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1.  Effect of health promotion and fluoride varnish on dental caries among Australian Aboriginal children: results from a community-randomized controlled trial* 
Objectives
We tested a dental health program in remote Aboriginal communities of Australia's Northern Territory, hypothesizing that it would reduce dental caries in preschool children.
Methods
In this 2-year, prospective, cluster-randomized, concurrent controlled, open trial of the dental health program compared to no such program, 30 communities were allocated at random to intervention and control groups. All residents aged 18–47 months were invited to participate. Twice per year for 2 years in the 15 intervention communities, fluoride varnish was applied to children's teeth, water consumption and daily tooth cleaning with toothpaste were advocated, dental health was promoted in community settings, and primary health care workers were trained in preventive dental care. Data from dental examinations at baseline and after 2 years were used to compute net dental caries increment per child (d3mfs). A multi-level statistical model compared d3mfs between intervention and control groups with adjustment for the clustered randomization design; four other models used additional variables for adjustment.
Results
At baseline, 666 children were examined; 543 of them (82%) were re-examined 2 years later. The adjusted d3mfs increment was significantly lower in the intervention group compared to the control group by an average of 3.0 surfaces per child (95% CI = 1.2, 4.9), a prevented fraction of 31%. Adjustment for additional variables yielded caries reductions ranging from 2.3 to 3.5 surfaces per child and prevented fractions of 24–36%.
Conclusions
These results corroborate findings from other studies where fluoride varnish was efficacious in preventing dental caries in young children.
doi:10.1111/j.1600-0528.2010.00561.x
PMCID: PMC3040293  PMID: 20707872
dental caries; fluoride varnish; health promotion; indigenous; randomized controlled trial
2.  Innovative interventions to promote positive dental health behaviors and prevent dental caries in preschool children: study protocol for a randomized controlled trial 
Trials  2013;14:118.
Background
Dental caries (tooth decay) is highly prevalent and is largely attributable to unhealthy self-care behaviors (diet and oral hygiene). The conventional (health) education (CE), focusing on disseminating information and giving normative advice, often fails to achieve sustained behavioral changes. This study incorporates two innovative elements into CE: (i) motivational interviewing (MI), a client-centered counseling for changing behaviors, and (ii) an interactive caries risk assessment (RA) tool, which is devised to facilitate dental counseling and may enhance MI in several ways. Through a randomized, controlled, evaluator-blinded trial, three intervention schemes (CE, CE + MI, and CE + MI + RA) will be compared for their effectiveness in eliciting dentally healthy behaviors and preventing caries in preschool children.
Methods/Design
This study targets 3-year-old children who are at a critical stage for embedding health habits. Children with unfavorable dental behaviors (insufficient toothbrushing and/or frequent snacking) and their parents will be recruited from 12 participating kindergartens. Parent-child dyads (n = 690) will be randomly assigned into three groups. In the first group (CE), oral health information and advice will be delivered to parents through pamphlets. In the second group (CE + MI), in addition to the pamphlets, individual MI counseling with each parent will be performed by one of two trained dental hygienists. In the third group (CE + MI + RA), besides pamphlets and MI, interactive RA will be integrated into MI to motivate parents and facilitate their informed decision making and goal planning. At baseline and after 12 and 24 months, parents will complete a questionnaire and children will undergo a dental examination. The effectiveness of the intervention schemes will be compared over 12 and 24 months. The primary outcome will be caries increment in children and proportion of caries-free children. Secondary outcomes will be changes in parental efficacy for protecting children’s oral health and changes in children’s dental behaviors.
Discussion
Motivating and empowering parents to cultivate dentally healthy habits of young children presents both promises and challenges. With careful methodological considerations, this study is expected to provide scientific evidence for public health workers, dentists, and dental auxiliaries (nurses and hygienists) to choose appropriate interventions to advance children’s oral health.
Trial registration
HKCTR-1455
doi:10.1186/1468-6708-14-118
PMCID: PMC3658868  PMID: 23782918
Motivational interviewing; Caries risk assessment; Oral health intervention; Oral health education; Dental counseling; Children; Preschool; Parents; Randomized controlled trial
3.  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
4.  A parent motivational interviewing program for dental care in children of a rural population 
Objectives: To determine the effectiveness of a motivational interviewing-based educational program in reducing the number and intensity of new caries and bacterial dental plaque levels at 6 months post randomization. Study Design: A randomized and single blind clinical trial in 100 schoolchildren between 6-10 years of age presenting the highest risk score of caries according to the Caries Management by Risk Assessment (CAMBRA) criteria was performed. These patients were randomized to two groups: control (in which the mothers initially received an oral prevention informative session) and experimental (in which the mothers received the initial informative session, followed by individual motivational interviewing sessions during a period of 6 months). The International Caries Detection and Assessment System (ICDAS) scores and bacterial plaque were evaluated at baseline, at 6 and 12 months. Results: After 12 months, children in the experimental group had 2.12 ± 0.8 new caries versus 3.5 ± 0.9 in the control group (t=7.39; p<0.001). Caries in the experimental group was seen to be limited to the enamel, with a median intensity of 2 (range 0-3) versus 3 (0-6) in the control group (U=1594; p<0.0001). Bacterial plaque determined by the O’Leary index decreased in both groups; however, it decreased more in the experimental than in the control group (34.3 vs. 20.6; t=-3.12, p= 0.002) respectively. Conclusions: Motivational interviewing is better than traditional educational programs in preventing caries and decreasing bacterial plaque.
Key words:Health educational, motivational interviewing, caries risk.
doi:10.4317/jced.51662
PMCID: PMC4312680
5.  Brief oral health promotion intervention among parents of young children to reduce early childhood dental decay 
BMC Public Health  2013;13:245.
Background
Severe untreated dental decay affects a child’s growth, body weight, quality of life as well as cognitive development, and the effects extend beyond the child to the family, the community and the health care system. Early health behavioural factors, including dietary practices and eating patterns, can play a major role in the initiation and development of oral diseases, particularly dental caries. The parent/caregiver, usually the mother, has a critical role in the adoption of protective health care behaviours and parental feeding practices strongly influence children’s eating behaviours. This study will test if an early oral health promotion intervention through the use of brief motivational interviewing (MI) and anticipatory guidance (AG) approaches can reduce the incidence of early childhood dental decay and obesity.
Methods
The study will be a randomised controlled study with parents and their new-born child/ren who are seen at 6–12 weeks of age by a child/community health nurse. Consenting parents will complete a questionnaire on oral health knowledge, behaviours, self-efficacy, oral health fatalism, parenting stress, prenatal and peri-natal health and socio-demographic factors at study commencement and at 12 and 36 months. Each child–parent pair will be allocated to an intervention or a standard care group, using a computer-generated random blocks. The standard group will be managed through the standard early oral health screening program; “lift the lip”. The intervention group will be provided with tailored oral health counselling by oral health consultants trained in MI and AG.
Participating children will be examined at 24, and 36 months for the occurrence of dental decay and have their height and weight recorded. Dietary information obtained from a food frequency chart will be used to determine food and dietary patterns. Data analysis will use intention to treat and per protocol analysis and will use tests of independent proportions and means. Multivariate statistical tests will also be used to take account of socio-economic and demographic factors in addition to parental knowledge, behaviour, self-efficacy, and parent/child stress.
Discussion
The study will test the effects of an oral health promotion intervention to affect oral health and general health and have the potential to demonstrate the “common risk factor” approach to health promotion.
Trial registration
Australian New Zealand Clinical Trials Registry: http://ACTRN12611000997954
doi:10.1186/1471-2458-13-245
PMCID: PMC3610190  PMID: 23509932
Motivational interviewing; Anticipatory guidance; Early childhood dental decay; Oral health promotion
6.  Impact of treating dental caries on schoolchildren’s anthropometric, dental, satisfaction and appetite outcomes: a randomized controlled trial 
BMC Public Health  2012;12:706.
Background
There are no randomized controlled trials to assess the impact of treating dental caries on various aspects of children’s health. This study was conducted to assess the impact of dental treatment of severe dental caries on children’s weight, height and subjective health related outcomes, namely dental pain, satisfaction with teeth and smile, dental sepsis and child’s appetite.
Methods
The study was a community-based, randomized, controlled trial in schoolchildren aged 6-7 years with untreated dental caries. Participants were randomly assigned to early (test) or regular (control) dental treatment. The primary outcome was Weight-for-age Z-score. Secondary outcomes were Height-for-age and BMI-for-age Z-scores, dental pain, dental sepsis, satisfaction with teeth and child’s appetite.
Results
86 children were randomly assigned to test (42 children) and control (44) groups. Mean duration of follow-up was 34.8 (±1.1) weeks. There were insignificant improvements in anthropometric outcomes between the groups after treatment of caries. However, treated children had significantly less pain experience (P = 0.006) (OR 0.09, [0.01-0.51]) and higher satisfaction with teeth (P = 0.001) (OR 9.91, [2.68-36.51]) compared to controls. Controls had significantly poorer appetites (P = 0.01) (OR 2.9, [1.24-6.82]) compared to treated children. All treated children were free of clinical dental sepsis whereas 20% (9 of 44) of controls who were free of sepsis at baseline had sepsis at follow-up.
Conclusions
Although dental treatment did not significantly improve the anthropometric outcomes, it significantly improved the dental outcomes and children’s satisfaction with teeth, smile and appetite. This is the first study to provide evidence that treatment of severe dental caries can improve children’s appetite.
Trial registration
Effect of Dental Treatment on Children's Growth. Clinical Trial Gov ID# NCT01243866
doi:10.1186/1471-2458-12-706
PMCID: PMC3497873  PMID: 22928903
Dental caries; Child; Anthropometry; HAZ; WAZ; Appetite; Pain; Sepsis; Satisfaction
7.  Motivational interviewing with American Indian mothers to prevent early childhood caries: study design and methodology of a randomized control trial 
Trials  2014;15:125.
Background
This randomized control trial assesses the effectiveness of motivational interviewing (MI) to encourage behavior change in new mothers relating to caries prevention when caring for their newborn American Indian (AI) infants and young AI children.
Methods/Design
The study is a randomized control trial. We hypothesize that when motivational interviewing is added to enhanced community oral health education services, the new mothers will achieve greater reduction of caries experience in their AI children compared to those who are receiving enhanced community services (ECS) alone. Six hundred mothers or caregivers of AI newborns will be enrolled into the study and randomized to one of the two intervention groups over a two-year period. The children will be followed until the child’s third birthday. A cost analysis of the study is being conducted in tandem with the enhanced community services, motivational interviewing behavioral interventions, and the dental screenings for the length of the study.
Discussion
The trial is now in the implementation phase and a number of threats to successful completion, such as recruitment and retention challenges in a vast, rural geographic area, have been addressed. The protocol provides a unique model for oral health interventions using principles of community-based participatory research and is currently on schedule to meet study objectives. If the study is successful, motivational interviewing intervention can be applied in AI communities to reduce ECC disparities in this disadvantaged population, with study of further applicability in other populations and settings.
Trial registration
ClinicalTrials.gov, NCT01116726.
doi:10.1186/1745-6215-15-125
PMCID: PMC4011767  PMID: 24735707
Early Childhood Caries; Motivational Interviewing; Oral Health Behavior Change; American Indian; Community-Based Participatory Research
8.  Community Mobilization in Mumbai Slums to Improve Perinatal Care and Outcomes: A Cluster Randomized Controlled Trial 
PLoS Medicine  2012;9(7):e1001257.
David Osrin and colleagues report findings from a cluster-randomized trial conducted in Mumbai slums; the trial aimed to evaluate whether facilitator-supported women's groups could improve perinatal outcomes.
Introduction
Improving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have been predominantly rural, but India is urbanizing. While working to improve health service quality, we tested an intervention in which urban slum-dweller women's groups worked to improve local perinatal health.
Methods and Findings
A cluster randomized controlled trial in 24 intervention and 24 control settlements covered a population of 283,000. In each intervention cluster, a facilitator supported women's groups through an action learning cycle in which they discussed perinatal experiences, improved their knowledge, and took local action. We monitored births, stillbirths, and neonatal deaths, and interviewed mothers at 6 weeks postpartum. The primary outcomes described perinatal care, maternal morbidity, and extended perinatal mortality. The analysis included 18,197 births over 3 years from 2006 to 2009. We found no differences between trial arms in uptake of antenatal care, reported work, rest, and diet in later pregnancy, institutional delivery, early and exclusive breastfeeding, or care-seeking. The stillbirth rate was non-significantly lower in the intervention arm (odds ratio 0.86, 95% CI 0.60–1.22), and the neonatal mortality rate higher (1.48, 1.06–2.08). The extended perinatal mortality rate did not differ between arms (1.19, 0.90–1.57). We have no evidence that these differences could be explained by the intervention.
Conclusions
Facilitating urban community groups was feasible, and there was evidence of behaviour change, but we did not see population-level effects on health care or mortality. In cities with multiple sources of health care, but inequitable access to services, community mobilization should be integrated with attempts to deliver services for the poorest and most vulnerable, and with initiatives to improve quality of care in both public and private sectors.
Trial registration
Current Controlled Trials ISRCTN96256793
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Substantial progress is being made to reduce global child mortality (deaths of children before the age of 5 years) and maternal mortality (deaths among women because of complications of pregnancy and childbirth)—two of the Millennium Development Goals agreed by world leaders in 2000 to end extreme poverty. Even so, worldwide, in 2010, 7.6 million children died before their fifth birthday and there were nearly 360,000 maternal deaths. Almost all child and maternal deaths occur in developing countries—a fifth of under-five deaths and more than a quarter of neonatal deaths (deaths during the first month of life, which account for two-fifths of all child deaths) occur in India alone. Moreover, most child and maternal deaths are caused by avoidable conditions. Specifically, the major causes of neonatal death—complications of preterm delivery, breathing problems during or after delivery, and infections of the blood (sepsis) and lungs (pneumonia)—and of maternal deaths—hemorrhage (abnormal bleeding), sepsis, unsafe abortion, obstructed labor, and hypertensive diseases of pregnancy—could all be largely prevented by improved access to reproductive health services and skilled health care workers.
Why Was This Study Done?
Experts believe that improvements to maternal and newborn health in low-income settings require both health service strengthening and community action. That is, the demand for better services, driven by improved knowledge about maternal and newborn health (perinatal issues), has to be increased in parallel with the supply of those services. To date, community mobilization around perinatal issues has largely been undertaken in rural settings but populations in developing countries are becoming increasingly urban. In India, for example, 30% of the population now lives in cities. In this cluster randomized controlled trial (a study in which groups of people are randomly assigned to receive alternative interventions and the outcomes in the differently treated “clusters” are compared), City Initiative for Newborn Health (CINH) researchers investigate the effect of an intervention designed to help women's groups in the slums of Mumbai work towards improving local perinatal health. The CINH aims to improve maternal and newborn health in slum communities by improving public health care provision and by working with community members to improve maternal and newborn care practices and care-seeking behaviors.
What Did the Researchers Do and Find?
The researchers enrolled 48 Mumbai slum communities of at least 1,000 households into their trial. In each of the 24 intervention clusters, a facilitator supported local women's groups through a 36-meeting learning cycle during which group members discussed their perinatal experiences, improved their knowledge, and took action. To measure the effect of the intervention, the researchers monitored births, stillbirths, and neonatal deaths in all the clusters and interviewed mothers 6 weeks after delivery. During the 3-year trial, there were 18,197 births in the participating settlements. The women in the intervention clusters were enthusiastic about acquiring new knowledge and made substantial efforts to reach out to other women but were less successful in undertaking collective action such as negotiations with civic authorities for more amenities. There were no differences between the intervention and control communities in the uptake of antenatal care, reported work, rest, and diet in late pregnancy, institutional delivery, or in breast feeding and care-seeking behavior. Finally, the combined rate of stillbirths and neonatal deaths (the extended perinatal mortality rate) was the same in both arms of the trial, as was maternal mortality.
What Do These Findings Mean?
These findings indicate that it is possible to facilitate the discussion of perinatal health care by urban women's groups in the challenging conditions that exist in the slums of Mumbai. However, they fail to show any measureable effect of community mobilization through the facilitation of women's groups on perinatal health at the population level. The researchers acknowledge that more intensive community activities that target the poorest, most vulnerable slum dwellers might produce measurable effects on perinatal mortality, and they conclude that, in cities with multiple sources of health care and inequitable access to services, it remains important to integrate community mobilization with attempts to deliver services to the poorest and most vulnerable, and with initiatives to improve the quality of health care in both the public and private sector.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001257.
The United Nations Childrens Fund (UNICEF) works for children's rights, survival, development, and protection around the world; it provides information on the reduction of child mortality (Millennium Development Goal 4); its Childinfo website provides information about all the Millennium Development Goals and detailed statistics about on child survival and health, newborn care, and maternal health (some information in several languages)
The World Health Organization also has information about Millennium Development Goal 4 and Millennium Development Goal 5, the reduction of maternal mortality, provides information on newborn infants, and provides estimates of child mortality rates (some information in several languages)
Further information about the Millennium Development Goals is available
Information on the City Initiative for Newborn Health and its partners and a detailed description of its trial of community mobilization in Mumbai slums to improve care during pregnancy, delivery, postnatally and for the newborn are available
Further information about the Society for Nutrition, Education and Health Action (SNEHA) is available
doi:10.1371/journal.pmed.1001257
PMCID: PMC3389036  PMID: 22802737
9.  Design of a community-based intergenerational oral health study: “Baby Smiles” 
BMC Oral Health  2013;13:38.
Background
Rural, low-income pregnant women and their children are at high risk for poor oral health and have low utilization rates of dental care. The Baby Smiles study was designed to increase low-income pregnant women’s utilization of dental care, increase young children’s dental care utilization, and improve home oral health care practices.
Methods/design
Baby Smiles was a five-year, four-site randomized intervention trial with a 2 × 2 factorial design. Four hundred participants were randomly assigned to one of four treatment arms in which they received either brief Motivational Interviewing (MI) or health education (HE) delivered during pregnancy and after the baby was born. In the prenatal study phase, the interventions were designed to encourage dental utilization during pregnancy. After childbirth, the focus was to utilize dental care for the infant by age one. The two primary outcome measures were dental utilization during pregnancy or up to two months postpartum for the mother, and preventive dental utilization by 18 months of age for the child. Medicaid claims data will be used to assess the primary outcomes. Questionnaires were administered at enrollment and 3, 9 and 18 months postpartum (study end) to assess mediating and moderating factors.
Discussion
This trial can help define the most effective way to provide one-on-one counseling to pregnant women and new mothers regarding visits to the dentist during pregnancy and after the child is born. It supports previous work demonstrating the potential of reducing mother-to-child transmission of Streptococcus mutans and the initiation of dental caries prevention in early childhood.
Trial registration
ClinicalTrials.gov Identifier NCT01120041
doi:10.1186/1472-6831-13-38
PMCID: PMC3751087  PMID: 23914908
Counseling; Motivation; Dental caries; Early childhood caries; Health Education; Dental; Mothers; Infant
10.  Home-Based Versus Mobile Clinic HIV Testing and Counseling in Rural Lesotho: A Cluster-Randomized Trial 
PLoS Medicine  2014;11(12):e1001768.
Niklaus Labhardt and colleagues investigate how different HIV testing and counseling strategies, based on home visits or mobile clinics, reach different populations in a rural African setting.
Please see later in the article for the Editors' Summary
Background
The success of HIV programs relies on widely accessible HIV testing and counseling (HTC) services at health facilities as well as in the community. Home-based HTC (HB-HTC) is a popular community-based approach to reach persons who do not test at health facilities. Data comparing HB-HTC to other community-based HTC approaches are very limited. This trial compares HB-HTC to mobile clinic HTC (MC-HTC).
Methods and Findings
The trial was powered to test the hypothesis of higher HTC uptake in HB-HTC campaigns than in MC-HTC campaigns. Twelve clusters were randomly allocated to HB-HTC or MC-HTC. The six clusters in the HB-HTC group received 30 1-d multi-disease campaigns (five villages per cluster) that delivered services by going door-to-door, whereas the six clusters in MC-HTC group received campaigns involving community gatherings in the 30 villages with subsequent service provision in mobile clinics. Time allocation and human resources were standardized and equal in both groups. All individuals accessing the campaigns with unknown HIV status or whose last HIV test was >12 wk ago and was negative were eligible. All outcomes were assessed at the individual level. Statistical analysis used multivariable logistic regression. Odds ratios and p-values were adjusted for gender, age, and cluster effect.
Out of 3,197 participants from the 12 clusters, 2,563 (80.2%) were eligible (HB-HTC: 1,171; MC-HTC: 1,392). The results for the primary outcomes were as follows. Overall HTC uptake was higher in the HB-HTC group than in the MC-HTC group (92.5% versus 86.7%; adjusted odds ratio [aOR]: 2.06; 95% CI: 1.18–3.60; p = 0. 011). Among adolescents and adults ≥12 y, HTC uptake did not differ significantly between the two groups; however, in children <12 y, HTC uptake was higher in the HB-HTC arm (87.5% versus 58.7%; aOR: 4.91; 95% CI: 2.41–10.0; p<0.001). Out of those who took up HTC, 114 (4.9%) tested HIV-positive, 39 (3.6%) in the HB-HTC arm and 75 (6.2%) in the MC-HTC arm (aOR: 0.64; 95% CI: 0.48–0.86; p = 0.002). Ten (25.6%) and 19 (25.3%) individuals in the HB-HTC and in the MC-HTC arms, respectively, linked to HIV care within 1 mo after testing positive. Findings for secondary outcomes were as follows: HB-HTC reached more first-time testers, particularly among adolescents and young adults, and had a higher proportion of men among participants. However, after adjusting for clustering, the difference in male participation was not significant anymore.
Age distribution among participants and immunological and clinical stages among persons newly diagnosed HIV-positive did not differ significantly between the two groups. Major study limitations included the campaigns' restriction to weekdays and a relatively low HIV prevalence among participants, the latter indicating that both arms may have reached an underexposed population.
Conclusions
This study demonstrates that both HB-HTC and MC-HTC can achieve high uptake of HTC. The choice between these two community-based strategies will depend on the objective of the activity: HB-HTC was better in reaching children, individuals who had never tested before, and men, while MC-HTC detected more new HIV infections. The low rate of linkage to care after a positive HIV test warrants future consideration of combining community-based HTC approaches with strategies to improve linkage to care for persons who test HIV-positive.
Trial registration
ClinicalTrials.gov NCT01459120
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Annually, about 2.3 million people become newly infected with HIV, the virus that causes AIDS by gradually destroying CD4 cells and other immune system cells, thereby leaving HIV-infected individuals susceptible to other serious infections. HIV can be transmitted through unprotected sex with an infected partner, from an HIV-positive mother to her unborn child, or through the injection of drugs with shared needles. Infection with HIV is usually diagnosed by looking for antibodies to HIV in the blood or saliva. After diagnosis, the progression of HIV infection is monitored by regularly counting the number of CD4 cells in the blood. Initiation of antiretroviral therapy (ART)—a combination of drugs that keeps HIV replication in check but that does not cure the infection—is recommended when an individual's CD4 count falls below 500 cells/µl or when he or she develops signs of advanced or severe disease, such as unusual infections.
Why Was This Study Done?
To control HIV/AIDS, HIV transmission needs to be reduced, and ART delivery needs to be increased. In settings of high HIV prevalence, universal coverage of HIV testing and counseling (HTC) is essential if these goals are to be met. Unfortunately, many people refuse “facility-based” HTC (HTC delivered at health care facilities) because they fear stigmatization and discrimination. Moreover, many people in resource-limited settings rarely visit health care facilities. Community-based HTC may be one way to increase the uptake of HTC, particularly among populations that are hard to reach, such as men and first-time testers, but which form of community-based HTC will be most effective? In this cluster-randomized trial, the researchers ask whether home-based HTC (HB-HTC)—community-based HTC in which health care workers go door-to-door to offer HTC to people in their own home—results in a higher uptake of HTC than HTC delivered through community gatherings and mobile clinics (MC-HTC) in two rural areas in Lesotho. Nearly a quarter of adults are HIV-positive in Lesotho, but only 61% of people who need ART currently receive treatment. A cluster-randomized trial compares outcomes in groups (clusters) of people chosen at random to receive different interventions.
What Did the Researchers Do and Find?
The researchers allocated 12 clusters, each comprising a health center and its catchment area, to the HB-HTC or MC-HTC intervention. In the HB-HTC arm (1,171 participants), HTC teams going door-to-door delivered a multi-disease campaign that included HTC to five villages in each cluster. In the MC-HTC arm (1,392 participants), the multi-disease campaign was delivered at community gatherings with subsequent service provision in mobile clinics. Overall, HTC uptake was higher in the HB-HTC arm than in the MC-HTC arm (92.5% and 86.7% uptake, respectively). Among participants aged ≥12 years, there was no significant difference in HTC uptake between the arms, whereas among children aged <12 years, HTC uptake was significantly higher in the HB-HTC arm than in the MC-HTC arm (87.5% versus 58.7%; a significant difference is a difference unlikely to have happened by chance). Among individuals who took up HTC, 3.6% and 6.2% tested positive for HIV in the HB-HTC arm and MC-HTC arm, respectively. In both arms, only a quarter of individuals who tested positive accessed HIV care within a month of their positive test result. Finally, HB-HTC reached more first-time testers (particularly among adolescents) and tended to reach more men than MC-HTC.
What Do These Findings Mean?
These findings suggest that, in rural Lesotho, both HB-HTC and MC-HTC delivered as part of a multi-disease campaign can achieve a high uptake of HTC. Various aspects of the trial design (for example, the small number of clusters) may limit the accuracy of the findings reported here. Notably, however, these findings suggest that the choice between HB-HTC and MC-HTC should be guided by the objective of the HTC intervention in specific settings. Where equity of access is of concern and where increased HTC coverage, particularly among groups in which HTC coverage is generally poor (including men, first-time testers, and children), is paramount, HB-HTC may be the preferred option. By contrast, the MC-HTC approach may be more appropriate in settings where the detection of new HIV infections is the major goal. Finally, and importantly, the findings of this trial highlight the need for further research into strategies designed to improve the linkage between HIV testing and enrollment into care.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001768.
The World Health Organization provides information on all aspects of HIV/AIDS, including information on HIV counseling and testing (in several languages)
Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS
NAM/aidsmap provides basic information about HIV/AIDS and summaries of recent research findings on HIV care and treatment
Information is available from Avert, an international AIDS charity, on many aspects of HIV/AIDS, including information on the global HIV/AIDS epidemic, on HIV testing, and on HIV/AIDS in Lesotho
The UK National Health Service Choices website provides information (including personal stories) about HIV/AIDS
The “UNAIDS Report on the Global AIDS Epidemic 2013” provides up-to-date information about the AIDS epidemic and efforts to halt it
Stories about living with HIV/AIDS are available through Avert and through healthtalk.org
More information about this trial is available
doi:10.1371/journal.pmed.1001768
PMCID: PMC4267810  PMID: 25513807
11.  Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services 
BMC Oral Health  2011;11:27.
Background
Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries.
The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children.
Methods/Design
A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit).
1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group.
The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will be obtained from parental questionnaires.
Discussion
This is a pragmatic trial conducted in general dental practice. It tests a composite caries prevention intervention, which represents an evidence based approach advocated by current guidance from the English Department of Health which is feasible to deliver to all low risk (caries free) children in general dental practice. The trial will provide valuable information to policy makers and clinicians on the costs and effects of caries prevention delivered to young children in general dental practice.
Trial registration
EudraCT No: 2009 - 010725 - 39
ISRCTN: ISRCTN36180119
Ethics Reference No: 09/H1008/93:
doi:10.1186/1472-6831-11-27
PMCID: PMC3196725  PMID: 21985746
12.  Steps to Growing Up Healthy: a pediatric primary care based obesity prevention program for young children 
BMC Public Health  2014;14:72.
Background
Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Brief interventions with simple behavior change messages are needed to reach high-risk children, particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4 years old.
Methods/Design
Mother-child dyads (targeted n = 150) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC + Phone); or 3) BMC plus monthly home visits by a CHW (BMC + Home). During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. Monthly contacts with CHWs are designed to identify and overcome barriers to goal progress. Dyads are assessed at baseline and 12 months and the primary outcome is change in the child’s BMI percentile. We hypothesize that BMC + Phone and BMC + Home will produce greater reductions in BMI percentiles than BMC alone and that BMC + Home will produce greater reductions in BMI percentiles than BMC + Phone.
Discussion
Steps to Growing Up Healthy will provide important information about whether a brief primary care-based intervention that utilizes a motivational interviewing and goal setting approach can be incorporated into routine care and is sufficient to prevent/reverse obesity in young children. The study will also explore whether monthly contact with a community health worker bridges the gap between the clinic and the community and is an effective strategy for promoting obesity prevention in high-risk families.
Trial registration
ClinicalTrials.gov NCT01973153
doi:10.1186/1471-2458-14-72
PMCID: PMC3933325  PMID: 24456698
Weight management; Latino; Low-income; Motivational interviewing
13.  The Effectiveness of Community Action in Reducing Risky Alcohol Consumption and Harm: A Cluster Randomised Controlled Trial 
PLoS Medicine  2014;11(3):e1001617.
In a cluster randomized controlled trial, Anthony Shakeshaft and colleagues measure the effectiveness of a multi-component community-based intervention for reducing alcohol-related harm.
Background
The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community), and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data.
Methods and Findings
We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000–20,000, were at least 100 km from an urban centre (population ≥ 100,000), and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI); feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department–based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001–2009) were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n = 2,977 and 2,255, respectively) were the following: long-term risky drinking, short-term high-risk drinking, short-term risky drinking, weekly consumption, hazardous/harmful alcohol use, and experience of alcohol harm. At the 5% level of statistical significance, there was insufficient evidence to conclude that the interventions were effective in the experimental, relative to control, communities for alcohol-related crime, traffic crashes, and hospital inpatient admissions, and for rates of risky alcohol consumption and hazardous/harmful alcohol use. Although respondents in the experimental communities reported statistically significantly lower average weekly consumption (1.90 fewer standard drinks per week, 95% CI = −3.37 to −0.43, p = 0.01) and less alcohol-related verbal abuse (odds ratio = 0.58, 95% CI = 0.35 to 0.96, p = 0.04) post-intervention, the low survey response rates (40% and 24% for the pre- and post-intervention surveys, respectively) require conservative interpretation. The main limitations of this study are as follows: (1) that the study may have been under-powered to detect differences in routinely collected data outcomes as statistically significant, and (2) the low survey response rates.
Conclusions
This RCT provides little evidence that community action significantly reduces risky alcohol consumption and alcohol-related harms, other than potential reductions in self-reported average weekly consumption and experience of alcohol-related verbal abuse. Complementary legislative action may be required to more effectively reduce alcohol harms.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12607000123448
Please see later in the article for the Editors' Summary
Editors' Summary
Background
People have consumed alcoholic beverages throughout history, but alcohol use is now an increasing global public health problem. According to the World Health Organization's 2010 Global Burden of Disease Study, alcohol use is the fifth leading risk factor (after high blood pressure and smoking) for disease and is responsible for 3.9% of the global disease burden. Alcohol use contributes to heart disease, liver disease, depression, some cancers, and many other health conditions. Alcohol also affects the well-being and health of people around those who drink, through alcohol-related crimes and road traffic crashes. The impact of alcohol use on disease and injury depends on the amount of alcohol consumed and the pattern of drinking. Most guidelines define long-term risky drinking as more than four drinks per day on average for men or more than two drinks per day for women (a “drink” is, roughly speaking, a can of beer or a small glass of wine), and short-term risky drinking (also called binge drinking) as seven or more drinks on a single occasion for men or five or more drinks on a single occasion for women. However, recent changes to the Australian guidelines acknowledge that a lower level of alcohol consumption is considered risky (with lifetime risky drinking defined as more than two drinks a day and binge drinking defined as more than four drinks on one occasion).
Why Was This Study Done?
In 2010, the World Health Assembly endorsed a global strategy to reduce the harmful use of alcohol. This strategy emphasizes the importance of community action–a process in which a community defines its own needs and determines the actions that are required to meet these needs. Although community action is highly acceptable to community members, few studies have looked at the effectiveness of community action in reducing risky alcohol consumption and alcohol-related harm. Here, the researchers undertake a cluster randomized controlled trial (the Alcohol Action in Rural Communities [AARC] project) to quantify the effectiveness of community action in reducing risky alcohol consumption and harms in rural communities in Australia. A cluster randomized trial compares outcomes in clusters of people (here, communities) who receive alternative interventions assigned through the play of chance.
What Did the Researchers Do and Find?
The researchers pair-matched 20 rural Australian communities according to the proportion of their population that was Aboriginal (rates of alcohol-related harm are disproportionately higher among Aboriginal individuals than among non-Aboriginal individuals in Australia; they are also higher among young people and males, but the proportions of these two groups across communities was comparable). They randomly assigned one member of each pair to the experimental group and implemented 13 interventions in these communities by negotiating with key individuals in each community to define and implement each intervention. Examples of interventions included general practitioner training in screening for alcohol use disorders and in implementing a brief intervention, and a school-based interactive session designed to reduce alcohol harm among young people. The researchers quantified the effectiveness of the interventions using routinely collected data on alcohol-related crime and road traffic crashes, and on hospital inpatient admissions for alcohol dependence or abuse (which were expected to increase in the experimental group if the intervention was effective because of more people seeking or being referred for treatment). They also examined drinking habits and experiences of alcohol-related harm, such as verbal abuse, among community members using pre- and post-intervention surveys. After implementation of the interventions, the rates of alcohol-related crime, road traffic crashes, and hospital admissions, and of risky and hazardous/harmful alcohol consumption (measured using a validated tool called the Alcohol Use Disorders Identification Test) were not statistically significantly different in the experimental and control communities (a difference in outcomes that is not statistically significantly different can occur by chance). However, the reported average weekly consumption of alcohol was 20% lower in the experimental communities after the intervention than in the control communities (equivalent to 1.9 fewer standard drinks per week per respondent) and there was less alcohol-related verbal abuse post-intervention in the experimental communities than in the control communities.
What Do These Findings Mean?
These findings provide little evidence that community action reduced risky alcohol consumption and alcohol-related harms in rural Australian communities. Although there was some evidence of significant reductions in self-reported weekly alcohol consumption and in experiences of alcohol-related verbal abuse, these findings must be interpreted cautiously because they are based on surveys with very low response rates. A larger or differently designed study might provide statistically significant evidence for the effectiveness of community action in reducing risky alcohol consumption. However, given their findings, the researchers suggest that legislative approaches that are beyond the control of individual communities, such as alcohol taxation and restrictions on alcohol availability, may be required to effectively reduce alcohol harms. In other words, community action alone may not be the most effective way to reduce alcohol-related harm.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001617.
The World Health Organization provides detailed information about alcohol; its fact sheet on alcohol includes information about the global strategy to reduce the harmful use of alcohol; the Global Information System on Alcohol and Health provides further information about alcohol, including information on control policies around the world
The US National Institute on Alcohol Abuse and Alcoholism has information about alcohol and its effects on health
The US Centers for Disease Control and Prevention has a website on alcohol and public health that includes information on the health risks of excessive drinking
The UK National Health Service Choices website provides detailed information about drinking and alcohol, including information on the risks of drinking too much, tools for calculating alcohol consumption, and personal stories about alcohol use problems
MedlinePlus provides links to many other resources on alcohol
More information about the Alcohol Action in Rural Communities project is available
doi:10.1371/journal.pmed.1001617
PMCID: PMC3949675  PMID: 24618831
14.  Primary Prevention of Gestational Diabetes Mellitus and Large-for-Gestational-Age Newborns by Lifestyle Counseling: A Cluster-Randomized Controlled Trial 
PLoS Medicine  2011;8(5):e1001036.
In a cluster-randomized trial, Riitta Luoto and colleagues find that counseling on diet and activity can reduce the birthweight of babies born to women at risk of developing gestational diabetes mellitus (GDM), but fail to find an effect on GDM.
Background
Our objective was to examine whether gestational diabetes mellitus (GDM) or newborns' high birthweight can be prevented by lifestyle counseling in pregnant women at high risk of GDM.
Method and Findings
We conducted a cluster-randomized trial, the NELLI study, in 14 municipalities in Finland, where 2,271 women were screened by oral glucose tolerance test (OGTT) at 8–12 wk gestation. Euglycemic (n = 399) women with at least one GDM risk factor (body mass index [BMI] ≥25 kg/m2, glucose intolerance or newborn's macrosomia (≥4,500 g) in any earlier pregnancy, family history of diabetes, age ≥40 y) were included. The intervention included individual intensified counseling on physical activity and diet and weight gain at five antenatal visits. Primary outcomes were incidence of GDM as assessed by OGTT (maternal outcome) and newborns' birthweight adjusted for gestational age (neonatal outcome). Secondary outcomes were maternal weight gain and the need for insulin treatment during pregnancy. Adherence to the intervention was evaluated on the basis of changes in physical activity (weekly metabolic equivalent task (MET) minutes) and diet (intake of total fat, saturated and polyunsaturated fatty acids, saccharose, and fiber). Multilevel analyses took into account cluster, maternity clinic, and nurse level influences in addition to age, education, parity, and prepregnancy BMI. 15.8% (34/216) of women in the intervention group and 12.4% (22/179) in the usual care group developed GDM (absolute effect size 1.36, 95% confidence interval [CI] 0.71–2.62, p = 0.36). Neonatal birthweight was lower in the intervention than in the usual care group (absolute effect size −133 g, 95% CI −231 to −35, p = 0.008) as was proportion of large-for-gestational-age (LGA) newborns (26/216, 12.1% versus 34/179, 19.7%, p = 0.042). Women in the intervention group increased their intake of dietary fiber (adjusted coefficient 1.83, 95% CI 0.30–3.25, p = 0.023) and polyunsaturated fatty acids (adjusted coefficient 0.37, 95% CI 0.16–0.57, p<0.001), decreased their intake of saturated fatty acids (adjusted coefficient −0.63, 95% CI −1.12 to −0.15, p = 0.01) and intake of saccharose (adjusted coefficient −0.83, 95% CI −1.55 to −0.11, p  =  0.023), and had a tendency to a smaller decrease in MET minutes/week for at least moderate intensity activity (adjusted coefficient 91, 95% CI −37 to 219, p = 0.17) than women in the usual care group. In subgroup analysis, adherent women in the intervention group (n = 55/229) had decreased risk of GDM (27.3% versus 33.0%, p = 0.43) and LGA newborns (7.3% versus 19.5%, p = 0.03) compared to women in the usual care group.
Conclusions
The intervention was effective in controlling birthweight of the newborns, but failed to have an effect on maternal GDM.
Trial registration
Current Controlled Trials ISRCTN33885819
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Gestational diabetes mellitus (GDM) is diabetes that is first diagnosed during pregnancy. Like other types of diabetes, it is characterized by high levels of sugar (glucose) in the blood. Blood-sugar levels are normally controlled by insulin, a hormone that the pancreas releases when blood-sugar levels rise after meals. Hormonal changes during pregnancy and the baby's growth demands increase a pregnant woman's insulin needs and, if her pancreas cannot make enough insulin, GDM develops. Risk factors for GDM, which occurs in 2%–14% of pregnant women, include a high body-mass index (a measure of body fat), excessive weight gain or low physical activity during pregnancy, high dietary intake of polyunsaturated fats, glucose intolerance (an indicator of diabetes) or the birth of a large baby in a previous pregnancy, and a family history of diabetes. GDM is associated with an increased rate of cesarean sections, induced deliveries, birth complications, and large-for-gestational-age (LGA) babies (gestation is the time during which the baby develops within the mother). GDM, which can often be controlled by diet and exercise, usually disappears after pregnancy but increases a woman's subsequent risk of developing diabetes.
Why Was This Study Done?
Although lifestyle changes can be used to control GDM, it is not known whether similar changes can prevent GDM developing (“primary prevention”). In this cluster-randomized controlled trial, the researchers investigate whether individual intensified counseling on physical activity, diet, and weight gain integrated into routine maternity care visits can prevent the development of GDM and the occurrence of LGA babies among newborns. In a cluster-randomized controlled trial, groups of patients rather than individual patients are randomly assigned to receive alternative interventions, and the outcomes in different “clusters” are compared. In this trial, each cluster is a municipality in the Pirkanmaa region of Finland.
What Did the Researchers Do and Find?
The researchers enrolled 399 women, each of whom had a normal blood glucose level at 8–12 weeks gestation but at least one risk factor for GDM. Women in the intervention municipalities received intensified counseling on physical activity at 8–12 weeks' gestation, dietary counseling at 16–18 weeks' gestation, and further physical activity and dietary counseling at each subsequent antenatal visits. Women in the control municipalities received some dietary but little physical activity counseling as part of their usual care. 23.3% and 20.2% of women in the intervention and usual care groups, respectively, developed GDM, a nonstatistically significant difference (that is, a difference that could have occurred by chance). However, the average birthweight and the proportion of LGA babies were both significantly lower in the intervention group than in the usual care group. Food frequency questionnaires completed by the women indicated that, on average, those in the intervention group increased their intake of dietary fiber and polyunsaturated fatty acids and decreased their intake of saturated fatty acids and sucrose as instructed during counseling, The amount of moderate physical activity also tended to decrease less as pregnancy proceeded in the intervention group than in usual care group. Finally, compared to the usual care group, significantly fewer of the 24% of women in the intervention group who actually met dietary and physical activity targets (“adherent” women) developed GDM.
What Do These Findings Mean?
These findings indicate that intensified counseling on diet and physical activity is effective in controlling the birthweight of babies born to women at risk of developing GDM and encourages at least some of them to alter their lifestyle. However, the findings fail to show that the intervention reduces the risk of GDM because of the limited power of the study. The power of a study—the probability that it will achieve a statistically significant result—depends on the study's size and on the likely effect size of the intervention. Before starting this study, the researchers calculated that they would need 420 participants to see a statistically significant difference between the groups if their intervention reduced GDM incidence by 40%. This estimated effect size was probably optimistic and therefore the study lacked power. Nevertheless, the analyses performed among adherent women suggest that lifestyle changes might be a way to prevent GDM and so larger studies should now be undertaken to test this potential primary prevention intervention.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001036.
The US National Institute of Diabetes and Digestive and Kidney Diseases provides information for patients on diabetes and on gestational diabetes (in English and Spanish)
The UK National Health Service Choices website also provides information for patients on diabetes and on gestational diabetes, including links to other useful resources
The MedlinePlus Encyclopedia has pages on diabetes and on gestational diabetes; MedlinePlus provides links to additional resources on diabetes and on gestational diabetes (in English and Spanish)
More information on this trial of primary prevention of GDM is available
doi:10.1371/journal.pmed.1001036
PMCID: PMC3096610  PMID: 21610860
15.  Antibiotic Selection Pressure and Macrolide Resistance in Nasopharyngeal Streptococcus pneumoniae: A Cluster-Randomized Clinical Trial 
PLoS Medicine  2010;7(12):e1000377.
Jeremy Keenan and colleagues report that during a cluster-randomized clinical trial in Ethiopia, nasopharyngeal pneumococcal resistance to macrolides was significantly higher in communities randomized to receive azithromycin compared with untreated control communities.
Background
It is widely thought that widespread antibiotic use selects for community antibiotic resistance, though this has been difficult to prove in the setting of a community-randomized clinical trial. In this study, we used a randomized clinical trial design to assess whether macrolide resistance was higher in communities treated with mass azithromycin for trachoma, compared to untreated control communities.
Methods and Findings
In a cluster-randomized trial for trachoma control in Ethiopia, 12 communities were randomized to receive mass azithromycin treatment of children aged 1–10 years at months 0, 3, 6, and 9. Twelve control communities were randomized to receive no antibiotic treatments until the conclusion of the study. Nasopharyngeal swabs were collected from randomly selected children in the treated group at baseline and month 12, and in the control group at month 12. Antibiotic susceptibility testing was performed on Streptococcus pneumoniae isolated from the swabs using Etest strips. In the treated group, the mean prevalence of azithromycin resistance among all monitored children increased from 3.6% (95% confidence interval [CI] 0.8%–8.9%) at baseline, to 46.9% (37.5%–57.5%) at month 12 (p = 0.003). In control communities, azithromycin resistance was 9.2% (95% CI 6.7%–13.3%) at month 12, significantly lower than the treated group (p<0.0001). Penicillin resistance was identified in 0.8% (95% CI 0%–4.2%) of isolates in the control group at 1 year, and in no isolates in the children-treated group at baseline or 1 year.
Conclusions
This cluster-randomized clinical trial demonstrated that compared to untreated control communities, nasopharyngeal pneumococcal resistance to macrolides was significantly higher in communities randomized to intensive azithromycin treatment. Mass azithromycin distributions were given more frequently than currently recommended by the World Health Organization's trachoma program. Azithromycin use in this setting did not select for resistance to penicillins, which remain the drug of choice for pneumococcal infections.
Trial registration
www.ClinicalTrials.gov NCT00322972
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In 1928, Alexander Fleming discovered penicillin, the first antibiotic (a drug that kills bacteria). By the early 1940s, scientists were able to make large quantities of penicillin and, in the following decades, several other classes of powerful antibiotics were discovered. For example, erythromycin—the first macrolide antibiotic—was developed in the early 1950s. For a time, it looked like bacteria and the diseases that they cause had been defeated. But bacteria rapidly become resistant to antibiotics. Under the “selective pressure” of an antibiotic, bacteria that have acquired a random change in their DNA that allows them to survive in the antibiotic's presence outgrow nonresistant bacteria. What's more, bacteria can transfer antibiotic resistance genes between themselves. Nowadays, antibiotic resistance is a major public health concern. Almost every type of disease-causing bacteria has developed resistance to one or more antibiotic in clinical use and multi-drug resistant bacteria are causing outbreaks of potentially fatal diseases in hospitals and in the community.
Why Was This Study Done?
Although epidemiological studies (investigations of the causes, distribution, and control of disease in population) show a correlation between antibiotic use and antibiotic resistance in populations, such studies cannot prove that antibiotic use actually causes antibiotic resistance. It could be that the people who use more antibiotics share other characteristics that increase their chance of developing antibiotic resistance (so-called “confounding”). A causal link between antibiotic use and the development of antibiotic resistance can only be established by doing a randomized controlled trial. In such trials, groups of individuals are chosen at random to avoid confounding, given different treatments, and outcomes in the different groups compared. Here, the researchers undertake a randomized clinical trial to assess whether macrolide resistance is higher in communities treated with azithromycin for trachoma than in untreated communities. Azithromycin—an erythromycin derivative—is used to treat common bacterial infections such as middle ear infections caused by Streptococcus pneumoniae. Trachoma—the world's leading infectious cause of blindness—is caused by Chlamydia trachomatis. The World Health Organization's trachoma elimination strategy includes annual azithromycin treatment of at-risk communities.
What Did the Researchers Do and Find?
In this cluster-randomized trial (a study that randomly assigns groups of people rather than individuals to different treatments), 12 Ethiopian communities received mass azithromycin treatment of children aged 1–10 years old at 0, 3, 6, and 9 months, and 12 control communities received the antibiotic only at 12 months. The researchers took nasopharyngeal (nose and throat) swabs from randomly selected treated children at 0 and 12 months and from randomly selected control children at 12 months. They isolated S. pneumoniae from the swabs and tested the isolates for antibiotic susceptibility. 70%–80% of the children tested had S. pneumoniae in their nose or throat. In the treated group, 3.6% of monitored children were carrying azithromycin-resistant S. pneumoniae at 0 months, whereas 46.9% were doing so at 12 months—a statistically significant increase. Only 9.2% of the monitored children in the untreated group were carrying azithromycin-resistant S. pneumoniae at 12 months, a significantly lower prevalence than in the treated group. Importantly, there was no resistance to penicillin in any S. pneumoniae isolates obtained from the treated children at 0 or 12 months; one penicillin-resistant isolate was obtained from the control children.
What Do These Findings Mean?
These findings indicate that macrolide resistance is higher in nasopharyngeal S. pneumoniae in communities receiving intensive azithromycin treatment than in untreated communities. Thus, they support the idea that frequent antibiotic use selects for antibiotic resistance in populations. Although the study was undertaken in Ethiopian communities with high rates of nasopharyngeal S. pneumoniae carriage, this finding is likely to be generalizable to other settings. Importantly, these findings have no bearing on current trachoma control activities, which use less frequent antibiotic treatments and are less likely to select for azithromycin resistance. The lack of any increase in penicillin resistance, which is usually the first-line therapy for S. pneumoniae infections, is also reassuring. However, although these findings suggest that the benefits of mass azithromycin treatment for trachoma outweigh any potential adverse affects, they nonetheless highlight the importance of continued monitoring for the secondary effects of mass antibiotic distributions.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000377.
The Bugs and Drugs website provides information about antibiotic resistance and links to other resources
The US National Institute of Allergy and Infectious Diseases provides information on antimicrobial drug resistance and on diseases caused by S. pneumoniae (pneumococcal diseases)
The US Centers for Disease Control and Prevention also have information on antibiotic resistance (in English and Spanish)
The World Health Organization has information about the global threat of antimicrobial resistance and about trachoma (in several languages)
More information about the trial described in this paper is available on ClinicalTrials.gov
doi:10.1371/journal.pmed.1000377
PMCID: PMC3001893  PMID: 21179434
16.  Using community volunteers to promote exclusive breastfeeding in Sokoto State, Nigeria 
Background
Exclusive Breastfeeding (EBF) refers to the practice of feeding breast milk only, (including expressed breast milk) to infants; and excluding water, other liquids, breast milk substitutes, and solid foods. Inadequately breastfed infants are likely to be undernourished and have childhood infections. EBF knowledge and infant feeding practices have not been studied sufficiently in Sokoto State, Nigeria. We describe the results of a randomized community trial to promote Exclusive Breastfeeding (EBF) in two local government areas Kware and Bodinga selected as intervention and control groups respectively.
Methods
During advocacy meetings with community leaders, a Committee was formed. Members of the Committee were consulted for informed consent and selection of ten female volunteers who would educate mothers about breastfeeding during home visits. Participants comprised mothers of infants who were breastfeeding at the time of the study. A total of 179 mothers were recruited through systematic random sampling from each community. Volunteers conducted in-person interviews using a structured questionnaire and counseled mothers in the intervention group only.
Results
At baseline, intervention and control groups differed significantly regarding maternal occupation (P=0.07), and age of the index child (P=0.07). 42% of infants in the intervention group were up to 6 months old and about 30% of them were exclusively breastfed. Intention to EBF was significantly associated with maternal age (P=0.01), education (P=0.00) and women who were exclusively breastfeeding (P=0.00). After counseling, all infants up to 6 months of age were exclusively breastfed. The proportion of mothers with intention to EBF increased significantly with maternal age (P=0.00), occupation (P=0.00) and women who were exclusively breastfeeding (P=0.01). Post-intervention surveys showed that source of information and late initiation of breastfeeding was not significantly associated with intention to EBF. Mothers who reported practicing EBF for 6 months, were older (P=0.00) multi-parous (P=0.05) and more educated (P=0.00) compared to those who did not practice EBF. Among them, significantly increased proportion of women agreed that EBF should be continued during the night (P=0.03), infant should be fed on demand (P=0.05), sick child could be given medication (P=0.02), EBF offered protection against childhood diarrhea (P=0.01), and helped mothers with birth spacing (P=0.00).
Conclusion
This study shows that there is a need for reaching women with reliable information about infant nutrition in Sokoto State. The results show decreased EBF practice among working mothers, young women, mothers with poor education and fewer than five children. Counseling is a useful strategy for promoting the duration of EBF for six months and for developing support systems for nursing mothers. Working mothers may need additional resources in this setting to enable them to practice EBF.
PMCID: PMC3282933  PMID: 22187590
Exclusive Breast Feeding; community interventions; health promotion; Nigeria
17.  A Guide for Health Professionals Working with Aboriginal Peoples: Executive Summary 
Objective
to provide Canadian health professionals with a network of information and recommendations regarding Aboriginal health.
Options
health professionals working with Aboriginal individuals and communities in the area of women’s health care.
Outcomes
improved health status of Aboriginal peoples in Canada.
Appropriateness and accessibility of women’s health services for Aboriginal peoples.
Improved communication and clinical skills of health professionals in the area of Aboriginal health.
Improved quality of relationship between health professionals and Aboriginal individuals and communities.
Improved quality of relationship between health care professionals and Aboriginal individuals and communities.
Evidence
recommendations are based on expert opinion and a review of the literature. Published references were identified by a Medline search of all review articles, randomized clinical control trials, meta-analyses, and practice guidelines from 1966 to February 1999, using the MeSH headings “Indians, North American or Eskimos” and “Health.”* Subsequently published articles were brought to the attention of the authors in the process of writing and reviewing the document. Ancillary and unpublished references were recommended by members of the SOGC Aboriginal Health Issues Committee and the panel of expert reviewers.
Values
information collected was reviewed by the principal author. The social, cultural, political, and historic context of Aboriginal peoples in Canada, systemic barriers regarding the publication of information by Aboriginal authors, the diversity of Aboriginal peoples in Canada, and the need for a culturally appropriate and balanced presentation were carefully considered in addition to more traditional scientific evaluation. The majority of information collected consisted of descriptive health and social information and such evaluation tools as the evidence guidelines of the Canadian Task Force on the Periodic Health exam were not appropriate.
Benefits, costs, and harms
utilization of the information and recommendations by Canadian health professionals will enhance understanding, communication, and clinical skills in the area of Aboriginal health. The resulting enhancement of collaborative relationships between Aboriginal peoples and their women’s health providers may contribute to health services that are more appropriate, effective, efficient, and accessible for Aboriginal peoples in Canada. The educational process may require an initial investment of time from the health professional.
Recommendations
Recommendations were grouped according to four themes: sociocultural context, health concerns, cross-cultural understanding, and Aboriginal health resources. Health professionals are encouraged to learn the appropriate names, demographics, and traditional geographic territories and language groups of the various Aboriginal groups in Canada. In addition, sensitivity to the impact of colonization and current socioeconomic challenges to the health status of Aboriginal peoples is warranted. Health services for Aboriginal peoples should take place as close to home as possible. Governmental obligations and policies regarding determination are recognized. With respect to health concerns, holistic definitions of health, based on Aboriginal perspectives, are put forward. Aboriginal peoples continue to experience a disproportionate burden of health problems. Health professionals are encouraged to become familiar with several key areas of morbidity and mortality. Relationships between Aboriginal peoples and their care providers need to be based on a foundation of mutual respect. Gaps and barriers in the current health care system for Aboriginal peoples are identified. Health professionals are encouraged to work with Aboriginal individuals and communities to address these gaps and barriers. Aboriginal peoples require culturally appropriate health care, including treatment in their own languages when possible. This may require interpreters or Aboriginal health advocates. Health professionals are encouraged to recognize the importance of family and community roles, and to respect traditional medicines and healers. Health professionals can develop their sensitivities towards Aboriginal peoples by participating in workshops, making use of educational resources, and by spending time with Aboriginal peoples in their communities. Aboriginal communities and health professionals are encouraged to support community-based, community-directed health services and health research for Aboriginal peoples. In addition, the education of more Aboriginal health professionals is essential. The need for a preventative approach to health programming in Aboriginal communities is stressed.
Validation
recommendations were reviewed and revised by the SOGC Aboriginal Health Issues Committee, a panel of expert reviewers, and the SOGC Council. In addition, this document was also reviewed and supported by the Assembly of First Nations, Canadian Institute of Child Health, Canadian Paediatric Society, College of Family Physicians of Canada, Congress of Aboriginal Peoples, Federation of Medical Women of Canada, Inuit Tapirisat of Canada, Metis National Council, National Indian and Inuit Community Health Representatives Organization, and Pauktuutit Inuit Women’s Association.
Sponsor
Society of Obstetricians and Gynaecologists of Canada.
PMCID: PMC3653835  PMID: 23682204 CAMSID: cams2752
18.  A retrospective analysis of caries treatment and development in relation to assessed caries risk in an adult population in Sweden 
BMC Oral Health  2014;14(1):126.
Background
The Public Dental Service of Västerbotten County (Sweden) recommends using population-based prevention strategies combined with an individual strategy for high-risk patients to manage caries. To facilitate this management strategy, all patients are evaluated for their risk of developing caries in the coming year using defined criteria. Using caries risk scoring over a seven-year period, the present study evaluates prophylactic measures, caries development, and non-operative treatments in adult patients.
Methods
From all adult patients (25–65 years; n = 76 320) scored with a high caries risk in 2005 (baseline) and with a dental visit in 2011, 200 subjects were randomly selected. In addition, an equally sized control group with a no/low caries risk was selected. Information concerning dental status, counselling, treatments, visits, and costs were retrieved from dental records.
Results
Over the seven-year study period, subjects with high caries risk had significantly higher caries incidence in spite of shorter recall intervals, more dental appointments, and higher costs for dental care than subjects with no/low caries risk. Non-operative measures, such as additional fluoride and individual counselling on diet at baseline (2005), was higher in the high caries risk group, whereas information about basic prophylaxis and counselling on oral hygiene showed only small differences. The frequency of non-operative measures given during the seven-year study period to patients in the high caries risk group is considered to be remarkably low and improvement, determined as reclassification from high to no/low caries risk from 2005 to 2011, was seen in only 13% of the participants.
Conclusions
This study formulated two major conclusions. First, adult patients with high or no/low caries represent different populations, that each contain distinct subpopulations, those who improve/impair or maintained their caries risk and disease progression. These groups need different strategies in disease treatment. Second, preventive measures and non-operative treatments were associated with improvements in caries risk and maintenance, but the extent to which such treatments were given to high caries risk subjects was unacceptably low. Improved adherence to the guidelines for caries treatment may reduce caries risk, visits to dental clinics, and costs for the patients.
doi:10.1186/1472-6831-14-126
PMCID: PMC4209083  PMID: 25326206
Caries; Caries risk; Caries prevention; Public dental care
19.  The Long-Term Effects of a Peer-Led Sex Education Programme (RIPPLE): A Cluster Randomised Trial in Schools in England 
PLoS Medicine  2008;5(11):e224.
Background
Peer-led sex education is widely believed to be an effective approach to reducing unsafe sex among young people, but reliable evidence from long-term studies is lacking. To assess the effectiveness of one form of school-based peer-led sex education in reducing unintended teenage pregnancy, we did a cluster (school) randomised trial with 7 y of follow-up.
Methods and Findings
Twenty-seven representative schools in England, with over 9,000 pupils aged 13–14 y at baseline, took part in the trial. Schools were randomised to either peer-led sex education (intervention) or to continue their usual teacher-led sex education (control). Peer educators, aged 16–17 y, were trained to deliver three 1-h classroom sessions of sex education to 13- to 14-y-old pupils from the same schools. The sessions used participatory learning methods designed to improve the younger pupils' skills in sexual communication and condom use and their knowledge about pregnancy, sexually transmitted infections (STIs), contraception, and local sexual health services. Main outcome measures were abortion and live births by age 20 y, determined by anonymised linkage of girls to routine (statutory) data. Assessment of these outcomes was blind to sex education allocation. The proportion of girls who had one or more abortions before age 20 y was the same in each arm (intervention, 5.0% [95% confidence interval (CI) 4.0%–6.3%]; control, 5.0% [95% CI 4.0%–6.4%]). The odds ratio (OR) adjusted for randomisation strata was 1.07 (95% CI 0.80–1.42, p = 0.64, intervention versus control). The proportion of girls with one or more live births by 20.5 y was 7.5% (95% CI 5.9%–9.6%) in the intervention arm and 10.6% (95% CI 6.8%–16.1%) in the control arm, adjusted OR 0.77 (0.51–1.15). Fewer girls in the peer-led arm self-reported a pregnancy by age 18 y (7.2% intervention versus 11.2% control, adjusted OR 0.62 [95% CI 0.42–0.91], weighted for non-response; response rate 61% intervention, 45% control). There were no significant differences for girls or boys in self-reported unprotected first sex, regretted or pressured sex, quality of current sexual relationship, diagnosed sexually transmitted diseases, or ability to identify local sexual health services.
Conclusion
Compared with conventional school sex education at age 13–14 y, this form of peer-led sex education was not associated with change in teenage abortions, but may have led to fewer teenage births and was popular with pupils. It merits consideration within broader teenage pregnancy prevention strategies.
Trial registration:
ISRCTN (ISRCTN94255362).
Judith Stephenson and colleagues report on a cluster randomized trial in London of school-based peer-led sex education and whether it reduced unintended teenage pregnancy.
Editors' Summary
Background.
Teenage pregnancies are fraught with problems. Children born to teenage mothers are often underweight, which can affect their long-term health; young mothers have a high risk of poor mental health after the birth; and teenage parents and their children are at increased risk of living in poverty. Little wonder, then, that faced with one of the highest teenage pregnancy rates in Western Europe, the Department of Health in England launched a national Teenage Pregnancy Strategy in 2000 to reduce teenage pregnancies. The main goal of the strategy is to halve the 1998 under-18 pregnancy rate—there were 46.6 pregnancies for every 1,000 young women in this age group in that year—by 2010. Approaches recommended in the strategy to achieve this goal include the provision of effective sexual health advice services for young people, active engagement of health, social, youth support, and other services in the reduction of teenage pregnancies, and the improvement of sex and relationships education (SRE).
Why Was This Study Done?
Although the annual under-18 pregnancy rate in England is falling, it is still very high, and it is extremely unlikely that the main goal of the Teenage Pregnancy Strategy will be achieved. Experts are, therefore, looking for better ways to reduce both teenage pregnancy rates and the high rates of sexual transmitted diseases among teenagers. Many believe that peer-led SRE—the teaching (sharing) of sexual health information, values, and behaviours by people of a similar age or status group—might be a good approach to try. Peers, they suggest, might convey information about sexual health and relationships better than teachers. However, little is known about the long-term effectiveness of peer-led SRE. In this randomized cluster trial, the researchers compare the effects of a peer-led SRE program and teacher-led sex education given to13- to 14-y-old pupils on abortion and live birth numbers among young women up to age 20 y. In a cluster randomized trial, participants are randomly assigned to the interventions being compared in “clusters”; in this trial, each “cluster” is a school.
What Did the Researchers Do and Find?
Twenty-seven schools in England (about 9,000 13- to 14-y-old pupils) participated in the RIPPLE (Randomized Intervention of PuPil-Led sex Education) trial. Each school was randomly assigned to peer-led SRE (the intervention arm) or to existing teacher-led SRE (the control arm). For peer-led SRE, trained 16- to 17-y-old peer educators gave three 1-h SRE sessions to the younger pupils in their schools. These sessions included practice with condoms, role play to improve sexual negotiating skills, and exercises to improve knowledge about sexual health. The researchers then used routine data on abortions and live births to find out how many female study participants had had an unintended pregnancy before the age of 20 y. One in 20 girls in both study arms had had one or more abortions. Slightly more girls in the control arm than in the intervention arm had had live births, but the difference was small and might have occurred by chance. However, significantly more girls in the intervention arm (11.2%) self-reported a pregnancy by age 18 than in the intervention arm (7.2%). There were no differences between the two arms for girls or boys in any other aspect of sexual health, including sexually transmitted diseases.
What Do These Findings Mean?
These findings indicate that the peer-led SRE program used in this trial had no effect on the number of teenage abortions but may have led to slightly fewer live births among the young women in the study. This particular peer-led SRE program was very short so a more extended program might have had a more marked effect on teenage pregnancy rates; this possibility needs to be tested, particularly since the pupils preferred peer-led SRE to teacher-led SRE. Even though peer-led SRE requires more resources than teacher-led SRE, this form of SRE should probably still be considered as part of a broad teenage prevention strategy, suggest the researchers. But, they warn, their findings should also “temper high expectations about the long-term impact of peer-led approaches” on young people's sexual health.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050224.
This study is further discussed in a PLoS Medicine Perspective by David Ross
Every Child Matters, a Web site produced by the UK government, includes information on teenage pregnancy, the Teenage Pregnancy Strategy, and teenage pregnancy statistics in England
Directgov, an official government Web site for UK citizens, provides advice for parents on talking to children about sex and teenage pregnancyand advice for young people on sexual health and preventing pregnancy
Teachernet, a UK source of online publications for schools, also provides information for parents about sex and relationships education and the UK government's current guidance on SRE in schools
Avert, an international AIDS charity, also provides a fact sheet on sex education
The Sex Education Forum in the UK is the national authority on Sex and Relationships Education
doi:10.1371/journal.pmed.0050224
PMCID: PMC2586352  PMID: 19067478
20.  The FiCTION dental trial protocol – filling children’s teeth: indicated or not? 
BMC Oral Health  2013;13:25.
Background
There is a lack of evidence for effective management of dental caries (decay) in children’s primary (baby) teeth and an apparent failure of conventional dental restorations (fillings) to prevent dental pain and infection for UK children in Primary Care. UK dental schools’ teaching has been based on British Society of Paediatric Dentistry guidance which recommends that caries in primary teeth should be removed and a restoration placed. However, the evidence base for this is limited in volume and quality, and comes from studies conducted in either secondary care or specialist practices. Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been questioned.
The FiCTION trial addresses the Health Technology Assessment (HTA) Programme’s commissioning brief and research question “What is the clinical and cost effectiveness of restoration caries in primary teeth, compared to no treatment?” It compares conventional restorations with an intermediate treatment strategy based on the biological (sealing-in) management of caries and with no restorations.
Methods/Design
This is a Primary Care-based multi-centre, three-arm, parallel group, patient-randomised controlled trial. Practitioners are recruiting 1461 children, (3–7 years) with at least one primary molar tooth where caries extends into dentine. Children are randomized and treated according to one of three treatment approaches; conventional caries management with best practice prevention, biological management of caries with best practice prevention or best practice prevention alone.
Baseline measures and outcome data (at review/treatment during three year follow-up) are assessed through direct reporting, clinical examination including blinded radiograph assessment, and child/parent questionnaires.
The primary outcome measure is the incidence of either pain or infection related to dental caries.
Secondary outcomes are; incidence of caries in primary and permanent teeth, patient quality of life, cost-effectiveness, acceptability of treatment strategies to patients and parents and their experiences, and dentists’ preferences.
Discussion
FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children’s primary teeth in Primary Care. This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth. The trial is currently recruiting patients.
Trial registration
Protocol ID: NCTU: ISRCTN77044005
doi:10.1186/1472-6831-13-25
PMCID: PMC3698078  PMID: 23725316
Dental caries; Caries prevention; Primary teeth; Prevention; Paediatric Dentistry; Restoration; Fillings; RCT; Primary care
21.  Recruiting and retaining pregnant women from a community health center at the US–Mexico border for the Mothers and Youth Access clinical trial 
Background
Recruitment and retention in clinical trials of minorities is low, particularly in rural underserved populations. This has slowed progress in addressing racial/ethnic disparities in oral health.
Purpose
To describe factors associated with successful recruitment, and identify predictors of continued retention of pregnant women attending a community health center into a randomized controlled clinical trial to prevent early childhood caries.
Methods
The Mothers and Youth Access (MAYA) Trial recruited women in the second trimester of pregnancy. At baseline, consenting women completed an oral health questionnaire and received a dental exam and oral health counseling. Four months postpartum, women returned with their babies for randomization with follow up at 9-, 12-, 18-, 24-, 30-, and 36-month postpartum visits. To assess predictors of retention, data about respondents’ demographics, and oral health-related knowledge, attitudes, and behaviors were obtained by questionnaire and analyzed by logistic and discrete time-to-event regression analyses.
Results
Of 556 predominantly Mexican-American women recruited at baseline, 195 (35%) were excluded after baseline for not meeting inclusion criteria; 361 (65%) continued to randomization. Factors such as race/ethnicity, annual household income, household composition, oral health-related knowledge and behaviors significantly related to retention until randomization. In multivariable models, women reporting a higher annual household income were less likely to be lost to attrition before randomization (odds ratio = 0.73, 95% confidence interval (CI) 0.60–0.89); while Mexican/Mexican-American women were less likely to be lost beyond randomization (hazard ratio = 0.53, 95% CI 0.26–1.08).
Limitations
Factors not measured at baseline may have been important in predicting attrition. The MAYA Trial is expected to finish by November 2008; therefore, complete results for total retention may differ from those reported here.
Conclusions
Recruitment and retention efforts for pregnant Hispanic women should place heavy emphasis on culture as ethnicity remained the only borderline significant predictor in post randomization retention.
doi:10.1177/1740774508093980
PMCID: PMC4238942  PMID: 18697848
22.  Effectiveness of motivational interviewing at improving oral health: a systematic review 
Revista de Saúde Pública  2014;48(1):142-153.
OBJECTIVE
To analyze the effectiveness of motivational interviewing (MI) at improving oral health behaviors (oral hygiene habits, sugar consumption, dental services utilization or use of fluoride) and dental clinical outcomes (dental plaque, dental caries and periodontal status).
METHODS
A systematic search of PubMed, LILACS, SciELO, PsyINFO, Cochrane and Google Scholar bibliographic databases was conducted looking for intervention studies that investigated MI as the main approach to improving the oral health outcomes investigated.
RESULTS
Of the 78 articles found, ten met the inclusion criteria, all based on randomized controlled trials. Most studies (n = 8) assessed multiple outcomes. Five interventions assessed the impact of MI on oral health behaviors and nine on clinical outcomes (three on dental caries, six on dental plaque, four on gingivitis and three on periodontal pockets). Better quality of evidence was provided by studies that investigated dental caries, which also had the largest population samples. The evidence of the effect of MI on improving oral health outcomes is conflicting. Four studies reported positive effects of MI on oral health outcomes whereas another four showed null effect. In two interventions, the actual difference between groups was not reported or able to be recalculated.
CONCLUSIONS
We found inconclusive effectiveness for most oral health outcomes. We need more and better designed and reported interventions to fully assess the impact of MI on oral health and understand the appropriate dosage for the counseling interventions.
doi:10.1590/S0034-8910.2014048004616
PMCID: PMC4206116  PMID: 24789647
Motivational Interviewing, utilization; Health Behavior; Patient Acceptance of Health Care; Health Promotion, methods; Oral Health; Review
23.  Influence of an Intervention to Prevent Early Childhood Caries Initiated before Birth on Children’s Use of Dental Services up to 7 Years of Age 
The Open Dentistry Journal  2014;8:104-108.
Background :
In a previously reported randomised controlled trial, advising first time mothers on the prevention of early childhood caries from before their child was born, decreased the prevalence of early childhood caries at 20 months of age 5-fold.
Objective:
We examined the effect of the intervention on the frequency and nature of dental visits up to 7 years of age.
Methods:
Of 649 expectant mothers who participated in the trial, 277 completed a “Child Oral Health Survey” 7 years later. Their answers were compared with those of a comparison group of 277 mothers selected at random among those living in the same area with a first child born in the same year enrolled with the South Australian School Dental Services (SA SDS).
Results:
Only 1.5% of children had a dental visit before 12 months of age and only 4% before 2 years of age unless a dental problem had arisen. The age at the first visit did not differ among groups, but the reasons for the visit did as did the number of visits and the need for treatment under sedation or anaesthesia. In the trial group, 34% of first visits were for pain, 29% for injury, and 29% for concern with appearance. In the comparison group, pain was the main concern in 49%, injury in 9.5%, and appearance in 25% (p=0.019). Over time, children in the trial had an average of 2.2 visits compared with 3.1 in the comparison group. In the intervention group of the trial, no child had required treatment under sedation or general anaesthesia compared with 2.9% in the control group, and 6.5% in the comparison group. Only 15% of mothers reported that they had received any information on caries prevention from health care professionals other than dental care practitioners.
Conclusion:
Providing first-time mothers with guidance on the prevention of childhood caries decreased the use of dental services to deal with problems in preschool children.
doi:10.2174/1874210601408010104
PMCID: PMC4062931  PMID: 24949107
Dental care; early childhood caries; health promotion; preschool children; randomised controlled trial.
24.  Salivary characteristics and dental caries: Evidence from general dental practices 
Background
Saliva is one of the intraoral host factors that influence caries development. The authors conducted a study to investigate whether salivary characteristics are associated with recent dental caries experience.
Methods
Dentist-investigators and dental staff members collected data pertaining to a two-year cumulative incidence of dental caries (previous 24 months) and salivary characteristics during baseline assessment in an ongoing longitudinal study. The systematic random sample consisted of patients (n = 1,763) visiting general dental practices (n = 63) within the Northwest Practice-based REsearch Collaborative in Evidence-based DENTistry (PRECEDENT). The authors estimated adjusted rate ratios (RRs) by using generalized estimating equations log-linear regression to relate salivary characteristics to coronal carious lesions into dentin.
Results
Low resting pH (≤ 6.0) in the overall sample and low stimulated salivary flow rate (≤ 0.6 milliliter/minute) in older adults (≥ 65 years old) were associated with increased dental caries (RR, 1.6; 95 percent confidence interval [CI], 1.1–2.2; RR, 2.4; 95 percent CI, 1.5–3.8, respectively). Low buffering capacity was associated with decreased dental caries in children and adolescents (RR, 0.3; 95 percent CI, 0.1–1.0; RR, 0.2; 95 percent CI, 0.1–0.7, respectively). A thick, sticky or frothy salivary consistency also was associated with decreased dental caries in adults (RR, 0.6; 95 percent CI, 0.4–1.0). Associations between other salivary characteristics and dental caries for the overall sample and within each age group were not statistically significant.
Conclusions
Salivary characteristics were associated weakly with previous dental caries experience, but the authors did not find consistent trends among the three age groups. Different salivary characteristics were associated with an increased caries experience in older adults and a lowered caries experience in children and adolescents and adults.
Practical Implications
Further investigations are needed in this population setting to understand the study’s conflicting results. The study findings cannot support the use of salivary tests to determine caries risk in actual clinical settings.
PMCID: PMC3874545  PMID: 23633704
25.  Protocol for “Seal or Varnish?” (SoV) trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay 
BMC Oral Health  2012;12:51.
Background
Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS) and fluoride varnish (FV) to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting.
Methods/design
The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6–7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm). At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS) by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and acceptability through acceptability scales, a schools questionnaire and interviews with children, parents, dentists, dental nurses and school staff. The primary outcome measure will be the proportion of children developing new caries on any one of up to four treated first permanent molars.
Discussion
The objectives of this study have been identified by the National Institute for Health Research as one of importance to the National Health Service in the UK. The results of this trial will provide guidance on which of these technologies should be adopted for the prevention of dental decay in the most susceptible tooth-surface in the most at risk children.
Trial registrations
ISRCTN ref: ISRCTN17029222 EudraCT: 2010-023476-23 UKCRN ref: 9273
doi:10.1186/1472-6831-12-51
PMCID: PMC3534529  PMID: 23167481
Dental caries; Clinical trial; Pit and fissure sealants; Fluoride varnish; Preventive dentistry; Oral health

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