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Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation.

Gamble C, Dudley L, Allam A, Bell P, Goodare H, Hanley B, Preston J, Walker A, Williamson P, Young B - BMJ Open (2014)

Bottom Line: Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research.Comments on PPI by reviewers should be directional rather than state that an increase is required.Challenges facing applicants in initiating PPI prior to funding need to be addressed.

View Article: PubMed Central - PubMed

Affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.

No MeSH data available.


Related in: MedlinePlus

Percentage of outline applications containing patient and public involvement (PPI) details by the year in which the application was made. The number of trials included within each year is indicated at the top of each bar.
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BMJOPEN2014005234F2: Percentage of outline applications containing patient and public involvement (PPI) details by the year in which the application was made. The number of trials included within each year is indicated at the top of each bar.

Mentions: Twenty-six applications (26/90=28.9%) specified a role of PPI within the development of the outline application. In 13 this was managerial, on a responsive basis in seven, unclear in two and ‘other’ approaches used in four (eg, a patient survey or pilot feedback). Within the ‘other’ approaches it was difficult to determine conclusively whether this was PPI or whether they were examples of data collection aimed at ascertaining the public opinion. In the three applications that specified use of a survey the extent of the distribution of the survey was unclear in two. PPI was planned to occur within the full application for 32 trials (35.6%). In 18 this was managerial, responsive in 9 and unclear in 5. Forty-three (48%) applications indicated that PPI was planned after the trial was funded. This was as: managerial in 22; responsive in 6; a member of the TSC in 8; unclear in 5 and other in 2. Table 4 provides a summary of the specification of PPI within the outline applications by the disease area. The numbers of outline applications by year with and without details of PPI are displayed in figure 1, with figure 2 showing the percentage of applications with PPI. Figure 1 shows a general trend for increasing the number of funded applications; however, the proportion of those containing PPI fluctuates, ranging from approximately one half to two-thirds (figure 2), with the exception of 2003, for which only one application was available.


Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation.

Gamble C, Dudley L, Allam A, Bell P, Goodare H, Hanley B, Preston J, Walker A, Williamson P, Young B - BMJ Open (2014)

Percentage of outline applications containing patient and public involvement (PPI) details by the year in which the application was made. The number of trials included within each year is indicated at the top of each bar.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4120322&req=5

BMJOPEN2014005234F2: Percentage of outline applications containing patient and public involvement (PPI) details by the year in which the application was made. The number of trials included within each year is indicated at the top of each bar.
Mentions: Twenty-six applications (26/90=28.9%) specified a role of PPI within the development of the outline application. In 13 this was managerial, on a responsive basis in seven, unclear in two and ‘other’ approaches used in four (eg, a patient survey or pilot feedback). Within the ‘other’ approaches it was difficult to determine conclusively whether this was PPI or whether they were examples of data collection aimed at ascertaining the public opinion. In the three applications that specified use of a survey the extent of the distribution of the survey was unclear in two. PPI was planned to occur within the full application for 32 trials (35.6%). In 18 this was managerial, responsive in 9 and unclear in 5. Forty-three (48%) applications indicated that PPI was planned after the trial was funded. This was as: managerial in 22; responsive in 6; a member of the TSC in 8; unclear in 5 and other in 2. Table 4 provides a summary of the specification of PPI within the outline applications by the disease area. The numbers of outline applications by year with and without details of PPI are displayed in figure 1, with figure 2 showing the percentage of applications with PPI. Figure 1 shows a general trend for increasing the number of funded applications; however, the proportion of those containing PPI fluctuates, ranging from approximately one half to two-thirds (figure 2), with the exception of 2003, for which only one application was available.

Bottom Line: Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research.Comments on PPI by reviewers should be directional rather than state that an increase is required.Challenges facing applicants in initiating PPI prior to funding need to be addressed.

View Article: PubMed Central - PubMed

Affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.

No MeSH data available.


Related in: MedlinePlus