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1.  Risk indicators for severe impaired oral health among indigenous Australian young adults 
BMC Oral Health  2010;10:1.
Background
Oral health impairment comprises three conceptual domains; pain, appearance and function. This study sought to: (1) estimate the prevalence of severe oral health impairment as assessed by a summary oral health impairment measure, including aspects of dental pain, dissatisfaction with dental appearance and difficulty eating, among a birth cohort of Indigenous Australian young adults (n = 442, age range 16-20 years); (2) compare prevalence according to demographic, socio-economic, behavioural, dental service utilisation and oral health outcome risk indicators; and (3) ascertain the independent contribution of those risk indicators to severe oral health impairment in this population.
Methods
Data were from the Aboriginal Birth Cohort (ABC) study, a prospective longitudinal investigation of Aboriginal individuals born 1987-1990 at an Australian regional hospital. Data for this analysis pertained to Wave-3 of the study only. Severe oral health impairment was defined as reported experience of toothache, poor dental appearance and food avoidance in the last 12 months. Logistic regression models were used to evaluate effects of demographic, socio-economic, behavioural, dental service utilisation and clinical oral disease indicators on severe oral health impairment. Effects were quantified as odds ratios (OR).
Results
The percent of participants with severe oral health impairment was 16.3 (95% CI 12.9-19.7). In the multivariate model, severe oral health impairment was associated with untreated dental decay (OR 4.0, 95% CI 1.6-9.6). In addition to that clinical indicator, greater odds of severe oral health impairment were associated with being female (OR 2.0, 95% CI 1.2-3.6), being aged 19-20 years (OR 2.1, 95% CI 1.2-3.6), soft drink consumption every day or a few days a week (OR 2.6, 95% 1.2-5.6) and non-ownership of a toothbrush (OR 1.9, 95% CI 1.1-3.4).
Conclusions
Severe oral health impairment was prevalent among this population. The findings suggest that public health strategies that address prevention and treatment of dental disease, self-regulation of soft drink consumption and ownership of oral self-care devices are needed if severe oral health impairment among Indigenous Australian young adults is to be reduced.
doi:10.1186/1472-6831-10-1
PMCID: PMC2827466  PMID: 20102640
2.  A phase II clinical trial of a dental health education program delivered by aboriginal health workers to prevent early childhood caries 
BMC Public Health  2012;12:681.
Background
Early Childhood Caries (ECC) is a widespread problem in Australian Aboriginal communities causing severe pain and sepsis. In addition dental services are difficult to access for many Aboriginal children and trying to obtain care can be stressful for the parents. The control of dental caries has been identified as a key indictor in the reduction of Indigenous disadvantage. Thus, there is a need for new approaches to prevent ECC, which reflect the cultural norms of Aboriginal communities.
Methods/Design
This is a Phase II single arm trial designed to gather information on the effectiveness of a dental health education program for Aboriginal children aged 6 months, followed over 2 years. The program will deliver advice from Aboriginal Health Workers on tooth brushing, diet and the use of fluoride toothpaste to Aboriginal families. Six waves of data collection will be conducted to enable estimates of change in parental knowledge and their views on the acceptability of the program. The Aboriginal Health Workers will also be interviewed to record their views on the acceptability and program feasibility. Clinical data on the child participants will be recorded when they are 30 months old and compared with a reference population of similar children when the study began. Latent variable modeling will be used to interpret the intervention effects on disease outcome.
Discussion
The research project will identify barriers to the implementation of a family centered Aboriginal oral health strategy, as well as the development of evidence to assist in the planning of a Phase III cluster randomized study.
Trial registration
ACTRN12612000712808
doi:10.1186/1471-2458-12-681
PMCID: PMC3520707  PMID: 22909327
Oral health; Aboriginal families; Health promotion
3.  Oral health and social and emotional well-being in a birth cohort of Aboriginal Australian young adults 
BMC Public Health  2011;11:656.
Background
Social and emotional well-being is an important component of overall health. In the Indigenous Australian context, risk indicators of poor social and emotional well-being include social determinants such as poor education, employment, income and housing as well as substance use, racial discrimination and cultural knowledge. This study sought to investigate associations between oral health-related factors and social and emotional well-being in a birth cohort of young Aboriginal adults residing in the northern region of Australia's Northern Territory.
Methods
Data were collected on five validated domains of social and emotional well-being: anxiety, resilience, depression, suicide and overall mental health. Independent variables included socio-demographics, dental health behaviour, dental disease experience, oral health-related quality of life, substance use, racial discrimination and cultural knowledge.
Results
After adjusting for other covariates, poor oral health-related items were associated with each of the social and emotional well-being domains. Specifically, anxiety was associated with being female, having one or more decayed teeth and racial discrimination. Resilience was associated with being male, having a job, owning a toothbrush, having one or more filled teeth and knowing a lot about Indigenous culture; while being female, having experienced dental pain in the past year, use of alcohol, use of marijuana and racial discrimination were associated with depression. Suicide was associated with being female, having experience of untreated dental decay and racial discrimination; while being female, having experience of dental disease in one or more teeth, being dissatisfied about dental appearance and racial discrimination were associated with poor mental health.
Conclusion
The results suggest there may be value in including oral health-related initiatives when exploring the role of physical conditions on Indigenous social and emotional well-being.
doi:10.1186/1471-2458-11-656
PMCID: PMC3176220  PMID: 21851641
4.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
Objective
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
Technology
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT Trial
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
Conclusions
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
5.  Dental caries in 14- and 15-year-olds in New South Wales, Australia 
BMC Public Health  2013;13:1060.
Background
Dental caries remains one of the most common chronic diseases of adolescents. In Australia there have been few epidemiological studies of the caries experience of adolescents with most surveys focusing on children. The New South Wales (NSW) Teen Dental Survey 2010 is the second major survey undertaken by the Centre for Oral Health Strategy. The survey is part of a more systematic and efficient approach to support State and Local Health District dental service planning and will also be used for National reporting purposes.
Methods
Data for the NSW Teen Dental Survey were collected in 2010 from a random sample of Year 9 secondary school students aged 14 to 15 years from metropolitan and non-metropolitan schools under the jurisdiction of the NSW Department of Education and Training, the Catholic Education Commission and Independent Schools in New South Wales. Nineteen calibrated examiners performed 1269 clinical examinations at a total of 84 secondary schools across NSW. The survey was accompanied by a questionnaire looking at oral health related behaviours, risk factors and the usage of the Medicare Teen Dental Plan.
Results
175 schools were contacted, with 84 (48%) accepting the invitation to participate in the study. A total of 5,357 student consent forms and parent information packages were sent out and 1,256 students were examined; leading to a student participation rate of 23%. The survey reported a mean DMFT for 14 and 15 year olds of 1.2 and it was identified that 45.4% of students had an experience of dental caries. Major variations in caries experience reported occurred by remoteness, water fluoridation status, socio-economic status and household income levels.
Conclusions
The NSW Teen Dental Survey provided state-wide data that will contribute to the national picture on adolescent oral health. The mean DMFT score of 1.2 is similar to the national caries experience data for this age group from the Australian Child Dental Health Survey in 2009.
doi:10.1186/1471-2458-13-1060
PMCID: PMC3840655  PMID: 24209635
Teen dental survey; School children; Adolescents; Caries experience
6.  Oral hygiene practices and dental service utilization among pregnant women 
Background
Daily oral hygiene and regular dental visits are important components of oral health care. The authors’ objective in this study was to examine women's oral hygiene practices and use of dental services during pregnancy.
Methods
The authors developed a written oral health questionnaire and administered it to 599 pregnant women. They collected demographic information, as well as data on oral hygiene practices and use of dental services during pregnancy. They used χ2 and multivariable logistic regression models to assess associations between oral hygiene practice and dental service use during pregnancy and to identify maternal predictor variables.
Results
Of the 599 participants, 83 percent (n = 497) reported brushing once or twice per day. Twenty-four percent (n = 141) reported flossing at least once daily; Hispanic women were more likely to floss than were white or African American women (28 percent [52 of 183] versus 22 percent [54 of 248] versus 19 percent [23 of 121], respectively, P < .001). Seventy-four percent (n = 442) of the participants reported having received no routine dental care during pregnancy. Hispanic women were significantly less likely than were black or white women to receive routine dental care during pregnancy (13 percent versus 21 percent versus 36 percent, respectively, P < .001). The authors found that being older than 36 years, being of Hispanic race or ethnicity, having an annual income of less than $30,000, flossing infrequently and receiving no dental care when not pregnant were significantly associated with lack of routine dental care during pregnancy (adjusted odds ratios, 95 percent confidence intervals: 2.56 [1.33-4.92]; 2.19 [1.11-4.29]; 2.02 [1.12-3.65]; 1.86 [1.13-3.07]; and 4.35 [2.5-7.69], respectively). A woman's lack of receiving routine dental care when not pregnant was the most significant predictor of lack of receiving dental care during pregnancy.
Conclusion
Racial, ethnic and economic disparities related to oral hygiene practices and dental service utilization during pregnancy exist.
Clinical Implications
Medical and dental care providers who treat women of reproductive age and pregnant women need to develop policy strategies to address this population's access barriers to, and use of, dental care services.
PMCID: PMC4380010  PMID: 20436103
Pregnancy; oral hygiene; dental care utilization
7.  Dental Anxiety and the Use of Oral Health Services Among People Attending Two HIV Primary Care Clinics in Miami 
Public Health Reports  2012;127(Suppl 2):36-44.
Objectives
We examined factors associated with dental anxiety among a sample of HIV primary care patients and investigated the independent association of dental anxiety with oral health care.
Methods
Cross-sectional data were collected in 2010 from 444 patients attending two HIV primary care clinics in Miami-Dade County, Florida. Corah Dental Anxiety Scores and use of oral health-care services were obtained from all HIV-positive patients in the survey.
Results
The prevalence of moderate to severe dental anxiety in this sample was 37.8%, while 7.9% of the sample was characterized with severe dental anxiety. The adjusted odds of having severe dental anxiety were 3.962 times greater for females than for males (95% confidence interval [CI] 1.688, 9.130). After controlling for age, ethnicity, gender, education, access to dental care, and HIV primary clinic experience, participants with severe dental anxiety had 69.3% lower adjusted odds of using oral health-care services within the past 12 months (vs. longer than 12 months ago) compared with participants with less-than-severe dental anxiety (adjusted odds ratio = 0.307, 95% CI 0.127, 0.742).
Conclusion
A sizable number of patients living with HIV have anxiety associated with obtaining needed dental care. Routine screening for dental anxiety and counseling to reduce dental anxiety are supported by this study as a means of addressing the impact of dental anxiety on the use of oral health services among HIV-positive individuals.
PMCID: PMC3314391  PMID: 22547875
8.  Dental utilization by children in Hispanic agricultural worker families in California 
Background
Agricultural worker families encounter multiple barriers to accessing all needed dental care. This study investigated predisposing, enabling, and need factors associated with children's past year dental utilization among Hispanic agricultural worker families in central California.
Methods
Oral health survey and clinical data were collected from families participating in a larger, population-based study in 2006-7. Generalized estimating equation logit regression assessed effects on a dental visit among children aged 0-17 (n=405). Analyses adjusted for clustering of children in the same household. Predisposing (sociodemographics), enabling (child's dental insurance, usual source of dental care, caregiver past year dental visit, acculturation level, income and education), and need (caregiver's oral health rating, perception of cavities, and clinically-determined treatment urgency) factors were examined.
Results
Half (51%) the children had a past year dental visit, while 23% had never been to a dentist. In the final model, children were less likely to have a past year dental visit if they were foreign-born, male, had caregivers that thought they had cavities or were unsure, and if the dentist recommended treatment ‘at earliest convenience’. Children aged 6-12, with a regular dental care source, and whose caregivers had a recent dentist visit were more likely to have a past year dental visit.
Conclusions
Children were more likely to have a past year dental visit if they had a usual source of dental care (OR =4.78, CI=2.51-9.08), and if the caregiver had a past year dental visit (OR=1.88, CI=1.04-3.38). Emphasis should be placed on these two modifiable factors to increase children's dental utilization.
PMCID: PMC4301614  PMID: 25621285
Cross-Sectional Studies/utilization; Dental Health Surveys/utilization; Hispanic Americans
9.  Minimising barriers to dental care in older people 
BMC Oral Health  2008;8:7.
Background
Older people are increasingly retaining their natural teeth but at higher risk of oral disease with resultant impact on their quality of life. Socially deprived people are more at risk of oral disease and yet less likely to take up care. Health organisations in England and Wales are exploring new ways to commission and provide dental care services in general and for vulnerable groups in particular. This study was undertaken to investigate barriers to dental care perceived by older people in socially deprived inner city area where uptake of care was low and identify methods for minimising barriers in older people in support of oral health.
Methods
A qualitative dual-methodological approach, utilising both focus groups and individual interviews, was used in this research. Participants, older people and carers of older people, were recruited using purposive sampling through day centres and community groups in the inner city boroughs of Lambeth, Southwark and Lewisham in South London. A topic guide was utilised to guide qualitative data collection. Informants' views were recorded on tape and in field notes. The data were transcribed and analysed using Framework Methodology.
Results
Thirty-nine older people and/or their carers participated in focus groups. Active barriers to dental care in older people fell into five main categories: cost, fear, availability, accessibility and characteristics of the dentist. Lack of perception of a need for dental care was a common 'passive barrier' amongst denture wearers in particular. The cost of dental treatment, fear of care and perceived availability of dental services emerged to influence significantly dental attendance. Minimising barriers involves three levels of action to be taken: individual actions (such as persistence in finding available care following identification of need), system changes (including reducing costs, improving information, ensuring appropriate timing and location of care, and good patient management) and societal issues (such as reducing isolation and loneliness). Older people appeared to place greater significance on system and societal change than personal action.
Conclusion
Older people living within the community in an inner city area where NHS dental care is available face barriers to dental care. Improving access to care involves actions at individual, societal and system level. The latter includes appropriate management of older people by clinicians, policy change to address NHS charges; consideration of when, where and how dental care is provided; and clear information for older people and their carers on available local dental services, dental charges and care pathways.
doi:10.1186/1472-6831-8-7
PMCID: PMC2335092  PMID: 18366785
10.  Influence of cigarette smoking on the overall perception of dental health among adults aged 20-79 years, United States, 1988-1994. 
Public Health Reports  2005;120(2):124-132.
OBJECTIVE: Investigation into the relationship between lifestyle factors (particularly cigarette smoking) and perceived oral health has been limited. Data from the third National Health and Nutrition Examination Survey (NHANES II), 1988-1994, were used to explore this relationship in a large sample of U.S. adults. METHODS: This study used data on 13,357 dentate participants in NHANES III aged 20-79 years. In NHANES III, information on perceived dental health, sociodemographic attributes, smoking status, frequency of dental visits, dental insurance, and general health perception were collected during a home interview, and oral health status was assessed at a mobile examination center. RESULTS: Overall, 34.4% of individuals in the study sample reported having an unfavorable perception of their dental health by qualifying it as "fair" or "poor." Furthermore, 46.6% of smokers had an unfavorable dental health perception, compared to 28.3% of non-smokers. An interaction between smoking and race/ethnicity was found in logistic regression modeling. Stratified results show that cigarette smoking was not a significant predictor for an unfavorable dental health perception among individuals who self-identified as Mexican American, but smoking was a significant predictor for an unfavorable dental health perception among those who identified as non-Hispanic black or non-Hispanic white. CONCLUSIONS: This is the first study to describe the effects of smoking on dental health perception while controlling for examined oral health status. Because perceived dental health is a potential indicator for dental care utilization, a better knowledge of the factors that influence dental health perception is not only important for dental services planning, but also for understanding oral health-related quality of life issues. Additionally, given that smoking may negatively affect dental health perception, these findings have potential implications for smoking cessation activities conducted by dental care providers.
PMCID: PMC1497695  PMID: 15842113
11.  Dental caries prevalence, oral health knowledge and practice among indigenous Chepang school children of Nepal 
BMC Oral Health  2013;13:20.
Background
Chepang communities are one of the most deprived ethnic communities in Nepal. According to the National Pathfinder Survey, dental caries is a highly prevalent childhood disease in Nepal. There is no data concerning the prevalence of caries along with knowledge, attitude and oral hygiene practices among Chepang schoolchildren. The objectives of this study were to 1) record the prevalence of dental caries 2) report experience of dental pain 3) evaluate knowledge, attitude and preventive practices on oral health of primary Chepang schoolchildren.
Method
A cross sectional epidemiological study was conducted in 5 government Primary schools of remote Chandibhanjyang Village Development Committee (VDC) in Chitwan district. Ethical approval was taken from the Institutional Review Board within the Research Department of the Institute of Medicine (IOM) Tribhuvan University. Consent was obtained from parents for conducting clinical examination and administrating questionnaire. Permission was taken from the school principal in all schools. Data was collected using a pretested questionnaire on 131 schoolchildren aged 8-16-year- olds attending Grade 3–5. Clinical examination was conducted on 361 school children aged 5–16 –year-olds attending grade 1–5. Criteria set by the World Health Organization (1997) was used for caries diagnosis. The questionnaires, originally constructed in English and translated into Nepali were administered to the schoolchildren by the researchers. SPSS 11software was used for data analysis.
Results
Caries prevalence for 5–6 –year-old was above the goals recommended by WHO and Federation of Dentistry international (FDI) of less than 50% caries free children. Caries prevalence in 5-6-year-olds was 52% and 12-13-year-olds was 41%. The mean dmft/DMFT score of 5–6 –year-olds and 12 -13-year -olds was 1.59, 0.31 and 0.52, 0.84 respectively. The DMFT scores increased with age and the d/D component constituted almost the entire dmft/DMFT index. About 31% of 8-16-year-olds school children who participated in the survey reported having suffered from oral pain. Further, the need for treatment of decayed teeth was reported at 100%. About 76% children perceived teeth as an important component of general health and 75% reported it was required to eat. A total 93% children never visited a dentist or a health care service. Out of 56% children reporting cleaning their teeth daily, only 24% reported brushing their teeth twice daily. About 86% of the children reported using toothbrush and toothpaste to clean their teeth. Although 61% children reported to have received oral health education, 82% children did not know about fluoride and its benefit on dental health. About 50% children reported bacteria as the main cause of tooth decay and 23% as not brushing teeth for gingivitis. Frequency of sugar exposure was low; 75% of children reported eating sugar rich food once daily.
Conclusions
Caries prevalence of 5–6 –year- old Chepang school children is above the recommended target set by FDI/WHO. The study reported 31% schoolchildren aged 8-16-year old suffered oral pain and decayed component constituted almost the entire dmft/DMFT index. The brushing habit was reportedly low with only 24% of the children brushing twice daily. A nationwide scientifically proven, cost effective school based interventions is needed for prevention and control of caries in schoolchildren in Nepal.
doi:10.1186/1472-6831-13-20
PMCID: PMC3655880  PMID: 23672487
Dental caries; School children; Oral hygiene
12.  Social capital and dental pain in Brazilian northeast: a multilevel cross-sectional study 
BMC Oral Health  2013;13:2.
Background
There is limited evidence on possible associations between social determinants and dental pain. This study investigated the relationship of neighborhood and individual social capital with dental pain in adolescents, adults and the elderly.
Methods
A population-based multilevel study was conducted involving 624 subjects from 3 age groups: 15–19, 35–44 and 65–74 years. They were randomly selected from 30 census tracts in three cities in the State of Paraíba, Brazil. A two-stage cluster sampling was used considering census tracts and households as sampling units. The outcome of study was the presence of dental pain in the last 6 months. Information on dental pain, demographic, socio-economic, health-related behaviors, use of dental services, self-perceived oral health and social capital measures was collected through interviews. Participants underwent a clinical examination for assessment of dental caries. Neighborhood social capital was evaluated using aggregated measures of social trust, social control, empowerment, political efficacy and neighborhood safety. Individual social capital assessment included bonding and bridging social capital. Multilevel logistic regression was used to test the relationship of neighborhood and individual social capital with dental pain after sequential adjustment for covariates.
Results
Individuals living in neighborhoods with high social capital were 52% less likely to report dental pain than those living in neighborhoods with low social capital (OR = 0.48, 95% CI = 0.27-0.85). Bonding social capital (positive interaction) was independently associated with dental pain (OR = 0.88, 95% CI = 0.80-0.91). Last dental visit, self-perceived oral health and number of decayed teeth were also significantly associated with dental pain.
Conclusions
Our findings suggest that contextual and individual social capital are independently associated with dental pain.
doi:10.1186/1472-6831-13-2
PMCID: PMC3543847  PMID: 23289932
Dental pain; Epidemiology; Oral health; Social capital; Socioeconomic factors
13.  Methods and background characteristics of the TOHNN study: a population-based study of oral health conditions in northern Norway 
International Journal of Circumpolar Health  2016;75:10.3402/ijch.v75.30169.
Objectives
The aim of the Tromstannen – Oral Health in Northern Norway (TOHNN) study was to investigate oral health and dental-related diseases in an adult population. This article provides an overview of the background of the study and a description of the sample characteristics and methods employed in data collection.
Study design
Cross-sectional population-based study including a questionnaire and clinical dental examination.
Methods
A randomly selected sample of 2,909 individuals (20–79 years old) drawn from the population register was invited to participate in the study. The data were collected between October 2013 and November 2014 in Troms County in northern Norway. The questionnaire focused on oral health-related behaviours and attitudes, oral health-related quality of life, sense of coherence, dental anxiety and symptoms from the temporomandibular joint. The dental examinations, including radiographs, were conducted by 11 dental teams in 5 dental offices. The examination comprised of registration of dental caries, full mouth periodontal status, temporomandibular disorders, mucosal lesions and height and weight. The participants were grouped by age (20–34, 35–49, 50–64 and 65–79) and ethnicity (Norwegian, Sámi, other European and other world).
Results
From the original sample of 2,909 individuals, 1,986 (68.3%) people participated, of whom 1,019 (51.3%) were women. The highest attendance rate was among women 20–34 years old (80.3%) and the lowest in the oldest age group of women (55.4%). There was no difference in response rate between rural and urban areas. There was a positive correlation between population size and household gross income (p < 0.001) and education level (p < 0.001). The majority of Sámi resided in smaller municipalities. In larger cities, most participants used private dental health care services, whereas, in rural areas, most participants used the public dental health care service.
Conclusion
The TOHNN study has the potential to generate new knowledge on a wide range of oral health conditions beneficial to the population in Troms County. Due to the high participation rate, generalization both nationally and to the circumpolar area ought to be possible.
doi:10.3402/ijch.v75.30169
PMCID: PMC4762226  PMID: 26900910
epidemiology; survey; dental health; adults; prevalence
14.  Reducing disease burden and health inequalities arising from chronic disease among Indigenous children: an early childhood caries intervention 
BMC Public Health  2012;12:323.
Background
This study seeks to determine if implementing a culturally-appropriate early childhood caries (ECC) intervention reduces dental disease burden and oral health inequalities among Indigenous children living in South Australia, Australia.
Methods/Design
This paper describes the study protocol for a randomised controlled trial conducted among Indigenous children living in South Australia with an anticipated sample of 400. The ECC intervention consists of four components: (1) provision of dental care; (2) fluoride varnish application to the teeth of children; (3) motivational interviewing and (4) anticipatory guidance. Participants are randomly assigned to two intervention groups, immediate (n = 200) or delayed (n = 200). Provision of dental care (1) occurs during pregnancy in the immediate intervention group or when children are 24-months in the delayed intervention group. Interventions (2), (3) and (4) occur when children are 6-, 12- and 18-months in the immediate intervention group or 24-, 30- and 36-months in the delayed intervention group. Hence, all participants receive the ECC intervention, though it is delayed 24 months for participants who are randomised to the control-delayed arm. In both groups, self-reported data will be collected at baseline (pregnancy) and when children are 24- and 36-months; and child clinical oral health status will be determined during standardised examinations conducted at 24- and 36-months by two calibrated dental professionals.
Discussion
Expected outcomes will address whether exposure to a culturally-appropriate ECC intervention is effective in reducing dental disease burden and oral health inequalities among Indigenous children living in South Australia.
doi:10.1186/1471-2458-12-323
PMCID: PMC3413605  PMID: 22551058
15.  Dental pain, oral impacts and perceived need for dental treatment in Tanzanian school students: a cross-sectional study 
Background
Dental caries, dental pain and reported oral problems influence people's oral quality of life and thus their perceived need for dental care. So far there is scant information as to the psychosocial impacts of dental diseases and the perceived treatment need in child populations of sub-Saharan Africa.
Objectives
Focusing on primary school students in Kilwa, Tanzania, a district deprived of dental services and with low fluoride concentration in drinking water, this study aimed to assess the prevalence of dental pain and oral impacts on daily performances (OIDP), and to describe the distribution of OIDP by socio-demographics, dental caries, dental pain and reported oral problems. The relationship of perceived need estimates with OIDP was also investigated.
Methods
A cross-sectional study was conducted in 2008. A total of 1745 students (mean age 13.8 yr, sd = 1.67) completed an extensive personal interview and under-went clinical examination. The impacts on daily performances were assessed using a Kiswahili version of the Child-OIDP instrument and caries experience was recorded using WHO (1997) criteria.
Results
A total of 36.2% (41.3% urban and 31.4% rural, p < 0.001) reported at least one OIDP. The prevalence of dental caries was 17.4%, dental pain 36.4%, oral problems 54.1% and perceived need for dental treatment 46.8% in urban students. Corresponding estimates in rural students were 20.8%, 24.4%, 43.3% and 43.8%. Adjusted OR for reporting oral impacts if having dental pain ranged from 2.5 (95% CI 1.8–3.6) (problem smiling) to 4.7 (95% CI 3.4–6.5) (problem sleeping),- if having oral problems, from 1.9 (95% CI 1.3–2.6) (problem sleeping) to 3.8 (95% CI 2.7–5.2) (problem eating) and if having dental caries from 1.5 (95% CI 1.1–2.0) (problem eating) to 2.2 (95% CI 1.5–2.9) (problem sleeping). Students who perceived need for dental care were less likely to be females (OR = 0.8, 95% CI 0.6–0.9) and more likely to have impacts on eating (OR = 1.9, 95% CI 1.4–2.7) and tooth cleaning (OR = 1.6, 95% CI 1.6–2.5).
Conclusion
Substantial proportions of students suffered from untreated dental caries, oral impacts on daily performances and perceived need for dental care. Dental pain and reported oral problems varied systematically with OIDP across the eight impacts considered. Eating and tooth cleaning problems discriminated between subjects who perceived need for dental treatment and those who did not.
doi:10.1186/1477-7525-7-73
PMCID: PMC2726126  PMID: 19643004
16.  Determining the optimal model for role-substitution in NHS dental services in the United Kingdom 
BMC Oral Health  2013;13:46.
Background
Role-substitution describes a model of dental care where Dental Care Professionals (DCPs) provide some of the clinical activity previously undertaken by General Dental Practitioners. This has the potential to increase technical efficiency, the capacity to care and reduce costs. Technical efficiency is defined as the production of the maximum amount of output from a given amount of input so that the service operates at the production frontier i.e. optimal level of productivity. Academic research into technical efficiency is becoming increasingly utilised in health care, although no studies have investigated the efficiency of NHS dentistry or role-substitution in high-street dental practices. The aim of this study is to examine the barriers and enablers that exist for role-substitution in general dental practices in the NHS and to determine the most technically efficient model for role-substitution.
Methods/design
A screening questionnaire will be sent to DCPs to determine the type and location of role-substitutive models employed in NHS dental practices in the United Kingdom (UK). Semi-structured interviews will then be conducted with practice owners, DCPs and patients at selected sites identified by the questionnaire. Detail will be recorded about the organisational structure of the dental team, the number of NHS hours worked and the clinical activity undertaken. The interviews will continue until saturation and will record the views and attitudes of the members of the dental team. Final numbers of interviews will be determined by saturation.
The second work-stream will examine the technical efficiency of the selected practices using Data Envelopment Analysis and Stochastic Frontier Modeling. The former is a non-parametric technique and is considered to be a highly flexible approach for applied health applications. The latter is parametric and is based on frontier regression models that estimate a conventional cost function.
Discussion
Maximising health for a given level and mix of resources is an ethical imperative for health service planners. This study will determine the technical efficiency of role-substitution and so address one of the key recommendations of the Independent Review of NHS dentistry in England.
doi:10.1186/1472-6831-13-46
PMCID: PMC3849722  PMID: 24063247
17.  An oral health literacy intervention for Indigenous adults in a rural setting in Australia 
BMC Public Health  2012;12:461.
Background
Indigenous Australians suffer substantially poorer oral health than their non-Indigenous counterparts and new approaches are needed to address these disparities. Previous work in Port Augusta, South Australia, a regional town with a large Indigenous community, revealed associations between low oral health literacy scores and self-reported oral health outcomes. This study aims to determine if implementation of a functional, context-specific oral health literacy intervention improves oral health literacy-related outcomes measured by use of dental services, and assessment of oral health knowledge, oral health self-care and oral health- related self-efficacy.
Methods/design
This is a randomised controlled trial (RCT) that utilises a delayed intervention design. Participants are Indigenous adults, aged 18 years and older, who plan to reside in Port Augusta or a nearby community for the next two years. The intervention group will receive the intervention from the outset of the study while the control group will be offered the intervention 12 months following their enrolment in the study. The intervention consists of a series of five culturally sensitive, oral health education workshops delivered over a 12 month period by Indigenous project officers. Workshops consist of presentations, hands-on activities, interactive displays, group discussions and role plays. The themes addressed in the workshops are underpinned by oral health literacy concepts, and incorporate oral health-related self-efficacy, oral health-related fatalism, oral health knowledge, access to dental care and rights and entitlements as a patient. Data will be collected through a self-report questionnaire at baseline, at 12 months and at 24 months. The primary outcome measure is oral health literacy. Secondary outcome measures include oral health knowledge, oral health self-care, use of dental services, oral health-related self-efficacy and oral health-related fatalism.
Discussion
This study uses a functional, context-specific oral health literacy intervention to improve oral health literacy-related outcomes amongst rural-dwelling Indigenous adults. Outcomes of this study will have implications for policy and planning by providing evidence for the effectiveness of such interventions as well as provide a model for working with Indigenous communities.
doi:10.1186/1471-2458-12-461
PMCID: PMC3416720  PMID: 22716205
18.  Association between dental fear and oral health habits and treatment need among University students in Finland: a national study 
BMC Oral Health  2016;16:26.
Background
First-year university students are in a new, independent life situation, which may affect health behaviour, including oral health habits. The aim of this study was to evaluate the association between dental fear and oral health habits, while considering the simultaneous effects of attitude toward food and treatment need at dental check-ups.
Methods
The data (n = 8514) for this national cross-sectional study were collected from health registers of Finnish Student Health Service. As part of health examination all first-year university students in Finland were sent an electronic questionnaire asking about general, psychological and oral health, and health habits. Dental fear was measured by the question: “How afraid are you of visiting a dentist?” (reply alternatives: “Not at all”, “Somewhat” and “Very”). Chi-square tests and Multiple logistic regression analyses were used to determine the associations between dental fear and oral health habits (tooth brushing, tobacco use, frequency of eating and drinking, eating habits and interval between dental check-ups) as well as attitude to food and treatment need at dental check-ups while controlling for age, gender, general mood and feelings in social situations.
Results
Of the oral health habits, tooth brushing and tobacco use were associated with dental fear. Those who brushed their teeth once a day or less often or used tobacco regularly were more likely to have high dental fear than those who brushed their teeth twice a day or more often or used tobacco occasionally or not at all. Students who reported not having a normal attitude to food were more likely to have high dental fear than were those reporting normal attitude to food, but the frequency of eating and drinking was not associated with dental fear. Students who reported needing treatment frequently or at every dental check-up were more likely to have high dental fear than those who reported rarely or never needing treatment.
Conclusion
Those students with high dental fear seem to be at risk of having poor oral health habits and abnormal attitude to food, which may increase the risk of deterioration of oral health and the need for treatment. Dental teams should make efforts in helping fearful patients to find motivation for good oral health habits.
doi:10.1186/s12903-016-0179-y
PMCID: PMC4769491  PMID: 26922793
Dental fear; University students; Dental health; Tooth brushing; Attitude to food
19.  Common risk factor approach to address socioeconomic inequality in the oral health of preschool children – a prospective cohort study 
BMC Public Health  2014;14:429.
Background
Dental caries remains the most prevalent chronic condition in children and a major contributor to poor general health. There is ample evidence of a skewed distribution of oral health, with a small proportion of children in the population bearing the majority of the burden of the disease. This minority group is comprised disproportionately of socioeconomically disadvantaged children. An in-depth longitudinal study is needed to better understand the determinants of child oral health, in order to support effective evidence-based policies and interventions in improving child oral health. The aim of the Study of Mothers’ and Infants’ Life Events Affecting Oral Health (SMILE) project is to identify and evaluate the relative importance and timing of critical factors that shape the oral health of young children and then to seek to evaluate those factors in their inter-relationship with socioeconomic influences.
Methods/Design
This investigation will apply an observational prospective study design to a cohort of socioeconomically-diverse South Australian newborns and their mothers, intensively following these dyads as the children grow to toddler age. Mothers of newborn children will be invited to participate in the study in the early post-partum period. At enrolment, data will be collected on parental socioeconomic status, mothers’ general and dental health conditions, details of the pregnancy, infant feeding practice and parental health behaviours and practices. Data on diet and feeding practices, oral health behaviours and practices, and dental visiting patterns will be collected at 3, 6, 12 and 24 months of age. When children turn 24-30 months, the children and their mothers/primary care givers will be invited to an oral examination to record oral health status. Anthropometric assessment will also be conducted.
Discussion
This prospective cohort study will examine a wide range of determinants influencing child oral health and related general conditions such as overweight. It will lead to the evaluation of the inter-relationship among main influences and their relative effect on child oral health. The study findings will provide high level evidence of pathways through which socio-environmental factors impact child oral health. It will also provide an opportunity to examine the relationship between oral health and childhood overweight.
doi:10.1186/1471-2458-14-429
PMCID: PMC4039048  PMID: 24885129
Children; Early childhood caries; Socioeconomic inequality; Prospective cohort study
20.  Challenges and strategies for cohort retention and data collection in an indigenous population: Australian Aboriginal Birth Cohort 
Background
Longitudinal prospective birth cohort studies are pivotal to identifying fundamental causes and determinants of disease and health over the life course. There is limited information about the challenges, retention, and collection strategies in the study of Indigenous populations. The aim is to describe the follow-up rates of an Australian Aboriginal Birth Cohort study and how they were achieved.
Methods
Participants were 686 babies enrolled between January 1987 and March 1990, born to a mother recorded in the Delivery Suite Register of the Royal Darwin Hospital (RDH) as a self-identified Aboriginal. The majority of the participants (70%) resided in Northern Territory within rural, remote and very remote Aboriginal communities that maintain traditional connections to their land and culture. The Aboriginal communities are within a sparsely populated (0.2 people/ km2) area of approximately 900,000 km2 (347sq miles), with poor communication and transport infrastructures. Follow-ups collecting biomedical and lifestyle data directly from participants in over 40 locations were conducted at 11.4 years (Wave-2) and 18.2 years (Wave-3), with Wave-4 follow-up currently underway.
Results
Follow-ups at 11 and 18 years of age successfully examined 86% and 72% of living participants respectively. Strategies addressing logistic, cultural and ethical challenges are documented.
Conclusions
Satisfactory follow-up rates of a prospective longitudinal Indigenous birth cohort with traditional characteristics are possible while maintaining scientific rigor in a challenging setting. Approaches included flexibility, respect, and transparent communication along with the adoption of culturally sensitive behaviours. This work should inform and assist researchers undertaking or planning similar studies in Indigenous and developing populations.
doi:10.1186/1471-2288-14-31
PMCID: PMC3942517  PMID: 24568142
Epidemiological method; Prospective longitudinal cohort; Ethnic minority; Health determinants; Australian; Aboriginal
21.  Dental Caries Experience and Use of Dental Services among Brazilian Prisoners 
This ross-sectional study involving 127 male prisoners evaluates the use of dental services and dental caries among Brazilian inmates. Data were collected by interview and clinical examination. Sociodemographic and sentencing information as well as use of dental services, self-reported dental morbidity, self-perception, and oral health impacts were investigated. The mean DMFT index value was 19.72. Of the components, the decayed component showed the highest mean value (11.06 ± 5.37). Statistically significant association was found between DMFTs with values from 22 to 32 and oral health satisfaction (p = 0.002), difficulty speaking (p = 0.024), shame of talking (p = 0.004) and smiling (p < 0.001). Regarding the use of dental services, 80% had their last dental appointment less than one year ago, with most visits occurring in prison (80%), with restorative treatment (32%), followed by dental pain (26.4%), being the main reasons for such appointments. Most prisoners used dental services provided by the prison. Although restorative treatment has been the main reason for the use of dental services, “decayed” and “missing” components contributed to the high mean DMFT index.
doi:10.3390/ijerph111212118
PMCID: PMC4276604  PMID: 25429680
dental caries; tooth loss; prisons; prisoners
22.  Current status of collaborative relationships between dialysis facilities and dental facilities in Japan: results of a nationwide survey 
BMC Nephrology  2015;16:17.
Background
Recent studies have reported an association between periodontal disease and mortality among dialysis patients. Therefore, preventive dental care should be considered very important for this population. In Japan, no systematic education has been undertaken regarding the importance of preventive dental care for hemodialysis patients—even though these individuals tend to have oral and dental problems. The aim of this study was to investigate the current state of collaborative relationships between hemodialysis facilities and dental services in Japan and also to identify strategies to encourage preventive dental visits among hemodialysis outpatients.
Methods
A nationwide questionnaire on the collaborative relationship between dialysis facilities and dental facilities was sent by mail to all medical facilities in Japan offering outpatient hemodialysis treatment.
Results
Responses were obtained from 1414 of 4014 facilities (35.2%). Among the 1414 facilities, 272 (19.2%) had a dental service department. Approximately 100,000 dialysis outpatients were receiving treatment at these participating facilities, which amounts to one-third of all dialysis patients in Japan. Of those patients, 82.9% received hemodialysis at medical facilities without dental departments. Only 87 of 454 small clinics without in-house dental departments (19.2%) had collaborative registered dental clinics. Medical facilities with registered dental clinics demonstrated a significantly more proactive attitude to routine collaboration on dental matters than facilities lacking such clinics.
Conclusions
Our nationwide survey revealed that most dialysis facilities in Japan have neither an in-house dental department nor a collaborative relationship with a registered dental clinic. Registration of dental clinics appears to promote collaboration with dental facilities on a routine basis, which would be beneficial for oral health management in hemodialysis patients.
Electronic supplementary material
The online version of this article (doi:10.1186/s12882-015-0001-0) contains supplementary material, which is available to authorized users.
doi:10.1186/s12882-015-0001-0
PMCID: PMC4358784  PMID: 25880326
Oral health care; Hemodialysis patient; Collaborative relationship between medical and dental facilities; Nationwide questionnaire
23.  Non-dental primary care providers’ views on challenges in providing oral health services and strategies to improve oral health in Australian rural and remote communities: a qualitative study 
BMJ Open  2015;5(10):e009341.
Objectives
To investigate the challenges of providing oral health advice/treatment as experienced by non-dental primary care providers in rural and remote areas with no resident dentist, and their views on ways in which oral health and oral health services could be improved for their communities.
Design
Qualitative study with semistructured interviews and thematic analysis.
Setting
Four remote communities in outback Queensland, Australia.
Participants
35 primary care providers who had experience in providing oral health advice to patients and four dental care providers who had provided oral health services to patients from the four communities.
Results
In the absence of a resident dentist, rural and remote residents did present to non-dental primary care providers with oral health problems such as toothache, abscess, oral/gum infection and sore mouth for treatment and advice. Themes emerged from the interview data around communication challenges and strategies to improve oral health. Although, non-dental care providers commonly advised patients to see a dentist, they rarely communicated with the dentist in the nearest regional town. Participants proposed that oral health could be improved by: enabling access to dental practitioners, educating communities on preventive oral healthcare, and building the skills and knowledge base of non-dental primary care providers in the field of oral health.
Conclusions
Prevention is a cornerstone to better oral health in rural and remote communities as well as in more urbanised communities. Strategies to improve the provision of dental services by either visiting or resident dental practitioners should include scope to provide community-based oral health promotion activities, and to engage more closely with other primary care service providers in these small communities.
doi:10.1136/bmjopen-2015-009341
PMCID: PMC4636644  PMID: 26515687
QUALITATIVE RESEARCH
24.  Interventions for tobacco cessation in the dental setting 
Background
Tobacco use has significant adverse effects on oral health. Oral health professionals in the dental office or community setting have a unique opportunity to increase tobacco abstinence rates among tobacco users.
Objectives
This review assesses the effectiveness of interventions for tobacco cessation delivered by oral health professionals and offered to cigarette smokers and smokeless tobacco users in the dental office or community setting.
Search methods
We searched the Cochrane Tobacco Addiction Group Specialized Register (CENTRAL), MEDLINE (1966-November 2011), EMBASE (1988-November 2011), CINAHL (1982-November 2011), Healthstar (1975-November 2011), ERIC (1967-November 2011), PsycINFO (1984-November 2011), National Technical Information Service database (NTIS, 1964-November 2011), Dissertation Abstracts Online (1861-November 2011), Database of Abstract of Reviews of Effectiveness (DARE, 1995-November 2011), and Web of Science (1993-November 2011).
Selection criteria
We included randomized and pseudo-randomized clinical trials assessing tobacco cessation interventions conducted by oral health professionals in the dental office or community setting with at least six months of follow-up.
Data collection and analysis
Two authors independently reviewed abstracts for potential inclusion and abstracted data from included trials. Disagreements were resolved by consensus. The primary outcome was abstinence from smoking or all tobacco use (for users of smokeless tobacco) at the longest follow-up, using the strictest definition of abstinence reported. The effect was summarised as an odds ratio, with correction for clustering where appropriate. Heterogeneity was assessed using the I2 statistic and where appropriate a pooled effect was estimated using an inverse variance fixed-effect model.
Main results
Fourteen clinical trials met the criteria for inclusion in this review. Included studies assessed the efficacy of interventions in the dental office or in a community school or college setting. Six studies evaluated the effectiveness of interventions among smokeless tobacco (ST) users, and eight studies evaluated interventions among cigarette smokers, six of which involved adult smokers in dental practice settings. All studies employed behavioral interventions and only one required pharmacotherapy as an interventional component. All studies included an oral examination component. Pooling all 14 studies suggested that interventions conducted by oral health professionals can increase tobacco abstinence rates (odds ratio [OR] 1.71, 95% confidence interval [CI] 1.44 to 2.03) at six months or longer, but there was evidence of heterogeneity (I2 = 61%). Within the subgroup of interventions for smokers, heterogeneity was smaller (I2 = 51%), but was largely attributable to a large study showing no evidence of benefit. Within this subgroup there were five studies which involved adult smokers in dental practice settings. Pooling these showed clear evidence of benefit and minimal heterogeneity (OR 2.38, 95% CI 1.70 to 3.35, 5 studies, I2 = 3%) but this was a posthoc subgroup analysis. Amongst the studies in smokeless tobacco users the heterogeneity was also attributable to a large study showing no sign of benefit, possibly due to intervention spillover to control colleges; the other five studies indicated that interventions for ST users were effective (OR 1.70; 95% CI 1.36 to 2.11).
Authors’ conclusions
Available evidence suggests that behavioral interventions for tobacco cessation conducted by oral health professionals incorporating an oral examination component in the dental office or community setting may increase tobacco abstinence rates among both cigarette smokers and smokeless tobacco users. Differences between the studies limit the ability to make conclusive recommendations regarding the intervention components that should be incorporated into clinical practice, however, behavioral counselling (typically brief) in conjunction with an oral examination was a consistent intervention component that was also provided in some control groups.
doi:10.1002/14651858.CD005084.pub3
PMCID: PMC3916957  PMID: 22696348
25.  Portable Dental Chairs and Their Role in Assisting the Community Outreach Program- a Qualitative Approach 
Objective: Certain conditions limit the independence of deprived people. However, those conditions do not limit the right of these people to receive dental care. Portable dental units may make it possible for the deprived and elderly to receive the care they deserve in more areas. This study aimed to explore dentists’ perceptions of the use of portable dental units in community outreach programs as a precursor to our quantitative study in the future.
Materials and Methods: Qualitative semi-structured interviews were conducted by one interviewer, seven dentists, two specialists, and 11 final-year dental students who had experience with portable dental units in Isfahan, Iran. The qualitative research method was chosen first due to the rarity of information readily available about the units and second due to their specialist application; with which only certain members of the dental community have experience.
Results: Participants described a range of observations they had made whilst using the portable dental units in different locations. The qualitative data were primarily concerned with the range of ideas the interviewers distinguished as relevant when describing the portable dental units. The predominant view most noted within interviews was that the portable units are very useful for the community outreach programs, with two subcategories of serviceability and access to oral health. Other factors mentioned were the competence of the portable dental unit and the factors affecting each individual patient.
Conclusion: Our findings illustrate a number of features that may enhance the reputation of portable dental units, due to their useful nature.
PMCID: PMC4264095  PMID: 25512750
Mobile Health units; Health Services Accessibility; Oral Helth

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