Table 1.
Studies where concealment was observed. Acute coronary syndrome (ACS), Antiretrovirals (ARV), Not applicable (NA), Antiretroviral therapy (ART), Medication event monitoring systems (MEMS).
| CONCEALMENT | ||||||
|---|---|---|---|---|---|---|
| No | Studies | Types (N) | Conditions/Deception Types | Remarks | Relevant Findings | Insight |
| 1 | Fogel, J. M., et al. (2013)(26) | Clinical Trial (209) | HIV/Drug History | Unreported ARV drug use | Enrollment Samples | No |
| Only 209 (11.9%) of the 1763 index participants in HPTN 052 were | None of the women in this substudy reported receiving ARV drugs BUT 48/209 (23.0%) had ≥1 ARV drug(s) detected: | |||||
| tested in this substudy | − 45 (46.9%) in the virally suppressed group. | |||||
| − 2 of 48 (4.2%) in the low viral load group. | ||||||
| − 1 of 65 (1.5%) in the high viral load group. | ||||||
| Follow-up Samples | ||||||
| Participants who had ARV drugs detected at enrollment continued to use ARV drugs off study after enrollment. | ||||||
| − 16 (100%) of the virally suppressed group who were randomized to the delayed ART arm. | ||||||
| 2 | Shiovitz, T. M., et al. (2013)(29) | Clinical Trial (1132) | Central nervous system studies/Coenrollment | CTSdatabase, a central | 29/1161 (3%) re-entered at same site. | No |
| nervous system-focused trial participant | Excluding the 29 above, 3.45% were certain duplicates. | |||||
| registry | ||||||
| Southern California | ||||||
| 9 months | ||||||
| 3 | Shiovitz, T. M., et al. (2011)(25) | Letter to the Editor (4) | Depression/Coenrollment | “duplicate subjects within a protocol is often >5% of screened subjects”. | Yes | |
| 4 | Boyar, D. and N. M. Goldfarb (2010)(11) | Clinical Trial (2081) | 27 phase 1 drug trials/Coenrollment | Clinical Research Subject Verification Program (clinicalRSVP) | 1. 453/2081 (22%) | No |
| 5 sites in South Florida | 2. 50 (0.25%) re-enroll within 30 days of receiving a dose in a previous study. | |||||
| 18 weeks, 21 phase 1 studies | 3. 186 (0.9%) within 60 days. | |||||
| 2 large research sites in the local area did not participate. | ||||||
| 5 | Edelblute, H. B. and J. A. Fisher (2015) (12) | Clinical Trial (180) | Healthy volunteers/Coenrollment | Web-based “clinical trial diary” (CTD) | 3 participants were detected to have higher than average rate of screening for new clinical trials in a 6-month period. | Yes |
| HealthyVOICES Project | ||||||
| 7 Phase I clinics across US | ||||||
| Profile of a “healthy volunteer” in US | ||||||
| 6 | Karim, Q. A., et al. (2011)(28) | Clinical Trial (398) | HIV/Coenrollment | Audit | 135/398 (34%) | No |
| Close proximity of trial sites | ||||||
| 7 | Darragh, A., et al. (1985)(32) | Case Report (1) | Healthy volunteers/Drug History | Depot flupenthixol | NA | Yes |
| 8 | Kolata, G. B. (1980)(19) | Case Report(1) | Healthy volunteer/Drug History | “Anorexia nervosa/bulimia | NA | Yes |
| Nurse | ||||||
| Selfdestructiveness/irrational” | ||||||
| 9 | Kahle, E. M., et al. (2014)(30) | Clinical Trial (3371) | HIV/Drug History | ART testing was performed on | Antiretrovirals were detected in 171 (22.2%)/771 | No |
| 771 (96.6%) of the persons with <2000 copies per milliliter of plasma HIV-1 RNA | − 157 (46.0%)/341 in those with undetectable plasma HIV-1 RNA. | |||||
| − 14 (3.3%)/430 in those with low detectable plasma HIV-1 RNA. | ||||||
| 10 | Apseloff, G., et al. (1996)(31) | Case Series(4) | Healthy volunteers/Medical History | Participant 1 - Family cardiac history and symptoms. | Yes | |
| Participant 2 and 3 - Dietary restrictions. | ||||||
| Participant 4 - History of diabetes. | ||||||
| 11 | Pell, J. P., et al. (2008)(41) | Clinical Trial (1061) | ACS/Smoking Status | Serum cotinine | 1. Ex smoker - 635 (60%), 11% deceit | Yes |
| 2. Never smoker - 426 (40%), 2% deceit. | ||||||
| 12 | Ronan, G., et al. (1981) (42) | Clinical Trial (57) | ACS/Smoking Status | CarboxyHb | 5/57 (8.8%) | No |
| 13 | Squire, E. N., Jr., et al. (1991)(43) | Letter to the Editor (52) | Asthma/Smoking Status | “Where There’s Smoke There Are Liars” | 7/52 (13.5%) | Yes |
| Self-report of concealment | ||||||
| 14 | Shin, D. W., et al. (2014)(45) | Surveys (178) | Cancers/Smoking Status | Self-report | 1. 46.7% patients concealed from health care providers (HCPs). | NA |
| 2. 9.3% family members from HCPs. | ||||||
| 15 | Martinez, M. E., et al. (2004)(40) | Clinical Trial (729) | Colorectal adenomas/Smoking Status | Plasma cotinine | 1. 56/283 (19.8%) neversmoker misclassified. 2. 99/446 (22.2%) former smoker misclassified. | Unknown |
| 16 | Pell, J. P., et al. (2008)(41) | Clinical Trial (746) | General population/Smoking Status | Salivary cotinine | 1. Ex-smokers - 289 (39%), 12% deceit | Yes |
| 2. Never-smokers - 457 (61%), 3% deceit | ||||||
| 17 | Wagenknecht, L. E., et al. (1992)(51) | Clinical Trial (3445) | General population/Smoking Status | Serum cotinine | Smoking prevalance, SR/Cotinine - 30.9/32.2% | Unknown |
| Overall misclassification - 145/3445(4.2%), never smoker - 72/2790(2.6%), ex - 73/655(11.2%) | ||||||
| 18 | Caraballo, R. S., et al. (2001)(33) | Surveys (11083) | General population/Smoking Status | NHANES III (1988–1994) | 166/11083 (1.5%) | Yes |
| serum cotinine | ||||||
| 19 | Curry, L. E., et al. (2013)(52) | Surveys (2800) | 11083/Smoking Status | Self-report concealment from health care providers | 1. Total - 8.9% non-disclosure (ND) | NA |
| − Current smoker −1296, 12.9% ND | ||||||
| − Ex smoker - 1504, 5.9% ND | ||||||
| 2. Active ND - 49.8%, Passive (in person) - 42.5%, Passive (online/form) - 34% | ||||||
| 20 | Fendrich, M., et al. (2005)(53) | Surveys (536) | General population /Smoking Status | Serum cotinine | 1. Overall smoking, SR/Cotinine - 37%/38% | No |
| 2. Underreport - 189/536 (35%) | ||||||
| 21 | Klesges, L. M., et al. (1992)(34) | Surveys (6032) | General population /Smoking Status | NHANES II (1976–1980) | 166/3918 (4.2%) | Yes |
| CarboxyHb | ||||||
| 22 | Stuber, J. and S. Galea (2009)(54) | Surveys (835) | General population /Smoking Status | Self-report | 63/835 (7.6%) | NA |
| 23 | Woodward, M. and H. Tunstall- Pedoe (1992)(35) | Surveys (3977) | General population /Smoking Status | Expired air CO, serum thiocyanate, serum cotinine | Deceivers (%) | No |
| Scottish Heart Health Study | 1. All three tests - 1.2% | |||||
| 2. ≥ 2 tests −2.2% | ||||||
| 3. ≥ 1 tests is 16.4%. | ||||||
| 24 | Yeager, D. S. and J. A. Krosnick (2010)(36) | Surveys | General population /Smoking Status | Serum Cotinine | 0.89% - 0.94% | Yes |
| 25 | Apseloff, G., et al. (1994)(9) | Surveys (282) | Phase 1 volunteers/Smoking Status | Urinary cotinine | 45/282 (16%) | Unknown |
| 26 | Ebner, N., et al. (2013)(39) | Clinical Trial (59) | Heart Failure/Smoking Status | Serum cotinine | 1. Total - 10/59 (16.9% discordance) | Unknown |
| − Ex-smokers - 6/35 (17.1%) | ||||||
| − Non smokers - 4/24 (16.7%) | ||||||
| 2. No discordance in 20 control non-smoking participants. | ||||||
| 27 | Robertson, A., et al. (1987)(37) | Surveys (155) | Office workers/Smoking Status | Serum thiocyanate | 3/155 (1.9%) | No |
| Expired carbon monoxide | ||||||
| 28 | Coon, D., et al. (2013)(38) | Clinical Trial (415) | Plastic surgery/Smoking Status | Urine nicotine | 1. Ex-smokers - 139, 9.8% deceit | Yes |
| 2. Never smokers - 237, 1.5% deceit | ||||||
| 29 | Webb, D. A., et al. (2003)(55) | Surveys (48) | Pregnant/Smoking Status | Urine cotinine | 35/48 (73%) | Unknown |
| 30 | Jackson, A. A., et al. (2004)(56) | Clinical Trial (402) | Smoking cessation trial/Smoking Status | Expired air CO | 57/402 (14%) of selfreported non-smokers were deceivers. | Unknown |
| 59/251 (24%) of selfreported ex-smokers were deceivers. | ||||||
| 31 | Dietz, P. M., et al. (2011)(44) | Survey (4197) | Women/Smoking Status | Serum cotinine | Non-disclosure, Pregnant/Non-pregnant - 16.3/7.4% | Yes |
| 32 | Risch, S. C., et al. (1990)(14) | Surveys (103) | Healthy volunteers/Various | 5/105 - Psychiatric disorders | 26/103 (25%) | Yes |
| 21/103 - Positive urine toxicology | ||||||
| 33 | Bentley, J. P. and P. G. Thacker (2004)(10) | Surveys (270) | Healthy volunteers/Various | Neglect to tell about negative | Higher monetry payments associated with greater withholding but not risk rating. | Yes |
| effects and restricted | ||||||
| activities | ||||||
| 34 | Hermann, R., et al. (1997)(13) | Surveys (440) | Healthy volunteer/Various | 52% > 1 study/year | 1. Eligibilty questions - 13/440 (3%) | Yes |
| 2. Smoking - 11% | ||||||
| 3. Drinking - 11% | ||||||
| 35 | Devine, E. G., et al. (2013)(4) | Surveys (99) | Experienced research participants (≥2 studies)/Various | No. of studies in the past year, mean - 12 | 75% (43% coenroll) | Yes |
| Lifetime studies, mean - 55 | ||||||
| Lifetime reported earning, mean - US$23531 | ||||||
| 36 | Devine, E. G., et al. (2015)(8) | Surveys (100) | Experienced research participants (≥2 studies)/Various | 50/100 (50%) | 1. 32/100 (32%) | Yes |
| 2. Mean age fabricator/concealer/genuine 47/54/60 | ||||||
| 3. Female (%) - Fabricator/Genuine 19/71 | ||||||
| 37 | Cramer, J. A., et al. (1990)(46) | Clinical Trial (20) | Epileptics/White Coat Compliance | MEMS bottles | Compliance rates 5 days before visit/5 days after/1 month after (%) - 88/86/73 | Yes |
| Drug levels - 30/37 in therapeutic range | ||||||
| 38 | Kass, M. A., et al. (1986)(47) | Clinical Trial (184) | Glaucoma/White Coat Compliance | “Miniature compliance monitor” | Mean compliance(%) Within 24hr of visit/Entire Period - 88/76 | No |
| 39 | Norell, S. E. (1981)(57) | Clinical Trial (82) | Glaucoma/White Coat Compliance | “Eyedrop bottle in a medication monitor box” | Strong correlation between missed doses and the time elapsed since the last clinic visit. | No |
| 40 | Okeke, C. O., et al. (2009)(48) | Clinical Trial (196) | Glaucoma/White Coat Compliance | Travatan Dosing Aid | Mean adherence rate(%) First+Last week/Middle weeks - 43/35 | Yes |
| 41 | Podsadecki, T. J., et al. (2008)(49) | Clinical Trial (178) | HIV/White Coat Compliance | MEMS | For 20% of all PK visits, drug intake would be perfect 1 to 3 days before PK sampling, whereas the estimated compliance during the remainder of the inter-PK visit period would be ≤90%. | Unknown |
| 42 | Gillespie, D., et al. (2014)(50) | Clinical Trial (58) | Ulcerative Colitis/White coat compliance | MEMS | 43% higher adherence perivisit. | Unknown |