You are on page 1of 70

The Saudi Center for

Evidence Based Health Care

Breast Cancer

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

April 2014

The Saudi Center for EBHC Clinical Practice Guideline 6

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

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

April 2014

Use of Screening Strategies for
Detection of Breast Cancer ii

Guideline Adaptation Panel Members

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

The Saudi Oncology Society

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

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

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

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

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

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

7/100. low. and Makkah region (26. and development of guidelines.000). 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.4/100.2 According searches for information that was required to to the 2009 Cancer Incidence Report of the develop full guidelines for the KSA.Use of Screening Strategies for Detection of Breast Cancer 2 duce variability in clinical practice across the Executive summary Kingdom.8 Quality of evi- mography can identify early stage breast can.4/100.2% guideline panel to follow the structured con- of all morphological breast cancer variants.1% of all newly diagnosed female cancers. Moderate quality evi- a program of rigorous adaptation and de novo dence indicates moderate confidence. of treatment effects) is categorized as: high.7 mortality.000. The guideline panel met in Ri- improve survival remains the cornerstone of yadh on December 5. consistency and precision of the estimates. and breast self.5 We also conducted systematic occur in less developed countries. moderate.3 breast cancer is the searches for information about patients’ val- most common among women representing ues and preferences and cost (resource use) 25. mate of the effect. Mam. 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. Based on the In 2009 the age-specific incidence rate was updated systematic reviews we prepared 22. Poten- acceptance of the value of regular breast can.000). In Saudi Arabia. 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 .4 The guideline working group developed and Mammography. The ultimate goals that the true effect is likely close to the esti- are to provide guidance for clinicians and re. almost by the Canadian Task Force on Preventive 50% of breast cancer cases and 58% of deaths Health Care. On the other hand. It is estimated that worldwide over ed existing systematic reviews that were used 508.6 We an age at diagnosis was 48 years (range 19 to used this information to prepare the evidence 99 years). the infiltrating duct to recommendation tables that served the carcinoma (ICD-O-3.1 There is widespread recommendations during this meeting. the quality of the supporting evidence accord- examination can all identify tumors. For all selected questions we updat- world. 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. 2013 and formulated all breast cancer control. clinical breast examination by graded the recommendations and assessed a health care professional. directness. including Kingdom of Saudi Arabia.1 Although breast cancer is thought to Average-risk Women Aged 40 to 74” guideline be a disease of the developed world. it could also lead to over diagnosis and overtreatment.1 The reason for this is that breast cancer can be more effectively treated at an How to use these guidelines early stage. Development and Evaluation) approach. or very low based on consid- Methodology eration of risk of bias.1/100. 8500) accounts for 78.000 women died in 2011 due to breast for the 2010 “Screening for Breast Cancer in cancer. (Grading of Recommendations. ing to the GRADE approach. Riyadh region (29. Assessment. specific to the Saudi context. The three regions with the summaries of available evidence supporting highest incidence were Eastern region each recommendation following the GRADE (33.000). dence (confidence in the available estimates cer. The medi.

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

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

000). 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. we briefly describe the methodology we world. average-risk women aged 40 to 74” guideline nate the majority of breast cancers in low.000 women died in 2011 due to breast and quality of the supporting evidence. The guidance about population-based screening three regions with the highest incidence were strategies to detect breast cancer in women.2% of all morphologi- makers may also benefit from these guide. almost separate publication.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. these policies cannot elimi. stage breast cancer.7/100.9 50% of breast cancer cases and 58% of deaths occur in less developed countries . by the Canadian Task Force on Preventive and middle-income countries where it is diag. Saudi Arabia to establish a program of rigor. For all selected questions we updat- western lifestyles. widespread acceptance of the value of regular versity working group produced clinical prac. breast cancer mortality. The median age at diagnosis in medical oncology and radiology in the was 48 years (range 19 to 99 years).1 There is methodological support of the McMaster Uni. Although some risk reduc. In Saudi Kingdom of Saudi Arabia.1 Although breast cancer is thought to present the details of the methodology in a be a disease of the developed world. searches for information about patients’ val- port of the Kingdom of Saudi Arabia (KSA). Mammography can identify early Kingdom. cancer outcome and survival remains the cor- try of Health (MoH) of Saudi Arabia with the nerstone of breast cancer control. for the 2010 “Screening for breast cancer in tion strategies. being to provide guidance for clinicians and and breast self-examination can all identify reduce variability in clinical practice across the tumors. The Saudi Expert Panel selected the topic of dence of breast cancer is increasing in the de. ed existing systematic reviews that were used tion could be achieved implementing preven.5 We also conducted systematic nosed in very late stages.000).3 . In 2009 the age- The purpose of this document is to provide specific incidence rate was 22.000. the infiltrating duct carcinoma (ICD-O- professionals. searches for information that was required to develop full guidelines for the KSA. in part. On the other hand. 8500) accounts for 78.000). It is estimated that worldwide over used to develop and grade recommendations 508. and Makkah region cludes primary care physicians and specialists (26.1% of all newly diag- nosed female cancers. including According to the 2009 Cancer Incidence Re. it could also lead to overdiagnosis and over- ous adaptation and de novo development of treatment. 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. due to the increase in dressed herein using a formal prioritization life expectancy.2 The inci. We cancer. clinical breast guidelines in the Kingdom.4/100. this guideline and all clinical questions ad- veloping world. Riyadh region The target audience of these guidelines in. the ultimate goal examination by a health care professional. Health Care. the Minis. (29.Use of Screening Strategies for Detection of Breast Cancer 5 breast cancer is the most common among Scope and purpose women representing 25.4 Mammography. Other health care Arabia.1/100. Easter region (33.4/100. lines. urbanization and adoption of process. Early detection in order to improve breast Given the importance of this topic. cal breast cancer variants. public health officers and policy 3.

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

04 used to screen for breast cancer [95%CI 0. few women consider issues of fur- tematic search update conducted did not re. terms. 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.100 women would Other women refuse breast cancer screening need to be screened every 2 to 3 years. The sys. representative from the patients that partici- phy compared to no screening reduces deaths pated during the panel meeting. phy in particular for perceived reduction of dence to recommendation table 1). no judged to be “low”. and therefore. 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. There was disagreement within the panel about the rela- Recommendations tive importance of the outcome false positive results. mortality. 75 because of fear.72 – 0.72 – 1. absence of women would have an unnecessary breast symptoms. High quality evidence). to save one additional life from breast many of the studies were done when partici- cancer over about 11 years of follow-up. involved in decision making with their care ing interval. existing in other countries. is considerable uncertainty regarding the cer screening”. However. the overall quality Question 1: Should screening for breast can. ther testing or harm arising from false- trieve any additional evidence. fatalistic beliefs. Use of digital mammography for breast attended the panel meeting. three A recent Cochrane systematic review10 that sources of data informed this topic: literature included data from eight randomized con. Then. Low quality evidence). but some would go for screening if .11-13 panel mem- trolled trials (RCT) showed that. er. After further input from a patient that I. tive mammogram leading to unnecessary anx. The panel agreed that there imaging be used as a strategy for breast can. this age group. The majority of women prefer to be jointly iety and follow-up testing. reports that most women value mammogra- nificant effect on all-cause mortality (See evi. among women all ages? 5. Regarding screen. and 690 women will have a false posi. the use of mammogra. the absolute effect of mammography may also be higher. Should breast self-examination be benefit and considerable harm (RR 1. 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. the evidence shows that when providers. or work or family responsibilities biopsy. of the evidence for this recommendation was cer with mammography (digital) vs. 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. However.50].94]. about 2. which was addressed in the baseline risk in this specify age subgroup.82 3. In absolute positives in their decision-making. that do not allow for daytime appointments.Use of Screening Strategies for Detection of Breast Cancer 7 2. in women bers’ clinical experience. in pants were already in screening programs. 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. Should mammography (digital) be [95%CI. 0. The literature ascribed to breast cancer in 15% without sig. and the opinion of a below 50 years of age. the outcome of cancer screening false positive results was rated down from critical to important.

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

86 [95%CI. this age group. in false positive results. positives in their decision-making.000. many of the studies were done when partici- gies as a way to incorporate actively pa. this recommendation places higher value for trieve any additional evidence. pants were already in screening programs. Moderate quality evidence). High to estimate cost-effectiveness ratios. 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. about 720 women would need to be screened every 2 to 3 years.Use of Screening Strategies for Detection of Breast Cancer 9 the guideline panel determined that there is mortality.500 breast cancer mortality (RR 0. Moreover.15 The representative from the patients that partici. 26 women Resource use: would have an unnecessary breast biopsy. their clinical experience. roborated panel’s perception and. three would cost between $24. studies from other regions that incorporated mented in intervals <24 months there is a re. The sys. 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. but some would go for screening if A recent Cochrane systematic review10 that recommended by their providers.75 – 0. per QALY gained for triennial screening those bers’ clinical experience.200 and $14. they also suggest im. fatalistic beliefs. Implementing screening mined that mammography and clinical breast ≥24 months also suggests a reduction in examination cost an additional USD 35. 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. saved. plementing shared-decision making strate. the use of mammogra. Finally. review stated that the cost per life years tion was judged to be “Moderate”. or used modeling techniques of 14% (RR 0. in women at decided that any psychological effect of false- least 50 years of age. tematic search update conducted did not re. ther testing or harm arising from false- sirable consequences. Regarding screening interval. The overall compared with no screening. from annual and biennial screening of women aged 40-49 was $26. to save one additional life from breast cancer irrespective of the consequences of cancer over about 11 years of follow-up. However. a recent systematic review14 including 26 dence shows that when the option is imple. tient participating in the panel meeting cor- dence to recommendation table 2). women aged 50-69? The majority of women prefer to be jointly involved in decision making with their care Summary of findings: providers. fits. The literature mental cost is small relative to the net bene- reports that most women value mammogra. deter- quality evidence). Based on included data from seven randomized con.51 – per quality-adjusted life year (QALY) saved 0. panel determined that probably the incre- pated during the panel meeting. tients’ perspective into the decision. cost-effectiveness data alongside randomized duction in the risk of death from breast cancer controlled trials.98].88]. However. few women consider issues of fur- a close balance between desirable and unde. testing. Other women refuse breast cancer screening because of fear.000 US sources of data informed this topic: literature dollars per QALY gained.000.000 to $65. In addition the quality of the evidence for this recommenda. the guideline panel trolled trials (RCT) showed that. ceived benefits on mortality. absence of Question 2: Should mammography (digital) symptoms. Values and preferences: respectively. In absolute being alive and prevents death from breast terms. or work or family responsibilities be used to screen for breast cancer among that do not allow for daytime appointments. the cost existing in other countries. phy in particular for perceived reduction of . the pa- nificant effect on all-cause mortality (See evi. the evi. and the opinion of a aged 47 to 49 was about US$45. 0. 11-13 panel mem. therefore.67 [95%CI 0.

However. and monitored.Use of Screening Strategies for Detection of Breast Cancer 10 Acceptability: panel determined that desirable conse- Panel members mentioned that they are in. 0. three dation. Low Research priority: quality evidence). The overall quality of the evi- using more accurate and direct evidence from dence for this recommendation was judged to the local context. 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. quences probably outweigh undesirable con- formed of previous initiatives for implement. sources of data informed this topic: literature existing in other countries. this option is acceptable for all be used to screen for breast cancer among the stakeholders. 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. Given other competing health risks. The literature group is similar to the ones reported in the reports that most women value mammogra- literature in other countries. in this age group. Availability of assessment clinics for Two County. 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. panel recognized the necessity for educating 95% CI 0. update conducted did not retrieve any addi- tional evidence. the panel men.01) (See evidence to recom- the population on the importance of breast mendation table 3). unnecessary breast biopsy. the reduction in breast cancer mortality (RR 0.01]. breast cancer is not a priority or a main Recommendation 2: health problem. values and preferences. In addition. They about 450 women would need to be screened also mentioned that all radiologists diagnosing every 2 to 3 years. representative from the patients that partici- dence of breast cancer in the KSA for this age pated during the panel meeting. and the opinion of a Based on local cancer registry data. women aged 70-74? Implementation considerations: The panel highlights that this recommenda. 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.45–1. In absolute terms.45 – 1. The guideline phy in particular for perceived reduction of . In addition.16 From the panel’s Question 3: Should mammography (digital) point of view. sequences in most settings. Cost effectiveness studies be “low”. ing breast cancer screening using mammog- raphy in the Kingdom. East and West) found that women with positive (true & false) screening screening led to a non-statistically significant results should be guaranteed.68 [95%CI. The systematic search cancer screening strategies. 96 women will fied and be monitored periodically.11-13 panel mem- Remarks: bers’ clinical experience. age group. Regarding screening interval. Summary of findings: tion represents a good opportunity for shared A recent systematic review10 that conducted a decision-making. 11 women would have an and reporting mammograms should be certi. the result of mammograms is important. 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. Centers have a false positive mammogram leading to offering the service should also be regulated unnecessary anxiety and follow-up testing.68. moderate-quality evidence). The panel considered that the op- are also needed to inform future guidelines tion might not be relevant for this particular and stakeholders. the inci.

the panel men- mammograms in the context of Saudi Arabia. Recommendation 3: respectively. the population on the importance of breast tient participating in the panel meeting cor. or used modeling techniques Research priority: to estimate cost-effectiveness ratios. 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.000 US with mammography in women aged 70–74 dollars per QALY gained. the pa. Moreover. absence of the stakeholders. They false positive results. or work or family responsibilities that do not allow for daytime appointments. Centers Although there are no published or un. However. the guideline panel Kingdom. ing breast cancer screening using mammog- pants were already in screening programs. Based on disabilities should be guaranteed across the their clinical experience. Panel members mentioned that they are in- positives in their decision-making. In addition. also mentioned that all radiologists diagnosing and reporting mammograms should be certi- Resource use: fied and be monitored periodically. formed of previous initiatives for implement- many of the studies were done when partici.Use of Screening Strategies for Detection of Breast Cancer 11 mortality. eases. offering the service should also be regulated published data on the cost-effectiveness of and monitored. but some would go for screening if decision-making. deter. from annual and biennial screening of women aged 40-49 was $26. screening with mammography seems to be not a priority for this age group.000. few women consider issues of fur. fatalistic beliefs. this option is acceptable for all because of fear. 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. Cost effectiveness studies compared with no screening. 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. saved. In addition the are also needed to inform future guidelines review stated that the cost per life years and stakeholders. In addition.000.200 and $14.15 The panel determined that probably the incre. panel recognized the necessity for educating ceived benefits on mortality. symptoms. cancer screening strategies. Based . therefore. raphy in the Kingdom. the will have a lower value compared to the per. the cost years (Conditional recommendation. women with positive (true & false) screening positive results and frequency of screening results should be guaranteed.000 to $65. 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. Availability of assessment clinics for decided that any psychological effect of false. low- per QALY gained for triennial screening those quality evidence) aged 47 to 49 was about US$45. Remarks: mental cost is not small relative to the net Giving the competing risks with other dis- benefits. roborated panel’s perception and. The access for women with recommended by their providers.500 using more accurate and direct evidence from per quality-adjusted life year (QALY) saved the local context. Acceptability: ther testing or harm arising from false. Finally.16 From the panel’s Other women refuse breast cancer screening point of view.

dation. In case this option is offered psychological effect of false-positive results to women between 70 to 74 years old. three method of screening for breast cancer in sources of data informed this topic: literature women of all ages. increased harm for benign breast biopsy. very-low quality evidence) bers’ clinical experience. breast cancer mortality in the context of Saudi ings of two studies conducted in Russia17 and Arabia. 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. fatalistic beliefs. The . 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. Remarks: pated during the panel meeting. differences between the option and control groups in all-cause mortality (RR 0. 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. creasing mortality. but ture in other countries. There is very limited evidence on the effec- cated in the updated literature search. However. 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.98 [95%CI Acceptability: 0. Use of breast self-examination for breast ception and.83-1. The cited studies also detected an acceptable for all the stakeholders. 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. cision making with their care providers. and the opinion of a representative from the patients that partici. Research priority: cer mortality or all-cause mortality were lo. and easy to implement.11-13 panel mem. mortality. the guideline panel decided that any in most settings. the incidence allow for daytime appointments.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. “moderate” to “very low” given that there is Recommendation 4: no data informing breast cancer mortality. The panel determined that the strength of en refuse breast cancer screening because of the recommendation should be fear. therefore. Based on their clinical ex- probably outweigh desirable consequences perience.Use of Screening Strategies for Detection of Breast Cancer 12 on local cancer registry data. Some wom.2]) (See evidence to recommendation From the panel’s point of view. this option is table 4). The guideline panel some would go for screening if recommended determined that undesirable consequences by their providers. 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. absence of symptoms. the guideline panel determined that Shanghai. the patient participating in the panel meeting corroborated panel’s per- II. (Conditional recommen- existing in other countries. No new studies on the im- pact of breast self-examination on breast can. Finally. tiveness of breast self-examination. weak/conditional based on the extensive or work or family responsibilities that do not level of uncertainty and lack of evidence. 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.

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

Balshem H. 11. Gøtzsche PC. 5. Art. Connor Gorber S. 2014. Journal of 2010. 2006. 2004 update. Cancer Cochrane Database of Systematic Incidence and Mortality Worldwide: Reviews. DOI: 2013. Schunemann screening program in Saudi Arabia. Oxman AD. Preston SD. Ministry of Health. García AD. 2012. France: Denmark based on discrete ranking International Agency for Research on data. Helfand M. Young SE. Cancer. clinical epidemiology.176(6):266-271. effectiveness of breast cancer 6. screening using mammography. Organization. Abulkhair OA. Thabane L.30(5):350-357. The first f. McMaster University Guideline prospective randomized investigation Working Group. al. 3. national public breast cancer 8. Barooti E. canadienne. Issue 6.fr.who. Cost-benefit analysis Prevention. Cost 2011. Phillips KA. Nov 22 Nosratnejad S.pub5. et al. Vol 7.Use of Screening Strategies for Detection of Breast Cancer 14 References 1. 4. Apr 17. 13. IARC. Rating Annals of Saudi medicine. Manikhas AG. Glasziou PP. summary of findings tables.int/iris/bitstream/10 16. 2012. Akl EA. Ervik M. Al-Eid HS. A review of Registry: Cancer Incidence Report studies examining stated preferences 2009. Jazieh AR. 10. Sep-Oct the quality of evidence. Semiglazov VF.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 . Soerjomataram I. vol.16(3):811-821. Tonelli M. Al Tahan FM.1002/14651858.183(17):1991-2001. Houssami N. Moiseyenko VM. Accessed December 2013. HJ. Prev Chronic Dis. a GRADE guidelines: 1. 2011. et al.: World Health 2014.64(4):401-406. 2013. Methodology for the [Russia (St. J Adv Canadian Medical Association journal Nurs. 2002. The global burden of disease: University Clinical Practice Guidelines. Apr Salkeld GP. GLOBOCAN 2012 v1. Accessed February 7. 10. systematic review. WHO mammography in women 70 years Handbook for Guideline and over: a systematic review.pd Musaad SM. Lyon. 11 [Internet] CD001877. clinical epidemiology.0. 7: Breast Cancer of mammography screening in Screening. Benefits. WHO.64(4):383-394. Journal of 15.2008. No. harms and costs of screening 7. 2013. 665/75146/1/9789241548441_eng. Rashidian A. Med J Development. et al. Joffres M. 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. Barratt AL. Arabia. 2011. Saudi Cancer Walsh J. Results of a 9. Jørgensen KJ. GRADE guidelines: 3. 2002. Gyrd-Hansen D.65(6):1130-1140.iarc. Marshall D. A decision et al.CD001877.3(3):A75. Screening 2. Hosseini H. Saudi Arabia: Kingdom of Saudi for cancer screening. Guyatt G. 2000. = journal de l'Association medicale 14. Aust. Van Bebber S. World Health Organization. Irwig LM. http://globocan. Handbooks of Cancer 12. Introduction. http://apps. Barfar E. et for breast cancer with mammography.: IARC CancerBase No.42(4):347-357. CMAJ : screening: systematic review. Ferlay J. 2009. Ackerson K. Iranian journal of GRADE evidence profiles and public health. Int J Technol Assess Health Care.

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

the infiltrating duct carcinoma (ICD-O-3. it could also lead to overdiagnosis and overtreatment. The median age at diagnosis was 48 years (range 19 to 99 years). and Makkah region 60 years. In Saudi of view. Ministry of Health. Saudi screening as the single most important public health strategy to reduce breast cancer mortality. the pick at 45 years Arabia. Mammography can identify early stage breast cancer. the Incidence of breast cancer is 25 per 100. breast cancer is determined that the age-specific the most common among women representing 25. There is widespread acceptance of the value of regular breast cancer Al-Eid HS. On the Incidence Report 2009. Saudi other hand.7/100. priority? X Early detection in order to improve breast cancer outcome and survival remains the cornerstone of breast cancer control.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. the guideline panel According to the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia.4/100.1% of all newly diagnosed female cancers.000 Based on the data described in the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. Mammography.000).000). 8500) accounts for the 78. In incidence has a bimodal 2009 the age-specific incidence rate was 22. examination by a health care professional. No Yes disease compared to statistics problem a reported in the literature. . and breast self-examination can all identify tumours. García AD. Riyadh region (29. From the panel’s point (26. Cancer Registry: Cancer The reason for this is that breast cancer can be more effectively treated at an early stage.4/100.1/100.000).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. 2012. The three regions with the highest inci- presentation with picks at 45 and dence were Easter region (33.000. clinical breast Arabia: Kingdom of Saudi Arabia.

97 HIGH positive mammogram leading to Are the mortality (0. § Overdiagnose: Any invasive or effects? noninvasive breast cancer .85 LOW No Yes . about: Are the undesirable No Probably Uncertain Probably Yes Varies Breast cancer 625 448 474 fewer RR 0. 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) 1.91 to per 132.690 women will have a false All cause 2.388 1.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. .100 women would need to be anticipated mortality per 195.04) effects No Probably Closely Probably Yes Varies up testing 726 more) large No balanced Yes relative to X False positive 32. distress.2.373 484 fewer RR 0.75 women would have an small? fewer) unnecessary breast biopsy .172 per 79.000.000) (RR) evidence cancer over about 11 years in this (95%CI) (95%CI) (GRADE) age group.615 unnecessary anxiety and follow- desirable fewer to 1.96) .75 to screened every 2 to 3 years effects X to 792 0.700 LOW undesirable results .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.300 (115 fewer (0.098 (1. After further imput from Is there All cause mortality Critical High a patient that attended the panel important meeting.919 per 152. 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. per 100. two thought it was Breast cancer mortality Critical Low important.

82 (95%CI.04 – 0. distress.18 – 0.14) Perceived benefits of mammography 0.16 (0.5 – Medium 0. the guideline panel decided that .19) 0. LOW detected by screening that would (organized BCS) per 100.09 (0. 0. LOW symptoms or death in a person’s biopsies or Per 100. See table - old psychological below responses <24 months: RR 0.04 – 0.72 – 0.22) Fear 0. clinical experience. LOW cancer in women 40 to 49 years or other .2 – Small LOW Somatization 0. . few women representative from the patients.94) High quality evidence Psychological Effects of False-Positive Mammograms ≥24 months: Increase effect size ¶ (95% CI) RR 1.22 (0. 500 .04 (95%CI 0.10 – 0. 500 .11 (0.000 relative risk of death from breast Anxiety.8 – Large Perceived likelihood of getting breast cancer 0.27) 0.17) Frequency of breast self examination 0.14) ¶ Cohen’s effect size interpreta- tion Anxiety 0.Use of Screening Strategies for Detection of Breast Cancer 20 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Overdiagnose § .19) Summary of the evidence for patients’ values and preferences: Based on local literature.88 (0. .03 – 0.05 – 0. Screening interval fatal breast cancer of 20 to 25 cases in - Screening with mammography on 100.12 (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 .000 not have been identified clinically or would not have resulted in Unnecessary . .72 – 1. consider issues of further testing or harm arising from false-positives in their decision making.50) Effect Certainty of the evidence Low quality evidence Distress 0.06 – 0. and feedback from a Most women value mammography in particular for perceived reduction of mortality.11 (0.

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

500 per quality-adjusted life year (QALY) saved compared with no small? human resources.4. Vol. .707 per life year Apr 2013. 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. had twice the cost. 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 $24.000 US dollars tion screened and a similar reduction in predicted breast cancer cost small No Probably Uncertain Probably Yes Varies per QALY gained. from annual and biennial RE S O URCE US E screening of those aged 40-49 was $26. The cost per life years saved. and X 35. respec- Compared to no screening.Use of Screening Strategies for Detection of Breast Cancer 22 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS Are the Under lack of local evidence on costs. No.000 to$ 65. The relative to nial screening those aged 47 to 49 was about US$45. pp. a Systematic Review. the cost per QALY gained for trien- No Yes mortality rate (25%) 20 years after the start of the program. 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. X 3% discounted cost-effectiveness ratio for organized screening the net Rashidian. Moreover.000. both yielded a similar reduction in Is the tively. widely available across regions in the Kingdom. Iranian J Publ Health. with a ratio of €22. From the panel point of X stakeholders? X view. this option is acceptable for all the stakeholders. the guideline panel agreed No Probably Uncertain Probably Yes Varies resources No Yes that the resources needed to allocate are not small. two studies from the US and UK were of well-trained radiologists are needed. A.671 to €24.000. a higher number In those aged less than 50. Although digital mammogram equipment is screening. Cost Effectiveness of Breast Cancer Screening Using was €11.200 and $14.512 per life year gained while opportunistic screening benefits? Mammography. Among the required Mammography and clinical breast examination cost an additional USD costs related to this intervention can be listed: equipment. identified. 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.. et al. 42.

low-quality evidence) Justification Probably higher incidence than in the other countries in which studies were done. (Conditional recommendation. 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. 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. implement? X Availability of assessment clinics for women with positive (true + false positive) screening results. probably higher benefit on breast cancer mortality justifies a recommendation in favour of the option Subgroup None considerations .Use of Screening Strategies for Detection of Breast Cancer 23 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS The panel highlights that this recommendation would represent a good opportunity for implementing shared decision-making.

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

48 and I2 =0% 4. Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No.04) (1. p-value for testing heterogeneity is 0. p-value for testing heterogeneity is 0.8%) (0.96) (115 fewer to 792 fewer) All-cause mortality (follow-up: median 11 years) 2 Randomized None None2 None 6 None7 Undetected8 ⊕⊕⊕⊕ 1.000.388/132. Insufficient number of studies to assess publication bias 6.000 IMPORTANT Low .098 2.85 474 fewer CRITICAL trials Low (0. Insufficient number of studies to assess publication bias .Use of Screening Strategies for Detection of Breast Cancer 25 Evidence profile: 1. No serious heterogeneity.7%) 1. Should mammography vs. no intervention be used for breast cancer screening in women 40 to 49 years old? Author(s): Alonso Carrasco-Labra.373/79.000 bias bias (95% CI) (95% CI) Breast cancer mortality 8 Randomized Serious 1 Serious2 None 3 None4 Undetected5 ⊕⊕⊝⊝ 448/152.97 484 fewer CRITICAL trials High (1.615 fewer to 726 more) False positive results 2 Observational None None None None Undetected9 ⊕⊕⊝⊝ 32.75 to 0. Total sample size is large and the total number of events is >300 5.700/100.919 RR 0. - studies (32.97 to 1.300 625/195.7%) (1. The panel agreed that there is considerable uncertainty regarding the baseline risk in this subgroup. Blinding and allocation concealment were unclear for five studies 2. No serious heterogeneity. . of Study Absolute per Risk of Publication Quality Relative Importance studies design Indirectness Inconsistency Imprecision Mammography Control 1. They provided evidence suggesting that the baseline risk in Saudi population may be higher 3. High risk of bias.65 and I2 =0% 7.172 RR 0. Sample size is large and total number of events is > 300 8.

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

7/100. In Saudi Arabia. clinical breast examination by a health care professional. the infiltrating duct carcinoma (ICD-O-3. In 2009 the age-specific incidence the Kingdom of rate was 22. breast cancer is the most com. 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. no known mutations in the methods are frequently used in contemporary practice. the . no history of breast cancer in a first controversy remains over which screening services should be provided and to whom (age groups). Riyadh Saudi Arabia. the Kingdom of tify tumours. 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. There is widespread acceptance of the value of regular breast cancer screening as the single most im.000). BRCA1/BRCA2 genes or no previous exposure of the chest wall to radiation). 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).000). 8500) accounts for the 78. The reason for this is that breast cancer can be 2009 Cancer more effectively treated at an early stage.4/100. these degree relative. it could also lead to overdiagnosis and overtreatment. Incidence Report of Mammography. the No Probably Uncertain Probably Yes Varies region (29.1/100. Mammography can identify early stage breast cancer Saudi Arabia. and breast self-examination can all iden. On the other hand.000). The three regions with the highest incidence were Easter region (33.4/100. 100. cancer. Incidence Report of mon among women representing 25. However.Use of Screening Strategies for Detection of Breast Cancer 27 Evidence to recommendation framework 2 2. 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.2% of all morpholog.1% of all newly diagnosed female cancers. described in the portant public health strategy to reduce breast cancer mortality.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. cancer is 25 per problem a ical breast cancer variants.000. and Makkah region (26.

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

204 women will small? False positive results 28. identified clinically or relative to X breast cancer of 20 to 25 cases in 100.902 more) 1. or other psychological responses Important Low rated down from ? critical to important.530 more to (1.000 - would not have undesirabl resulted in Anxiety.90) every 2 to 3 years Are the . per 100. RR 1.050 fewer) 0.78 MODERATE . distress.167 (3. 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 1.000 .083 1.000 (1.68 to need to be screened 2. distress.200 LOW have a false positive .000) effect evidence desirable No Probably Uncertain Probably Yes Varies this age group.2 to invasive or 6.154 per 66. 500 .96 to unnecessary breast anticipated 620 more) 1.06 HIGH have an No Probably Uncertain Probably Yes Varies e No Yes per 19. (95%CI) (RR) (GRADE) anticipate No Yes about: (95%CI) d effects X large? Breast cancer 743 639 1.694 per 19.424 5.35 to 1.40 LOW anxiety and follow-up (organized BCS) per 100.150 more RR 1.068 (622 fewer to (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 .2) biopsy X effects .711 (140 fewer to (0.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.206 per 135. or LOW e effects? other psychological .387 fewer RR 0. . mammogram leading to unnecessary Overdiagnose § .3 HIGH § Overdiagnose: Any biopsies or surgery per 66. See table below .45) testing Unnecessary 1.000.720 women would mortality per 115. . symptoms or death responses in a person’s lifetime is called overdiagnosis (20 yrs period) Psychological Effects of False-Positive Mammograms Screening interval .26 women would undesirabl All cause mortality 690 734 220 more RR 1.

86 (95%CI. 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 .51 – 0.88) Summary of the evidence for patients’ values and preferences: Moderate quality evidence Most women value mammography in particular for perceived reduction of mortality.12 (0. 0. The majority of women prefer to be jointly involved in decision making 0.04 – 0.05 – 0.98) Perceived benefits of mammography 0.14) RR 0. absence of symptoms.22 (0.11 (0.22) from breast cancer in Fear 0.06 – 0.27) years old LOW Somatization 0.2 – Small not allow for daytime appointments.18 – 0.10 – 0.8 – Large Based on local literature. However. few women consider issues of further testing or harm arising from false-positives in their decision making.03 – 0. and feedback from a representative from the patients.88 (0. 0.04 – 0.5 – Medium with their care providers.67 (95%CI 0. many of the studies were done when participants were already in screening programs.16 (0. or work or family responsibilities that do 0. clinical experience.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 0.19) <24 months: Perceived likelihood of getting breast cancer 0. fatalistic beliefs. but some would go for screening if recommended by their providers.75 – 0.09 (0.11 (0. Other women refuse breast cancer ¶ Cohen’s effect size interpretation screening because of fear.19) evidence ≥24 months: RR 0.14) women 50 to 69 Anxiety 0.17) High quality Frequency of breast self examination 0.

those aged 40-49 was $26. from annual and biennial screening of of well-trained radiologists are needed.000. 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. 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. and X small? human resources. Although digital mammogram equipment is In those aged less than 50. From the panel point of X stakeholders view. Apr 2013.512 per life year gained while opportunistic screening benefits? had twice the cost. this option is acceptable for all the stakeholders. Barratt et al RE S O URCE US E had reported that starting the screening from age 40 instead of 50 would cost $24.4. et al. 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$45. ? . Vol. the guideline panel agreed No Probably Uncertain Probably Yes Varies resources No Yes Mammography and clinical breast examination cost an additional USD 35.000. 42. Moreover. A. respectively. The cost per life years saved. Is the A CCE P T A B ILIT Y option Panel members mentioned that they are informed of previous No Probably Uncertain Probably Yes Varies acceptable No Yes small-scale initiatives for implementing breast cancer screening None identified to key using mammography in the Kingdom. a Systematic Review.Use of Screening Strategies for Detection of Breast Cancer 31 CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS Are the Under lack of local evidence on costs.000 US dollars per QALY gained.000 to$ 65.. 347-357 was €11. a higher number fied.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. Cost Effectiveness of Breast Cancer Screening Using Mam- relative to 3% discounted cost-effectiveness ratio for organized screening X mography. with a ratio of €22.671 to €24.200 and $14. costs related to this intervention can be listed: equipment. two studies from the US and UK were identi- widely available across regions in the Kingdom. The Rashidian. Among the required quality-adjusted life year (QALY) saved compared with no screening.500 per that the resources needed to allocate are not small. the Compared to no screening. No. the net pp. Iranian J Publ Health.

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.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. 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.

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 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 . 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. moderate-quality evidence). The access for women with disabilities should be guaranteed across the Kingdom. Monitoring and evaluation The panel considered that control and audit the result of mammograms is important. In addition. In addition. considerations Availability of assessment clinics for women with positive (true + false) screening results.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.

Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged 50-59 years.47%) (0. The Canadian National Breast Screening Study-1: breast cancer mortality after 11 to 16 years of follow-up. 2000. Ann Intern Med. To T. To T. heterogeneity not applicable 7. PM:12204013. no intervention be used for breast cancer screening in women 50 to 69 years old? Author(s): Alonso Carrasco-Labra.000 bias bias (95% CI) (95% CI) Breast cancer mortality (follow-up: median 11 years) 7 Randomized Serious 1 None2 None 3 None4 Undetected5 ⊕⊕⊕⊝ 639/135.068 743/115. PM:10995804.000 IMPORTANT Low . of Study Absolute per Risk of Publication Quality Relative Importance studies design Indirectness Inconsistency Imprecision Mammography Control 1. Baines CJ. 137(5 Part 1): 305-12. Blinding and allocation concealment were unclear for five studies 2.Miller AB.Use of Screening Strategies for Detection of Breast Cancer 34 Evidence profile: 2. 2002.694 RR 1.000. Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. Sample size is large and total number of events is > 300 REFERENCES . Should mammography vs.68 to 0. Single study. . p-value for testing heterogeneity is 0. A ran- domized screening trial of mammography in women age 40 to 49 years.5%) (0.387 fewer CRITICAL trials Moderate (0. intervention.2%) 1. J Natl Cancer Inst.200/100.90) (622 fewer to 2. comparator and outcome 3.12 and I2 =41% 4.06 220 more CRITICAL trials High (3. . The question addressed is the same for the evidence regarding the population. Total sample size is large and the total number of events is >300 5. - studies (28.65%) (0. 92(18): 1490-9.Miller AB. . and Wall C.050 fewer) All-cause mortality (follow-up: median 11 years) 1 Randomized None None2 None6 None7 Undetected5 ⊕⊕⊕⊕ 734/19. No serious heterogeneity. Baines CJ.2) (140 fewer to 620 more) False positive results 2 Observational None None2 None None Undetected5 ⊕⊕⊝⊝ 28.206 RR 0.96 to 1. and Wall C. High risk of bias. Insufficient number of studies to assess publication bias 6.711 690/19.7%) (3.78 1.

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

The median age at diagnosis was is 25 per 100.000). 8500) accounts for the 78. and Makkah region (26.1/100. In Saudi Arabia. Mammography can literature.000).000 48 years (range 19 to 99 years). Given other competing health risks. the guideline panel determined cornerstone of breast cancer control. The three Cancer Incidence Report of the Kingdom of regions with the highest incidence were Easter region (33.7/100. Use of Screening Strategies for Detection of Breast Cancer 36 Evidence to recommendation framework 3 3. the pick at 45 effectively treated at an early stage. 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. 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. Ministry of Health. the infiltrating duct carcinoma (ICD-O- Varies 3. the Incidence of breast cancer (29.000). breast self-examinations and clinical breast examina- no history of breast cancer in a first degree relative. breast cancer is the most common among women representing 25. The reason for this is that breast cancer can be more From the panel’s point of view. ing services should be provided and to whom (age groups). clinical breast examination by a health care disease compared to statistics reported in the professional. reduce breast cancer mortality. Saudi Arabia: Kingdom of Saudi Arabia. controversy remains over which screen- genes or no previous exposure of the chest wall to radiation).1% of all newly diagnosed Based on the data described in the 2009 female cancers.2% of all morphological breast cancer variants. Riyadh region Saudi Arabia. According to the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. 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. identify early stage breast cancer Al-Eid HS. breast cancer is not a priority or a main health problem.000. it could also lead to overdiagno- years represents an earlier onset of the sis and overtreatment. and breast self-examination can all identify tumours. 201 . García AD. On the other hand. Mammography. these methods are frequently used in contemporary practice. In 2009 the age-specific incidence rate was 22. Background: Regular screening for breast cancer with mammography. Saudi Cancer Registry: Cancer Incidence Report 2009.4/100.4/100. no known mutations in the BRCA1/BRCA2tions are widely recommended to reduce mortality due to breast cancer. 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. However.

307 per 10. two thnught it Is there was important.68 LOW about 11 years in this undesirable No Probably Uncertain Probably Yes Varies mortality per 7.45 to 1. about: anticipated 39 more) effects X . 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.450 women would small? All cause mortality need to be screened . Anxiety. critical.339 (3.000) (RR) the (95%CI) (95%CI) evidence (GRADE) To save one life from breast cancer over Are the Breast cancer 50 49 2. 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 1.01) No Yes age group. 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. distress.734 fewer to (0.000.218 fewer RR 0.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 .

14) from breast cancer in women 70 to 74 years Perceived benefits of mammography 0.16 (0.03 – 0.19) <24 months: Not available .Use of Screening Strategies for Detection of Breast Cancer 38 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS . every 2 to 3 years .10 – 0. .04 – 0.12 (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 0.88 (0. See table below . or LOW symptoms or death in a No Probably Closely Probably Yes Varies other psychological .000 clinically or would not Are the have resulted in desirable Anxiety. distress.19) relative risk of death Perceived likelihood of getting breast cancer 0.200 LOW an unnecessary breast results .09 (0.11 (0. . .17) old Frequency of breast self examination 0. .000 .18 – 0. . biopsy .22 (0.88 to 0. per 100. .09 LOW false positive (organized BCS) per 100.22) Fear 0. by screening that would cancer of 20 to 25 cases in not have been identified 100.11 (0.27) Screening with LOW mammography on Somatization 0.000 - - § 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 .11 women would have False positive 21. 500 LOW and follow-up testing biopsies or surgery per 100.14) Screening interval Anxiety 0. 500 . .000 (0.05 – 0.04 – 0. RR 0.06 – 0.96) mammogram leading to unnecessary anxiety Unnecessary .96 women will have a Overdiagnose § .

many of the studies were done when participants were already in screening programs. fatalistic beliefs. However.8 – Large Based on local literature.68 (95%CI 0. clinical experience.5 – Medium 0. The majority of women prefer to be jointly interpretation involved in decision making with their care providers. the guideline panel decided that any psycological effect of false-positive results and frequency of screening will have a lower value compared to the perceived benefits on mortality . or work or family ¶ Cohen’s effect size responsibilities that do not allow for daytime appointments.01) Most women value mammography in particular for perceived reduction of mortality. absence of symptoms.2 – Small their providers. 0. but some would go for screening if recommended by 0. Other women refuse breast cancer screening because of fear.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 0.45 – 1. and feedback from a representative from the patients. few women consider Low quality evidence issues of further testing or harm arising from false-positives in their decision making.

a higher number In those aged less than 50. pp. benefits? had twice the cost. 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.. Iranian J Publ Health. et al.671 to €24. No. the guideline panel agreed No Probably Uncertain Probably Yes Varies resources No Yes that the resources needed to allocate are not small. Cost Effectiveness of Breast Cancer Screening Using the net was €11. respec- tively. two studies from the US and UK were of well-trained radiologists are needed.500 per quality-adjusted life year (QALY) saved compared with no costs related to this intervention can be listed: equipment. 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. Moreover. Barratt et al had reported that starting the screening from Compared to no screening. with a ratio of €22. Vol. The cost per life years saved.000. The relative to 3% discounted cost-effectiveness ratio for organized screening X Rashidian.000 US dollars breast cancer mortality (13%) during the lifespan of the popula- incremental per QALY gained. mortality rate (25%) 20 years after the start of the program.707 per life year Apr 2013. and X small? screening. identified. 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.200 and $14.4. 347-357 gained Cost-effectiveness of opportunistic versus organized mam- mography screening for women aged 50 to 69 (Switzerland) What would The guideline panel agreed that since mammography for breast be the Increased Probably Uncertain Probably Reduced Varies cancer screening is not systematically offered and widely availa- E Q UIT Y impact increased reduced None identified ble across the Kingdom. ? . this option is acceptable for all the stakeholders.000 to$ 65. human resources. from annual and biennial RE S O URCE US E screening of those aged 40-49 was $26. From the panel point of X stakeholders view. the cost per QALY gained for trien. Although digital mammogram equipment is widely available across regions in the Kingdom. A.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.512 per life year gained while opportunistic screening Mammography. both yielded a similar reduction in Is the age 40 instead of 50 would cost $24.000. 42. Among the Mammography and clinical breast examination cost an additional USD required 35.

Availability of assessment clinics for women with positive (true + false positive) screening results. the panel guideline considered that given other competing health risks. Balance of consequences Undesirable consequences Undesirable consequences probably The balance between Desirable consequences Desirable consequences clearly outweigh outweigh desirable and undesirable consequences probably outweigh clearly outweigh desirable consequences desirable consequences is closely balanced or uncertain undesirable consequences undesirable consequences in most settings in most settings in most settings in most settings X Type of recommendation We recommend against We suggest not offering We suggest offering We recommend offering offering this option this option this option this option X Recommendation (text) The Saudi Expert Panel suggests no screening with mammography in women aged 70–74 years every 2 to 3 years (Conditional recommendation.Use of Screening Strategies for Detection of Breast Cancer 41 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- Is the F E A S IB ILIT Y No Probably Uncertain Probably Yes Varies gies. the panel proposed that this should be done every 2 to 3 years Subgroup considerations None . 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. low-quality evidence) Justification In this group. In addition. option No Yes None identified feasible to X The access for women with disabilities should be guaranteed implement? across the Kingdom.

In addition. Centres offering the service should also be regulate and monitor. In addition. 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. Availability of assessment clinics for women with positive (true + false) screening considerations results. 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 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 .

Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. and van der Maas PJ.75 and I2 =0% 4. Ten-year risk of false positive screening mammograms and clinical breast examina- tions. 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. 1995. van Oortmarssen GJ.Habbema JD. Impreci. . Lubbe JT.200/100. Insufficient number of studies to assess publication bias REFERENCES . .Hofvind S. 77(2): 317-20. but the total number of events is <300 5. of Study Risk of Inconsisten. 2004.68 2. new results from the Swedish Two- County Trial. Publica.000 IMPORTANT Low . . and Tretli S. Serious imprecision. - studies (21. High risk of bias. CRITICAL ies report- . . . . PM:7736395 . Fagerberg G. . comparator and outcome 3. no intervention be used for breast cancer screening in women 70 to 74 years old? Author(s): Alonso Carrasco-Labra. Total sample size is large.339 50/7.Tabár L. 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. and Fletcher SW.2%) 1. 338(16): 1089-96.218 fewer CRITICAL trials Low (0. Barton MB. Arena PJ. . Moceri VM. N Engl J Med. Evidence to recommendation framework 4 . 101(7): 1501-7. The cumulative risk of a false-positive recall in the Norwegian Breast Cancer Screening Program.Use of Screening Strategies for Detection of Breast Cancer 43 Evidence profile: 3.7%) (0. PM:15378474.Elmore JG. Gad A. Thoresen S. intervention. Duffy SW.734 fewer to 39 more) All-cause mortality No stud. . . - ing this outcome False positive results 2 Observational None None2 None None Undetected ⊕⊕⊝⊝ 21. Cancer. van Putten DJ.01) (3.45 to 1. p-value for testing heterogeneity is 0. 75(10): 2507-17. J Natl Cancer Inst. Blinding and allocation concealment were unclear 2. PM:9545356. . Efficacy of breast cancer screening by age.307 RR 0. .47%) (0. 1998. Chen HH. 1986. Cancer. Should mammography vs. No serious heterogeneity. PM:3461193. Polk S. Smart CR. The question addressed is the same for the evidence regarding the population.

breast self-examinations and clini- (defined as those with no previous breast can. regular breast cancer screening as the single most important public health strategy to From the panel’s point of view.2% of all morphological breast cancer variants. the infiltrating duct carcinoma (ICD. the pick at 45 reduce breast cancer mortality.000). no known mutations in the methods are frequently used in contemporary practice.1% of all newly diagnosed Cancer Incidence Report of the Kingdom of female cancers. Cancer Incidence Report of the Kingdom of P RO B LE M Is the No Yes Saudi Arabia. Saudi Cancer Registry: identify early stage breast cancer. The three Saudi Arabia. There is widespread acceptance of the value of presentation with picks at 45 and 60 years. controversy remains over which screening services should be provided and to whom (age groups). no history of breast cancer in a first de. The reason for this is that breast cancer can be more years represents an earlier onset of the effectively treated at an early stage.4/100.000. In 2009 the age-specific incidence rate was 22.000 (29. Mammography can Al-Eid HS. cal breast examinations are widely recommended to reduce mortality due to breast cancer. cer. clinical breast examination by a health care literature. On the other hand. Riyadh region 25 per 100. Option: Screening for breast cancer using breast self-examination Comparison: No screening Setting: Outpatients Perspective: Health system CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS According to the 2009 Cancer Incidence Report of the Kingdom of Saudi Arabia. The median age at diagnosis was 48 years (range 19 to 99 years). 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.Use of Screening Strategies for Detection of Breast Cancer 44 4. disease compared to statistics reported in the nosis and overtreatment. professional. . However. Based on the data described in the 2009 No Probably Uncertain Probably Yes Varies O-3. Cancer Incidence Report 2009. it could also lead to overdiag. Saudi Arabia: Kingdom of Saudi Arabia. 8500) accounts for the 78.7/100. the Incidence of breast cancer is regions with the highest incidence were Easter region (33. BRCA1/BRCA2 genes or no previous exposure of the chest wall to radiation). Mammography. and breast self-examination can all identify tumours.000). García AD.4/100.000). and Makkah region (26. In Saudi Arabia. 2012. these gree relative. breast Based on the data described in the 2009 cancer is the most common among women representing 25. 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. Ministry of Health.1/100.

two thought it was important. .000.000) 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 .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 . but found .763 per 193. 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. . positives were critical. All cause mortality Critical MODERATE After further input from a Is there important False positive results Important . - cause mortality. value the X Anxiety.596 (254 fewer to (0. 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.83 to 1. 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. 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. distress.2) associated with teaching effects X 234 more) Breast Self Exam to women small? aged 31 to 64. or other main Important . . patient that attended the uncertainty panel meeting.98 MODERATE in breast cancer mortality anticipated per 193.

14) Anxiety 0. few women consider issues of further testing or harm arising from false-positives in their decision making. Anxiety. for benign breast biopsy. . - . ¶ Cohen’s effect size inter- However.22) effects? Fear 0. .06 – 0.03 – 0. potential harms of Breast (organized BCS) Self Exam and the corresponding lack of Unnecessary .19) LOW § Overdiagnose: Any invasive or noninvasive Perceived likelihood of getting breast cancer 0.05 – 0. . Breast self-exam has been responses . .10 – 0.88 (0. Are the Accuracy estimates: Psychological Effects of False-Positive Mammograms . many of the studies were done when participants were already in screening programs.27) Somatization 0. .04 – 0. or other psychological See table below .11 (0.17) screening that would not have been identified Frequency of breast self examination 0. . .Sensitivity: range from desirable effects large No Probably Uncertain Probably Yes Varies 12% to 41% No Yes Effect Increase effect size ¶ (95% CI) Certainty of the relative to evidence . distress.09 (0.Use of Screening Strategies for Detection of Breast Cancer 46 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS False positive evidence of increased harm results .14) breast cancer detected by Perceived benefits of mammography 0. suggested as a monthly examination of the woman’s breasts. .Specificity: range from undesirable X 66% and 81% Distress 0. .22 (0. effectiveness in decreasing mortality.18 – 0. .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 – 0.16 (0. This rise concern for the Overdiagnose § . evidence of their biopsies or surgery .11 (0.12 (0.

8 – Large some would go for screening if recommended by their providers.5 – Medium 0. absence of pretation symptoms. fatalistic beliefs. but 0. Based on local literature.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.2 – Small majority of women prefer to be jointly involved in decision making with their care providers. or work or family responsibilities that do not allow for daytime appointments. 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 . The 0. clinical experience. and feedback from a representative from the patients.

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. Among the required resources it can be listed: healthy Is the None identified women educational programs. location for incremental in-person sessions. educational material. 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. the RE S O URCE US E guideline panel agreed that the resources needed to allocate are small. as long as the on health X educational program is widely available across the Kingdom. 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. X implement? . X stakeholders ? Is the F E A S IB ILIT Y No Probably Uncertain Probably Yes Varies option No Yes The panel considered this option as feasible and easy to imple- None identified feasible to ment.

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

Ivanova OA.Thomas DB. 94(19): 1445-57. High risk of bias. . Stalsberg H. - this outcome All-cause mortality 2 Randomized Serious1 None2 None3 None4 Undetected5 ⊕⊕⊕⊝ 292/193.763 RR 0. . J Natl Cancer Inst. . Chagunava OA. . . of Study Risk of Publication Quality Breast self. Randomized trial of breast self-examination in Shanghai: final results.596 298/193. Orlov AA. . and Self SG.15%) (0. Wang WW.Semiglazov VF. No serious heterogeneity. . Zhao GL. . Li W. Wu C. . Ray RM. Hu YW. Porter P. Should breast self-examination vs. 8(4): 498- 502. Coriaty Z. Sample size is large and total number of events >300 5. . Blinding and allocation concealment were unclear 2. . Evans I. The question addressed is the same for the evidence regarding the population. . .98 30 fewer CRITICAL trials Moderate (0. Lin MG. Relative Absolute Importance studies design Indirectness Inconsistency Imprecision Control bias bias examination (95% CI) (95% CI) Breast cancer mortality No studies CRITICAL reporting .58 and I2 =0% 4. PM:1397215. and Barash NJ. Eur J Epidemiol. .15) (254 fewer to 234 more) False positive No studies IMPORTANT reporting . . Migmanova NS. no intervention be used for breast cancer screening in women of all ages? Author(s): Alonso Carrasco-Labra. The role of breast self-examination in early breast cancer detection (results of the 5-years USSR/WHO randomized study in Leningrad). Chen FL. . 1992. Allison CJ. PM:12359854. p-value for testing heterogeneity is 0. . - this outcome 1. Bavli JL. Insufficient number of studies to assess publication bias REFERENCES .84 to 1. . Pan LD.15%) (0. Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. . Seleznyov NK. Gao DL. Moiseyenko VM.Use of Screening Strategies for Detection of Breast Cancer 50 Evidence profile: 4. comparator and outcome 3. Popova RT. 2002. .

From the panel’s other hand.4/100. the infiltrating duct carcinoma (ICD-O-3. Mammography. no history of breast cancer in a first de.4/100.000. disease compared to statistics reported in the literature. 8500) accounts for the 78. In the Kingdom of Saudi Arabia.000). clinical breast point of view. controversy remains over which screening services should be provided and to whom (age groups). Riyadh region (29. 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. 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. On the 45 and 60 years. the pick at 45 years examination by a health care professional.1/100. However. breast self-examinations and clin- (defined as those with no previous breast can. 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. The median age at diagnosis was 48 years (range 19 to 99 years). and Makkah region 100. represents an earlier onset of the Mammography can identify early stage breast cancer. these gree relative. bimodal presentation with picks at The reason for this is that breast cancer can be more effectively treated at an early stage. breast cancer is 2009 Cancer Incidence Report of the most common among women representing 25.7/100. the Early detection in order to improve breast cancer outcome and survival remains the cornerstone of guideline panel determined that the breast cancer control. no known mutations in the methods are frequently used in contemporary practice. . it could also lead to overdiagnosis and overtreatment. BRCA1/BRCA2 genes or no previous exposure of the chest wall to radiation).2% of all morphological P RO B LE M Is the Based on the data described in the No Yes breast cancer variants. cer.000).Use of Screening Strategies for Detection of Breast Cancer 51 Evidence to Recommendation Framework 5 5. The three regions with the highest inci- Incidence of breast cancer is 25 per dence were Easter region (33.1% of all newly diagnosed female cancers. the 2009 the age-specific incidence rate was 22. and breast self-examination can all identify tumours.000). In Saudi Ara- No Probably Uncertain Probably Yes Varies bia. ical breast examinations are widely recommended to reduce mortality due to breast cancer.000 (26.

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

. .positive predictive Overdiagnose § . .14) Perceived benefits of mammography 0. or breast cancer detected Are the other psychological . . 88% to 99% .sensitivity: range from 40% to 69% False positive .19) Perceived likelihood of getting breast cancer 0. .specificity: range from results .10 – 0.000) effect (RR) of the undesirable No Probably Uncertain Probably Yes Varies examination reduces breast cancer No Yes (95%CI) (95%CI) evidence anticipated mortality or all-cause effects X (GRADE) mortality.12 (0.09 (0. . § Overdiagnose: Any . .22) Fear 0.27) LOW Somatization 0. . small? Breast cancer mortality . .05 – 0.11 (0. invasive or noninvasive Anxiety.17) ¶ Cohen’s effect size .04 – 0. - Accuracy of clinical All cause mortality breast examination: . .14) Anxiety 0.88 (0. . . . . - biopsies or surgery . - (organized BCS) value: 4% to 50% Unnecessary . distress.03 – 0.000.16 (0. 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. .18 – 0.06 – 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. .22 (0.

absence of symptoms. but some would go for screening if recommended by their providers.5 – Medium 0. Based on local literature. 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 .04 – 0. and feedback from a representative from the patients.8 – Large Summary of the evidence for patients’ values and preferences: Most women value mammography in particular for perceived reduction of mortality. clinical experience. However. or work or family responsibilities that do not allow for daytime appointments.11 (0. Other women refuse breast cancer screening because of fear.Use of Screening Strategies for Detection of Breast Cancer 54 ADDITIONAL CRITERIA JUDGEMENTS RESEARCH EVIDENCE CONSIDERATIONS Frequency of breast self examination 0.2 – Small 0. The majority of women prefer to be jointly involved in decision making with their care providers. few women consider issues of further testing or harm arising from false-positives in their decision making. fatalistic beliefs.19) interpretation 0. many of the studies were done when participants were already in screening programs.

X implement? .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. No Probably Uncertain Probably Yes Varies cost small No Yes relative to X the net benefits? What would be the Increased Probably Uncertain Probably Reduced Varies E Q UIT Y increased reduced The guideline panel considered that health inequities would be impact None identified reduced if this intervention were implemented. on health X inequities? Is the A CCE P T A B ILIT Y option No Probably Uncertain Probably Yes Varies acceptable No Yes The guideline panel determined that this option is acceptable to None identified to key key stakeholders X stakeholders ? Is the F E A S IB ILIT Y No Probably Uncertain Probably Yes Varies option No Yes The panel considered this option as feasible and easy to imple- None identified feasible to ment. the Is the None identified guideline panel agreed that the resources needed to allocate incremental probably are small.

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

. . - outcome All-cause mortality No studies CRITICAL reporting this . . . . of Study Risk of Publication Quality Clinical breast exam. . .Use of Screening Strategies for Detection of Breast Cancer 57 Evidence profile: 5. 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. Should clinical breast examination vs. . . . . . - outcome False positive results No studies IMPORTANT reporting this . . . . . . . . . . . Tejan Baldeh Date: 2013-11-28 Quality assessment Nº of participants Effect No. - outcome . . . . .

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

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

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

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

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

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

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

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

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