Table 2.
Studies where fabrication was observed. Self-report (SR), Nebuliser Chronolog (NC), Physician’s Report (PR), Canister weight (CW), Medication event monitoring systems (MEMS), Pill counts (PC), Inhaled corticosteroids (ICS), Self-report questionaire (SRQ), Device compliance report (DCR).
| FABRICATION | ||||||
|---|---|---|---|---|---|---|
| No | Studies | Types (N) | Conditions/Deception Types | Remarks | Relevant Findings | Insight |
| 1 | Coutts, J., et al. (1992)(63) | Clinical Trial(14) | Asthma/Canister Dumping | Children 9–16 years | 1 participant activated nebuliser 77 times minutes immediately before clinic attendance. | No |
| 2 | Simmons, M. S., et al. (2000)(60) | Clinical Trial(231) | COPD/Canister Dumping | Lung Health Study, LHS (1 year) | Dumping (%), Uninformed - 30/101 (30%) | 101 uninformed |
| All participants | Dumping (%), Informed - 1/135 (<1%) | |||||
| 3 | Rand, C. S., et al. (1995)(61) | Clinical Trial(3923) | COPD /Canister Dumping | Lung Health Study, LHS (2 years) | 1. At 1 year, SR = CW - 48%, SR < CW - 19%, SR > CW - 33% | No |
| Special Intervention arm ONLY | 2. At 2 year, SR = CW - 48%, SR < CW - 23%, SR > CW - 29% | |||||
| SR - 3923, CW - 73% returned all canisters at 1 yr, 70% at 2 yr. | 3. 9% at Year 1 and 12% at Year 2 had CW > 110% | |||||
| 4. Year 1, 9.4% of overcompliers found to have an inaccurate SR of smoking status compared to 6.2% of nonovercompliers. | ||||||
| At Year 2, 8.3% of overcompliers cf 4.8% of nonovercompliers | ||||||
| 4 | Tashkin, D. P., et al. (1991)(58) | Clinical Trial(197) | COPD/Canister Dumping | Lung Health Study, LHS (4 months) | 1. Uninformed group, n=85 | 85 Uninformed |
| All participants | SR/NC ≥ 2×/day (%) - 87/52 | |||||
| CW/NC - 85/52 | ||||||
| Dumping - 18% | ||||||
| 2. Feedback group, n= 112 | ||||||
| SR/NC - 89/78 | ||||||
| CW/NC −80/78 | ||||||
| Dumping - 0 | ||||||
| 5 | Rand, C. S., et al. (1992)(59) | Clinical Trial(70) | COPD/Canister Dumping | Lung Health Study, LHS (4 months) | 1. SR overestimates NC in 70%. | No |
| Special Intervention arm ONLY | 2. 14% ≥ 1 dumping episode | |||||
| 3. By CW criteria, 9/10 dumpers would have been classified as having satisfactory or better adherence. | ||||||
| 6 | Mawhinney, H., et al. (1991)(15) | Clinical Trial(34) | Asthma/Canister Dumping | Valid conclusions about efficacy of the drugs could only have been drawn in 6/ 34 patients. | Multiple simultaneous activations (≥10 recorded at same time) recorded in at least 6 patients. | Unknown |
| 7 | Braunstein, G., et al. (1996)(62) | Clinical Trial(201) | Asthma/Canister Dumping | 1. “Dumping was evident in some patients”. | No | |
| 2. CW/SR overestimated compliance using NC as gold standard. | ||||||
| 3. PR was the least accurate of the four methods. | ||||||
| 8 | Okatch, H., et al. (2016)(67) | Clinical Trial(289) | HIV/Pill Dumping | Overadherers (OAs) if at least 33% (1 in 3) of their reference drug pill count | OAs - PC 48/289 (17%) | No |
| > 100% adherence | ||||||
| 9 | Cramer, J. A., et al. (1989)(64) | Clinical Trial(24) | Epileptics/Pill Dumping | PC/MEMS - 92%/76% | Yes | |
| 10 | Rudd, P., et al. (1989)(21) | Clinical Trial(121) | Hypertensives/Pill Dumping | 1. Mean compliance rates by PC approximate 100%. | No | |
| 2. 8% to 15% of the subgroups given a second drug exhibited <80% or >120% compliance by PC. | ||||||
| 11 | Rudd, P., et al. (1990)(65) | Clinical Trial(21) | Chronic medical conditions/Pill Dumping | 1. PC/MEMS - 95%/90% | Unknown | |
| 2. PC misclassified participants’ response on 18 of 81 occasions (22%). | ||||||
| 12 | Corneli, A. L., et al. (2015)(66) | Surveys(224) | HIV/Pill Dumping | 78(35%) | NA | |
| 13 | Devine, E. G., et al. (2015)(8) | Surveys(100) | Research Participants/Symptoms | 1. 32/100 (32%) | Yes | |
| 2. Mean age fabricator/concealer/genuine 47/54/60 | ||||||
| 3. Female (%) - Fabricator/Genuine 19/71 | ||||||
| 14 | Gong, H., et al. (1988)(68) | Clinical Trial(75) | Asthma/Overreporting adherence | SR vs NC | Mean daily SR adherence (%) higher than that of NC in 8% of participants. | No |
| 15 | Milgrom, H., et al. (1996)(69) | Clinical Trial(24) | Asthma/Overreporting adherence | SR vs NC | 1. Inh β-agonist, median use, SR/NC (%) - 78/62 | No |
| 2. ICS, median use, SR/NC (%) - 95/54 | ||||||
| 3. 92% exaggerate ICS use, 71% β-agonist. | ||||||
| 16 | Spector, S. L., et al. (1986)(70) | Clinical Trial(19) | Asthma/Overreporting adherence | SR vs NC | Appropriate usage (% of the days studied), SR/ NC - 90/47 | No |
| 17 | Waterhouse, D. M., et al. (1993)(81) | Clinical Trial(24) | Cancers/Overreporting adherence | SR vs PC vs MEMS | SR/PC/MEMS adherence rate (%) - 98/92/69 | No |
| 18 | Zeller, A., et al. (2008)(82) | Clinical Trial(66) | Chronic medical conditions/Overreporting adherence | SR vs MEMS | 1. 78.8% over-reported their adherence on SR vs MEMS. | Variable |
| 2. SR negatively associated with MEMS-measured-timing adherence, correct dosing, and self-administration adherence. | ||||||
| 3. Awareness about MEMS resulted in better adherence rates. | ||||||
| 19 | Cate, H., et al. (2015)(71) | Clinical Trial(208) | Glaucoma/Overreporting adherence | SRQ vs Travalert® dosing aid (TDA) | Adherence (≥80%), SRQ/TDA (%) - 57–60/54 | Yes |
| 20 | Kass, M. A., et al. (1986)(47) | Clinical Trial(184) | Glaucoma/Overreporting adherence | SR vs “Miniature compliance monitor (MCM)” | SR/MCM (%) - 97/76 | No |
| 21 | Okeke, C. O., et al. (2009)(48) | Clinical Trial(196) | Glaucoma/Overreporting adherence | SR vs PR vs Travatan Dosing Aid (TtDA) | Mean adherence rate, SR/PR/TtDA (%) - 95/77/71 | Yes |
| 22 | Nieuwenhuis, M. M., et al. (2012)(83) | Clinical Trial(37) | Heart Failure/Overreporting adherence | SR vs MEMS | SR/MEMS (%) - 100/76% | Unknown |
| 23 | Deschamps, A. E., et al. (2004)(79) | Clinical Trial(43) | HIV/Over-reporting adherence | SR vs PR vs MEMS | Non-adherence, prevalence, SR/PR/MEMS (%) - 5 – 41/2428/40 | Yes |
| 24 | Corneli, A. L., et al. (2015)(66) | Surveys(224) | HIV/Over-reporting adherence | SR | 31% | NA |
| 25 | Shi, L., et al. (2010)(80) | Meta- analysis(1684) | Various/Overreporting adherence | SRQ vs MEMS | 1. Mean of adherence, SRQs/MEMS (%) - 84.0/74.9 | Unknown |
| 2. 10/11 studies, SRQ adherence > MEMs. | ||||||
| 3. SRQs give a good estimate of medication adherence. | ||||||
| 26 | Kribbs, N. B., et al. (1993)(84) | Clinical Trial(35) | OSA on CPAP/Overreporting adherence | SR vs DCR | 1. Average duration of use, SR/DCR (minutes) - 376/306 (23%). | No |
| 2. Nightly use of CPAP untrue in 6/21 (29%). | ||||||
| 27 | Rauscher, H., et al. (1993)(76) | Clinical Trial(63) | OSA on CPAP/Overreporting adherence | SR vs DCR | 1. SR/DCR (hours) - 6.1/4.9 | Yes |
| 2. Used >80%, SR/Machine (%) - 87/30 | ||||||
| 28 | Roecklein, K. A., et al. (2010)(77) | Clinical Trial(28) | OSA on CPAP/Overreporting adherence | SR vs DCR | 1. Feedback group (2 weeks), SR/DCR (hours) - 4.1/4.6 | Yes |
| 2. Feedback(3 months), SR/DCR (hours) - 4.7/2.4 | ||||||
| 3. Control(2 weeks), SR/DCR (hours) - 3.4/2.4 | ||||||
| 4. Control(3 months), SR/DCR (hours) −4.1/2.0 | ||||||
| 29 | Sowho, M. O., et al. (2015)(78) | Clinical Trial(10) | OSA on CPAP/Overreporting adherence | SR vs DCR | 1. SR/DCR (hour) - 4.3/3.5 | Yes |
| 2. Nights >4 h (14 days), SR/Machine - 8.3/5.5 | ||||||
| 3. Self-reported adherence was significantly higher than objectively assessed adherence. | ||||||
| 30 | Engleman, H. M., et al. (1996)(72) | Surveys(62) | OSA on CPAP/Overreporting adherence | SR vs DCR | 1.SR/DCR (hour) - 6.0/5.1 | Yes |
| 31 | Hsieh, C. F., et al. (2016)(73) | Surveys(107) | OSA on CPAP/Overreporting adherence | SR vs DCR | SR/DCR (hour) - 6.5/5.5 | Yes |
| 32 | Pepin, J. L., et al. (1995)(75) | Surveys(193) | OSA on CPAP/Overreporting adherence | SR vs DCR | SR/DCR (hour) - 7.4/6.5 | Yes |
| 33 | Touskova, T., et al. (2015)(85) | Clinical Trial(49) | Osteoporosis/Overreporting adherence | SR vs PC vs MEMS | SR/PC/MEMS - 87/100/59 | No |
| 34 | Gillespie, D., et al. (2014)(50) | Clinical Trial(58) | Ulcerative Colitis/Overreporting adherence | PC vs MEMS | PC/MEMS, median (%) - 96.7/89.2 | Unknown |