Effect of a Home Pregnancy Test Intervention on Cohort Retention and Pregnancy Detection: A Randomized Trial.

We conducted a parallel, nonblinded randomized trial to assess whether offering home pregnancy tests (HPTs) to preconception cohort study participants influenced cohort retention or pregnancy detection. Pregnancy Study Online participants were female, aged 21-45 years, attempting pregnancy, and not using fertility treatment. At enrollment (2017-2018), 1,493 participants with 6 or fewer cycles of attempt time were randomly assigned with 50% probability to receive 12 Clearblue visual HPTs plus the standard protocol (n = 720) or the standard protocol alone (n = 773). Women completed bimonthly questionnaires for 12 months or until conception, whichever came first. In intent-to-treat analyses, retention (≥1 follow-up) was higher in the HPT arm (n = 598; 83%) than the standard protocol arm (n = 535 (69%); mean difference = 15%, 95% CI: 10, 19). Mean time at first pregnancy testing was identical in both arms (2 days before expected menses), as was mean gestational weeks at first positive pregnancy test (4 weeks). Conception was reported by 78% of women in the HPT arm and 75% in the standard protocol arm. Spontaneous abortion was reported by 21% in the HPT arm (mean gestational weeks = 7) and 21% in the standard protocol arm (mean gestational weeks = 6). Randomization of HPTs was associated with greater cohort retention but had little impact on incidence or timing of pregnancy detection.

Do home pregnancy tests bring women to community health workers for antenatal care counselling? A randomized controlled trial in Madagascar.

Task-shifting the provision of pregnancy tests to community health workers (CHWs) in low-resource settings has the potential to reach significantly more underserved women at risk of pregnancy with essential reproductive health services. This study assessed whether an intervention to supply CHWs with home pregnancy tests brought more clients for antenatal care (ANC) counselling. We implemented a randomized controlled trial among CHWs providing reproductive health services to women in Eastern Madagascar. We used ordinary least squares regressions to estimate the effect of the intervention, with district- and month-fixed effects and CHW baseline characteristics as control variables. Our outcomes of interest included whether the intervention increased: (1) the number of women at risk of pregnancy who sought services from CHWs; (2) the number of these women who knew they were pregnant by the end of visit; and (3) the number of these women who received ANC counselling during visit. We found that providing pregnancy tests to CHWs to distribute to their clients for free significantly increased the number of women at risk of pregnancy who sought services from CHWs. At follow-up, treatment-group CHWs provided services to 6.3 clients compared with 4.2 clients among control-group CHWs, which represents a 50% relative increase from the control-group mean. A significantly higher number of these clients knew they were pregnant by the end of the visit, with a mean of 0.95 in treatment compared with 0.10 in control (Coeff. 0.86; 95% CI 0.59-1.13). A significantly higher number of these clients received antenatal counselling at the visit (Coeff. 0.4; 95% CI 0.14-0.64). Introducing free home pregnancy tests as part of community-based health services can improve pregnancy care by attracting more clients at risk of pregnancy to services at the community level, enabling more women to confirm they are pregnant and receive antenatal counselling.

Overreliance on Cost Reduction as a Featured Element of Sensor Design.

In this Perspective, we examine the role of cost in sensor design, its meaning within the context of converting academic prototypes into commercial products, and the importance of these issues to clear scientific communication. The possible motivations to consider the cost of a technology, sensor, or assay are both numerous and apparent. However, the idea that the cost of reagents and materials at the laboratory scale will directly translate to the purchase price for a user is inaccurate. While calculating the bill of materials is easy, there are many business considerations that make commercial products entirely different from academic prototypes. With these critical aspects of commercialization considered, academics are often not equipped to predict what the final price of an assay, sensor, or instrument will be to the end user. When used without proper context and accuracy, an overreliance on the phrase "low cost" in the absence of a sufficient discussion of cost weakens the meaning of this popular term and precludes practical scientific advancements. To demonstrate how the relationship between a bill of materials and "expected purchase price" breaks down when considering academic innovations, we discuss pregnancy tests as a case study where an academic bill of materials can lead to both overestimations and underestimations of pricing.

Cost-effectiveness analysis and mortality impact estimation of scaling-up pregnancy test kits in Madagascar, Ethiopia and Malawi.

Cost-effective, innovative approaches are needed to accelerate progress towards ending preventable infant, child and maternal mortality. To inform policy decisions, we conducted a cost-effectiveness analysis of adding urine pregnancy test kits to the maternal and reproductive services package offered at the community level in Madagascar, Ethiopia and Malawi. We used a decision tree model to compare the intervention with the status quo for each country. We also completed single factor sensitivity analyses and Monte Carlo simulations with 10 000 iterations to generate the probability distribution of the estimates and uncertainty limits. Among a hypothetical cohort of 100 000 women of reproductive age, we estimate that over a 1-year period, the intervention would save 26, 35 and 48 lives in Madagascar, Ethiopia, and Malawi, respectively. The Incremental Cost Effectiveness Ratio (ICER) for the cost per life saved varies by country: $2311 [95% Uncertainty Interval (UI): $1699; $3454] in Madagascar; $2969 [UI: $2260; $5041] in Ethiopia and $1228 [UI: $918; $1777] in Malawi. This equates to an average cost per Disability Adjusted Life Year (DALY) averted of $36.28, $47.95 and $21.92, respectively. Based on WHO criteria and a comparison with other maternal, newborn, and child health interventions, we conclude that the addition of urine pregnancy tests to an existing community health worker maternal and reproductive services package is highly cost-effective in all three countries. To optimize uptake of family planning and antenatal care services and, in turn, accelerate the reduction of mortality and DALYs, decision makers and program planners should consider adding urine pregnancy tests to the community-level package of services.

Providing free pregnancy test kits to community health workers increases distribution of contraceptives: results from an impact evaluation in Madagascar.

OBJECTIVES: To improve access to contraceptives in remote and rural areas, sub-Saharan African countries are allowing community health workers (CHWs) to distribute hormonal contraceptives. Before offering hormonal contraceptives, CHWs must determine pregnancy status but often lack a reliable way to do so. No studies have evaluated the impact of providing CHWs with urine pregnancy test kits. We assessed the impact of giving CHWs free pregnancy test kits on the number of new clients purchasing hormonal contraceptives from CHWs. STUDY DESIGN: We implemented a randomized experiment in Eastern Madagascar among CHWs who sell injectable and oral hormonal contraceptives. A total of 622 CHWs were stratified by region and randomly assigned at the individual level. Treatment-group CHWs were given free pregnancy tests to distribute (n analyzed=272) and control-group CHWs did not receive the tests (n analyzed=263). We estimated an ordinary least-squares regression model, with the monthly number of new hormonal contraceptive clients per CHW as our primary outcome. RESULTS: We find that providing CHWs with free pregnancy test kits increases the number of new hormonal contraceptive clients. Treatment-group CHWs provide hormonal contraceptives to 3.1 new clients per month, compared to 2.5 in the control group. This difference of 0.7 clients per month (95% confidence interval 0.13-1.18; p=.014) represents a 26% increase. CONCLUSIONS: Giving CHWs free pregnancy tests is an effective way to increase distribution of hormonal contraceptives. As pregnancy tests become increasingly affordable for health-care systems in developing countries, community-based distribution programs should consider including the tests as a low-cost addition to CHWs' services. IMPLICATIONS: No study has evaluated the impact of giving CHWs free urine pregnancy test kits for distribution to improve provision of hormonal contraceptives. Giving CHWs free pregnancy test kits significantly increases the number of clients to whom they sell hormonal contraceptives. Community-based distribution programs should consider including these tests among CHWs' services.

Free pregnancy testing increases maternity care volume in family medicine residencies.

BACKGROUND AND OBJECTIVES: Increased prenatal volume in family medicine residencies is associated with a higher proportion of graduates including maternity care in their post-residency practices. However, family medicine residencies struggle just to meet the Residency Review Committee's minimum requirements for maternity care volume. Our objective was to evaluate the effectiveness of free pregnancy testing on increasing maternity care volume in our residency. METHODS: In this before-after intervention study, free pregnancy testing was offered at the residency's Family Health Center (FHC) from May 2011 through November 2012 to established patients and non-patients. Participants with positive tests were provided information on maternity care and an opportunity to schedule an initial prenatal visit. The primary outcome was the percentage of self-referred patients who established prenatal care at FHC. RESULTS: Over 19 months, 241 tests were performed on 224 women with a mean age of 26.2±6.3. Over half were minorities (130 [58%]). Most were under-insured or uninsured (193 [86.1%]). Ninety-nine women (41.1%) had positive tests; 74 of these 99 women (74.7%) established prenatal care at FHC, and 57 of these 74 women (77%) were new patients. The number of obstetric patients increased 13% from 405 to 456 patients. The percentage of self-referred patients increased from 31.9% to 40.8% (P<.001). The total cost of 241 pregnancy tests was $256.24, and maternity care revenue for just one patient was $1,553. CONCLUSIONS: The program's return on investment is favorable. Offering free pregnancy testing is a simple and inexpensive way to increase maternity care volume in a family medicine residency.

Cost benefit analysis of same day pregnancy tests in elective orthopaedic surgery.

UNLABELLED: We reviewed the results of 4,723 day of surgery pregnancy tests performed at two of our institution's locations, our ambulatory surgery center and our acute orthopaedics hospital over a 23 month time period. All patients were scheduled for elective orthopaedic surgery. There were seven positive results (0.15%) and one false negative result (0.02%). The cost per positive result for both hospital locations was $1,005.32. INTRODUCTION: Performing elective surgery on pregnant women can harm the mother and fetus. In order to minimize the likelihood of this happening, we administer a urine pregnancy test to each woman of childbearing age on the date of surgery. From November 2009 to September 2011, we performed 4,723 urine human chorionic gonadotropin (hCG) pregnancy tests on the day of surgery. We reviewed the results and cost of each pregnancy test. We then used these results to calculate the percentage of positive tests and the cost of diagnosing each pregnant female on the date of their surgery. METHODS: We obtained the records of all urine hCG pregnancy tests performed from November 2009 to September 2011. Each test was reviewed to determine if the result was positive or negative. Costs were calculated using the charges incurred for a qualitative hCG pregnancy test. We then contacted each patient with a positive result to determine if the urine hCG test results were accurate. RESULTS: 4,723 pregnancy tests were reviewed over a 23 month period with 7 (0.15%) having a positive result. Over the 23 month time period, we were notified of one false negative result (0.02%). The Positive Predictive Value (PPV) was 100% and the Negative Predictive Value (NPV) was 99.9%. The cost of a single urine hCG test was $1.49, the total cost for all 4,723 tests was $7,037.27. The cost of diagnosing 7 positive tests was $1,005.32. CONCLUSION: Routinely performing urine hCG pregnancy tests on the day of surgery is a cost effective method of preventing elective orthopaedic surgery on pregnant women. Of 4,723 women tested 7 had a positive result and 1 had a false negative result. The cost of $1,005.32 for each positive test must be compared with the benefit of not performing elective surgery on a pregnant female.

Health consumption as work: the home pregnancy test as a domesticated health tool.

A growing array of biomedical goods and services has become central to the North American experience of navigating illness and pursuing good health. Yet despite the utility of consumption as an analytical framework within the social sciences, the selection, purchase, and use of biomedical goods and services has been understudied. By using the home pregnancy test as a case study, we suggest new approaches to thinking about the consumption of these goods and services. We chose the home pregnancy test because it is the best-known example of a mass-produced diagnostic tool used by consumers. We draw on two sources of data for this qualitative analysis: a set of stories submitted between 2003 and 2005 by women and men to an online exhibit mounted by the National Institutes of Health called "A Thin Blue Line: The History of the Pregnancy Test Kit," which we analysed between 2006 and 2007; and web sampling conducted in 2009 and 2010 of personal web and video logs of women and men who have posted stories and opinions about their experiences with contemporary home pregnancy testing products. We adapt the term "domestication" from Science and Technology Studies scholarship to describe the movement of diagnostic devices into homes for use by consumers. Specifically, we propose that the consumption of domesticated biomedical devices, goods, and services should be theorized as work performed by consumers, in two senses: as a form of tool use that allows non-experts to produce diagnostic knowledge about their own bodies and health; and as the ongoing biopolitical work that is expected of citizens to produce healthy bodies. Our paper draws attention to these understudied phenomena, while suggesting new approaches to theorizing the social and cultural elements of goods and services for health.

Economics of resynchronization strategies including chemical tests to identify nonpregnant cows.

Our objectives were to assess (1) the economic value of decreasing the interval between timed artificial insemination (TAI) services when using a pregnancy test that allows earlier identification of nonpregnant cows; and (2) the effect of pregnancy loss and inaccuracy of a chemical test (CT) on the economic value of a pregnancy test for dairy farms. Simulation experiments were performed using a spreadsheet-based decision support tool. In experiment 1, we assessed the effect of changing the interbreeding interval (IBI) for cows receiving TAI on the value of reproductive programs by simulating a 1,000-cow dairy herd using a combination of detection of estrus (30 to 80% of cows detected in estrus) and TAI. The IBI was incremented by 7d from 28 to 56 d to reflect intervals either observed (35 to 56 d) or potentially observed (28 d) in dairy operations. In experiment 2, we evaluated the effect of accuracy of the CT and additional pregnancy loss due to earlier testing on the value of reproductive programs. The first scenario compared the use of a CT 31 ± 3 d after a previous AI with rectal palpation (RP) 39 ± 3 d after AI. The second scenario used a CT 24 ± 3 d after AI or transrectal ultrasound (TU) 32 d after AI. Parameters evaluated included sensitivity (Se), specificity (Sp), questionable diagnosis (Qd), cost of the CT, and expected pregnancy loss. Sensitivity analysis was performed for all possible combinations of parameter values to determine their relative importance on the value of the CT. In experiment 1, programs with a shorter IBI had greater economic net returns at all levels of detection of estrus, and use of chemical tests available on the market today might be beneficial compared with RP. In experiment 2, the economic value of programs using a CT could be either greater or less than that of RP and TU, depending on the value for each of the parameters related to the CT evaluated. The value of the program using the CT was affected (in order) by (1) Se, (2) Sp, (3) pregnancy loss, (4) proportion of Qd, (5) percentage of cows AI in estrus, and (6) cost of CT. A change of 1% in the Se of the CT was 1.8 times more important than a similar change in Sp or pregnancy loss, and 13.7, 55.0, and 305.8 times more important than similar changes in Qd, cows inseminated in estrus, and cost of CT. We conclude that the major effect of using a CT is the potential of decreasing the IBI. Moreover, inaccuracy of the CT and additional pregnancy loss due to earlier testing resulted in smaller economic differences than when using RP or TU 8d later.

Patient history and physician suspicion accurately exclude pregnancy.

OBJECTIVES: Reliance upon patient assessment in excluding pregnancy is questionable. Physicians are encouraged to obtain pregnancy tests in all women of childbearing age. We affirmed the accuracy of women and their physicians in predicting pregnancy. METHODS: This was a prospective, observational study performed in a suburban academic emergency department on adult women with an ordered pregnancy test. A standardized gynecologic history was obtained by trained research assistants. Subjects estimated their likelihood of pregnancy as impossible, possible, or definite. Emergency department physicians estimated the likelihood of pregnancy as high, moderate, or low. All women had either a serum or urine ß-human chorionic antigen. The diagnostic characteristics of patient and physician predictions of pregnancy were calculated with 95% confidence intervals (CIs). RESULTS: We enrolled 377 subjects. Median age was 29 (interquartile range, 22-37) years. Twelve percent of the women were pregnant. Women's estimates of pregnancy were as follows: impossible, 64.7%; possible, 22.5%; and definite, 12.7%. The pregnancy rates among women with estimates of impossible, possible, and definite were 0% (95% CI, 0%-1.5%), 4.7% (95% CI, 1.9%-11.5%), and 89.6% (95% CI, 77.8%-95.5%) (P < .001). Physicians' suspicions of pregnancy were high (13.7%), moderate (11.3%), and low (75.1%). The rate of pregnancy among low, moderate, and high physician suspicion groups were 0% (95% CI, 0%-1.4%), 9.5% (95% CI, 3.8%-22%), and 84.3% (95% CI, 72%-92%) (P < .001). CONCLUSIONS: There were no pregnancies among women who estimated pregnancy as impossible or whose physicians thought that the likelihood of pregnancy was low. Routine pregnancy testing before radiological imaging and medication administration may not be required in adult women of childbearing age.

A detailed cost analysis of in vitro fertilization and intracytoplasmic sperm injection treatment.

OBJECTIVE: To provide detailed information about costs of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) treatment stages and to estimate the cost per IVF and ICSI treatment cycle and ongoing pregnancy. DESIGN: Descriptive micro-costing study. SETTING: Four Dutch IVF centers. PATIENT(S): Women undergoing their first treatment cycle with IVF or ICSI. INTERVENTION(S): IVF or ICSI. MAIN OUTCOME MEASURE(S): Costs per treatment stage, per cycle started, and for ongoing pregnancy. RESULT(S): Average costs of IVF and ICSI hormonal stimulation were euro 1630 and euro 1585; the costs of oocyte retrieval were euro 500 and euro 725, respectively. The cost of embryo transfer was euro 185. Costs per IVF and ICSI cycle started were euro 2381 and euro 2578, respectively. Costs per ongoing pregnancy were euro 10,482 and euro 10,036, respectively. CONCLUSION(S): Hormonal stimulation covered the main part of the costs per cycle (on average 68% and 61% for IVF and ICSI, respectively) due to the relatively high cost of medication. The costs of medication increased with increasing age of the women, irrespective of the type of treatment (IVF or ICSI). Fertilization costs (IVF laboratory) constituted 12% and 20% of the total costs of IVF and ICSI. The total cost per ICSI cycle was 8.3% higher than IVF.

Urinary-based ovulation and pregnancy: point-of-care testing.

OBJECTIVE: To review the literature concerning ovulation prediction devices and pregnancy detection tests for home use. DATA SOURCES: Articles were identified through searches of the MEDLINE (1966-May 2003), EMBASE (1980-May 2003), and International Pharmaceutical Abstracts (1970-May 2003) databases using the key words ovulation, ovulation detection, pregnancy test, diagnostic reagent kit, and diagnostic test. Additional references were located through review of the bibliographies of the articles found in the literature search. Searches were not limited by time restriction, language, or use of human or animal subjects. STUDY SELECTION AND DATA EXTRACTION: Review articles, textbook chapters, and experimental and observational studies on home use ovulation and pregnancy tests were selected. DATA SYNTHESIS: Luteinizing hormone (LH)-based ovulation tests have demonstrated accurate and superior ovulation detection when compared to basal body temperature charting, calendar calculation, salivary ferning, or observation of vaginal or cervical discharge changes. Systems using LH and estrone-3-glucuronide (E3G) have also demonstrated accurate detection of the fertile period. Literature evaluating home use of pregnancy tests has demonstrated accurate use by lay persons. CONCLUSIONS: Urinary-based ovulation prediction and pregnancy detection tests available for use by nonprofessionals enable women and couples to take an active role in the family planning process. Numerous products are available at reasonable costs to the consumer.

When the test really counts: part one: earliest pregnancy detection.

We tested 18 pregnancy-test kits to find out which brands work best. Buy the top performers and follow our tips for the most accurate results.

Home and laboratory pregnancy-testing kits.

Home pregnancy test kits are more sensitive than many pregnancy kits used in laboratories or health centres. Nurses should know the sensitivity of the kit used in their centre or laboratory. A positive home pregnancy test should always be treated as the correct result until sufficient tests have been carried out to prove otherwise.

Preoperative pregnancy testing: a survey of current practice.

STUDY OBJECTIVE: To examine contemporary practices and opinions regarding preoperative testing requirements, with special emphasis on perioperative pregnancy recognition and consequences thereof. DESIGN AND SETTING: Anonymous questionnaire survey distributed to 300 (almost exclusively American) physicians attending the 1996 Society of Obstetric Anesthesia and Perinatology meeting. MEASUREMENTS AND MAIN RESULTS: Responses from 169 anesthesiologists indicated that approximately one-third mandated pregnancy testing via departmental policy. More anesthesiologists (p = 0.02) mandated routine pregnancy testing of all elective (30%) versus all emergency (17%) surgical patients. Sixty-six percent versus 20% percent, respectively, would require rather than simply offer pregnancy testing when history indicated possible pregnancy; 20% and 15%, respectively, of those surveyed indicated elective surgery would be canceled by the anesthesiologist if the patient were pregnant or refused testing (p = NS). Although 98% of respondents recognized a legal requirement to report child abuse, and 82% believed pregnancy in a juvenile (i.e., the child's age is under local legal defined age for consent to sex) by definition constituted child abuse, fewer than 4% would report this information to the police, even if the impregnating male were known to be an adult. CONCLUSIONS: The desire to identify pregnancy using patient history was most prevalent among anesthesiologists, with less than one third using mandatory, departmentally imposed screening programs. Positive test results in minors are shared primarily with surgeons and patients, occasionally with parents and social services, but rarely with police, although a positive test almost universally signified child abuse, and mandatory reporting laws were acknowledged by anesthesiologists surveyed.