Limits...
Factors Associated with Clinical Research Recruitment in a Pediatric Academic Medical Center--A Web-Based Survey.

Denhoff ER, Milliren CE, de Ferranti SD, Steltz SK, Osganian SK - PLoS ONE (2015)

Bottom Line: Recruitment method appeared to be the only significant and independent factor associated with achieving 80% or more of target enrollment in closed to enrollment protocols.Closed to enrollment protocols that used recruitment in person were 4.55 times (95% CI 1.30 to 15.93; p = 0.02) more likely to achieve 80% or more of their target enrollment when compared to those that used other recruitment methods.Future research is needed on larger and more diverse samples to gain a better understanding of how the characteristics and qualifications of the individuals who conduct recruitment influence participant enrollment as well as how best to approach patient and families for their participation.

View Article: PubMed Central - PubMed

Affiliation: The Clinical Research Center, Boston Children's Hospital, Boston, MA, United States of America.

ABSTRACT

Background: One of the most difficult aspects of conducting clinical research is the ability to successfully recruit participants. Pediatric clinical research presents unique recruitment challenges that relate to the need for parental consent on behalf of a minor, child assent, and school attendance. Yet, this has been less well studied. We conducted a survey of investigators performing human subjects research in a single large academic pediatric hospital to better understand characteristics of studies with successful recruitment.

Methods: We conducted a web-based survey from September 2011 to December 2011 of all principal investigators with an Institutional Review Board approved human subjects protocol at Boston Children's Hospital, a pediatric Academic Medical Center. The survey captured various characteristics of the protocols including study design, staffing, resources, and investigator experience and training as well as respondents' perceived barriers and facilitators to recruitment. We used chi square tests and Mantel-Haenszel test for linear trend to examine the relationship between selected predictor variables and the binary outcome of successful vs. unsuccessful recruitment and multivariable logistic regression analyses to examine the simultaneous influence of potential predictors on each outcome.

Results: Among the 349 eligible investigators, 52% responded to the survey, and 181 with valid data were included in the analyses. Two-thirds of the 87 protocols closed to enrollment reached 80% or more of their target enrollment, whereas, only one-third of the 94 protocols actively recruiting were meeting 80% of their target. Recruitment method appeared to be the only significant and independent factor associated with achieving 80% or more of target enrollment in closed to enrollment protocols. Closed to enrollment protocols that used recruitment in person were 4.55 times (95% CI 1.30 to 15.93; p = 0.02) more likely to achieve 80% or more of their target enrollment when compared to those that used other recruitment methods. Other potentially modifiable factors such as number of study visits, study duration and investigator experience were suggestive of being meaningfully related to recruitment.

Conclusion: Recruiting in person may promote reaching an acceptable target enrollment in pediatric as well as adult clinical research. Future research is needed on larger and more diverse samples to gain a better understanding of how the characteristics and qualifications of the individuals who conduct recruitment influence participant enrollment as well as how best to approach patient and families for their participation.

No MeSH data available.


Related in: MedlinePlus

Frequency distribution of the percent of target enrollment for actively recruiting (n = 94) and closed to enrollment (n = 87) protocols.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4608599&req=5

pone.0140768.g001: Frequency distribution of the percent of target enrollment for actively recruiting (n = 94) and closed to enrollment (n = 87) protocols.

Mentions: Eighty-seven investigators (48.1%) reported that their protocols were closed to enrollment; while 94 investigators (51.9%) reported that their protocols were actively recruiting participants at the time the survey was completed (Table 1). The majority (67.4%) of the 181 protocols were observational studies. Among the 59 clinical trials, 42.4% were drug trials; 15.3% were device trials; and 32.2% were behavioral interventions. The study visits took place in multiple settings but primarily in the clinical settings including hospital ambulatory clinics (45.7%), off site or satellite ambulatory clinics (24.6%), inpatient units (35.9%), or Clinical and Translational Study Unit (16.9%). Nearly half of all protocols (46.1%) reported that they had experienced delays in their study recruitment timeline ranging from 1 to 36 months (median delay 6 months; interquartile range 4 to 12 months). Overall, approximately half (49.7%) of all protocols achieved 80% or more of their target enrollment. The distribution of percent of target enrollment for closed to enrollment and actively recruiting protocols is shown in Fig 1. For those protocols that were closed to enrollment, two-thirds (65.5%) reached 80% or more of their target enrollment; whereas substantially fewer (35.1%) protocols that were actively recruiting had reached 80% or more of their expected target enrollment based on their anticipated recruitment timeline. Fig 2 shows that actively recruiting protocols were widely dispersed at times along their recruitment timeline. A relatively greater number of protocols were falling short of 80% of their expected target enrollment at times beyond the midpoint of their timeline when compared to times earlier than the midpoint; 38 (40.4%) vs. 23 (24.5%) protocols, respectively.


Factors Associated with Clinical Research Recruitment in a Pediatric Academic Medical Center--A Web-Based Survey.

Denhoff ER, Milliren CE, de Ferranti SD, Steltz SK, Osganian SK - PLoS ONE (2015)

Frequency distribution of the percent of target enrollment for actively recruiting (n = 94) and closed to enrollment (n = 87) protocols.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4608599&req=5

pone.0140768.g001: Frequency distribution of the percent of target enrollment for actively recruiting (n = 94) and closed to enrollment (n = 87) protocols.
Mentions: Eighty-seven investigators (48.1%) reported that their protocols were closed to enrollment; while 94 investigators (51.9%) reported that their protocols were actively recruiting participants at the time the survey was completed (Table 1). The majority (67.4%) of the 181 protocols were observational studies. Among the 59 clinical trials, 42.4% were drug trials; 15.3% were device trials; and 32.2% were behavioral interventions. The study visits took place in multiple settings but primarily in the clinical settings including hospital ambulatory clinics (45.7%), off site or satellite ambulatory clinics (24.6%), inpatient units (35.9%), or Clinical and Translational Study Unit (16.9%). Nearly half of all protocols (46.1%) reported that they had experienced delays in their study recruitment timeline ranging from 1 to 36 months (median delay 6 months; interquartile range 4 to 12 months). Overall, approximately half (49.7%) of all protocols achieved 80% or more of their target enrollment. The distribution of percent of target enrollment for closed to enrollment and actively recruiting protocols is shown in Fig 1. For those protocols that were closed to enrollment, two-thirds (65.5%) reached 80% or more of their target enrollment; whereas substantially fewer (35.1%) protocols that were actively recruiting had reached 80% or more of their expected target enrollment based on their anticipated recruitment timeline. Fig 2 shows that actively recruiting protocols were widely dispersed at times along their recruitment timeline. A relatively greater number of protocols were falling short of 80% of their expected target enrollment at times beyond the midpoint of their timeline when compared to times earlier than the midpoint; 38 (40.4%) vs. 23 (24.5%) protocols, respectively.

Bottom Line: Recruitment method appeared to be the only significant and independent factor associated with achieving 80% or more of target enrollment in closed to enrollment protocols.Closed to enrollment protocols that used recruitment in person were 4.55 times (95% CI 1.30 to 15.93; p = 0.02) more likely to achieve 80% or more of their target enrollment when compared to those that used other recruitment methods.Future research is needed on larger and more diverse samples to gain a better understanding of how the characteristics and qualifications of the individuals who conduct recruitment influence participant enrollment as well as how best to approach patient and families for their participation.

View Article: PubMed Central - PubMed

Affiliation: The Clinical Research Center, Boston Children's Hospital, Boston, MA, United States of America.

ABSTRACT

Background: One of the most difficult aspects of conducting clinical research is the ability to successfully recruit participants. Pediatric clinical research presents unique recruitment challenges that relate to the need for parental consent on behalf of a minor, child assent, and school attendance. Yet, this has been less well studied. We conducted a survey of investigators performing human subjects research in a single large academic pediatric hospital to better understand characteristics of studies with successful recruitment.

Methods: We conducted a web-based survey from September 2011 to December 2011 of all principal investigators with an Institutional Review Board approved human subjects protocol at Boston Children's Hospital, a pediatric Academic Medical Center. The survey captured various characteristics of the protocols including study design, staffing, resources, and investigator experience and training as well as respondents' perceived barriers and facilitators to recruitment. We used chi square tests and Mantel-Haenszel test for linear trend to examine the relationship between selected predictor variables and the binary outcome of successful vs. unsuccessful recruitment and multivariable logistic regression analyses to examine the simultaneous influence of potential predictors on each outcome.

Results: Among the 349 eligible investigators, 52% responded to the survey, and 181 with valid data were included in the analyses. Two-thirds of the 87 protocols closed to enrollment reached 80% or more of their target enrollment, whereas, only one-third of the 94 protocols actively recruiting were meeting 80% of their target. Recruitment method appeared to be the only significant and independent factor associated with achieving 80% or more of target enrollment in closed to enrollment protocols. Closed to enrollment protocols that used recruitment in person were 4.55 times (95% CI 1.30 to 15.93; p = 0.02) more likely to achieve 80% or more of their target enrollment when compared to those that used other recruitment methods. Other potentially modifiable factors such as number of study visits, study duration and investigator experience were suggestive of being meaningfully related to recruitment.

Conclusion: Recruiting in person may promote reaching an acceptable target enrollment in pediatric as well as adult clinical research. Future research is needed on larger and more diverse samples to gain a better understanding of how the characteristics and qualifications of the individuals who conduct recruitment influence participant enrollment as well as how best to approach patient and families for their participation.

No MeSH data available.


Related in: MedlinePlus