OVERDETECTION INFORMATION IN A BREAST CANCER SCREENING DECISION AID

Transcription

1 OVERDETECTION INFORMATION IN A BREAST CANCER SCREENING DECISION AID RANDOMISED CONTROLLED TRIAL Jolyn Hersch SYDNEY MEDICAL SCHOOL Screening and Test Evaluation Program (STEP) Sydney School of Public

2 ACKNOWLEDGEMENTS PhD supervisors: Primary Kirsten McCaffery; Associate Jesse Jansen, Les Irwig, Alexandra Barratt Project collaborators: Nehmat Houssami, Kevin McGeechan, Haryana Dhillon, Gemma Jacklyn, Hazel Thornton, Jenn Kidd, Kirsten Howard, Petra Macaskill Funding support - National Health and Medical Research Council (project grant; Screening and Test Evaluation Program grant) - Informed Medical Decisions Foundation (George Bennett grant) - Sydney Catalyst; Cancer Research Network (travel grants) 2

3 OVERDETECTION / OVERDIAGNOSIS Screening early diagnosis + treatment reduce breast cancer deaths Overdiagnosis / overdetection Image from guardian.co.uk - Finding disease that would not present clinically in woman s lifetime - Leads to overtreatment With screening, what is the overdiagnosed proportion of cancers? - Estimates range from 1% to 50% - 19% in screening period, invited women (independent UK panel 2012) - 30% in screening period, screened women (Jacklyn et al. 2016) 3

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5 HOW OVERDETECTION IS ASSESSED Research comparing groups (populations) with & without screening - e.g. randomised controlled trials (RCTs) 2 similar groups that differ on whether they were offered screening Follow these groups over many years More women in screened group diagnosed with breast cancer Some cancers found by screening would never cause symptoms - Else unscreened group would have just as many cancers diagnosed 5

6 OVERDETECTION / OVERDIAGNOSIS Screening early diagnosis + treatment reduce breast cancer deaths Overdiagnosis / overdetection Image from guardian.co.uk - Finding disease that would not present clinically in woman s lifetime - Leads to overtreatment With screening, what is the overdiagnosed proportion of cancers? - Estimates range from 1% to 50% - 19% in screening period, invited women (independent UK panel 2012) - 30% in screening period, screened women (Jacklyn et al. 2016) 6

7 INFORMED CHOICE Encourage women to have breast screening taking active role in decisions is too daunting info on harms might jeopardise screening uptake inappropriate to mention overdetection, as estimates vary Give balanced info: pros & cons let women decide informed decisions require balanced info reasonable individuals may differ in their choices withholding info on harms violates ethical principle of autonomy 7

8 THIS RESEARCH PROJECT Overdetection is a significant harm of breast screening Understanding risk of overdetection is critical to informed decisions But public awareness is minimal How should information on the nature and extent of overdetection be communicated? 8

9 QUALITATIVE RESEARCH Focus groups with 50 diverse women Explained and discussed risk of overdetection Explored women s understanding and sources of confusion 9

10 ...THE DECISION AID 10

11 BOOKLET DEVELOPMENT Screening literature & model of outcomes RESEARCH EVIDENCE Risk communication & decision aid literature Qualitative focus group study findings Outcomes of screening mammography to support informed choices (1) Breast cancer mortality benefit and (2) overdetection Estimates from INFORMATION meta-analysis of breast BOOKLET screening RCTs Adjusted for to women reflect screening approaching attendance screening rather than age invitation Applied to current local data (3) False positives current local data 11

12 BOOKLET DEVELOPMENT Screening literature & model of outcomes RESEARCH EVIDENCE Risk communication & decision aid literature Qualitative focus group study findings INFORMATION BOOKLET for women approaching screening age PILOTING & REFINEMENT Interviews with women to test & improve comprehension & acceptability 12

13 OFFERING CHOICE Invites reader to consider whether she wants to screen empowering democratic gives feeling of control Aims to persuade reader to screen incredibly encouraging of screening makes you feel anxious and guilty if you don t screen 13

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15 ILLUSTRATION OF CONCEPT 15

16 VISUALISING RISK IPDAS (Trevena et al.) 2013 Presenting quantitative info visual snapshot easy to process helps you understand big vs small good for non stats minded people 16

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18 OVERDETECTION IN CONTEXT 18

19 SUMMARY TABLE 19

20 PLAIN LANGUAGE message content text appearance visuals layout and design understandability 20

21 KEY ASPECTS OF DESIGN Information booklet for women considering breast screening + Screening as a choice + Conceptual illustrations + Evidence-based information + Diagrams for probabilities + Addressing key questions + Facilitating comparisons + Health literacy principles + Consumer pilot testing 21

22 THE DECISION AID 22

23 THE DECISION AID 23

24 RANDOMISED TRIAL: RATIONALE Breast screening can cause overdetection, leading to overdiagnosis and overtreatment of inconsequential cancers - Harm to emotional wellbeing, physical health in short / long term Women unaware of risk of overdetection - This prevents them being able to make informed decisions about participation in screening Evidence lacking re how info on overdetection affects women s breast screening decisions 24

25 RESEARCH QUESTIONS What are the consequences of providing written info about overdetection of breast cancer to women approaching the age of invitation to screening? - How does the info affect women s attitudes, decisions, wellbeing, psychosocial outcomes, and screening participation? - Can overdetection info (in a decision aid) improve informed choice about breast screening in a community sample? 25

26 Women aged years RECRUITMENT DESIGN & PARTICIPANT FLOW Send BreastScreen NSW leaflet Mail-out #1 Telephone survey: Baseline measures (n = 942) BASELINE R Quantitative stream (n = 879) Qualitative stream (n = 63) R Send decision aid (DA) booklet Intervention DA (n = 440): benefit + overdetection + false positives Control DA (n = 439): benefit + false positives only Mail-out #2 Telephone survey (n = 838) Primary outcome = informed choice Secondary outcomes 3 weeks Telephone surveys (n = 790; n = 746) Secondary outcomes 6 & 12 months 26

27 OUTCOMES INFORMED CHOICE Primary outcome = informed choice Benefit Adequate knowledge (concept/number) of 3 screening outcomes AND either positive attitude + intending to screen Overdetection or negative attitude + not intending to screen False positives 27

28 INFORMED CHOICE FRAMEWORK Adequate knowledge Positive attitude Intending to screen Informed choice adequate knowledge and consistent attitudes + intentions Accept screening Decline screening Partly uninformed choice Accept Decline Accept Decline Completely uninformed choice Accept Decline 28

29 OUTCOMES Primary outcome = informed choice Secondary outcomes (some still in progress) - Decision process: decisional conflict & confidence - Psychosocial outcomes: anticipated regret, risk perceptions, anxiety, breast cancer worry, quality of life, decision regret - Screening attendance over 2 years 29

30 SAMPLE CHARACTERISTICS Characteristic Intervention Control Age (mean) 49.7 years 49.7 years Country of birth - Australia - UK - India - New Zealand - Other Highest educational qualification completed - Primary or secondary school - Trade certificate - Diploma or advanced diploma - Degree or graduate diploma/certificate 79% 05% 02% 02% 12% 25% 30% 16% 28% 81% 06% 02% 01% 11% 30% 25% 16% 29% 30

31 DECISION AID UTILISATION Outcome Intervention Control Did you read booklet all the way through? - Yes How long did you spend reading the booklet? - Mean: 97% 98% 16 minutes 13 minutes How much of info in booklet was new to you? - All - Most - Some - None 04% 26% 67% 04% 04% 16% 68% 12% 31

32 KNOWLEDGE Outcome Intervention Control Difference (IG CG) P value Adequate knowledge ALL 3 OUTCOMES Adequate knowledge BENEFIT Adequate knowledge FALSE POSITIVES Adequate knowledge OVERDETECTION 29% 17% 12% <.01 65% 61% 04% =.25 58% 66% --8% =.02 55% 27% 28% <.01 32

33 ATTITUDES & INTENTIONS Outcome Intervention Control Difference (IG CG) P value Adequate knowledge Positive attitudes towards screening Intending to have breast screening 29% 17% -12% <.01 69% 83% -14% <.01 74% 87% -13% <.01 33

34 INFORMED CHOICE Outcome Intervention Control Difference (IG CG) P value Adequate knowledge Positive attitudes towards screening Intending to have breast screening Made an informed choice 29% 17% -12% <.01 69% 83% -14% <.01 74% 87% -13% <.01 24% 15% 09% <.01 34

35 SENSITIVITY ANALYSIS Outcome Intervention Control Difference (IG CG) P value Adequate concept. knowledge Positive attitudes towards screening Intending to undergo screening MADE INFORMED CHOICE 59% 21% -38% <.01 69% 83% -14% <.01 74% 87% -13% <.01 50% 19% 030% <.01 35

36 DECISIONAL CONFLICT Outcome Intervention Control P value Decisional conflict (DCS 0-100) % 29% 22% 50% 30% 20% 36

37 CONFIDENCE IN DECISION MAKING Outcome Intervention Control P value Decisional conflict (DCS 0-100) % 29% 22% 50% 30% 20% Confidence in decision making (scale 1-5) <.01 37

38 ANXIETY Outcome Intervention Control P value Anxiety (STAI-short 20-80)

39 PERCEIVED RISK Outcome Intervention Control P value Anxiety (STAI-short 20-80) Perceived risk (absolute) No chance Low chance Medium / high chance 05% 60% 35% 05% 54% 41%.2 Perceived risk (relative) Much / a bit lower About the same A bit / much higher 37% 55% 08% 33% 58% 09%.8 39

40 WORRY ABOUT BREAST CANCER Outcome Intervention Control P value Breast cancer worry Not worried at all A bit worried Quite worried Very worried 42% 51% 06% 02% 32% 55% 09% 04% <.01 40

41 ANTICIPATED REGRET Outcome Intervention Control P value Breast cancer worry Not worried at all A bit worried Quite worried Very worried 42% 51% 06% 02% 32% 55% 09% 04% <.01 May regret if do not screen (Strongly) agree (Strongly) disagree / neither 74% 26% 84% 16% <.01 May regret if do screen (Strongly) agree / neither (Strongly) disagree 26% 74% 13% 87% <.01 41

42 DECISION AID ACCEPTABILITY Outcome Intervention Control P value DA clear & easy to understand Strongly agree Agree (Strongly) disagree / neither 35% 51% 14% 52% 42% 06% <.01 Would recommend DA Strongly agree Agree (Strongly) disagree / neither 34% 49% 17% 50% 39% 11% <.01 How balanced did you find DA Slanted towards screening Completely balanced Slanted away from screening 21% 43% 36% 31% 52% 17% <.01 42

43 SUMMARY OF PRIMARY FINDINGS Compared with the control decision aid, the intervention led to improved knowledge about breast screening less positive attitudes towards having breast screening reduced intentions to have breast screening in next 2-3 years more women making an informed choice 43

44 SECONDARY FINDINGS Including information on overdetection in a decision aid - Reduced breast cancer worry - Did not raise anxiety or decisional conflict - Slightly reduced confidence in decision making - Made decision aid slightly less clear and easy to understand - Affected perceptions of balance of decision aid This information challenged women s expectations - Need to ensure women are supported in making their decisions 44

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46 KNOWLEDGE & ATTITUDES, 12m Outcome Intervention Control P value Adequate conceptual knowledge Positive attitudes towards screening 40% 20% <.01 77% 85% <.01 46

47 ANXIETY & PERCEIVED RISK, 6m Outcome Intervention Control P value Anxiety (STAI-short 20-80) Perceived risk (absolute) No chance Low chance Medium / high chance 04% 64% 32% 04% 57% 39%.1 Perceived risk (relative) Much / a bit lower About the same A bit / much higher 32% 61% 07% 29% 62% 10%.4 47

48 ANXIETY & PERCEIVED RISK, 12m Outcome Intervention Control P value Anxiety (STAI-short 20-80) Perceived risk (absolute) No chance Low chance Medium / high chance 03% 63% 35% 04% 59% 38%.5 Perceived risk (relative) Much / a bit lower About the same A bit / much higher 38% 53% 10% 31% 60% 09%.1 48

49 BREAST CANCER WORRY, 6 & 12m Outcome Intervention Control P value 6m Breast cancer worry Not worried at all A bit worried Quite worried Very worried 45% 51% 04% 01% 38% 55% 06% 02%.05 12m Breast cancer worry Not worried at all A bit worried Quite worried Very worried 47% 49% 04% 01% 39% 55% 05% 02%.07 49

50 MAMMOGRAPHY, 6m 35% 30% 25% 20% 15% 6 months 10% 5% 0% Intervention Control 50

51 MAMMOGRAPHY, 12m 35% 30% 25% 20% 15% 12 months 6 months 10% 5% 0% Intervention Control 51

52 DISCUSSION Efficacy trial may not reflect intervention effect in real world Overdetection info can be communicated in written format - Builds on qualitative findings: women understood & valued info Informed women may make different decisions about screening that better align with their personal values Important ethical responsibility to inform women Info provision is powerful must use evidence-based methods 52

53 NEXT STEPS Final 2 year follow-up telephone interviews are ongoing - Range of outcomes as per previous follow-up rounds - Intentions to screen over next 2-3 years - Mammography data from self-report AND objective records - BreastScreen NSW - Medicare Benefits Scheme Qualitative interview data analysis Further analyses on quantitative data 53

54 ACKNOWLEDGEMENTS PhD supervisors: Primary Kirsten McCaffery; Associate Jesse Jansen, Les Irwig, Alexandra Barratt Project collaborators: Nehmat Houssami, Kevin McGeechan, Haryana Dhillon, Gemma Jacklyn, Hazel Thornton, Jenn Kidd, Kirsten Howard, Petra Macaskill Funding support - National Health and Medical Research Council (project grant; Screening and Test Evaluation Program grant) - Informed Medical Decisions Foundation (George Bennett grant) - Sydney Catalyst; Cancer Research Network (travel grants) 54

55 REFERENCES Hersch J, Jansen J, Irwig L, Barratt A, Thornton H, Howard K, McCaffery K. How do we achieve informed choice for women considering breast screening? Preventive Medicine 2011; 53: Hersch J, Jansen J, Barratt A, Irwig L, Houssami N, Howard K, Dhillon H, McCaffery K. Women's views on overdiagnosis in breast cancer screening: a qualitative study. BMJ 2013; 346: f158. Hersch J, Barratt A, Jansen J, Houssami N, Irwig L, Jacklyn G, Dhillon H, Thornton H, McGeechan K, Howard K, McCaffery K. The effect of information about overdetection of breast cancer on women's decision-making about mammography screening: study protocol for a randomised controlled trial. BMJ Open 2014; 4: e Hersch J, Jansen J, Barratt A, Irwig L, Houssami N, Jacklyn G, Thornton H, Dhillon H, McCaffery K. Overdetection in breast cancer screening: development and preliminary evaluation of a decision aid. BMJ Open 2014; 4: e Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial. Lancet 2015; 385: Hersch J, Jansen J, McCaffery K. Informed and shared decision making in breast screening. In: Houssami N, Miglioretti D, editors. Breast Cancer Screening: An Examination of Scientific Evidence. London: Elsevier; jolyn.hersch@sydney.edu.au 55