European Commission Initiative on Breast Cancer (ECIBC): … · 2019. 11. 25. · organisational barriers that influence the participation in breast cancer screening programmes and

EUROPEAN COMMISSION JOINT RESEARCH CENTRE Directorate F - Health, Consumers & Reference Materials (Ispra) Health in Society

European Commission, Via Enrico Fermi 2749, I-21027 Ispra (Varese) - Italy. Telephone: (39)0332-78-9111. E-mail: [email protected]

European Commission Initiative on Breast Cancer (ECIBC):

European guidelines on breast cancer screening and diagnosis

mailto:[email protected]

25/11/2019 © European Commission I http://healthcare-quality.jrc.ec.europa.eu Page 2/13

QUESTION

Should a tailored communication strategy vs. a general communication strategy be used for socially disadvantaged women?

POPULATION: socially disadvantaged women between the ages of 50 and 69

INTERVENTION: a tailored communication strategy

COMPARISON: a general communication strategy

MAIN OUTCOMES: Participation rate; number of people making informed choices; better/increased accessibility to information; confidence in making decisions; increased awareness of information; satisfaction with the decision-making process;

SETTING: European Union

PERSPECTIVE: Population (National Health System)

BACKGROUND: Breast cancer is the most common cancer among women worldwide, with an estimated 1.7 million new cases occurring in 2012(1) and the second leading cause of cancer death among women in high-income countries. The importance of early detection and treatment of breast cancer is well recognised (2)(3) and is supported by the observed decrease in breast cancer deaths among women in high-resource regions undergoing screening mammography (4, 5).

For breast cancer screening programmes to bring about reductions in breast cancer mortality at the population level, a substantial proportion of the population must participate. In order to see the impact of breast cancer screening at the population level, >70% of the population invited should participate (6, 7). In addition, those populations that are classically far from the health system should be specifically targeted. Programmes with low uptake can be ineffective. There are several socio-demographic, economic, motivational and organisational barriers that influence the participation in breast cancer screening programmes and create inequalities in cancer care (8, 9, 10)(Cuthbertson(11, 12). Because of this, certain subpopulations of women (e.g. socially disadvantaged) represent vulnerable populations who participate less in breast cancer screening programmes.

CONFLICT OF INTEREST:

Management of Conflicts of Interest (CoI): CoIs for all Guidelines Development Group (GDG) members were assessed and managed by theEuropean Commission Joint Research Centre (JRC) following an established procedure in line with institutional 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: Roberto d'Amico. Miranda Langendam, as external expert, was also not allowed to vote, according to the ECIBC rules of procedure.

http://healthcare-quality.jrc.ec.europa.eu/


ASSESSMENT

Problem Is the problem a priority?

JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS

○ No

○ Probably no

○ Probably yes

● Yes

○ Varies

○ Don't know

Breast cancer is one of the most common forms of cancer and the leading cause of death in women in

Europe (13). The implementation of mammography screening programmes has been identified as an

effective public health intervention to reduce breast cancer mortality (2)(3). Several studies have

demonstrated a reduction in mortality for breast cancer in Europe after the implementation of

population-based breast cancer screening programmes (14) (5). For these reasons, mammography

screening is a well-established public health intervention in Europe and elsewhere (15). Organised

breast cancer screening involves a pathway of activities from promoting and inviting potential

participants undergoing the screening test procedure, recall after the appropriate time lapse for those

who screened negative and for those that screen positive, to providing timely diagnostic procedures and

treatment. Inequalities could arise at any point along the pathway, and inequalities in outcomes are

likely to be the result of the cumulative effects of inequalities along the entire pathway.

Moreover, it is intuitive that, in order to achieve a reduction in mortality for breast cancer, it is essential

to reach most target populations and maximise participation rates. Programmes that fail to achieve this

are likely to introduce serious inequalities in the population, as it is shown that women belonging to the

most disadvantaged groups of the population are also those who participate less (8). To avoid this,

tailored strategies may identify and address barriers for these particular subpopulations of women.

The GDG prioritised this question for the ECIBC.

Desirable Effects How substantial are the desirable anticipated effects?


● Trivial

○ Small

○ Moderate

○ Large

○ Varies

○ Don't know

The tailored intervention in the study identified was a personalised tailored letter, which included

specific risk factor data extracted from the woman’s medical chart. The comparison group received a

letter that contained generic information about risk factors for breast and cervical cancer, and the

importance of screening and early detections. Recipients were encouraged to schedule a visit for clinical

breast examination and a mammogram.

Outcomes № of

participants

(studies)

Follow up

Certainty of

the evidence

(GRADE)

Relative

effect

(95% CI)

Anticipated absolute effects* (95% CI)

Risk with general

communication

strategy

Risk difference

with tailored

communication

strategy

Participation rate 478 ⨁⨁⨁◯ RR 0.42 Study population

The GDG notes that a decrease in participation was observed

with the only RCT found. Therefore, no desirable anticipated

effects were noted. The GDG agreed by consensus that the

desirable anticipated effects were trivial.



(1 RCT)1 MODERATEa (0.29 to

0.62)

31 per 100 18 fewer per 100

(22 fewer to 12

fewer)

Low


(11 fewer to 6

fewer)

Number of people

making informed

choices - not

measured

- - - - -

Better/increased

accessibility to

information - not

measured

- - - - -

Confidence in

making decisions -

not measured

- - - - -

Increased

awareness of

information - not

measured

- - - - -

Satisfaction with

the decision-

making process -

not measured

- - - - -

1. Jibaja-Weiss ML, Volk RJ Kingery P Smith QW Holcomb JD.. Tailored messages for breast and cervical cancer screening of low-income and minority women using medical records data.. Education and Counselling; 2003.

a. Downgraded for indirectness because the study was conducted in USA.



Undesirable Effects How substantial are the undesirable anticipated effects?


○ Large

● Moderate

○ Small

○ Trivial

○ Varies

○ Don't know

The tailored intervention in the study identified was a personalised tailored letter which included

specific risk factor data extracted from the woman’s medical chart. The comparison group received a

letter that contained generic information about risk factors for breast and cervical cancer, and the

importance of screening and early detections. Recipients were encouraged to schedule a visit for clinical

breast examination and a mammogram.

Outcomes № of

participants

(studies)

Follow up

Certainty of

the evidence

(GRADE)

Relative

effect

(95% CI)

Anticipated absolute effects* (95% CI)

Risk with general

communication

strategy

Risk difference

with tailored

communication

strategy

Participation rate 478

(1 RCT)1 ⨁⨁⨁◯

MODERATEa

RR 0.42

(0.29 to

0.62)

Study population


(22 fewer to 12

fewer)

Low


(11 fewer to 6

fewer)

Number of people

making informed

choices - not

measured

- - - - -

Better/increased

accessibility to

information - not

measured

- - - - -

Confidence in

making decisions -

- - - - -

The GDG notes that the baseline participation rate in this study is

31%, (Jibaja-Weiss 2003). This is higher than in the

recommendation of targeted strategy vs. general communication

strategy which was 15%. Therefore, the relative reduction in

participation may be lower if the baseline participation rate was

lower.

The GDG felt the baseline participation in this study from the

United States, was lower than in European settings, which is why

they rated the quality of the evidence down for indirectness.

The GDG also noted that no undesirable outcomes were

measured in the study and so this judgement is based only on

the decrease in the participation rate.

The GDG judged by consensus that the undesirable anticipated

effects are moderate.



not measured

Increased

awareness of

information - not

measured

- - - - -

Satisfaction with

the decision-

making process -

not measured

- - - - -

1. Jibaja-Weiss ML, Volk RJ Kingery P Smith QW Holcomb JD.. Tailored messages for breast and cervical cancer screening of low-income and minority women using medical records data.. Education and Counselling; 2003.

a. Downgraded for indirectness because the study was conducted in USA.

Certainty of evidence What is the overall certainty of the evidence of effects?


○ Very low

○ Low

● Moderate

○ High

○ No included studies

The GDG judged by consensus that the overall certainty of the

evidence of effects is moderate as that is the quality of the

evidence of the only outcome measured.



Values Is there important uncertainty about or variability in how much people value the main outcomes?


○ Important uncertainty or variability

● Possibly important uncertainty or variability

○ Probably no important uncertainty or

variability

○ No important uncertainty or variability

○ No known undesirable outcomes

No systematic review was conducted. The GDG judged by consensus that there is possibly important

uncertainty or variability in how much people value the main

outcomes.

Balance of effects Does the balance between desirable and undesirable effects favor the intervention or the comparison?


○ 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

The GDG expressed their concern with the type of intervention

used in this trial. The GDG judged by consensus that should the

tailored intervention use the same approach of the trial included

as evidence, where a decreased participation rate was observed,

the balance of effects probably favours the comparison.

Resources required How large are the resource requirements (costs)?


○ Large costs

○ Moderate costs

○ Negligible costs and savings

○ Moderate savings

○ Large savings

○ Varies

● Don't know

No relevant economic evaluations were identified.



Certainty of evidence of required resources What is the certainty of the evidence of resource requirements (costs)?


○ Very low

○ Low

○ Moderate

○ High

● No included studies


Cost effectiveness Does the cost-effectiveness of the intervention favor the intervention or the comparison?


○ 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


Equity What would be the impact on health equity?


○ Reduced

● Probably reduced

○ Probably no impact

○ Probably increased

○ Increased

○ Varies

○ Don't know

No systematic review was conducted. The GDG agreed by consensus that if the tailored interventions

targeting socially disadvantaged women were similar to the one

used in the trial analysed, health equity would probably be

reduced.



Acceptability Is the intervention acceptable to key stakeholders?


○ No

○ Probably no

○ Probably yes

○ Yes

○ Varies

● Don't know

No systematic review was conducted.

Feasibility Is the intervention feasible to implement?


○ No

○ Probably no

○ Probably yes

○ Yes

● Varies

○ Don't know

No systematic review was conducted. The GDG noted that this population would need to first be

identified in a feasible manner in order to target communication.

The biggest barrier is actively reaching these women.

Access to phone numbers for socially disadvantaged women may

impact feasibility of this intervention if tailored communication is

conducted by phone.

The GDG notes that consideration of the invitation process to the

screening programme, whether it is by postal code or just age,

must be considered in order to assess the feasibility of reaching

and targeting socially disadvantaged women.



SUMMARY OF JUDGEMENTS

JUDGEMENT

PROBLEM No Probably no Probably yes Yes

Varies Don't know

DESIRABLE EFFECTS Trivial Small Moderate Large

Varies Don't know

UNDESIRABLE EFFECTS Large Moderate Small Trivial

Varies Don't know

CERTAINTY OF EVIDENCE Very low Low Moderate High

No included studies

VALUES Important uncertainty

or variability

Possibly important uncertainty or

variability

Probably no important uncertainty or variability

No important uncertainty or variability

No known undesirable outcomes

BALANCE OF EFFECTS 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

RESOURCES REQUIRED Large costs Moderate costs Negligible costs and

savings Moderate savings Large savings Varies Don't know

CERTAINTY OF EVIDENCE OF

REQUIRED RESOURCES Very low Low Moderate High

No included studies

COST EFFECTIVENESS 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

EQUITY Reduced Probably reduced Probably no impact Probably increased Increased Varies Don't know

ACCEPTABILITY No Probably no Probably yes Yes

Varies Don't know

FEASIBILITY No Probably no Probably yes Yes

Varies Don't know



TYPE OF RECOMMENDATION 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

○ ● ○ ○ ○

CONCLUSIONS

Recommendation

The ECIBC's Guidelines Development Group suggests not using a tailored communication strategy over a general communication strategy to improve participation in breast cancer screening programmes of socially

disadvantaged women between the ages of 50 and 69 (conditional recommendation, moderate certainty of the evidence).

Justification

Overall justification

On the basis of the specific tailored communication strategy providing individualised cancer risk considered, the GDG suggests against tailoring interventions for socially disadvantaged women, as some tailored

interventions appear to do more harm than good. However, the impact of other types of tailored interventions is unknown.

Detailed justification Desirable Effects No desirable effects of tailored communication were identified.

Undesirable Effects The GDG notes that this recommendation is based on a single intervention from one randomised controlled trial (RCT), which shows a lower participation rate with a specific tailored communication strategy. There may be

different impacts with other tailored interventions.

Subgroup considerations

None were considered by the GDG.



Implementation considerations

The GDG suggests against tailored interventions for socially disadvantaged women. Therefore, no implementation considerations were identified.

Monitoring and evaluation

Monitoring and evaluation of tailored communication strategies that differ from that considered in the randomised controlled trial (RCT) reviewed for this recommendation is suggested to assess the impact of alternative

tailored communication interventions.

Research priorities

1. Due to the scarcity of evidence in the different approaches to tailoring communication, the GDG suggests research exploring other tailored interventions for this population. There is the need to have a narrower

definition of what tailored interventions are.

2. The GDG noted that there is incongruity with the research evidence that was found for tailored interventions for communication strategies for socially disadvantaged women. On the basis of the specific tailored

communication strategy in the randomised controlled trial (RCT) reviewed, the GDG suggests against tailoring interventions for socially disadvantaged women, however, the impact of other types of tailored interventions is

unknown. Further research examining all interventions targeting or tailoring socially disadvantaged women is suggested.



REFERENCES SUMMARY 1. Ferlay J, Steliarova-Foucher E,Lortet-Tieulent J,Rosso S,Coebergh JW,Comber H,Forman D,Bray F.. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer; 2013. 2. Cancer, International,Agency,for,Research,on. Breast cancer screening, IARC Handbooks of Cancer prevention. Available from: http://publications.iarc.fr/; 2016. 3. Organization, World,Health. Breast Cancer: prevention and control. httpww.who.int/cancer/detection/breastcancer/en/; 2014 .. 4. Moss SM, Cuckle H,Evans A,Johns L,Waller M,Bobrow L, Group., Trial,Management. Effect of mammographic screening from age 40 years on breast cancer mortality at 10 years´follow-up: a randomised controlled trial. Lancet Oncol; 2015. 5. Moss SM, Nyström L,Jonsson H,Paci E,Lynge E,Njor S,Broeders M,Euroscreen Working Group. The impact of mammographic screening on breast cancer mortality in Europe: a review of observational studies. J Med Screen; 2012. 6. Perry N, Broeders M,DeWolf C et al (editors). European Guidelines for quality assurance in breast cancer screening and diagnosis. European Communities; 2006. 7. Giordano L, von Karsa L,Tomatis M et al. .. Eunice Working Group (2012a). Mammographic screening programmes in Europe:organisation, coverage and participation. J Med Screen; 2012. 8. Deandrea S, Molina-Barceló A,Uluturk A et al. Presence, characteristics and equity of access to breast cancer screening programmes in 27 European countries in 2010 and 2014. Results from an international survey. Preventive Medicine; 2016. 9. Vahabi M, Lofters A,Kumar M et al. Breast cancer screening disparities among immigrant women by world region of origin: a population-based Study in Ontario, Canada. Cancer Medicine; 2016. 10. Moser K, Patnick J,Beral V. Inequalities in reported use of breast and cervical screening in Great Britain: analysis of cross sectional survey data. BMJ 2009;338:b2025; 2009. 11. Cuthbertson SA, Goyder E,Poole J. . Inequalities in breast cancer stage at diagnosis in the Trent region, and implications for the NHS Breast Screening Programme. Journal of public health (Oxford, England); 2009. 12. Palència L, Espelt A,Rodríguez-Sanz M,Puigpinós R,Pons-Vigués M,Pasarín MI,Spadea T,Kunst AE,Borrell C. Socio-economic inequalities in breast and cervical cancer screening practices in Europe: influence of the type of screening program. Int J Epidemiol; 2010. 13. Ferlay, J. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.fr/today, accessed [03/12/2018].; 2018. 14. Moss SM, Nyström L,Jonsson H et al.. The impact of mammographic screening on breast cancer mortality in Europe: a review of trend studies. J Med Screen; 2012. 15. Ponti A, Anttila A,Ronco G,Senore C,Basu P,Segnan N et al. (IARC). Cancer screening in the European Union. Report on the implementation of the Council Recommendation on cancer screening (second report). Brussels: European Commission; 2017.


Documents

European Commission Initiative on Breast Cancer (ECIBC): … · 2019. 11. 25. · organisational barriers that influence the participation in breast cancer screening programmes and