type of recommendation We recommend against We suggest not offering We suggest offering We recommend offering offering this option this option this option this option X Recommendation (text) The Saudi Expert Panel suggests that clinical breast examination by a health care professional is not used as a single method of screening for breast cancer in women of all ages. This recommendation does not relate to routine physical examination.

Use of Screening Strategies for Detection of Breast Cancer 57 Evidence profile: 5. - outcome All-cause mortality No studies CRITICAL reporting this . . Should clinical breast examination vs. . . Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. . . - outcome False positive results No studies IMPORTANT reporting this . of Study Risk of Publication Quality Clinical breast exam. . . . . . . . . . no intervention be used for breast cancer screening in women of all ages? Author(s): Alonso Carrasco-Labra. . . . . . . . . . . . Relative Absolute Importance studies design Indirectness Inconsistency Imprecision Control bias bias ination (95% CI) (95% CI) Breast cancer mortality No studies CRITICAL reporting this . . - outcome . .

20. 16 and 20 22. (meta-analy$ or metaanaly$ or (systematic$ adj10 review$)). (screen$ or (rountine$ adj3 (test$ or check$ or diagnos$ or detect$))). 25 or 27 or 29 31. exp breast neoplasms/ 13. 11 or 12 14. exp mortality/ 19. 9 and 14 17. (random$ or rct). 27. limit 24 to (meta analysis or practice guideline or randomized controlled trial) 26. 8. 24 and 28 30. exp mass screening/ 7. limit 23 to (english language and humans) 25. 24 not 30 32. exp physical examination/ 11.Use of Screening Strategies for Detection of Breast Cancer 58 Appendix 2: Search Strategies and Results Question: Should mammography. 24 and 26 28. 21 or 22 24. 6 or 7 9. 10 and 13 15.mp. clinical breast examination. 29. and self-breast examination be used to screen for breast cancer? Database: OVID Medline Search strategy: screening Date of search: 11/2013 1. exp neoplasms/di 3. 9 and 15 18.fs. 5 and 8 10. 1 or 4 6. limit 31 to ed=20101001-20131115 33. 17 and 20 23. 2 and 3 5. 18 or 19 21. exp breast/ 12. exp breast neoplasms/ 2.mp. limit 30 to ed=20101001-20131115 Study Types: Randomized controlled trials Records Retrieved 30 . exp breast/ 4.mp. mo. exp mammography/ 16.

1 and 4 6.mp. ((breast$ or mammary) adj3 (neoplas$ or tumor$ or cancer$ or carcinom$)).Use of Screening Strategies for Detection of Breast Cancer 59 Database: Cochrane Central Search strategy: screening in general Date of search: 11/2013 1. 4 and 7 10.mp. (screen$ or (rountine$ adj3 (test$ or check$ or diagnos$ or detect$))). 2.mp. ((breast$ or mammary) adj3 (neoplas$ or tumor$ or cancer$ or carcinom$)). ((digital$ or computer$) adj7 mammogra$). 2 or 3 5.mp. (screen$ or (rountine$ adj3 (test$ or check$ or diagnos$ or detect$))). limit 5 to last 2 years 7. 8. 2. 3. 2.mp. limit 9 to last 2 years Study Types: Systematic reviews of Randomized controlled trials Records Retrieved 2 Database: Cochrane database of systematic reviews Search strategy: digital mammography Date of search: 11/2013 1. 1 not 7 9. 3. 2 or 3 5.mp.kw. 1 and 4 6. ((clinical$ or physical$) adj3 (exam$ or detect$ or diagnos$)). 2. ((clinical$ or physical$) adj3 (exam$ or detect$ or diagnos$)). 4.mp. ((breast$ or mammary) adj3 (neoplas$ or tumor$ or cancer$ or carcinom$)). limit 1 to yr="2010 -Current" Study Types: Randomized controlled trials Records Retrieved 1 Database: Cochrane database of systematic reviews Search strategy: screening in general Date of search: 11/2013 1. 4.mp. limit 5 to yr="2010 -Current" Study Types: Randomized controlled trials Records Retrieved 22 Database: Cochrane Central Search strategy: digital mammography Date of search: 11/2013 1. ((digital$ or computer$) adj7 mammogra$). limit 1 to yr="2010 -Current" .

9 or 10 or 11 13. 17. 4 and 7 9. exp breast diseases/di. 5. 1 or 2 or 3 5.mp. 7 and 12 14. ct 12. 5 or 6 8. exp mammography/ae. 16. (overtest$ or overdiagnos$ or over-test$ or over-diagnos$). (overtreat$ or over-treat$). 3 and 7 and 10 12. exp mammography/ 2. exp carcinoma.mp. over-diagnos$. 6. exp breast/ 6. 1 and 2 4. (false$ adj (positiv$ or negativ$)). limit 13 to ed=20101001-20131115 Study Types: Randomized controlled trials Records Retrieved 24 Database: OVID Medline Search strategy: Adverse effects Date of search: 11/2013 1. 18. noninfiltrating/ 2. ct 10. ct 11. exp mass screening/ 4. exp mass screening/ 9. overdiagnos$. ((incorrect$ or false$ or wrong$ or bias$ or mistake$ or error$ or erroneous$) adj3 (result$ or find- . exp breast neoplasms/ 3.Use of Screening Strategies for Detection of Breast Cancer 60 Study Types: Systematic reviews of Randomized controlled trials Records Retrieved 1 Database: OVID Medline Search strategy: Ductal carcinoma in situ Date of search: 11/2013 1. exp mammography/ 10. exp mass screening/ae.mp.mp. ep 7. 3 and 12 14.mp. misdiagnos$. exp physical examination/ 3. exp diagnostic errors/ 15. intraductal. exp Diagnostic errors/ 8. 8 or 9 11. 7. 4 or 5 or 6 13. exp physical examination/ae.mp.

mp. ct 18. 14. mammogra$. 15. or/23-26 28. exp mammography/ 2.mp. exp breast/ 9.fs. exp prejudice/ 26. 8 and 21 23. 3. or/1-6 8. ct 19. ((physical$ or clinical$ or manual$) adj3 exam$). exp stereotyping/ 27. 8 and 27 29. ((advers$ adj3 effect$) or harm$ or contraindicat$). 19. ae. (observ$ adj3 bias$).mp. ((inappropriat$ or unnecess$ or unneed$) adj3 (treat$ or Surg$ or therap$ or regimen$)). or/8-10 12. 13 or 22 or 28 30. et 24. 20. limit 30 to (meta analysis or randomized controlled trial) 32. ep 10. 7 and 11 13. 7. limit 29 to english language 31.mp. 34. 30 and 35 37. 32 or 33 or 34 36. 31 or 36 38.mp. 21. or/14-20 22. or/17-19 21.mp. exp "wounds and Injuries"/ci. exp physical examination/ 4. limit 37 to ed=20101001-20131115 Study Types: Randomized controlled trials and observational studies Records Retrieved 147 Database: Cochrane Central Search strategy: Adverse effects Date of search: 11/2013 1. ct 20. exp mammography/ae. exp mass screening/ae. or/13-14 16. exp breast diseases/di.mp. comparative study. exp evaluation studies/ 33. exp epidemiologic studies/ 35.pt. screen$. exp mass screening/ 6.mp. 11. (breast$ or mammar$). psychological/ 25. 5. exp stress. 12 and 15 17. exp physical examination/ae. 11 and 20 .Use of Screening Strategies for Detection of Breast Cancer 61 ing$ or test$ or diagnos$)).

psychological/ 31. 26. 9 and 14 17. exp breast neoplasms/ 2. limit 21 to ed=20101001-20131115 Study Types: Economic evaluation and cost-effectiveness studies Records Retrieved 64 . 10 and 13 15.mp. 5 and 8 10. 25. exp breast/ 12.mp. 18 and 19 21. exp "Costs and Cost Analysis"/ 20. exp "wounds and Injuries"/ci. exp diagnostic errors/ 23. 34. exp breast neoplasms/ 13. 16 or 17 19. 2 and 3 5.mp. 11 or 12 14. exp physical examination/ 11. et 30. 6 or 7 9. exp neoplasms/di 3. exp mammography/ 16. (observ$ adj3 bias$).mp.Use of Screening Strategies for Detection of Breast Cancer 62 22. exp stereotyping/ 33. limit 36 to yr="2010 -Current" Study Types: Randomized controlled trials and observational studies Records Retrieved 45 Database: OVID Medline Search strategy: Costs Date of search: 11/2013 1. (diagnos$ adj3 (error$ or mistak$ or incorrect$)). or/29-33 35. or/22-26 28. (screen$ or (rountine$ adj3 (test$ or check$ or diagnos$ or detect$))). (anxiet$ or anxious$ or fear$ or discriminat$ or unfair$ or prejudic$ or stigma$ or stereotyp$). exp breast/ 4. 12 and 34 36.mp. 12 and 27 29. exp mass screening/ 7. exp prejudice/ 32. (overtest$ or overdiagnos$ or over-test$ or over-diagnos$). 27. 24. 9 and 15 18. (false$ adj (result$ or positiv$ or negativ$)).mp. 8. 16 or 21 or 28 or 35 37. exp stress. 1 or 4 6. limit 20 to english language 22.

4.mp.mp.mp. 3. TX women? N3 preference? or TX women? N3 acceptance or TX women? N3 satisfaction or TX wom- en? N3 experience? S11. TI breast cancer screening S2.mp.Publication Year from: 2010-2013.mp. ((clinical$ or physical$) adj3 (exam$ or detect$ or diagnos$)). (screen$ or (rountine$ adj3 (test$ or check$ or diagnos$ or detect$))). ((breast$ or mammary) adj3 (neoplas$ or tumor$ or cancer$ or carcinom$)). limit 5 to yr="2010 -Current" Study Types: Randomized controlled trials Records Retrieved 3 Database: Cochrane database of systematic reviews Search strategy: Costs Date of search: 11/2013 1. 5. S4 or S7 S9. 1 and (2 or 3) and 4 6. 2. (cost or costs or costing or economic$ or financial$). S1 or S2 or S3 S5.mp. 3. ((clinical$ or physical$) adj3 (exam$ or detect$ or diagnos$)). TX consumer? N3 choice? or TX patient? N3 choice? or TX women* N3 choice? S13. French] . (MM "Mammography") S4. S5 and S6 S8.Use of Screening Strategies for Detection of Breast Cancer 63 Database: Cochrane Central Search strategy: Costs Date of search: 11/2013 1. Language: English. 5. 2. (screen$ or (rountine$ adj3 (test$ or check$ or diagnos$ or detect$))). S8 and S13 S15. (cost or costs or costing or economic$ or financial$). (MM "Breast Neoplasms+") S7.mp. ((breast$ or mammary) adj3 (neoplas$ or tumor$ or cancer$ or carcinom$)). 1 and (2 or 3) and 4 6. S9 or S10 or S11 or S12 S14.mp. MM "Patient Compliance" or MM "Consumer Participation" or MH "Patient Satisfaction" or MH "Treatment Refusal" or MH "Consumer Satisfaction" S10. S8 and S13 [Limiters . 4. limit 5 to yr="2010 -Current" Study Types: Systematic reviews of randomized controlled trials and economic evaluations Records Retrieved 2 Database: EBSCO CINAHL Search strategy: Patients values and preferences Date of search: 11/2013 S1. TX consumer? N3 preference? or TX consumer? N3 acceptance or TX consumer? N3 satisfaction or TX consumer? N3 experience? S12. (MH "Breast Neoplasms/DI") S3. (MM "Cancer Screening") S6.

tw. 2 exp *Breast Neoplasms/di 3 exp *Mammography/ 4 or/1-3 5 *mass screening/ 6 exp *Breast neoplasms/ 7 5 and 6 8 4 or 7 9 *"patient acceptance of healthcare"/ or *patient compliance/ or *patient participation/ or patient satis- faction/ or patient preference/ or *treatment refusal/ 10 (women? adj3 (acceptance or preference? or satisfaction or experience?)).tw. exp neoplasms/di 3. (screen$ or (rountine$ adj3 (test$ or check$ or diagnos$ or detect$))). 14 ((conjoint or contingent) adj3 (valuation or analysis)). 5 and 8 10. exp breast/ 4. 6 or 7 9.tw. 13 willingness to pay. 11 or 12 14. exp breast neoplasms/ 2. exp breast/ 12. 1 or 4 6.tw.mp. 15 or/9-14 16 8 and 15 17 limit 16 to (english or french) 18 limit 17 to yr="2010 -Current" Study Types: Randomized controlled trials and observational studies Records Retrieved 305 Database: OVID Medline Search strategy: Breast cancer screening frequency Date of search: 11/2013 1. 10 and 13 15. exp mass screening/ 7.Use of Screening Strategies for Detection of Breast Cancer 64 Study Types: Randomized controlled trials and observational studies Records Retrieved 125 Database: OVID Medline Search strategy: Patients values and preferences Date of search: 11/2013 1 breast cancer screening.ti. exp physical examination/ 11. 8. 11 (consumer? adj3 (acceptance or preference? or satisfaction or experience?)). exp breast neoplasms/ 13. 12 (patient? adj3 (acceptance or preference? or satisfaction or experience?)). exp mammography/ . 2 and 3 5.tw.

Use of Screening Strategies for Detection of Breast Cancer 65 16.tw. frequency. schedule. limit 23 to (english or french) 25. 9 and 15 18.Grey literature search Search strategy: Date of search: 11/2013 • “breast cancer screening AND harms” • “mammography AND harms” • “mammography AND costs” • “breast cancer screening AND costs” The search was limited to Saudi Arabia Study Types: Randomized controlled trials. 21 or 22 24. 32.tw. registries Records Retrieved Relevant: 2 . 25 and 32 34. (annual* or yearly). observational studies. biennial.fs. exp mortality/ 19. 20. 18 or 19 21. 29. 17 and 20 23.tw. 31. (biannual or bi-annual). limit 33 to yr="2010 -Current" Study Types: Randomized controlled trials Records Retrieved 62 Database: Google . 30. mo. 27.tw. (interval not confidence interval). 16 and 20 22. 9 and 14 17. 26 or 27 or 28 or 29 or 30 or 31 33.tw. limit 24 to humans 26.tw. 28.

Excluded: 445 Included for Full Text 10 review: Selection (Full Text Review) No. Retrieved: 835 Cochrane: 76 Medline: 632 Embase: - Other: 127 Duplicates: 380 No.Use of Screening Strategies for Detection of Breast Cancer 66 Summary of Searches Total No. Total 455 Without duplicates: Screening (Title and Abstract Review) No. Excluded: 6 .