Racial and ethnic distribution of US randomized controlled trials in obstetrics: a retrospective review.

OBJECTIVES: To determine the racial and ethnic compositions of the participants in obstetric randomized controlled trials (RCTs) and compare them to the US general population. METHODS: RCTs published in two premier US journals, American Journal of Obstetrics and Gynecology, Obstetrics and Gynecology from January 2010 to April 2020 were analyzed. The racial and ethnic distributions of the study participants were extracted and expressed as percentages for each article. Obstetrics articles were selected and then further divided into subcategories. Statistical analyses were performed on racial and ethnicity representation in each subcategory compared to a US population norm. RESULTS: Overall, a wide variation of racial and ethnic distribution was noted among studies. However, statistically significant overrepresentation of Non-Hispanic Black population and underrepresentation of White and Asian races were noted while Hispanic population's representation was comparable to the US general population. This observation was persistent across most of the subcategories. CONCLUSIONS: RCTs in the field of Obstetrics showed an overrepresentation of Black population. This observation was unique when we consider the previous reports in other fields of medicine. These findings should be taken into consideration when interpreting the results of RCTs conducted in US.

Non-adherence to labor guidelines in cesarean sections done for failed induction and arrest of dilation.

OBJECTIVES: In 2014, the American College of Obstetrics and Gynecology published guidelines for diagnosing failed induction of labor (FIOL) and arrest of dilation (AOD) to prevent cesarean delivery (CD). The objectives of this study were to determine the rate of adherence to these guidelines and to compare the association of guideline adherence with physician CD rates and obstetric/neonatal outcomes. METHODS: Retrospective cohort review of singleton primary cesarean deliveries for FIOL and AOD at a single academic institution from 2014 to 2016. Univariate and multivariate analyses were used to compare adherence to the guidelines with physician CD rates and obstetric/neonatal outcomes. RESULTS: Of the 591 cesarean deliveries in the study, 263 were for failed induction, 328 for AOD and 79% (468/591) were not adherent to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine (ACOG/SMFM) guidelines. Of the failed inductions, 82% (215/263) and of the AODs 77% (253/328) were not adherent. There was no difference between adherent and non-adherent CDs with regard to maternal characteristics, or obstetric/neonatal outcomes. Duration of oxytocin use after rupture of membranes, dilation at time of CD, and birth weight were statistically higher in adherent CDs. On multivariate linear regression, physician CD rates were inversely correlated with adherence to ACOG/SMFM guidelines (p<0.0001), gestational age (p=0.007), and parity (p=0.003). CONCLUSIONS: Our study shows that physician non-compliance with ACOG guidelines was high. Adherence to these guidelines was associated with lower physician CD rates, without an increase in obstetric or neonatal complications.

Operational feasibility of routine bacterial monitoring of platelets.

Bacterial contamination of platelets poses the greatest risk of mortality and morbidity to platelet transfusion recipients. Some European countries have introduced routine bacterial monitoring of platelets to reduce the risk of transmission of bacteria. A pilot study was carried out at the Northern Ireland Blood Transfusion Service, using the BacT/ALERT automated culture system, to assess the operational feasibility of routine bacterial monitoring of platelets. About 4885 platelet concentrates (PCs) were tested in a 1-year period. Of the 28 (0.57%) initial reactive cultures, 13 (46%) were reproducible on repeat culturing. Of these, 10 were detected within 24 h of incubation either in aerobic or both aerobic and anaerobic culture bottles. A sample of time-expired units (423) that had initial negative culture results remained negative when retested on day 8. About 213 time-expired units were subjected to routine quality assessment and more than 85% were found to conform to quality standards specified in the UKBTS guidelines for platelet count (> or =240 x 10(9) per adult dose PC) and pH (6.4-7.4). There was a reduction in the platelet count because of the volume removed (15 mL) for sampling. Routine bacterial testing with day 2 sampling and a negative culture result after 24 h as a mandatory release criterion would improve product safety. Implementation of 100% testing would be operationally feasible but may require extension of the shelf life if unacceptable wastage is to be avoided.

The clinical outcome of non-RhD antibody affected pregnancies in Northern Ireland.

We assessed the clinical outcome of pregnancies with non-Rh-D antibody in Northern Ireland using retrospective case note review. During the study period (April 1999- March 2000) 186 women with clinically significant antibodies were identified from the records of the antenatal laboratory of the Northern Ireland Blood Transfusion Service. Eighty-five women were included in the study using the criteria mentioned above. None of the fetuses required intrauterine transfusion during this period. One baby required exchange transfusion, three were given top-up transfusions and 17 had phototherapy. Nine babies with a positive direct antiglobulin test (DAT) received no treatment. The incidence of anti-Kell could be reduced by transfusing Kell negative red cells to premenopausal women. It is important that all pregnant women are tested at least twice in their pregnancy to detect the antibodies formed late in the pregnancy. It is useful to formulate a standard protocol for antenatal interventions. Non Rh-D antibodies can cause significant anaemia for up to six weeks in the neonatal period, hence early detection of maternal antibodies is important so that the neonates are followed up for an appropriate length of time.

Individual differences and the reliability of 2F1-F2 distortion-product otoacoustic emissions: effects of time-of-day, stimulus variables, and gender.

Distortion product otoacoustic emissions (DPOAEs) measured from the ear canal can be a sensitive tool to detect changes in cochlear function over time. However, if multiple-measurement procedures are to be useful clinically, testing needs to be reliable and sources of variability within individuals should be known. Herein, the influence of time-of-day (TOD), stimulus frequency, stimulus sound pressure level (SPL), and gender were evaluated on 2f1-f2 DPOAE amplitude in 16 adult volunteers with normal hearing. The effects of oral temperature and resting-pulse rate were also assessed. This study demonstrated a TOD main effect, with a period approximating one cycle-per-day. The magnitude of this effect averaged less than one dB and was not dependent on stimulus (frequency or SPL) or participant variables (gender, oral temperature, or resting-pulse rate), nor was it synchronized to a particular point-in-time. Stimulus level and gender effects on DPOAEs across frequency were also observed. Using generalizability theory (GT), DP iso-level/frequency profiles (DPILFPs) were found to be reliable measures within-subjects over a contiguous 24-hour time period. Significant and reliable between-subject differences were also documented. This study demonstrates the influence of stimulus and participant variables, quantifies the within-subject reliability over a 24-hour time period, and confirms that significant and reliable between-subject differences exist on DPOAEs across frequency, SPL, and gender.

Human immunodeficiency virus infection in Northern Ireland 1980-1989.

To 31st December 1989, 71 persons are known to have attended medical practitioners in Northern Ireland with a diagnosis of Human Immunodeficiency Virus (HIV) infection. Twenty-one of these persons have had the diagnosis of Acquired Immune Deficiency Syndrome (AIDS) and 11 have died. The distribution of reports in the "at risk" categories of homosexual/bisexual males, injecting drug users, heterosexual males and females was significantly different (p less than 0.001) from those reported in the United Kingdom as a whole. Of tests for HIV infection carried out in patients attending the genitourinary medicine department of the Royal Victoria Hospital between 1987-1989, 0.16% have been positive. The prognostic value of the T4 lymphocyte count at presentation for the subsequent development of AIDS was significant (p = 0.0011). The commonest AIDS indicator disease diagnosed was Pneumocystis carinii pneumonia which was seen in seven of the 21 patients (33%).

Biomechanical performance of cardiovascular needles.

Standardized reproducible tests have been developed to determine the biomechanical performance of cardiovascular needles. The parameters used to assess performance were sharpness, resistance to bending, and ductility. Three comparable groups of taper point cardiovascular needles were selected from different manufacturers for these biomechanical studies. The results of this testing demonstrated that needle geometry, needle composition, and the manufacturer were important determinants of needle performance. When needles of comparable size were evaluated, the biomechanical performance of cardiovascular needles manufactured by Ethicon, Inc., were superior to needles produced by other manufacturers. The superior performance characteristics of the cardiovascular needles produced by Ethicon, Inc., were related to their unique stainless steel alloy, American Society for Testing Materials 45500, which has greater yield and tensile strengths than the alloy used by the other manufacturers. Scanning electron microscopic photographs of the Ethicon, Inc., needle revealed a uniform taper point geometry without irregularities. The deformations of the points of cardiovascular needles produced by the other manufacturers could alter their performance.

A beveled, conventional cutting edge surgical needle: a new innovation in wound closure.

A new beveled, conventional cutting edge needle has been developed with superior performance characteristics over those of other conventional cutting edge needles. It is composed of a unique stainless steel, ASTM 45500, that has been heat-treated after the curving process to enhance its resistance to bending. The angle of presentation of its cutting edges has been decreased to enhance needle sharpness. On the basis of the results of experimental and clinical investigations, this new needle is recommended for closure of lacerations.

Emergency medicine magnifying loupes.

A magnifying loupe system has been evaluated for use in emergency medicine. Physicians uniformly preferred a Keplerian lens system over that of the Galilean lens system. The advantages of the Keplerian lens were its increased field of view and its brighter and clearer peripheral image. The Keplerian loupes allowed the physician to visualize the exquisite details of wound configuration and to perform wound closure using microsurgical techniques.

Hepatitis B virus infection in Northern Ireland 1970-1987.

In the 18 years between 1970 and 1987, 504 patients were found to have hepatitis B surface antigen (HBsAg) in their blood. Acute hepatitis was present in 184 patients and six died (3.3%). The annual incidence of acute hepatitis B virus infection in Northern Ireland was about one-quarter that of England and Wales. A decrease in acute infection occurred in 1986-87, while in England and Wales acute infection has fallen by more than half since the peak in 1984. Hepatitis B virus infection in health care staff and patients in high risk groups were reviewed: 32% were in those of foreign origin or who had known foreign contacts. In blood donors there was a marked fall in incidence of hepatitis B surface antigen carriage from 1982 onwards: the incidence in antenatal patients and those screened for rubella antibody (mainly females) was half that of new blood donors in 1972-81. Carrier rates in blood donors and antenatal patients were less than those from other parts of the United Kingdom. All indices show that Northern Ireland has a lower incidence of hepatitis B virus infection than the rest of the United Kingdom.

Water treatment of hydrotherapy exercise pools.

The major objectives of water treatment of hydrotherapy pools are to disinfect the water and to balance the water appropriately. A variety of disinfectant systems utilizing either halogens, ozone, or metals have been implemented in hydrotherapy pools. Regardless of the disinfectant system employed, continual and appropriate monitoring of the system is mandatory to prevent infection. Water balancing refers to the control of the water mineral concentration so that the water does not damage the pool. Five major factors that influence water balance are pH, total alkalinity, calcium hardness, total dissolved solids, and temperature. The extent to which these five factors affect water balance can be computed by the Langelier saturation index.

Increasing demands on today's blood donors.

Recently in Northern Ireland there has been a rapid increase in demand for a variety of blood components. To meet this need a large proportion of routine blood donations must be processed at the Transfusion Centre. In addition, several blood components are collected direct from donors by apheresis techniques. Apheresis is currently restricted to the collection of components from highly selected donors, but in future this method is likely to be employed for collection of some routine components. This changing pattern is placing increasing demands on many of our blood donors.