Abstract
OBJECTIVES:
We compared two research consent techniques: a standardized video plus usual consent or usual consent alone.
METHODS:
Individuals who completed 24 month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study1 were invited to participate in an extended, longitudinal follow-up study (E-OPTIMAL).2 Potential participants who were 1) able to provide consent and 2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process vs. the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completed follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls completed. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into E-OPTIMAL. Groups were compared using an intention to treat principle, using unadjusted student’s t-test (continuous) and chi-square or Fisher’s exact (categorical) tests. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p<0.05.
RESULTS:
Of the 327 OPTIMAL completers, 305 were randomized to the consent process study (153 video vs. 152 no video). Groups were similar in demographics, surgical treatment and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs. no video 94.1%, p=0.65). There were no significant differences in the primary outcome (video 79.1% vs. no video 75.7%, p=0.47) or in any secondary outcomes. Being “very satisfied” overall with study information (97.7% vs. 88.5%, p=0.01); “strong agreement” for feeling informed about the study (81.3% vs. 70.8%, p=0.06), understanding the study purpose (83.6% vs. 71.0%, p=0.02), nature and extent (82.8% vs. 70.2%, p=0.02), and potential societal benefits (82.8% vs. 67.9%, p=0.01); and research coordinator/study nurse relationship being “very important” (72.7% vs. 63.4%, p=0.03) were better in the video compared to no video consent group.
CONCLUSIONS:
The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.
Background and Aims:
Pelvic floor disorders, including pelvic organ prolapse, urinary incontinence, and fecal incontinence, affect approximately 20% of women and represent a significant public health problem.3 The lifetime risk that a woman in the United States will have surgery for prolapse or urinary incontinence is 20%, with reoperation rates approaching 30%.4 Given the high recurrence rate and the projected 35% increase in demand for care for pelvic floor disorders by 20305, rigorous trials evaluating outcomes for pelvic reconstructive surgery are needed to guide clinical practice.
Randomized controlled trials are the gold standard for objectively evaluating the effectiveness of healthcare interventions. Despite their importance, patient recruitment is often challenging, with only one-third of trials achieving recruitment goals, and one-fourth failing to reach even 50% of the projected sample size.6,7 Adverse consequences of poor recruitment may include under-powered studies, need for trial extension with associated additional costs and labor, premature study closure, and delays in dissemination of important results for clinical practice.6
One potential strategy to improve patient recruitment and retention is to enhance the informed consent process with an audio-visual presentation that provides information about the disease, and includes details of trial participation. Audio-visual presentation methods may improve the quality of information communicated, reduce investigator bias,8 enhance understanding of complex concepts, and facilitate subject recruitment.9 Two recent Cochrane reviews evaluating this strategy identified a total of nineteen randomized and quasi-randomized controlled trials.9,10 Although results from both reviews suggest that this intervention makes little difference in the rate of participation or willingness to participate, the reviewers acknowledge that the value of audio-visual interventions remains unclear due to the large body of poor quality studies, and the inclusion of many hypothetical studies.8,10 They further encouraged investigators to continue exploring novel methods of providing information to potential trial participants, and emphasized more rigorous evaluation of recruitment strategies in high quality real clinical trials.8,10
Pelvic organ prolapse is downward descent of the female bladder, uterus, or post-hysterectomy vaginal cuff and the small or large bowel, resulting in protrusion of the vagina, uterus, or both through the opening of the vagina. The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study was a multicenter randomized trial comparing two transvaginal approaches to prolapse repair, sacrospinous ligament fixation and uterosacral ligament vaginal vault suspension.1 Two-year outcomes have been published.1 The extended OPTIMAL (E-OPTIMAL) study was designed to lengthen the follow up of these women, and compare 5-year success and complication rates.2 E-OPTIMAL thus provided a unique opportunity to address current limitations in the literature and examine recruitment strategies within a real clinical trial and test the null hypothesis of no difference between standard vs. video-enhanced recruitment methods. The objective of this embedded study was to determine if a standardized video recruitment tool improves patient enrollment and retention in a long-term study of women undergoing vaginal reconstructive surgery.
Methods:
The OPTIMAL study was a 2×2 factorial trial comparing 2-year outcomes in women undergoing vaginal apical prolapse repair with mid-urethral sling for stress urinary incontinence.1,11 There were two randomized assignments: 1) perioperative behavioral therapy with pelvic floor muscle training versus usual care and 2) surgical intervention. Anatomic, functional and adverse events outcomes were not significantly different between the surgical groups, and no benefit was seen from behavioral therapy with pelvic floor muscle training on urinary incontinence symptoms at 6 months or prolapse outcomes at 2 years.1 There were statistically and clinically significant improvements in quality of life, sexual function and body image at 2 years without group differences.1,12 Participants in the original trial were asked to complete a questionnaire on motivation and barriers for participation in research at 24-months.
After their completion of the OPTIMAL trial, women were assessed for eligibility to participate in the extended E-OPTIMAL study. We excluded individuals who were unable to provide informed consent or were long-term residents of a skilled nursing facility. Women who unable to return for annual visits were not excluded but were permitted to participate in the telephone interview, although in-person participation was encouraged.
Interventions
Participating institutional review boards permitted randomization without disclosure of consent method randomization to individuals undergoing research consent, due to the strong likelihood that a formal research consent process regarding the research consent process itself could affect the findings of the intended study. Participants who completed 2 years of follow up in the OPTIMAL trial were randomized into one of two consent method assignments prior to the coordinator’s invitation for enrollment in the extended E-OPTIMAL study: 1) standardized video followed by the usual consent process or 2) usual consent process alone. The standardized video included the rationale for women’s health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. During the usual informed consent process, the local research coordinator invited the potential participant to consider follow-up for 3 more years. For participants assigned to the video group, the potential participant viewed the study video before undergoing the usual informed consent process. The study coordinator was not masked to the enrollment intervention. Evaluators of outcome assessments were masked to surgical, behavioral therapy with pelvic floor muscle training, and enrollment process randomizations. Masking of the randomized original OPTIMAL trial interventions was continued until that time that all E-OPTIMAL study participants completed the OPTIMAL trial.
Outcomes
The primary outcome for the extended study enrollment intervention was the proportion of eligible subjects who consented to enroll in the extended study and completed end-of-study data collection events in year 3 of the extended trial follow-up (equivalent to year 5 from enrollment in the original OPTIMAL trial). Multiple data collection events occurred, including an in-person evaluation at the clinical site and a quality of life telephone interview by the central facility at the Data Coordinating Center. Allowable windows for timed evaluations and telephone interviews included a three-month window on each side of the anniversary of the initial surgery.
Secondary exploratory outcomes for the enrollment intervention were the proportion of OPTIMAL participants who enrolled in the extended study as well as the proportion who completed follow-up annual study tasks at 3, 4 and 5 years after surgery. The total number of completed in-person clinic visits and quality of life assessment were also calculated. Subjective evaluation of satisfaction with the study informed consent process as well as study-level and personal-level motivation and barriers to enrollment in E-OPTIMAL were assessed. Reasons for participating in women’s health research or in this specific study were also collected yearly during extended follow-up. Characteristics affecting willingness and ability to participate in research (e.g. distance to travel and method of survey administration) were also assessed. Women who agreed to participate in the E-OPTIMAL study were compared to those who did not agree in order to identify factors associated with participation.
The estimated sample size for the OPTIMAL trial was 340 randomized participants (170 per surgical treatment group) to provide 80% power for differentiating failure rates of 30% and 17% (success rates of 70% and 83%) using a two-tailed 5% level of significance using the dichotomous definition of surgical failure 2 years after surgery.1 A total of 400 participants were expected to be enrolled (200 per group) in the OPTIMAL trial accounting for a projected 15% drop out/loss to follow-up rate over 2 years. Based on the enrollment and attrition in a long-term study following women treated for prolapse by abdominal sacral colpopexy, we conservatively assumed that at least 75% of participants in the OPTIMAL trial (n=255) would enroll in the extended study and the annual drop-out or loss to follow-up rate would be approximately 5%.13 As such, we anticipated approximately 218 participants would provide year 5 data for the E-OPTIMAL extended longitudinal study. The addition of the video to the informed consent process improving the proportion who enrolled and completed the extended study by 15% or more was felt to be clinically important. With N=340 (170/group), there would be an 87% power to detect a 15% difference in this proportion between the enrollment interventions (64% vs. 79%) using a two-sided Type I error rate of 5%.
The primary endpoint for the E-OPTIMAL enrollment intervention was assessed using the chi-square test. The primary analysis was conducted using an intention to treat principle by analyzing all participants in the enrollment group to which they were randomized. Statistical tests were 2-sided, and significance was evaluated at an alpha level of 0.05. No adjustments were made for performing multiple statistical tests; however, comparisons of secondary outcomes were considered exploratory. All procedures were approved by local institutional ethics review boards of participating sites and participating patients provided written informed consent for the E-OPTIMAL extended study (after randomization to the consent intervention).
Results:
The original OPTIMAL cohort (n=374) included 327 (87%) participants who completed the 2-year primary outcome. Of those participants, 305 (93%, or 82% of original OPTIMAL participants) were enrolled and randomized to video (153) or no video (152) (Figure 1).
Figure 1. OPTIMAL and Extended Study Participant Flow.
* Of these 30 participants in total that did not consent, 29 provided responses to the Motivations and Barriers to Enrollment questionnaire; the missing response was from a participant in the “No Video” group.
Table 1 demonstrates the baseline and characteristics of the women randomized to no video vs. video. Overall, there were no differences in age, race, medical history, surgical treatment or surgical outcomes in the two groups. For the primary outcome, the type of consent process (no video vs. video) did not impact likelihood to enroll or complete follow up at any time point (Table 2). Higher rates of “very important” or “strong agreement” with factors affecting the decision to participate in the study were noted in the video group for a) relationship with the research coordinator/study nurse, b) feeling well informed about the study, c) understanding the purpose of the study, d) the nature and extent of the study, and e) the societal benefits of the study (Figure 2). Overall satisfaction with the information provided about the study was also higher in the video group than the no video group (p=0.01) (Figure 2).
Table 1.
Characteristics of Participants Randomized to No Video vs. Video
| Characteristic | Category | Video (N=153) | No Video (N=152) |
|---|---|---|---|
| Characteristic assessed at OPTIMAL baseline visit | |||
| Age at Surgical Randomization | Mean (n=305) | 57.5 (10.9) | 57.3 (10.8) |
| Race | White | 124 (81.0%) | 132 (86.8%) |
| Black | 13 (8.5%) | 8 (5.3%) | |
| Asian | 2 (1.3%) | 1 (0.7%) | |
| American Indian/Alaska Native | 1 (0.7%) | 1 (0.7%) | |
| Other | 13 (8.5%) | 10 (6.6%) | |
| Hispanic | 29 (19.0%) | 30 (19.7%) | |
| Insurance: Private or HMO | 104 (68.0%) | 100 (65.8%) | |
| Insurance: Medicare/Medicaid | 43 (28.1%) | 45 (29.6%) | |
| Insurance: Self Pay | 2 (1.3%) | 4 (2.6%) | |
| Insurance: Other | 29 (19.0%) | 29 (19.1%) | |
| Number of Vaginal Deliveries | Mean (n=305) | 3.0 (2.1) | 2.9 (1.7) |
| Number of Caesarean Deliveries | Mean (n=305) | 0.1 (0.3) | 0.1 (0.6) |
| Menopausal Status | Pre-Menopausal | 38 (24.8%) | 50 (32.9%) |
| Post-Menopausal | 107 (69.9%) | 95 (62.5%) | |
| Not Sure | 8 (5.2%) | 7 (4.6%) | |
| Estrogen by Oral or Skin Patch | 19 (12.4%) | 19 (12.5%) | |
| Estrogen by Vaginal Cream or Tablets | 33 (21.6%) | 42 (27.6%) | |
| Current Smoker | 13 (8.5%) | 11 (7.2%) | |
| Diabetes | 15 (9.9%) | 20 (13.6%) | |
| Connective Tissue Disease | 3 (2.0%) | 2 (1.3%) | |
| Prior Hysterectomy | 38 (24.8%) | 39 (25.7%) | |
| Prior SUI Surgery | 7 (4.6%) | 5 (3.3%) | |
| Prior POP Surgery | 9 (5.9%) | 12 (7.9%) | |
| Body Mass Index | Mean (n=304) | 29.3 (5.6) | 28.2 (5.2) |
| POP-Q Stage at Baseline | 2 | 56 (36.6%) | 61 (40.1%) |
| 3 | 91 (59.5%) | 84 (55.3%) | |
| 4 | 6 (3.9%) | 7 (4.6%) | |
| Main Study Randomized Surgical Treatment | ULS | 78/153 (51.0%) | 76/152 (50.0%) |
| SSLF | 75/153 (49.0%) | 76/152 (50.0%) | |
| Supervised PME | 3/151 (2.0%) | 9/150 (6.0%) | |
| Regular PME | 29/152 (19.1%) | 39/150 (26.0%) | |
| Outcome assessed at OPTIMAL 2-year visit | |||
| 24 Month: Surgical Success | 97/140 (69.3%) | 93/140 (66.4%) | |
| 24 Month: Long-term Anatomic Failure for PMT | 32/148 (21.6%) | 31/147 (21.1%) | |
| 24 Month: Any Bothersome Bulge Symptoms | 22/141 (15.6%) | 25/136 (18.4%) | |
| 24 Month: Apical Descent | 16/148 (10.8%) | 15/146 (10.3%) | |
| 24 Month: Anterior Prolapse | 19/148 (12.8%) | 15/147 (10.2%) | |
| 24 Month: Posterior Prolapse | 1/148 (0.7%) | 5/147 (3.4%) | |
| 24 Month: Apical Prolapse | 0/148 (0.0%) | 2/146 (1.4%) | |
| 24 Month: Either Surgical or Pessary Retreatment for POP | 6/148 (4.1%) | 8/148 (5.4%) | |
| Consented to enrollment in EOPTIMAL | 142 (92.8%) | 143 (94.1%) | |
Table 2:
E-OPTIMAL enrollment and completion of follow up
| Video | No video | Unadjusted p-value | |
|---|---|---|---|
| 1° Outcome (% consented & complete data at yr 5 n/N (%)) | 121/153 (79.1%) | 115/152 (75.7%) | 0.47 |
| Enrolled in the extended study n/N (%) | 142/153 (93%) | 143/152 (94%) | 0.65 |
| Complete follow up at each year n/N (%) | Yr 3: 139/142 (97.9%) Yr 4: 131/142 (92.3%) Yr 5: 124/142 (87.3%) |
135/143 (94.4%) 124/143 (86.7%) 120/143 (83.9%) |
0.13 0.13 0.41 |
| Completion of expected data collection points n/N (%) | 712/852 (83.6%) | 699/858 (81.5%) | 0.25 |
| Completion of in person visits n/N (%) | 354/426 (83.1%) | 355/429 (82.8%) | 0.89 |
| Completion of QOL calls n/N (%) | 358/426 (84.0%) | 344/429 (80.2%) | 0.14 |
Figure 2:
Comparison of Factors Associated with Decision to Participate in E-OPTIMAL: Percent of participants who responded “very important”, “strongly agree”, or “very satisfied”
For those women who enrolled in E-OPTIMAL study, the reasons for participating in women’s health research or in this specific study did not vary significantly over the 5-year study, except for some statistically (but likely not clinically relevant) changes in the desire to “improve my own health” (E-Table 3). At the time of enrollment in the extended study (year 2), factors rated by participants as being important or very important to show appreciation for their contributions to the study included “sharing results of the study” (91% of participants) and “verbal appreciation” (85% of participants), while only 44% rated “money” as important or very important (Figure 3 and E-Table 3). Similarly, a number of factors were rated as “very important” or “important” for driving a decision to participate in a research study, but compensation via money or other gifts were rated least highly (Figures 4a–d). Factors affecting the decision to participate in research did not change over the course of the 5-year study (E-Table 3).
ETable 3:
Motivation and Barriers Described by Research Participants
| Variable | Category | Year 2 (N=285) | Year 3 (N=259) | Year 4 (N=227) | Year 5 (N=227) | Unadjusted P-value |
|---|---|---|---|---|---|---|
| Reasons for participating in women’s health research: I enjoy making contributions to medical research | Ranked first | 52/285 (18.2%) | 41/259 (15.8%) | 43/227 (18.9%) | 45/227 (19.8%) | 0.91 |
| Ranked second | 61/285 (21.4%) | 54/259 (20.8%) | 44/227 (19.4%) | 49/227 (21.6%) | ||
| Ranked third | 73/285 (25.6%) | 64/259 (24.7%) | 62/227 (27.3%) | 49/227 (21.6%) | ||
| Did Not Rank | 99/285 (34.7%) | 100/259 (38.6%) | 78/227 (34.4%) | 84/227 (37.0%) | ||
| I want to contribute to medical knowledge that may help others, including my loved ones, in the future | Ranked first | 140/285 (49.1%) | 132/259 (51.0%) | 106/227 (46.7%) | 118/227 (52.0%) | 0.36 |
| Ranked second | 86/285 (30.2%) | 75/259 (29.0%) | 86/227 (37.9%) | 72/227 (31.7%) | ||
| Ranked third | 27/285 (9.5%) | 23/259 (8.9%) | 11/227 (4.8%) | 19/227 (8.4%) | ||
| Did Not Rank | 32/285 (11.2%) | 29/259 (11.2%) | 24/227 (10.6%) | 18/227 (7.9%) | ||
| I want to improve my own health | Ranked first | 85/285 (29.8%) | 71/259 (27.4%) | 61/227 (26.9%) | 50/227 (22.0%) | 0.74 |
| Ranked second | 86/285 (30.2%) | 78/259 (30.1%) | 65/227 (28.6%) | 69/227 (30.4%) | ||
| Ranked third | 65/285 (22.8%) | 67/259 (25.9%) | 60/227 (26.4%) | 69/227 (30.4%) | ||
| Did Not Rank | 49/285 (17.2%) | 43/259 (16.6%) | 41/227 (18.1%) | 39/227 (17.2%) | ||
| I think that studies improve my own access to a specific medical test or treatment | Ranked first | 10/285 (3.5%) | 12/259 (4.6%) | 13/227 (5.7%) | 7/227 (3.1%) | 0.97 |
| Ranked second | 29/285 (10.2%) | 26/259 (10.0%) | 21/227 (9.3%) | 22/227 (9.7%) | ||
| Ranked third | 51/285 (17.9%) | 45/259 (17.4%) | 42/227 (18.5%) | 40/227 (17.6%) | ||
| Did Not Rank | 195/285 (68.4%) | 176/259 (68.0%) | 151/227 (66.5%) | 158/227 (69.6%) | ||
| I think that health care is better for research participants | Ranked first | 10/285 (3.5%) | 1/259 (0.4%) | 4/227 (1.8%) | 2/227 (0.9%) | 0.19 |
| Ranked second | 10/285 (3.5%) | 13/259 (5.0%) | 5/227 (2.2%) | 11/227 (4.8%) | ||
| Ranked third | 27/285 (9.5%) | 25/259 (9.7%) | 24/227 (10.6%) | 24/227 (10.6%) | ||
| Did Not Rank | 238/285 (83.5%) | 220/259 (84.9%) | 194/227 (85.5%) | 190/227 (83.7%) | ||
| I want the extra money or incentives (for example, gifts) | Ranked first | 2/285 (0.7%) | 0/259 (0.0%) | 2/227 (0.9%) | 2/227 (0.9%) | 0.72 |
| Ranked second | 3/285 (1.1%) | 4/259 (1.5%) | 3/227 (1.3%) | 0/227 (0.0%) | ||
| Ranked third | 28/285 (9.8%) | 22/259 (8.5%) | 18/227 (7.9%) | 19/227 (8.4%) | ||
| Did Not Rank | 252/285 (88.4%) | 233/259 (90.0%) | 204/227 (89.9%) | 206/227 (90.7%) | ||
| Reasons for participating in this study: I enjoy making contributions to medical research | Ranked first | 64/285 (22.5%) | 55/259 (21.2%) | 62/227 (27.3%) | 52/227 (22.9%) | 0.58 |
| Ranked second | 75/285 (26.3%) | 61/259 (23.6%) | 50/227 (22.0%) | 65/227 (28.6%) | ||
| Ranked third | 81/285 (28.4%) | 70/259 (27.0%) | 57/227 (25.1%) | 53/227 (23.3%) | ||
| Did Not Rank | 65/285 (22.8%) | 73/259 (28.2%) | 58/227 (25.6%) | 57/227 (25.1%) | ||
| I want to contribute to medical knowledge that may help others, including my loved ones, in the future | Ranked first | 140/285 (49.1%) | 127/259 (49.0%) | 102/227 (44.9%) | 125/227 (55.1%) | 0.53 |
| Ranked second | 87/285 (30.5%) | 90/259 (34.7%) | 84/227 (37.0%) | 64/227 (28.2%) | ||
| Ranked third | 23/285 (8.1%) | 17/259 (6.6%) | 18/227 (7.9%) | 18/227 (7.9%) | ||
| Did Not Rank | 35/285 (12.3%) | 25/259 (9.7%) | 23/227 (10.1%) | 20/227 (8.8%) | ||
| I want to improve my own health | Ranked first | 75/285 (26.3%) | 61/259 (23.6%) | 52/227 (22.9%) | 33/227 (14.5%) | 0.01 |
| Ranked second | 77/285 (27.0%) | 73/259 (28.2%) | 56/227 (24.7%) | 63/227 (27.8%) | ||
| Ranked third | 72/285 (25.3%) | 89/259 (34.4%) | 78/227 (34.4%) | 78/227 (34.4%) | ||
| Did Not Rank | 61/285 (21.4%) | 36/259 (13.9%) | 41/227 (18.1%) | 53/227 (23.3%) | ||
| I think that studies improve my own access to a specific medical treatment, such as physical therapy | Ranked first | 9/285 (3.2%) | 8/259 (3.1%) | 5/227 (2.2%) | 3/227 (1.3%) | 0.88 |
| Ranked second | 22/285 (7.7%) | 20/259 (7.7%) | 22/227 (9.7%) | 21/227 (9.3%) | ||
| Ranked third | 40/285 (14.0%) | 28/259 (10.8%) | 28/227 (12.3%) | 29/227 (12.8%) | ||
| Did Not Rank | 214/285 (75.1%) | 203/259 (78.4%) | 172/227 (75.8%) | 174/227 (76.7%) | ||
| I think that health care is better for research participants | Ranked first | 8/285 (2.8%) | 5/259 (1.9%) | 7/227 (3.1%) | 6/227 (2.6%) | 0.90 |
| Ranked second | 9/285 (3.2%) | 6/259 (2.3%) | 8/227 (3.5%) | 11/227 (4.8%) | ||
| Ranked third | 31/285 (10.9%) | 31/259 (12.0%) | 22/227 (9.7%) | 28/227 (12.3%) | ||
| Did Not Rank | 237/285 (83.2%) | 217/259 (83.8%) | 190/227 (83.7%) | 182/227 (80.2%) | ||
| I want the extra money or incentives (for example, gifts) | Ranked first | 1/285 (0.4%) | 0/259 (0.0%) | 3/227 (1.3%) | 2/227 (0.9%) | 0.72 |
| Ranked second | 4/285 (1.4%) | 2/259 (0.8%) | 2/227 (0.9%) | 2/227 (0.9%) | ||
| Ranked third | 22/285 (7.7%) | 16/259 (6.2%) | 18/227 (7.9%) | 13/227 (5.7%) | ||
| Did Not Rank | 258/285 (90.5%) | 241/259 (93.1%) | 204/227 (89.9%) | 210/227 (92.5%) | ||
| What are the most important ways for your research team to show their appreciation to you for your contributions to the study? Money | Very Important | 45/280 (16.1%) | 42/249 (16.9%) | 31/221 (14.0%) | 33/217 (15.2%) | 0.97 |
| Important | 77/280 (27.5%) | 68/249 (27.3%) | 60/221 (27.1%) | 52/217 (24.0%) | ||
| Neither Important nor Unimportant | 109/280 (38.9%) | 94/249 (37.8%) | 94/221 (42.5%) | 92/217 (42.4%) | ||
| Unimportant | 49/280 (17.5%) | 45/249 (18.1%) | 36/221 (16.3%) | 40/217 (18.4%) | ||
| Less waiting time for appointment | Very Important | 68/279 (24.4%) | 62/250 (24.8%) | 49/225 (21.8%) | 52/217 (24.0%) | 0.98 |
| Important | 112/279 (40.1%) | 106/250 (42.4%) | 98/225 (43.6%) | 91/217 (41.9%) | ||
| Neither Important nor Unimportant | 71/279 (25.4%) | 63/250 (25.2%) | 60/225 (26.7%) | 52/217 (24.0%) | ||
| Unimportant | 28/279 (10.0%) | 19/250 (7.6%) | 18/225 (8.0%) | 22/217 (10.1%) | ||
| Gifts | Very Important | 67/277 (24.2%) | 63/244 (25.8%) | 48/221 (21.7%) | 44/214 (20.6%) | 0.79 |
| Important | 14/277 (5.1%) | 16/244 (6.6%) | 14/221 (6.3%) | 14/214 (6.5%) | ||
| Neither Important nor Unimportant | 118/277 (42.6%) | 95/244 (38.9%) | 105/221 (47.5%) | 94/214 (43.9%) | ||
| Unimportant | 78/277 (28.2%) | 70/244 (28.7%) | 54/221 (24.4%) | 62/214 (29.0%) | ||
| Share results of study | Very Important | 162/282 (57.4%) | 122/252 (48.4%) | 122/224 (54.5%) | 114/219 (52.1%) | 0.48 |
| Important | 94/282 (33.3%) | 107/252 (42.5%) | 89/224 (39.7%) | 88/219 (40.2%) | ||
| Neither Important nor Unimportant | 23/282 (8.2%) | 20/252 (7.9%) | 10/224 (4.5%) | 15/219 (6.8%) | ||
| Unimportant | 3/282 (1.1%) | 3/252 (1.2%) | 3/224 (1.3%) | 2/219 (0.9%) | ||
| Free parking | Very Important | 88/279 (31.5%) | 65/251 (25.9%) | 52/224 (23.2%) | 60/219 (27.4%) | 0.68 |
| Important | 83/279 (29.7%) | 91/251 (36.3%) | 83/224 (37.1%) | 73/219 (33.3%) | ||
| Neither Important nor Unimportant | 80/279 (28.7%) | 71/251 (28.3%) | 64/224 (28.6%) | 66/219 (30.1%) | ||
| Unimportant | 28/279 (10.0%) | 24/251 (9.6%) | 25/224 (11.2%) | 20/219 (9.1%) | ||
| Verbal appreciation | Very Important | 104/280 (37.1%) | 72/249 (28.9%) | 68/224 (30.4%) | 59/215 (27.4%) | 0.34 |
| Important | 133/280 (47.5%) | 125/249 (50.2%) | 113/224 (50.4%) | 121/215 (56.3%) | ||
| Neither Important nor Unimportant | 33/280 (11.8%) | 42/249 (16.9%) | 36/224 (16.1%) | 27/215 (12.6%) | ||
| Unimportant | 10/280 (3.6%) | 10/249 (4.0%) | 7/224 (3.1%) | 8/215 (3.7%) | ||
| Factors affecting decision to participate in a research study: Pain or discomfort involved for study procedures | Very Important | 62/277 (22.4%) | 64/249 (25.7%) | 47/224 (21.0%) | 48/219 (21.9%) | 0.88 |
| Important | 87/277 (31.4%) | 70/249 (28.1%) | 81/224 (36.2%) | 68/219 (31.1%) | ||
| Neither Important nor Unimportant | 90/277 (32.5%) | 79/249 (31.7%) | 66/224 (29.5%) | 72/219 (32.9%) | ||
| Unimportant | 38/277 (13.7%) | 36/249 (14.5%) | 30/224 (13.4%) | 31/219 (14.2%) | ||
| Extra time involved for study | Very Important | 49/279 (17.6%) | 48/251 (19.1%) | 33/220 (15.0%) | 37/218 (17.0%) | 0.26 |
| Important | 78/279 (28.0%) | 84/251 (33.5%) | 89/220 (40.5%) | 83/218 (38.1%) | ||
| Neither Important nor Unimportant | 97/279 (34.8%) | 76/251 (30.3%) | 62/220 (28.2%) | 62/218 (28.4%) | ||
| Unimportant | 55/279 (19.7%) | 43/251 (17.1%) | 36/220 (16.4%) | 36/218 (16.5%) | ||
| Travel time or distance | Very Important | 43/277 (15.5%) | 44/252 (17.5%) | 38/224 (17.0%) | 40/220 (18.2%) | 0.83 |
| Important | 94/277 (33.9%) | 81/252 (32.1%) | 69/224 (30.8%) | 79/220 (35.9%) | ||
| Neither Important nor Unimportant | 87/277 (31.4%) | 90/252 (35.7%) | 77/224 (34.4%) | 69/220 (31.4%) | ||
| Unimportant | 53/277 (19.1%) | 37/252 (14.7%) | 40/224 (17.9%) | 32/220 (14.5%) | ||
| Travel costs | Very Important | 41/279 (14.7%) | 44/251 (17.5%) | 29/225 (12.9%) | 33/218 (15.1%) | 0.80 |
| Important | 94/279 (33.7%) | 76/251 (30.3%) | 74/225 (32.9%) | 70/218 (32.1%) | ||
| Neither Important nor Unimportant | 95/279 (34.1%) | 93/251 (37.1%) | 85/225 (37.8%) | 87/218 (39.9%) | ||
| Unimportant | 49/279 (17.6%) | 38/251 (15.1%) | 37/225 (16.4%) | 28/218 (12.8%) | ||
| Uncertainty about which treatment you’ll receive (randomization) | Very Important | 46/280 (16.4%) | 47/253 (18.6%) | 31/225 (13.8%) | 38/220 (17.3%) | 0.30 |
| Important | 90/280 (32.1%) | 73/253 (28.9%) | 85/225 (37.8%) | 82/220 (37.3%) | ||
| Neither Important nor Unimportant | 98/280 (35.0%) | 94/253 (37.2%) | 85/225 (37.8%) | 75/220 (34.1%) | ||
| Unimportant | 46/280 (16.4%) | 39/253 (15.4%) | 24/225 (10.7%) | 25/220 (11.4%) | ||
| Difficulty scheduling visits (for example, taking time off from work, other activities) | Very Important | 55/281 (19.6%) | 46/253 (18.2%) | 38/225 (16.9%) | 39/219 (17.8%) | 0.99 |
| Important | 85/281 (30.2%) | 73/253 (28.9%) | 65/225 (28.9%) | 70/219 (32.0%) | ||
| Neither Important nor Unimportant | 81/281 (28.8%) | 83/253 (32.8%) | 73/225 (32.4%) | 65/219 (29.7%) | ||
| Unimportant | 60/281 (21.4%) | 51/253 (20.2%) | 49/225 (21.8%) | 45/219 (20.5%) | ||
| Not enough money | Very Important | 55/278 (19.8%) | 52/252 (20.6%) | 38/222 (17.1%) | 38/220 (17.3%) | 0.64 |
| Important | 24/278 (8.6%) | 26/252 (10.3%) | 26/222 (11.7%) | 16/220 (7.3%) | ||
| Neither Important nor Unimportant | 118/278 (42.4%) | 108/252 (42.9%) | 97/222 (43.7%) | 111/220 (50.5%) | ||
| Unimportant | 81/278 (29.1%) | 66/252 (26.2%) | 61/222 (27.5%) | 55/220 (25.0%) | ||
| Not enough gifts or other reward (not including money) | Very Important | 67/279 (24.0%) | 61/253 (24.1%) | 50/222 (22.5%) | 48/218 (22.0%) | 0.28 |
| Important | 7/279 (2.5%) | 16/253 (6.3%) | 17/222 (7.7%) | 8/218 (3.7%) | ||
| Neither Important nor Unimportant | 117/279 (41.9%) | 106/253 (41.9%) | 87/222 (39.2%) | 101/218 (46.3%) | ||
| Unimportant | 88/279 (31.5%) | 70/253 (27.7%) | 68/222 (30.6%) | 61/218 (28.0%) | ||
| Family care responsibilities (for spouse, parent or child) | Very Important | 60/278 (21.6%) | 60/246 (24.4%) | 49/215 (22.8%) | 39/212 (18.4%) | 0.90 |
| Important | 67/278 (24.1%) | 56/246 (22.8%) | 52/215 (24.2%) | 50/212 (23.6%) | ||
| Neither Important nor Unimportant | 86/278 (30.9%) | 82/246 (33.3%) | 68/215 (31.6%) | 77/212 (36.3%) | ||
| Unimportant | 65/278 (23.4%) | 48/246 (19.5%) | 46/215 (21.4%) | 46/212 (21.7%) | ||
| Travel to visits: Typically, how do you get to your clinical research visits? | Drive your own car | 228/281 (81.1%) | 195/249 (78.3%) | 161/216 (74.5%) | 162/214 (75.7%) | 0.50 |
| Take public transportation | 9/281 (3.2%) | 5/249 (2.0%) | 9/216 (4.2%) | 8/214 (3.7%) | ||
| Walk | 3/281 (1.1%) | 2/249 (0.8%) | 2/216 (0.9%) | 3/214 (1.4%) | ||
| Family member drives you | 38/281 (13.5%) | 39/249 (15.7%) | 34/216 (15.7%) | 39/214 (18.2%) | ||
| Friend drives you | 2/281 (0.7%) | 6/249 (2.4%) | 7/216 (3.2%) | 1/214 (0.5%) | ||
| Other | 1/281 (0.4%) | 2/249 (0.8%) | 3/216 (1.4%) | 1/214 (0.5%) | ||
| Typically, how long does it take you to travel to your OPTIMAL clinical research visits? | Less than 15 minutes | 15/281 (5.3%) | 14/254 (5.5%) | 12/221 (5.4%) | 14/218 (6.4%) | 0.98 |
| 15 minutes to less than 30 minutes | 99/281 (35.2%) | 81/254 (31.9%) | 71/221 (32.1%) | 69/218 (31.7%) | ||
| 30 minutes to less than 1 hour | 98/281 (34.9%) | 93/254 (36.6%) | 76/221 (34.4%) | 72/218 (33.0%) | ||
| 1 hour or greater | 69/281 (24.6%) | 66/254 (26.0%) | 62/221 (28.1%) | 63/218 (28.9%) | ||
| Preferences for ways to answer questions about your health in a study: Clinic visit | Ranked first | 134/285 (47.0%) | 119/259 (45.9%) | 110/227 (48.5%) | 115/227 (50.7%) | 0.13 |
| Ranked second | 64/285 (22.5%) | 59/259 (22.8%) | 51/227 (22.5%) | 32/227 (14.1%) | ||
| Ranked third | 57/285 (20.0%) | 42/259 (16.2%) | 36/227 (15.9%) | 39/227 (17.2%) | ||
| Did Not Rank | 30/285 (10.5%) | 39/259 (15.1%) | 30/227 (13.2%) | 41/227 (18.1%) | ||
| Telephone interview | Ranked first | 85/285 (29.8%) | 68/259 (26.3%) | 58/227 (25.6%) | 41/227 (18.1%) | 0.11 |
| Ranked second | 123/285 (43.2%) | 104/259 (40.2%) | 89/227 (39.2%) | 100/227 (44.1%) | ||
| Ranked third | 50/285 (17.5%) | 52/259 (20.1%) | 47/227 (20.7%) | 48/227 (21.1%) | ||
| Did Not Rank | 27/285 (9.5%) | 35/259 (13.5%) | 33/227 (14.5%) | 38/227 (16.7%) | ||
| Internet questionnaire | Ranked first | 37/285 (13.0%) | 45/259 (17.4%) | 35/227 (15.4%) | 36/227 (15.9%) | 0.81 |
| Ranked second | 41/285 (14.4%) | 33/259 (12.7%) | 35/227 (15.4%) | 40/227 (17.6%) | ||
| Ranked third | 61/285 (21.4%) | 50/259 (19.3%) | 49/227 (21.6%) | 41/227 (18.1%) | ||
| Did Not Rank | 146/285 (51.2%) | 131/259 (50.6%) | 108/227 (47.6%) | 110/227 (48.5%) | ||
| Mail-in questionnaire | Ranked first | 28/285 (9.8%) | 18/259 (6.9%) | 25/227 (11.0%) | 26/227 (11.5%) | 0.69 |
| Ranked second | 45/285 (15.8%) | 51/259 (19.7%) | 43/227 (18.9%) | 40/227 (17.6%) | ||
| Ranked third | 101/285 (35.4%) | 97/259 (37.5%) | 86/227 (37.9%) | 80/227 (35.2%) | ||
| Did Not Rank | 111/285 (38.9%) | 93/259 (35.9%) | 73/227 (32.2%) | 81/227 (35.7%) |
Figure 3.
Opinions expressed by E-OPTIMAL participants (n=285): important ways in which research team can show appreciation for study contributions.
Figure 4a-d:
Motivation and Barriers Described by Research Participants
For women enrolled in E-OPTIMAL, the vast majority drove their own car (81%) and traveled between 15 min and 1 hour to their appointment (70%). These women generally preferred to answer questions about their health for this study by in person clinic visit (47% ranked first) followed by telephone interview (30% ranked first), then by internet (13% ranked first) and finally by mail-in questionnaire (10% ranked first). (E-Table 3)
Women who consented to participate in E-OPTIMAL (N=285) did not differ significantly from women who declined to participate (N=29) in their ranking of reasons for participating in women’s health research, reasons for participating in this study, or in ways for the research team to show appreciation for participation. When asked about factors affecting the decision to participate in a research study, however, women declining to participate, compared to those who did enroll, more often cited as “very important” concerns about “travel costs” (42% vs 15%, p=0.01), “difficulty scheduling visits” (39% vs. 20%, p=0.01), and “not enough gifts or other reward” (46% vs. 24%, p=0.05). The same group indicated significantly lower preference for “ways to answer questions about your health in a study” via clinic visit (38% vs. 45% ranked first, p=0.05) or telephone interview (10% vs. 30% ranked first, p<0.001) than did women who chose to enroll in E-OPTIMAL. In both groups, approximately half the participants did not rank “internet questionnaire” as a preferred method of answering questions about health in a study (48% vs. 51%, p=0.46).
Conclusions:
The addition of a video during the consent process for enrollment in a longitudinal, observational extension of a surgical randomized trial did not affect traditional metrics of study recruitment or retention. The video was associated with multiple desirable outcomes including an increased sense of satisfaction with study information and in an improved understanding of the study purpose, nature and extent. The video was also associated with the perception of a better relationship with the study coordinator/nurse.
The traditional study consent process relies heavily on print and verbal communication. However, it is well recognized that many individuals are “visual” learners who experience more effective communication in visual formats, such as video. The findings of this study suggest that video may be a useful adjunct to the traditional consent methods with the goal of to improving satisfaction with participation experience and understanding of the study purpose. Investigators and participants alike benefit from improved understanding of study purpose and participants responsibilities. In addition, the use of the video may facilitate standardization for key aspects of the proposed study.
We found it interesting that the video did not change the traditional metrics of recruitment and retention. Individuals who value “making contributions to medical research” and contributing “to medical knowledge that may help others” may have more altruistic tendencies and be willing to volunteer for medical research with the traditional levels of information provided. Nonetheless, the additional sense of understanding provided by the additional video may help to reinforce their commitment and willingness to participate in future research. The findings that payment for participation or gifts were the least important motivator for enrollment may be reflected by the demographic nature of the E OPTIMAL study population (predominant non-Hispanic white). Walters et al, have reported that payments may be more important for Hispanic subjects.14 Additionally, research has supported that payment is an important motivator for study participants.15 Thus, researchers should not assume based on our findings that compensation is not important for study enrollment.
This study is strengthened by the multi-center nature of the initial OPTIMAL study and the robust infrastructure for the E-OPTIMAL extended, longitudinal observational study.2 As with all studies, several limitations are noted, including the lack of participant representation during video development, the lack of a “cognitive interview” equivalent for video script and the inability to further characterize non-participants. In addition, the video was used at a single point during enrollment; additional videos (“booster” doses) could have been used during the study to reinforce the importance of completing study tasks. While the study did not reach the targeted sample size for detecting a clinically meaningful 15% difference between groups for the primary outcome, the observed difference between groups (3.4%) provides no indication that the actual difference is that large.
The use of a single ancillary video appeared to improve study participant understanding of the purposes, nature and extent of upcoming research study. While the enhanced understanding was not associated with changes in traditional participation metrics including differential enrollment rates or completed study visits, investigators may wish to use these findings to consider augmenting their consent processes with visual means, such as a video, to help standardize study information and better inform potential participants. The personal decision to participate in research remains complex and often fragile. Investigators have an ethical responsibility to support the decisions of potential participant while upholding the rigor of studies that rely on high levels of recruitment, retention and complete data.
Acknowledgments
Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health (Grants U10 HD041261, U10 HD041269, U10 HD069013, U10 HD054214, U10 HD054215, U10 HD041267, U10 HD054241, U10 HD041250, U01 HD041249, U10 HD069025, U10 HD069010, U10 HD069006, U01 HD069031, U10 HD054136 and U10 HD041248.
Footnotes
Trial Registration: National Institute of Child Health and Human Development Pelvic Floor Disorders Network ClinicalTrials.gov ID: NCT01166373
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