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
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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.
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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?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
● 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.
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(1 RCT)1 MODERATEa (0.29 to
0.62)
31 per 100 18 fewer per 100
(22 fewer to 12
fewer)
Low
15 per 100 9 fewer per 100
(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.
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Undesirable Effects How substantial are the undesirable anticipated effects?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
○ 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
31 per 100 18 fewer per 100
(22 fewer to 12
fewer)
Low
15 per 100 9 fewer per 100
(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.
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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?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
○ 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.
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Values Is there important uncertainty about or variability in how much people value the main outcomes?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
○ 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?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
○ 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)?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
○ Large costs
○ Moderate costs
○ Negligible costs and savings
○ Moderate savings
○ Large savings
○ Varies
● Don't know
No relevant economic evaluations were identified.
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Certainty of evidence of required resources What is the certainty of the evidence of resource requirements (costs)?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
○ Very low
○ Low
○ Moderate
○ High
● No included studies
No relevant economic evaluations were identified.
Cost effectiveness Does the cost-effectiveness of the intervention favor the intervention or the comparison?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
○ 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
No relevant economic evaluations were identified.
Equity What would be the impact on health equity?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
○ 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.
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Acceptability Is the intervention acceptable to key stakeholders?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
○ No
○ Probably no
○ Probably yes
○ Yes
○ Varies
● Don't know
No systematic review was conducted.
Feasibility Is the intervention feasible to implement?
JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS
○ 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.
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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
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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.
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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.
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