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Effect of electronic reminders on patients' compliance during clear aligner treatment: an interrupted time series study


Abstract and Figures

Patient compliance is relevant to achieving therapeutic goals during clear aligner therapy (CAT). The aim of this study was to evaluate the efficacy of remote electronic (e-)reminders and e-feedback on compliance during CAT using an interrupted time series (ITS) analysis. We used routinely collected mobile application data from a German healthtech company (PlusDental, Berlin). Our primary outcome was self-reported compliance (aligner wear time min. 22 h on 75% of their aligners were classified as fully compliant, min. 22 h on 50–74.9% of their aligners: fairly compliant; min. 22 h on < 50% of their aligners: poorly compliant). E-reminders and e-feedback were introduced in the 1st quarter of 2020. Compliance was assessed at semi-monthly intervals from June-December 2019 (n = 1899) and June-December 2020 (n = 5486), resulting in a pre- and post-intervention group. ITS and segmented regression modelling were used to estimate the effect on the change in levels and trends of poor compliance. Pre-intervention, poor compliance was at 24.47% (95% CI: 22.59% to 26.46%). After the introduction of e-reminders and e-feedback (i.e., post-intervention), the percentage of poorly compliant patients decreased substantially, levelling off at 9.32% (95% CI: 8.31% to 10.45%). E-reminders and e-feedback were effective for increasing compliance in CAT patients. Clinical Significance: Orthodontists and dentists may consider digital monitoring and e-reminders to improve compliance and increase treatment success.
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Eect of electronic reminders
on patients’ compliance
during clear aligner treatment:
an interrupted time series study
Lan Huong Timm1,4,5*, Gasser Farrag1,5, Daniel Wolf1, Martin Baxmann2 & Falk Schwendicke3
Patient compliance is relevant to achieving therapeutic goals during clear aligner therapy (CAT). The
aim of this study was to evaluate the ecacy of remote electronic (e-)reminders and e-feedback on
compliance during CAT using an interrupted time series (ITS) analysis. We used routinely collected
mobile application data from a German healthtech company (PlusDental, Berlin). Our primary
outcome was self-reported compliance (aligner wear time min. 22 h on 75% of their aligners were
classied as fully compliant, min. 22 h on 50–74.9% of their aligners: fairly compliant; min. 22 h
on < 50% of their aligners: poorly compliant). E-reminders and e-feedback were introduced in the
1st quarter of 2020. Compliance was assessed at semi-monthly intervals from June-December 2019
(n = 1899) and June-December 2020 (n = 5486), resulting in a pre- and post-intervention group. ITS and
segmented regression modelling were used to estimate the eect on the change in levels and trends
of poor compliance. Pre-intervention, poor compliance was at 24.47% (95% CI: 22.59% to 26.46%).
After the introduction of e-reminders and e-feedback (i.e., post-intervention), the percentage of
poorly compliant patients decreased substantially, levelling o at 9.32% (95% CI: 8.31% to 10.45%).
E-reminders and e-feedback were eective for increasing compliance in CAT patients.
Clinical Signicance: Orthodontists and dentists may consider digital monitoring and e-reminders to
improve compliance and increase treatment success.
Patient compliance during orthodontic therapy (e.g., towards wearing a removable appliance, attending regular
re-evaluation and adaptation visits, adhering to specic oral hygiene requirements) has been shown highly
relevant to achieving therapeutic goals and reducing adverse eects14. Both chairside approaches (oentimes
involving written information, videos, or teaching aids, and demanding signicant chairside time, i.e. generat-
ing considerable costs)5 and remote interventions (e.g. telephone, text, or online reminders, which are scalable
and come at high accessibility) have been suggested to improve compliance58; the latter have been proven to
improve patient compliance in healthcare in general911. Considering the widespread use of smartphones globally,
remote interventions through messages and mobile applications oer a viable, low-cost, and equitable strategy
to improve compliance4,11.
Studies have shown that mobile short messaging could have a positive impact on short-term behavioural
outcomes12 and that active reminders (weekly text messaging) for patients undergoing orthodontic treatment
could improve oral health13. Weekly reminders were also found to improve the memorability of the information
given by orthodontists in the oce, increasing compliance3.
During clear aligner treatment (CAT), electronic messaging and self-management or regular notications
by the treating dentist using mobile applications may improve patients’ understanding of their therapy, their
compliance, and the resulting outcomes. e ecacy of such remote electronic reminders on compliance during
CAT, however, remains unclear.
Using the interrupted time-series (ITS) approach, we aimed to measure the impact of active electronic (e-)
reminders and automatic e-feedback on patient compliance during CAT. e objectives of the present study were
1Sunshine Smile GmbH, Windscheidstraße 18, 10627 Berlin, Germany. 2Orthodentix, Arnoldstrasse 13 b,
47906 Kempen, Germany. 3Department of Oral Diagnostics, Digital Health and Health Services Research, Charité
Universitätsmedizin Berlin, Aßmannshauser Straße 4-6, 14197 Berlin, Germany. 4DrSmile - DZK Deutsche
Zahnklinik GmbH, Königsallee 92a, 40212 Düsseldorf, Germany. 5These authors contributed equally: Lan Huong
Timm and Gasser Farrag. *email:
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(1) to analyse patient compliance before and aer the introduction of an e-reminder system during CAT, and
(2) to evaluate whether the eects of this reminder system varied by gender and age.
Materials and methods
Study design and sample. An ITS analysis was conducted to evaluate the eect of using e-reminders and
e-feedback on patient compliance during CAT. Data were collected by PlusDental, a brand of the Sunshine Smile
GmbH (Berlin, Germany), during the course of routine treatment of patients, and were anonymized for research
use. e study was conducted according to the guidelines of the Declaration of Helsinki. e data were collected
retrospectively as a part of the treatment and anonymized for research use, which according to the Berlin State
Hospital Act (Landeskrankenhausgesetz Berlin) and the recommendations of the Datenschutz und IT-Sicher-
heit im Gesundheitswesen (DIG) task force of the German Association for Medical Informatics, Biometry, and
Epidemiology (GMDS) does not require approval from an ethics committee.
All patients were instructed to report each aligner change as well as the daily aligner wearing time using the
app-based questionnaire as described in detail by Timm etal.14. e aligner change interval depended on the
prescribed wear protocol, either aer every 7days or aer 14days of wear. Hence, reporting of changing aligners
and average wear time were provided every 1–2weeks.
We classied patients into fully, fairly and poorly compliant. Aligner wear time of ≥ 22h with ≥ 75% of align-
ers and consistent use of the mobile application for aligner check-in were classied as full compliance. Patients
with inconsistent app use were classied as either fairly compliant or poorly compliant based on aligner wear
time: Aligner wear time of 22h with 50–74.9% of aligners was classied as fair compliance, and aligner wear
time of ≥ 22h with only < 50% of aligners was classied as poor compliance. us, patients who provided no or
inadequate information about their compliance would be classied as poorly compliant.
e implementation of e-reminders and automatic e-feedback was our intervention. e implementation
occurred at the beginning of 2020, i.e., as of the 1st quarter of 2020 onwards these reminders were used (see
below). e reporting of the study follows the STrengthening the Reporting of OBservational studies in Epide-
miology (STROBE) checklist; the employed methodology is in accordance with the World Medical Association
Declaration of Helsinki15.
Data of all patients aged 18–64years that (based on one intraoral scan) nished their treatment successfully
with the so-called 1–1-2 system14 (see subsection: "Intervention and data collection") during the second half of
2019, i.e., never received e-reminders or e-feedback during their therapy (n = 1899 patients) and the second half
of 2020, i.e., always received e-reminders and e-feedback (n = 5486 patients) were available. e introduction of
e-reminders and e-feedback was the only dierence between the two versions of the mobile application. A com-
prehensive sample was drawn (i.e., no random sampling, etc.). e patients showed the following characteristics
prior to therapy: Malocclusion in the anterior and/or premolar region to be treated with CAT; adults (> 18years)
with a permanent dentition; absence of active periodontal disease or local and/or systemic conditions that can
aect bone metabolisms; no extractions being required for the orthodontic treatment (Fig.1).
Intervention and data collection. A new e-reminder and e-feedback had been implemented and
deployed to the PlusDental mobile application in the rst quarter of 2020, reminding patients towards the 22h
aligner wearing time for ensuring tooth movement and instructing them to remove aligners only for eating,
drinking, and oral hygiene. If patients recorded a wearing time of less than 22h per day (they were actively asked
to record this when changing aligners), they were sent an automatic e-feedback and given background informa-
tion to increase the wearing time with the next aligner as “important information”.
All patients underwent standardized clinical and laboratory processes, as described in detail by Timm etal.14.
At the rst visit, a complete clinical examination, a full set of digital photographs and an intraoral scan as well
as radiographs according to the recommendations of the British Orthodontic Society were performed16. A basic
periodontal examination17,18 and a CMD screening19 were carried out in order to rule out contraindications to
CAT. Eventually, patients received their set of aligners required for CAT. e aligners were trimmed 2mm above
the gingival margin and the 1–1–2 treatment protocol, consisting of 3 consequent aligners per step (0.5mm for
one week, 0.625mm for one week, then 0.75mm for 2weeks), was followed. At this visit, patients were informed
about the importance of wearing the aligners for 22h per day and were instructed to check-in every aligner
change using the mobile app (including, as described, recording of the wearing time).
Figure1. Flowchart of the included groups.
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A set of standardized intra- and extra-oral photographs were uploaded to the mobile application by patients
at least every two months for a follow-up to ensure close monitoring of treatment and to encourage patient
Outcome and outcome measures. e outcome in this study was self-reported patient compliance,
recorded using the (application-based) questionnaire, measuring the daily aligner wearing time. Patients with
consistent use of the mobile application for aligner check-in and an aligner wearing time of 22h on 75% of their
aligners were classied as fully compliant, as dened previously14. Patients with inconsistent application usage
were classied as fairly or poorly compliant based on the aligner wearing time: Patients with the aligner wearing
time of 22h on 50–74.9% of their aligners were classied as fairly compliant and patients with an aligner wearing
time of 22h on only < 50% of their aligners as poorly compliant14.
ITS Analysis. A semi-monthly cross-section of recorded patient poor compliance was employed for our ITS
analysis. e data was partitioned by time, gender and age range (18 to 35, 36 to 55, and 56 to 64), resulting in 58
data points for the last six months of 2019 (pre-intervention cohort) and 64 data points for the last six months
of 2012 (post-intervention cohort), as recommended for ITS20. Because it was found that the patient compliance
was associated with a temporary slope change followed by a level change21 aer the introduction of the interven-
tion, the ITS was partitioned into three segments to account for this pattern: pre-intervention, post-intervention
segment A (2020-07-01 to 2020-09-15) and post-intervention segment B (2020-10-01 to 2020-12-15). Since the
outcome (poor compliance) is a count proportion, logistic regression was used for the analysis. e global model
was as follows:
Yt is the proportion of poor compliance among patients who were treated in each halfmonth t, Xt is the vector
of the 8 covariates at time t, and E[Yt | Xt] is the expected value of Yt given the covariates Xt;
timet is a continuous variable that represents the time elapsed (in halfmonths) from the start of the observa-
tion period;
segment_At is an indicator variable for whether halfmonth t was in post-intervention segment A (1 if in
segment A, 0 otherwise);
segment_A_timet is a continuous variable giving the time elapsed (in halfmonths) within post-intervention
segment A;
segment_Bt is an indicator variable for whether halfmonth t was in post-intervention segment B (1 if in seg-
ment B, 0 otherwise);
segment_B_timet is a continuous variable giving the time elapsed (in halfmonths) within post-intervention
segment B;
gender_m is an indicator for gender (0 if female, 1 if male);
age_36_55 is an indicator for age (1 if the age range is 36 to 55, 0 otherwise);
age_56_64 is an indicator for age (1 if the age range is 56 to 64, 0 otherwise);
β0 is an estimate of the log of the baseline odds; and
each βi is an estimate of the log of the odds ratio of the respective covariate.
Some additional explanation of the last two points is given: e odds of an event with probability p is the
ratio p / (1 – p). In this case p is the probability of a patient being poorly compliant. If all the covariates are 0,
then the estimated odds of poor compliance are exp(β0). e other coecients relate to odds ratios. For instance,
exp(β6) is an estimate of the ratio of the odds given gender_m = 1 to the odds given gender_m = 0 (with all other
covariates equal), i.e. exp(β6) is a measure of how more/less likely male patients are to be poorly compliant than
female patients.
e methodology proposed by Burnham & Anderson22 was used, in particular multimodel inference (MMI).
e essential idea is to average over dierent models, rather than attempting to select a single best model. e key
ingredient is the Akaike information criterion (AIC), a measure of relative model quality founded on information
theory. To this end, all submodels of the global model were tted to the data; that is, for each of the 256 subsets of
i : 1 ≤ i ≤ n}, a model using only the selected covariates was tted to the data. (For brevity we conate covariates
with their coecients in the model.) e AIC of each model was calculated. Note that the small-sample version
of the AIC (AICc) was not used: Although the data seemingly consists of only 122 (= 58 + 64) points, each of
these points represents a group of patients. Indeed, the number of patients was used to weight the points in the
model tting, which is in fact equivalent to tting a logistic regression model on the level of individual patients,
with a response of either 1 (poorly compliant) or 0 (not poorly compliant). For each model, the dierence ∆ in
its AIC from the smallest AIC was calculated (so the top model has ∆ = 0). ese dierences were exponentiated
and then normalised to give the Akaike weight of each model. A subset of models was chosen on the basis of
the Akaike weights: e models {β0, β2, β3, β4, β6} and {β0, β2, β3, β4, β6, β8} had Akaike weights of 0.196 and
0.168 respectively, while the next highest weight was 0.099. ese two models were thus selected and their Akaike
weights renormalized. (Other selection criteria were explored, such as ∆ < 2 or the smallest subset such that the
sum of the Akaike weights was above 0.95, but each resulting averaged model suered from multicollinearity
x time
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amongst the covariates and in particular a non-positive-denite estimated covariance matrix.) e resulting
model, based on weighted averages over the selected models, is henceforth referred to as the MMI model.
e descriptive data analysis and pairwise testing were performed using JASP 0.14.1 (University of Amster-
dam, Amsterdam, e Netherlands). e ITS analysis was performed using version 0.13.1 of the Python library
statsmodels24. e pre-and post-intervention groups were pairwise compared with a two-sided Chi-square test
or a t-test for independent samples. p values less than 0.05 were considered statistically signicant.
Cohort characteristics. Data of 5486 patients were available for analysis; of these, 1615 (29.4%) were male
and 3871 (70.6%) females. e median age at treatment initiation was 28 (range 18–64) years, the mean age
was 29.1 (range 18–64) years. e largest age group were young adults (aged 18–35years, n = 4456), followed
by adults (aged 36–55years, n = 984) and older adults (aged > 55years, n = 46). While the mean age was not
signicantly dierent between pre-and post-intervention periods, there was a signicant gender and age group
distribution dierence (p < 0.05) between the cohorts (Table1).
Compliance. Patients were classied according to the compliance criteria into full, fair, and poor compli-
ance. Pre-intervention, 703/1899 (37.0%) patients showed full compliance, 729/1899 (38.4%) fair compliance,
and 467/1899 (24.6%) poor compliance, whereas post-intervention 2382/5486 (43.4%) of patients showed full
compliance, 2262/5486 (41.2%) fair compliance, and 842/5486 (15.3%) poor compliance. Compliance was
higher in males than females (p < 0.001). No signicant dierence in compliance was found between age groups
Given that gender, but not age group distribution was signicantly associated with compliance, we further
compared compliance in both cohorts stratied by gender (Table3). We conrmed that compliance was signi-
cantly higher in the post-intervention than the pre-intervention group in both genders.
Descriptive plots of poor compliance over time are given in Figs.2, 3 and 4. e coecients of the MMI model
are shown in Table4. Note that p-values are not given, since doing so would conate dierent analysis paradigms;
instead, the Akaike weights of the coecients can be used as a measure of the relative strength of evidence. Fig-
ure5 shows the MMI model by starting date of treatment. e values were calculated by taking the mean of each
covariate at the given starting date and then using the coecients in Table4 to make a point estimate. e 95%
condence band was calculated using the estimated covariance matrix of the MMI model (not shown). Similarly,
the gures given in the Abstract—24.47% (95% CI: 22.59% to 26.46%) poor compliance in the pre-intervention
period and 9.32% (95% CI: 8.31% to 10.45%) in post-intervention period segment B—were calculated by taking
the mean of each covariate within each segment and using these as inputs for the MMI model. e results of the
MMI model suggest that the introduction of e-reminders had the desired eect, namely reducing poor compli-
ance. Note in Table4 that the Akaike weight for age_55_64 is lower than the weights of the other coecients.
Table 1. Cohort characteristics, stratied into pre-and post-intervention periods.
Covariates Pre-intervention Post-intervention p value
No. of subjects (n) 1899 5486
Age (mean ± SD) 28.8 ± 7.4 29.1 ± 8.1 0.13
Gender, female / male (%) 75.6% / 24.4% 70.6% / 29.4% < 0.001
Age 18- to 35- years old (%)
Age 36- to 55- years old (%)
Age 56- to 64- years old (%)
1601 (84.3%)
286 (15.1%)
12 (0.6%)
4456 (81.2%)
984 (17.9%)
46 (0.8%) < 0.05
Table 2. Compliance in the pre-and post-intervention cohorts, stratied by age group and by gender. A Chi-
square test was used to test for dierences in the strata in each cohort.
Pre-Intervention Post-Intervention
sample Full
compliance Fair
compliance Poor
compliance Chi-square Overall
sample Full
compliance Fair
compliance Poor
compliance Chi-square
Male 463 (24.4%) 185 (9.7%) 197 (10.4%) 81 (4.3%) X2 (2,
n = 1899) = 16.72
p = 0.000233
(p = < 0.001)
1615 (29.4%) 763 (13.9%) 648 (11.8%) 204 (3.7%) X2 (2,
n = 5486) = 19.39
p = 0.000061
(p = < 0.001)
Female 1436 (75.6%) 518 (27.3%) 532 (28.0%) 386 (20.3%) 3871 (70.6%) 1619 (29.8%) 1614 (29.7%) 638 (11.7%)
18- to 35-
years old 1601 (84.3%) 588 (31.0%) 616 (32.4%) 397 (20.9%)
X2 (4,
n = 1899) = 2.80
p = 0.591
4456 (81.2%) 1925 (35.1%) 1843 (33.6%) 688 (12.5%)
X2 (4,
n = 5486) = 1.28
p = 0.864
36- to 55-
years old 286 (15.1%) 112 (5.9%) 109 (5.7%) 65 (3.4%) 984 (17.9%) 438 (8.0%) 401 (7.3%) 145 (2.6%)
56- to 64-
years old 12 (0.6%) 3 (0.2%) 4 (0.1%) 5 (0.3%) 46 (0.8%) 19 (0.3%) 18 (0.3%) 9 (0.2%)
Tot al 1899 (100%) 703 (37.0%) 729 (38.4%) 467 (24.6%) 5486 (100%) 2382 (43.4%) 2262 (41.2%) 842 (15.3%)
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Moreover, the sign of coecient is not stable over the 95% condence interval. Both of these points are consistent
with the ndings of the chi-squared test that age was not signicantly associated with compliance.
Over the pre-intervention period, no signicant dierence or trend in compliance was identied (Fig.5). In
comparison, aer the introduction of the e-reminders and e-feedback (i.e., post-intervention), the percentage
of poorly compliant patients decreased substantially and remained consistently and signicantly lower than
pre-intervention. e downward trend did not continue indenitely; Fig.5 shows that the trend levelled o in
October 2020, i.e., a temporary slope was followed by a level change as described. Note that the initial increase
in post-intervention segment A is consistent with a seasonal eect since both July 2019 and July 2020 saw peaks
in poor compliance.
is is the rst ITS study using real-world clinical data to investigate the impact of using e-reminders and
e-feedback via a mobile application during CAT. Our results showed that the introduction of e-reminders and
e-feedback signicantly and sustainably improved compliance. While compliance was generally higher in males
than females, the positive eect of the intervention was found in both males and females alike. Orthodontists and
dentists may want to employ mobile reporting options (like apps) to identify low compliance in CAT patients
and to address this low compliance using e-reminders.
Although a randomized controlled trial is considered the gold standard in attempting to prove causality and
to demonstrate the eectiveness of a new intervention, such trials are not always feasible nor needed25,26. For
instance, the running costs and time required for conducting trials, the associated bias by selection, and attrition
are among the limitations of randomized controlled studies2628. In our study, we instead opted for an ITS design,
which is one of the strongest quasi-experimental designs26 not requiring randomization and having been found to
Table 3. Compliance within gender groups pre-and post-intervention. A Chi-square test was used to test for
dierences between intervention groups.
Full Compliance Fair Compliance Poor Compliance Chi-Square
Pre-intervention 518 (36.1%) 532 (37.0%) 386 (26.9%) X2 (2, n = 5307) = 72.89
p = < 0.0001
Post-intervention 1619 (41.8%) 1614 (41.7%) 638 (16.5%)
Pre-intervention 185 (40.0%) 197 (42.5%) 81 (17.5%) X2 (2, n = 2078) = 10.91
p = 0.0042 (< 0.05)
Post-intervention 763 (47.2%) 648 (40.1%) 204 (12.6%)
Figure2. Mean poor compliance by starting date of treatment. Note that this gure contains data from the
mid-period (January to June 2020), which was excluded from the statistical analysis.
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have high internal validity20,21,29,30. Using the ITS approach on routine data allowed to demonstrate the eects of
the e-intervention on compliance in a large real-life population, i.e., with high generalizability and applicability.
In this study among CAT patients, we analysed factors inuencing patient compliance and trends before and
aer an intervention with e-reminders that emphasized the importance of compliance in wearing time. Since
the intervention (a new version of the mobile application, now including e-reminders, etc.) was deployed during
Figure3. Mean poor compliance by starting date of treatment, split by gender. e dashed vertical line
indicates the gap between the two segments.
Figure4. Mean poor compliance by starting date of treatment, split by age range. e dashed vertical line
indicates the gap between the two segments. e age range 56–64 was excluded from the gure due to the low
number of patients in this age group.
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the rst quarter of 2020, the period between January 2020 and June 2020 included both patients who had started
their treatment with the old app version and those starting with the new one; this period was therefore excluded
to ensure consistency. Based on that and to control for seasonality, the period from January 2019 to June 2020
was excluded as well.
Although the gender and age group distribution diered signicantly between the pre-intervention and post-
intervention groups, we did not nd this to impact on compliance: Age was not signicantly associated with
compliance, and the combined eect of gender and intervention on compliance was analysed accordingly using
stratication analysis. We found the proportion of individuals with poor compliance to decrease signicantly in
both males and females aer the introduction of the e-reminders and e-feedback.
To our knowledge, there is no published ITS study investigating the eect of an intervention on patient com-
pliance during CAT, nonetheless, the ndings can be compared to a range of other reports. Reminders have been
found to have a positive eect on compliance during orthodontic treatment based on the results of two systematic
reviews, which is in line with our study8,31. Our ndings are also in agreement with a randomized trial showing
signicantly increased levels of oral hygiene compliance in orthodontic patients that received verbal education
on their treatment during their rst visits7. Added to that, the positive eect of active reminders established in
our study is also similar to the nding by Eppright etal., where weekly text message reminders highlighting the
importance of oral hygiene were shown to improve oral hygiene compliance in orthodontic patients6. Moreover,
the eect of regular positive reinforcement on general oral health through text messaging established by Jadhav
etal. is also in agreement with our ndings13.
Among many methods, reminding the patient on a regular basis to adhere to the treatment protocol has
been demonstrated to increase compliance before32,33. Patients found the mobile applications easy to use and
Table 4. e coecients of the MMI model.
Coecient 95% condence interval Akaike weight
Constant term (β0)− 1.03 (− 1.14, − 0.92) 1.00
Segment A (β2) 0.31 (0.11, 0.50) 1.00
Segment A time (β3)− 0.35 (− 0.46, − 0.24) 1.00
Segment B (β4)− 1.13 (− 1.29, − 0.97) 1.00
Gender_m (β6)− 0.40 (− 0.55, − 0.26) 1.00
Age_56_64 (β8) 0.42 (− 0.19, 1.04) 0.46
Figure5. e MMI model by starting date of treatment. e purple line gives the point estimates of expected
poor compliance while the purple shaded area is the 95% condence band. Each point indicates the mean poor
compliance of the given group, whereby the size of the point is proportional to the number of patients contained
within that group. Points with fewer than 5 patients were excluded from the gure. e dashed vertical line
indicates the gap between the two segments.
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demonstrated the ability to use the app34,35, preferred the smartphone app intervention to other devices35, and
were satised with in-app functions that promote patient compliance with e-reminders36. e tendency to over-
estimate one’s own wearing times is reduced once patients know that the wearing time is monitored37. In addi-
tion to sending e-feedback and e-reminders to patients on regular basis, nancial incentives were reported to
enhance patient compliance38. In the context of the mobile application, a gaming component could be considered
to further optimize compliance39,40. e ecacy of these methods in CAT patients needs to be further studied.
is study has a number of strengths and limitations. First, it is one of the rst reports to demonstrate the
eect of e-reminders on improving patient compliance during CAT treatment. is nding is particularly signi-
cant as the literature indicates that orthodontic patients seeking treatment with removable appliances oen fail
to adhere to wearing times4143 or sometimes do not complete the prescribed therapy at all44. Another strength
is that it used real-world data and employed the ITS approach. By doing so, high generalizability and applicabil-
ity, as well as a relatively large sample size, were combined with high internal validity. Among the limitations of
this study is the exclusion of the January 2020 to June 2020 group due to the impracticability of deploying the
intervention for all the patients at the same time. However, as with many interventions, a transition period is
needed for the intervention to produce the anticipated eect. is lag period could be excluded from the analysis
to avoid faulty interpretation of the analysis20. e ITS analysis also had limitations: e decision to partition the
data into three segments was post-hoc, although it was necessary to correctly model the data since a two-segment
approach cannot reect a temporary slope followed by a level change. Moreover, it would have been useful to have
a longer pre-intervention time period to build on more time points and capture possible patterns of seasonality
and dierentiate them from outliers. A longer pre-intervention period may also help to alleviate issues with
multicollinearity (see Sect.ITS Analysis). As a result, and to tackle the aspect of seasonality, we only included
individuals over similar time periods in 2019 (pre-intervention) and 2020 (post-intervention). We showed that
during summer, compliance decreased, possibly due to dierent cognitive distractions during periods of good
weather45. Another limitation is that the aligner wearing hours were reported by the patients using self-reports,
which are susceptible to biases. More in-depth data analyses and, possibly, qualitative investigations are needed
to address these limitations in detail.
Within the limitations of this study, e-reminder and e-feedback were eective measures for increasing compli-
ance in CAT patients. Orthodontists and dentists may consider digital monitoring and e-reminders to improve
compliance and thereby increase treatment success.
Data availability
e data is available upon request to the corresponding author.
Received: 7 January 2022; Accepted: 19 September 2022
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Author contributions
L.H.T.: Conceptualization, Methodology, Formal analysis, Writing -Original Dra, Writing—Review and Edit-
ing. G.F.: Conceptualization, Writing -Original Dra, Writing—Review and Editing. D.W.: Formal analysis,
Writing—Review and Editing. M.B.: Writing—Review and Editing. F.S.: Conceptualization, Writing—Review
and Editing, Supervision.
Competing interests
Lan Huong Timm and Gasser Farrag declare current gainful employment by Sunshine Smile GmbH, the brand
owner of PlusDental. Daniel Wolf declares previous gainful employment by Sunshine Smile GmbH. Martin
Baxmann and Falk Schwendicke are members of the Scientic Board of the Sunshine Smile GmbH.
Additional information
Correspondence and requests for materials should be addressed to L.H.T.
Reprints and permissions information is available at
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... As non-adherence for at least two times/week has still proven to be intentional in around 25% of subjects [41], various support strategies based on novel technologies and electronic devices have been introduced over the past few years, with the aim of promoting adherence in adolescents with asthma [42]. Nevertheless, a review dedicated to these new trends showed that the adolescents' adherence to inhalers recorded by electronic monitoring was at less than 50% [43], even if recent experiences with electronic reminders are showing encouraging results from this point of view [44,45]. However, although previous studies investigating these interventions, aiming to promote adherence in adolescents with asthma, proved to be of limited effectiveness [46][47][48], additional studies oriented to better understanding and possibly removing the deeper reasons for such poor attitudes in adolescents regarding maintaining long-term asthma strategies are still needed, even in the case of mild asthma [49]. ...
Full-text available
Adolescents with asthma are usually insufficiently adherent to regular inhalation treatments, thus limiting their effectiveness. The aim of this study is to investigate the role of adherence to single-inhaler long-acting LABA/ICS dry-powder combination o.d. in affecting lung function, bronchial hyperreactivity, and health outcomes over a twelve-month survey of a group of non-smoking adolescents with mild to moderate asthma. Methods: Age, gender, BMI and atopy, forced expiratory volume in 1 s (FEV1), maximum mid-expiratory flow (MMEF), and maximum expiratory flow at 25% of lung filling (MEF25) were assessed via a Boolean selection process from the institutional database at recruitment, as well as after 6 and 12 months, together with the incidence of exacerbation, school days that were taken off, GP and specialist visits, and systemic steroid and/or antibiotic courses. Adherence was checked monthly via a direct telephone call. Statistics were calculated with an ANOVA trend analysis, assuming p < 0.05. Results: Two well-matched sample groups of 54 subjects each were obtained. The mean annual adherence to treatment ranged from 48.2% doses ± 10.9 sd to 79.3% doses ± 8.8 sd (p < 0.001), regardless of age and gender. Only adolescents that adhered to the o.d. ICS/LABA inhalation regimen progressively achieved complete control of all lung function parameters (FEV1: 0.001; MMEF: p < 0.002; MEF25 < 0.001;
Full-text available
Objective To test the feasibility and acceptability of a short-term reminder and incentives intervention in adolescents with low adherence to asthma medications. Methods Mixed-methods feasibility study in a tertiary care clinic. Adolescents recruited to a 24-week programme with three 8-weekly visits, receiving electronic reminders to prompt inhaled corticosteroid (ICS) inhalation through a mobile app coupled with electronic monitoring devices (EMD). From the second visit, monetary incentives based on adherence of ICS inhalation: £1 per dose, maximum £2 /day, up to £112/study, collected as gift cards at the third visit. End of study interviews and questionnaires assessing perceptions of asthma and ICS, analysed using the Perceptions and Practicalities Framework. Participants Adolescents (11–18 years) with documented low ICS adherence (<80% by EMD), and poor asthma control at the first clinic visit. Results 10 out of 12 adolescents approached were recruited (7 males, 3 females, 12–16 years). Eight participants provided adherence measures up to the fourth visits and received rewards. Mean study duration was 281 days, with 7/10 participants unable to attend their fourth visit due to COVID-19 lockdown. Only 3/10 participants managed to pair the app/EMD up to the fourth visit, which was associated with improved ICS adherence (from 0.51, SD 0.07 to 0.86, SD 0.05). Adherence did not change in adolescents unable to pair the app/EMD. The intervention was acceptable to participants and parents/guardians. Exit interviews showed that participants welcomed reminders and incentives, though expressed frustration with app/EMD technological difficulties. Participants stated the intervention helped through reminding ICS doses, promoting self-monitoring and increasing motivation to take inhalers. Conclusions An intervention using electronic reminders and incentives through an app coupled with an EMD was feasible and acceptable to adolescents with asthma. A pilot randomised controlled trial is warranted to better estimate the effect size on adherence, with improved technical support for the EMD.
Full-text available
Background Apps have been shown to be an effective tool in changing patients’ behaviours in orthodontics and can be used to improve their compliance with treatment. The Behaviour Change Techniques (BCTs) and quality (using MARS) within these apps have previously not been published. Objectives To evaluate the quality of these apps aiming to change behaviour. To assess BCTs used in patient focused orthodontic apps. Methods The UK Google Play and Apple App Stores were searched to identify all orthodontic apps and 305 apps were identified. All 305 apps were assessed for the presence of BCTs using an accepted taxonomy of BCTs (Behaviour Change Wheel (BCW)), widely utilised in healthcare. Of those containing BCTs, the quality was assessed using the Mobile App Rating Scale (MARS), a validated and multi-dimensional tool which rates apps according to 19 objective criteria. Data collection was carried out by two calibrated, independent assessors and repeated after 6 weeks for 25% of the apps by both assessors. Results BCTs were found in 31 apps, although only 18 of them were analysed for quality and 13 apps were excluded. Six different BCTs were identified: these were most commonly ‘prompts/cues’, and ‘information about health consequences’. All apps were shown to be of moderate quality (range 3.1–3.7/5). Inter-rater and intra-rater reliability for BCT and quality assessment were excellent. Conclusions The current availability of orthodontic apps of sufficient quality to recommend to patients is very limited. There is therefore a need for high-quality orthodontic apps with appropriate BCTs to be created, which may be utilised to improve patients’ compliance with treatment.
Full-text available
Compliance is highly relevant during clear aligner therapy (CAT). In this retrospective cohort study, we assessed compliance and associated covariates in a large cohort of CAT patients. A comprehensive sample of 2644 patients (75.0% females, 25.0% males, age range 18–64 years, median 27 years), all receiving CAT with PlusDental (Berlin, Germany) finished in 2019, was analyzed. Covariates included demographic ones (age, gender) as well as self-reported questionnaire-obtained ones (satisfaction with ones’ smile prior treatment, the experience of previous orthodontic therapy). The primary outcome was compliance: Based on patients’ consistent use of the mobile application for self-report and aligner wear time of ≥22 h, patients were classified as fully compliant, fairly compliant, or poorly compliant. Chi-square test was used to compare compliance in different subgroups. A total of 953/2644 (36.0%) of patients showed full compliance, 1012/2644 (38.3%) fair compliance, and 679/2644 (25.7%) poor compliance. Males were significantly more compliant than females (p = 0.000014), as were patients without previous orthodontic treatment (p = 0.023). Age and self-perceived satisfaction with ones’ smile prior to treatment were not sufficiently associated with compliance (p > 0.05). Our findings could be used to guide practitioners towards limitedly compliant individuals, allowing early intervention.
Full-text available
Clinical studies, especially randomized controlled trials, are essential for generating evidence for clinical practice. However, generalizability is a long‐standing concern when applying trial results to real‐world patients. Generalizability assessment is thus important, nevertheless, not consistently practiced. We performed a systematic review to understand the practice of generalizability assessment. We identified 187 relevant papers and systematically organized these studies in a taxonomy with three dimensions: (1) data availability (i.e., before or after trial [a priori vs a posteriori generalizability]), (2) result outputs (i.e., score vs non‐score), and (3) populations of interest. We further reported disease areas, underrepresented subgroups, and types of data used to profile target populations. We observed an increasing trend of generalizability assessments, but less than 30% of studies reported positive generalizability results. As a priori generalizability can be assessed using only study design information (primarily eligibility criteria), it gives investigators a golden opportunity to adjust the study design before the trial starts. Nevertheless, less than 40% of the studies in our review assessed a priori generalizability. With the wide adoption of electronic health records systems, rich real‐world patient databases are increasingly available for generalizability assessment; however, informatics tools are lacking to support the adoption of generalizability assessment practice.
Full-text available
Background: The efficacy of smartphone apps for improving medication adherence in type 2 diabetes is not well studied in Asian populations. Objective: This study aimed to determine the feasibility, acceptability, and clinical outcomes of using a smartphone app to improve medication adherence in a multiethnic Asian population with type 2 diabetes. Methods: We block randomized 51 nonadherent and digitally literate patients with type 2 diabetes between the ages of 21 and 75 years into two treatment arms (control: usual care; intervention: usual care+Medisafe app) and followed them up for 12 weeks. Recruitment occurred at a public tertiary diabetes specialist outpatient center in Singapore. The intervention group received email reminders to complete online surveys monthly, while the control group only received an email reminder(s) at the end of the study. Barriers to medication adherence and self-appraisal of diabetes were assessed using the Adherence Starts with Knowledge-12 (ASK-12) and Appraisal of Diabetes Scale (ADS) questionnaires at baseline and poststudy in both groups. Perception toward medication adherence and app usage, attitude, and satisfaction were assessed in the intervention group during and after the follow-up period. Sociodemographic data were collected at baseline. Clinical data (ie, hemoglobin A1c, body mass index, low-density lipoprotein, high-density lipoprotein, and total cholesterol levels) were extracted from patients' electronic medical records. Results: A total of 51 (intervention group: 25 [49%]; control group: 26 [51%]) participants were randomized, of which 41 (intervention group: 22 [88.0%]; control group: 19 [73.1%]) completed the poststudy survey. The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01). No changes were observed in the clinical outcomes. The average 12-week medication adherence rate of participants tracked by the app was between 38.3% and 100% in the intervention group. The majority (>80%) of the participants agreed that the app was easy to use and made them more adherent to their medication. Conclusions: Our feasibility study showed that among medication-nonadherent patients with type 2 diabetes, a smartphone app intervention was acceptable, improved awareness of medication adherence, and reduced self-reported barriers to medication adherence, but did not improve clinical outcomes in a developed Asian setting.
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Background: Randomised controlled trials (RCTs) are considered the gold standard when evaluating the causal effects of healthcare interventions. When RCTs cannot be used (e.g. ethically difficult), the interrupted time series (ITS) design is a possible alternative. ITS is one of the strongest quasi-experimental designs. The aim of this methodological study was to describe how ITS designs were being used, the design characteristics, and reporting in the healthcare setting. Methods: We searched MEDLINE for reports of ITS designs published in 2015 which had a minimum of two data points collected pre-intervention and one post-intervention. There was no restriction on participants, language of study, or type of outcome. Data were summarised using appropriate summary statistics. Results: One hundred and sixteen studies were included in the study. Interventions evaluated were mainly programs 41 (35%) and policies 32 (28%). Data were usually collected at monthly intervals, 74 (64%). Of the 115 studies that reported an analysis, the most common method was segmented regression (78%), 55% considered autocorrelation, and only seven reported a sample size calculation. Estimation of intervention effects were reported as change in slope (84%) and change in level (70%) and 21% reported long-term change in levels. Conclusions: This methodological study identified problems in the reporting of design features and results of ITS studies, and highlights the need for future work in the development of formal reporting guidelines and methodological work.
Background Adherence to prescribed medical interventions can predict the efficacy of the treatment. In physical health clinics, not adhering to prescribed therapy can take the form of not attending a scheduled clinic visit (no-show appointment) or prematurely terminating treatment against the advice of the provider (self-discharge). A variety of interventions, including mobile phone apps, have been introduced for patients to increase their adherence to attending scheduled clinic visits. Limited research has examined the impact of a mobile phone app among patients attending chiropractic and rehabilitation clinic visits. Objective This study aims to compare adherence to prescribed physical health treatment among patients attending a chiropractic and rehabilitation clinic who did and did not choose to adopt a phone-based app to complement their treatment. Methods The medical records of new patients who presented for care during 2019 and 2020 at 5 community-based chiropractic and rehabilitation clinics were reviewed for the number of kept and no-show appointments and to determine whether the patient was provider-discharged or self-discharged. During this 24-month study, 36.28% (1497/4126) of patients seen in the targeted clinics had downloaded the Kanvas app on their mobile phone, whereas the remaining patients chose not to download the app (usual care group). The gamification component of the Kanvas app provided the patient with a point every time they attended their visits, which could be redeemed as an incentive. Results During both 2019 and 2020, the Kanvas app group was provider-discharged at a greater rate than the usual care group. The Kanvas app group kept a similar number of appointments compared with the usual care group in 2019 but kept significantly more appointments than the usual care group in 2020. During 2019, both groups exhibited a similar number of no-show appointments; however, in 2020, the Kanvas app group demonstrated more no-show appointments than the usual care group. When collapsed across years and self-discharged, the Kanvas app group had a greater number of kept appointments compared with the usual care group. When provider-discharged, both groups exhibited a similar number of kept appointments. The Kanvas app group and the usual care group were similar in the number of no-show appointments when provider-discharged, and when self-discharged, the Kanvas app group had more no-show appointments compared with the usual care group. Conclusions Patients who did or did not have access to the Kanvas app and were provider-discharged exhibited a similar number of kept appointments and no-show appointments. When patients were self-discharged and received the Kanvas app, they exhibited 3.2 more kept appointments and 0.94 more no-show appointments than the self-discharged usual care group.
ABSTRACT Objectives: To compare the efficacy of traditional and digital communication strategies in improving compliance with fixed orthodontic therapy and to investigate the effect of gender, baseline oral hygiene habits, socioeconomics, and parents’ education on orthodontic compliance. Materials and Methods: Orthodontic patients were randomly allocated to three groups. Group 1 received traditional communication including verbal and written instructions, whereas group 2 and group 3 received, in addition to traditional communication, weekly text messages or e-mails with audiovisual links, respectively. Baseline demographics (age, gender, baseline oral hygiene habits, socioeconomics, and parents’ education) as well as compliance indicators (treatment duration, failed appointments, incidence and total number of appliance breakages) were recorded. For statistical analysis, Pearson chi-square, independent t-test, and one-way analysis of variance were used (P , .05). Results: Of 120 patients (aged 12 to 18 years) recruited, 108 completed the trial (G1¼37, G2¼35, G3 ¼ 36). Weekly text messages failed to improve patient compliance. On the other hand, sending weekly e-mails with audiovisual links significantly (P ¼ .014) reduced the incidence of appliance breakage as compared with the control group. Females had a significantly lower incidence of breakage (P ¼ .041) and a fewer total number of breakages (P ¼ .021). Patients from households with high income had significantly better compliance (P , .05). A higher level of parents’ education was significantly associated with a lower incidence and total number of breakages (P , .01). Conclusions: Communication with patients using link-rich e-mails and reminders could improve patient compliance with fixed orthodontic treatment. Female patients, high household income, and high parent education are associated with better compliance with fixed orthodontic treatment.
Background: Success of orthodontic removable appliance treatment relies on patient compliance. The aim of this quantitative and qualitative study was to explore the compliance and self-reported experience of adolescents in orthodontic treatment with headgear activator (HGA) or twin-block (TB) appliance. Materials/methods: The study group comprised 52 adolescents with a mean age of 12.6 (±1.3) years at the start of the treatment. The patients were treated at a free-of-charge public dental clinic. Participants were randomly allocated to two equal groups to be treated with either HGA or TB. Patient compliance was evaluated as appliance wear time and subjective experience. Appliance wear time was recorded with Theramon® microchip, and the self-reported subjective experience using a questionnaire. Results: In total, 30 patients completed the treatment during the follow-up period. HGA was worn on average 7 hours per day and TB 9 hours per day by those patients, who successfully completed the treatment. During a mean observation period of 13 months (range 7-23 months), the mean actual wear time was 43 per cent less than the advised 12 or 18 hours per day in the whole patient group, and 55 per cent in those patients, who completed the treatment. Compliance level was unrelated to the appliance type. Limitations: Study assessed a relatively small number of patients. Conclusions/implications: Adolescent patients wear HGA and TB less than advised. Individual variation in treatment adherence is considerable. Thereby, microelectronic wear-time documentation can be a cost-effective mean of identifying non-compliance.