Adolescents' self-reported experiences following a person-centred, theory-based educational intervention versus conventional education for improved oral hygiene: Analysis of secondary outcomes of a randomized field study.

AIM: To analyse adolescents' self-reported experiences and behavioural outcomes of a person-centred, theory-based intervention in comparison with conventional information/instruction for improved oral hygiene. MATERIALS AND METHODS: Data were derived from a prospective, multi-centred, two-arm, quasi-randomized field study focusing on the effectiveness of educational interventions for improved oral hygiene. Dental hygienists working within the Public Dental Service, Västra Götaland, Sweden, provided treatments, and adolescents with poor oral hygiene conditions were eligible for participation. The person-centred test intervention was based on social cognitive constructs, and motivational interviewing was used as an approach in communication. The control intervention included conventional information/instructions. Clinical examinations were performed, and questionnaires were distributed at baseline and at 6 months. Three-hundred and twelve patients were enrolled, and data from 276 patients, following treatment per protocol, were analysed. RESULTS: The test group was more satisfied with the education about gingivitis (very good: 61% vs. 37%) and communication during therapy (very good: 69% vs. 50%) and reported to a larger extent that they were much more careful regarding their oral hygiene after the treatment (30% vs. 15%) and had higher confidence about keeping up healthy gingival conditions, in comparison with the control group (all p < .01). CONCLUSIONS: The person-centred, theory-based intervention was superior in terms of adolescents' experiences of education and communication during therapy and self-reported oral hygiene behavioural outcomes at 6 months, in comparison with conventional information/instruction.

Preimplantation genetic testing and child health: a national register-based study.

STUDY QUESTION: Is preimplantation genetic testing (PGT) associated with adverse perinatal outcome and early childhood health? SUMMARY ANSWER: Children born after PGT had comparable perinatal outcomes to children born after IVF/ICSI and comparable findings regarding early childhood health. WHAT IS KNOWN ALREADY: PGT is offered to couples affected by monogenic disorders (PGT-M) or inherited chromosomal aberrations (PGT-SR), limiting the risk of transferring the disorder to the offspring. PGT, an invasive technique, requires genetic analysis of one or up to ten cells from the embryo and is combined with IVF or ICSI. Several studies, most of them small, have shown comparable results after PGT and IVF/ICSI concerning perinatal outcome. Only a few studies with limited samples have been published on PGT and childhood health. STUDY DESIGN, SIZE, DURATION: We performed a register-based study including all singletons born after PGT (n = 390) in Sweden during 1 January 1996-30 September 2019. Singletons born after PGT were compared with all singletons born after IVF/ICSI (n = 61 060) born during the same period of time and with a matched sample of singletons (n = 42 034) born after spontaneous conception selected from the Medical Birth Register. Perinatal outcomes, early childhood health, and maternal outcomes were compared between pregnancies after PGT and IVF/ICSI as well as between pregnancies after PGT and spontaneous conception. Primary outcomes were preterm birth (PTB) and low birthweight (LBW) whereas childhood morbidity was the secondary outcome. PARTICIPANTS/MATERIALS, SETTING, METHODS: Data on women who went through PGT and gave birth were obtained from the local databases at the two PGT centres in Sweden, whereas data on IVF treatment for the IVF/ICSI group were obtained from the national IVF registers. These data were then cross-linked to national health registers; the Medical Birth Register, the Patient Register, and the Cause of Death Register. Logistic multivariable regression analysis and Cox proportional hazards models were performed with adjustment for relevant confounders. MAIN RESULTS AND THE ROLE OF CHANCE: The mean follow-up time was 4.6 years for children born after PGT and 5.1 years for children born after spontaneous conception, whereas the mean follow-up time was 9.0 years for children born after IVF/ICSI. For perinatal outcomes, PTB occurred in 7.7% of children after PGT and in 7.3% of children after IVF/ICSI, whereas the rates were 4.9% and 5.2% for LBW (adjusted odds ratio (AOR) 1.22, 95% CI 0.82-1.81 and AOR 1.17, 95% CI 0.71-1.91, respectively). No differences were observed for birth defects. In comparison to spontaneous conception, children born after PGT had a higher risk for PTB (AOR 1.73, 95% CI 1.17-2.58). Regarding early childhood health, the absolute risk of asthma was 38/390 (9.7%) in children born after PGT and 6980/61 060 (11.4%) in children born after in IVF/ICSI, whereas the corresponding numbers were 34/390 (8.7%) and 7505/61 060 (12.3%) for allergic disorders. Following Cox proportional hazards models, no significant differences were found for these outcomes. Sepsis, hypothyroidism, attention deficit hyperactivity disorder, autism spectrum disorders, mental retardation, cerebral palsy, and epilepsy were diagnosed in a maximum of three PGT children. No PGT children died during the follow-up period. Regarding maternal outcomes, the rates of placenta praevia and caesarean delivery were significantly higher after PGT in comparison to spontaneous conception (AOR 6.46, 95% CI 3.38-12.37 and AOR 1.52, 95% CI 1.20-1.92, respectively), whereas no differences were seen comparing pregnancies after PGT and IVF/ICSI. LIMITATIONS, REASONS FOR CAUTION: The rather small sample size of children born after PGT made it impossible to adjust for all relevant confounders including fertilization method and culture duration. Moreover, the follow-up time was short for most of the children especially in the PGT group, probably lowering the absolute number of diagnoses in early childhood. WIDER IMPLICATIONS OF THE FINDINGS: The results are reassuring and indicate that the embryo biopsy itself has no adverse effect on the perinatal, early childhood, or maternal outcomes. Although the results are comparable to IVF/ICSI also regarding early childhood outcome, they should be taken with caution due to the low number of children with diagnoses and short follow-up time. Long-term follow-up studies on children born after PGT are scarce and should be conducted considering the invasiveness of the technique. STUDY FUNDING/COMPETING INTEREST(S): The study was financed by grants from the Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement (LUA/ALF 70940), the Board of National Specialised Medical Care at Sahlgrenska University Hospital and Hjalmar Svensson Research Foundation. There are no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: N/A.

Furcation involvement and tooth loss: A registry-based retrospective cohort study.

AIM: This registry-based retrospective cohort study aimed to evaluate the impact of furcation status on the risk for molar loss. MATERIALS AND METHODS: Subjects with and without furcation involvement (FI) in 2010/2011 were identified in a nationwide registry in Sweden (age- and gender-matched sample: 381,450 subjects; 2,374,883 molars). Data on dental and periodontal status were extracted for the subsequent 10-year period. Impact of FI (at baseline or detected during follow-up) on molar loss (i.e., tooth extraction) was evaluated through multilevel logistic regression and survival analyses. RESULTS: FI had a significant impact on molar loss. FI degrees 2 and 3 resulted in adjusted risk ratios of 1.67 (95% confidence interval [CI] 1.63-1.71) and 3.30 (95% CI 3.18-3.43), respectively. Following the first detection of deep FI (degrees 2-3), estimated survival decreased by 4% at 5 years and 8% at 10 years. In addition to FI, endodontic status and probing depth were relevant risk factors for molar loss. CONCLUSIONS: Furcation status had a clinically relevant impact on the risk for molar loss. Following first detection of deep FI, however, the decline in molar survival was minor.

Risk of dengue, Zika, and chikungunya transmission in the metropolitan area of Cucuta, Colombia: cross-sectional analysis, baseline for a cluster-randomised controlled trial of a novel vector tool for water containers.

BACKGROUND: Arbovirus diseases such as dengue, Zika, and chikungunya are a public health threat in tropical and subtropical areas. In the absence of a vaccine or specific treatment, vector management (in this case the control of the primary vector Aedes aegypti) is the best practice to prevent the three diseases. A good understanding of vector behaviour, ecology, human mobility and water use can help design effective vector control programmes. This study collected baseline information on these factors for identifying the arbovirus transmission risk and assessed the requirements for a large intervention trial in Colombia. METHODS: Baseline surveys were conducted in 5,997 households, randomly selected from 24 clusters (neighbourhoods with on average 2000 houses and 250 households inspected) in the metropolitan area of Cucuta, Colombia. The study established population characteristics including water management and mobility as well as larval-pupal indices which were estimated and compared in all clusters. Additionally, the study estimated disease incidence from two sources: self-reported dengue cases in the household survey and cases notified by the national surveillance system. RESULTS: In all 24 study clusters similar social and demographic characteristics were found but the entomological indicators and estimated disease incidence rates varied. The entomological indicators showed a high vector infestation: House Index = 25.1%, Container Index = 12.3% and Breteau Index = 29.6. Pupae per person Index (PPI) as an indicator of the transmission risk showed a large range from 0.22 to 2.04 indicating a high transmission risk in most clusters. The concrete ground tanks for laundry -mostly outdoors and uncovered- were the containers with the highest production of Ae. aegypti as 86.3% of all 17,613 pupae were identified in these containers. Also, the annual incidence of dengue was high: 841.6 self-reported cases per 100,000 inhabitants and the dengue incidence notified by the National surveillance system was 1,013.4 cases per 100,000 in 2019. Only 2.2% of the households used container water for drinking. 40.3% of the study population travelled during the day (when Aedes mosquitoes bite) outside their clusters. CONCLUSIONS: The production of Ae. aegypti mosquitoes occurred almost exclusively in concrete ground tanks for laundry (lavadero), the primary intervention target. The baseline study provides necessary evidence for the design and implementation of a cluster randomized intervention trial in Colombia.

Impact of Medical and Surgical Obesity Treatment on Dental Caries: A 2-Year Prospective Cohort Study.

The objective was to study the long-term effects on oral health of bariatric surgery compared with medical treatment of obesity. Swedish females with morbid obesity (n = 66; 18-35 years at baseline) were followed prospectively from before obesity treatment until 2 years after treatment. The main response variable was dental caries registered according to the ICDAS-II system. Possible confounding factors, such as sociodemographic characteristics, general health, oral health habits, and oral hygiene, were controlled for. The statistical methods included χ2 tests, Student's t tests, one-way ANOVA, Wilcoxon's nonparametric tests, and linear regression models. In the surgically treated patients (n = 40), a significant increase over time in enamel caries (mean increase 4.13 tooth surfaces ICDAS1-2), dentine caries (mean increase 2.18 tooth surfaces ICDAS3-6), and total caries (mean increase 6.30 tooth surfaces ICDAS1-6) was registered (all p < 0.001), which was not seen in the medically treated patients (n = 26). However, the difference between the treatment groups (surgical or medical) was only statistically significant for enamel caries (crude ß 4.89, p = 0.003) and total caries (crude ß 6.53, p < 0.001). The relationships were stable and independent of differences in confounders as socioeconomy, general health, and oral health behaviors. In conclusion, 2 years after obesity treatment, a significant increase in dental caries was registered in the surgically treated but not in the medically treated women. The dental service should intensify its preventive efforts in individuals undergoing obesity treatment.

Cancer in children born after frozen-thawed embryo transfer: A cohort study.

BACKGROUND: The aim was to investigate whether children born after assisted reproduction technology (ART), particularly after frozen-thawed embryo transfer (FET), are at higher risk of childhood cancer than children born after fresh embryo transfer and spontaneous conception. METHODS AND FINDINGS: We performed a registry-based cohort study using data from the 4 Nordic countries: Denmark, Finland, Norway, and Sweden. The study included 7,944,248 children, out of whom 171,774 children were born after use of ART (2.2%) and 7,772,474 children were born after spontaneous conception, representing all children born between the years 1994 to 2014 in Denmark, 1990 to 2014 in Finland, 1984 to 2015 in Norway, and 1985 to 2015 in Sweden. Rates for any cancer and specific cancer groups in children born after each conception method were determined by cross-linking national ART registry data with national cancer and health data registries and population registries. We used Cox proportional hazards models to estimate the risk of any cancer, with age as the time scale. After a mean follow-up of 9.9 and 12.5 years, the incidence rate (IR) of cancer before age 18 years was 19.3/100,000 person-years for children born after ART (329 cases) and 16.7/100,000 person-years for children born after spontaneous conception (16,184 cases). Adjusted hazard ratio (aHR) was 1.08, 95% confidence interval (CI) 0.96 to 1.21, p = 0.18. Adjustment was performed for sex, plurality, year of birth, country of birth, maternal age at birth, and parity. Children born after FET had a higher risk of cancer (48 cases; IR 30.1/100,000 person-years) compared to both fresh embryo transfer (IR 18.8/100,000 person-years), aHR 1.59, 95% CI 1.15 to 2.20, p = 0.005, and spontaneous conception, aHR 1.65, 95% CI 1.24 to 2.19, p = 0.001. Adjustment either for macrosomia, birth weight, or major birth defects attenuated the association marginally. Higher risks of epithelial tumors and melanoma after any assisted reproductive method and of leukemia after FET were observed. The main limitation of this study is the small number of children with cancer in the FET group. CONCLUSIONS: Children born after FET had a higher risk of childhood cancer than children born after fresh embryo transfer and spontaneous conception. The results should be interpreted cautiously based on the small number of children with cancer, but the findings raise concerns considering the increasing use of FET, in particular freeze-all strategies without clear medical indications. TRIAL REGISTRATION: Trial registration number: ISRCTN 11780826.

Rationale and design of switch Swedeheart: A registry-based, stepped-wedge, cluster-randomized, open-label multicenter trial to compare prasugrel and ticagrelor for treatment of patients with acute coronary syndrome.

BACKGROUND: European treatment guidelines recommend prasugrel over ticagrelor for treating patients with non-ST-elevation acute coronary syndrome (ACS), prompting several Swedish administrative regions to transition from ticagrelor to prasugrel as the preferred treatment for patients with ACS. We aim to systematically evaluate this transition to determine the relative efficacy of prasugrel versus ticagrelor in a real-world cohort of patients with ACS. STUDY DESIGN AND OBJECTIVES: The SWITCH SWEDEHEART trial is a prospective, multicenter, open-label, cross-sectional, stepped-wedge cluster-randomized clinical trial, in which administrative regions in Sweden will constitute the clusters. At the start of the study, all clusters will use ticagrelor as the P2Y12 inhibitor drug of choice for ACS. The order in which the clusters will implement the transition from ticagrelor to prasugrel will be randomly assigned. Every 9 months, 1 cluster will switch from ticagrelor to prasugrel as the P2Y12 inhibitor of choice for patients with ACS. The primary endpoint is the composite 1-year rate of the death, stroke, or myocardial infarction. CONCLUSIONS: The SWITCH SWEDEHEART study will provide an extensive randomized comparison between ticagrelor and prasugrel. Novel therapies are frequently costly and supported by evidence from few or small studies, and systematic evaluation after the introduction is rare. This study will establish an important standard for introducing and evaluating the effects of health care changes within our societies.

Efficacy and Safety of Clopidogrel Versus Ticagrelor as Part of Dual Antiplatelet Therapy in Acute Coronary Syndrome-A Systematic Review and Meta-analysis.

ABSTRACT: The efficacy and safety of clopidogrel compared with ticagrelor as part of dual antiplatelet therapy in patients, and in older patients, with acute coronary syndrome is reviewed. PubMed, Embase, the Cochrane Library, MEDLINE, and HTA databases were searched (September 2, 2020) for randomized controlled trials (RCTs). Pooled risk differences (clopidogrel minus ticagrelor) were estimated using random-effects meta-analyses, and certainty of evidence was assessed according to Grading of Recommendations Assessment, Development, and Evaluation. In all, 29 RCTs were identified. The risk difference for all-cause mortality was 0.6% (-0.03% to 1.3%), cardiovascular (CV) mortality: 0.6% (95% confidence interval: 0.01% to 1.1%), myocardial infarction (MI): 0.9% (0.4% to 1.3%), stent thrombosis: 0.7% (0.4 to 1.1%), clinically significant bleeding: -1.9% (-3.7% to -0.2%), major bleeding: -0.9% (-1.6% to -0.1%), and dyspnea: -5.8% (-7.7% to -3.8%). In older patients, there were no differences between the comparison groups regarding all-cause mortality, CV mortality, and MI, whereas the risk of clinically significant bleeding and major bleeding was lower in the clopidogrel group, -5.9% (-11 to -0.9%, 1 RCT) and -2.4% (-4.4% to -0.3%), respectively. Compared with ticagrelor, clopidogrel may result in little or no difference regarding all-cause mortality. Although not evident in older patients, it cannot be excluded that clopidogrel may be slightly less efficient in reducing the risk of CV mortality and MI, whereas ticagrelor is probably more efficacious in reducing the risk of stent thrombosis. Clopidogrel results in a reduced risk of dyspnea and clinically significant bleeding and in older people probably in a reduced risk of major bleeding.

A person-centred, theory-based, behavioural intervention programme for improved oral hygiene in adolescents: A randomized clinical field study.

AIM: To test the effectiveness of a person-centred and theory-based educational intervention to increase adolescents' adherence to adequate oral hygiene behaviour, that is, self-performed periodontal infection control. MATERIALS AND METHODS: Data were derived from a prospective, multi-centred, two-arm, quasi-randomized field study in which treatment was performed by dental hygienists (DHs) within the Public Dental Service, Västra Götaland, Sweden. Adolescents with poor oral hygiene conditions were invited to participate. The test intervention was based on cognitive behavioural theory and principles, and the DHs used a collaborative communicative approach, inspired by motivational interviewing. The control intervention consisted of conventional information/instruction. Clinical assessments and oral hygiene behaviours were evaluated at 6 months. RESULTS: Three-hundred and twelve adolescents were enrolled, of whom 274 followed the treatment to 6-month follow-up. There were significant improvements in gingival bleeding and plaque scores for both treatment groups at 6 months, with significantly greater improvements in the test group. Adolescents in the test group brushed their teeth and used interdental cleaning aids more frequently compared to participants in the control group at 6 months. CONCLUSION: A person-centred and theory-based oral health education programme is more effective than conventional oral health education in improving adolescents' oral hygiene behaviour and periodontal infection control. CLINICALTRIALS: gov (NCT02906098).

Health economic aspects of implant-supported restorative therapy.

BACKGROUND: It is poorly understood how much additional dental care patients consume subsequent to implant therapy. The aim of the present study is to evaluate costs associated with implant-supported restorative therapy during the long-term follow-up. MATERIAL AND METHODS: Costs associated with preventive measures and complication-related procedures over a mean follow-up period of 8.2 years were assessed in patient files of 514 Swedish subjects provided with implant-supported restorative therapy. The restorative therapy and each of the subsequent interventions were assigned a specific cost. Accumulated costs were calculated in three categories: (i) total cost including initial restorative therapy and complication-related interventions, (ii) cost of preventive measures alone, and (iii) cost of complication-related procedures alone. Potential differences by background variables were analyzed using growth curve models. RESULTS: In the whole sample, costs during follow-up ranged from 878 € (95% CI 743; 1,014) for patients with single-tooth restoration(s) to 1,210 € (95% CI 1,091; 1,329) for subjects with full-jaw restoration(s). The majority of costs during follow-up originated from preventive measures (741 € 95% CI 716; 766). Among individuals receiving ≥1 intervention dealing with a complication (n = 253), complication-related costs amounted to 557 € (95% CI 480; 634). For patients with full-jaw restorations, the corresponding amount was 769 € (95% CI 622; 916). Procedures related to peri-implantitis and technical complications resulted in costs similar to each other. Implant loss generated greater costs than any other type of complication. CONCLUSIONS: Costs related to implant-supported restorative therapy during follow-up were associated with the extent of initial therapy. The higher costs during follow-up noted in patients provided with full-jaw restorations were explained by complication-associated procedures. Implant loss was the most costly type of complication.

Accuracy of bone-level assessments following reconstructive surgical treatment of experimental peri-implantitis.

AIMS: The purpose of this study was to evaluate the accuracy of bone-level assessments using either cone-beam computed tomography (CBCT), intra-oral peri-apical (PA) radiographs or histology following reconstructive treatment of experimental peri-implantitis. MATERIALS AND METHODS: Six Labrador dogs were used. Experimental peri-implantitis was induced 3 months after implant placement. Surgical treatment of peri-implantitis was performed and peri-implant defects were allocated to one of four treatment categories; no augmentation, bone graft materials with or without a barrier membrane. Six months later, intra-oral PA radiographs and block biopsies from all implants sites were obtained. Marginal bone levels (MBLs) were measured using PA radiographs, CBCT and histology. RESULTS: Significant correlations of MBL assessments were observed between the three methods. The measurements in PA radiographs consistently resulted in an overestimation of the bone level of about 0.3-0.4 mm. The agreement between the methods was not influenced by the use of bone substitute materials in the management of the osseous defects. CONCLUSIONS: Although MBL assessments obtained from PA radiographs showed an overestimation compared to MBL assessments on corresponding CBCT images and histological sections, PA radiographs can be considered a reliable technique for peri-implant bone-level evaluations following reconstructive surgical therapy of experimental peri-implantitis.

Subjective health complaints in early adolescence reflect stress: A study among adolescents in Western Sweden.

Aims: Mental health problems are common among Swedish adolescents and are sometimes referred to as 'stress-related'. The overall aim of this study is to do an analysis of subjective health complaints (SHCs) and perceived general stress among adolescents in Sweden, both their prevalence and association, by gender, migration background, family structure and socioeconomic conditions. Methods: Data from the baseline (comprising 2283 adolescents aged 13) of the STudy of Adolescence Resilience and Stress (STARS) study in Västra Götaland in Sweden were used. SHCs were measured by the Psychosomatic Problems Scale (PSP-scale) and self-reported stress was measured by Cohen's Perceived Stress Scale (PSS-10). Socioeconomic conditions were measured with the Family Affluence Scale (FAS) and the MacArthur Scale of Subjective Social Status (SSS). Statistical analyses included Student's t-tests and ANOVAs of means, linear and logistic regression analyses and Pearson's correlations. Results: Social inequalities in both SHCs and self-reported stress were found; levels were higher among girls, adolescents living with one parent or in families with less favourable socioeconomic conditions. Self-reported stress and SHCs were found to be strongly correlated (r=0.70). Correlations with self-reported stress were stronger for psychological complaints (r=0.71) than for somatic complaints (r=0.52). Correlations did not vary with socioeconomic conditions of the family. Conclusions: SHCs do reflect general stress among adolescents, and it is appropriate to address the complaints as 'stress-related'. Measures to improve adolescents' mental health by reducing levels of SHCs should pay special attention to stressors in adolescents' daily lives and strengthening adolescent's coping resources and strategies.

Cardiovascular disease, obesity, and type 2 diabetes in children born after assisted reproductive technology: A population-based cohort study.

BACKGROUND: Some earlier studies have found indications of significant changes in cardiometabolic risk factors in children born after assisted reproductive technology (ART). Most of these studies are based on small cohorts with high risk of selection bias. In this study, we compared the risk of cardiovascular disease, obesity, and type 2 diabetes between singleton children born after ART and singleton children born after spontaneous conception (SC). METHODS AND FINDINGS: This was a large population-based cohort study of individuals born in Norway, Sweden, Finland, and Denmark between 1984 and 2015. Data were obtained from national ART and medical birth registers and cross-linked with data from national patient registers and other population-based registers in the respective countries. In total, 122,429 children born after ART and 7,574,685 children born after SC were included. Mean (SD) maternal age was 33.9 (4.3) years for ART and 29.7 (5.2) for SC, 67.7% versus 41.8% were primiparous, and 45.2% versus 32.1% had more than 12 years of education. Preterm birth (<37 weeks 0 days) occurred in 7.9% of children born after ART and 4.8% in children born after SC, and 5.7% versus 3.3% had a low birth weight (<2,500 g). Mean (SD) follow-up time was 8.6 (6.2) years for children born after ART and 14.0 (8.6) years for children born after SC. In total, 135 (0.11%), 645 (0.65%), and 18 (0.01%) children born after ART were diagnosed with cardiovascular disease (ischemic heart disease, cardiomyopathy, heart failure, or cerebrovascular disease), obesity or type 2 diabetes, respectively. The corresponding values were 10,702 (0.14%), 30,308 (0.74%), and 2,919 (0.04%) for children born after SC. In the unadjusted analysis, children born after ART had a significantly higher risk of any cardiovascular disease (hazard ratio [HR] 1.24; 95% CI 1.04-1.48; p = 0.02), obesity (HR 1.13; 95% CI 1.05-1.23; p = 0.002), and type 2 diabetes (HR 1.71; 95% CI 1.08-2.73; p = 0.02). After adjustment, there was no significant difference between children born after ART and children born after SC for any cardiovascular disease (adjusted HR [aHR]1.02; 95% CI 0.86-1.22; p = 0.80) or type 2 diabetes (aHR 1.31; 95% CI 0.82-2.09; p = 0.25). For any cardiovascular disease, the 95% CI was reasonably narrow, excluding effects of a substantial magnitude, while the 95% CI for type 2 diabetes was wide, not excluding clinically meaningful effects. For obesity, there was a small but significant increased risk among children born after ART (aHR 1.14; 95% CI 1.06-1.23; p = 0.001). Important limitations of the study were the relatively short follow-up time, the limited number of events for some outcomes, and that the outcome obesity is often not considered as a disease and therefore not caught by registers, likely leading to an underestimation of obesity in both children born after ART and children born after SC. CONCLUSIONS: In this study, we observed no difference in the risk of cardiovascular disease or type 2 diabetes between children born after ART and children born after SC. For obesity, there was a small but significant increased risk for children born after ART. TRIAL REGISTRATION NUMBER: ISRCTN11780826.

Does the family affluence scale reflect actual parental earned income, level of education and occupational status? A validation study using register data in Sweden.

AIM: To examine the external validity of the Family Affluence Scale (FAS) among adolescents in Sweden by using register data for parental earned income, level of education and occupational status. METHODS: Data from the baseline (2015-2019) of the Study of Adolescence Resilience and Stress (STARS), comprising 2283 13-year-olds in the region of Västra Götaland, were used. The FAS III consists of six items: unshared bedroom, car ownership, computer/tablet ownership, dishwasher, number of bathrooms and number of holidays abroad. Register data regarding earned income, educational level and occupational status from Statistics Sweden (2014-2018) were linked to adolescents. In total, survey data were available for 2280 adolescents, and register data were available for 2258 mothers and 2204 fathers. RESULTS: Total parental earned income was moderately correlated with adolescents' scoring on FAS (0.31 < r < 0.48, p < 0.001), depending on examination year. The low FAS group mainly comprised low-income households, and the high FAS group mainly comprised high-income households. Correlations between mothers' and fathers' educational level and adolescents' scoring on FAS were low (r = 0.19 and r = 0.21, respectively, p < 0.001). FAS was higher among adolescents whose parents were working, but the correlation between parents' occupational status and FAS was low (r = 0.22, p < 0.001). CONCLUSIONS: The FAS can mainly identify low- and high-income households in Sweden. It may be used as an alternative measure of parental earned income in studies using self-reported socioeconomic status among adolescents.

An ecological study of chronic kidney disease in five Mesoamerican countries: associations with crop and heat.

BACKGROUND: Mesoamerica is severely affected by an epidemic of Chronic Kidney Disease of non-traditional origin (CKDnt), an epidemic with a marked variation within countries. We sought to describe the spatial distribution of CKDnt in Mesoamerica and examine area-level crop and climate risk factors. METHODS: CKD mortality or hospital admissions data was available for five countries: Mexico, Guatemala, El Salvador, Nicaragua and Costa Rica and linked to demographic, crop and climate data. Maps were developed using Bayesian spatial regression models. Regression models were used to analyze the association between area-level CKD burden and heat and cultivation of four crops: sugarcane, banana, rice and coffee. RESULTS: There are regions within each of the five countries with elevated CKD burden. Municipalities in hot areas and much sugarcane cultivation had higher CKD burden, both compared to equally hot municipalities with lower intensity of sugarcane cultivation and to less hot areas with equally intense sugarcane cultivation, but associations with other crops at different intensity and heat levels were not consistent across countries. CONCLUSION: Mapping routinely collected, already available data could be a first step to identify areas with high CKD burden. The finding of higher CKD burden in hot regions with intense sugarcane cultivation which was repeated in all five countries agree with individual-level studies identifying heavy physical labor in heat as a key CKDnt risk factor. In contrast, no associations between CKD burden and other crops were observed.

A hybrid, effectiveness-implementation research study protocol targeting antenatal care providers to provide female genital mutilation prevention and care services in Guinea, Kenya and Somalia.

BACKGROUND: In settings with high prevalence of female genital mutilation (FGM), the health sector could play a bigger role in its prevention and care of women and girls who have undergone this harmful practice. However, ministries of health lack clear policies, strategic plans or dedicated funding to implement anti-FGM interventions. Along with limited relevant knowledge and skills to prevent the practice of FGM and care for girls and women living with FGM, health providers have limited interpersonal communication skills and self-efficacy, while some may have supportive attitudes towards FGM and its medicalization. We propose to test the effectiveness of a health system strengthening intervention that includes training antenatal care (ANC) providers on person-centred communication (PCC) for FGM prevention. METHODS: This will be a two-level, hybrid, effectiveness-implementation research study using a cluster randomized trial design in Guinea, Kenya and Somalia conducted over a 6 months period. In each country, within pre-selected regions/counties, 60 ANC clinics will be randomized to intervention and control arms. At baseline, all clinics will receive the level one intervention involving provision of FGM-related clinical guidelines and handbook as well as anti-FGM policies and posters. At month 3, intervention clinics will receive the level two intervention comprising of a training for ANC providers on PCC to challenge their FGM-related attitudes and build their communication skills to effectively provide FGM prevention counselling. A process evaluation will be conducted to understand 'how' and 'why' the intervention package achieves intended results. Multi-level regression modelling will be used for quantitative data analysis while qualitative data will be assessed using thematic content analysis to determine the effectiveness, feasibility and acceptability of the different intervention levels. DISCUSSION: The proposed study will strengthen the knowledge base regarding how to effectively involve health providers in FGM prevention and care. TRIAL REGISTRATION: Trial registration and date: PACTR201906696419769 (June 3rd, 2019).

Assessment of midwifery care providers intrapartum care competencies, in four sub-Saharan countries: a mixed-method study protocol.

BACKGROUND: We aim to assess competencies (knowledge, skills and attitudes) of midwifery care providers as well as their experiences and perceptions of in-service training in the four study countries; Benin, Malawi, Tanzania and Uganda as part of the Action Leveraging Evidence to Reduce perinatal mortality and morbidity in sub-Saharan Africa project (ALERT). While today more women in low- and middle-income countries give birth in health care facilities, reductions in maternal and neonatal mortality have been less than expected. This paradox may be explained by the standard and quality of intrapartum care provision which depends on several factors such as health workforce capacity and the readiness of the health system as well as access to care. METHODS: Using an explanatory sequential mixed method design we will employ three methods (i) a survey will be conducted using self-administered questionnaires assessing knowledge, (ii) skills drills assessing basic intrapartum skills and attitudes, using an observation checklist and (iii) Focus Group Discussions (FGDs) to explore midwifery care providers' experiences and perceptions of in-service training. All midwifery care providers in the study facilities are eligible to participate in the study. For the skills drills a stratified sample of midwifery care providers will be selected in each hospital according to the number of providers and, professional titles and purposive sampling will be used for the FGDs. Descriptive summary statistics from the survey and skills drills will be presented by country. Conventional content analysis will be employed for data analysis of the FGDs. DISCUSSION: We envision comparative insight across hospitals and countries. The findings will be used to inform a targeted quality in-service training and quality improvement intervention related to provision of basic intrapartum care as part of the ALERT project. TRIAL REGISTRATION: PACTR202006793783148-June 17th, 2020.

A systematic review and meta-analysis of risks and benefits with breast reduction in the public healthcare system: priorities for further research.

BACKGROUND: There is no consensus for when publicly funded breast reduction is indicated and recommendations in guidelines vary greatly, indicating a lack of evidence and unequal access. The primary aim of this review was to examine risks and benefits of breast reduction to treat breast hypertrophy. Secondary aims were to examine how the studies defined breast hypertrophy and indications for a breast reduction. METHODS: A systematic literature search was conducted in PubMed, MEDLINE All, Embase, the Cochrane Library, and PsycInfo. The included articles were critically appraised, and certainty of evidence was assessed using the GRADE approach. Meta-analyses were performed when possible. RESULTS: Fifteen articles were included; eight reporting findings from four randomised controlled trials, three non-randomised controlled studies, three case series, and one qualitative study. Most studies had serious study limitations and problems with directness. Few of the studies defined breast hypertrophy. The studies showed significantly improved health-related quality of life and sexuality-related outcomes in patients who had undergone breast reduction compared with controls, as well as reduced depressive symptoms, levels of anxiety and pain. Most effect sizes exceeded the reported minimal important difference for the scale. Certainty of evidence for the outcomes above is low (GRADE ⊕ ⊕). Although four studies reported significantly improved physical function, the effect is uncertain (very low certainty of evidence, GRADE ⊕). None of the included studies reported data regarding work ability or sick leave. Three case series reported a 30-day mortality of zero. Reported major complications after breast reduction ranged from 2.4 to 14% and minor complications from 2.4 to 69%. CONCLUSION: There is a lack of high-quality studies evaluating the results of breast reduction. A breast reduction may have positive psychological and physical effects for women, but it is unclear which women benefit the most and which women should be offered a breast reduction in the public healthcare system. Several priorities for further research have been identified. PRE-REGISTRATION: The study is based on a Health Technology Assessment report, pre-registered and then published on the website of The Regional HTA Centre of Region Västra Götaland, Sweden.

Patient-reported experiences and outcomes following two different approaches for non-surgical periodontal treatment: a randomized field study.

CONTEXT: The current report is part of a prospective, multi-center, two-arm, quasi-randomized field study focusing on the effectiveness in general praxis of evidence-based procedures in the non-surgical treatment of patients with periodontitis. OBJECTIVE: The specific aims were to (i) evaluate patient-reported experience and outcome measures of treatment following a guided approach to periodontal infection control (GPIC) compared to conventional non-surgical therapy (CNST) and to (ii) identify potential predictors of subjective treatment outcomes and patient's adherence to self-performed infection control, i.e. adequate oral hygiene. METHODS: The study sample consisted of 494 patients treated per protocol with questionnaire- and clinical data at baseline and 6-months. The GPIC approach (test) comprised patient education for adequate oral hygiene prior to a single session of full-mouth ultra-sonic instrumentation, while the CNST approach (control) comprised education and instrumentation (scaling and root planing) integrated at required number of consecutive appointments. Clinical examinations and treatment were performed by Dental Hygienists, i.e. not blinded. Data were processed with bivariate statistics for comparison between treatment groups and with multiple regression models to identify potential predictors of subjective and clinical outcomes. The primary clinical outcome was gingival bleeding scores. RESULTS: No substantial differences were found between the two treatment approaches regarding patient-reported experiences or outcomes of therapy. Patients' experiences of definitely being involved in therapy decisions was a significant predictor for a desirable subjective and clinical outcome in terms of; (i) that oral health was considered as much improved after therapy compared to how it was before, (ii) that the treatment definitively had been worth the cost and efforts, and (iii) adherence to self-performed periodontal infection control. In addition, to be a current smoker counteracted patients' satisfaction with oral health outcome, while gingival bleeding scores at baseline predicted clinical outcome in terms of bleeding scores at 6-months. CONCLUSIONS: The results suggest that there are no differences with regard to patient-reported experiences and outcomes of therapy following a GPIC approach to periodontal infection control versus CNST. Patients' experiences of being involved in therapy decisions seem to be an important factor for satisfaction with care and for adherence to self-performed periodontal infection control. Registered at: ClinicalTrials.gov (NCT02168621).

School performance in children born after ICSI.

STUDY QUESTION: Do children conceived after ICSI have similar school performance as children born after IVF? SUMMARY ANSWER: Children born after ICSI have similar school performance compared to children born after IVF. WHAT IS KNOWN ALREADY: Studies concerning the cognitive skills of children born after ICSI have shown diverging results. STUDY DESIGN, SIZE, DURATION: This nationwide, register-based cohort study included all singleton children born after ICSI (n = 6953), IVF (n = 11 713) or spontaneous conception (SC) (n = 2 022 995), in Sweden between 1985 and 2006. PARTICIPANTS/MATERIALS, SETTING, METHODS: Singleton children born after ICSI were identified in national IVF registers, cross-linked with the Medical Birth Register (MBR), the National Patient Register (NPR) and the Swedish Cause of Death Register (CDR) for characteristics and medical outcomes. Data on school performance, parental education and other parental characteristics were obtained through cross-linking to the National School Registry and to Statistics Sweden. The main control group, which consisted of children born after IVF, was identified in the national IVF registries while the second control group, consisting of children born after SC, was identified from the MBR. Simple and multivariable linear regression was used for analysis of continuous variables, and logistic regression was used for the analysis of binary outcomes. Adjustments were made for sex, year of birth, maternal smoking during pregnancy, parental age, parity, parental region of birth, parental level of education and frozen embryo transfer. MAIN RESULTS AND THE ROLE OF CHANCE: In the adjusted analyses, there was no significant difference between ICSI and IVF children for total score (adjusted odds ratios (AORs) 1.03; 95% CI -0.22 to 2.28; P = 0.11), specific subjects, qualifying for secondary school (AOR 1.02; 95% CI 0.82-1.26; P = 0.87) or poor school performance (AOR 0.92; 95% CI 0.75-1.14; P = 0.47). In the third grade, children born after ICSI had a significantly lower chance of passing all of the subtests in Mathematics (AOR 0.89; 0.83-0.96; P = 0.002) and Swedish (AOR 0.92; 0.85-0.99; P = 0.02) compared to children born after SC. When cross-linking children with missing data on school performances (2.1% for ICSI, 2.0% for IVF and 2.3% for SC) with the Cerebral Palsy Follow-up Register (CPUP) for cerebral palsy, 2.7% of ICSI children, 5.7% of IVF children and 1.7% of SC children without registered education were found. When cross-linking children with missing data on school performances with the NPR for mental retardation, 29.9% of ICSI children, 32.6% of IVF children and 35.0% of SC children with missing data were registered under such a diagnosis. LIMITATIONS, REASONS FOR CAUTION: The main limitation was that test scores were missing in a small percentage in both ICSI and IVF children. Although we were able to cross-link this subpopulation with the CPUP and the NPR, these diagnoses only partly explained the missing scores. Other limitations were unmeasured and unknown possible confounders, such as information about infertility diagnoses and indication for ICSI, were not available. WIDER IMPLICATIONS OF THE FINDINGS: These findings are important to most countries where IVF and ICSI are used since there may be differences in choice of procedure. In recent years, there has been an increasing trend towards using ICSI not only for treatment of male infertility but also when the sperm quality is normal. Our results indicate that the school performance of children born after ICSI is reassuring. STUDY FUNDING/COMPETING INTEREST(S): Financial support was received through Sahlgrenska University Hospital (ALFGBG - 70 940), Hjalmar Svensson Research Foundation and Nordforsk, project number 71 450. None of the authors declare any conflict of interest. TRIAL REGISTRATION NUMBER: N/A.