Recommendations from European Breast Guidelines

Should a decision aid that explains the benefits and harms of screening vs. "regular" invitation letter be used for informing women about the benefits and harms of breast cancer screening?

Recommendation

The ECIBC's Guidelines Development Group (GDG) suggests using a decision aid that explains the benefits and harms of screening over a "regular" invitation letter for informing women about the benefits and harms of breast cancer screening (conditional recommendation, moderate certainty in the evidence).

Recommendation strength

  •   Strong recommendation against the intervention
  •   Conditional recommendation against the intervention
  •   Conditional recommendation for either the intervention or the comparison
  • Conditional recommendation for the intervention
  •   Strong recommendation for the intervention

A recommendation can be strong or conditional.

When a recommendation is strong, most women will want to follow it. When a recommendation is conditional, the majority of women want to follow it but may need more discussion with their healthcare professional first.

Subgroup

The GDG considered the importance of aligning decision aids with the cultural contexts and literacy levels of the populations to whom they are distributed.

Justification

Overall justification

The GDG reviewed the evidence for decision aids and conditionally recommends their use.

As agreement within the GDG for the strength of this recommendation could not be reached, voting among the members without CoI resulted in the following: 9 members voted in favour of a 'strong recommendation' and 11 members voted in favour of a 'conditional recommendation'.

Detailed justification

Desirable Effects:
The GDG felt that, based on the evidence reviewed, there are moderate desirable anticipated effects due to increases in informed choice, confidence in making decisions and participants reporting adequate knowledge about screening.

Resources required:
The GDG members did not find research assessing the resources required. However, they felt that this would depend on the nature of the decision aids used. If delivered face–to-face, there would be large costs, though if they are delivered online, or alongside existing notification letters, there may be substantial cost savings with increased understanding. The GDG members were, however, uncertain about the resources required if additional questions arose from the delivery of a decision aid and how these would be managed.

Considerations

Implementation

1. The GDG does not support any specific decision aid that was included in the reviewed evidence. However, decision aids should be evidence-based and appropriate to the context of their use.
2. The GDG considered that the recommendation for use of decision aids applies to all age groups.
3. Decision aids should be tailored to the cultural-context and level of literacy of the population(s) for whom they are to be used.
4. The GDG wished to support the use of pictograms and graphical representations, where possible, in the form of decision aids, including a focus on graphics designed to explain the changes in both relative risk and absolute risk, for breast cancer screening.

Monitoring and Evaluation

The GDG felt that the quality of decision aids needs to be high. The GDG also feels that it is important to monitor and evaluate their implementation, as well as continue to study their use in research contexts.

Research Priorities

1. Further research should develop best practices for decision aids used in Europe to educate women on breast cancer screening.
2. Further research should evaluate the best ways of describing information in decision aids, including a comparison of the use of graphics versus text explanations for various populations.
3. Additional research should assess the perspectives, understanding, confidence and participation rates of women receiving these decision aids.
4. In particular, the GDG considered qualitative research would be useful for this.
5. The GDG has indicated a desire to include observational studies in the evidence review that will inform the next update of these guidelines.

Evidence

Download the evidence profile

Assessment

Background

There is debate about the balance of benefits and harms of mammography screening. This includes uncertainty about the relative magnitude of benefits and harms. Until recently the debate has mainly been confined to professionals and the public has remained largely unaware of the scale and balance of harms and benefits of screening (Hersch J, 2015).
On the one hand, mammography screening may reduce a woman’s risk of dying from breast cancer. On the other hand, there are several harms associated with the procedure (Barratt A, 2005). The most important harm is over-detection or overdiagnosis (Marmot MG, 2012). An overdiagnosed cancer is a cancer diagnosed by screening which is so slow-growing that it would never have been diagnosed in a person’s lifetime if the person had not been screened. Overdiagnosis leads to overtreatment (i.e. unnecessary treatment) (Hersch J, 2015). There are additional potential harms including radiation or anxiety caused by participation, being recalled for further assessment, and/or from receiving a false positive result. In view of this, it has been suggested that screening programmes should change from persuasive approaches to approaches based on providing information and women’s decision empowerment (Woloshin S, 2012).
Decision aids are defined by the International Patient Decision Aids Standards (IPDAS) Collaboration as evidence-based tools designed to help patients participate in making specific and deliberated choices among different healthcare options (Elwyn G, 2006). Overall, decision aids have been shown to increase patient's knowledge about their options, decrease decisional conflict and anxiety and have variable effect on uptake of the test or treatment in question (Stacey D, 2014)(Pace LE, 2014). Although several decisions aids have been designed for breast cancer screening only a few of them have been assessed and the levels of informed choice in this setting have remained low.

Management of Conflicts of Interest (CoI): CoIs for all Guidelines Development Group (GDG) members were assessed and managed by the Joint Research Centre (JRC) following an established procedure in line with European Commission rules. GDG member participation in the development of the recommendations was restricted, according to CoI disclosure. Consequently, for this particular question, the following GDG members were recused from voting: Edoardo Colzani, Roberto d'Amico, and Miranda Langendam.
For more information please visit http://ecibc.jrc.ec.europa.eu/gdg-documents

Is the problem a priority?
Yes *
* Possible answers: ( No , Probably no , Probably yes , Yes , Varies , Don't know )
Research Evidence
In addition to reducing breast cancer mortality, by early detection and treatment, mammographic screening detects cancers, proven to be cancers by pathological testing, that would not have come to clinical attention in the woman’s life were it not for screening (Marmot MG, 2012) i.e. overdiagnosis.
The significance of the benefits and harms of mammography also depends on women’s values and preferences. It is for this reason that decision-making on breast cancer screening attendance should involve an individual deliberation about each benefit and harm for and by that particular woman (van Agt H, 2014). The independent UK Panel on Breast cancer screening wrote that “information should be made available in a transparent and objective way to women invited to screening so that they can make informed decisions”(Marmot MG, 2012).
Although several decision aids have been designed for breast cancer screening only a few of them have been assessed and the levels of informed choice in this setting remain low.. These have provided limited evidence that suggests that decision aids can improve and standardise informed decision-making in breast cancer screening (Pace LE, 2014).
Additional Considerations

The GDG prioritised this question for the ECIBC.

How substantial are the desirable anticipated effects?
Moderate *
* Possible answers: ( Trivial , Small , Moderate , Large , Varies , Don't know )
Research Evidence
The included studies did not assess the outcome of better/increased accessibility to information:
Outcomes№ of participants
(studies)
Follow up
Certainty of the evidence
(GRADE)
Relative effect
(95% CI)
Anticipated absolute effects* (95% CI)
Risk with "regular" invitation letterRisk difference with a decision aid that explains the benefits and harms of screening
Informed choice
assessed with: Multi- Dimensional measure of informed choice
789
(2 RCTs)
1,2

MODERATE
a,b
RR 1.31
(0.98 to 1.75)
c
Study population
530 per 1,000164 more per 1,000
(11 fewer to 397 more)
Confidence in making decision
assessed with: decisional conflict scale
Scale from: 0 (no decisional conflict) to 100 (extreme decisional conflict).
41.95
(1 RCT)
1

MODERATE
d,e,f
-The mean confidence in making decision was 0MD 1.83 lower
(4.14 lower to 0.48 higher)
Participation rate
follow up: range 1 to 12 months
16880
(3 RCTs)
1,2,3

HIGH
g
RR 0.97
(0.94 to 1.00)
Study population
437 per 1,00013 fewer per 1,000
(26 fewer to 0 fewer)
Adequate knowledge (assessed with: women who had a score of at least 50% of available marks)1010
(2 RCTs)
1,2

HIGH
h
RR 1.23
(1.00 to 1.51)
Study population
659 per 1,000152 more per 1,000
(0 fewer to 336 more)
Satisfaction with the decision-making process (inferred from how helpful the decision aid was)i117
(1 observational study)
2

VERY LOW
j,k
not estimableStudy population
0 per 1,0000 fewer per 1,000
(0 fewer to 0 fewer)
Better/increased accessibility to information: - not measured-----
  1. 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-yearold women. Archives of Internal Medicine; 2007.
  2. 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 Education and Counseling; 2010.
  3. Bourmaud A, Soler-Michel P,Oriol M,Regnier V,Tinquaut F,Nourissat A,Bremond A,Moumjid N,Chauvin F. Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group. Oncotarget; 2016.
  1. Unimportant high statistical heterogeneity (I² = 84%, P = 0.01).
  2. 95% CI does not exclude benefit or harm in favour of any of the interventions.
  3. In a RCT that compared a decision aid including overdetection information as an outcome, compared with a decision aid without overdetection information, showed an increase of the number of women making an informed choice (RR=1.31, 95%CI 0.98 to 1.75) (Hersch 2015).
  4. The evidence for this outcome comes from a single study.
  5. No trials assessing this outcome directly were found. One trial reported decisional conflict scale.
  6. The CI does not cross the decision threshold.
  7. Intention to be screened was evaluated in two studies instead of real participation rate, which was evaluated in one of the included studies. However, we decided not to rate down in this domain because of the observed consistency between two different ways to measure.
  8. Unimportant high statistical heterogeneity (I² = 89%, P = 0.01).
  9. The importance of the outcome was lowered from 'critical' to 'important' because the GDG members felt this outcome influenced neither the direction nor the strength of the recommendation.
  10. Only one study provided information about this outcome.
  11. Satisfaction was inferred from how helpful the decision aid was.

Additional Considerations

No important inconsistencies were seen across studies.

The importance of the outcome, satisfaction with the decision-making, was reduced from 'critical' to 'important' because the GDG members felt this outcome influenced neither the direction nor the strength of the recommendation.

How substantial are the undesirable anticipated effects?
Trivial *
* Possible answers: ( Large , Moderate , Small , Trivial , Varies , Don't know )
Research Evidence
The included studies did not assess the outcome of better/increased accessibility to information:
Outcomes№ of participants
(studies)
Follow up
Certainty of the evidence
(GRADE)
Relative effect
(95% CI)
Anticipated absolute effects* (95% CI)
Risk with "regular" invitation letterRisk difference with a decision aid that explains the benefits and harms of screening
Informed choice
assessed with: Multi- Dimensional measure of informed choice
789
(2 RCTs)
1,2

MODERATE
a,b
RR 1.31
(0.98 to 1.75)
c
Study population
530 per 1,000164 more per 1,000
(11 fewer to 397 more)
Confidence in making decision
assessed with: decisional conflict scale
Scale from: 0 (no decisional conflict) to 100 (extreme decisional conflict).
41.95
(1 RCT)
1

MODERATE
d,e,f
-The mean confidence in making decision was 0MD 1.83 lower
(4.14 lower to 0.48 higher)
Participation rate
follow up: range 1 to 12 months
16880
(3 RCTs)
1,2,3

HIGH
g
RR 0.97
(0.94 to 1.00)
Study population
437 per 1,00013 fewer per 1,000
(26 fewer to 0 fewer)
Adequate knowledge (assessed with: women who had a score of at least 50% of available marks)1010
(2 RCTs)
1,2

HIGH
h
RR 1.23
(1.00 to 1.51)
Study population
659 per 1,000152 more per 1,000
(0 fewer to 336 more)
Satisfaction with the decision-making process (inferred from how helpful the decision aid was)i117
(1 observational study)
2

VERY LOW
j,k
not estimableStudy population
0 per 1,0000 fewer per 1,000
(0 fewer to 0 fewer)
Better/increased accessibility to information: - not measured-----
  1. 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-yearold women. Archives of Internal Medicine; 2007.
  2. 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 Education and Counseling; 2010.
  3. Bourmaud A, Soler-Michel P,Oriol M,Regnier V,Tinquaut F,Nourissat A,Bremond A,Moumjid N,Chauvin F. Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group. Oncotarget; 2016.
  1. Unimportant high statistical heterogeneity (I² = 84%, P = 0.01).
  2. 95% CI does not exclude benefit or harm in favour of any of the interventions.
  3. In a RCT that compared a decision aid including overdetection information as an outcome, compared with a decision aid without overdetection information, showed an increase of the number of women making an informed choice (RR=1.31, 95%CI 0.98 to 1.75) (Hersch 2015).
  4. The evidence for this outcome comes from a single study.
  5. No trials assessing this outcome directly were found. One trial reported decisional conflict scale.
  6. The CI does not cross the decision threshold.
  7. Intention to be screened was evaluated in two studies instead of real participation rate, which was evaluated in one of the included studies. However, we decided not to rate down in this domain because of the observed consistency between two different ways to measure.
  8. Unimportant high statistical heterogeneity (I² = 89%, P = 0.01).
  9. The importance of the outcome was lowered from 'critical' to 'important' because the GDG members felt this outcome influenced neither the direction nor the strength of the recommendation.
  10. Only one study provided information about this outcome.
  11. Satisfaction was inferred from how helpful the decision aid was.

What is the overall certainty of the evidence of effects?
Moderate *
* Possible answers: ( Very low , Low , Moderate , High , No included studies )
Is there important uncertainty about or variability in how much people value the main outcomes?
Possibly important uncertainty or variability *
* Possible answers: ( Important uncertainty or variability , Possibly important uncertainty or variability , Probably no important uncertainty or variability , No important uncertainty or variability , No known undesirable outcomes )
Research Evidence
Chewning 2012 performed a systematic literature review on patient preferences for shared decision in different contexts. The authors stratified studies into those that included patients who wished to delegate, and patients who wished to participate in the decision, autonomously or with the help of the physician. They reported that the majority of the respondents belong to the last group (63%, 75 studies), 21% preferred to delegate decisions (25 studies). In the remaining 16%, results were mixed. In studies focusing on cancer (27 studies published after 2000), 85% of patients preferred also to participate in the decision.
Additional Considerations

One systematic review assessing the effects of decision aids for people facing treatment or screening decisions included 115 studies. None of these studies measured preference-linked health outcomes (Stacey D, 2014).
Perspectives from the GDG patient members were shared and they disagree with the discussion about the existence of variability in how much people value the main outcomes – they felt there was probably no uncertainty in the results.
As agreement within the GDG could not be reached, voting among the members without CoI resulted in the following: 1 member voted "important uncertainty"; 13 members voted "possibly important uncertainty" and 6 members voted "probably no important uncertainty"

Does the balance between desirable and undesirable effects favor the intervention or the comparison?
Favors the intervention *
* Possible answers: ( Favors the comparison , Probably favors the comparison , Does not favor either the intervention or the comparison , Probably favors the intervention , Favors the intervention , Varies , Don't know )
Additional Considerations

As agreement within the GDG could not be reached, voting among the members without CoI resulted in the following: 10 + 1 members voted it "favours the intervention" and 10 members voted "probably favours the intervention".
***Holger Schünemann voted as chair for “favours the intervention” to break the voting tie.

How large are the resource requirements (costs)?
Moderate costs *
* Possible answers: ( Large costs , Moderate costs , Negligible costs and savings , Moderate savings , Large savings , Varies , Don't know )
Research Evidence
We did not identify any economic evaluations assessing this question.
Additional Considerations

The GDG discussed that there would be moderate costs associated with decision aids (DAs).

Cost increases due to development and distribution of decision aids, particularly if this involves a face-to-face intervention. For face to face interventions the GDG felt that there would be large costs.

The GDG discussed their concern about large costs of sending DAs with an invitation letter. This is related to the weight of mail. Especially true if reminder letters are sent. The cost of online material may be negligible (only prepared once and minimal cost for distribution) and may lead to cost savings.

Cost savings may also occur from increased screening participation and early breast cancer detection. However, the GDG took into account that there are unknown cost implications for women who have questions as a result of a decision aid, as this depends how these questions will be managed.
As agreement within the GDG could not be reached, voting among the members without CoI resulted in the following: 14 members voted there would be "moderate costs" and 6 members voted there would be "negligible costs and savings".

What is the certainty of the evidence of resource requirements (costs)?
No included studies *
* Possible answers: ( Very low , Low , Moderate , High , No included studies )
Research Evidence
We did not identify any economic evaluation assessing this question.
Does the cost-effectiveness of the intervention favor the intervention or the comparison?
No included studies *
* Possible answers: ( Favors the comparison , Probably favors the comparison , Does not favor either the intervention or the comparison , Probably favors the intervention , Favors the intervention , Varies , No included studies )
Research Evidence
We did not identify any economic evaluation assessing this question.
What would be the impact on health equity?
Probably increased *
* Possible answers: ( Reduced , Probably reduced , Probably no impact , Probably increased , Increased , Varies , Don't know )
Research Evidence
No systematic review was conducted.
Additional Considerations

Validated decision aids have been designed to support women of majority groups. There is concern about their applicability in disadvantaged populations, such as those with a lower socioeconomic status, lower educational level or different cultural heritage. Appropriately developed decision aids may have a positive impact on equity.
The evidence found that results are consistent across income and education levels.

The GDG members felt that if the tools were appropriately developed (for different literacy levels) they could increase health equity.

Is the intervention acceptable to key stakeholders?
Yes *
* Possible answers: ( No , Probably no , Probably yes , Yes , Varies , Don't know )
Research Evidence
Two studies provided information about the acceptability of decision aids to women.
- Mathieu 2010 reported that most women found decision aid clear (95%), informative (88%), helpful (88%) and would recommend it (89%). Besides 88% found decision aid either completely balanced or slightly towards or slightly against screening.
- Hersch 2015 found that both decision aids (with or without over-detection information) were rated clear and easy to understand (86% and 94%), and most women found the materials helpful (83% and 82%), and worth recommending to others (83% and 89%).
Additional Considerations

As agreement within the GDG could not be reached, voting among the members without CoI resulted in the following:
14 members voted "Yes" and 6 members voted "probably yes".

Is the intervention feasible to implement?
Yes *
* Possible answers: ( No , Probably no , Probably yes , Yes , Varies , Don't know )
Research Evidence
No systematic review was conducted.
Additional Considerations

No significant concerns for feasibility were identified.
As agreement within the GDG could not be reached, voting among the members without CoI resulted in the following:
15 members voted "Yes" and 5 members voted "probably yes".


References summary

  • Elwyn G, O’Connor A Stacey D Volk R Edwards A Coulter A et al, [Developing a quality criteria framework for patient decision aids: online international Delphi consensus process] BMJ; 2006
  • Pace LE, Keating NL, [A systematic assessment of benefits and risks to guide breast cancer screening decisions] JAMA; 2014
  • Marmot MG, Altman DG Cameron DA Dewar JA Thompson SG Wilcox M & Independent UK Panel on Breast Cancer Screening, [The benefits and harms of breast cancer screening: an independent review] Lancet; 2012
  • Barratt A, Howard K Irwig L Salkeld G Houssami N, [Model of outcomes of screening mammography: information to support informed choices] BMJ; 2005
  • Stacey D, Bennett CL Barry MJ Col NF Eden KB Holmes-Rovner M et al, [Decision aids for people facing health treatment or screening decisions] Cochrane Database Syst Rev; 2014
  • Woloshin S, Schwartz LM Black WC Kramer BS, [Cancer screening campaigns: getting past uninformative persuasion] N Engl J Med; 2012
  • Hersch J, Barratt A Jansen J Irwig L McGeechan K Jacklyn G 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
  • van Agt H, Korfage I Essink-Bot M, [Interventions to enhance informed choices among invitees of screening programmes—a systematic review] The European Journal of Public Health; 2014

Bibliography

Background
  • Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G 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; 385:1642-52.
  • Barratt A, Howard K, Irwig L, Salkeld G, Houssami N. Model of outcomes of screening mammography: information to support informed choices. BMJ 2005; 330: 936.
  • Marmot, MG, Altman, DG, Cameron, DA, Dewar, JA, Thompson, SG, Wilcox, M & Independent UK Panel Breast Canc S 2012, 'The benefits and harms of breast cancer screening: an independent review' Lancet 2012; 380 (9855): 1778-86.
  • Woloshin S, Schwartz LM, Black WC, Kramer BS. Cancer screening campaigns: getting past uninformative persuasion. N Engl J Med 2012; 367: 1677–79.
  • Elwyn G, O’Connor A, Stacey D, Volk R, Edwards A, Coulter A, et al. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ 2006; 333 (7565): 417.
  • Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014; 1: CD001431.
  • Pace LE, Keating NL. A systematic assessment of benefits and risks to guide breast cancer screening decisions. JAMA 2014; 311: 1327–35.
Evidence of effects
  • Bourmaud A, Soler-Michel P, Oriol M, Regnier V, Tinquaut F, Nourissat A et al. Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group. Oncotarget, 2016; (11): 12885-92.
  • Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G 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 Apr 25; 385: 1642-52.
  • 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-yearold women. Archives of Internal Medicine 2007; 167 (19): 2039–46.
  • 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 Education and Counseling 2010; 81 (1): 63–72.
  • Rimer BK, Halabi S, Sugg Skinner C, Lipkus IM, Strigo TS, Kaplan EB, et al. Effects of a mammography decisionmaking intervention at 12 and 24 months. American Journal of Preventive Medicine 2002; 22 (4): 247–57.
Values and preferences
  • No references included
Economic evidence
  • No references included
Acceptability
  • No references included