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Primary care endorsement letter and a patient leaflet to improve participation in colorectal cancer screening: results of a factorial randomised trial.

ABSTRACT: BACKGROUND: The trial aimed to investigate whether a general practitioner's (GP) letter encouraging participation and a more explicit leaflet explaining how to complete faecal occult blood test (FOBT) included with the England Bowel Cancer Screening Programme invitation materials would improve uptake. METHODS: A randomised controlled 2 × 2 factorial trial was conducted in the south of England. Overall, 1288 patients registered with 20 GPs invited for screening in October 2009 participated in the trial. Participants were randomised to either a GP's endorsement letter and/or an enhanced information leaflet with their FOBT kit. The primary outcome was verified with return of the test kit within 20 weeks. RESULTS: Both the GP's endorsement letter and the enhanced procedural leaflet, each increased participation by ∼6% - the GP's letter by 5.8% (95% CI: 4.1-7.8%) and the leaflet by 6.0% (95% CI: 4.3-8.1%). On the basis of the intention-to-treat analysis, the random effects logistic regression model confirmed that there was no important interaction between the two interventions, and estimated an adjusted rate ratio of 1.11 (P=0.038) for the GP's letter and 1.12 (P=0.029) for the leaflet. In the absence of an interaction, an additive effect for receiving both the GP's letter and leaflet (11.8%, 95% CI: 8.5-16%) was confirmed. The per-protocol analysis indicated that the insertion of an electronic GP's signature on the endorsement letter was associated with increased participation (P=0.039). CONCLUSION: Including both an endorsement letter from each patient's GP and a more explicit procedural leaflet could increase participation in the English Bowel Cancer Screening Programme by ∼10%, a relative improvement of 20% on current performance.

SUBMITTER: Hewitson P

PROVIDER: S-EPMC3170960 | biostudies-other | 2011 Aug

REPOSITORIES: biostudies-other

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Project description:BackgroundNew Zealand's Bowel Screening Pilot (BSP) used a mailed invitation to return a faecal immunochemical test. As a pilot it offered opportunities to test interventions for reducing ethnic inequities in colorectal cancer screening prior to nationwide programme introduction. Small media interventions (e.g. educational material and DVDs) have been used at both community and participant level to improve uptake. We tested whether a DVD originally produced to raise community awareness among the M?ori population would have a positive impact on participation and reduce the proportion of incorrectly performed tests (spoiled kits) if mailed out with the usual reminder letter.MethodsThe study was a parallel groups pseudo-randomised controlled trial. Over 12?months, all M?ori and Pacific ethnicity non-responders four weeks after being mailed the test kit were allocated on alternate weeks to be sent, or not, the DVD intervention with the usual reminder letter. The objective was to determine changes in participation and spoiled kit rates in each ethnic group, determined three months from the date the reminder letter was sent. Participants and those recording the outcomes (receipt of a spoiled or non-spoiled test kit) were blinded to group assignment.Results2333 M?ori and 2938 Pacific people participated (11 withdrew). Those who were sent the DVD (1029 M?ori and 1359 Pacific) were less likely to participate in screening than those who were not (1304 M?ori and 1579 Pacific). Screening participation was reduced by 12.3% (95% CI 9.1-15.5%) in M?ori (13.6% versus 25.9%) and 8.3% (95% CI 5.8-10.8%) in Pacific (10.1% versus 18.4%). However, spoiled kit rates (first return) were significantly higher among those not sent the DVD (33.1% versus 12.4% in M?ori and 42.1% versus 21.9% in Pacific).ConclusionThe DVD sent with the reminder letter to BSP non-responders reduced screening participation to an extent that more than offset the lower rate of spoiled kits.Trial registrationAustralia and New Zealand Clinical Trials Registry ACTRN12612001259831 . Registered 30 November 2013.

Project description:Decision aids can support informed choice in mammography screening, but for the German mammography screening programme no systematically evaluated decision aid exists to date. We developed a decision aid for women invited to this programme for the first time based on the criteria of the International Patient Decision Aids Standards Collaboration.To determine whether a decision aid increases informed choice about mammography screening programme participation.A representative sample of 7,400 women aged 50 was drawn from registration offices in Westphalia-Lippe, Germany. Women were randomised to receive usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. Data were collected online at baseline, post-intervention, and 3 months follow-up. The primary outcome was informed choice. Secondary outcomes were the constituents of informed choice (knowledge, attitude, intention/uptake), decisional conflict, decision regret, and decision stage. Outcomes were analysed using latent structural equation models and ?2-tests.1,206 women participated (response rate of 16.3%). The decision aid increased informed choice. Women in the control group had lower odds to make an informed choice at post-intervention (OR 0.26, 95% CI 0.18-0.37) and at follow-up (OR 0.66, 95% CI 0.46-0.94); informed choices remained constant at 30%. This was also reflected in lower knowledge and more decisional conflict. Post-intervention, the uptake intention was higher in the control group, whereas the uptake rate at follow-up was similar. Women in the control group had a more positive attitude at follow-up than women receiving the decision aid. Decision regret and decision stage were not influenced by the intervention.This paper describes the first systematic evaluation of a newly developed decision aid for the German mammography screening programme in a randomised controlled trial. Our decision aid proved to be an effective tool to enhance the rate of informed choice and was made accessible to the public.German Clinical Trials Register DRKS00005176.

Project description:BackgroundSharing trial results with participants is an ethical imperative but often does not happen. We tested an Enhanced Webpage versus a Basic Webpage, Mailed Printed Summary versus no Mailed Printed Summary, and Email List Invitation versus no Email List Invitation to see which approach resulted in the highest patient satisfaction with how the results were communicated.Methods and findingsWe carried out a cluster randomised, 2 by 2 by 2 factorial, nonblinded study within a trial, with semistructured qualitative interviews with some patients (ISRCTN96189403). Each cluster was a UK hospital participating in the ICON8 ovarian cancer trial. Interventions were shared with 384 ICON8 participants who were alive and considered well enough to be contacted, at 43 hospitals. Hospitals were allocated to share results with participants through one of the 8 intervention combinations based on random permutation within blocks of 8, stratified by number of participants. All interventions contained a written plain English summary of the results. The Enhanced Webpage also contained a short video. Both the Enhanced Webpage and Email contained links to further information and support. The Mailed Printed Summary was opt-out. Follow-up questionnaires were sent 1 month after patients had been offered the interventions. Patients' reported satisfaction was measured using a 5-point scale, analysed by ordinal logistic regression estimating main effects for all 3 interventions, with random effects for site, restricted to those who reported receiving the results and assuming no interaction. Data collection took place in 2018 to 2019. Questionnaires were sent to 275/384 randomly selected participants and returned by 180: 90/142 allocated Basic Webpage, 90/133 Enhanced Webpage; 91/141 no Mailed Printed Summary, 89/134 Mailed Printed Summary; 82/129 no Email List Invitation, 98/146 Email List Invitation. Only 3 patients opted out of receiving the Mailed Printed Summary; no patients signed up to the email list. Patients' satisfaction was greater at sites allocated the Mailed Printed Summary, where 65/81 (80%) were quite or very satisfied compared to sites with no Mailed Printed Summary 39/64 (61%), ordinal odds ratio (OR) = 3.15 (1.66 to 5.98, p < 0.001). We found no effect on patient satisfaction from the Enhanced Webpage, OR = 1.47 (0.78 to 2.76, p = 0.235) or Email List Invitation, OR = 1.38 (0.72 to 2.63, p = 0.327). Interviewees described the results as interesting, important, and disappointing (the ICON8 trial found no benefit). Finding out the results made some feel their trial participation had been more worthwhile. Regardless of allocated group, patients who received results generally reported that the information was easy to understand and find, were glad and did not regret finding out the results. The main limitation of our study is the 65% response rate.ConclusionsNearly all respondents wanted to know the results and were glad to receive them. Adding an opt-out Mailed Printed Summary alongside a webpage yielded the highest reported satisfaction. This study provides evidence on how to share results with other similar trial populations. Further research is needed to look at different results scenarios and patient populations.Trial registrationISRCTN: ISRCTN96189403.

Project description:BACKGROUND:Improving response rates in epidemiologic studies is important for the generalizability of the outcome. The aim of this study was to examine whether it can be advantageous for participation to target different versions of the cover letters to different sample subgroups. METHODS:A randomized trial was incorporated in a cross-sectional health survey in Denmark (n =?25,000) where a motivational sentence in the cover letter intended to heighten perceptions of relevance of the survey was varied among 11 sample subgroups (treatment groups). Ten different versions of a sentence outlining questionnaire themes were tested: each mentioned three out of five themes: stress, alcohol, sex, sleep problems, and contact with family and friends. An eleventh group, the control group, omitted this sentence. RESULTS:On average, the additional motivational sentence resulted in a significantly lower response rate overall compared to the control group. However, the additional motivational sentence was found to have heterogeneous effects on survey response. Furthermore, the nature of the heterogeneity differed between the versions of the sentence. Specifically, the additional sentence tended to produce a higher response rate among the youngest age group and a lower response rate in the oldest age group compared to the generic letter. The use of alcohol in the motivational sentence tended to have a positive effect on response in the age group 16-24?years, and stress tended to have a positive effect in the age group ?65?years. On the contrary, sex tended to have a negative effect in the age groups 45-64?years and???65?years. However, a significant interaction was only found between the use of stress and age group (p?=?<?0.0001). CONCLUSION:The findings of significant and heterogeneous effects suggest that there is potential for a targeted approach to improve both response rates and sample composition. The uneven effect of the separate themes across age groups suggests that the selection of themes to be included in the motivational sentence is important for the use of targeted appeals to be successful and warrants further research to better identify which themes works in which contexts, in which subgroups and under which circumstances. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT03046368 , retrospectively registered February 8th, 2017.

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Primary care endorsement letter and a patient leaflet to improve participation in colorectal cancer screening: results of a factorial randomised trial.

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