question should a letter plus a phone call to remind vs. a letter … · letter outcomes of...

QUESTION

Should a letter plus a phone call to remind vs. a letter alone be used for inviting women for further diagnostic assessment?

POPULATION: inviting women for further diagnostic assessment

INTERVENTION: a letter plus a phone call to remind

COMPARISON: a letter alone

MAIN OUTCOMES:

Participation in further assessment; informed decision making; satisfaction with decision making; anxiety.

SETTING: European Union

PERSPECTIVE: Population (National Health System)

BACKGROUND: Breast cancer screening is a public health initiative that involves a system of informing and offering a defined target population to participate, administering and evaluate the invitation and screening procedure and referral for further assessment, ensuring timely results of the screening test and eventual diagnosis, staging and access to effective treatment with routine evaluation of the process.

Breast cancer screening should be viewed as a continuous process encompassing all the components, from invitation to treatment and follow up.

The different stages of screening should correspond to different communication modalities and information needs. Therefore, it would be appropriate to provide women with different types of information according to the different screening phases (i.e. invitation, negative results and recall). Women recalled for further assessment might need information about the procedures and on possible outcomes. At this stage it might be appropriate to provide women with additional and more detailed information using different formats. It is crucial that women diagnosed with breast cancer have the opportunity to meet health professionals and be able to discuss various options and outcomes with professionals in a supportive environment.

The way and time in which this information is conveyed to women, especially if a further assessment is needed, could have a strong impact on women's anxiety, stress, quality of life and general well-being. Similarly, how negative results are conveyed to women could impact subsequent participation and on women's trust on breast screening initiatives.

CONFLICT OF INTEREST:

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, Markus Follman, Paolo Giorgi Rossi, Axel Gräwingholt and Kenneth Young; Miranda Langendam, as external expert, was also not allowed to vote, according to the ECIBC rules of procedure.

ASSESSMENT

Problem Is the problem a priority?

JUDGEMENT RESEARCH EVIDENCE ADDITIONAL CONSIDERATIONS

○ No

○ Probably no

○ Probably yes

● Yes

○ Varies

○ Don't know

Breast cancer screening is a public health initiative that includes a system of informing women about the

results of the tests being performed within a timely manner. The way test results are communicated

could have an impact on satisfaction, anxiety, stress, quality of life and general well-being.

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

Outcomes № of participants

(studies)

Follow up

Certainty of

the evidence

(GRADE)

Relative

effect

(95% CI)

Anticipated absolute

effects* (95% CI)

Risk

with a

letter

alone

Risk difference

with a letter

plus a phone

call to remind

Participation in

further

assessment

(participation

rate)

16289

(14

RCTs)1,10,11,12,13,14,2,3,4,5,6,7,8,9

⨁⨁◯◯

LOWa,b,c

RR 1.45

(1.25 to

1.69)

Low

100 per

1.000 d

45 more per

1.000

(25 more to 69

more)

Informed decision

making - not

measured

- - - - -

Anxiety - not

measured

- - - - -

Satisfaction - not

measured

- - - - -

The GDG decided to base its judgement on the evidence used for

another recommendation "Should letters plus phone calls vs.

letters be used for inviting asymptomatic women to breast

cancer screening programmes?"

For this recommendation, the intervention was directed at

women invited to subsequent breast cancer screening rounds, so

women who receive the invitation for the first time would not be

included in this population. For this reason, the baseline risk was

changed from 60% to 10%.

The GDG judged that the desirable effects are small.

1. Bodiya A, Vorias D,Dickson HA. Does telephone contact with a physician's office staff improve mammogram screening rates? . Family Medicine; 1999.

2. Chambers JA, Gracie K,Millar R,Cavanagh J,Archibald D,Cook A,et al.. A pilot randomized controlled trial of telephone intervention to increase Breast Cancer Screening uptake in socially deprived areas in Scotland (TELBRECS).. Journal of medical screening; 2015.

3. Champion V, Skinner CS,Hui S,Monahan P,Juliar B,Daggy J,et al.. The effect of telephone versus print tailoring for mammography adherence. Patient Education and Counseling; 2007.

4. Goelen G, De Clercq G,Hanssens S.. A community peer-volunteer telephone reminder call to increase breast cancer-screening attendance. Oncology nursing forum.; 2010.

5. Hegenscheid K, Hoffmann W,Fochler S,Domin M,Weiss S,Hartmann B,et al.. Telephone counseling and attendance in a national mammography-screening program: A randomized controlled trial. American Journal of Preventive Medicine; 2011.

6. Lantz PM, Stencil D Lippert MT Beversdorf S Jaros L Remington PL.. Breast and cervical cancer screening in a low-income managed care sample: The efficacy of physician letters and phone calls.. American Journal of Public Health; 1995.

7. Mayer JA, Clapp EJ,Bartholomew S,Elder J. Facility-based inreach strategies to promote annual mammograms.. American Journal of Preventive Medicine; 1994.

8. Page A, Morrell S,Chiu C,Taylor R,Tewson R. Recruitment to mammography screening: a randomised trial and meta-analysis of invitation letters and telephone calls. Aust N Z J Public Health. ; 2006.

9. Phillips L, Hendren S,Humiston S,Winters P,Fiscella K.. Improving breast and colon cancer screening rates: a comparison of letters, automated phone calls, or both. Journal of the American Board of Family Medicine : JABFM; 2015.

10. Puschel K, Coronado G,Soto G,Gonzalez K,Martinez J,Holte S,et al. Strategies for increasing mammography screening in primary care in Chile: Results of a randomized clinical trial.. Cancer Epidemiology Biomarkers and Prevention; 2010.

11. Richardson A, Williams S,Elwood M,Bahr M,Medlicott T.. Participation in breast cancer screening: randomised controlled trials of doctors' letters and of telephone reminders. Australian journal of public health; 1994.

12. Valanis B, Whitlock EE,Mullooly J,Vogt T,Smith S,Chen C,et al. Screening rarely screened women: time-to-service and 24-month outcomes of tailored interventions. Preventive medicine; 2003.

13. Vernon SW, Gilstrap EL,Jackson GL,Hughes JI.. An intervention to increase participation in a work site cancer screening program. . Health Values: The Journal of Health Behavior, Education & Promotion ; 1992.

14. Vogt TM, Glass A,Galsgow RE,La Chance PA,Lichtenstein E.. The safety net: a cost-effective approach to improving Brest and cervical cáncer screening. 2003; J Womens Health.

a. Two trials (Page 2006 and Hegenscheid 2011) were at high risk of selection bias and two trials (Mayer 1994 and Vernon 1992) were at high risk of attrition bias. However, a sensitivity analysis excluding these trials from the analysis still showed a a significant effect (RR= 1,62 [1,31, 2,01]), therefore evidence was not downgraded for risk of bias.

b. High statistical heterogeneity (I2=82%). The majority of studies show a consistent direction of effect, with overlapping 95% confidence intervals, therefore evidence was not downgraded for inconsistency.

c. Downgraded for indirectness because the majority of included studies were conducted outside Europe, the included population is not specific to women invited for further assessment and as the outcome is about participation in screening and not specific for further assessment.

d. This recommendation targets only at women for further assessment, so the baseline risk was changed from 60% to 10% in this new PICO during the Meeting in June 2018.

Undesirable Effects How substantial are the undesirable anticipated effects?


○ Large

○ Moderate

○ Small

● Trivial

○ Varies

○ Don't know

Outcomes № of participants

(studies)

Follow up

Certainty of

the evidence

(GRADE)

Relative

effect

(95% CI)

Anticipated absolute

effects* (95% CI)

Risk

with a

letter

alone

Risk difference

with a letter

plus a phone

call to remind

Participation in

further

assessment

(participation

rate)

16289

(14

RCTs)1,10,11,12,13,14,2,3,4,5,6,7,8,9

⨁⨁◯◯

LOWa,b,c

RR 1.45

(1.25 to

1.69)

Low

100 per

1.000 d

45 more per

1.000

(25 more to 69

more)

Informed decision

making - not

measured

- - - - -

Anxiety - not

measured

- - - - -

Satisfaction - not

measured

- - - - -

1. Bodiya A, Vorias D,Dickson HA. Does telephone contact with a physician's office staff improve mammogram screening rates? . Family Medicine; 1999.

2. Chambers JA, Gracie K,Millar R,Cavanagh J,Archibald D,Cook A,et al.. A pilot randomized controlled trial of telephone intervention to increase Breast Cancer Screening uptake in socially deprived areas in Scotland (TELBRECS).. Journal of medical screening; 2015.

3. Champion V, Skinner CS,Hui S,Monahan P,Juliar B,Daggy J,et al.. The effect of telephone versus print tailoring for mammography adherence. Patient Education and Counseling; 2007.

4. Goelen G, De Clercq G,Hanssens S.. A community peer-volunteer telephone reminder call to increase breast cancer-screening attendance. Oncology nursing forum.; 2010.

5. Hegenscheid K, Hoffmann W,Fochler S,Domin M,Weiss S,Hartmann B,et al.. Telephone counseling and attendance in a national mammography-screening program: A randomized controlled trial. American Journal of Preventive Medicine; 2011.

6. Lantz PM, Stencil D Lippert MT Beversdorf S Jaros L Remington PL.. Breast and cervical cancer screening in a low-income managed care sample: The efficacy of physician letters and phone calls.. American Journal of Public Health; 1995.

7. Mayer JA, Clapp EJ,Bartholomew S,Elder J. Facility-based inreach strategies to promote

The GDG noted that outcomes related to undesirable effects

were not included in any studies reviewed. Some members of

the GDG felt that perhaps some women would not appreciate

receiving a call if they had made an informed decision not to

participate in screening.

However, overall, the GDG agreed that the undesirable effects

were trivial.

annual mammograms.. American Journal of Preventive Medicine; 1994. 8. Page A, Morrell S,Chiu C,Taylor R,Tewson R. Recruitment to mammography screening: a

randomised trial and meta-analysis of invitation letters and telephone calls. Aust N Z J Public Health. ; 2006.

9. Phillips L, Hendren S,Humiston S,Winters P,Fiscella K.. Improving breast and colon cancer screening rates: a comparison of letters, automated phone calls, or both. Journal of the American Board of Family Medicine : JABFM; 2015.

10. Puschel K, Coronado G,Soto G,Gonzalez K,Martinez J,Holte S,et al. Strategies for increasing mammography screening in primary care in Chile: Results of a randomized clinical trial.. Cancer Epidemiology Biomarkers and Prevention; 2010.

11. Richardson A, Williams S,Elwood M,Bahr M,Medlicott T.. Participation in breast cancer screening: randomised controlled trials of doctors' letters and of telephone reminders. Australian journal of public health; 1994.

12. Valanis B, Whitlock EE,Mullooly J,Vogt T,Smith S,Chen C,et al. Screening rarely screened women: time-to-service and 24-month outcomes of tailored interventions. Preventive medicine; 2003.

13. Vernon SW, Gilstrap EL,Jackson GL,Hughes JI.. An intervention to increase participation in a work site cancer screening program. . Health Values: The Journal of Health Behavior, Education & Promotion ; 1992.

14. Vogt TM, Glass A,Galsgow RE,La Chance PA,Lichtenstein E.. The safety net: a cost-effective approach to improving Brest and cervical cáncer screening. 2003; J Womens Health.

a. Two trials (Page 2006 and Hegenscheid 2011) were at high risk of selection bias and two trials (Mayer 1994 and Vernon 1992) were at high risk of attrition bias. However, a sensitivity analysis excluding these trials from the analysis still showed a a significant effect (RR= 1,62 [1,31, 2,01]), therefore evidence was not downgraded for risk of bias.

b. High statistical heterogeneity (I2=82%). The majority of studies show a consistent direction of effect, with overlapping 95% confidence intervals, therefore evidence was not downgraded for inconsistency.

c. Downgraded for indirectness because the majority of included studies were conducted outside Europe, the included population is not specific to women invited for further assessment and as the outcome is about participation in screening and not specific for further assessment.

d. This recommendation targets only at women for further assessment, so the baseline risk was changed from 60% to 10% in this new PICO during the Meeting in June 2018.

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


○ Very low

● Low

○ Moderate

○ High

○ No included studies

The GDG judged that the certainty of the evidence is low.

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 that there is probably no important uncertainty

or variability in how much women called for further assessment

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 judged that the balance probably favours the

intervention considering that the evidence taken into account is

indirect (intervention for inviting women to screening not for

further assessment).

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 systematic review was conducted.

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


The GDG judged that equity would probably be increased.

Acceptability Is the intervention acceptable to key stakeholders?


○ No

○ Probably no

○ Probably yes

● Yes

○ Varies

○ Don't know

No systematic review was conducted. The GDG judged that the intervention is acceptable to key

stakeholders because in the majority of the European breast

cancer screening programmes surveyed this type of intervention

is already in place (survey results reported below in the

feasibility section).

Feasibility Is the intervention feasible to implement?


○ No

○ Probably no

○ Probably yes

● Yes

○ Varies

○ Don't know


- Survey data (unpublished) from 21 European breast cancer screening programmes from 18 countries

(Belgium, Austria, Croatia, Finland, Germany, Latvia, Lithuania, Netherlands, Slovenia, Denmark, Cyprus,

Italy, Spain, Norway, Malta, England, Ireland, and Wales) showed that the majority use phone calls alone

to invite women for further assessment or in combination with a posted letter or an email.

Attendance rate for further assessment in the 21 programmes participating in the survey ranged from

49% to 100%. However, there were no substantial differences with the content of the material used.

These are the findings regarding the content of the letters used by 4 programmes participating in the

survey:

Logistic information:

1.Providing information for future screening appointments

50% of programmes explain to the women how to obtain the appointment for further assessment and

The GDG judged that the intervention is feasible to implement

because in the majority of the European breast cancer screening

programmes surveyed this type of intervention is already in

place.

the documentation that they should bring with them

50% of programmes specify that the costs of further assessment should be covered by the woman

Background information:

2.Info on what to expect when you are called for further assessment

50% of programmes explained the examinations that may be carried out during the further assessment.

3.Info on what to expect after the assessment

Only one programme describes the possible outcomes.

Consequences of screening:

Only one programme reports on the benefits, harms and limitations of screening (that there is greater

success in treatment when detected early, that it does not detect all cancers, that there is a risk of

radiation and may be discomfort) in letters sent for inviting for further assessment.

Notification of the results:

4. How women will be informed

One programme (25%) reported that the results will be given by the radiologist and one programme

reported that the GP would contact the woman to inform the results of further assessment.

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 (GDG) suggests using a letter plus phone call over letter alone for inviting women for further diagnostic assessment within a breast cancer screening programme (conditional

recommendation, low certainty of the evidence).

Justification

Overall justification

The GDG made a conditional recommendation for the intervention, based on the desirable anticipated effects, the moderate costs and the judgement that the intervention was acceptable and feasible feasible to

implement.

Detailed justification Desirable Effects The GDG judged that the benefits, for women between the ages of 50-69 where screening is strongly recommended, measured by the increase in participation in screening (an adequate outcome for this age group)

observed with the intervention were small.

Equity The GDG judged that equity would probably be increased.

Subgroup considerations

None identified.

Implementation considerations

None identified.

Monitoring and evaluation

None identified.

Research priorities

GDG suggested that other type of interventions may be explored i.e. SMS and face-to-face communications.

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