Postnatal experiences, knowledge and perceptions of women with gestational diabetes.

AIM: Women with gestational diabetes mellitus (GDM) are at increased risk of Type 2 diabetes. This study aimed to explore experiences, knowledge and perceptions of women with GDM to inform the design of interventions to prevent or delay Type 2 diabetes. METHODS: Semi-structured interviews were carried out with 16 women with GDM who were recruited from a clinic in one Scottish health board. A framework approach was used to manage and analyse data according to themes informed by psychological theory (self-regulation model and theory of planned behaviour). RESULTS: GDM is not seen as an important, or even real diagnosis among some women, and this perception may result from the perceived minimal impact of GDM on their lives. Some women did experience a bigger emotional and practical impact. Knowledge and understanding of Type 2 diabetes was poor in general and many women were unconcerned about their future risk. Lower concern appeared to be linked to a lower perceived impact of GDM. Lifestyle changes discussed by women mostly related to diet and were motivated primarily by concern for their baby's health. Many women did not maintain these changes postnatally, reporting significant barriers. CONCLUSIONS: This study has suggested potential avenues to be explored in terms of content, timing and potential recipients of interventions. Educational interventions postnatally could address illness perceptions in women with GDM and redress the situation where lack of aftercare downplays its seriousness. For lifestyle interventions, the child's health could be used as a motivator within the context of later joint or family interventions.

Protocol-developing meta-ethnography reporting guidelines (eMERGe).

BACKGROUND: Designing and implementing high-quality health care services and interventions requires robustly synthesised evidence. Syntheses of qualitative research studies can provide evidence of patients' experiences of health conditions; intervention feasibility, appropriateness and acceptability to patients; and advance understanding of health care issues. The unique, interpretive, theory-based meta-ethnography synthesis approach is suited to conveying patients' views and developing theory to inform service design and delivery. However, meta-ethnography reporting is often poor quality, which discourages trust in, and use of, meta-ethnography findings. Users of evidence syntheses require reports that clearly articulate analytical processes and findings. Tailored research reporting guidelines can raise reporting standards but none exists for meta-ethnography. This study aims to create an evidence-based meta-ethnography reporting guideline articulating the methodological standards and depth of reporting required to improve reporting quality. METHODS/DESIGN: The mixed-methods design of this National Institute of Health Research-funded study (http://www.stir.ac.uk/emerge/) follows good practice in research reporting guideline development comprising: (1) a methodological systematic review (PROSPERO registration: CRD42015024709) to identify recommendations and guidance in conducting/reporting meta-ethnography; (2) a review and audit of published meta-ethnographies to identify good practice principles and develop standards in conduct/reporting; (3) an online workshop and Delphi studies to agree guideline content with 45 international qualitative synthesis experts and 45 other stakeholders including patients; (4) development and wide dissemination of the guideline and its accompanying detailed explanatory document, a report template for National Institute of Health Research commissioned meta-ethnographies, and training materials on guideline use. DISCUSSION: Meta-ethnography, devised in the field of education, is now used widely in other disciplines. Methodological advances relevant to meta-ethnography conduct exist. The extent of discipline-specific adaptations of meta-ethnography and the fit of any adaptions with the underpinning philosophy of meta-ethnography require investigation. Well-reported meta-ethnography findings could inform clinical decision-making. A bespoke meta-ethnography reporting guideline is needed to improve reporting quality, but to be effective potential users must know it exists, trust it and use it. Therefore, a rigorous study has been designed to develop and promote a guideline. By raising reporting quality, the guideline will maximise the likelihood that high-quality meta-ethnographies will contribute robust evidence to improve health care and patient outcomes.

Coenrollment in a randomized trial of high-frequency oscillation: prevalence, patterns, predictors, and outcomes*.

OBJECTIVE: Enrollment of individual patients into more than one study has been poorly evaluated. The objective of this study was to describe the characteristics of patients, researchers and centers involved in coenrollment, studies precluding coenrollment, and the prevalence, patterns, predictors, and outcomes of coenrollment in a randomized clinical trial. DESIGN, SETTING, METHODS: We conducted an observational study nested within the OSCILLation for Acute Respiratory Distress Syndrome Treated Early Trial, which compared high-frequency oscillatory ventilation to conventional ventilation. We collected patient, center, and study data on coenrollment in randomized patients. Multilevel regression examined factors independently associated with coenrollment, considering clustering within centers. We examined the effect of coenrollment on safety and the trial outcome. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Overall, 127 of 548 randomized patients (23.2%) were coenrolled in 25 unique studies. Coenrollment was reported in 17 of 39 centers (43.6%). Patients were most commonly coenrolled in one additional randomized clinical trial (76; 59.8%). Coenrollment was less likely in older patients (odds ratio, 0.87; 95% CI, 0.76-0.997), and in ICUs with greater than 26 beds (odds ratio, 0.56; 95% CI, 0.34-0.94), and more likely by investigators with more than 11 years of experience (odds ratio, 1.73; 95% CI, 1.06-2.82), by research coordinators with more than 8 years of experience (odds ratio, 1.87; 95% CI, 1.11-3.18) and in Canada (odds ratio, 4.66; 95% CI, 1.43-15.15). Serious adverse events were similar between coenrolled high-frequency oscillatory ventilation and control patients. Coenrollment did not modify the treatment effect of high-frequency oscillatory ventilation on hospital mortality. CONCLUSIONS: Coenrollment occurred in 23% of patients, commonly in younger patients, in smaller centers with more research infrastructure, and in Canada. Coenrollment did not influence patient safety or trial results.

Descriptive analysis of implant and prosthodontic survival rates with fixed implant-supported rehabilitations in the edentulous maxilla.

BACKGROUND: This descriptive study reviewed the 1- to 15-year survival rates of fixed implant rehabilitations in the edentulous maxilla. METHODS: An electronic search was conducted, and cohort studies with 1- to 15-year follow-ups were identified by two independent reviewers. The implant and prosthodontic survival rates were reviewed at 1-, 3-, 5-, 10-, and 15-year endpoints. Descriptive analysis includes surface characteristics, bone-augmentation procedure, prosthetic design, and implant number and distribution along the edentulous maxilla. RESULTS: Thirty-three studies, including 1,320 patients and 8,376 implants, were selected for analysis. The overall calculated implant survival rates ranged from 94% (1 year) to 87.7% (15 years). The implant survival rates for rough-surface implants ranged from 97% (1 year) to 98% (15 years); machined implants showed survival rates of 92% to 87.7%; respectively. Implants placed in native bone had greater survival rates than those placed in augmented bone. The prosthodontic survival rate ranged from 98.2% at 1 year to 92.1% at the 10-year endpoint, and it was only influenced by the implant number and distribution. CONCLUSIONS: Implants with rough surfaces showed a statistically higher survival rate than machined implants at all intervals. Implants placed in augmented bone had a statistically lower survival rate, except for rough-surface implants, for which no statistical difference between augmented and non-augmented bone survival rates was found. Machined implants showed a stable survival rate only when placed in native bone. When machined implants were placed in augmented bone, the survival rate decreased significantly at each study endpoint. The prosthetic design, veneering material, and the number of prostheses per arch had no influence on the prosthodontic survival rate. Implant number and distribution along the edentulous maxilla seemed to influence the prosthodontic survival rate.

Screening for familial ovarian cancer--management and outcome of women with moderate to high risk of developing ovarian cancer.

Five percent to ten percent of ovarian cancers are hereditary. Individual genetic risk of developing ovarian malignancy is discussed in women. Currently, prophylactic surgery is advised to women with a moderate to high risk of developing ovarian cancer. Workload and outcome of the multidisciplinary familial ovarian screening clinic in South Wales were assessed. This was an observational study of 145 women registered with the Familial Ovarian Screening Clinic between January 1998 and December 2003. The data were retrieved from the medical notes. Yearly follow-ups were investigated with a transvaginal scan and CA125 level. Post-surgery women were followed up with yearly CA125 estimations: 46.9% fell into moderate-risk and 50.3% into high-risk category. The median age was 42 (SD 10.4), 71.7% were pre menopausal, and 10.3% had a personal history of breast cancer and 1.4% colon cancer. Whereas 36.5% opted for surgery, the remaining women (but two) opted for annual follow-up. Histology of the women who had surgery showed three cases of malignancies (fallopian tube carcinoma, atypical ovarian epithelial cells, and metastatic breast cancer). Seven women developed breast cancer during the observation period. The follow-up period is too short to come to a final conclusion as to the benefits of yearly screening in this group of women. In our series, a significant number of patients developed malignancies, despite prophylactic surgery.

Rehospitalisation after birth hospitalisation: patterns among infants of all gestations.

AIM: To analyse rehospitalisation of newborns of all gestations. METHODS: A total of 33,276 surviving infants of all gestations born between 1 October 1998 and 31 March 2000 at seven Kaiser Permanente Medical Care Program (KPMCP) delivery services were studied retrospectively. RESULTS: Rehospitalisation rates within two weeks after nursery discharge ranged from 1.0% to 3.7%. The most common reason for rehospitalisation was jaundice. Among babies > or =34 weeks, the most important factor with respect to rehospitalisation was use of home phototherapy. Among babies who were not rehospitalised for jaundice, African-American race (adjusted odds ratio (AOR) = 0.56), and having a scheduled outpatient visit (AOR = 0.73) or a home visit (AOR = 0.59) within 72 hours after discharge were protective. Factors associated with increased risk were: being small for gestational age (AOR = 1.83), gestational age of 34-36 weeks without admission to the neonatal intensive care unit (AOR = 1.65), Score for Neonatal Acute Physiology, version II, > or =10 (AOR = 1.95), male gender (AOR = 1.24), having both a home as well as a clinic visit within 72 hours after discharge (AOR = 1.84), and birth facility (range of AORs = 1.52-2.36). Asian race was associated with rehospitalisation (AOR = 1.49) when all hospitalisations were considered, but this association did not persist if hospitalisations for jaundice were excluded. CONCLUSIONS: In this insured population with access to integrated care, rehospitalisation rates for jaundice were strongly affected by availability of home phototherapy and by follow up. For other causes, moderate prematurity and follow up visits played a large role, but variation between centres persisted even after controlling for multiple factors. Future research should include development of better process measures for evaluation of follow up strategies.

Experiences of men with breast cancer: an exploratory focus group study.

Management and care of men with breast cancer is based on that developed for women. Our study reports that men have specific issues regarding certain aspects of their breast cancer experience, including diagnosis, disclosure, support and gender-specific information, and offers suggestions for improved patient care.

Population-based study of rotavirus vaccination and intussusception.

BACKGROUND: During the first year that the rhesus rotavirus tetravalent vaccine (RRV-TV) was licensed, the Vaccine Adverse Event Reporting System received several reports of intussusception after vaccination. To evaluate the risk of intussusception, we conducted a retrospective cohort study in ten managed care organizations. METHODS: Cases of intussusception were identified by searching electronic databases for diagnoses of intussusception (ICD-9 Code 560.0) in infants 1 to 11 months of age and confirmed by medical chart review. Vaccination and enrollment data were obtained from administrative databases. Incidence rate ratios (RR) of intussusception were computed by dividing incidence rates in prespecified risk intervals after vaccination by the background rate of intussusception and adjusted for age by Poisson regression. Cox proportional hazard regression was used to evaluate risk by vaccine dose. RESULTS: Of 463,277 children 56,253 had been vaccinated with a total of 91 371 doses of RRV-TV. The incidence rate of intussusception was 25/100,000 person years among unexposed infants and 340/100,000 person years 3 to 7 days postvaccination. In the interval 3 to 7 days after vaccination, the age-adjusted RR was 16.0 (95% confidence interval, 5.5 to 46.7) for all doses combined and 30.4 (95% confidence interval, 8.8 to 104.9) after the first dose. RRs for the 8- to 14- and 15- to 21-day risk intervals were >1.0, but the confidence intervals substantially overlapped 1.0. The attributable risk was one case of intussusception per 11 073 children vaccinated. CONCLUSIONS: RRV-TV is associated with an increased risk of intussusception. The risk is greatest 3 to 7 days after the first vaccination dose.

Smoking cessation interventions among hospitalized patients: what have we learned?

BACKGROUND: We conducted a structured review of controlled studies on inpatient hospital-based smoking cessation interventions. METHODS: Electronic searches were conducted with two different search engines, and reference sections of articles located were also reviewed. The RE-AIM framework was used to organize the review around the issues of reach, efficacy, adoption, implementation, and maintenance of interventions. RESULTS: Thirty-one intervention articles were located, 20 of which included a comparison condition and were included in the review. Overall, a moderate number of studies (13/20) reported on reach, which was highly variable and limited (30-50% in most studies), while few reported on implementation (7/20). Longer term cessation results produced relative risk ratios of 0.9-2.3, with a median of 1.5. Increases in quit rates above the control condition ranged from -1 to 10% (median 4%) among general admission patients and from 7 to 36% (median 15%) among cardiac admission patients. Studies with a dedicated smoking cessation counselor and 3-5 months of relapse prevention had a significant impact on cessation rates. Study settings (adoption) were limited to university, Veterans affairs, and HMO hospitals. Maintenance at the individual level was variable and related to the presence of a relatively intensive initial intervention and a sustained relapse prevention intervention. CONCLUSIONS: Efficacious inpatient smoking programs have been developed and validated. The challenge now is to translate these interventions more widely into practice, given changing hospitalization patterns.

Randomized trial of a specialist genetic assessment service for familial breast cancer.

BACKGROUND: Because of the growing demand for genetic assessment, there is an urgent need for information about what services are appropriate for women with a family history of breast cancer. Our purpose was to compare the psychologic impact and costs of a multidisciplinary genetic and surgical assessment service with those of current service provisions. METHODS: We carried out a prospective randomized trial of surgical consultation with (the trial group) and without (the control group) genetic assessment in 1000 women with a family history of breast cancer. All P: values are from two-sided tests. RESULTS: Although statistically significantly greater improvement in knowledge about breast cancer was found in the trial group (P: =.05), differences between groups in other psychologic outcomes were not statistically significant. Women in both groups experienced statistically significant reductions in anxiety and found attending the clinics to be highly satisfying. An initial specialist genetic assessment cost pound 14.27 (U.S. $22.55) more than a consultation with a breast surgeon. Counseling and genetic testing of affected relatives, plus subsequent testing of family members of affected relatives identified as mutation carriers, raised the total extra direct and indirect costs per woman in the trial group to pound 60.98 (U.S. $96.35) over costs for the control subjects. CONCLUSIONS: There may be little benefit in providing specialist genetics services to all women with a family history of breast cancer. Further investigation of factors that may mediate the impact of genetic assessment is in progress and may reveal subgroups of women who would benefit from specialist genetics services.

A comparison of methods currently used in clinical practice to estimate familial breast cancer risks.

BACKGROUND: With the identification of genes predisposing to hereditary breast cancer, the accurate and consistent estimation of a woman's risk of developing breast cancer based on her family history is of paramount importance if national service guidelines are to be developed. PATIENTS AND METHODS: The residual lifetime risk of developing breast cancer was estimated for 200 women attending a breast cancer genetic assessment clinic by three different methods currently in use in the UK. Risks were computed on the basis of the Cancer and Steroid Hormone (CASH) study data and were classified as 'low/moderate' (<20%) or 'high' (>20%). These risk categories are representative of those currently used to allocate surveillance and genetic testing. Risks were then compared to estimates derived by other methods used in current clinical practice, including those of Houlston and Murday. RESULTS: The CASH data-based method ascribed 27% to the high risk category, as compared to 53% for the combined Houlston and Murday methods. A method based on the number of affected relatives alone ascribed only 14% to the high risk category. Overall, 108 (54%) women were placed in the same risk category by all three methods. CONCLUSIONS: This study demonstrates that there is a significant degree of variability between methods currently used to estimate breast cancer risk which has serious implications for individual patient management, service provision and multicentre studies evaluating the benefits of genetic testing for breast cancer susceptibility.

Effect of a pediatric self-care book on utilization of services in a group model HMO.

The purpose of this study was to determine the effect of a pediatric self-care book (SCB) with nurse telephone support on use of health services. The study was performed in a pediatric department of Kaiser Permanente in a suburb of Denver, Colorado. Well patients seen at age 2 weeks to 2.5 months (infant group) or 14 to 19 months (toddler group) were enrolled. Intervention families received a copy of the book, Your Child's Health and were oriented on its use. Rates of sick visits, advice nurse calls, pharmacy prescriptions, emergency department visits, and hospital admissions were assessed. Visit and call rates were calculated, and mean rates of the SCB group and the control group were then compared. Of 1,104 enrols, 527 received the SCB; the other 577 served as controls. The SCB group had 14.0% fewer total visits (excluding well-baby visits) than controls did (p = 0.018). For infants and toddlers who were not first-borns, the intervention was associated with a statistically significant decrease in sick visits (23%), advice nurse phone calls (24%), and pharmacy prescriptions (26%); no statistically significant differences in study outcomes were seen among first-born study subjects. Promotion of self-care in a group model health maintenance organization can decrease use of services by families of young children.

BRCA1 and BRCA2 in breast cancer families from Wales: moderate mutation frequency and two recurrent mutations in BRCA1.

Mutations in the BRCA1/BRCA2 genes account for varying proportions of breast cancer families studied, and demonstrate considerable variation in mutational spectra coincident with ethnic and geographical diversity. We have screened for mutations in 17 families from Wales with two or more cases of breast cancer under age 50 and/or ovarian cancer. Eight out of 17 (47%) families had demonstrable mutations. Six out of 17 (35%) carried BRCA1 mutations and 2 out of 17 (12%) carried BRCA2 mutations. Two recurrent mutations in BRCA1 were identified, which appear to represent founder mutations in this population. These data support the existence of additional breast and ovarian cancer susceptibility genes.

The accuracy of a lead questionnaire in predicting elevated pediatric blood lead levels.

OBJECTIVES: To determine the prevalence of elevated blood lead levels and to evaluate the accuracy of a lead screening questionnaire in a western United States urban inner-city pediatric population. DESIGN: A convenience sample of children between the ages of 6 months and 6 years seen for a well-child visit were enrolled. Venous blood lead levels were measured and a lead screening questionnaire was completed. SETTING: The primary care clinics of the 10 community health centers of the city and county of Denver, Colorado. Approximately 85% of children receiving services are below the 150% poverty level and 54% are insured through the state's Medicaid program. SUBJECTS: A total of 2978 children seen for a well-child visit from February 1993 to January 1994. MAIN OUTCOME MEASURES: The prevalence of elevated blood lead levels and the operating characteristics of both the Centers for Disease Control and Prevention lead screening questionnaire and the complete questionnaire used in Denver, using venous blood lead levels as the criterion standard. RESULTS: The mean blood lead level was 0.20 mumol/L (4.19 micrograms/dL). Eighty-five children had blood lead levels of 0.48 mumol/L (10 micrograms/dL), representing 2.9% of the study group (95% confidence interval [CI], 2.3-3.5). Only 0.3% of the cohort had blood lead levels greater than 0.96 mumol/L (20 micrograms/dL). The sensitivity, specificity, and positive predictive value of the Centers for Disease Control and Prevention questionnaire was 57%, 51%, and 3%, respectively. The sensitivity, specificity, and positive predictive value of the complete questionnaire was 59.7%, 36%, and 2.6%, respectively. The marginal cost of identifying a child with a blood lead level greater than 0.96 mumol/L (20 micrograms/dL) was $4925. CONCLUSIONS: Few of the low-income children in this study had blood lead levels greater than 0.48 mumol/L (10 micrograms/dL). The questionnaire did little better than chance at predicting the presence or absence of elevated blood lead levels and cannot replace a blood lead level test for childhood lead screening in this community.