online appendix 1. search design: inclusion and exclusion ...10.1007... · web viewonline...

ONLINE APPENDIX Use of patient decision aids increased younger women's reluctance to begin screening mammography:

a systematic review and meta-analysis

Table of ContentsOnline Appendix 1. Search design: inclusion and exclusion criteria.......................................................................2

Online Appendix 2. Search strategy........................................................................................................................3

Online Appendix 3. List of included and excluded studies with the reasons..........................................................5

Online Appendix 4. Comparison of BCS-PtDAs...................................................................................................24

Online Appendix 5. Risk of bias assessment for before-after studies...................................................................28

Online Appendix 6. Risk of bias assessment for Randomized Controlled Trials..................................................30

Online Appendix 7. Proportions of women aged 38–50 and 69–71, who would not wish to be screened...........32

Online Appendix 8. Proportions of women aged 38–50, who would not wish to be screened.............................33

Online Appendix 9. Proportions of women aged 69–71, who would not wish to be screened.............................34

Online Appendix 10. Additional analyses.............................................................................................................35

References..............................................................................................................................................................40

Table of FigureseFigure 1: Forest plot of the proportion of women who were intended to undergo screening mammography

(subgroups: RCTs and before-and-after studies)..........................................................................................35eFigure 2: Forest plot of the proportion of women who were intended to undergo screening mammography

(subgroups: women age 38–50)....................................................................................................................36eFigure 3: Forest plot of the proportion of women who were intended to undergo screening mammography

(subgroups: women age 69–71 and 75–89)..................................................................................................36eFigure 4: Forest plot of the proportion of women who were undecided about undergoing screening

mammography (subgroups: RCTs and before-and-after studies)................................................................36eFigure 5: Forest plot of the proportion of women who were undecided about undergoing screening

mammography (subgroups: women age 38–50)..........................................................................................37eFigure 6: Forest plot of the proportion of women who were undecided about undergoing screening

mammography (subgroups: women age 69–71 and 75–89).........................................................................37eFigure 7: Forest plot of the proportion of women who were decided about undergoing screening

mammography (subgroups: RCTs and before-and-after studies)................................................................38eFigure 8: Forest plot of the proportion of women who were decided about undergoing screening

mammography (subgroups: women age 38–50)..........................................................................................38eFigure 9: Forest plot of the proportion of women who were decided about undergoing screening

mammography (subgroups: women age 69–71 and 75–89).........................................................................39



Online Appendix 1. Search design: inclusion and exclusion criteriaCategory Include Exclude

Population Women age ≥38 years old. Men, women age <38 years, women with breast cancer; women who had breast cancer; women with pre-existing breast cancer.

Intervention All kinds of decision aids (i.e., paper-based, computer-based include mobile technology based [tablet, mobile phone], and audiotape)

Comparisons 1. Proportion of women (age 38–50 and 69–89) who were decided about screening mammography vs. proportion of women (age 38–50 and 69–89) who were decided about screening mammography after using a BCS-PtDA

2. Proportion of women (age 38–50 and 69–89) who were undecided about screening mammography vs. proportion of women (age 38–50 and 69–89) who were undecided about screening mammography after using a BCS-PtDA

3. Proportion of women (age 38–50 and 69–89) who plan to undergo screening mammography vs. proportion of women (age 38–50 and 69–89) who plan to undergo screening mammography after using a BCS-PtDA

4. Proportion of women (age 38–50 and 69–89) who did not wish to undergo screening mammography vs. proportion of women (age 38–50 and 69–89) who did not wish to undergo screening mammography after using a BCS-PtDA

Outcomes Women with an average risk for breast cancer reconsider/not reconsider their decision to start or continue screening mammography after using a BCS-PtDA.

Outcomes not listed as included.

Timing Immediate outcomes No follow-up after using an aid.

Setting Settings and populations of women applicable to U.S.

Study Design

randomized controlled trials, non-randomized studies, cohort studies, case-control studies, and before-after studies

Study designs not listed as included.

Language We did not limit our search to the studies published in English.

Data Sources MEDLINE Epub Ahead of Print, MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE(R) Daily and MEDLINE (OvidSP), Scopus, Cochrane Central Register of Controlled Trials (CENTRAL) (OvidSP), PsycINFO (OvidSP), Health and Psychosocial Instruments (OvidSP), Health Technology Assessment (OvidSP), PsycARTICLES.

Sources not listed as included.

Search Dates We did not apply any time limits.



Online Appendix 2. Search strategyUpdated on August 16, 2016

Databases: MEDLINE Epub Ahead of Print, MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE(R) Daily, MEDLINE (OvidSP) (1946 to August 16, 2016), Cochrane Central Register of Controlled Trials (CENTRAL) (OvidSP) (1991 to July 2016), PsycINFO (OvidSP) (1806 to July Week 4 2016), Health and Psychosocial Instruments (OvidSP) (1985 to July 2016), Health Technology Assessment (OvidSP) (2001 to 3rd Quarter 2016), PsycARTICLES Full Text (OvidSP).Step Search Strategy1 exp Health Behavior/2 exp Attitude to Health/3 1 or 24 decision support techniques/5 exp Decision Making/6 ((aid* or assist* or help*) adj5 (decis* or decid* or choic* or choos* or option*)).mp. [mp=title,

abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier]

7 (patient* adj5 (choic* or choos* or opt or opts or option* or intent* or view*)).mp. [mp=title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier]

8 ((chang* or alter* or differ*) adj5 (decis* or decid* or choic* or choos* or option* or intent* or view* or mind or minds)).mp. [mp=title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier]

9 (inform* adj3 (choic* or choos* or consent*)).mp. [mp=title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier]

10 ((willing or unwilling) adj5 participa*).mp. [mp=title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier]

11 6 or 7 or 8 or 9 or 1012 4 or 513 11 and 1214 3 and 1315 exp Breast Neoplasms/16 exp Mass Screening/17 exp breast cancer/di18 exp Mammography/19 15 and 1620 mammogra*.mp.21 17 and 2022 18 or 19 or 2123 14 and 22



Updated on August 24, 2016

Databases: ScopusStep

Search Strategy

1 TITLE-ABS-KEY ((((aid* OR assist* OR help*) W/5 (decis* OR decid* OR choic* OR choos* OR option*)) OR (patient* W/5 (choic* OR choos* OR option* OR intent* OR view* OR plan*)) OR ((chang* OR differ*) W/5 (decis* OR decid* OR choic* OR choos* OR option* OR intent* OR view* OR plan* OR mind OR minds)) OR (inform* W/3 (choic* OR choos* OR consent*))) AND ("decision support" OR (decision* W/4 mak*) OR ptda*) AND ((("breast neoplasm*" OR "breast cancer" OR "breast tumor*" OR "breast tumour*") AND "mass screening") OR mammogra*))

2 AND (3 EXCLUDE (DOCTYPE , "re")4 OR EXCLUDE(DOCTYPE,"ed")5 OR EXCLUDE(DOCTYPE,"sh")6 OR EXCLUDE(DOCTYPE,"no")7 OR EXCLUDE(DOCTYPE,"le")8 OR EXCLUDE (DOCTYPE , "ch")9 OR EXCLUDE (DOCTYPE , "cr")10 )



Online Appendix 3. List of included and excluded studies with the reasons2.1. List of Included Studies

1. Eden KB, Scariati P, Klein K, et al. Mammography decision aid reduces decisional conflict for women in their forties considering screening. J Women’s Heal. 2015;24(12):1013-1020. doi:10.1089/jwh.2015.5256.

2. Hersch J, Barratt A, Jansen J, et al. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: A randomised controlled trial. Lancet. 2015;385(9978):1642-1652. doi:10.1016/S0140-6736(15)60123-4.

3. Mathieu E, Barratt AL, McGeechan K, Davey HM, Howard K, Houssami N. Helping women make choices about mammography screening: An online randomized trial of a decision aid for 40-year-old women. Patient Educ Couns. 2010;81(1):63-72. doi:10.1016/j.pec.2010.01.001.

4. Mathieu E, Barratt A, Davey HM, McGeechan K, Howard K, Houssami N. Informed choice in mammography screening: A randomized trial of a decision aid for 70-year-old women. Arch Intern Med. 2007;167(19):20-39. doi:10.1001/archinte.167.19.2039.

5. Scariati P, Nelson L, Watson L, Bedrick S, Eden KB. Impact of a decision aid on reducing uncertainty: pilot study of women in their 40s and screening mammography. BMC Med Inform Decis Mak. 2015;15(1):1-10. doi:10.1186/s12911-015-0210-2.

6. Schonberg MA, Hamel MB, Davis RB, et al. Development and Evaluation of a Decision Aid on Mammography Screening for Women 75 Years and Older. JAMA Intern Med. 2014;174(3):417. doi:10.1001/jamainternmed.2013.13639.

2.2. List of Excluded Studies

Wrong or no outcome7. Lewis CL, Pignone MP, Sheridan SL, Downs SM, Kinsinger LS. A Randomized Trial of Three

Videos that Differ in the Framing of Information about Mammography in Women 40 to 49 Years Old. J Gen Intern Med. 2003;18(11):875-883. doi:10.1046/j.1525-1497.2003.21152.x.

8. Pasternack I, Saalasti-Koskinen U, Mäkelä M. Decision aid for women considering breast cancer screening. Int J Technol Assess Health Care. 2011;27(4):357-362. doi:10.1017/S026646231100050X.

Wrong or lack of intervention9. Lewis CL, Kistler CE, Amick HR, et al. Older adults’ attitudes about continuing cancer screening

later in life: a pilot study interviewing residents of two continuing care communities. BMC Geriatr. 2006;6(1):10. doi:10.1186/1471-2318-6-10.

10. Nojomi M, Namiranian N, Myers RE, Razavi-Ratki SK, Alborzi F. Factors associated with breast cancer screening decision stage among Womenin Tehran, Iran. Int J Prev Med. 2014;5(2):196-202.

Wrong publication type11. Hersch J, Jansen J, Barratt A, et al. Overdetection in breast cancer screening: development and

preliminary evaluation of a decision aid. BMJ Open. 2014;4(9):e006016. doi:10.1136/bmjopen-2014-006016.

Wrong study design12. Lin J-W, Chu P-L, Liou J-M, Hwang J-J. Applying a Multiple Screening Program Aided by a

Guideline-driven Computerized Decision Support System—A Pilot Experience in Yun-Lin, Taiwan. J Formos Med Assoc. 2007;106(1):58-68. doi:10.1016/S0929-6646(09)60217-5.

13. Mazurowski MA, Habas PA, Zurada JM, Tourassi GD. Decision optimization of case-based computer-aided decision systems using genetic algorithms with application to mammography. Phys Med Biol. 2008;53(4):895-908. doi:10.1088/0031-9155/53/4/005.

14. Povyakalo AA, Alberdi E, Strigini L, Ayton P. How to discriminate between computer-aided and computer-hindered decisions: A case study in mammography. Med Decis Mak. 2013;33(1):98-107. doi:10.1177/0272989X12465490.

15. Tisnado DM, Moore AA, Levin JR, Rosen S. Developing and Testing a Decision Aid for Use by Providers in Making Recommendations: About Mammography Screening in Older Women. J Appl Gerontol. 2015;34(3):343-358. doi:10.1177/0733464812467397.



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Online Appendix 4. Comparison of BCS-PtDAs

Paper

Intervention PtDA

Control

Patients’, caregivers’, or stakeholders’ engagement to the

creation of a PtDA

Format Following IPDAS

Risk screening

in the PtDA

Information included and

the source

Terms explained to

women

Values clarificatio

n

Personalization

Screening data

presentedLength Statement

Support of the statement from

the paper

Hersch et al., 20152

Access to BCS-PtDA

Booklet (text and diagrams)

Somewhat (IPDAS was used to create visual context)

No(only women with an average risk for breast cancer were included in the study)

- Screening outcomes- Reduction in breast cancer mortality from screening3

Abnormal,biopsy, ultrasound scans,breast cancer screening,breast cancer,chemotherapy, clinical examination, cells,false-positive,gene mutation,hormone therapy,over-detection,over-diagnosis,radiotherapy,screening mammogram,surgery

No Somewhat1. Data were specific for women participants2. Patient with reported symptoms was advised to see a physician)

Event per 1,000 women using 1,000-circle diagrams

11 pages (A4 paper format)

Control PtDA was identical to the intervention decision aid but omitted all content about over-detection

Yes* “We developed and revised the materials based on input fromlay-person collaborators and independent experts and after a thorough piloting process” pp.1643

Mathieu et al., 20104

Access to BCS-PtDA

Computerized internet-based (text and diagrams)

No(the PtDA was developed using framework5)

Yes - Screening outcomes for women 40 years old (harms and benefits of screening mammography)- Number of additional tests for women with positive

Breast cancer,family history

Yes Yes1. Data were specific for women participants2. Patient with reported symptoms was advised to see a physician)3. Women were provided an interactive web-

Event per 1,000 women using 1,000-circle diagrams

9 web pages Patients did not receive access to the PtDA and were offered to answer outcome questions. The access to a PtDA was provided

Yes* The PtDA “underwent extensive consumer pilot testing”pp. 66

http://www.mammogram.med.usyd.edu.au/



http://www.sciencedirect.com/science/MiamiMultiMediaURL/1-s2.0-S0140673615601234/1-s2.0-S0140673615601234-mmc1.pdf/271074/html/S0140673615601234/e061f446193555e0af37be12df1a4f8a/mmc1.pdf





results6

- Risk factors that can led to breast cnacer7

based survey that helped identify women’s risk factor, clarify own values, clarify screening plans.4. Women were provided a link to Breast Cancer Risk Assessment Tool8 to find own risk for breast cancer

after the questions were answered.

Mathieu et al., 20079

Access to BCS-PtDA

Paper booklet (text and diagrams)

No(the PtDA was developed using framework5)

No (developed according to the paper5)

- Screening outcomes (for women in their 70s)- Risk factors that can lead to breast cancer7,8,10,11

Mammogram Yes Yes1. Data were specific for women-participants2. Patient with reported symptoms was advised to see a physician)3. Women were provided a worksheet that helped identify women’s risk factors, clarify own values, clarify screening plans.4. Women were provided a link to Breast Cancer Risk Assessment Tool8 to find own risk for breast cancer.

Event per 1,000 women using “1,000-face” diagrams

23 pages (A4 paper format)

The booklet contained “small amount of information regarding screening at different ages” and did not have “numeric information about the outcomes of screening.”

Yes* “In pilot testing of the decision aid (with 29 women aged 70-71years) … Based on the feedback from women, however, we kept this information in the decision aid.”pp. 2041

“The worksheet contained a values clarification exercise andexamples of how other women had completed the values clarification exercise. These were based on women’s responses during development.”pp. 2042

Scariati et al., 201512

Computerized internet-

Somewhat(“the content

Yes - Screening outcomes (for

† Yes Somewhat1. Data were

† 35 minutes (approximatel

No control Unclear(however,

“potentially important factors

http://www.psych.usyd.edu.au/cemped/docs/Mammogram_DecisionAid.pdf





based (text and diagrams)

was guided by … (IPDAS) collaboration criteria”13 pp. 2)

women in their 70s)- Screening process- Risk factors that can lead to breast cancer

specific for women participants2. Women were offered two interactive exercises to identify own values, important factors for their decisions, and understand expectations and concerns.

y took to patients to get through the PtDA)

discussed with stakeholders)

for women’s consideration were consulted with subject matter experts” pp.2

“Healthcare professional and graduate students also provided feedback on content, comprehensibility, length and adherence to privacy and security standards.”pp. 3

Eden et al., 201514

Computerized internet-based (text, diagrams, and animations)

Yes‡ Yes(validated personal risk assessment instrument)

- Screening outcomes (for women in their 40)- Breast cancer development process- Risk factors that can lead to breast cancer

Average risk for breast cancer,benefits,BRCA1/2breast cancer,decision aid,gene marker,harm of screening,mammogram,ovarian cancer

Yes Yes1. Data were specific for women participants2. Patient with reported symptoms of breast cancer was advised to see a provider3. Women were provided an interactive exercise to identify own values, important factors for their decisions, and understand expectations.

Event per 70 women

30 minutes (maximum time spent to complete a survey and use the PtDA)

No control Yes(tree iteration of testing)

“We conducted interviews with users and clinical experts who evaluated it for face validity, patient comprehension, and ease of use. Based on feedback, we redesigned the decision aid as a mobile application for use”pp. 1014

Schonberg et al., 201415

Access to

Pamphlet Yes‡ Yes - Screening outcomes16–20

- Health/Lifeexpectancy21

No Yes Yes1. Data were specific for women

Event per 1,000 women using

11 pages(took 5–10 minutes to read)

No control Yes* “we assembled a 10-member expert panel (internists, geriatricians,

http://jamanetwork.com/data/Journals/INTEMED/929788/IOI130136supp1_prod.pdf



BCS-PtDA

- Screening process- Risk factors that can lead to breast cancer7,22,23

- Possible treatment24–27

participants2. Patient with reported symptoms was advised not to use a PtDA3. Women were provided an exercise to identify whether they will benefit from mammography based on their health history

1,000-circle diagram

health services researchers, and a psychologist) to review iterative versions.”

“we tested the comprehensibility of the DA among 5 older women who had recently decided whether to be screened”

“The DA was revised based on their feedback. We then tested the DA among 15 older women who were contemplating mammography.”pp. 418

All data retrieved only form the published papers, appendixes, protocols, or available PtDAs.

IPDAS – International Patient Decision Aid Standards

* The level of patients’, caregivers’, or stakeholders’ engagement, their role in a PtDA development process, and input that affected creation of a PtDA remain unclear.† Unknown because the PtDA is not publicly available.‡ The number of the IPDAS criteria that were satisfied remains unknown.





Online Appendix 5. Risk of bias assessment for before-after studiesQuality Assessment Tool for before-after (pre-post) studies with no control group: Scariati et al., 2015

Criteria Yes No Other(CD, NR, NA)*

1. Was the study question or objective clearly stated? Y2. Were eligibility/selection criteria for the study population prespecified and clearly described? Y3. Were the participants in the study representative of those who would be eligible for the test/service/intervention in the general or clinical population of interest?

N Not every women has social media, convenient sample

4. Were all eligible participants that met the prespecified entry criteria enrolled? Y5. Was the sample size sufficiently large to provide confidence in the findings? Y6. Was the test/service/intervention clearly described and delivered consistently across the study population?

Y

7. Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?

Y

8. Were the people assessing the outcomes blinded to the participants' exposures/interventions? NR Was not reported in the original paper

9. Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis?

Y

10. Did the statistical methods examine changes in outcome measures from before to after the intervention? Were statistical tests done that provided p values for the pre-to-post changes?

Y

11. Were outcome measures of interest taken multiple times before the intervention and multiple times after the intervention (i.e., did they use an interrupted time-series design)?

N

12. If the intervention was conducted at a group level (e.g., a whole hospital, a community, etc.) did the statistical analysis take into account the use of individual-level data to determine effects at the group level?

NA Only 51 women who use social media

Quality Rating (Good, Fair, or Poor) (see guidance)Rater #1 initials: EHRater #2 initials: IIAdditional Comments (If POOR, please state why): FAIR

*Y, yes; N, no; CD, cannot determine; NA, not applicable; NR, not reported

Quality Assessment Tool for before-after (pre-post) studies with no control group: Eden et al., 2015

Criteria Yes NoOther

(CD, NR, NA)*1. Was the study question or objective clearly stated? Y2. Were eligibility/selection criteria for the study population prespecified and clearly described? Y3. Were the participants in the study representative of those who would be eligible for the test/service/intervention in the general or clinical population of interest?

N Targeted rural women, not representative of US

4. Were all eligible participants that met the prespecified entry criteria enrolled? Y5. Was the sample size sufficiently large to provide confidence in the findings? Y6. Was the test/service/intervention clearly described and delivered consistently across the study population?

Y


Y

8. Were the people assessing the outcomes blinded to the participants' exposures/interventions? Y9. Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis?

Y


Y


N


NA

Quality Rating (Good, Fair, or Poor) (see guidance)Rater #1 initials: EHRater #2 initials: II



Additional Comments (If POOR, please state why): FAIR*Y, yes; N, no; CD, cannot determine; NA, not applicable; NR, not reported

Quality Assessment Tool for before-after (pre-post) studies with no control group: Schonberg et al., 2014Criteria Yes No Other

(CD, NR, NA)*1. Was the study question or objective clearly stated? Y2. Were eligibility/selection criteria for the study population prespecified and clearly described? Y3. Were the participants in the study representative of those who would be eligible for the test/service/intervention in the general or clinical population of interest?

Y

4. Were all eligible participants that met the prespecified entry criteria enrolled? Y5. Was the sample size sufficiently large to provide confidence in the findings? N6. Was the test/service/intervention clearly described and delivered consistently across the study population?

Y


Y

8. Were the people assessing the outcomes blinded to the participants' exposures/interventions? Y9. Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis?

Y


Y


N


NA Study involved women aged 75 and older

Quality Rating (Good, Fair, or Poor) (see guidance)Rater #1 initials: EHRater #2 initials: IIAdditional Comments (If POOR, please state why): FAIR*Y, yes; N, no; CD, cannot determine; NA, not applicable; NR, not reported



Online Appendix 6. Risk of bias assessment for Randomized Controlled Trials

eFigure 6. Risk of bias summary: review authors' judgements about each risk of bias item for each included RCTs

eFigure 7. Risk of bias graph: Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included RCTs

eTable 1. Assessment of methodological quality table for the study by Hersch et al., 2015

Bias Authors' Support for judgement



judgementRandom sequence generation (selection bias)

Low risk "A programmer who had no contact with participants generated the randomisation sequence using a computer system"

Allocation concealment (selection bias) Low risk computer program - "interviewers were unaware of the materials that women would receive (ensuring allocation concealment)"

Blinding of participants and personnel (performance bias)

Low risk "Women knew they would receive one of two versions of an information booklet but did not know how these differed or which one was theintervention"

Blinding of outcome assessment (detection bias)

Low risk "Researchers who analysed data were unaware of the random allocation."

Incomplete outcome data (attrition bias) Low risk 53% vs 50.7%Selective reporting (reporting bias) Low risk Article reports both non-significant and significant findings. "The published

protocol describes the design, which includes a qualitative substudy that we will present separately."

Other bias Low risk Seems free

eTable 2. Assessment of methodological quality table for the study by Mathieu et al., 2007

Bias Authors' judgement Support for judgement

Random sequence generation (selection bias)

Low risk "… which assigned allocations in accordance with a simple randomization schedule ..." using a computer program

Allocation concealment (selection bias) Low risk "... women were randomized to receive a decision aid or usual care (hereinafter, intervention and control groups, respectively) by interview staff who accessed a previously concealed computer program"

Blinding of participants and personnel (performance bias)

Unclear risk Unclear which group they would be assigned to but randomized


Low risk Interviewers were blinded to outcome measures

Incomplete outcome data (attrition bias) Low risk 4.4% (control) vs 4.5% (intervention)Selective reporting (reporting bias) Low risk Article reports both non-significant and significant findings. "The trial was registered

with the Australian Clinical Trials Registry and the Clinical Trials Registration System."

Other bias Low risk Seems free

eTable 3. Assessment of methodological quality table for the study by Mathieu et al., 2010

Bias Authors' judgement Support for judgement

Random sequence generation (selection bias)

Low risk "… randomization was conducted in a concealed manner by a computer generated simple randomization schedule ..."

Allocation concealment (selection bias) Unclear risk Allocation is not definedBlinding of participants and personnel (performance bias)

Unclear risk Blinding was not described


Low risk Analyzers unaware of random allocation

Incomplete outcome data (attrition bias) Low risk 4.5% in intervention group vs 4.7% in control groupSelective reporting (reporting bias) Unclear risk Article reports both non-significant and significant findings. However, the

protocol was not cited.Other bias Low risk Seems free



Online Appendix 7. Proportions of women aged 38–50 and 69–71, who would not wish

to be screened

Moderate quality of evidence (GRADE): We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

Our analysis suggests that with usual care, 105 women out of 1,000 aged 38–50 and 69–71 decided not to undergo screening mammography. Additional 50 (95% CI 4–118) women out of 1,000 the same age categories, may not plan to undergo screening mammography after using a BCS-PtDA.



Online Appendix 8. Proportions of women aged 38–50, who would not wish to be

screened

Moderate quality of evidence (GRADE): We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

The analysis of the intention of the women (38–50 years old) shows that in the usual care group, 111 women out of 1,000 decided not to be screened, compared to 196 (95% CI 149–260) out of 1,000 for the decision aid group. This suggests that an additional 85 women (38–50 years old) out of 1,000 may change their primary plans and would not want to be screened after using a BCS-PtDA.



Online Appendix 9. Proportions of women aged 69–71, who would not wish to be

screened

Very low quality of evidence (GRADE): We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.



Online Appendix 10. Additional analyses1. Proportion of women aged 38–50 and 69–89 who planned to undergo screening mammography

Two studies28,29 indicated that a lower proportion of women have planned to undergo screening mammography after using a BCS-PtDA. The other four studies30–33 found that BCS-PtDAs had no statistically significant effect. The analysis of randomized showed no difference in the proportion of women (aged 35–50 and 69–71) who have planned to undergo screening mammography (RR 0.98; 95% CI 0.81 to 1.18; P=0.80; eFigure 1, subgroup 1.4.1). RCTs had displayed significant considerable heterogeneity (I2=91%, P<0.001) that can be explained by the fact that Hersch et al., 201529 included in the study only women with an average risk for breast cancer. Before-after studies showed similar results as the RCTs. The level of moderate heterogeneity between before-after studies can be explained by the fact that one study28 had included women from a different age group (75–89 years). Heterogeneity between RCTs and before-after studies is insignificant (I2=0%, P=0.83).

eFigure 1: Forest plot of the proportion of women who were intended to undergo screening mammography (subgroups: RCTs and before-and-after studies)

2. Proportion of women aged 38–50 (RCTs) and 38–49 (before-after studies) who planned to begin screening mammography

The analysis (eFigure 2-subgroup 1.5.1) showed no statistically significant change in the proportion of women aged 38–50 facing a decision about starting screening mammography who planned to undergo screening mammography after using a BCS-PtDA (RR 0.93; 95% CI 0.73 to 1.18; P=0.53). Before-after studies either did not show any significant effect of BCS-PtDAs.



eFigure 2: Forest plot of the proportion of women who were intended to undergo screening mammography (subgroups: women age 38–50)

3. Proportion of women aged 69–71 (RCT) and 75–89 (before-after study) who planned to discontinue screening mammography

Exposure to a BCS-PtDA did not change significant the proportion of women aged 69–71 who have planned to undergo screening mammography (eFigure 3). The considerable level of heterogeneity (I2=88.4%, P=0.003) between studies can be explained by the different study design.

Test for subgroup differences: Chi² = 8.64, df = 1 (P=0.003), I² = 88.4%.

eFigure 3: Forest plot of the proportion of women who were intended to undergo screening mammography (subgroups: women age 69–71 and 75–89)

4. Proportion of women aged 38–50 and 69–89 who were undecided about their screening plans

Analysis of the overall effect of all RCTs indicated that, as compared to usual care interventions, BCS-PtDAs did not elicit a significant change in the proportion of women who were unsure about starting screening, nor in women who were unsure about continuing screening (RR 0.80; 95% CI 0.27–2.46; P=0.70; [I2=94%, P<0.001], eFigure 4). The level of heterogeneity can be explained by the difference in studies populations. The before-after studies support the lack of any effect.

eFigure 4: Forest plot of the proportion of women who were undecided about undergoing screening mammography (subgroups: RCTs and before-and-after studies)



5. Proportion of women aged 38–50 (RCTs) and 38–49 (before-after study) who were undecided about beginning screening mammography

eFigure 5: Forest plot of the proportion of women who were undecided about undergoing screening mammography (subgroups: women age 38–50)

6. Proportion of women aged 69–71 (RCT) and 75–89 (before-after study) who were undecided about discontinuing screening mammography

One RCT31 showed (eFigure 6) that BCS-PtDA can effect proportion of women who were undecided, and less number of women aged 61–79 will remain undecided after using a BCS-PtDA (RR 0.40; 95% CI 0.28–0.84; P=0.01). However, the before-after study28 had provided opposite significant result, and might suggest that less number of women will remain undecided with usual care (RR 2.60; 95% CI 1.01–6.69; P=0.05).


eFigure 6: Forest plot of the proportion of women who were undecided about undergoing screening mammography (subgroups: women age 69–71 and 75–89)

7. Proportion of women aged 38–50 (RCTs) and 69–89 (before-after studies) who have made a decision to, or not to participate in the screening mammography

Our analysis found no evidence that the use of BCS-PtDAs changed the proportion of women (aged 38–50 and 69–71) who decided about screening; overall RR from RCTs was 1.07 (95% CI 0.91 to 1.27; P=0.40; [I2=95%, P<0.001], eFigure 7, subgroup 1.10.1). The pooled RR from before-after studies was 0.98 (95% CI 0.85 to 1.12; P=0.74; eFigure 7, subgroup 1.10.2).



eFigure 7: Forest plot of the proportion of women who were decided about undergoing screening mammography (subgroups: RCTs and before-and-after studies)

8. Proportion of women aged 38–50 (RCTs) and 38–49 (before-after studies) who had made a decision to begin screening, or not to begin screening mammography

There was no evidence that BCS-PtDAs led to a change in the number of women (aged 38–50) who decided to start (RR 1.10; 95% CI 0.72 to 1.67; P=0.67, eFigure 8, subgroup 1.11.1). One RCT displayed a significant effect of the BCS-PtDA and suggested that more women (aged 69–71) will be decided after using a BCS-PtDA (RR 1.06; 95% CI 1.01 to 1.10; P=0.008, eFigure 9, subgroup 1.12.1).

eFigure 8: Forest plot of the proportion of women who were decided about undergoing screening mammography (subgroups: women age 38–50)

9. Proportion of women aged 69–71 (RCT) and 75–89 (before-after study) who had made a decision to discontinue, or not to discontinue screening mammography




eFigure 9: Forest plot of the proportion of women who were decided about undergoing screening mammography (subgroups: women age 69–71 and 75–89)



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