| Literature DB >> 25575599 |
Victor D Dinglas, Minxuan Huang, Kristin A Sepulveda, Mariela Pinedo, Ramona O Hopkins, Elizabeth Colantuoni, Dale M Needham1.
Abstract
BACKGROUND: Effective strategies for contacting and recruiting study participants are critical in conducting clinical research. In this study, we conducted two sequential randomized controlled trials of mail- and telephone-based strategies for contacting and recruiting participants, and evaluated participant-related variables' association with time to survey completion and survey completion rates. Subjects eligible for this study were survivors of acute lung injury who had been previously enrolled in a 12-month observational follow-up study evaluating their physical, cognitive and mental health outcomes, with their last study visit completed at a median of 34 months previously.Entities:
Mesh:
Year: 2015 PMID: 25575599 PMCID: PMC4407535 DOI: 10.1186/1471-2288-15-5
Source DB: PubMed Journal: BMC Med Res Methodol ISSN: 1471-2288 Impact factor: 4.615
Baseline characteristics of study population by treatment groups in mail and telephone randomized trials
| Mail trial | Telephone trial | |||||
|---|---|---|---|---|---|---|
| Characteristics 1 | All participants (N = 332) | Personalized envelope (N = 166) | Business envelope (N = 166) | All participants (N = 171) | Study name in message (N = 86) | P.I. name in message (N = 85) |
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| Age, mean (SD) | 48.8 (15.0) | 48.2 (15.4) | 49.4 (14.7) | 46.0 (14.7) | 46.7 (14.0) | 45.3 (15.5) |
| Male, n (%) | 160 (48) | 77 (46) | 83 (50) | 84 (49) | 44 (51) | 40 (47) |
| Minority2, n (%) | 64 (20) | 27 (17) | 37 (23) | 42 (26) | 19 (23) | 23 (28) |
| Employment status3 | ||||||
| Employed (full- or part-time), n (%) | 97 (30) | 41 (25) | 56 (34) | 52 (31) | 32 (38) | 20 (24) |
| Unemployed, n (%) | 79 (24) | 43 (26) | 36 (22) | 43 (26) | 15 (18) | 28 (34) |
| Retired or disabled, n (%) | 151 (46) | 80 (49) | 71 (44) | 72 (43) | 37 (44) | 35 (42) |
| Months since last contact, mean (SD) | 33.7 (7.3) | 34.2 (7.2) | 33.3 (7.4) | 33.5 (7.5) | 35.2 (7.1) | 31.7 (7.5) |
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| FPI overall score | 2.0 (0.7) | 2.0 (0.7) | 2.0 (0.7) | 1.9 (0.7) | 1.9 (0.8) | 2.0 (0.7) |
| FPI body care subscale score | 2.5 (0.6) | 2.5 (0.6) | 2.5 (0.6) | 2.5 (0.7) | 2.4 (0.7) | 2.6 (0.6) |
| FPI maintaining household subscale score | 1.9 (0.9) | 1.9 (0.9) | 1.9 (0.9) | 1.9 (0.9) | 1.8 (1.0) | 1.9 (0.8) |
| FPI physical exercise subscale score | 1.6 (0.9) | 1.6 (0.9) | 1.7 (0.9) | 1.6 (0.9) | 1.6 (1.0) | 1.6 (0.9) |
| SF-36 Physical Component Summary | 40.5 (12.5) | 40.7 (12.4) | 40.3 (12.7) | 40.5 (12.8) | 40.0 (13.3) | 41.1 (12.3) |
| SF-36 Mental Component Summary | 44.9 (14.8) | 45.0 (14.4) | 44.6 (15.2) | 42.1 (14.8) | 41.4 (14.3) | 42.9 (15.3) |
| EQ-5D visual analogue scale | 69.1 (22.7) | 70.3 (22.3) | 67.9 (23.0) | 67.4 (23.7) | 65.5 (24.2) | 69.2 (23.3) |
| EQ-5D utility score | 0.7 (0.2) | 0.7 (0.2) | 0.7 (0.2) | 0.7 (0.3) | 0.7 (0.3) | 0.7 (0.2) |
| MMSE score | 25.6 (1.9) | 25.5 (2.0) | 25.7 (1.8) | 25.5 (2.2) | 25.4 (2.6) | 25.6 (1.7) |
| HADS-depression subscale score | 6.0 (4.9) | 5.9 (4.9) | 6.2 (5.0) | 6.7 (4.9) | 6.8 (5.1) | 6.6 (4.7) |
| HADS-anxiety subscale score | 7.0 (5.1) | 7.0 (5.3) | 7.1 (4.9) | 8.0 (5.0) | 7.9 (4.7) | 8.0 (5.2) |
| IES-R score | 1.0 (1.0) | 1.0 (1.0) | 1.0 (1.0) | 1.1 (1.0) | 1.1 (1.0) | 1.2 (1.0) |
| FACIT score | 62.3 (18.6) | 62.3 (20.0) | 62.2 (17.1) | 60.2 (16.9) | 59.4 (15.6) | 61.1 (18.0) |
Abbreviations: SD (Standard Deviation), FPI (Functional Performance Inventory), SF-36 (Short Form-36 Health Survey), EQ-5D (EuroQol Five Dimensions Questionnaire), MMSE (Mini-Mental State Examination), HADS (Hospital Anxiety and Depression Scale), IES-R (Impact of Event Scale-Revised), FACIT (Functional Assessment of Chronic Illness Therapy).
1Missing values for each variable: months since last contact (1, 1), white (12, 7), employment (5, 4), all FPI scores (10, 7), SF-36 Physical and Mental Component Summaries (17, 10), EQ-5D VAS (10, 7), EQ-5D utility (9, 6), MMSE (20, 12), HADS subscales (14, 9), IES-R (16, 11), FACIT (16, 10).
2Minority race includes African American, Asian, American Indian and Alaskan Native.
3Status as at last contact with research participant.
Figure 1CONSORT flow diagram for mail trial. Mail survey completion rate: (81 + 67) respondents/(157 + 147) potential respondents = 49%.
Figure 2CONSORT flow diagram for phone trial. Telephone survey completion rate: [(19 + 16) respondents + (11 + 12) answered telephone on first call]/(55 + 58) potential respondents = 51%. 1 Excluded from analysis of randomized trial of telephone messages, but censored in analysis of the entire cohort. 2 Included in calculation of survey completion rate, but excluded from Cox models.
Figure 3Estimated proportions of participants remaining to be contacted over time. These 3 panels display the survival function for time to survey completion since randomization for the mail- and telephone-based randomized trials. Panel A displays the overall survival function for all participants participating in the trials. Panels B and C display the survival function for the mail and telephone randomized trials, respectively.
Bivariable and multivariable associations of baseline characteristics with time to survey completion in entire cohort
| Bivariable model | Multivariable model | |||
|---|---|---|---|---|
| Predictors | HR (95% CI) 1 | P-value | HR (95% CI) 1 | P-value |
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| Age ≤40 years old |
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| Male | 0.86 (0.64, 1.16) | 0.315 | 0.70 (0.49, 1.01) | 0.052 |
| Minority2 |
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| Employment status3 | ||||
| Employed (full- or part- time) | Ref | Ref | ||
| Unemployed | 0.95 (0.62, 1.44) | 0.789 | 1.11 (0.71, 1.74) | 0.653 |
| Retired or disabled | 1.27 (0.89, 1.79) | 0.184 | 1.31 (0.83, 2.09) | 0.248 |
| Month since last contact | 1.00 (0.98, 1.02) | 0.869 | 0.99 (0.97, 1.01) | 0.465 |
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| FPI overall score | 1.10 (0.88, 1.37) | 0.418 | 0.84 (0.45, 1.56) | 0.584 |
| FPI body care subscale score | 1.26 (0.96, 1.65) | 0.099 | 1.27 (0.77, 2.10) | 0.350 |
| FPI maintaining household subscale score | 1.06 (0.89, 1.26) | 0.532 | 1.08 (0.71, 1.65) | 0.709 |
| FPI physical exercise subscale score | 1.07 (0.90, 1.26) | 0.443 | 1.13 (0.79, 1.62) | 0.497 |
| SF-36 Physical Component Summary | 1.00 (0.99, 1.01) | 0.805 | 0.99 (0.96, 1.02) | 0.487 |
| SF-36 Mental Component Summary |
|
| 1.01 (0.99, 1.04) | 0.262 |
| EQ-5D visual analogue scale | 1.00 (0.99, 1.01) | 0.201 | 1.00 (0.99, 1.01) | 0.607 |
| EQ-5D utility score | 1.41 (0.75, 2.66) | 0.290 | 0.97 (0.25, 3.70) | 0.960 |
| MMSE score | 1.01 (0.92, 1.11) | 0.835 | 0.95 (0.85, 1.07) | 0.420 |
| HADS-depression subscale score | 0.97 (0.94, 1.00) | 0.067 | 1.02 (0.95, 1.09) | 0.445 |
| HADS-anxiety subscale score |
|
| 0.99 (0.93, 1.06) | 0.810 |
| IES-R score |
|
| 1.07 (0.79, 1.45) | 0.652 |
| FACIT score | 1.01 (0.99, 1.02) | 0.068 | 1.01 (0.99, 1.03s) | 0.223 |
Abbreviations: SD (Standard Deviation), HR (Hazard Ratio), CI (Confidence Interval), FPI (Functional Performance Inventory), SF-36 (Short Form-36 Health Survey), EQ-5D (EuroQol Five Dimensions Questionnaire), MMSE (Mini-Mental State Examination), HADS (Hospital Anxiety and Depression Scale), IES-R (Impact of Event Scale-Revised), FACIT (Functional Assessment of Chronic Illness Therapy).
1A hazard ratio (HR) < 1 indicates a longer time to contact with the participant. All the significant associations (p<0.05) in models are highlighted in bold.
2Minority race includes African American, Asian, American Indian and Alaskan Native.
3Status as at last contact with research participant.