Table 3 Study characteristics

Chi Y. Bahk, et al. 2019 [11]

Patients and Physicians

App is primarily intended for the patients using the app reside in the USA

MedWatcher

11 May, 2013 to 7 December, 2014

Through the MedWatcher app (19 month duration)

1349 reports (an average 103 per month) with (ratio 14.7:1)

11.4 min (± 10) was spent to complete a Essure AE report

Average VigiGrade completeness scores were high, averaging 0.80 (± 0.15)

Considered ‘‘well documented’’ 55.9% of the time compared with an international Average of 13% for all medical products

24% of reports from physicians are considered well documented

Through conventional methods

(132 months post- marketing authorization duration)

943 reports (an average of seven per month)

40 min was spent to complete a voluntary AE report

Average VigiGrade completeness score is 0.45 for the 7.0 million reports

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Franc ̧ois Montastruc, et al. 2017 [12]

healthcare professionals

general public

VigiBIP

10 January, 2015 to 1 February, 2017

Through the VigiBIP app

Reports received—193 (4.7%)

Hospital Reporters- 112 (58.0%)

Patient Reporters- 13 (6.7%)

Extra-Hospital Reporters- 68 (35.2%)

Through conventional methods (phone, e-mail, fax, letter, website)

Reports received −3909 (95.3%)

Hospital Reporters- 2648 (67.8%)

Patient Reporters- 133 (3.4%)

Extra-Hospital Reporters- 1126 (28.8%)

Hospital Reporters (p = 0.005)

Patient Reporters (p = 0.01)

Extra-Hospital Reporters- (p = 0.06)

Sachin Kumar Kuchya, et al. 2017 [13]

Healthcare professionals

ADR reporting app© (App©)

1 March, 2015 to 31 January 2016

Through the ADR reporting app© (App©)

Valid Submissions

100% (136/136)

Average completeness score- 34.7 (± 2.4)

Through conventional methods (paper based ADRs form)

Valid Submissions 96.2% (257/267)

Average completeness score- 29.2 (± 2.4)

(p < 0.001)

Gilles Defer, et al. 2020 [14]

Persons with relapsing remitting multiple sclerosis

The median age of patients was 38 years

sclerosis academic expert centers and general hospitals, and by private practice neurologists

My eReport France App

18 April, 2017 to 24 April, 2019

Through the My eReport France App

Mean number of ADRs reports per patient- 0.47

64 ADRs in 43 reports from 91 patients

Clinical quality score of the 64 ADRs reported

Median (57%),

23 (36%) were well documented

40 (62%) were moderately documented

1 (2%) was poorly documented

Through conventional methods

Mean number of ADRs reports per patient- 0.03

3 ADRs in 2 reports 68 patients

Clinical quality score of the 3 ADRs reported

Median [71–79] (79%)

2 excellently documented

one was well documented

(p = 0.002)

Ingrid Oosterhuis, et al. 2018 [15]

Physicians

Pharmacists

Other health professionals

Patients

WEB-RADR apps

launch date of the app in each country to 1 September, 2016

Through the WEB-RADR apps

UK- 144 (28%)

Physicians-[19,20,21,22,23,24,25,26,27,28,29]%

Pharmacists- [29,30,31,32,33,34,35,36,37]%

Other health professionals- [0–10]%

Patients-(28%)

Netherlands- 106 (60%)

Physicians- [19,20,21,22,23,24,25,26,27,28,29]%

Pharmacists- [0–10]%

Other health professionals-[0–10]%

Patients-(60%)

Croatia- 37 (32%)

Physicians-[0–10]%

Pharmacists- [60]%

Other health professionals-[0–10]%

Patients- (32%)

Moderate quality of app: 78–85% for all countries

Through conventional methods (paper forms and electronic forms)

UK- 22,582 (18%)

Physicians- [29,30,31,32,33,34,35,36,37]%

Pharmacists- [19]%

Other health professionals- [19,20,21,22,23,24,25,26,27,28,29]%

Patients-(28%)

Netherlands- 5779 (57%)

Physicians-[19,20,21,22,23,24,25,26,27,28,29]%

Pharmacists-[9,10,11,12,13,14,15,16,17,18,19]%

Other health professionals-[0–10]%

Patients-(57%)

Croatia- 307 (7%)

Physicians-[40–50]%

Pharmacists- [40–50]%

Other health professionals-[0–10]%

Patients-(7%)

Moderate quality of reference: 78–98% for all countries

UK (p < 0.01)

Netherlands (p = 0.5)

Croatian (p < 0.01)

Seth Kwaku Seaneke, et al. 2023 [16]

Healthcare Professionals

Med Safety App

14 December, 2020 to 15 January, 2021

Trough the Med Safety App (Total n = 122)

Physicians- 15 (12.3%)

Nurses- 0 (0%)

Pharmacists-72 (59.0%)

Disease Control Officers- 0 (0.0%)

Other Healthcare Professionals- 12 (9.8%)

Consumers and lawyers- 23 (18.9%)

Not stated/missing- 0 (0.0%)

Through conventional methods (FDA’s paper-based CIOMS 1 form)

(Total n = 6825)

Physicians- 324 (4.7%)

Nurses- 1104 (16.2%)

Pharmacists- 1104 (15.6%)

Disease Control Officers- 1278 (18.7)

Other Healthcare Professionals- 868 (12.7%)

Consumers and lawyers- 171 (2.5%)

Not stated/missing- 2018 (29.6)

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