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Table 4 Total cost and cost per participant for each retention strategy for all trials

From: How much is the lack of retention evidence costing trial teams in Ireland and the UK?

Strategy

Cost

CINNAMON trial [16]

Ireland (Hypothetical trial)

UK

(Hypothetical trial)

MAMI trial [14]

MOON trial [15]

Strategy 1: Newsletters (posted)

€2040

(£1754.40)

€1657.67

(£1425.60)

€895.68

(£770.29)

€755.17

(£649.45)

€1931.83

(£1661.33)

($2289.44)

Assumptions

2 newsletters per year; 500 participants; 1-year trial period.

2 newsletters per year; 500 participants; 1-year trial period.

2 newsletters per year; 60 participants; 2-year trial perioda.

2 newsletters per year; 154 participants; 1-year trial period.

2 newsletters per year; 428 participants; 2-year trial period.

Effect estimateb

“The evidence is very uncertain about the effect on retention of including a newsletter compared to no newsletter: RD = − 0% (95% CI − 4% to 3%); GRADE: very low”

Cost per participant retained

Current evidence suggests no retention benefit, unable to calculate cost per participant retained due to lack of evidence

Strategy 1: Newsletters (emailed)

€791.78

(£680.93)

€639.45

(£549.93)

€919.88

(£791.10)

€546.59

(£470.07)

€1094.17

(£940.96)

($1296.72)

Assumptions

2 newsletters electronically sent per year; 500 participants; 1 year trial period

2 newsletters electronically sent per year; 500 participants; 1 year trial period

2 newsletters electronically sent per year; 60 participants; 2-year trial period

2 newsletters electronically sent per year; 154 participants; 1 year trial period

2 newsletters electronically sent per year; 428 participants; 2-year trial period

Effect estimate

“The evidence is very uncertain about the effect on retention of including a newsletter compared to no newsletter: RD = − 0% (95% CI − 4% to 3%); GRADE: very low”

Cost per participant retained

Current evidence suggests no retention benefit, unable to calculate cost per participant retained due to lack of evidence

Strategy 2: A timeline of participant visits for sites (site reminder)c

€79.18

(£68.09)

€111.95

(£96.28)

€101.34

(£87.15)

€111.95

(£96.28)

€112.23

(£96.52)

($133.01)

Assumptions

Data Manager develops reminder schedule software, electronically emails the software to the sites (10 sites).

Carried out once.

This software is used to notify staff of upcoming participant trial visits

Data Manager develops reminder schedule software, electronically emails the software to the sites (10 sites).

Carried out once.

This software is used to notify staff of upcoming participant trial visits

Data Manager develops reminder schedule software, electronically emails the software to the sites (1 site).

Carried out once.

This software is used to notify staff of upcoming participant trial visits

Data Manager develops reminder schedule software, electronically emails the software to the sites (1 site).

Carried out once.

This software is used to notify staff of upcoming participant trial visits

Data Manager develops reminder schedule software, electronically emails the software to the sites (5 sites).

Carried out once.

This software is used to notify staff of upcoming participant trial visits

Effect estimate

No evidence provided in the systematic review

Cost per participant retained

Unable to calculate cost per participant retained due to lack of evidence

A timeline of participant visits for sites (participant reminder)c

€9232.18

(£7939.68)

€6103.57

(£5249.08)

€304.74

(£262.08)

€1957.37

(£1683.34)

€14803.70

(£12730.79)

($17544.05)

Assumptions

Research nurse contacts 500 participants – 5 min per call-carried out once for each visit (3 visits)

Failed contact attempts – research nurse contacts 500 participants - 2 failed contact attempts (1 min each) – carried out once for each visit (3 visits)

Trial Manager contacts 500 participants – 5 min per call-carried out once for each visit (3 visits)

Failed contact attempts – trial manager contacts 500 participants - 2 failed contact attempts (1 min each) – carried out once for each visit (3 visits)

Research nurse contacts 60 participants – 5 min per call-carried out once (1 trial visit)

Failed contact attempts – research nurse contacts 60 participants - 2 failed contact attempts (1 min each) – carried out once (1 trial visit)

Trial Manager contacts 154 participants – 5 min per call-carried out once for each visit (3 visits)

Failed contact attempts – trial manager contacts 154 participants - 2 failed contact attempts (1 min each) – carried out once for each visit (3 visits)

Research nurse contacts 428 participants – 5 min per call-carried out once for each visit (9 trial visits)

Failed contact attempts – research nurse contacts 428 participants - 2 failed contact attempts (1 min each) – carried out once for each visit (9 trial visit)

Effect estimate

No evidence provided in the systematic review

Cost per participant retained

Unable to calculate cost per participant retained due to lack of evidence

Strategy 3: Inclusion of pre-paid envelopes (questionnaire)

€1690.00

(£1453.40)

€1346.56

(£1158.04)

€170.98

(£147.04)

€832.79

(£716.20)

€667.40

(£573.94)

($790.94)

Assumptions

1 questionnaire to all 500 participants; cost of stamp to send out and to return; 1 reminder to 30% of participants (150); cost of stamp to send out and to return;

1 questionnaire to all 500 participants; cost of stamp to send out and to return; 1 reminder to 30% of participants (150); cost of stamp to send out and to return

1 questionnaire to all 60 participants; cost of stamp to send out and to return; 1 reminder to 30% of participants (18); cost of stamp to send out and to return

2 questionnaires to all 154 participants; cost of stamp to send out and to return; 1 reminder for each questionnaire to 30% of participants (47); cost of stamp to send out and to return

1 questionnaire to all 428 participants; cost of stamp to send out and to return; 1 reminder to 30% of participants (129); cost of stamp to send out and to return

Effect estimate

“Various strategies compared to usual practice for return postage, such as free post versus second class stamp; high priority mail stamp versus usual postage; and personal form may increase retention slightly: RD = 4% (95% CI − 0% to 9%); GRADE: low” d

Additional participants retained

20

20

3

7

18

Cost per participant retained

€84.50

(£72.67)

€67.33

(£57.90)

€57

(£s49.02)

€118.97

(£102.31)

€37.08

(£31.88)

($43.94)

Strategy 4: Telephone reminders

Telephone reminders for trial visits

€9153

(£7871.59)

€5991.62

(£5152.80)

€203.40

(£174.92)

€1845.42

(£1587.06)

€14691.47

(£12634.27)

($17411.04)

  Assumptions

Research nurse contacts 500 participants– 5 min per call-carried out once for each visit (3 visits)

Failed contact attempts – research nurse contacts 500 participants - 2 failed contact attempts (1 min each) – carried out for each visit (3 visits)

Trial Manager contacts 500 participants– 5 min per call-carried out once for each visit (3 visits)

Failed contact attempts – trial manager contacts 500 participants - 2 failed contact attempts (1 min each) – carried out for each visit (3 visits)

Research nurse contacts 60 participants– 5 min per call-carried out once (1 trial visit)

Failed contact attempts – research nurse contacts 60 participants - 2 failed contact attempts (1 min each) – carried out once (1 trial visit)

Trial Manager contacts 154 participants– 5 min per call-carried out once for each visit (3 visits)

Failed contact attempts – trial manager contacts 154 participants - 2 failed contact attempts (1 min each) – carried out for each visit (3 visits)

Research nurse contacts 428 participants– 5 min per call-carried out once for each visit (9 trial visits)

Failed contact attempts – research nurse contacts 428 participants - 2 failed contact attempts (1 min each) – carried out once for each visit (9 trial visit)

  Effect estimate

“Telephone reminders compared to usual follow-up may result in little or no difference to retention (smoking cessation (14)): RD = − 1% (95% CI -18% to 15%); GRADE low (− 2 levels: imprecision-single study, n = 127; wide CI crossing RD = 0)” e

  Cost per participant retained

With a risk difference of negative 1 there are no participants retained with this strategy so cost per participant retained cannot be calculated

Telephone reminders for questionnaire response

€423.75

(£364.43)

€568.62

(£489.01)

€34.58

(£29.74)

€356.33

(£306.44)

€246.00

(£211.56)

($291.54)

  Assumptions

Research assistant contacts 30% of participants (150) – 5 min per call – carried out once

Failed contact attempts – research assistant contacts 150 participants– 2 failed attempts - 1 min per attempt –carried out once

Research assistant contacts 30% of participants (150) – 5 min per call – carried out once

Failed contact attempts – research assistant contacts 150 participants– 2 failed attempts - 1 min per attempt –carried out once

Research assistant contacts 30% of participants (18) – 5 min per call – carried out once

Failed contact attempts – research assistant contacts 18 participants– 2 failed attempts - 1 min per attempt –carried out once

Research assistant contacts 30% of participants (47)– 5 min per call – carried out twice

Failed contact attempts – research assistant contacts 47 participants– 2 failed attempts - 1 min per attempt –carried out twice

Research assistant contacts 30% of participants (129) – 5 min per call – carried out once

Failed contact attempts – research assistant contacts 129 participants– 2 failed attempts - 1 min per attempt –carried out once

  Effect estimate

“Telephone reminders compared to usual follow-up may result in little or no difference to retention (smoking cessation [11]): RD = − 1% (95% CI −18% to 15%); GRADE low (− 2 levels: imprecision-single study, n = 127; wide CI crossing RD = 0)”e

  Cost per participant retained

With a risk difference of negative 1 there are no participants retained with this strategy so cost per participant retained cannot be calculated

Telephone reminders for at home data collection

  

€244.08

(£209.91)

  

  Assumptions

  

Research nurse contacts 30% of participants [18] – 5 min per call - 1 reminder for each at home data collection (4 in total)

  

  Effect estimate

“Telephone reminders compared to usual follow-up may result in little or no difference to retention (smoking cessation [11]): RD = − 1% (95% CI − 18% to 15%); GRADE low (− 2 levels: imprecision-single study, n = 127; wide CI crossing RD = 0)”e

  Cost per participant retained

With a risk difference of negative 1 there are no participants retained with this strategy so cost per participant retained cannot be calculated

Strategy 5: Data collection scheduled with routine care

€20250

(£17415.02)

€15697.67

(£13500)

€900

(£774.00)

€4834.88

(£4158)

€32503.25

(£27951.92)

($38520)

Assumptions

Carried out by a research nurse during a routine care visit – 15 min – carried out 3 times for each participant (once for each trial visit)

Carried out by a research nurse during a routine care visit – 15 min – carried out 3 times for each participant (once for each trial visit)

Carried out by a research nurse during a routine care visit – 15 min – carried out twice for each participant (outpatient clinic data collection and data collection at birth)

Carried out by a research nurse during a routine care visit – 15 min – carried out 3 times for each participant - once for each trial visit (3 trial visits)

Carried out by a research nurse during a routine care visit – 15 min – carried out 9 times for each participant - once for each trial visit (9 trial visits)

Effect estimate

No evidence provided in the systematic review

Cost per participant retained

Unable to calculate cost per participant retained due to lack of evidence

Strategy 6: Site initiation training on missing data

€7000

(£6020.00)

€7376.74

(£6344)

€400

(£344.00)

€388.83

(£334.40)

€2953.31

(£2539.76)

($3500)

Assumptions

Prep, site training and report per site @€400 per day plus travel and overnight costs.

Carried out once for each site (10 sites)

Prep, site training and report by Trial manager (11 h of work) – plus travel and overnight costs. Carried out once for each site (10 sites)

Prep, site training and report per site @€400 per day.

Carried out once (1 site)

Prep, site training and report by Trial Manager (11 h of work) Carried out once (1 site)

Prep, site training and report per site @€400 per day plus travel and overnight costs.

Carried out once for each site (5 sites)

Effect estimate

No evidence provided in the systematic review

Cost per participant retained

Unable to calculate cost per participant retained due to lack of evidence

Strategy 7: Investigator meetings face to face

€14000

(£12040.01)

€14753.48

(£12688)

€1600

(£1376)

€777.67

(£668.80)

€11813.22

(£10159.06)

($14000)

Assumptions

Prep, meeting, and report per site @€400 per day plus travel and overnight costs.

Carried out twice per site over 1 year trial period (10 sites)

Prep, meeting, and report by Trial manager (11 h of work) – plus travel and overnight costs. Carried out twice per site over 1 year trial period (10 sites)

Prep, meeting, and report per site @€400 per day

Carried out 4 times for each site over 2-year trial period (1 site)

Prep, meeting, and report by Trial manager (11 h of work). Carried out twice per site over 1 year trial period (1 site)

Prep, meeting, and report per site @€400 per day plus travel and overnight costs.

Carried out 4 times for each site over 2-year trial period (5 sites)

Effect estimate

No evidence provided in the systematic review

Cost per participant retained

Unable to calculate cost per participant retained due to lack of evidence

Strategy 8: Routine site visits by CTU staff

€14000

(£12040.01)

€14753.48

(£12688)

€1600

(£1376)

€777.67

(£668.80)

€11813.22

(£10159.06)

($14000)

Assumptions

Prep, site visit and report per site @€400 per day plus travel and overnight costs.

Carried out twice per site over 1 year trial period (10 sites)

Prep, site visit and report by Trial manager (11 h of work) – plus travel and overnight costs. Carried out twice per site over 1 year trial period (10 sites)

Prep, site visit and report per site @€400 per day

Carried out 4 times per site over 2-year trial period (1 site)

Prep, site visit and report by Trial manager (11 h of work). Carried out twice per site over 1 year trial period (1 site)

Prep, site visit and report per site @€400 per day plus travel and overnight costs

Carried out 4 times per site over 2-year trial period (5 sites)

Effect estimate

No evidence provided in the systematic review

Cost per participant retained

Unable to calculate cost per participant retained due to lack of evidence

Strategy 9: Targeted recruitment of sites/GPsf

€1620

(£1393.20)

€1060.46

(£912)

€30

(£25.80)

€35.35

(£30.40)

€506.28

(£435.39)

($600)

Assumptions

Research nurse carries out site selection and investigation (1 h work per site) – 30 sites are targeted

Trial manager carries out site selection and investigation (1 h work per site) – 30 sites are targeted

Research nurse carries out site selection and investigation (1 h work per site) –single centre so only 1 site targeted

Trial manager carries out site selection and investigation (1 h work per site) – single centre so only 1 site targeted

Research nurse carries out site selection and investigation (1 h work per site) – 15 sites are targeted

Effect estimate

No evidence provided in the systematic review

Cost per participant retained

Unable to calculate cost per participant retained due to lack of evidence

Strategy 10: Flexibility in appointments

€4050

(£3483.00)

€3139.53

(£2700)

€270

(£232.20)

€1004.65

(£864)

€2177.01

(£1872.17)

($2580)

Assumptions

Research nurse carries out out-of-hours visits for 10% of participants (50) – 1.5-h visit

Research nurse carries out out-of-hours visits for 10% of participants (50) – 1.5-h visit

Research nurse carries out out-of-hours visits for 10% of participants (6) – 1.5-h visit

Research nurse carries out out-of-hours visits for 10% of participants (16) – 1.5-h visit

Research nurse carries out out-of-hours visits for 10% of participants (43) – 1.5-h visit

Effect estimate

No evidence provided in the systematic review

Cost per participant retained

Unable to calculate cost per participant retained due to lack of evidence

  1. aItalic font indicates the real trial information that we used, e.g. number of trial participants, number of trial sites, number of trial visits and any retention methods used within the trials, e.g. MOON trial sent out 2 questionnaires to participants
  2. The non-italic font which indicates the assumptions we applied. A full description of the trial characteristics and any retention activities conducted by the real-life trials are documented in Additional file 1
  3. bEvidence from the most recent Cochrane Systematic Review [9]
  4. cThere was no clear explanation as to what this strategy entails therefore we made the following two assumptions. Assumptions for “a timeline of participant visits for sites – site reminder”: The data manager develops reminder schedule software, which is costed as 3 h of work, the software is emailed to the trial sites for the sites to use, costed at 10 min of work. This reminder schedule software can be modified to suit the trial follow-up schedule and to notify staff of upcoming participant trial visits. Assumption for “a timeline of participant visits for sites – participant reminder”: this costing assumption includes the cost of the “site reminder” plus the cost of the trial manager/research nurse telephoning each participant for each visit (5 min of work) plus the cost of failed telephone contact attempts (2 attempts per participant)
  5. dWe assumed benefit was applied across the whole response to all cycles. The Cochrane review found that return postage which included “preaddressed second class stamped envelope”, “high priority stamp to the mailing” and “personalised postal follow-up” all combined likely lead to a 4% benefit, so it is likely that pre-paid envelopes on their own may not provide a 4% benefit on retention. For the ease of calculation, we calculated the cost per participant retained by using pre-paid envelopes based on a 4% benefit
  6. eWe chose to select telephone reminders compared to usual follow up compared to postal follow up in as we believe it is the most relevant comparison for trial teams
  7. fAssumptions for “targeted recruitment of GPs/sites” again there was no clear information what this strategy entails therefore we interpreted this as trial teams targeting sites that would be most likely to participate/sites that had the facilities and experience to participate/sites that have conducted similar trials previously, we costed the time taken to conduct background research into which sites these would be and associated investigation into recruitment