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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.

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

For all selected questions we updat- world. and Makkah region (26. 8500) accounts for 78. mate of the effect. Mam.1% of all newly diagnosed female cancers. It is estimated that worldwide over ed existing systematic reviews that were used 508. moderate. and breast self. specific to the Saudi context. Poten- acceptance of the value of regular breast can.1 There is widespread recommendations during this meeting. directness. of treatment effects) is categorized as: high.000 women died in 2011 due to breast for the 2010 “Screening for Breast Cancer in cancer. The three regions with the summaries of available evidence supporting highest incidence were Eastern region each recommendation following the GRADE (33.7/100. The medi. On the other hand.1 The reason for this is that breast cancer can be more effectively treated at an How to use these guidelines early stage. 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. Riyadh region (29.000). the quality of the supporting evidence accord- examination can all identify tumors.000).4/100.Use of Screening Strategies for Detection of Breast Cancer 2 duce variability in clinical practice across the Executive summary Kingdom. Development and Evaluation) approach. dence (confidence in the available estimates cer.8 Quality of evi- mography can identify early stage breast can. sensus process and transparently document all decisions made during the meeting (see Early detection of breast cancer in order to Appendix 1). but there is a possibility . 2013 and formulated all breast cancer control. Assessment.6 We an age at diagnosis was 48 years (range 19 to used this information to prepare the evidence 99 years). it could also lead to over diagnosis and overtreatment. Moderate quality evi- a program of rigorous adaptation and de novo dence indicates moderate confidence.2% guideline panel to follow the structured con- of all morphological breast cancer variants. clinical breast examination by graded the recommendations and assessed a health care professional. In Saudi Arabia.4/100. and development of guidelines. (Grading of Recommendations. The guideline panel met in Ri- improve survival remains the cornerstone of yadh on December 5. The ultimate goals that the true effect is likely close to the esti- are to provide guidance for clinicians and re. ing to the GRADE approach. low. Based on the In 2009 the age-specific incidence rate was updated systematic reviews we prepared 22.1 Although breast cancer is thought to Average-risk Women Aged 40 to 74” guideline be a disease of the developed world. or very low based on consid- Methodology eration of risk of bias.5 We also conducted systematic occur in less developed countries. almost by the Canadian Task Force on Preventive 50% of breast cancer cases and 58% of deaths Health Care.2 According searches for information that was required to to the 2009 Cancer Incidence Report of the develop full guidelines for the KSA. including Kingdom of Saudi Arabia.000. 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. 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.7 mortality.4 The guideline working group developed and Mammography.3 breast cancer is the searches for information about patients’ val- most common among women representing ues and preferences and cost (resource use) 25. consistency and precision of the estimates.1/100.000). the infiltrating duct to recommendation tables that served the carcinoma (ICD-O-3.

these two grades is essential for sagacious tially different from the effect estimate and clinical decision making. Finally. proportion would not. Should breast self-examination be used to screen for breast cancer among women all ages? . Key questions 5. Should mammography (digital) be used to screen for breast cancer among women aged 70-74? 4. Adherence to this rec. For clinicians Most individuals should receive the Recognize that different choices will be intervention. with his or her values and preferences.Use of Screening Strategies for Detection of Breast Cancer 3 that it is substantially different. Should screening for breast cancer among women all ages? with mammography (digital) vs. but many would not. Should mammography (digital) be used to screen for breast cancer among women aged 50-69? 3. Should clinical breast examination be used to screen for breast cancer 1. Decision aids may be useful helping in- dividuals making decisions consistent with their values and preferences. The recommendation can be Policy making will require substantial ers adapted as policy in most situations debate and involvement of various stakeholders. 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. further research is likely to have important potential for reducing the uncertainty. 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. 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. For policy mak. Table 1). and that the true pressed as either strong (‘guideline panel rec- effect may be substantially different. Understanding the interpretation of certain. Low quality evidence indicates that our confidence in the The strength of recommendations is ex- effect estimate is limited. no screening be used in women aged 40– 49 years? 2. Formal deci- sion aids are not likely to be needed to help individuals make decisions consistent with their values and preferences. the true effect is likely to be substan.

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

stage breast cancer. The guidance about population-based screening three regions with the highest incidence were strategies to detect breast cancer in women. The median age at diagnosis in medical oncology and radiology in the was 48 years (range 19 to 99 years). widespread acceptance of the value of regular versity working group produced clinical prac. for the 2010 “Screening for breast cancer in tion strategies. average-risk women aged 40 to 74” guideline nate the majority of breast cancers in low. lines. (29.4/100. the infiltrating duct carcinoma (ICD-O- professionals. 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. cancer outcome and survival remains the cor- try of Health (MoH) of Saudi Arabia with the nerstone of breast cancer control. We cancer. Other health care Arabia.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. in part. urbanization and adoption of process. being to provide guidance for clinicians and and breast self-examination can all identify reduce variability in clinical practice across the tumors.1 There is methodological support of the McMaster Uni. Riyadh region The target audience of these guidelines in.1% of all newly diag- nosed female cancers. public health officers and policy 3. we briefly describe the methodology we world. almost separate publication.000. For all selected questions we updat- western lifestyles.2% of all morphologi- makers may also benefit from these guide. searches for information about patients’ val- port of the Kingdom of Saudi Arabia (KSA). it could also lead to overdiagnosis and over- ous adaptation and de novo development of treatment. breast cancer mortality. Easter region (33. Early detection in order to improve breast Given the importance of this topic. Health Care.3 . In Saudi Kingdom of Saudi Arabia.000). cal breast cancer variants. this guideline and all clinical questions ad- veloping 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. clinical breast guidelines in the Kingdom.7/100. ed existing systematic reviews that were used tion could be achieved implementing preven.Use of Screening Strategies for Detection of Breast Cancer 5 breast cancer is the most common among Scope and purpose women representing 25. Although some risk reduc. the Minis.4 Mammography.1/100. 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. the ultimate goal examination by a health care professional. and Makkah region cludes primary care physicians and specialists (26.4/100. In 2009 the age- The purpose of this document is to provide specific incidence rate was 22.1 Although breast cancer is thought to present the details of the methodology in a be a disease of the developed world. Saudi Arabia to establish a program of rigor.000). including According to the 2009 Cancer Incidence Re. searches for information that was required to develop full guidelines for the KSA.9 50% of breast cancer cases and 58% of deaths occur in less developed countries .000 women died in 2011 due to breast and quality of the supporting evidence. by the Canadian Task Force on Preventive and middle-income countries where it is diag. On the other hand. It is estimated that worldwide over used to develop and grade recommendations 508. Mammography can identify early Kingdom. these policies cannot elimi. The Saudi Expert Panel selected the topic of dence of breast cancer is increasing in the de. 8500) accounts for 78.2 The inci.

vant for the Saudi context and addressed in mendations is essential for sagacious clinical this guideline. the strength of a recommendation is either strong Key questions or conditional (weak) and has explicit implica- tions (see Table 1).8 Quality of evidence is classified as The Ministry of Health of Saudi Arabia and “high”. 2013 and formulated summaries of available evidence supporting all recommendations during this meeting. The guideline panel met in updated systematic reviews we prepared Riyadh on December 5.  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.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. 49 years? . Assessment. but there is a pos- these guidelines by rote or in a blanket fash- sibility that it is substantially different. can take into account all of the often- compelling unique features of individual clini-  Moderate: We are moderately confi- cal circumstances. Po- each recommendation following the GRADE tential conflicts of interests of all panel mem- (Grading of Recommendations. 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. third-party payers. Based on the (see Appendix 1).9 Based on this information and the input of KSA panel members we prepared the evi. institutional review committees. Therefore. “moderate”.7 Appendix 2). Clinicians. 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. dictates. no the guideline panel to follow the structured screening be used in women aged 40– consensus process and transparently docu. particularly when lack of published evidence was identified. “low”. other stakeholders. Understanding the inter. According to the GRADE approach. For details on the process by decision-making. which the questions were selected please re- fer to the separate methodology publication. 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. 1. They should never be effect is likely to be substantially dif- omitted when quoting or translating recom- ferent from the estimate of effect. bers were managed according to the World Development and Evaluation) approach (see Health Organization (WHO) rules. 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 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. ion. mendations from these guidelines.6 The guideline panel provided additional information. Should screening for breast cancer dence-to-recommendation tables that served with mammography (digital) vs. How to use these We assessed the quality of evidence using the guidelines system described by the GRADE working group. The definition of for breast cancer in women. No guidelines and recommendations timate of the effect. pa- each category is as follows: tients.

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. which was addressed in the baseline risk in this specify age subgroup.50]. Should breast self-examination be benefit and considerable harm (RR 1. phy in particular for perceived reduction of dence to recommendation table 1). Regarding screen.Use of Screening Strategies for Detection of Breast Cancer 7 2. that do not allow for daytime appointments. However.72 – 1. and therefore. terms. involved in decision making with their care ing interval.04 used to screen for breast cancer [95%CI 0. Low quality evidence). 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. The majority of women prefer to be jointly iety and follow-up testing. Then. in women bers’ clinical experience. Should mammography (digital) be [95%CI. but some would go for screening if . representative from the patients that partici- phy compared to no screening reduces deaths pated during the panel meeting. In absolute positives in their decision-making. 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. and 690 women will have a false posi. to save one additional life from breast many of the studies were done when partici- cancer over about 11 years of follow-up. no judged to be “low”. Use of digital mammography for breast attended the panel meeting. 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. the evidence shows that when providers. 75 because of fear. about 2.94]. mortality. There was disagreement within the panel about the rela- Recommendations tive importance of the outcome false positive results. or work or family responsibilities biopsy. er. ther testing or harm arising from false- trieve any additional evidence. in pants were already in screening programs. The panel agreed that there imaging be used as a strategy for breast can. the outcome of cancer screening false positive results was rated down from critical to important.11-13 panel mem- trolled trials (RCT) showed that. 0. However. this age group.82 3. among women all ages? 5. the use of mammogra.72 – 0. few women consider issues of fur- tematic search update conducted did not re. After further input from a patient that I. The sys. absence of women would have an unnecessary breast symptoms. the overall quality Question 1: Should screening for breast can.100 women would Other women refuse breast cancer screening need to be screened every 2 to 3 years. fatalistic beliefs. is considerable uncertainty regarding the cer screening”. High quality evidence). reports that most women value mammogra- nificant effect on all-cause mortality (See evi. tive mammogram leading to unnecessary anx. existing in other countries. of the evidence for this recommendation was cer with mammography (digital) vs. three A recent Cochrane systematic review10 that sources of data informed this topic: literature included data from eight randomized con. The literature ascribed to breast cancer in 15% without sig. and the opinion of a below 50 years of age. 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.

therefore. the pa. the guideline panel raphy in the Kingdom.500 using more accurate and direct evidence from per quality-adjusted life year (QALY) saved the local context. This fact may indicate that higher benefit on breast cancer Acceptability: mortality justifies a recommendation in favor Panel members mentioned that they are in.16 From the panel’s decided that any psychological effect of false.200 and $14. point of view. Centers Although there are no published or un. Although The panel considered that control and audit digital mammogram equipment is widely the result of mammograms is important. the inci- panel determined that probably the incre. The Saudi Expert Panel suggests screening respectively. Availability of assessment clinics for false positive results. Since .000. compared with no screening. which studies were conducted. using mammography in this age group.000. needed to allocate are not small. will have a lower value compared to the per- ceived benefits on mortality. fied and be monitored periodically. The panel highlights that this recommenda- roborated panel’s perception and. offering the service should also be regulated published data on the cost-effectiveness of and monitored. 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. from annual and biennial screening of women aged 40-49 was $26. deter.15 The Based on local cancer registry data. women with positive (true & false) screening results should be guaranteed.000 US ommendation. the cost per QALY gained for triennial screening those Remarks: aged 47 to 49 was about US$45.Use of Screening Strategies for Detection of Breast Cancer 8 recommended by their providers. or used modelling techniques Research priority: to estimate cost-effectiveness ratios. this option is acceptable for all positive results and frequency of screening the stakeholders. low-quality evidence) dollars per QALY gained. Finally. the Resource use: panel recognized the necessity for educating Under lack of local evidence on costs. In addition the review stated that the cost per life years Recommendation 1: saved. 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. Among the costs related to this intervention can be listed: Monitoring and evaluation: equipment. a also mentioned that all radiologists diagnosing higher number of well-trained radiologists are and reporting mammograms should be certi- needed. tion represents a good opportunity for shared this recommendation places higher value for decision-making. of implementing breast cancer screening formed of previous initiatives for implement. They available across regions in the Kingdom. Based on ing breast cancer screening using mammog- their clinical experience. Moreover.000 to $65. In addition. the the population on the importance of breast guideline panel agreed that the resources cancer screening strategies. dence of breast cancer in the KSA seems to mental cost is small relative to the net bene. Implementation considerations: tient participating in the panel meeting cor. In addition. and human resources. be higher than in the other countries in fits. the panel men- mammograms in the context of Saudi Arabia. (Conditional rec- would cost between $24. 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. 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.

roborated panel’s perception and.15 The representative from the patients that partici. to save one additional life from breast cancer irrespective of the consequences of cancer over about 11 years of follow-up. The sys. High to estimate cost-effectiveness ratios.Use of Screening Strategies for Detection of Breast Cancer 9 the guideline panel determined that there is mortality. 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. Values and preferences: respectively. 26 women Resource use: would have an unnecessary breast biopsy. In absolute being alive and prevents death from breast terms. However. ther testing or harm arising from false- sirable consequences. Finally. plementing shared-decision making strate. Other women refuse breast cancer screening because of fear. few women consider issues of fur- a close balance between desirable and unde. absence of Question 2: Should mammography (digital) symptoms.000. the use of mammogra.67 [95%CI 0. from annual and biennial screening of women aged 40-49 was $26.98].000 US sources of data informed this topic: literature dollars per QALY gained. a recent systematic review14 including 26 dence shows that when the option is imple. the cost existing in other countries. tients’ perspective into the decision. studies from other regions that incorporated mented in intervals <24 months there is a re.000. therefore. per QALY gained for triennial screening those bers’ clinical experience. the pa- nificant effect on all-cause mortality (See evi. Moreover. tient participating in the panel meeting cor- dence to recommendation table 2). ceived benefits on mortality.200 and $14. The literature mental cost is small relative to the net bene- reports that most women value mammogra.88]. Implementing screening mined that mammography and clinical breast ≥24 months also suggests a reduction in examination cost an additional USD 35. 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. pants were already in screening programs. fits.500 breast cancer mortality (RR 0. but some would go for screening if A recent Cochrane systematic review10 that recommended by their providers. 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.51 – per quality-adjusted life year (QALY) saved 0. in women at decided that any psychological effect of false- least 50 years of age. many of the studies were done when partici- gies as a way to incorporate actively pa. cost-effectiveness data alongside randomized duction in the risk of death from breast cancer controlled trials. The overall compared with no screening. Moderate quality evidence). Based on included data from seven randomized con.75 – 0. fatalistic beliefs. and the opinion of a aged 47 to 49 was about US$45. panel determined that probably the incre- pated during the panel meeting. or work or family responsibilities be used to screen for breast cancer among that do not allow for daytime appointments. or used modeling techniques of 14% (RR 0. tematic search update conducted did not re. positives in their decision-making. their clinical experience.000 to $65. phy in particular for perceived reduction of . testing.86 [95%CI. In addition the quality of the evidence for this recommenda. this age group. the guideline panel trolled trials (RCT) showed that. Regarding screening interval. deter- quality evidence). women aged 50-69? The majority of women prefer to be jointly involved in decision making with their care Summary of findings: providers. the evi. However. three would cost between $24. 0. this recommendation places higher value for trieve any additional evidence. review stated that the cost per life years tion was judged to be “Moderate”. in false positive results. about 720 women would need to be screened every 2 to 3 years. saved. 11-13 panel mem. they also suggest im.

ing breast cancer screening using mammog- raphy in the Kingdom. In absolute terms. 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. However. and monitored. breast cancer is not a priority or a main Recommendation 2: health problem. age group. In addition. sequences in most settings. update conducted did not retrieve any addi- tional evidence. representative from the patients that partici- dence of breast cancer in the KSA for this age pated during the panel meeting. the inci.16 From the panel’s Question 3: Should mammography (digital) point of view.01]. 96 women will fied and be monitored periodically. the reduction in breast cancer mortality (RR 0. Given other competing health risks. The guideline phy in particular for perceived reduction of .45–1.11-13 panel mem- Remarks: bers’ clinical experience. Centers have a false positive mammogram leading to offering the service should also be regulated unnecessary anxiety and follow-up testing. 11 women would have an and reporting mammograms should be certi. The panel considered that the op- are also needed to inform future guidelines tion might not be relevant for this particular and stakeholders. The literature group is similar to the ones reported in the reports that most women value mammogra- literature in other countries.68.01) (See evidence to recom- the population on the importance of breast mendation table 3). quences probably outweigh undesirable con- formed of previous initiatives for implement. three dation. in this age group. 0. 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. 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. Summary of findings: tion represents a good opportunity for shared A recent systematic review10 that conducted a decision-making. women aged 70-74? Implementation considerations: The panel highlights that this recommenda. The overall quality of the evi- using more accurate and direct evidence from dence for this recommendation was judged to the local context. East and West) found that women with positive (true & false) screening screening led to a non-statistically significant results should be guaranteed. 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. Cost effectiveness studies be “low”. the result of mammograms is important. moderate-quality evidence). this option is acceptable for all be used to screen for breast cancer among the stakeholders. Regarding screening interval. panel recognized the necessity for educating 95% CI 0. the panel men. Low Research priority: quality evidence). The systematic search cancer screening strategies. and the opinion of a Based on local cancer registry data.68 [95%CI. values and preferences. Availability of assessment clinics for Two County.Use of Screening Strategies for Detection of Breast Cancer 10 Acceptability: panel determined that desirable conse- Panel members mentioned that they are in. unnecessary breast biopsy. sources of data informed this topic: literature existing in other countries. In addition. They about 450 women would need to be screened also mentioned that all radiologists diagnosing every 2 to 3 years.45 – 1. 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.

formed of previous initiatives for implement- many of the studies were done when partici. Moreover.000. In addition.Use of Screening Strategies for Detection of Breast Cancer 11 mortality. In addition. cancer screening strategies. Acceptability: ther testing or harm arising from false. women with positive (true & false) screening positive results and frequency of screening results should be guaranteed. the cost years (Conditional recommendation. 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.500 using more accurate and direct evidence from per quality-adjusted life year (QALY) saved the local context.16 From the panel’s Other women refuse breast cancer screening point of view. Recommendation 3: respectively. Finally. from annual and biennial screening of women aged 40-49 was $26. ing breast cancer screening using mammog- pants were already in screening programs. 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. panel recognized the necessity for educating ceived benefits on mortality. but some would go for screening if decision-making. 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. the guideline panel Kingdom. Availability of assessment clinics for decided that any psychological effect of false. the will have a lower value compared to the per. Centers Although there are no published or un. eases.15 The panel determined that probably the incre. fatalistic beliefs.200 and $14. low- per QALY gained for triennial screening those quality evidence) aged 47 to 49 was about US$45. this option is acceptable for all because of fear.000 to $65. Cost effectiveness studies compared with no screening. offering the service should also be regulated published data on the cost-effectiveness of and monitored. the pa. 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. therefore. 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. Based . The access for women with recommended by their providers.000. In addition the are also needed to inform future guidelines review stated that the cost per life years and stakeholders. However. Remarks: mental cost is not small relative to the net Giving the competing risks with other dis- benefits. absence of the stakeholders. few women consider issues of fur. also mentioned that all radiologists diagnosing and reporting mammograms should be certi- Resource use: fied and be monitored periodically. They false positive results. or used modeling techniques Research priority: to estimate cost-effectiveness ratios.000 US with mammography in women aged 70–74 dollars per QALY gained. Based on disabilities should be guaranteed across the their clinical experience. deter. the population on the importance of breast tient participating in the panel meeting cor. saved. symptoms. or work or family responsibilities that do not allow for daytime appointments. roborated panel’s perception and. 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. raphy in the Kingdom.

very-low quality evidence) bers’ clinical experience. There is very limited evidence on the effec- cated in the updated literature search. three method of screening for breast cancer in sources of data informed this topic: literature women of all ages. 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. but ture in other countries. No new studies on the im- pact of breast self-examination on breast can. weak/conditional based on the extensive or work or family responsibilities that do not level of uncertainty and lack of evidence. increased harm for benign breast biopsy. However. tiveness of breast self-examination. 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 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 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. Remarks: pated during the panel meeting. Finally. “moderate” to “very low” given that there is Recommendation 4: no data informing breast cancer mortality. the incidence allow for daytime appointments. Based on their clinical ex- probably outweigh desirable consequences perience. The . fatalistic beliefs. differences between the option and control groups in all-cause mortality (RR 0. mortality. and the opinion of a representative from the patients that partici. 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. breast cancer mortality in the context of Saudi ings of two studies conducted in Russia17 and Arabia.11-13 panel mem. 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.2]) (See evidence to recommendation From the panel’s point of view. absence of symptoms. The guideline panel some would go for screening if recommended determined that undesirable consequences by their providers. The cited studies also detected an acceptable for all the stakeholders. the guideline panel decided that any in most settings.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. cision making with their care providers. the patient participating in the panel meeting corroborated panel’s per- II. The panel determined that the strength of en refuse breast cancer screening because of the recommendation should be fear. therefore. Some wom. 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.83-1.98 [95%CI Acceptability: 0. (Conditional recommen- existing in other countries. dation. and easy to implement. this option is table 4). Use of breast self-examination for breast ception and. In case this option is offered psychological effect of false-positive results to women between 70 to 74 years old. creasing mortality. Research priority: cer mortality or all-cause mortality were lo. the guideline panel determined that Shanghai.

Use of Screening Strategies for Detection of Breast Cancer 13 guideline panel also highlighted that. especially in regions where Under lack of local evidence on costs for this mammography may not be offered. ages. breast self-examination plays a Resource use: secondary role. by their providers. The option described mortality. this recommendation cancer screening. (Conditional recommendation. This and frequency of screening will have a lower recommendation does not relate to routine value compared to the perceived benefits on physical examination. no evi- bers’ clinical experience. Clinical breast examination could be used as perience. The of women prefer to be jointly involved in de. guideline panel also highlighted that when cision making with their care providers. Remarks: en refuse breast cancer screening because of The panel determined that the strength of fear. However. fatalistic beliefs. the guideline panel decided that any method for breast cancer screening only psychological effect of false-positive results when mammography is unavailable. absence of symptoms. this option some would go for screening if recommended should always be offered first to patients. 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. There are no published or unpublished breast cancer screening data on the cost effectiveness of clinical breast examination. but mammography is available. (See evidence to recommendation table 5). Finally. and the opinion of a dence). when vents death from breast cancer irrespective of mammography is available. intervention. breast examination in the context of breast ception and. the guideline panel agreed that the resources needed to allocate probably are III. The majority level of uncertainty and lack of evidence. places higher value for being alive and pre- . therefore. should always be offered first to patients. Based on their clinical ex.11-13 panel mem. 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. 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. the patient participating in in this recommendation covers only clinical the panel meeting corroborated panel’s per. Some wom. representative from the patients that partici- pated during the panel meeting. In this regard. the recommendation should be or work or family responsibilities that do not weak/conditional based on the extensive allow for daytime appointments. 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. Use of clinical breast examination for small. this option the consequences of false positive results.

16(3):811-821. 2013. A decision et al. Thabane L. et al.3(3):A75. Arabia. 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. Helfand M. Sep-Oct the quality of evidence.Use of Screening Strategies for Detection of Breast Cancer 14 References 1. 5. The global burden of disease: University Clinical Practice Guidelines. Barratt AL. systematic review. Akl EA. Schunemann screening program in Saudi Arabia.pd Musaad SM. France: Denmark based on discrete ranking International Agency for Research on data. WHO mammography in women 70 years Handbook for Guideline and over: a systematic review. GRADE guidelines: 3. World Health Organization. Cancer Cochrane Database of Systematic Incidence and Mortality Worldwide: Reviews. Handbooks of Cancer 12. et al. canadienne. http://globocan. Ferlay J.64(4):383-394. al. Ervik M. Guyatt G. 7: Breast Cancer of mammography screening in Screening. Issue 6.42(4):347-357. Gøtzsche PC.int/iris/bitstream/10 16. Jazieh AR. 665/75146/1/9789241548441_eng. et al. 2004 update. national public breast cancer 8. IARC. Screening 2. 2000. Apr 17. 2014. 2006. Cancer. 2002. 2009. Introduction. harms and costs of screening 7. Rashidian A. 10. Iranian journal of GRADE evidence profiles and public health. Methodology for the [Russia (St. 2012. Prev Chronic Dis. Oxman AD. Gyrd-Hansen D.fr. Irwig LM. Van Bebber S. GLOBOCAN 2012 v1. Int J Technol Assess Health Care. Barfar E. Cost 2011. Manikhas AG. WHO. = journal de l'Association medicale 14. summary of findings tables. et for breast cancer with mammography. 4.who. Art.pub5. Saudi Arabia: Kingdom of Saudi for cancer screening. 10. McMaster University Guideline prospective randomized investigation Working Group. Ministry of Health. DOI: 2013.iarc. Moiseyenko VM.65(6):1130-1140. 2011. Saudi Cancer Walsh J. 11 [Internet] CD001877. Lyon.0. 13.: World Health 2014.64(4):401-406. The first f. a GRADE guidelines: 1. screening using mammography. Nov 22 Nosratnejad S. Joffres M. HJ. 2002. A review of Registry: Cancer Incidence Report studies examining stated preferences 2009. Marshall D. Balshem H. Results of a 9. Ackerson K. effectiveness of breast cancer 6. Barooti E. Jørgensen KJ. García AD.2008. Houssami N. Benefits. J Adv Canadian Medical Association journal Nurs. Accessed December 2013. CMAJ : screening: systematic review. Vol 7. Journal of 15. Preston SD.1002/14651858. Al-Eid HS. Soerjomataram I. Apr Salkeld GP. Hosseini H. Phillips KA. Abulkhair OA.176(6):266-271. clinical epidemiology. Semiglazov VF. clinical epidemiology. Connor Gorber S. Accessed February 7. http://apps.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 . Rating Annals of Saudi medicine. Med J Development. Tonelli M.30(5):350-357. Organization. Young SE. vol. 2012.CD001877. 2013. 11. Glasziou PP. 3.183(17):1991-2001. Cost-benefit analysis Prevention. Journal of 2010.: IARC CancerBase No. Al Tahan FM. Aust. No. 2011.

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

No Yes disease compared to statistics problem a reported in the literature. the guideline panel According to the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. examination by a health care professional. Cancer Registry: Cancer The reason for this is that breast cancer can be more effectively treated at an early stage.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. Ministry of Health.000). Saudi screening as the single most important public health strategy to reduce breast cancer mortality. 2012. priority? X Early detection in order to improve breast cancer outcome and survival remains the cornerstone of breast cancer control. The three regions with the highest inci- presentation with picks at 45 and dence were Easter region (33. In incidence has a bimodal 2009 the age-specific incidence rate was 22.1% of all newly diagnosed female cancers. 8500) accounts for the 78. it could also lead to overdiagnosis and overtreatment.000 Based on the data described in the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. and breast self-examination can all identify tumours.000. There is widespread acceptance of the value of regular breast cancer Al-Eid HS.000).4/100. Saudi other hand.1/100.2% 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. the Incidence of breast cancer is 25 per 100. García AD. and Makkah region 60 years. clinical breast Arabia: Kingdom of Saudi Arabia. breast cancer is determined that the age-specific the most common among women representing 25.4/100.000). . The median age at diagnosis was 48 years (range 19 to 99 years). Mammography can identify early stage breast cancer. In Saudi of view. Mammography. the infiltrating duct carcinoma (ICD-O-3.7/100. the pick at 45 years Arabia. From the panel’s point (26. Riyadh region (29. On the Incidence Report 2009.

000 . 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. After further imput from Is there All cause mortality Critical High a patient that attended the panel important meeting.96) .919 per 152. per 100.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.2.04) effects No Probably Closely Probably Yes Varies up testing 726 more) large No balanced Yes relative to X False positive 32.100 women would need to be anticipated mortality per 195. 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) 1.75 women would have an small? fewer) unnecessary breast biopsy .85 LOW No Yes .700 LOW undesirable results .000.615 unnecessary anxiety and follow- desirable fewer to 1.75 to screened every 2 to 3 years effects X to 792 0. .388 1.690 women will have a false All cause 2.91 to per 132. 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 0.172 per 79. § Overdiagnose: Any invasive or effects? noninvasive breast cancer . distress. about: Are the undesirable No Probably Uncertain Probably Yes Varies Breast cancer 625 448 474 fewer RR 0.97 HIGH positive mammogram leading to Are the mortality (0.098 (1.300 (115 fewer (0.000) (RR) evidence cancer over about 11 years in this (95%CI) (95%CI) (GRADE) age group.

19) Summary of the evidence for patients’ values and preferences: Based on local literature.72 – 1.2 – Small LOW Somatization 0. consider issues of further testing or harm arising from false-positives in their decision making.11 (0.04 – 0.88 (0.27) 0.11 (0. LOW detected by screening that would (organized BCS) per 100. 500 . .04 – 0.17) Frequency of breast self examination 0.8 – Large Perceived likelihood of getting breast cancer 0.09 (0.10 – 0.05 – 0.22 (0.5 – Medium 0. LOW cancer in women 40 to 49 years or other .Use of Screening Strategies for Detection of Breast Cancer 20 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Overdiagnose § . .94) High quality evidence Psychological Effects of False-Positive Mammograms ≥24 months: Increase effect size ¶ (95% CI) RR 1.18 – 0.14) Perceived benefits of mammography 0.000 not have been identified clinically or would not have resulted in Unnecessary .16 (0. the guideline panel decided that .19) 0.14) ¶ Cohen’s effect size interpreta- tion Anxiety 0. 0.82 (95%CI.72 – 0. LOW symptoms or death in a person’s biopsies or Per 100. and feedback from a Most women value mammography in particular for perceived reduction of mortality. clinical experience. Screening interval fatal breast cancer of 20 to 25 cases in - Screening with mammography on 100.50) Effect Certainty of the evidence Low quality evidence Distress 0. few women representative from the patients.12 (0.04 (95%CI 0.03 – 0.06 – 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 . distress. .22) Fear 0. 500 . See table - old psychological below responses <24 months: RR 0.000 relative risk of death from breast Anxiety.

fatalistic beliefs. . any psycological effect of false- Other women refuse breast cancer screening because of fear. absence of positive results and frequency of symptoms. 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. 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.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.

widely available across regions in the Kingdom. The cost per life years saved.512 per life year gained while opportunistic screening benefits? Mammography.707 per life year Apr 2013.4. identified. the cost per QALY gained for trien- No Yes mortality rate (25%) 20 years after the start of the program. Cost Effectiveness of Breast Cancer Screening Using was €11. Iranian J Publ Health. respec- Compared to no screening. with a ratio of €22. . A. Moreover. The relative to nial screening those aged 47 to 49 was about US$45. X 3% discounted cost-effectiveness ratio for organized screening the net Rashidian. Among the required Mammography and clinical breast examination cost an additional USD costs related to this intervention can be listed: equipment. et al.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. both yielded a similar reduction in Is the tively. 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. 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. No. pp.000.000 US dollars tion screened and a similar reduction in predicted breast cancer cost small No Probably Uncertain Probably Yes Varies per QALY gained.. 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. Although digital mammogram equipment is screening. 42.000. from annual and biennial RE S O URCE US E screening of those aged 40-49 was $26.671 to €24. From the panel point of X stakeholders? X view.000 to$ 65.200 and $14. Vol.500 per quality-adjusted life year (QALY) saved compared with no small? human resources. a higher number In those aged less than 50. 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. a Systematic Review. had twice the cost. two studies from the US and UK were of well-trained radiologists are needed. the guideline panel agreed No Probably Uncertain Probably Yes Varies resources No Yes that the resources needed to allocate are not small. and X 35.

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. 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. low-quality evidence) Justification Probably higher incidence than in the other countries in which studies were done. 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. probably higher benefit on breast cancer mortality justifies a recommendation in favour of the option Subgroup None considerations . (Conditional recommendation. implement? X Availability of assessment clinics for women with positive (true + false positive) screening results.

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. The access for women with disabilities should be guaranteed considerations across the Kingdom. Centres offering the service should also be regulated and monitored. 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 . They also mentioned that all radiologists diagnosing and reporting mammograms should be certified and be evaluation monitored periodically. Availability of assessment clinics for women with positive (true + false) screening results. Monitoring and The panel considered that control and audit the result of mammograms is important. In addition.

000 IMPORTANT Low .04) (1.919 RR 0. Insufficient number of studies to assess publication bias .97 to 1. Should mammography vs. Blinding and allocation concealment were unclear for five studies 2.300 625/195. No serious heterogeneity.098 2. The panel agreed that there is considerable uncertainty regarding the baseline risk in this subgroup. p-value for testing heterogeneity is 0.8%) (0.65 and I2 =0% 7.172 RR 0.700/100.615 fewer to 726 more) False positive results 2 Observational None None None None Undetected9 ⊕⊕⊝⊝ 32. Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. They provided evidence suggesting that the baseline risk in Saudi population may be higher 3.48 and I2 =0% 4.96) (115 fewer to 792 fewer) All-cause mortality (follow-up: median 11 years) 2 Randomized None None2 None 6 None7 Undetected8 ⊕⊕⊕⊕ 1. Total sample size is large and the total number of events is >300 5.97 484 fewer CRITICAL trials High (1.75 to 0. no intervention be used for breast cancer screening in women 40 to 49 years old? Author(s): Alonso Carrasco-Labra. .7%) (1.85 474 fewer CRITICAL trials Low (0. No serious heterogeneity. p-value for testing heterogeneity is 0.000. of Study Absolute per Risk of Publication Quality Relative Importance studies design Indirectness Inconsistency Imprecision Mammography Control 1. - studies (32. Sample size is large and total number of events is > 300 8.7%) 1.388/132.Use of Screening Strategies for Detection of Breast Cancer 25 Evidence profile: 1. Insufficient number of studies to assess publication bias 6.373/79. High risk of bias.000 bias bias (95% CI) (95% CI) Breast cancer mortality 8 Randomized Serious 1 Serious2 None 3 None4 Undetected5 ⊕⊕⊝⊝ 448/152.

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

2% of all morpholog. Incidence Report of Mammography. The reason for this is that breast cancer can be 2009 Cancer more effectively treated at an early stage.000).1% of all newly diagnosed female cancers.4/100. cancer. Incidence Report of mon among women representing 25. described in the portant public health strategy to reduce breast cancer mortality.4/100. and breast self-examination can all iden. However.000. There is widespread acceptance of the value of regular breast cancer screening as the single most im.Use of Screening Strategies for Detection of Breast Cancer 27 Evidence to recommendation framework 2 2. the Kingdom of tify tumours.7/100. Riyadh Saudi Arabia. In Saudi Arabia. the . it could also lead to overdiagnosis and overtreatment. and Makkah region (26. cancer is 25 per problem a ical breast cancer variants.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. BRCA1/BRCA2 genes or no previous exposure of the chest wall to radiation). The three regions with the highest incidence were Easter region (33. the No Probably Uncertain Probably Yes Varies region (29. these degree relative.000). clinical breast examination by a health care professional.000). no known mutations in the methods are frequently used in contemporary practice. 100. no history of breast cancer in a first controversy remains over which screening services should be provided and to whom (age groups). the infiltrating duct carcinoma (ICD-O-3. breast cancer is the most com. 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. 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. 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). Mammography can identify early stage breast cancer Saudi Arabia. On the other hand.1/100. 8500) accounts for the 78. In 2009 the age-specific incidence the Kingdom of rate was 22. 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.

. 2012. Ministry of Health. the pick at 45 years represents an earlier onset of the disease compared to statistics reported in the literature. two thought it important Important important important important No known was important. Saudi Cancer Registry: Cancer Incidence Report 2009. 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. 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. García AD. Al-Eid HS.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. From the panel’s point of view. Saudi Arabia: Kingdom of Saudi Arabia.

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.424 5.35 to 1.000 - would not have undesirabl resulted in Anxiety.06 HIGH have an No Probably Uncertain Probably Yes Varies e No Yes per 19.711 (140 fewer to (0.902 more) 1. .78 MODERATE .068 (622 fewer to (0.2 to invasive or 6.694 per 19. 500 . or LOW e effects? other psychological . RR 1. distress.530 more to (1.206 per 135. distress.000.387 fewer RR 0.4) 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 .96 to unnecessary breast anticipated 620 more) 1.000 (1. 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 1.200 LOW have a false positive .3 HIGH § Overdiagnose: Any biopsies or surgery per 66. .90) every 2 to 3 years Are the .050 fewer) 0.154 per 66. mammogram leading to unnecessary Overdiagnose § . symptoms or death responses in a person’s lifetime is called overdiagnosis (20 yrs period) Psychological Effects of False-Positive Mammograms Screening interval .000) effect evidence desirable No Probably Uncertain Probably Yes Varies this age group.40 LOW anxiety and follow-up (organized BCS) per 100.000 .68 to need to be screened 2. per 100.45) testing Unnecessary 1. (95%CI) (RR) (GRADE) anticipate No Yes about: (95%CI) d effects X large? Breast cancer 743 639 1.083 1.26 women would undesirabl All cause mortality 690 734 220 more RR 1.720 women would mortality per 115.204 women will small? False positive results 28. See table below . or other psychological responses Important Low rated down from ? critical to important. identified clinically or relative to X breast cancer of 20 to 25 cases in 100.2) biopsy X effects .167 (3.150 more RR 1.

12 (0.05 – 0.98) Perceived benefits of mammography 0.5 – Medium with their care providers. and feedback from a representative from the patients. few women consider issues of further testing or harm arising from false-positives in their decision making.88) Summary of the evidence for patients’ values and preferences: Moderate quality evidence Most women value mammography in particular for perceived reduction of mortality.14) women 50 to 69 Anxiety 0.14) RR 0.27) years old LOW Somatization 0. fatalistic beliefs.2 – Small not allow for daytime appointments.86 (95%CI.22) from breast cancer in Fear 0.51 – 0.19) evidence ≥24 months: RR 0.10 – 0.04 – 0. absence of symptoms. but some would go for screening if recommended by their providers.22 (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 .11 (0.18 – 0.75 – 0.8 – Large Based on local literature. many of the studies were done when participants were already in screening programs.88 (0. The majority of women prefer to be jointly involved in decision making 0.04 – 0.19) <24 months: Perceived likelihood of getting breast cancer 0.06 – 0.03 – 0.09 (0.67 (95%CI 0.16 (0.17) High quality Frequency of breast self examination 0. However. 0. 0.11 (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. or work or family responsibilities that do 0. Other women refuse breast cancer ¶ Cohen’s effect size interpretation screening because of fear. clinical experience.

those aged 40-49 was $26. The Rashidian. 42. a Systematic Review. and X small? human resources.671 to €24. A. from annual and biennial screening of of well-trained radiologists are needed. two studies from the US and UK were identi- widely available across regions in the Kingdom.000 to$ 65.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. ? .000. Among the required quality-adjusted life year (QALY) saved compared with no screening. Moreover. From the panel point of X stakeholders view. Vol.000 US dollars per QALY gained. et al. Although digital mammogram equipment is In those aged less than 50. Apr 2013. 347-357 was €11.200 and $14. The cost per life years saved. No. Barratt et al RE S O URCE US E had reported that starting the screening from age 40 instead of 50 would cost $24. 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.. costs related to this intervention can be listed: equipment.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.000. respectively. a higher number fied. 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. the net pp. Cost Effectiveness of Breast Cancer Screening Using Mam- relative to 3% discounted cost-effectiveness ratio for organized screening X mography. Iranian J Publ Health.500 per that the resources needed to allocate are not small. the Compared to no screening. 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.512 per life year gained while opportunistic screening benefits? had twice the cost. the guideline panel agreed No Probably Uncertain Probably Yes Varies resources No Yes Mammography and clinical breast examination cost an additional USD 35.4. 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. with a ratio of €22. this option is acceptable for all the stakeholders.

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. No Yes None identified option feasible to X The access for women with disabilities should be guaranteed implement? across the Kingdom. In addition. Availability of assessment clinics for women with positive (true + false positive) screening results.

Justification - Subgroup considerations None Implementation  The panel considered that shared decision making is crucial for this recommendation. Centres offering the service should also be regulate and monitor. the panel recognized the necessity for educating the population on the importance of breast cancer screening strategies. They also mentioned that all radiologists diagnosing and reporting mammograms should be certified and be monitored periodically. The access for women with disabilities should be guaranteed across the Kingdom. 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. In addition. moderate-quality evidence). considerations Availability of assessment clinics for women with positive (true + false) screening results. In addition.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.

.96 to 1. Baines CJ. The question addressed is the same for the evidence regarding the population. comparator and outcome 3. Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged 50-59 years. To T.2%) 1.200/100.78 1. High risk of bias. Sample size is large and total number of events is > 300 REFERENCES . 137(5 Part 1): 305-12. A ran- domized screening trial of mammography in women age 40 to 49 years. and Wall C. Single study.206 RR 0.Miller AB. The Canadian National Breast Screening Study-1: breast cancer mortality after 11 to 16 years of follow-up.Use of Screening Strategies for Detection of Breast Cancer 34 Evidence profile: 2.5%) (0.65%) (0. 2000. Total sample size is large and the total number of events is >300 5.000 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. Insufficient number of studies to assess publication bias 6. 92(18): 1490-9. J Natl Cancer Inst. p-value for testing heterogeneity is 0. no intervention be used for breast cancer screening in women 50 to 69 years old? Author(s): Alonso Carrasco-Labra. intervention.12 and I2 =41% 4.000 IMPORTANT Low .050 fewer) All-cause mortality (follow-up: median 11 years) 1 Randomized None None2 None6 None7 Undetected5 ⊕⊕⊕⊕ 734/19.Miller AB. Ann Intern Med.68 to 0.387 fewer CRITICAL trials Moderate (0. heterogeneity not applicable 7. Blinding and allocation concealment were unclear for five studies 2.694 RR 1. Should mammography vs. of Study Absolute per Risk of Publication Quality Relative Importance studies design Indirectness Inconsistency Imprecision Mammography Control 1. PM:10995804.068 743/115. .711 690/19. - studies (28.2) (140 fewer to 620 more) False positive results 2 Observational None None2 None None Undetected5 ⊕⊕⊝⊝ 28.000. PM:12204013.06 220 more CRITICAL trials High (3. No serious heterogeneity.90) (622 fewer to 2. Baines CJ. and Wall C.47%) (0. Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. To T. . 2002.7%) (3.

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

clinical breast examination by a health care disease compared to statistics reported in the professional. the guideline panel determined cornerstone of breast cancer control. 8500) accounts for the 78. these methods are frequently used in contemporary practice. Use of Screening Strategies for Detection of Breast Cancer 36 Evidence to recommendation framework 3 3. Ministry of Health.4/100. The median age at diagnosis was is 25 per 100.4/100. the infiltrating duct carcinoma (ICD-O- Varies 3. breast cancer is not a priority or a main health problem. and breast self-examination can all identify tumours. controversy remains over which screen- genes or no previous exposure of the chest wall to radiation). In Saudi Arabia. 201 . Mammography. no known mutations in the BRCA1/BRCA2tions are widely recommended to reduce mortality due to breast cancer.000 48 years (range 19 to 99 years). Riyadh region Saudi Arabia.1% of all newly diagnosed Based on the data described in the 2009 female cancers. However. According to the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. the pick at 45 effectively treated at an early stage. Given other competing health risks. 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. Saudi Arabia: Kingdom of Saudi Arabia. identify early stage breast cancer Al-Eid HS. the Incidence of breast cancer (29. García AD. ing services should be provided and to whom (age groups).000).7/100. Saudi Cancer Registry: Cancer Incidence Report 2009.000. Background: Regular screening for breast cancer with mammography.000). On the other hand.000). and Makkah region (26. Mammography can literature. it could also lead to overdiagno- years represents an earlier onset of the sis and overtreatment. reduce breast cancer mortality. In 2009 the age-specific incidence rate was 22.1/100. 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. breast cancer is the most common among women representing 25. The three Cancer Incidence Report of the Kingdom of regions with the highest incidence were Easter region (33. 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. breast self-examinations and clinical breast examina- no history of breast cancer in a first degree relative.2% of all morphological breast cancer variants. The reason for this is that breast cancer can be more From the panel’s point of view.

about: anticipated 39 more) effects X .45 to 1. 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. Anxiety. 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 1.218 fewer RR 0.734 fewer to (0.000.339 (3.450 women would small? All cause mortality need to be screened .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 . 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.68 LOW about 11 years in this undesirable No Probably Uncertain Probably Yes Varies mortality per 7. distress.000) (RR) the (95%CI) (95%CI) evidence (GRADE) To save one life from breast cancer over Are the Breast cancer 50 49 2.307 per 10. critical. two thnught it Is there was important.

14) from breast cancer in women 70 to 74 years Perceived benefits of mammography 0.11 women would have False positive 21.11 (0.09 (0. RR 0.05 – 0. or LOW symptoms or death in a No Probably Closely Probably Yes Varies other psychological .22 (0.16 (0. 500 LOW and follow-up testing biopsies or surgery per 100.200 LOW an unnecessary breast results . See table below .04 – 0.000 clinically or would not Are the have resulted in desirable Anxiety.04 – 0.06 – 0.14) Screening interval Anxiety 0. biopsy .27) Screening with LOW mammography on Somatization 0.12 (0. .88 to 0.10 – 0.19) relative risk of death Perceived likelihood of getting breast cancer 0.22) Fear 0.17) old Frequency of breast self examination 0.Use of Screening Strategies for Detection of Breast Cancer 38 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS .96) mammogram leading to unnecessary anxiety Unnecessary .18 – 0.09 LOW false positive (organized BCS) per 100.11 (0.000 (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. 500 .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 .88 (0.96 women will have a Overdiagnose § . .19) <24 months: Not available . every 2 to 3 years . . by screening that would cancer of 20 to 25 cases in not have been identified 100. .03 – 0. . per 100. distress. . .000 .

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 . absence of symptoms.8 – Large Based on local literature. The majority of women prefer to be jointly interpretation involved in decision making with their care providers. However.2 – Small their providers.45 – 1.68 (95%CI 0. 0. many of the studies were done when participants were already in screening programs. but some would go for screening if recommended by 0. fatalistic beliefs. clinical experience.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 0.01) Most women value mammography in particular for perceived reduction of mortality.5 – Medium 0. few women consider Low quality evidence issues of further testing or harm arising from false-positives in their decision making. Other women refuse breast cancer screening because of fear. and feedback from a representative from the patients. or work or family ¶ Cohen’s effect size responsibilities that do not allow for daytime appointments.

Cost Effectiveness of Breast Cancer Screening Using the net was €11.200 and $14.000 to$ 65.500 per quality-adjusted life year (QALY) saved compared with no costs related to this intervention can be listed: equipment.000.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. 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. Vol. the cost per QALY gained for trien. this option is acceptable for all the stakeholders. 42. respec- tively. a higher number In those aged less than 50. The relative to 3% discounted cost-effectiveness ratio for organized screening X Rashidian.671 to €24. Barratt et al had reported that starting the screening from Compared to no screening.. Iranian J Publ Health.000. 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. From the panel point of X stakeholders view. a Systematic Review. 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. ? . A. The cost per life years saved. pp.512 per life year gained while opportunistic screening Mammography. with a ratio of €22. the guideline panel agreed No Probably Uncertain Probably Yes Varies resources No Yes that the resources needed to allocate are not small. identified. Moreover.000 US dollars breast cancer mortality (13%) during the lifespan of the popula- incremental per QALY gained. Although digital mammogram equipment is widely available across regions in the Kingdom. No.707 per life year Apr 2013. two studies from the US and UK were of well-trained radiologists are needed. 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. mortality rate (25%) 20 years after the start of the program. human resources. both yielded a similar reduction in Is the age 40 instead of 50 would cost $24. from annual and biennial RE S O URCE US E screening of those aged 40-49 was $26. Among the Mammography and clinical breast examination cost an additional USD required 35.4. benefits? had twice the cost. and X small? screening. et al.

the panel proposed that this should be done every 2 to 3 years Subgroup considerations None . option No Yes None identified feasible to X The access for women with disabilities should be guaranteed implement? across the Kingdom. 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 guideline considered that given other competing health risks. 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. 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. 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. low-quality evidence) Justification In this group. Availability of assessment clinics for women with positive (true + false positive) screening results.

the panel recognized the necessity for educating the population on the importance of breast cancer screening strategies. In addition. Availability of assessment clinics for women with positive (true + false) screening considerations results. Monitoring and evaluation The panel considered that control and audit the result of mammograms is important.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. Centres offering the service should also be regulate and monitor. They also mentioned that all radiologists diagnosing and reporting mammograms should be certified and be monitored periodically. 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 .

comparator and outcome 3. Fagerberg G.000 IMPORTANT Low . and van der Maas PJ. - studies (21. 1995. CRITICAL ies report- . Evidence to recommendation framework 4 . Impreci. . 75(10): 2507-17. . Total sample size is large. No serious heterogeneity.01) (3.Elmore JG.Hofvind S. and Fletcher SW. Publica. Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. 2004. Blinding and allocation concealment were unclear 2. High risk of bias. . van Putten DJ. . . . Cancer. Age-specific reduction in breast cancer mortality by screening: an analysis of the results of the Health Insurance Plan of Greater New York study. N Engl J Med. . intervention. . Should mammography vs. Arena PJ.45 to 1. The cumulative risk of a false-positive recall in the Norwegian Breast Cancer Screening Program. PM:3461193.Tabár L. PM:15378474. Insufficient number of studies to assess publication bias REFERENCES . . . Polk S. PM:9545356. 338(16): 1089-96. Barton MB. .Habbema JD. Moceri VM.734 fewer to 39 more) All-cause mortality No stud. Efficacy of breast cancer screening by age.7%) (0. no intervention be used for breast cancer screening in women 70 to 74 years old? Author(s): Alonso Carrasco-Labra. Duffy SW.339 50/7. Ten-year risk of false positive screening mammograms and clinical breast examina- tions. p-value for testing heterogeneity is 0.75 and I2 =0% 4. but the total number of events is <300 5. Cancer.307 RR 0. 77(2): 317-20. The question addressed is the same for the evidence regarding the population.68 2. PM:7736395 .200/100. 101(7): 1501-7. Chen HH. 1986. Gad A. Lubbe JT.218 fewer CRITICAL trials Low (0. J Natl Cancer Inst.2%) 1. of Study Risk of Inconsisten.47%) (0. and Smith RA. . 1998. Smart CR. and Tretli S.Use of Screening Strategies for Detection of Breast Cancer 43 Evidence profile: 3. new results from the Swedish Two- County Trial. 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. van Oortmarssen GJ. Thoresen S. - ing this outcome False positive results 2 Observational None None2 None None Undetected ⊕⊕⊝⊝ 21. Serious imprecision.

4/100.1% of all newly diagnosed Cancer Incidence Report of the Kingdom of female cancers. breast self-examinations and clini- (defined as those with no previous breast can. On the other hand. 2012. disease compared to statistics reported in the nosis and overtreatment.000. no known mutations in the methods are frequently used in contemporary practice. Mammography can Al-Eid HS. breast Based on the data described in the 2009 cancer is the most common among women representing 25. The reason for this is that breast cancer can be more years represents an earlier onset of the effectively treated at an early stage. cer. However. Saudi Cancer Registry: identify early stage breast cancer. García AD. 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.4/100. controversy remains over which screening services should be provided and to whom (age groups). . no history of breast cancer in a first de. Cancer Incidence Report of the Kingdom of P RO B LE M Is the No Yes Saudi Arabia.Use of Screening Strategies for Detection of Breast Cancer 44 4. Based on the data described in the 2009 No Probably Uncertain Probably Yes Varies O-3. and breast self-examination can all identify tumours. Cancer Incidence Report 2009. regular breast cancer screening as the single most important public health strategy to From the panel’s point of view. the Incidence of breast cancer is regions with the highest incidence were Easter region (33.2% of all morphological breast cancer variants.1/100.000). In Saudi Arabia. cal breast examinations are widely recommended to reduce mortality due to breast cancer. it could also lead to overdiag. and Makkah region (26. BRCA1/BRCA2 genes or no previous exposure of the chest wall to radiation). Ministry of Health. 8500) accounts for the 78. The median age at diagnosis was 48 years (range 19 to 99 years). In 2009 the age-specific incidence rate was 22.000). There is widespread acceptance of the value of presentation with picks at 45 and 60 years. The three Saudi Arabia. Mammography.000). the infiltrating duct carcinoma (ICD. Riyadh region 25 per 100.000 (29. Saudi Arabia: Kingdom of Saudi Arabia. clinical breast examination by a health care literature. 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. the pick at 45 reduce breast cancer mortality. 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.7/100. these gree relative. professional.

value the X Anxiety.596 (254 fewer to (0.98 MODERATE in breast cancer mortality anticipated per 193. 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. All cause mortality Critical MODERATE After further input from a Is there important False positive results Important .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 . 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. or other main Important . two thought it was important. but found .83 to 1.000) 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 . positives were critical.763 per 193. patient that attended the uncertainty panel meeting. distress. - cause mortality. . 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. 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. . .000.

Use of Screening Strategies for Detection of Breast Cancer 46 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS False positive evidence of increased harm results . .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 . . .Specificity: range from undesirable X 66% and 81% Distress 0. for benign breast biopsy.19) LOW § Overdiagnose: Any invasive or noninvasive Perceived likelihood of getting breast cancer 0. Breast self-exam has been responses .11 (0. . .17) screening that would not have been identified Frequency of breast self examination 0. many of the studies were done when participants were already in screening programs. few women consider issues of further testing or harm arising from false-positives in their decision making.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. potential harms of Breast (organized BCS) Self Exam and the corresponding lack of Unnecessary . suggested as a monthly examination of the woman’s breasts.06 – 0.05 – 0. Anxiety. . or other psychological See table below . This rise concern for the Overdiagnose § .12 (0. Are the Accuracy estimates: Psychological Effects of False-Positive Mammograms .14) Anxiety 0. evidence of their biopsies or surgery .10 – 0. .22) effects? Fear 0.14) breast cancer detected by Perceived benefits of mammography 0. - .27) Somatization 0. . .09 (0.16 (0. effectiveness in decreasing mortality.22 (0.88 (0.11 (0.04 – 0.18 – 0. . distress. ¶ Cohen’s effect size inter- However.03 – 0.

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 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 . Based on local literature. clinical experience. fatalistic beliefs. absence of pretation symptoms.8 – Large some would go for screening if recommended by their providers. or work or family responsibilities that do not allow for daytime appointments.5 – Medium 0.2 – Small majority of women prefer to be jointly involved in decision making with their care providers. and feedback from a representative from the patients. The 0. but 0.

location for incremental in-person sessions. X implement? . the RE S O URCE US E guideline panel agreed that the resources needed to allocate are small. health care professionals to deliver the mes- No Probably Uncertain Probably Yes Varies cost small No Yes sage. 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. 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. educational material. Among the required resources it can be listed: healthy Is the None identified women educational programs. as long as the on health X educational program is widely available across the Kingdom.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. 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.

especially in regions where mammography may not be offered. 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. .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. Subgroup considerations None Implementation  The panel considered this option as feasible and easy to implement. breast self-examination plays a secondary role. considerations Monitoring and evaluation - Research priorities There is very limited evidence on the effectiveness of breast self-examination. (Conditional recommendation. In this regard. The guideline panel also highlight- ed that when mammography is available.

. Stalsberg H. . Chen FL. Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. and Barash NJ. J Natl Cancer Inst. Zhao GL. Insufficient number of studies to assess publication bias REFERENCES . Evans I.Use of Screening Strategies for Detection of Breast Cancer 50 Evidence profile: 4. . - this outcome 1. The question addressed is the same for the evidence regarding the population. . comparator and outcome 3. .Semiglazov VF. p-value for testing heterogeneity is 0. . Coriaty Z. 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. of Study Risk of Publication Quality Breast self. Moiseyenko VM. Ray RM. High risk of bias. . Wu C. 1992. Should breast self-examination vs. . Migmanova NS. .Thomas DB. Wang WW. . Bavli JL. Orlov AA. Eur J Epidemiol. . . Allison CJ. . .15%) (0. PM:1397215. . . 2002. 8(4): 498- 502. Pan LD. Li W. Gao DL. . Sample size is large and total number of events >300 5. Randomized trial of breast self-examination in Shanghai: final results. Chagunava OA.15%) (0.84 to 1. . Ivanova OA. . no intervention be used for breast cancer screening in women of all ages? Author(s): Alonso Carrasco-Labra. Hu YW.58 and I2 =0% 4. 94(19): 1445-57. . - this outcome All-cause mortality 2 Randomized Serious1 None2 None3 None4 Undetected5 ⊕⊕⊕⊝ 292/193. Lin MG.596 298/193.15) (254 fewer to 234 more) False positive No studies IMPORTANT reporting . Blinding and allocation concealment were unclear 2.763 RR 0. PM:12359854. No serious heterogeneity. Porter P. Popova RT. Seleznyov NK. The role of breast self-examination in early breast cancer detection (results of the 5-years USSR/WHO randomized study in Leningrad). and Self SG.

4/100. bimodal presentation with picks at The reason for this is that breast cancer can be more effectively treated at an early stage. BRCA1/BRCA2 genes or no previous exposure of the chest wall to radiation). However. In Saudi Ara- No Probably Uncertain Probably Yes Varies bia. breast cancer is 2009 Cancer Incidence Report of the most common among women representing 25.7/100. the pick at 45 years examination by a health care professional. From the panel’s other hand.Use of Screening Strategies for Detection of Breast Cancer 51 Evidence to Recommendation Framework 5 5. 8500) accounts for the 78. The three regions with the highest inci- Incidence of breast cancer is 25 per dence were Easter region (33. ical breast examinations are widely recommended to reduce mortality due to breast cancer. no history of breast cancer in a first de. . the infiltrating duct carcinoma (ICD-O-3. no known mutations in the methods are frequently used in contemporary practice. On the 45 and 60 years. 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. problem a 2009 Cancer Incidence Report of priority? X the Kingdom of Saudi Arabia. the 2009 the age-specific incidence rate was 22. disease compared to statistics reported in the literature. 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). the Early detection in order to improve breast cancer outcome and survival remains the cornerstone of guideline panel determined that the breast cancer control.4/100.000). In the Kingdom of Saudi Arabia. The median age at diagnosis was 48 years (range 19 to 99 years). cer. it could also lead to overdiagnosis and overtreatment. represents an earlier onset of the Mammography can identify early stage breast cancer.000).000).000. Riyadh region (29.1% of all newly diagnosed female cancers. and Makkah region 100.2% of all morphological P RO B LE M Is the Based on the data described in the No Yes breast cancer variants. breast self-examinations and clin- (defined as those with no previous breast can. these gree relative.000 (26.1/100. and breast self-examination can all identify tumours. 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. Mammography. clinical breast point of view.

distress. sies or surgery outcomes? Anxiety. Saudi Arabia: Kingdom of Saudi Arabia. 2012. Saudi Cancer Registry: Cancer Incidence Report 2009. García AD. 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 . Ministry of Health. 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 . 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. from critical to important. 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.Use of Screening Strategies for Detection of Breast Cancer 52 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Al-Eid HS.

. 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 0.11 (0.19) Perceived likelihood of getting breast cancer 0. - biopsies or surgery .sensitivity: range from 40% to 69% False positive . - Accuracy of clinical All cause mortality breast examination: . .09 (0. .03 – 0.10 – 0.specificity: range from results . or breast cancer detected Are the other psychological .22 (0. . invasive or noninvasive Anxiety.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. . .06 – 0.14) Perceived benefits of mammography 0. - (organized BCS) value: 4% to 50% Unnecessary .05 – 0.88 (0. . . .positive predictive Overdiagnose § .16 (0.14) Anxiety 0.18 – 0. distress. .27) LOW Somatization 0. . § Overdiagnose: Any . . small? Breast cancer mortality .17) ¶ Cohen’s effect size . .22) Fear 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. . .04 – 0.000. . 88% to 99% .12 (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 . few women consider issues of further testing or harm arising from false-positives in their decision making. fatalistic beliefs.5 – Medium 0. but some would go for screening if recommended by their providers.Use of Screening Strategies for Detection of Breast Cancer 54 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Frequency of breast self examination 0.11 (0.8 – Large Summary of the evidence for patients’ values and preferences: Most women value mammography in particular for perceived reduction of mortality. The majority of women prefer to be jointly involved in decision making with their care providers. and feedback from a representative from the patients.2 – Small 0. clinical experience.04 – 0. many of the studies were done when participants were already in screening programs. However. absence of symptoms.19) interpretation 0. or work or family responsibilities that do not allow for daytime appointments. Other women refuse breast cancer screening because of fear. Based on local literature.

the Is the None identified guideline panel agreed that the resources needed to allocate incremental probably are small. 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.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. X implement? .

(Conditional recommendation. 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. This recommendation does not relate to routine physical 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. The panel recognizes that more research in this area is needed in order to inform further recommendations on this regard . The option described in this recommendation covers only clinical breast examination in the context of breast cancer screening. Subgroup considerations None Implementation  - considerations Monitoring and evaluation - Research priorities There is very limited evidence on the effectiveness of clinical breast examination. this option should always be offered first to patients. The guideline panel also highlight- ed that when mammography is available. Clinical breast examination could be used as method for breast cancer screening only when mammography is unavailable.

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

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

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

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

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

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

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

11 (consumer? adj3 (acceptance or preference? or satisfaction or experience?)).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.tw. 13 willingness to pay.tw. 6 or 7 9. exp breast/ 12.tw. 8. exp breast neoplasms/ 2. (screen$ or (rountine$ adj3 (test$ or check$ or diagnos$ or detect$))). 2 and 3 5.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. 12 (patient? adj3 (acceptance or preference? or satisfaction or experience?)). exp physical examination/ 11. 11 or 12 14. 1 or 4 6. exp breast neoplasms/ 13. exp breast/ 4. exp neoplasms/di 3.mp. exp mass screening/ 7. 14 ((conjoint or contingent) adj3 (valuation or analysis)). 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. 5 and 8 10. exp mammography/ . 10 and 13 15.

29. 28. 9 and 15 18.tw.tw. 9 and 14 17. observational studies.fs. frequency. 20. 16 and 20 22. (interval not confidence interval). 17 and 20 23.tw. 32. limit 23 to (english or french) 25. (annual* or yearly). 30. 26 or 27 or 28 or 29 or 30 or 31 33.tw. 25 and 32 34. schedule.tw. 31. 21 or 22 24. biennial. registries Records Retrieved Relevant: 2 . 18 or 19 21.tw. (biannual or bi-annual). mo.Use of Screening Strategies for Detection of Breast Cancer 65 16. 27.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. limit 33 to yr="2010 -Current" Study Types: Randomized controlled trials Records Retrieved 62 Database: Google . exp mortality/ 19. limit 24 to humans 26.

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. Excluded: 6 . Total 455 Without duplicates: Screening (Title and Abstract Review) No.Use of Screening Strategies for Detection of Breast Cancer 66 Summary of Searches Total No.