The impact of embryo vitrification on placental histopathology features and perinatal outcome in singleton live births.

STUDY QUESTION: Does embryo vitrification affect placental histopathology pattern and perinatal outcome in singleton live births? SUMMARY ANSWER: Embryo vitrification has a significant effect on the placental histopathology pattern and is associated with a higher prevalence of dysfunctional labor. WHAT IS KNOWN ALREADY: Obstetrical and perinatal outcomes differ between live births resulting from fresh and frozen embryo transfers. The effect of embryo vitrification on the placental histopathology features associated with the development of perinatal complications remains unclear. STUDY DESIGN, SIZE, DURATION: Retrospective cohort study evaluating data of all live births from one academic tertiary hospital resulting from IVF treatment with autologous oocytes during the period from 2009 to 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS: All patients had placentas sent for pathological evaluation irrelevant of maternal or fetal complications status. Placental, obstetric and perinatal outcomes of pregnancies resulting from hormone replacement vitrified embryo transfers were compared with those after fresh embryo transfers. A multivariate analysis was conducted to adjust the results for determinants potentially associated with the development of placental histopathology abnormalities. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 1014 singleton live births were included in the final analysis and were allocated to the group of pregnancies resulting from fresh (n = 660) and hormone replacement frozen (n = 354) embryo transfers. After the adjustment for confounding factors the frozen embryo transfers were found to be significantly associated with chorioamnionitis with maternal (odds ratio (OR) 2.0; 95% CI 1.2-3.3) and fetal response (OR 2.6; 95% CI 1.2-5.7), fetal vascular malperfusion (OR 3.9; 95% CI 1.4-9.2), furcate cord insertion (OR 2.3 95% CI 1.2-5.3), villitis of unknown etiology (OR 2.1; 95% CI 1.1-4.2), intervillous thrombi (OR 2.1; 95% CI 1.3-3.7), subchorionic thrombi (OR 3.4; 95% CI 1.6-7.0), as well as with failure of labor progress (OR 2.5; 95% CI 1.5-4.2). LIMITATIONS, REASONS FOR CAUTION: Since the live births resulted from frozen-thawed embryos included treatment cycles with previously failed embryo transfers, the factors over embryo vitrification may affect implantation and placental histopathology. WIDER IMPLICATIONS OF THE FINDINGS: The study results contribute to the understanding of the perinatal future of fresh and vitrified embryos. Our findings may have an implication for the clinical decision to perform fresh or frozen-thawed embryo transfer. STUDY FUNDING/COMPETING INTEREST(S): Authors have not received any funding to support this study. There are no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: N/A.

Treatment of bone loss in proximal femurs of postmenopausal osteoporotic women with AGN1 local osteo-enhancement procedure (LOEP) increases hip bone mineral density and hip strength: a long-term prospective cohort study.

This first-in-human study of AGN1 LOEP demonstrated that this minimally-invasive treatment durably increased aBMD in femurs of osteoporotic postmenopausal women. AGN1 resorption was coupled with new bone formation by 12 weeks and that new bone was maintained for at least 5-7 years resulting in substantially increased FEA-estimated femoral strength. INTRODUCTION: This first-in-human study evaluated feasibility, safety, and in vivo response to treating proximal femurs of postmenopausal osteoporotic women with a minimally-invasive local osteo-enhancement procedure (LOEP) to inject a resorbable triphasic osteoconductive implant material (AGN1). METHODS: This prospective cohort study enrolled 12 postmenopausal osteoporotic (femoral neck T-score ≤ - 2.5) women aged 56 to 89 years. AGN1 LOEP was performed on left femurs; right femurs were untreated controls. Subjects were followed-up for 5-7 years. Outcomes included adverse events, proximal femur areal bone mineral density (aBMD), AGN1 resorption, and replacement with bone by X-ray and CT, and finite element analysis (FEA) estimated hip strength. RESULTS: Baseline treated and control femoral neck aBMD was equivalent. Treated femoral neck aBMD increased by 68 ± 22%, 59 ± 24%, and 58 ± 27% over control at 12 and 24 weeks and 5-7 years, respectively (p < 0.001, all time points). Using conservative assumptions, FEA-estimated femoral strength increased by 41%, 37%, and 22% at 12 and 24 weeks and 5-7 years, respectively (p < 0.01, all time points). Qualitative analysis of X-ray and CT scans demonstrated that AGN1 resorption and replacement with bone was nearly complete by 24 weeks. By 5-7 years, AGN1 appeared to be fully resorbed and replaced with bone integrated with surrounding trabecular and cortical bone. No procedure- or device-related serious adverse events (SAEs) occurred. CONCLUSIONS: Treating femurs of postmenopausal osteoporotic women with AGN1 LOEP results in a rapid, durable increase in aBMD and femoral strength. These results support the use and further clinical study of this approach in osteoporotic patients at high risk of hip fracture.

Toward a national consumer survey: evaluation of the CABHS and MHSIP instruments.

This article describes a study evaluating the Consumer Assessment of Behavioral Health Survey (CABHS) and the Mental Health Statistics Improvement Program (MHSIP) surveys. The purpose of the study was to provide data that could be used to develop recommendations for an improved instrument. Subjects were 3,443 adults in six behavioral health plans. The surveys did not differ significantly in response rate or consumer burden. Both surveys reliably assessed access to treatment and aspects of appropriateness and quality. The CABHS survey reliably assessed features of the insurance plan; the MHSIP survey reliably assessed treatment outcome. Analyses of comparable items suggested which survey items had greater validity. Results are discussed in terms of consistency with earlier research using these and other consumer surveys. Implications and recommendations for survey development, quality improvement, and national policy initiatives to evaluate health plan performance are presented.

Use of consumer ratings for quality improvement in behavioral health insurance plans.

BACKGROUND: The Consumer Assessment of Behavioral Healthcare Services (CABHS) survey collects consumers' reports about their health care plans and treatment. The use of the CABHS to identify opportunities for improvement, with specific attention to how organizations have used the survey information for quality improvement, is described. METHODS: In 1998 and 1999, data were collected from five groups of adult patients in commercial health plans and five groups of adult patients in public assistance health plans with services received through four organizations (one of three managed behavioral health care organizations or a health system). Patients who received behavioral health care services during the previous year were mailed the CABHS survey. Non-respondents were contacted by telephone to complete the survey. RESULTS: Response rates ranged from 49% to 65% for commercial patient groups and from 36% to 51% for public assistance patients. Promptly getting treatment from clinicians and aspects of care most influenced by health plan policies and operations, such as access to treatment and plan administrative services, received the least positive responses, whereas questions about communication received the most positive responses. In addition, questions about access- and plan-related aspects of quality showed the most interplan variability. Three of the organizations in this study focused quality improvement efforts on access to treatment. DISCUSSION: Surveys such as the CABHS can identify aspects of the plan and treatment that are improvement priorities. Use of these data is likely to extend beyond the behavioral health plan to consumers, purchasers, regulators, and policymakers, particularly because the National Committee for Quality Assurance is encouraging behavioral health plans to use a similar survey for accreditation purposes.

Health plan characteristics and consumers' assessments of quality.

Many purchasers and consumers of health care have become concerned about the quality of care being delivered in managed care plans. Little is known, however, about the health plan characteristics that are associated with better performance. We used survey responses from 82,583 Medicare beneficiaries from 182 health plans to study the association of consumers' assessments of care with health plan characteristics. For-profit and nationally affiliated health plans received much worse scores on the outcomes of interest, particularly for overall ratings of the health plan and composite measures of customer service and access to care. Health plans accredited by the National Committee for Quality Assurance did not receive higher scores.

Providing consumers with information about the quality of health plans: the Consumer Assessment of Health Plans demonstration in Washington State.

BACKGROUND: In 1995 the Agency for Health Care Policy and Research began a five-year project, Consumer Assessment of Health Plans (CAHPS), to create instruments to collect data from consumers about their health care experiences, to develop sophisticated methods to convey these data to consumers, and to evaluate the value of these data to consumers who are selecting health plans. Results were obtained from one of the first CAHPS demonstration sites, the Washington State Health Care Authority. METHODS: The survey was distributed in May-June 1997 to 15,885 enrollees in 20 health plans; 8,204 (51.6%) surveys were completed. Survey results were summarized in a report that described the performance of plans, which was distributed to 97,000 enrollees, and reactions to the report were obtained from more than 1,500 individuals. RESULTS: Nearly everyone who was mailed the report said they saw it. A large proportion said they read most or all of it, and most thought the report was easy to understand, contained information needed to rate plans, and was helpful to learning about differences between plans. Those who used the CAHPS performance report were more likely to switch plans and to report that they were confident they had selected the best plan for their situation. DISCUSSION: The study was unique in that it attempted to evaluate whether employees read the performance report, how they reacted to it, and whether reading it influenced their decision to switch plans or their confidence that they had selected a suitable plan. Choosing a new plan probably stimulated more intense scrutiny of the report than not anticipating switching.

The Consumer Assessment of Health Plan Study (CAHPS) survey of children's health care.

BACKGROUND: Little is known about the experience of children and families with pediatric care. Asking parents about their experiences and the treatment of their children in health care plans can yield important information about selected aspects of medical care quality. Such data can be used to motivate, focus, and evaluate quality improvement efforts. METHODS: Development of the Child Core Survey followed the survey development principles of the Consumer Assessment of Health Plan Study (CAHPS) project, starting with assembly of existing instruments, consultation with experts, focus groups, and cognitive testing. A field test of the survey was conducted by mail among members enrolled in 1 of 25 plans originally identified as providing health care services to the public employees of the state of Washington (response rate, 52%). RESULTS: The 3,083 respondents rated personal doctors most highly, with overall care and specialty care rated nearly as well, and plan administration rated lowest. Parent-clinician and child-clinician communication, as well as spending sufficient time with the child were the strongest correlates of assessments of overall care and of personal doctors. Plans differed significantly in their performance along all the dimensions of child health care assessed in the survey except for aspects of access ("getting the care you need"). IMPLICATIONS: The Child Core Survey from the CAHPS provides a readily accessible method to assess the interpersonal care of children. Such data could be used to make plans accountable to the needs of children, to focus specific improvement initiatives, or both.

Development of a consumer survey for behavioral health services.

A consumer survey was designed to assess the quality of mental health and substance abuse services and evaluate insurance plans that provide such services. This paper describes the development of the Consumer Assessment of Behavioral Health Services instrument, which began with a review of existing consumer satisfaction surveys and input from several groups working toward development of nationally standardized satisfaction instruments. Consumer focus groups were used to ensure that all the important domains of quality were included, and group members were interviewed to ensure that all items on the instrument were understandable. Results of a pilot test conducted with 160 consumers, 82 enrolled in Medicaid plans and 78 in commercial plans, suggested that the survey was able to distinguish between the two groups in terms of evaluations of their care and insurance plans. Future efforts will focus on further testing of larger, more diverse samples and on developing scoring and reporting formats for the survey that will be useful to consumers and purchasers in choosing behavioral health services and plans.

Psychometric properties of the CAHPS 1.0 survey measures. Consumer Assessment of Health Plans Study.

OBJECTIVES: Consumer surveys are being used increasingly to assess the quality of care provided by health plans, physician groups, and clinicians. The purpose of the Consumer Assessment of Health Plans Study (CAHPS) is to develop an integrated and standardized set of surveys designed to collect reliable and valid information about health plan performance from consumers. This article reports psychometric results for the CAHPS 1.0 survey items in samples of individuals with Medicaid or private health insurance coverage. METHODS: Reliability estimates for CAHPS 1.0 measures were estimated in a sample of 5,878 persons on Medicaid and 11,393 persons with private health insurance. Correlations of the CAHPS global rating of the health plan with willingness to recommend the plan and intention to re-enroll were estimated in a sample of 313 persons on Medicaid. The association of the rating of the health plan with ratings using a 5-point Excellent-to-Poor response scale also was investigated in the latter sample and in a sample of 539 persons with private health insurance. RESULTS: The CAHPS measures appeared to have good reliability, particularly at the health-plan level. Responses from 300 consumers per health plan tend to yield estimates that are reliable enough for health plan comparisons, especially among the privately insured. The global health plan rating was significantly correlated with consumers' willingness to recommend the plan to family and friends and to their intention to re-enroll in the plan if given a choice. CONCLUSIONS: The CAHPS 1.0 survey instrument appears to have excellent psychometric properties.

The impact of having parents report about both their own and their children's experiences with health insurance plans.

OBJECTIVES: The aim of this study was to determine whether parents rate their children's care differently when they also rate their own care than when they do not. METHODS: Subjects were employees of Washington State who had been enrolled in a health plan for at least 6 months and who had at least one covered child. Subjects were randomly assigned to four study groups that were surveyed using different protocols. To assess the stability of responses over time, a follow-up telephone interview was conducted with individuals in two of the groups. RESULTS: Parents or guardians who received both the Adult and Child Surveys were less likely to complete a survey than those who received only one survey. Responses to selected survey questions were quite stable between survey administrations. Parents who rated only their child's health care experiences generally gave more positive responses than those who also rated their own care, although few of these differences were statistically significant. This may have been due, in part, to the lower response rates in the latter group. The pairs of survey questions that ask about the adult's and child's experiences with the same aspects of care had moderate to high levels of association. The pair with the weakest association asked how clearly the doctor or nurse explained things to the adult or the child. CONCLUSIONS: Sending both an adult and child survey to an adult could have an effect on the pattern of responses and result in lower response rates, but this might be a cost-effective way to collect reports about both adult and child health care.

A double-blinded, randomized, controlled clinical trial to compare cefazolin and cefonicid for antimicrobial prophylaxis in clean orthopedic surgery.

A double-blind, prospective randomized study was performed to compare cefazolin and cefonicid given for prophylaxis to 102 patients undergoing orthopedic surgery. Risk factors (e.g., age, sex, type of operation performed) among the two groups were similar. All patients had foreign material (prosthesis or other hardware) inserted at operation. There was a total of 6 infections (3 wound and 3 urinary tract) in 6 patients among the 48 receiving cefazolin (12.5%), whereas no infections were observed among the 54 patients who received cefonicid. Cefonicid, given once daily, provides protection against postoperative infection that is not inferior to cefazolin. A larger study is needed to confirm whether cefonicid is indeed superior to cefazolin.

Hip arthroplasty in mentally impaired patients.

The outcome of elective hip arthroplasty in 11 mentally impaired patients was compared with a cohort of 244 mentally competent patients. The impaired patients had a diagnosis of cerebral palsy, schizophrenia, or Down's syndrome, and were unable to give their own surgical consent. Major complications requiring additional surgery occurred in 5 of the mentally impaired patients. Three patients sustained fractures of the femur below the stem and were treated with plating, 1 developed a deep infection requiring prosthesis removal, and 1 developed a thoracic decubiti with bone involvement requiring debridement and rotation flap coverage. Three of these patients also developed urinary tract infections. Of the other 6 mentally impaired patients, 3 developed urinary tract infections, and 1 had a deep venous thrombosis. Functional independence was improved after surgery in the mentally impaired patients. However, the average cost of hospitalization, length of stay, and complication rate were significantly higher (p < 0.05) than those of the mentally competent patients.

[Pitfalls in the diagnosis of tuberculous arthritis].

Jewish immigrants from Russia, and Arabs added to the population register since 1967, have a relatively high incidence of bone and joint tuberculosis. These patients now account for most of this disease in Israel. Skeletal tuberculosis imitates various joint conditions, most commonly, rheumatoid arthritis, and therefore presents a diagnostic problem. Injections of corticosteroids and/or immunosuppressive therapy can reactivate quiescent tuberculous lesions. During a 12-year period 14 patients with tuberculous arthritis involving 16 joints were seen in this hospital. They included 9 males and 5 females, 14-70 years old, 4 of whom were known to have had previous skeletal tuberculosis: 3 had spinal and 1 had hip involvement. None of the other 10 had a clinical history of tuberculosis, nor X-ray evidence of active pulmonary disease. 7 patients were diagnosed postoperatively as having joint tuberculosis on histopathological and bacteriological examination; 3 had positive cultures from joint aspirations. Most commonly involved were the spine and knee--4 cases of each. The wrist and acromioclavicular joint were affected in 2 cases each, and the hip, sacroiliac joint, ankle and elbow joints in 1 case each. The youngest patient, 14 years old, had triple-joint involvement of the wrist and the acromioclavicular and sacroiliac joints; the others had single-joint disease. In 1 patient the disease was reactivated after 36 years by surgical conversion of a fused hip to a mobile artificial joint. 3, whose joints were injected with corticosteroids, developed active, destructive tuberculous arthritis. A patient with rheumatoid arthritis who underwent total knee replacement was found to have active tuberculous arthritis.(ABSTRACT TRUNCATED AT 250 WORDS)