Evaluation of the Effect of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention: A Randomised Controlled Trial
Phase: NA
Conditions: Retention, Compliance, Orthodontic, Periodontal Health
Sponsor: Queen Mary University of London

 
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JRMO Non-CTIMP Protocol Template (Version 2 25/02/2016) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TITLE PAGE 
Evaluation of tailored electronic reminders on compliance with removable 
orthodontic retention: a randomised controlled trial. 
 
 

 
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Full Title Evaluation of tailored electronic reminders on compliance with 
removable orthodontic retention: a randomised controlled trial. 
 
 
Short Title/Acronym Evaluation of tailored electronic reminders on compliance 
with removable orthodontic retention. 
 
 
Sponsor 
  
Queen Mary, University of London  
 
Contact 
person 
of 
the 
above 
sponsor 
organisations is: 
 
 
Dr Sally Burtles, 
Director of Research Services and Business 
Development, 
Joint Research Management Office 
 
5 Walden Street 
London 
E1 2EF 
Phone: 020 7882 7265 
Email:  sponsorsrep@bartshealth.nhs.uk 
 
 
REC Reference 
13/LO/1512 
 
Chief Investigator Dr Fleming 
 
Insert as applicable list of  
Site: 
The Royal London hospital 
Whitechapel Road 
Whitechapel 
London 
E1 1BB 

 
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Contents Page 
 
 
 TOC \o "1-3" \h \z \u  
GLOSSARY OF TERMS AND ABBREVIATIONS  
SIGNATURE PAGE 
SUMMARY/SYNOPSIS  
INTRODUCTION 
TRIAL OBJECTIVES  
METHODOLOGY  
Inclusion Criteria 
Exclusion Criteria  
Study Design / Plan – Study Visits  
Study Scheme Diagram 
STUDY PROCEDURES 
Schedule of Assessment (in Diagrammatic Format) 
End of Study Definition  
STATISTICAL CONSIDERATIONS (if applicable) 
ETHICS 
SAFETY CONSIDERATIONS (if applicable) 
DATA HANDLING AND RECORD KEEPING  
Confidentiality  
Record Retention and Archiving 
LABORATORIES (if applicable) 
PRODUCTS, DEVICES, TECHNIQUES AND TOOLS (if applicable) 
SAFETY REPORTING (if applicable) 
MONITORING &AUDITING (if applicable) 
TRIAL COMMITTEES 
FINANCE AND FUNDING  
INDEMNITY  
DISSEMINATION OF RESEARCH FINDINGS (if applicable) 
REFERENCES 
APPENDICES  

 
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GLOSSARY  of Terms and Abbreviations 
AE 
 
 
Adverse Event 
 
 
AR 
 
 
Adverse Reaction 
ASR 
 
 
Annual Safety Report 
CA 
 
 
Competent Authority 
CI 
 
 
Chief Investigator 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organisation 
DMC  
 
Data Monitoring Committee 
EC 
 
 
European Commission 
GAfREC 
Governance Arrangements for NHS Research Ethics Committees 
ICF 
 
 
Informed Consent Form 
JRMO  
 
Joint Research Management Office 
NHS REC 
 
National Health Service Research Ethics Committee 
NHS R&D 
 
National Health Service Research & Development   
Participant 
 
An individual who takes part in a clinical trial 
PI 
 
 
Principal Investigator 
PIS 
 
 
Participant Information Sheet  
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
RCT 
 
 
Randomised Controlled Trial 
REC  
 
Research Ethics Committee 
SAE 
 
 
Serious Adverse Event 
SDV 
 
 
Source Document Verification 
SOP  
 
Standard Operating Procedure  
SSA 
 
 
Site Specific Assessment 
TMG  
 
Trial Management Group 
TSC 
 
 
Trial Steering Committee 

 
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SIGNATURE PAGE 
 
 
Chief Investigator Agreement 
 
 
The clinical study as detailed within this research protocol (Version 2, dated 25 
February 2016), or any subsequent amendments will be conducted in 
accordance with the Research Governance Framework for Health & Social Care 
(2005), the World Medical Association Declaration of Helsinki (1996) and the 
current applicable regulatory requirements and any subsequent amendments of 
the appropriate regulations. 
 
Chief Investigator Name: Dr Padhraig Fleming 
Chief Investigator Site: The Dental Hospital, Barts Health NHS Trust 
Signature and Date: 
 
 (25/02/2016) 
 
 
Principal Investigator Agreement (Dalya Al Moghrabi) 
 
 
The clinical study as detailed within this research protocol (Version 2, date 25 
February 2016), or any subsequent amendments will be conducted in 
accordance with the Research Governance Framework for Health & Social Care 
(2005), the World Medical Association Declaration of Helsinki (1996) and the 
current applicable regulatory requirements and any subsequent amendments of 
the appropriate regulations. 
 
Principal Investigator Name: Dalya Al Moghrabi 
Principal Investigator Site: The Dental Hospital, Barts Health NHS Trust 
Signature and Date: 
 
 (25/02/2016) 

 
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   SUMMARY/SYNOPSIS 
 
 
Short Title 
Evaluation of tailored electronic 
reminders on compliance with 
removable orthodontic retention 
 
Methodology 
Mixed methods design 
Part 1: A Randomized Controlled Trial 
Part 2: Qualitative investigation using 
one-to-one interviews  
Research Sites 
The Dental Hospital, Barts Health NHS 
trust 
Objectives/Aims 
The primary objective is to analyse the
effect 
of 
electronic 
reminders 
on
compliance with removable orthodontic
retention.  
The secondary objectives are to assess
the subjective levels of retainers wear
and to measure upper/lower anterior
irregularity and transverse dimensions.
We also aim to explore patients'
experience with electronic reminders in
a related qualitative element. 
Number of Participants/Patients 
Based on sample size calculation, 
patients referred into the orthodontic 
Department, Royal London Hospital will
be recruited. 
Main Inclusion Criteria 
Inclusion Criteria: 
- Aged 12 to 21 years; 
- Planned for removable retention with 
Essix-type vacuum-formed retainers 
- Fit and well and on no medication;  
- In the permanent dentition. 
Statistical Methodology and Analysis 
(if applicable) 
Data analysis will involve descriptive
and analytical statistics performed using

 
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software (SPSS, New York, NY, USA).
Assessment of the reliability of the
measures used in the study will be
tested by assessing agreement between
the measurements (Bland and Altman,
1986). Baseline characteristics will be
summarised to ensure that all groups
are similar with respect to potential
confounding 
variables. 
Inferential
statistics will be used to compare
differences in the duration of appliance
wear between the treatment groups. If
the data follows a normal distribution,
linear regression analysis will be used to
assess the influence of retention
protocol on the main outcome. This
technique will allow for confounding
factors including degree of crowding
pre-treatment; age; and gender. The
level of statistical significance will be
pre-specified at P<0.05. 
Transcripts of the interviews will be
entered in NVivo 10 TM qualitative data
analysis software (QSR International)
and anonymised for analysis.  
The Framework approach will be used
to analyse the qualitative data (Gale et
al., 2013). This approach facilitates the
thematic analysis of qualitative data in a
structured 
way 
around 
the 
key
questions in the topic guide. 
Proposed Start Date 
May 2016 
Proposed End Date 
24 months after recruitment of the final 
participant. 
Study Duration 
24 months 
 
 
 
 
INTRODUCTION  
 
The introduction acts as the starting point for outlining the background and 
justification for the research, with clear concise objectives which have 
scientific merit and relate to existing literature. 

 
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Orthodontic retention following treatment is essential to resist the tendency of 
teeth to return to their pre-treatment positions. Removable retainers worn on full- 
or part-time basis are acceptable retention procedures. However, removable 
retention places an onerous premium on excellent long-term compliance.   
Within the biomedical literature there is ample evidence alluding to the 
effectiveness of electronic and telecommunication systems in improving 
adherence to long-term use of medications (Reidel et al., 2008; Armstrong et al., 
2009; Boland et al., 2014), self-monitoring of chronic conditions (Logan et al., 
2007) and in terms of attendance at appointments (Gurol-Uranci et al., 2013). 
Specifically tailored approaches have proven particularly effective (Stacy et al., 
2009). There is, however, no reported usage of these approaches within 
orthodontics. Moreover, electronic reminders to improve compliance with 
removable retention regimes among orthodontic patients have not been 
explored.  
The primary aims of this study is to analyse the effect of electronic reminders on 
compliance with orthodontic retention at 3, 6 and 12 months following removal of 
fixed appliances. 
The secondary aims are to assess the subjective levels of retainers wear, and to 
measure upper/lower anterior irregularity and transverse dimensions. We also 
aim to explore patients' experience with electronic reminders in a related 
qualitative element. 
 
 
 
TRIAL OBJECTIVES 
 
Primary /Secondary Objectives to be outlined as defined by the 
Primary/Secondary Endpoints which are also to be listed here.  
 
The primary objective is to explore the effect of electronic reminders on 
compliance with orthodontic retention.  
The secondary objectives are to assess the subjective levels of retainer wear and 
to measure upper/lower anterior irregularity and transverse dimensional changes 
during the retention phase. We also aim to explore patients' experience with 
electronic reminders in a related qualitative element. 
- Primary Endpoint  
Objective level of compliance with retainer wear at 6 months (T3) of orthodontic 
retention.  
 
- Secondary Endpoints  
Objective level of compliance with retainer wear at 3 months (T2) and 12 months 
(T4) of orthodontic retention.  

 
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METHODOLOGY  
Inclusion criteria: 
- Aged 12 to 21 years; 
- Planned for removable retention with Essix-type vacuum-formed retainers; 
- Fit and well and on no medication; 
- In the permanent dentition. 
 
The exclusion criteria: 
- Inability to access or peruse electronic mail; 
- Cleft lip and palate and other craniofacial anomalies. 
 
 
Study Design / Plan – Study Visits 
Subjects will be recruited for inclusion at a routine adjustment appointment prior 
to planned removal of the appliances in the Orthodontic Department at Institute 
of Dentistry, Barts and The London School of Medicine and Dentistry, UK. 
Following removal of the appliances, consenting participants will be randomly 
allocated to one of two groups by computer-generated random allocation. 
Allocation will be concealed from the treating clinician using of an opaque sealed 
envelope system. Study models will be available for all participants following 
removal of the appliances (T1).  
Participants in both groups will have follow-up scheduled for 3 (T2), 6 (T3) and 
12 (T4) months following removal of the appliances. All participants will be 
instructed to wear vacuum-formed (Essix-type) retainers on a full-time basis for 6 
months, followed by night-time wear for a further 6 months (Gill et al., 2007). A 
Thera-MonTM micro-electronic timer will be integrated within the upper Essix-
type retainer. All participants will be given standard advice at each recall visit. If 
any patient from both groups fails to attend their routine retainer check visit, 
another appointment will be arranged and posted through Royal Mail. 
Participants in the intervention group will receive tailored electronic reminders. 
The frequency and content of the reminders will be informed by the qualitative 
findings of an ongoing trial, but are likely to include an intra-oral photograph 
taken pre-treatment and following removal of the active appliances, instructions 
on the necessary duration of retention, advice on maintenance of retainers, 
departmental details, advice on appropriate management for appliance 
breakages, and delineation of the implication of suboptimal retainer wear. 
Participants in the control group will not receive additional reminders.  
Treating clinicians will be kept blind to the study group.  
All patients failing an appointment will be sent another. Those wishing to 
withdraw from the trial may do so at any point without affecting continuing care 
with records taken at the point of withdrawal from the study with data analysis on 
an intention to treat basis.  

 
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One-to-one interviews will be undertaken by the researcher on subset of 
participants in confidential, non-clinical areas at the Institute of Dentistry. The 
interviews will be based on a topic guide, which will draw on existing literature 
and professional experiences. This will facilitate discussion based around the 
aims of the research. Themes to be explored are likely to be patients’ acceptance 
and experience of electronic reminders. Discussions will be recorded digitally and 
transcribed verbatim. Transcripts will be entered in NVivo 10 TM qualitative data 
analysis software (QSR International) and anonymised for analysis. 
 
 
Study Scheme Diagram  
To reinforce the above and which demonstrates the life cycle of the study in a 
schematic form (see example below) 
 
Please refer to figure 1. 
 
 
 

 
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STUDY PROCEDURES   
 
 
Participants will be recruited by treating clinicians at Institute of Dentistry, Barts 
and The London School of Medicine and Dentistry. Potentially eligible 
participants will be given an information sheet detailing the study and its 
objectives at the visit prior to removal of their fixed appliances. Participants 
agreeing to be involved will be asked to sign a consent form for inclusion in the 
study at the following visit. Patients under 16-18 years can consent for 
themselves only if they were deemed mature to make a decision, this will be 
decided by the CI and PI. Otherwise, the parent will be asked to consent for their 
child. 
 
Following removal of the appliances, consenting participants will be randomly 
allocated to one of two groups by computer-generated random allocation. 
Allocation will be concealed from the treating clinician using of an opaque sealed 
envelope system. Standard orthodontic study models will be available for all 
participants following removal of the appliances (T1). 
Participants will then be reviewed at 3, 6 and 12 months for regular retainer 
checks and collection of records i.e. study models and microsensor readings.  
One-to-one interviews will be undertaken in a confidential non-clinical areas. 
Interviews will continue until data saturation has been achieved characterized by 
a lack of new emergent themes. 
 
All documents including models will be securely held in a locked office, photos 
will also be stored on an encrypted trust computer.  
 
Schedule of Assessment (in Diagrammatic Format)  
Please use a table format to detail the schedule of assessments that the 
participant will undergo at each visit (see example below). 
 
 
Assessment  Randomization Retention 
phase 
Treatment 
phase 
End of Study 
Follow up visits 
Enrollment, 
written 
information 
sheet, 
consent 
Computer-
generated 
random 
allocation. 
Allocation will be 
concealed from 
the treating 
clinician using of 
an opaque 
3-monthly 
retainer check 
visits and 
records 
collation (study 
models and 
timer readings) 
One-to-one 
interview with 
subset of 
recruited 
participants 
End of retainer 
check visits 
24 months 

 
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sealed envelope 
system 
 
End of Study Definition  
Follow-up of retention procedures will be undertaken over a 24-month period. 
The final retainer checks will be undertaken at 12 and 24 months in keeping with 
standard orthodontic practice. The study will be completed following the 24-
month visit. 
 
 
STATISTICAL CONSIDERATIONS  
 
Summary 
The study compares compliance levels in two groups. Only group one will 
receive an electronic reminder. The research question is therefore summarised 
as “does electronic reminders improve compliance levels with orthodontic 
retainers”. 
 
The research question is expressed as the following set of hypotheses: 
Null hypothesis:  Periodic, tailored electronic reminders are ineffective in 
improving compliance with orthodontic retention. 
 
Alternative Hypothesis:  Periodic, tailored electronic reminders are effective in 
improving compliance with orthodontic retention. 
 
Sample Size Calculation 
Based on previous research (Tsomos et al., 2014) alluding to a non-compliance 
rate of 31% characterized by wear of the appliance for less than 2 hours daily a 
minimum of 68 participants (34 in each group) is required with a power of 80% to 
detect a minimum difference of 25% in compliance rates at the 0.05 level of 
statistical significance. To compensate for a dropout rate of at least 10%, the final 
number to be enrolled in the trial is 84. 
For the second part of the study, Initially, 10 one-to-one interviews will be 
undertaken. Interviews will continue until data saturation has been achieved 
characterized by a lack of new emergent themes. 
Statistical Methods 
Data analysis will involve descriptive and analytical statistics performed using 
software (SPSS, New York, NY, USA). Assessment of the reliability of the 
measures used in the study will be tested by assessing agreement between the 
measurements (Bland and Altman, 1986). Baseline characteristics will be 
summarized to ensure that all groups are similar with respect to potential 
confounding variables. Inferential statistics will be used to compare differences in 

 
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the duration of appliance wear between the treatment groups. If the data follows 
a normal distribution, linear regression analysis will be used to assess the 
influence of retention protocol on the main outcome. This technique will allow for 
confounding factors including degree of crowding pre-treatment; age; and 
gender. The level of statistical significance will be pre-specified at P<0.05. 
For the second part of the study the Framework approach will be used to analyse 
the qualitative data (Gale et al.,2013). This approach facilitates the thematic 
analysis of qualitative data in a structured way around the key questions in the 
topic. 
 
 
 

 
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ETHICS  
 
The Principal Investigator will ensure that the study will be carried out in 
accordance with the ethical principles in the Research Governance Framework 
for Health and Social Care, Second Edition, 2005 and its subsequent 
amendments as applicable and applicable legal and regulatory requirements.  
 
Ethical approval shall be sought from Barts Health NHS Trust and sponsorship 
shall be sought from Queen Mary University of London. This is done via 
completion of appropriate protocol and any subsequent amendments along with 
an accompanying material provided to the patient, all will be submitted to an 
independent research ethics committee. Because this project involves treatment 
of children, ethical practice is of utmost importance. The treatment carried out in 
this trial will in no way differ from the standard routine care of patients ordinarily 
presenting in the same manner apart from one group receiving electronic 
reminders. The trial will compare a group of patients receiving electronic 
reminders and the other group not receiving any form of reminders. In terms of 
obtaining informed consent, the project will be thoroughly explained at the first 
visit (a brief will already have been given by referring practitioner), a written 
information sheet and consent form will be given and follow up arranged if the 
patient is happy to participate (at least 24 hours will be given to consider options) 
consent form will then be signed by the parent and patient. Patients under 16-18 
years can consent for themselves only if they were deemed mature to make a 
decision, this will be decided by the CI and PI. Otherwise, the parent will be 
asked to consent for their child. 
 
SAFETY CONSIDERATIONS: 
There are no additional safety issues that are not present with routine orthodontic 
treatment surrounding the study. Possibility of harm to participants is minimal and 
most likely to be caused by misuse or mis handling of the appliance. Lab safety 
issues are not an issue as all lab work is quality assured, radiation protection is in 
line with local protocol and procedure and security of patients and records will be 
in line with hospital and departmental standards 
 
DATA HANDLING AND RECORD KEEPING:  
- Confidentiality 
Information related to participants will be kept confidential and managed in 
accordance with the Data Protection Act, NHS Caldecott Principles, The 
Research Governance Framework for Health and Social Care, and the 
conditions of Research Ethics Committee Approval. 
 
- Record Retention and Archiving 
When the research trial is complete, the records will be kept for a 
further 20 years. As this trial involves Barts Health Trust patients and is 
undertaken by Trust staff, and sponsored by QMUL, the approved 

 
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repository for long-term storage of local records is the Trust Modern 
Records Centre  
 
 
LABORATORIES (if applicable) 
 
- Central/Local Laboratories  
Lab work will be processed in line with local departmental policy, as is the normal 
for standard provision of this appliance treatment.    
 
 
 
 SAFETY REPORTING  
 
 
Adverse Events (AE) 
An AE is any untoward medical occurrence in a subject to whom a 
medicinal product has been administered, including occurrences which are 
not necessarily caused by or related to that product.  An AE can therefore 
be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom or disease temporarily associated with study activities. 
 
Notification and reporting Adverse Events or Reactions 
If the AE is not defined as SERIOUS, the AE is recorded in the study file 
and the participant is followed up by the research team. The AE is 
documented in the participants’ medical notes (where appropriate) and the 
CRF. 
 
Serious Adverse Event (SAE) 
In other research other than CTIMPs, a serious adverse event (SAE) is 
defined as an untoward occurrence that: 
(a) Results in death; 
(b) Is life-threatening; 
(c) Requires hospitalisation or prolongation of existing 
hospitalisation; 
(d) Results in persistent or significant disability or incapacity; 
(e) Consists of a congenital anomaly or birth defect; or 
(f) Is otherwise considered medically significant by the investigator. 
 
An SAE occurring to a research participant should be reported to the main 
REC where in the opinion of the Chief Investigator the event was: 
• Related – that is, it resulted from administration of any of the research 
procedures, and 
• Unexpected – that is, the type of event is not listed in the protocol as an 
expected occurrence. 
 
 
Notification and Reporting of Serious Adverse Events  

 
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Serious Adverse Event (SAEs) that are considered to be ‘related’ and 
‘unexpected’ are to be reported to the sponsor within 24 hours of learning of 
the event and to the Main REC within 15 days in line with the required 
timeframe. For further guidance on this matter, please refer to NRES website 
and JRMO SOPs 
 
Please note in the case of a blinded study, it is recommended the treatment 
code for the patient is broken in the reporting of an ‘unexpected and related’ 
SAE. Please seek advice on how this can be achieved whilst maintaining the 
team blind. The unblinding of single cases by the PI/CI in the course of a 
clinical trial should only be performed if necessary for the safety of the trial 
subject. 
 
Urgent Safety Measures 
The CI may take urgent safety measures to ensure the safety and protection 
of the clinical trial subjects from any immediate hazard to their health and 
safety. The measures should be taken immediately. In this instance, the 
approval of the REC prior to implementing these safety measures is not 
required. However, it is the responsibility of the CI to inform the sponsor and 
Main Research Ethics Committee (via telephone) of this event immediately.  
 
The CI has an obligation to inform both the Main REC in writing within 3 
days, in the form of a substantial amendment. The sponsor (Joint Research 
Management Office [JRMO]) must be sent a copy of the correspondence 
with regards to this matter. For further guidance on this matter, please refer 
to NRES website and JRMO SOPs. 
 
Annual Safety Reporting  
The CI will send the Annual Progress Report to the main REC using the 
NRES template (the anniversary date is the date on the MREC “favourable 
opinion” letter from the MREC) and to the sponsor. Please see NRES 
website and JRMO SOP for further information 
 
Overview of the Safety Reporting responsibilities 
The CI/PI has the overall pharmacovigilance oversight responsibility. The 
CI/PI has a duty to ensure that safety monitoring and reporting is conducted 
in accordance with the sponsor’s requirements.  
 
 
Who 
When 
How 
To Whom 
SAE 
Principle 
Investigator 
-Report to 
Sponsor within 
24 hours of 
learning of the 
event 
 
-Report to the 
MREC within 
15 days of 
SAE Report 
form for Non-
CTIMPs, 
available from 
NRES website. 
Sponsor and 
MREC 

 
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learning of the 
event 
 
Urgent 
Safety 
Measures  
Principle 
Investigator  
Contact the 
Sponsor and 
MREC 
Immediately 
 
Within 3 days  
By phone 
 
 
 
 
Substantial 
amendment 
form giving 
notice in 
writing setting 
out the 
reasons for the 
urgent safety 
measures and 
the plan for 
future action. 
Main REC 
and Sponsor  
 
 
 
Main REC 
with a copy 
also sent to 
the sponsor. 
The MREC 
will 
acknowledge 
this within 30 
days of 
receipt.  
 
 
 
MONITORING &AUDITING 
 
The study will be monitored by the principle and chief investigator in keeping with 
Good Clinical Practice and the sponsor QMUL 
 
Definition:  
“A systematic and independent examination of trial related activities and 
documents to determine whether the evaluated trial related activities were 
conducted, and the data were recorded, analysed and accurately reported 
according to the protocol, sponsor's standard operating procedures (SOPs), 
Good Clinical Practice (GCP), and the applicable regulatory requirement(s).” 
 
A study may be identified for audit by any method listed below:  
1.  A project may be identified via the risk assessment process. 
2.  An individual investigator or department may request an audit. 
3.  A project may be identified via an allegation of research misconduct or 
fraud or a suspected breach of regulations. 
4.  Projects may be selected at random. The Department of Health states that 
Trusts should be auditing a minimum of 10% of all research projects. 
5.  Projects may be randomly selected for audit by an external organisation. 
 
Internal audits may be conducted by a sponsor’s or funder representative. 
 
TRIAL COMMITTEES 
 

 
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As this is a single centre trial, carried out solely by the chief and principle 
investigator there are no trial committees 
 
FINANCE AND FUNDING 
No additional costs will be incurred for the clinical study in view of the fact that 
the participants will attend their routine retainer check visits with no additional 
treatment being undertaken. An application for funding has been submitted to the 
European Orthodontic Society. The funding aims to facilitate the development 
and refinement of the electronic reminders. These costs are non-clinical but will 
provide professional expertise to facilitate the development of the reminders as 
part of a fully-funded PhD research project. 
 
INDEMNITY  
 
Our sponsor is QMUL who will indemnify this study subject to successful granting 
of ethical approval  
 
DISSEMINATION OF RESEARCH FINDINGS: 
 
Once the trial is complete study results will be disseminated via presentation at 
national meeting and publication in peer reviewed journal.  
 
 
REFERENCES 
 
Armstrong AW, Watson AJ, Makredes M, Frangos JE, Kimball AB, Kvedar JC. Text-message 
reminders to improve sunscreen use: a randomized, controlled trial using electronic monitoring. 
Arch Dermatol. 2009;145:1230-6. 
 
Boland MV, Chang DS, Frazier T, Plyler R, Jefferys JL, Friedman DS. Automated  
telecommunication-based reminders and adherence with once-daily glaucoma medication dosing: 
the automated dosing reminder study. JAMA Ophthalmol. 2014;132:845-50. 
 
Gurol-Uranci I, de Jongh T, Vodopivec-Jamsek V, Atun R, Car J. Mobile phone messaging 
reminders for attendance at healthcare appointments. Coch Database Syst Rev. 2013; 12: 
CD007458. 
 
Logan AG, McIsaac WJ, Tisler A et al. Mobile phone-based remote patient monitoring system for 
management of hypertension in diabetic patients. AJH 2007; 20:942-48. 
 
Reidel K, Tamblyn R, Patel V, Huang A. Pilot study of an interactive voice response system to 
improve medication refill compliance. BMC Med Inform Decis Mak. 2008;8:46. 
 
Stacy JN, Schwartz SM, Ershoff D, Shreve MS. Incorporating tailored interactive patient solutions 
using interactive voice response technology to improve statin adherence: results of a randomized 
clinical trial in a managed care setting. Popul Health Manag. 2009;12:241-54. 

 
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Version 2 (25/02/2016)  
Evaluation of tailored electronic reminders on compliance with removable 
orthodontic retention: a randomised controlled trial.