Table 3 Self-monitoring review characteristics and main findings
Review authors (year), and topic focus | Methods and study details | Main findings for time in therapeutic range (TTR), proportion of days covered (PDC), or adherence |
|---|---|---|
Education, decision aids and self-management (n = 4) | ||
Clarkesmith et al. (2017); [44] education; decision aids; self-management plus education | Search: update of 2013 review; February 2016 Included: 11 RCTs on AF (20 articles); 2246 adults Published: 1999 to 2014 Quality tool: Cochrane and GRADE Primary outcome: TTR, days in range and INR values in range | Low-quality evidence (six studies) suggests that education, with or without a decision aid or self-management, may improve values or time in range (e.g., mean TTR 69% SD 25.1 intervention, 64% SD 28.2% control; and self-management plus education MD 6.31%, 95% CI − 5.63 to 18.25) |
Jang (2021) [55] Education, warfarin | Search: May 2020 Included: 12 studies, 4 RCTs and 1 other on AF, 1 RCT and 6 other on mixed conditions Published: 2014 to 2020 Quality tool: Downs and Black Outcomes: TTR, MMAS, knowledge, QoL, bleeding, mortality | All measures of knowledge were improved INR measures (TTR), mortality and readmission all improved with education |
Song et al. (2021) [62] Decision aids DOAC and VKA | Search: January 2021 Included: 10 studies on AF Published: 1999 to 2018 Quality tool: Cochrane Outcomes: Adherence, knowledge, uptake, stroke and bleeding | Effects unclear for adherence (3 studies). Two studies found improved adherence with the decision aid at 3Â months; one found no difference at 6Â months |
Torres Roldan (2021) [64] Decision aids DOAC and warfarin | Search: May 2020 Included: 2 RCTs, 4 other studies on AF Published: 2013 to 2020 Quality tool: Cochrane and NOS Outcomes: Adherence, knowledge, decision conflict, QoL | Adherence (MMAS and PQA) improved (two studies) |
Self-monitoring (n = 7) | ||
Dhippayom et al. (2020) [54] Telemedicine warfarin | Search: September 2019 Included: 3 RCTs and 9 other studies, 11,478 patients, mixed conditions Published: 2005 to 2018 Quality tool: Cochrane EPOC Outcomes: TTR (undefined), INR in range, bleeding and thromboembolic events | For TTR (11 studies), self-testing with remote automated management was better than usual face-to-face care (MD 8.78%; 95% CI 0.06 to 17.50). Self-testing was the preferred option for TTR |
Dhippayom et al. (2021) [53] Self-care warfarin | Search: May 2020 Included: 16 RCTs, 5859 patients, 2 AF and 14 mixed conditions Published: 2001 to 2020 Quality tool: Cochrane EPOC Outcomes: TTR, INR in range, bleeding, thromboembolic events, and mortality | For TTR (13 trials), more time was in range with weekly self-management (MD 7.67%, 95% CI 0.26 to 15.08), and weekly self-testing with remote management (MD 5.65%, 95% CI 0.04 to 11.26), compared with usual care |
Heneghan et al. (2016); [46] self-testing or self-management | Search: update of 2010 review; July, 2015 Included: 28 RCTs (27 articles); two on AF, 20 mixed; 8950 participants Published: 1989 to 2012 Quality tool: GRADE Primary outcome: TTR, INR values in range | Low-quality evidence suggests no difference between self-testing and usual care for AF patients (one trial) Moderate-quality evidence for and against self-testing on time in range (three trials longer, four shorter TTR); and supporting self-testing on values in range (two trials, p < 0.05), in mixed populations Low-quality evidence that self-management improves time in range for AF patients (one trial p = 0.0061) Moderate-quality evidence for and against self-management on time in range (three trials longer, and three shorter TTR); and supporting self-management on values in range (eight trials), in mixed populations |
Ng et al. (2020) [38] Self-care of warfarin vs DOACs | Search: November 2017 Included: 37 RCTs, 100,142 patients; 4 RCTs AF and 4 mixed for warfarin bundles Published: 2004 to 2014 Quality tool: Cochrane Outcomes: TTR, efficacy, stroke, bleeding and mortality | TTR was improved with warfarin care bundles (8 RCTs) that included genotype-guided dosing, self-management, self-testing and/or device implantation (mean 68.9%) compared with warfarin usual care (mean 61.1%) |
Sharma et al. (2015); [48] self-testing or self-management | Search: update of 2007 Cochrane review;a from 2007 to May 2013 Included: 26 RCTs (45 articles); two on AF, 18 mixed; 8763 participants Published: 1996 to 2012 Quality tool: Cochrane Primary outcome: TTR (% of time), INR values in range | Low-quality evidence suggests no difference between self-testing and usual care for AF patients (one trial), while self-testing may improve time and values in range in mixed populations (time; WMD 4.44%, 95% CI 1.71 to 7.18) Self-management improves time in range for AF patients (one trial), but in mixed populations, no effect on time in range (six trials), and conflicting evidence for values in range (five trials more values in range, two fewer) |
Tran et al. (2021) [63] Telepharmacy warfarin | Search: November 2020 Included: 11 studies, 8,395 patients with mixed conditions Published: 2005 to 2018 Quality tool: Downs and Black Outcomes: TTR, thromboembolic events, bleeding, extreme INR, hospitalisation, mortality | No significant difference in TTR between in-person and remote pharmacist management (WMD − 0.02, 95% CI − 5.3 to 5.3; six studies, n = 957). Heterogeneity was moderate. Two studies did not use the Rosendaal [65] method |
Xia et al. (2018) [61] Telemedicine (self-testing) warfarin | Search: July 2017 Included: 10 studies, 16,915 patients with mixed conditions Published: 2005 to 2017 Quality tool: NOS Outcomes: TTR, bleeding, thromboembolic events, hospital visits and admissions | TTR no significant differences between online and hospital management (OR − 0.55, 95% CI − 9.06 to 7.95; five studies, n = 2366). Heterogeneity was high |
Pharmacist management (n = 4) | ||
Entezari-Maleki et al. (2016); [45] pharmacist-managed warfarin therapy | Search: January 2014 Included: 24 RCTs and non-RCTs on AF and VTE; 11,607 participants Published: 1995 to 2013 Quality tool: Downs and Black, and Jadad Primary outcome: TTR | Uncertain-quality evidence that pharmacist management may improve time in range (84.3% v 82.2%, 95% CI − 26.3 to 30.5, three trials; 72.1% v 56.7%, 95% CI 4.2 to 26.6, five observational studies) |
Hou (2017) [66] Pharmacist management, warfarin | Search: April 2017 Included: 8 RCTs, 9 observational studies, 2 AF and VTE, 15 mixed conditions Published: 1998 to 2016 Quality tool: Cochrane, NOS and GRADE Outcomes: TTR, time in expanded range, bleeding, thrombosis, mortality, satisfaction, and costs | TTR (3 RCTs and 3 cohort studies) improved with pharmacist management (WMD: 8.03, 95% CI 2.19–13.88, p = 0.007); no significant difference for RCTs alone, nor for expanded range |
Manzoor et al. (2017); [47] pharmacist-managed anticoagulation services | Search: May 2017 Included: 25 RCTs and non-RCTs; 23 on AF or VTE, two mixed; 12,252 adults Published: 1985 to 2016 Quality tool: Downs and Black Primary outcome: TTR, INR values in range, mean prothrombin | Uncertain-quality evidence that pharmacist management may improve time and values in range (23 out of 25 studies; improvement 1.7 to 28.0%; 19 statistically significant) |
Zhou et al. (2016); [49] pharmacist-managed warfarin services | Search: July 2015 Included: eight RCTs on mixed conditions; 1493 adults Published: 2003 to 2013 Quality tool: Cochrane and GRADE Primary outcome: TTR | High-quality evidence that pharmacist management may improve time in range (MD 3.66, 95% CI 2.20 to 5.11; four trials), although this was not significant for time in extended therapeutic range (moderate-quality evidence) |
Adherence, discontinuation, switching, and persistence (n = 8) | ||
Afzal et al. (2019) [50] Adherence DOACs | Search: November 2018 Included: 5 RCTs and 16 other studies; for adherence, 3 on AF, 1 on VTE and 1 on AF and VTE Published: 2013 to 2018 Quality tool: Cochrane and NOS Outcomes: MMAS-8, satisfaction, HRQoL, compliance, expectations | Adherence similar between DOACs and VKA (five studies). Higher adherence with more knowledge of OAC treatment (one study) |
Buck et al. (2021) [51] Discontinuing DOAC or VKA | Search: 2019 Included: 12 studies on AF Published: 2014 to 2019 Quality tool: Gough’s dimension A Outcomes: Discontinuation | For VKA, at 1 year, discontinuation ranged from 6.8 to 17.3%, and for dabigatran was 36.8%. Similar rates VKA to dabigatran at 2 years. Discontinuation at 2 years ranged from 5.7 to 12% for warfarin, and 4.5 to 5.9% for other DOACs |
Deitelzweig et al. (2021) [52] Persistence DOAC vs VKA | Search: July 2019 Included: 36 studies, on AF; 18 in the NMA, 395,593 patients Published: 2014 to 2019 Quality tool: ROBINS-I and GRADE Outcomes: Odds ratio on non-persistence at 30, 60 and 90 days | At 30 and 90 days all DOACs had lower odds of non-persistence than VKA. At 60 days, dabigatran had higher odds than, and apixaban and rivaroxaban were not significantly different to, VKAs. Over all measures, apixaban was most likely to have the lowest non-persistence (p = 95.7% at 30 days, p = 76.9% at 60 days and p = 98.4% at 90 days) |
Ozaki et al. (2020) [56] Persistence DOACs | Search: June 2018 Included: 48 studies, 594,784 patients with AF Published: 2013 to 2018 Quality tool: NOS Outcomes: PDC, adherence (PDC ≥ 80%), and persistence | Mean PDC apixaban 81%, rivaroxaban 79%, dabigatran 72% (14 studies). Adherence was 71% (95% CI 64 to 78) for apixaban, 60% (95% CI 52 to 68) for dabigatran, and 70% (95% CI 64 to 75) for rivaroxaban (21 studies). Apixaban and rivaroxaban had higher persistence than VKA (OR 1.44, 95% CI 1.12 to 1.86; 24 studies) |
Prentice et al. (2020) [57] Adherence to Rivaroxaban and Dabigatran | Search: August 2018 Included: 5 studies, 80,230 patients with AF Published: 2015 to 2017 Quality tool: GRACE checklist Outcomes: PDC ≥ 80% | Adherence higher with rivaroxaban than dabigatran (RR 1.08, 95% CI 1.03 to 1.12). PDC ≥ 80% for rivaroxaban ranged from 59.5 to 83.5%; for dabigatran ranged from 57.3 to 78.3% |
Romoli et al. (2021) [58] Switching DOACs | Search: March 2020 Included: 5 studies, 259,308 patients with AF Published: 2017 to 2019 Quality tool: NOS Outcomes: risk of switching | Apixaban lower risk of switching than dabigatran (OR 0.29, 95% CI 0.25 to 0.34), and rivaroxaban (OR 0.58, 95% CI 0.50 to 0.67). Dabigatran higher risk than rivaroxaban (OR 2.35 95% CI 1.89 to 2.81) |
Salmasi et al. (2020) [59] Adherence to DOACs and warfarin | Search: March 2019 Included: 30 studies, 593,683 patients with AF Published: 2001 to 2019 Quality tool: STROBE and ISPOR Outcomes: PDC ≥ 80%, MPR ≥ 80%, and compliance | Mean adherence (PDC ≥ 80%) at 1 year, for apixaban was 82% (95% CI 74 to 89), rivaroxaban 77% (95% CI 69 to 86), and dabigatran 75% (95% CI 68 to 82) |
Shehab et al. (2019) [60] Adherence DOAC and VKA | Search: June 2016 Included: 6 studies, 1,640,157 patients (one study 1.5 million), on AF Published: 2015 to 2016 Quality tool: STROBE Outcomes: PDC > 80%, MMAS-8, and phone interview | Dabigatran 72.7% (95% CI 62.5 to 82.9), apixaban 59.9% (95% CI 32.0 to 123.1), rivaroxaban 59.3% (95% CI 38.7 to 80.0), heterogeneity was very high. VKA 29.5% |