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Some practices require mandatory preoperative laboratory testing for select patients presenting for anesthesia and surgery. Such mandatory preanesthesia laboratory testing has significant ethical implications related to informed consent and patient autonomy. Assumptions that a patient provides "presumed consent" by merely presenting for a test are flawed because such consents are often not informed and do not acknowledge patient autonomy. By placing a condition on access to a medical treatment, mandatory preanesthesia testing may not be ethically justifiable. Not all laboratory tests are "ethically equal"; several raise specific questions regarding informed consent, related to their potential to cause significant harm.

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BACKGROUND: Many women in low- and middle-income countries, including Kenya, access antenatal care (ANC) late in pregnancy. Home pregnancy testing can enable women to detect pregnancy early, but it is not widely available. Our study explored the acceptability and potential of home pregnancy testing delivered by community health volunteers (CHV) on antenatal care initiation in rural Kenya. METHODS: This study was part of a public health intervention to improve uptake and quality of ANC. Between November and December 2020, we conducted 37 in-depth interviews involving women who tested positive or negative for a urine pregnancy test provided by CHVs; CHVs and their supervisors involved in the delivery of the pregnancy tests; facility healthcare workers; and key informants. Using Sekhon et al.'s framework of acceptability, the interviews explored participants' perceptions and experiences of home pregnancy testing, including acceptability, challenges, and perceived effects on early ANC uptake. Data were analysed thematically in NVivo12 software. RESULTS: Home pregnancy testing was well-received by women who trusted test results and appreciated the convenience and autonomy it offered. Adolescents cherished the privacy, preferring home testing to facility testing which could be a stigmatising experience. Testing enabled earlier pregnancy recognition and linkage to ANC as well as reproductive decision-making for those with undesired pregnancies. Community delivery of the test enhanced the reputation and visibility of the CHVs as credible primary care providers. CHVs in turn were motivated and confident to deliver home pregnancy testing and did not find it as an unnecessary burden; instead, they perceived it as a complement to their work in providing ANC in the community. Challenges identified included test shortages, confidentiality and safeguarding risks, and difficulties accessing facility-based care post-referral. Newly identified pregnant adolescents hesitated to seek ANC due to stigma, fear of reprimand, unwanted parental notification, and perceived pressure from healthcare workers to keep the pregnancy. CONCLUSION: Home pregnancy testing by CHVs can improve early ANC initiation in resource-poor settings. Mitigating privacy, confidentiality, and safeguarding concerns is imperative. Additional support for women transitioning from pregnancy identification to ANC is essential to ensure appropriate care. Future research should focus on integrating home pregnancy testing into routine community health services.

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BACKGROUND: As an adjunct to verification of performance characteristics of a qualitative serum hCG lateral flow immunoassay (LFI), we performed image analysis to characterize the dose vs response curve (visibility of the test line), as a means of understanding the transition from negative to positive as a function of increasing [hCG]. METHODS: Using serum samples of known [hCG], device images were obtained using a scanner at the prescribed reading time (5 min). Image analysis (using Python and R) was used to obtain the integral (S) of the test-line color as a function of [hCG]. RESULTS: Data for S as a function of [hCG] were well characterized by a simple hyperbola: S = Smax [hCG]/([hCG] + K), where K = 202 mIU/ml (r = 0.997). Replicates of S at K had CV of 7.3 %. By eye, uncertainty of test results among users occurred only below the assay's stated sensitivity of 10 mIU/ml, in region of S < 3 % of Smax, and signal:noise ratio < 3. CONCLUSIONS: By image analysis, the dose vs response (Test line integral) for this qualitative serum hCG LFI was a simple hyperbola. Characterization of the dose vs response curve was useful in verification of the assay's performance characteristics.

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BACKGROUND: Screening programmes aim to identify individuals at higher risk of developing a disease or condition. While globally, there is agreement that people who attend screening should be fully informed, there is no consensus about how this should be achieved. We conducted a mixed methods study across eight different countries to understand how countries address informed choice across two screening programmes: breast cancer and fetal trisomy anomaly screening. METHODS: Fourteen senior level employees from organisations who produce and deliver decision aids to assist informed choice were interviewed, and their decision aids (n = 15) were evaluated using documentary analysis. RESULTS: We discovered that attempts to achieve informed choice via decision aids generate two key tensions (i) between improving informed choice and increasing uptake and (ii) between improving informed choice and comprehensibility of the information presented. Comprehensibility is fundamentally at tension with an aim of being fully informed. These tensions emerged in both the interviews and documentary analysis. CONCLUSION: We conclude that organisations need to decide whether their overarching aim is ensuring high levels of uptake or maximising informed choice to participate in screening programmes. Consideration must then be given to all levels of development and distribution of information produced to reflect each organisation's aim. The comprehensibility of the DA must also be considered, as this may be reduced when informed choice is prioritised.

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An effective method to detect human chorionic gonadotropin (hCG) is of significance for early pregnancy testing and clinical diagnosis of non-pregnancy related diseases. Herein, a sensitive sandwich-like electrochemical immunosensor of hCG was constructed by introducing nanogold/graphene (Au/GNS) hybrids and ferrocene/gold nanoparticles (Fc/Au) as the sensing platform and signal amplifier, respectively. In this sensing platform, the Au/GNS hybrid was dedicated to increasing the loading capacity of primary antibody (Ab1) and accelerate the electron transport, and Au is devoted to assembling secondary antibodies (Ab2) and Fc derivative (Fc-SH) to fabricate signal amplifier (Ab2-AuNPs-Fc). By selecting Fc as the signal probe, results revealed that peak currents increased when the special recognition among Ab1, hCG, and Ab2 occurred. A novel and sensitive sandwich-like immunosensor of hCG was thus constructed. After optimizing various testing conditions, a wide linearity from 0.005 to 7.0 ng mL-1 and a low detection limit of 1.0 pg mL-1 were achieved for hCG analysis, suggesting this method is useful for hCG analysis.

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The earlier a woman learns about her pregnancy status, the sooner she can make decisions about her own and infant's health. This paper examines how women learn about their pregnancy status and measures how access to pregnancy tests affects earlier pregnancy knowledge. Using 10 years of individual-level monthly panel data in Nepal, we find that, on average, women learn they are pregnant in their 4.6th month of pregnancy. Living approximately a mile further from a clinic offering pregnancy tests increases the time a woman knows she is pregnant by one week (5 percent increase) and decreases the likelihood of knowing in the first trimester by 4.5 percentage points (16 percent decrease). Women with prior pregnancies experience the most substantial effects of distance within the first two trimesters, while, for women experiencing their first pregnancy, distance does not affect knowledge. These results suggest that, while access to clinics can increase pregnancy awareness for women who recognize pregnancy symptoms, other complementary policies are needed to increase pregnancy awareness of women in their first pregnancy.

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This article examines the West German controversy over Duogynon, a 'hormone pregnancy test' and the drug at the centre of the first major, international debate over iatrogenic birth defects in the post-thalidomide era. It recovers an asymmetrical power struggle over the uneven distribution of biomedical knowledge and ignorance (about teratogenic risk) that pitted parent-activists, whistleblowers and investigative journalists against industrialists, scientific experts and government officials. It sheds new light on the nexus of reproduction, disability, epidemiology and health activism in West Germany. In addition, it begins to recover an internationally influential discourse that, in the post-thalidomide world, seems to have resuscitated antenatal drug use as safe until proven harmful.

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Objective: To provide an overview of college health centers' practices surrounding education, counseling and referral after a patient receives a positive pregnancy test. Participants: College health centers that participated in the annual ACHA Pap Test and STI Survey years 2008 to 2014. Methods: Descriptive analyses for items regarding all-options and limited counseling/education and types of referrals (adoption, abortion and prenatal care) provided to students. Chi-square statistics were calculated to examine trends over time and differences between demographic characteristics. Results: There were no significant differences across time but there were significant differences between regions of the US and if the institution was faith-based, though few had strong association values. Conclusions: The results indicate most college health centers are following best practices regarding counseling and education for a positive pregnancy test result. Understanding limitations for those institutions not in compliance require further exploration.

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BACKGROUND/AIMS: The Clinical Trials Coordination and Facilitation Group has issued recommendations on contraception and pregnancy testing to help sponsors meet regulatory expectations and harmonize practices to limit embryofetal risks in clinical trials. Our objective was to assess the compliance of French academic clinical trials with these recommendations and to describe the mitigation measures required by sponsors in their trials. METHODS: A cross-sectional study was performed on the French academic drug trials authorized by the national competent authority between January 2015 and June 2018. We included trials which tested systemic administration of drugs and enrolled men or women of childbearing potential. RESULTS: Data from 97 trials included were compiled. One-third of the trials (23.8%-43.3%, 95% confidence interval) complied with the Clinical Trial Facilitation and Coordination Group recommendations. No improvement over time or according to embryofetotoxic status or drug duration exposure was found. Contraception was required in 56.7% of trials and was more often required in case of potentially embryofetotoxic drugs (68.5% vs 41.9%, p = 0.013) or exposure over 1 month (71.7% vs 43.8%, p = 0.006). Pregnancy testing at inclusion was required in 59.1% of trials and additional testing in 17.2%. Pregnancy testing at inclusion was more often required in trials with drug exposure above 1 month (67.4% vs 45.8%, p = 0.035). CONCLUSION: French academic sponsors barely met the recommendations on contraception and pregnancy testing potentially leading to potential embryofetal risks in case of pregnancy. They need to implement these recommendations quickly.

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Surgery in a patient with unrecognised pregnancy has serious ethical and medicolegal implications. There are no guidelines in India for preoperative pregnancy testing (POPT) in surgical patients. This review was undertaken to ascertain utility of routine POPT and whether any specific indication for POPT could be suggested. We performed a literature search to identify publications pertaining to POPT in surgical patients. Searches included PubMed, Google Scholar and internet search for national guidelines. Studies pertaining to incidence of unrecognised pregnancy, cost-effectiveness of POPT, effect of surgery and anaesthesia on pregnancy are included. We excluded articles which were available in languages other than English and those whose full texts were unavailable. Most of the literature about reproductive outcomes after anaesthesia exposure is based on old data. The evidence for teratogenic effect of anaesthetic drugs on human foetus is still inconclusive. Apart from anaesthesia and surgery, the outcome after surgery in unrecognised pregnant patient depends on other factors such as indication for surgery, high incidence of foetal loss in early pregnancy, stress and lifestyle of patient. As it is difficult to unsnarl the effect of these factors, POPT should be offered to all patients who based on history could be possibly pregnant. The cost-effectiveness of POPT appears doubtful, but considering costs associated with miscarriages and medicolegal litigations due to unclear association with anaesthesia, it may indeed be cost-effective.

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PURPOSE: A presurgical pregnancy testing protocol is recommended to prevent the administration of surgery and anesthesia to women of childbearing years who present for surgery with an undetected pregnancy. It is important to determine the compliance, cost analysis, time required, and barriers to complete a presurgical pregnancy testing protocol. DESIGN: Postimplementation qualitative and quantitative evaluation of a presurgical pregnancy protocol. METHODS: A review of the patient's electronic medical record, survey of the nursing staff, and an administrative interview was conducted 1 year after implementation of the presurgical pregnancy protocol. FINDINGS: Overall presurgical pregnancy protocol compliance was 0.7%. The total labor and equipment costs were $19,033 to $30,202 per year. Nurses reported significant time- and patient-related barriers to execute the protocol. CONCLUSIONS: A pregnancy testing protocol is a valuable safety measure that faces barriers, which can impede compliance. Through the use of simplified protocols, educational interventions for patients and providers, protocol compliance can be increased.

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OBJECTIVES: To identify key delays and associated factors in women's pathway to second-trimester abortion that could inform strategies to increase earlier presentation. STUDY DESIGN: We performed a secondary analysis using data collected from May 2012 to June 2013 as part of a randomized controlled trial among women having abortion at 13.0-20.0 weeks at a public hospital in South Africa. We used ultrasound and participant interview data to calculate 3 key intervals: (1) conception to suspicion of pregnancy, (2) suspicion to first healthcare visit for abortion, and (3) first healthcare visit to abortion procedure. We compared intervals for women at 13-15.0 weeks versus 15.1-20.0 weeks gestation at abortion using Wilcoxon rank-sum tests and tested for associations between gestational age at key events using multivariable linear regression. RESULTS: Median (interquartile range[IQR]) durations for the 3 intervals among women at 13-15 weeks (n=93) compared to 15.1-20 weeks (n=63) gestation were: (1) 36 days (IQR 21-53 days) versus 62 days (36-71 days), p<.001; (2) 29 days (IQR 15-46 days) versus 23 days (IQR 11-39 days), p=.64; (3) 14 days (IQR 7-21 days) versus 14 days (IQR 12-21 days), p=.32. Multivariable logistic regression showed marginal associations between gestational age at suspicion of pregnancy and no prior pregnancy (aOR=3.8, 95% CI 1.0-14.6) and living in informal housing (aOR=3.1, 95% CI 1.0-9.1). Gestational age on the day of the abortion procedure was significantly associated with living in informal housing (aOR=3.1, 95% CI 1.4-6.6). CONCLUSION: The only differences in delay in obtaining second trimester abortion between South African women having an earlier and later second trimester procedure is due to longer time to suspect pregnancy. IMPLICATIONS: Interventions to improve early pregnancy recognition should be explored and referral processes should be streamlined to avoid unnecessary delays accessing abortion care and possibly reduce the proportion of abortions performed later in the second trimester in South Africa.

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Purpose: Chemotherapeutic agents used to treat Hodgkin lymphoma are teratogenic. Pregnancy screening before the start of chemotherapy is supported by clinical guidelines. There are limited data on pregnancy screening before the start of Hodgkin therapy but previous studies suggest that it is not consistently completed. The objective of this study is to evaluate the completion of pregnancy screening before the start of chemotherapy in females with Hodgkin lymphoma. Methods: A retrospective chart review was performed for all female patients, regardless of age, with newly diagnosed Hodgkin lymphoma from 2000 to 2015 at the Hospital for Sick Children. Demographic, disease, and treatment data were captured. Outcome data included completion of pregnancy testing within 2 weeks before the start of therapy and documentation of contraceptive counseling. Results: One hundred twenty-two female patients with Hodgkin lymphoma between the ages of 5 and 17 years were identified. Sixty patients (49%) had ß-human chorionic gonadotropin (ß-HCG) testing done before the start of therapy. Testing modalities included serum and urine qualitative and serum quantitative ß-HCG tests. Older age (p < 0.01), documentation of menstrual status (p = 0.02), and diagnosis between 2008 and 2015 (p < 0.01) were associated with higher incidence of screening, although enrollment on a therapeutic trial was not (p = 0.37). Contraceptive counseling was documented for 19 patients (16%), and 11 patients (9%) were prescribed contraceptive medications. Conclusion: Prechemotherapy pregnancy screening was completed on less than half of females with Hodgkin lymphoma. The adoption of strategies to improve the consistency of pregnancy screening is required.

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Systematic gaps for pregnancy screening and testing of patients with cancer persist. Absent or inconsistent guidelines and policies are barriers to standardized practice. Awareness among oncology nurses is needed to promote safe cancer care, prevent patient harm, and uphold patient-centered care.

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Radiation therapy (RT) can be lethal to a developing fetus; therefore, determining pregnancy status before RT is essential. We here sought to determine how many women treated with RT at our institution for over one year were at risk for pregnancy when starting RT. We retrospectively reviewed the medical records of all female patients 12-55 years old treated with radiation, i.e. 1 October 2012 to 31 September 2013. Patients were categorised as 'at risk' if they had a uterus and 'no risk' if they had a hysterectomy. Documented birth control, pregnancy test status, and timing of the pregnancy test in relation to the radiation start date were recorded. We included 131 female patients with a median age of 48 years (range 14-55 years). Breast cancer was the most prevalent disease site (18%) followed by head/neck and central nervous system (both 11%). Of the 131 patients, 35 were deemed 'no risk' and 95 (72%) were 'at risk'. Pregnancy testing of the 'at risk' population was done in 47%, but only 17% of the pregnancy testing was performed accurately, which we defined as a test performed within 14 days before starting RT. Over one year, 66% (63/95) of 'at risk' women were not tested appropriately before starting RT. Most (66%) women of child-bearing age with an intact uterus receiving RT at our institution were not appropriately tested for pregnancy before the initiation of RT. These data laid the foundation for our formal pregnancy testing policies for women undergoing RT.

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Antigenic domains are defined to contain a limited number of neighboring epitopes recognized by antibodies (Abs) but their molecular relationship remains rather elusive. We thoroughly analyzed the antigenic surface of the important pregnancy and tumor marker human chorionic gonadotropin (hCG), a cystine knot (ck) growth factor, and set antigenic domains and epitopes in molecular relationships to each other. Antigenic domains on hCG, its free hCGα and hCGß subunits are dependent on appropriate inherent molecular features such as molecular accessibility and protrusion indices that determine bulging structures accessible to Abs. The banana-shaped intact hCG comprises ∼7500Å(2) of antigenic surface with minimally five antigenic domains that encompass a continuum of overlapping non-linear composite epitopes, not taking into account the C-terminal peptide extension of hCGß (hCGßCTP). Epitopes within an antigenic domain are defined by specific Abs, that bury nearly 1000Å(2) of surface accessible area on the antigen and recognize a few up to 15 amino acid (aa) residues, whereby between 2 and 5 of these provide the essential binding energy. Variability in Ab binding modes to the contact aa residues are responsible for the variation in affinity and intra- and inter-species specificity, e.g. cross-reactions with luteinizing hormone (LH). Each genetically distinct fragment antigen binding (Fab) defines its own epitope. Consequently, recognition of the same epitope by different Abs is only possible in cases of genetically identical sequences of its binding sites. Due to combinatorial V(D)J gene segment variability of heavy and light chains, Abs defining numerous epitopes within an antigenic domain can be generated by different individuals and species. Far more than hundred Abs against the immuno-dominant antigenic domains of either subunit at both ends of the hCG-molecule, the tips of peptide loops one and three (L1+3) protruding from the central ck, encompassing hCGßL1+3 (aa 20-25+64+68-81) and hCGαL1 (aa 13-22; Pro16, Phe17, Phe18) plus hCGαL3 (Met71, Phe74), respectively, have been identified in the two "ISOBM Tissue Differentiation-7 Workshops on hCG and Related Molecules" and in other studies. These Abs recognize distinct but overlapping epitopes with slightly different specificity profiles and affinities. Heterodimeric-specific epitopes involve neighboring αL1 plus ßL2 (hCGß44/45 and 47/48). Diagnostically important Abs recognize the middle of the molecule, the ck (aa Arg10, Arg60 and possibly Gln89) and the linear hCGßCTP "tail" (aa 135-145; Asp139, Pro144, Gln145), respectively. Identification of antigenic domains and of specific epitopes is essential for harmonization of Abs in methods that are used for reliable and robust hCG measurements for the management of pregnancy, pregnancy-related disease and tumors.

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Routine preoperative testing is not cost-effective, because it is unlikely to identify significant abnormalities. Abnormal findings from routine testing are more likely to be false positive, are costly to pursue, introduce a new risk, increase the patient's anxiety, and are inconvenient to the patient. Abnormal findings rarely alter the surgical or anesthetic plan, and there is usually no association between perioperative complications and abnormal laboratory results. Incidental findings and false positive results may lead to increased hospital visits and admissions. Preoperative testing needs to be done based on a targeted history and physical examination and the type of surgery.

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