Table 2 Main results or findings of included studies in terms of the ‘who, what and when’ of results dissemination

Garcia 1987 [10]

N/A

N/A

N/A

N/A

Not reported

N/A

N/A

Di Blasi 2002 [11]

N/A

Unblinding

N/A

N/A

Not reported

N/A

N/A

Partridge 2004 [12]

N/A

N/A

N/A

N/A

Not reported

N/A

N/A

Dinnett 2005 [13]

Individual

Unblinding

Telephone

The summary of the study results was prepared by a senior member of the PROSPER executive who had been unblinded and involved in the analysis of the primary data.

Not reported

Simultaneously with publication

1391/2520 (55%)

Dixon-Woods 2006 [14]

Aggregate

The leaflet explained that the results might remind participants of a difficult time, and offered the opportunity to contact the ORACLE team in case of any questions.

Postal

The results leaflet comprised a two page summary of the ORACLE findings, written in close collaboration with a consumer representative from the trial steering committee.

Written in close collaboration with a consumer representative from the trial steering committee.

Simultaneously with publication

All of the 8941 women who were recruited to ORACLE in the UK were offered the opportunity to request the trial results, 1803 (20% of all participants) requested this information.

Avins 2008 [15]

Aggregate

Using the tables and figures from the published manuscript

Face-to-face

Publication

Not specified

Not reported

After publication

For the first meeting, 58 letters of invitation were mailed and 13 participants expressed interest in attending but only 3 participants actually attended the presentation (5%). For the second meeting, 167 invitations were mailed and 30 participants expressed a desire to attend though only 17 participants were present at the meeting (10%).

Dorsey 2008 [16]

Aggregate

A summary of the study’s results that included results of the primary and secondary measures and principal safety findings.

Media release

Telephone

Teleconference

Not specified

Not reported

Simultaneously with press release

114 out of 217—(52.5% )

Johnson 2008 [17]

N/A

N/A

N/A

N/A

Not reported

Not specified

N/A

Darbyshire 2009 [18]

Aggregate

N/A

Press release

Not specified

Not reported

Simultaneously with publication

N/A

Partridge 2009 [19]

Aggregate

The interim trial results and recommendation

Postal

Not specified

Not reported

Not specified

N/A

Brealey 2010 [20]

Aggregate

Two leaflets (short and long) summarising the trial findings, and a one-page questionnaire. The short leaflet was a one-page summary in the style of an abstract that was written in plain language using bullet points, with minimum use of numbers, and no pictures or diagrams.

The longer leaflet was four pages in length which included a picture of MRI of the knee and two diagrams (a pie chart and bar chart) presenting results of the trial. The content of the leaflet was more technical with greater use of numbers and percentages and explained the main results in terms of confidence intervals.

Postal

Not specified

Not reported

After publication

Not specified

Dalal 2010 [21]

Aggregate

Summary of the study findings based on the published journal abstract, which was suitable for lay readers

Pt preference (Postal, electronic, face-to-face presentation, online)

A lay summary leaflet of the research results was prepared with the help of two patients with cardiac disease.

A lay summary leaflet of the research results was prepared with the help of two patients with cardiac disease.

After publication

Not specified

Getz 2010 [22]

Aggregate

Each of the formats presented the same core information identified by the CISCRP editorial translation team.

Face-to-face

Online

Audio

Translated the clinical trial results that were posted on http://clinicaltrials.gov into lay language

The CISCRP team included medical and consumer writers, graphic artists, web-page designers, as well as technical staff and professional voiceovers from Public Health Television.

After publication

Not specified

Mancini 2010 [23]

Aggregate

Not specified

Online

Not specified

Not reported

Not specified

Not specified

Cox 2011 [24]

N/A

N/A

N/A

N/A

Not reported

N/A

N/A

Dixon-Woods 2011 [25]

Aggregate

Reported the principal findings of the OCS, a reminder of the original ORACLE trial, the background, and reasons for the follow-up study, and the medical conditions and functioning problems that had been studied in the OCS. It further included basic explanations of clinical trials, placebos, and randomisation, as well as details of the scientific papers reporting the study findings.

Postal

Informed by the findings of the focus groups and input from other stakeholders, a results leaflet for participants was produced, and an integrated process of feedback and support was developed.

Not reported

Not specified

Not specified

Locock 2011 [26]

N/A

N/A

N/A

N/A

Not reported

N/A

N/A

Williams 2011 [27]

Aggregate and individual

The frequency figures were used to demonstrate the effect of treatment. The letter indicated that, because of the qualitatively different effect of treatment on the different types of cataract, the investigators could not recommend regular use of the supplement for the prevention of cataract.

Efforts were made to present data in the letter so that they were understandable to a lay population. For example, instead of presenting hazard ratios and tests of significance as was done in the published paper, absolute frequencies of end-points in the study arms were presented.

Postal

The material for dissemination of the results to the participants (a letter and two questionnaires) was prepared by the Steering Committee.

The letter and enclosed questionnaire were shown to a small number of elderly patients to ensure that they were clear and comprehensible

After publication

The offer to reveal treatment assignment was accepted by 480 of 610 (78.7%) responders.

Darbyshire 2012 [28]

Aggregate

Headline results

Postal

N/A

Not reported

Simultaneously with publication

N/A

Ferrierre 2012 [29]

N/A

Not specified

N/A

N/A

Not reported

Not specified

Not specified

Getz 2012 [30]

Aggregate

Lay summary of clinical trial results

Postal

Online

Telephone

Lay summary based on technical summary developed for posting on ClinicalStudyResults.org and ClinicalTrials.gov.

Not reported

Not specified

Not specified

Mancini 2012 [31]

Aggregate

Not specified

Online

Not specified

Not reported

8 months after the first public disclosure of the conclusions

Sarradon-Eck 2012 [32]

Aggregate

Not specified

Face-to-face

A medical journalist, with the help of expert patients from the French Cancer League, then wrote a patients’ leaflet explaining the trial results.

Not reported

Not specified

N/A

Armstrong 2013 [33]

Aggregate

The leaflet presented the results separately for the two conditions for which women were being treated in the trial—preterm rupture of the membranes (PROM) or spontaneous preterm labour (SPL). A covering letter reminded each woman which condition she presented with when she joined the ORACLE trial and directed her to the most relevant set of results within the leaflet.

N/A

Not specified

Not reported

Not specified

Not specified

Chen 2015 [34]

N/A

N/A

N/A

N/A

Not reported

N/A

N/A

Tarrant 2015 [35]

Aggregate

Headings in the leaflet

-What the ORACLE Clinical Trial aimed to do

-How the ORACLE Clinical Trial was designed

-Groups in the ORACLE Clinical Trial

-Results of the original ORACLE Trial: summary

-Impact of the ORACLE Trial

-The ORACLE Children Study

-What was measured in the ORACLE Children Study

-Results of the ORACLE Children Study

-What is Cerebral Palsy?

-Impact of the ORACLE Children Study

-What is a clinical Trial?

What is a placebo?

Why is randomisation needed?

Who can I contact?

Where can I find the scientific papers?

Postal

Not specified

Not reported

Not specified

N/A

Elzinga 2016 [36]

N/A

N/A

N/A

Not specified

Not reported

N/A

N/A

Dietrich 2017 [37]

N/A

N/A

N/A

TransCelerate interviewed sponsors, conducted surveys with patients and HCPs, and conducted advisory boards with patients and sites to capture the current status and identify possible future practices related to information exchange

Not reported

N/A

N/A

Racine 2018

Aggregate

Headings:

What was the TRUST Thyroid Trial?

Who was in charge of the trial?

What was the aim of the TRUST Trial?

How long was the TRUST trial?

Who took part in the TRUST trial?

Why did you ask me to take part?

What is subclinical hypothyroidism (SCH)?

What are the symptoms of SCH?

How is SCH diagnosed?

How is SCH treated?

What is Levothyroxine?

What are the side effects of Levothyroxine?

How was the trial carried out?

What were the results of the TRUST trial?

Should doctors treat people with subclinical hypothyroidism?

What should I do now?

Media release:

TRIAL RESULTS

European 5-year study of 737 older adults

No worthwhile benefits from levothyroxine treatment

About the TRUST research project

Postal

Iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment.

PPI group to refine the method and adult literacy review for plain English assessment.

Not specified

Feedback sent to all 101 participants

Scott 2018 [39]

Aggregate

Two-page summary consisted of 5 paragraphs, the first comprised a section thanking the families for their participation, disclosing publications and presentations that resulted from the study, and describing the benefits and risks of receiving the research results. Second, the study was summarised, including the hypotheses and methods. Results were then presented in a bulleted, easy to read format, then summarised in a brief paragraph, along with future directions. A section offering future neuropsychological assessment opportunities and contact information for researchers was provided. At the end of the summary, a reference to the survey was enclosed, along with publication citations.

Postal

The lay summary was developed based on the COG recommendations for returning a summary of research results

Not reported

2 years after completion of study

N/A

Aldinger 2018 [40]

Aggregate

Two summaries for separate trials were developed.

Each plain-language summary began with a note of appreciation and a disclaimer that newer information may be available since the summary was completed.

Study information in the template contained a summary of the study group and treatments, timeframe, and location of the sites. Next, the template described the study design and included a section on ‘side effects.’ The study results were then summarised with the disclaimer that they were limited to the particular study of the people who enrolled. Final comments included the official name of the study, the ClinicalTrials.gov unique identifier, the sponsor of the study, where further information could be found, and who to contact for additional information.

Online

Base on existing template that had been published [14] and its features incorporated into the European Union directive on plain-language summaries [15].

Each plain-language summary was prepared by a member of the study team and was reviewed and edited by another. Both of these individuals had been members or leaders of the multi-stakeholder group that developed the plain-language summary template. Each summary was then reviewed for accuracy and approved by the research teams of integrative medicine studies. Health literacy and numeracy principles were used throughout..”

Each summary was then reviewed for accuracy and approved by the research teams of integrative medicine studies.

As a model for a plain-language summary of aggregate research results, we used a published template that had been developed and vetted by a multi-stakeholder group, including patient advocates.

N/A

N/A

Lindquist 2019 [41]

N/A

N/A

N/A

N/A

Not reported

N/A

N/A

Schroter 2019 [2]

N/A

N/A

N/A

N/A

Patient partners as study leads/team

N/A

N/A