Continuation of Reversible Contraception Following Enrollment in the Zika Contraception Access Network (Z-CAN) in Puerto Rico, 2016-2020.

The Zika Contraception Access Network (Z-CAN) provided access to high-quality client-centered contraceptive services across Puerto Rico during the 2016-2017 Zika virus outbreak. We sent online surveys during May 2017-August 2020 to a subset of Z-CAN patients at 6, 24, and 36 months after program enrollment (response rates: 55-60 percent). We described contraceptive method continuation, method satisfaction, and method switching, and we identified characteristics associated with discontinuation using multivariable logistic regression. Across all contraceptive methods, continuation was 82.5 percent, 64.2 percent, and 49.9 percent at 6, 24, and 36 months, respectively. Among continuing users, method satisfaction was approximately ≥90 percent. Characteristics associated with decreased likelihood of discontinuation included: using an intrauterine device or implant compared with a nonlong-acting reversible contraceptive method (shot, pills, ring, patch, or condoms alone); wanting to prevent pregnancy at follow-up; and receiving as their baseline method the same method primarily used before Z-CAN. Other associated characteristics included: receiving the method they were most interested in postcounseling (6 and 24 months) and being very satisfied with Z-CAN services at the initial visit (6 months). Among those wanting to prevent pregnancy at follow-up, about half reported switching to another method. Ongoing access to contraceptive services is essential for promoting reproductive autonomy, including supporting patients with continued use, method switching, or discontinuation.

A Randomized Controlled Trial of Clinical Hypnosis as an Opioid-Sparing Adjunct Treatment for Pain Relief in Adults Undergoing Major Oncologic Surgery.

Clinical hypnosis is an effective strategy for managing acute pain in the surgical setting. However, the opioid sparing effects of clinical hypnosis are not as well understood. This pre-registered (NCT03730350) randomized, controlled trial (RCT) examined the impact of clinical hypnosis, pre- and post-surgery, on opioid consumption during hospitalization as well as on measures of pain intensity, pain interference, depressed mood, anxiety, sleep, and pain catastrophizing. Participants (M = 57.6 years; SD = 10.9) awaiting oncologic surgery were randomized to treatment-as-usual (n = 47) or hypnosis (n = 45). Intent-to-treat analyses were conducted using linear mixed effects modeling. A significant Group × Time interaction, F(6, 323.34) = 3.32, p = 0.003, indicated an opioid sparing effect of clinical hypnosis during the acute postoperative period. Hypnosis also protected against increases in pain catastrophizing at one-week after surgery, F (1, 75.26) = 4.04, p = 0.048. A perioperative clinical hypnosis intervention had a sparing effect on opioid consumption in-hospital after major oncologic surgery. These findings extend the efficacy of clinical hypnosis as an adjunct tool for perioperative pain management.

Changes in Commercial Insurance Claims for Contraceptive Services During the Beginning of the COVID-19 Pandemic-United States, January 2019-September 2020.

OBJECTIVE: We describe changes in commercial insurance claims for contraceptive services during the beginning of the COVID-19 pandemic. METHODS: We analyzed commercial insurance claims using IQVIA PharMetrics Plus data from more than 9 million U.S. females aged 15-49 years, enrolled during any month, January 2019 through September 2020. We calculated monthly rates of outpatient claims for intrauterine devices (IUDs), implants, and injectable contraception and monthly rates of pharmacy claims for contraceptive pills, patches, and rings. We used Joinpoint regression analysis to identify when statistically significant changes occurred in trends of monthly claims rates for each contraceptive method. We calculated monthly percentages of claims for contraceptive counseling via telehealth. RESULTS: Monthly claims rates decreased for IUDs (-50%) and implants (-43%) comparing February 2020 with April 2020 but rebounded by June 2020. Monthly claims rates for injectables decreased (-19%) comparing January 2019 with September 2020, and monthly claims rates for pills, patches, and rings decreased (-22%) comparing July 2019 with September 2020. The percentage of claims for contraceptive counseling occurring via telehealth was low (<1%) in 2019, increased to 34% in April 2020, and decreased to 9-12% in June-September 2020. CONCLUSIONS: Substantial changes in commercial insurance claims for contraceptive services occurred during the beginning of the COVID-19 pandemic, including transient decreases in IUD and implant claims and increases in telehealth contraceptive counseling claims. Contraceptive claims data can be used by decision makers to identify service gaps and evaluate use of interventions like telehealth to improve contraceptive access, including during public health emergencies.

Trial protocol for a multicenter randomized controlled trial to assess the efficacy and safety of intravenous ketamine for chronic daily headaches: the "KetHead" trial.

BACKGROUND: Chronic daily headaches (CDH) are common and associated with significant morbidity, poor quality of life, and substantial burden on the healthcare system. CDH tends to be refractory to conventional medical management and/or patients cannot afford expensive treatments. It is stipulated that CDH share a mechanism of central sensitization in the trigeminocervical complex, mediated by activation of the N-methyl-D-aspartate (NMDA) receptors. Ketamine, a non-competitive NMDA antagonist, has been used in the treatment of chronic pain, but its role in CDH has not been completely established. This trial aims to evaluate the effect of high-dose IV ketamine infusions (compared to placebo) on the number of headache days at 28 days post-infusion. METHODS: A multicenter, placebo-controlled, randomized controlled trial will be conducted with two parallel groups and blinding of participants and outcome assessors. The study will include 56 adults with a CDH diagnosis as per ICHD-3 criteria. Participants will be randomized (1:1) to either ketamine (1 mg. kg-1 bolus followed by infusion of 1 mg. kg-1. h-1 for 6 h) or placebo (0.9% saline in the same volume and infusion rate as the trial medication) bolus and infusion for 6 h. The impact on the number of monthly headache days, headache intensity, physical activity, mood, sleep, quality of life, analgesic consumption, and adverse effects will be recorded at baseline, immediately post-infusion, and from 1 to 28 days, 29 to 56 days, and 57 to 84 days after the infusion DISCUSSION: Despite advancements in treatment, many patients continue to suffer from CDH. This trial investigates whether high-dose IV ketamine infusions can effectively and safely improve the CDH burden as compared to a placebo infusion. This treatment could become a safe, affordable, and widely available option for patients living with refractory headache. TRIAL REGISTRATION: ClinicalTrials.gov NCT05306899. Registered on April 1, 2022.

Is the COVID-19 Pandemic Continuing to Impact Sexual and Reproductive Health Services for Adolescents? Findings From a 2021 Survey of US Physicians.

PURPOSE: We examined the impact of the COVID-19 pandemic in Fall 2021 on sexual and reproductive health (SRH) services among physicians whose practice provided these services to adolescents just before the pandemic. METHODS: Data were from the DocStyles online panel survey administered September-November 2021 to US physicians who reported their practice provided SRH services to adolescent patients before the pandemic (n = 948). We calculated prevalence of service delivery challenges (e.g., limited long-acting reversible contraception services) and use of strategies to support access (e.g., telehealth) in the month prior to survey completion, compared these estimates with prevalence "at any point during the COVID-19 pandemic", and examined differences by physician specialty and adolescent patient volume. RESULTS: Fewer physicians reported their practice experienced service delivery challenges in the month prior to survey completion than at any point during the pandemic. About 10% indicated limited long-acting reversible contraception and sexually transmitted infection testing services in the prior month overall; prevalence varied by physician specialty (e.g., 26% and 17%, respectively by service, among internists). Overall, about 25% of physicians reported reductions in walk-in hours, weekend/evening hours, and adolescents seeking care in the prior month. While most practices that initiated strategies supporting access to services during the pandemic used such strategies in the prior month, some practices (22%-37% depending on the strategy) did not. DISCUSSION: Findings suggest some physicians who serve adolescents continued to experience challenges providing SRH services in the Fall 2021, and some discontinued strategies to support access that had been initiated during the pandemic.

Contraception claims by medication for opioid use disorder prescription status among insured women with opioid use disorder, United States, 2018.

OBJECTIVE(S): To understand how contraception method use differed between women prescribed and not prescribed medications for opioid use disorder (MOUD) among commercially-insured and Medicaid-insured women. STUDY DESIGN: IBM Watson Health MarketScan Commercial Claims and Encounters database and the Multi-State Medicaid database were used to calculate the (1) crude prevalence, and (2) adjusted odds ratios (adjusted for demographic characteristics) of using long-acting reversible or short-acting hormonal contraception methods or female sterilization compared with none of these methods (no method) in 2018 by MOUD status among women with OUD, aged 20 to 49 years, with continuous health insurance coverage through commercial insurance or Medicaid for ≥6 years. Claims data was used to define contraception use. Fisher exact test or χ2 test with a P-value ≤ 0.0001, based on the Holm-Bonferroni method, and 95% confidence intervals were used to determine statistically significant differences for prevalence estimates and adjusted odds ratios, respectively. RESULTS: Only 41% of commercially-insured and Medicaid-insured women with OUD were prescribed MOUD. Medicaid-insured women with OUD prescribed MOUD had a significantly lower crude prevalence of using no method (71.1% vs 79.0%) and higher odds of using female sterilization (aOR, 1.33; 95% CI: 1.06-1.67 vs no method) than those not prescribed MOUD. Among commercially-insured women there were no differences in contraceptive use by MOUD status and 66% used no method. CONCLUSIONS: Among women with ≥ 6 years of continuous insurance coverage, contraceptive use differed by MOUD status and insurance. Prescribing MOUD for women with OUD can be improved to ensure quality care. IMPLICATIONS: Only two in five women with OUD had evidence of being prescribed MOUD, and majority did not use prescription contraception or female sterilization. Our findings support opportunities to improve prescribing for MOUD and integrate contraception and MOUD services to improve clinical care among women with OUD.

Intrauterine Device Training, Attitudes, and Practices Among U.S. Health Care Providers: Findings from a Nationwide Survey.

BACKGROUND: Provider training in intrauterine device (IUD) procedures is a key strategy for improving evidence-based IUD care. We examined the influence of IUD training on IUD attitudes and practices among U.S. family planning providers. METHODS: In 2019, we conducted a cross-sectional survey of U.S. family planning providers. We performed logistic regression to examine associations between training in routine IUD placement and specific IUD safety attitudes, confidence performing IUD procedures, and specific IUD practices. RESULTS: Among 1,063 physicians and advanced practice clinicians, 85.1% reported training in routine IUD placement. Overall, IUD training was associated with accurately stating IUDs are safe for queried groups, including patients immediately postpartum (prevalence ratio [PR] 4.22; 95% confidence interval [CI] 1.29-13.85). Trained providers reported higher confidence in routine IUD placement for parous (PR 7.71; 95% CI 1.31-45.3) and nulliparous (PR 7.12; 95% CI 1.17-43.5) women and in IUD removal (PR 2.06; 95% CI 1.12-3.81). Among providers with IUDs available onsite, IUD training was associated with frequent same-day IUD provision for adults (PR 7.32; 95% CI 2.16-24.79) and adolescents (PR 7.63; 95% CI 2.22-26.24). Trained providers were also less likely to routinely use misoprostol before IUD placement for nulliparous (PR 0.19; 95% CI 0.11-0.33) and parous women (PR 0.07; 95% CI 0.03-0.16). CONCLUSION: Training in routine IUD placement was associated with evidence-based IUD safety attitudes, confidence in performing IUD procedures, and clinical practices aligned with Centers for Disease Control and Prevention contraception guidance. Expanding IUD training might increase evidence-based care and patient access to the full range of contraception, including IUDs.

Immediate oral versus immediate topical versus delayed oral antibiotics for children with acute otitis media with discharge: the REST three-arm non-inferiority electronic platform-supported RCT.

BACKGROUND: Acute otitis media is a painful infection of the middle ear that is commonly seen in children. In some children, the eardrum spontaneously bursts, discharging visible pus (otorrhoea) into the outer ear. OBJECTIVE: To compare the clinical effectiveness of immediate topical antibiotics or delayed oral antibiotics with the clinical effectiveness of immediate oral antibiotics in reducing symptom duration in children presenting to primary care with acute otitis media with discharge and the economic impact of the alternative strategies. DESIGN: This was a pragmatic, three-arm, individually randomised (stratified by age < 2 vs. ≥ 2 years), non-inferiority, open-label trial, with economic and qualitative evaluations, supported by a health-record-integrated electronic trial platform [TRANSFoRm (Translational Research and Patient Safety in Europe)] with an internal pilot. SETTING: A total of 44 English general practices. PARTICIPANTS: Children aged ≥ 12 months and < 16 years whose parents (or carers) were seeking medical care for unilateral otorrhoea (ear discharge) following recent-onset (≤ 7 days) acute otitis media. INTERVENTIONS: (1) Immediate ciprofloxacin (0.3%) solution, four drops given three times daily for 7 days, or (2) delayed 'dose-by-age' amoxicillin suspension given three times daily (clarithromycin twice daily if the child was penicillin allergic) for 7 days, with structured delaying advice. All parents were given standardised information regarding symptom management (paracetamol/ibuprofen/fluids) and advice to complete the course. COMPARATOR: Immediate 'dose-by-age' oral amoxicillin given three times daily (or clarithromycin given twice daily) for 7 days. Parents received standardised symptom management advice along with advice to complete the course. MAIN OUTCOME MEASURE: Time from randomisation to the first day on which all symptoms (pain, fever, being unwell, sleep disturbance, otorrhoea and episodes of distress/crying) were rated 'no' or 'very slight' problem (without need for analgesia). METHODS: Participants were recruited from routine primary care appointments. The planned sample size was 399 children. Follow-up used parent-completed validated symptom diaries. RESULTS: Delays in software deployment and configuration led to small recruitment numbers and trial closure at the end of the internal pilot. Twenty-two children (median age 5 years; 62% boys) were randomised: five, seven and 10 to immediate oral, delayed oral and immediate topical antibiotics, respectively. All children received prescriptions as randomised. Seven (32%) children fully adhered to the treatment as allocated. Symptom duration data were available for 17 (77%) children. The median (interquartile range) number of days until symptom resolution in the immediate oral, delayed oral and immediate topical antibiotic arms was 6 (4-9), 4 (3-7) and 4 (3-6), respectively. Comparative analyses were not conducted because of small numbers. There were no serious adverse events and six reports of new or worsening symptoms. Qualitative clinician interviews showed that the trial question was important. When the platform functioned as intended, it was liked. However, staff reported malfunctioning software for long periods, resulting in missed recruitment opportunities. Troubleshooting the software placed significant burdens on staff. LIMITATIONS: The over-riding weakness was the failure to recruit enough children. CONCLUSIONS: We were unable to answer the main research question because of a failure to reach the required sample size. Our experience of running an electronic platform-supported trial in primary care has highlighted challenges from which we have drawn recommendations for the National Institute for Health Research (NIHR) and the research community. These should be considered before such a platform is used again. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12873692 and EudraCT 2017-003635-10. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 67. See the NIHR Journals Library website for further project information.

Ear infections are common in childhood. Some are complicated by a burst eardrum, followed by discharge from the ear. The usual treatment for this is a short course of antibiotics taken by mouth. However, alternative treatment using antibiotic drops, or a 'wait and see' policy before starting antibiotics, would result in less antibiotic use and reduce the subsequent risk of antibiotic resistance, which is bad for both patients and the environment. This study set out to see if these alternative treatments were as effective as the usual treatment for children with ear discharge. Although ear infections are common, only one in six children develops ear discharge, so only a few children might be available to take part at each general practice. We planned to use an electronic recruitment system to help us to gather enough patients. The system [called the 'TRANSFoRm' (Translational Research and Patient Safety in Europe) platform] was designed to remind busy general practitioners and nurses about the study and take them through the recruitment process step by step, as well as to support trial processes. Although the TRANSFoRm platform had been developed and tested, it had not been used in general practices before. We were surprised to find that there were many technical problems in setting up the TRANSFoRm platform in general practices, and staff were too busy and/or did not have the skills to overcome the technical issues. As a result, recruiting patients was slow and the study was halted before we had enough children to answer the main research question. In total, we managed to get 44 general practices and 22 children, but this was not enough. We still think that this kind of research and electronic trial platforms are important. We have noted many system and technical issues that need to be solved to enable funders and researchers to use this recruitment approach in the future.

Changes in U.S. Healthcare Provider Practices Related to Emergency Contraception.

INTRODUCTION: Emergency contraception (EC), including EC pills (ECPs) and the copper intrauterine device, can prevent pregnancy after sexual encounters in which contraception was not used or used incorrectly. The U.S. Selected Practice Recommendations for Contraceptive Use (U.S. SPR), initially released in 2013, provides evidence-based clinical recommendations on the provision of EC. The objective of this analysis was to assess the percentage of health care providers reporting frequent provision of select EC practices around the time of and after the release of the U.S. SPR. METHODS: We conducted two cross-sectional mailed surveys using different nationwide samples of office-based physicians and public-sector providers in 2013 and 2014 (n = 2,060) and 2019 (n = 1,420). We compared the percentage of providers reporting frequent provision of select EC practices by time period, overall, and by provider type. RESULTS: In 2019, few providers frequently provided an advance prescription for ECPs (16%), an advance supply of ECPs (7%), or the copper intrauterine device as EC (8%), although 41% frequently provided or prescribed regular contraception at the same time as providing ECPs. Providers in 2019 were more likely than providers in 2013 and 2014 to provide or prescribe contraception at the same time as providing ECPs (adjusted prevalence ratio, 1.26; 95% confidence interval, 1.001-1.59) and to provide a copper intrauterine device as EC (adjusted prevalence ratio, 3.87; 95% confidence interval 2.10-7.15); there were no other significant differences by time period. CONCLUSIONS: Few providers report frequent implementation of recommended EC practices. Understanding the barriers faced by providers and clinics in implementing these practices may improve access to EC.

Challenges to implementing electronic trial data collection in primary care: a qualitative study.

BACKGROUND: Within-consultation recruitment to primary care trials is challenging. Ensuring procedures are efficient and self-explanatory is the key to optimising recruitment. Trial recruitment software that integrates with the electronic health record to support and partially automate procedures is becoming more common. If it works well, such software can support greater participation and more efficient trial designs. An innovative electronic trial recruitment and outcomes software was designed to support recruitment to the Runny Ear randomised controlled trial, comparing topical, oral and delayed antibiotic treatment for acute otitis media with discharge in children. A qualitative evaluation investigated the views and experiences of primary care staff using this trial software. METHODS: Staff were purposively sampled in relation to site, role and whether the practice successfully recruited patients. In-depth interviews were conducted using a flexible topic guide, audio recorded and transcribed. Data were analysed thematically. RESULTS: Sixteen staff were interviewed, including GPs, practice managers, information technology (IT) leads and research staff. GPs wanted trial software that automatically captures patient data. However, the experience of getting the software to work within the limited and complex IT infrastructure of primary care was frustrating and time consuming. Installation was reliant on practice level IT expertise, which varied between practices. Although most had external IT support, this rarely included supported for research IT. Arrangements for approving new software varied across practices and often, but not always, required authorisation from Clinical Commissioning Groups. CONCLUSIONS: Primary care IT systems are not solely under the control of individual practices or CCGs or the National Health Service. Rather they are part of a complex system that spans all three and is influenced by semi-autonomous stakeholders operating at different levels. This led to time consuming and sometimes insurmountable barriers to installation at the practice level. These need to be addressed if software supporting efficient research in primary care is to become a reality.

COVID-19 and Sexual and Reproductive Health Care: Findings From Primary Care Providers Who Serve Adolescents.

PURPOSE: Among U.S. primary care physicians who delivered sexual and reproductive health (SRH) services to adolescents before the COVID-19 pandemic, we examine (1) changes in availability of in-person SRH services; (2) changes in accessibility and utilization of SRH services; and (3) use of strategies to support provision of SRH services during the pandemic. METHODS: Data were from the DocStyles provider survey administered September-October 2020. Descriptive analyses were restricted to family practitioners, internists, and pediatricians whose main work setting was outpatient and whose practice provided family planning or sexually transmitted infection services to ≥ one patient aged 15-19 years per week just before the COVID-19 pandemic (n = 791). RESULTS: Among physicians whose practices provided intrauterine device/implant placement/removal or clinic-based sexually transmitted infection testing before the COVID-19 pandemic, 51% and 36% indicated disruption of these services during the pandemic, respectively. Some physicians also reported reductions in walk-in hours (38%), evening/weekend hours (31%), and adolescents seeking care (43%) in the past month. At any point during the pandemic, 61% provided contraception initiation/continuation and 44% provided sexually transmitted infection services via telehealth. Among these physicians, about one-quarter reported confidentiality concerns with telehealth in the past month. There were small increases or no changes in other strategies to support contraceptive care. CONCLUSIONS: Findings suggest disruption of certain SRH services and issues with access because of the pandemic among primary care providers who serve adolescents. There are opportunities to enhance implementation of confidential telehealth services and other service delivery strategies that could help promote adolescent SRH in the United States.

Need for Contraceptive Services Among Women of Reproductive Age - 45 Jurisdictions, United States, 2017-2019.

Ensuring access to contraceptive services is an important strategy for preventing unintended pregnancies, which account for nearly one half of all U.S. pregnancies (1) and are associated with adverse maternal and infant health outcomes (2). Equitable, person-centered contraceptive access is also important to ensure reproductive autonomy (3). Behavioral Risk Factor Surveillance System (BRFSS) data collected during 2017-2019 were used to estimate the proportion of women aged 18-49 years who were at risk for unintended pregnancy* and had ongoing or potential need for contraceptive services.† During 2017-2019, in the 45 jurisdictions§ from which data were collected, 76.2% of women aged 18-49 years were considered to be at risk for unintended pregnancy, ranging from 67.0% (Alaska) to 84.6% (Georgia); 60.7% of women had ongoing or potential need for contraceptive services, ranging from 45.3% (Puerto Rico) to 73.7% (New York). For all jurisdictions combined, the proportion of women who were at risk for unintended pregnancy and had ongoing or potential need for contraceptive services varied significantly by age group, race/ethnicity, and urban-rural status. Among women with ongoing or potential need for contraceptive services, 15.2% used a long-acting reversible method (intrauterine device or contraceptive implant), 25.0% used a short-acting reversible method (injectable, pill, transdermal patch, or vaginal ring), and 29.5% used a barrier or other reversible method (diaphragm, condom, withdrawal, cervical cap, sponge, spermicide, fertility-awareness-based method, or emergency contraception). In addition, 30.3% of women with ongoing or potential need were not using any method of contraception. Data in this report can be used to help guide jurisdictional planning to deliver contraceptive services, reduce unintended pregnancies, ensure that the contraceptive needs of women and their partners are met, and evaluate efforts to increase access to contraception.

COVID-19 and family planning service delivery: Findings from a survey of U.S. physicians.

Equitable access to contraception is critical for reproductive autonomy. Using cross-sectional data from the DocStyles survey administered September-October 2020 (68% response rate), we compared changes in family planning-related clinical services and healthcare delivery strategies before and during the COVID-19 pandemic and assessed service provision issues among 1063 U.S. physicians whose practice provided family planning services just before the pandemic. About one-fifth of those whose practices provided the following services or strategies just before the pandemic discontinued these services during the pandemic: long-acting reversible contraception (LARC) placement (16%); LARC removal (17%); providing or prescribing emergency contraceptive pills (ECPs) in advance (18%); and reminding patients about contraception injections or LARC removal or replacement (20%). Many practices not providing the following services or strategies just before the pandemic initiated these services during the pandemic: telehealth for contraception initiation (43%); telehealth for contraception continuation (48%); and renewing contraception prescriptions without requiring an office visit (36%). While a smaller proportion of physicians reported service provision issues in the month before survey completion than at any point during the pandemic, about one-third still reported fewer adult females seeking care (37%) and technical challenges with telehealth (32%). Discontinuation of key family planning services during the COVID-19 pandemic may limit contraception access and impede reproductive autonomy. Implementing healthcare service delivery strategies that reduce the need for in-person visits (e.g., telehealth for contraception, providing or prescribing ECPs in advance) may decrease disruptions in care. Resources exist for public health and clinical efforts to ensure contraception access during the pandemic.

Update to U.S. Selected Practice Recommendations for Contraceptive Use: Self-Administration of Subcutaneous Depot Medroxyprogesterone Acetate.

U.S. Selected Practice Recommendations for Contraceptive Use (U.S. SPR), adapted by CDC from global guidance developed by the World Health Organization (WHO), provides evidence-based guidance on contraceptive use for U.S. health care providers (1). During January-February, 2021, CDC evaluated the 2019 WHO recommendation on self-administered subcutaneous depot medroxyprogesterone acetate (DMPA-SC) (2). CDC adopted the WHO recommendation on the basis of moderate-certainty evidence that self-administered DMPA-SC is safe and effective, and has higher continuation rates compared with provider-administered DMPA. The new U.S. SPR recommendation states that self-administered DMPA-SC should be made available as an additional approach to deliver injectable contraception. Provider-administered DMPA should remain available. Self-administered DMPA-SC is a user-controlled method that has the potential to improve contraceptive access and increase reproductive autonomy. Self-administered DMPA-SC should be offered in a noncoercive manner through a shared decision-making process between patients and their health care providers, with a focus on patient preferences and equitable access to the full range of contraceptive methods.

Required examinations and tests before initiating contraception: Provider practices from a national cross-sectional survey.

OBJECTIVE(S): We estimated the prevalence of requiring specific examinations or tests before providing contraception in a nationwide survey of family planning providers. STUDY DESIGN: We conducted a cross-sectional survey of public-sector health centers and office-based physicians providing family planning services across the United States in 2019 (n = 1395). We estimated the weighted proportion of providers (or their health center or practice) who required blood pressure measurement, pelvic examination (bimanual examination and cervical inspection), Papanicolaou (Pap) smear, clinical breast examination (CBE), and chlamydia and gonorrhea (CT/GC) screening before initiating hormonal or intrauterine contraception (IUC) for healthy women. We performed multivariable regression to identify factors associated with pelvic examination practices aligned with clinical recommendations; these recommendations classify examinations and tests as recommended or unnecessary before initiation of specific contraceptive methods. RESULTS: The overall response rate was 51%. Most providers required blood pressure measurement before initiating each method. Unnecessary CBE, Pap smears, and CT/GC screening were required by 14% to 33% of providers across methods. Fifty-two to 62% of providers required recommended pelvic examination before IUC placement; however, 16% to 23% of providers required unnecessary pelvic examinations before non-intrauterine hormonal method initiation. Factors associated with recommendation-aligned pelvic examination practices included having a higher proportion of patients using public funding (Medicaid or other assistance) and more recently completing formal clinical training. CONCLUSIONS: Almost half (47%) of providers did not require necessary pelvic examination before placing IUC. Conversely, many providers required unnecessary examinations and tests before contraception initiation for patients. IMPLICATIONS: Most providers required the few recommended examinations and tests for safe contraceptive provision. Reduction of unnecessary examinations and tests may reduce barriers to contraceptive access. There are also opportunities to increase use of recommended examinations, as up to 48% of providers did not require recommended pelvic examination before IUC.

Removing Unnecessary Medical Barriers to Contraception: Celebrating a Decade of the U.S. Medical Eligibility Criteria for Contraceptive Use.

In 2010, the Centers for Disease Control and Prevention (CDC) released the U.S. Medical Eligibility Criteria for Contraceptive Use, providing recommendations for health care providers on safe use of contraception for people with certain characteristics or medical conditions. Adapted from World Health Organization guidance, the goal of the recommendations is to remove unnecessary medical barriers to contraception. Over the past decade, CDC has updated recommendations based on new evidence, collaborated with national partners to disseminate and implement the guidelines, and conducted provider surveys to assess changes in attitudes and practices around contraception safety and provision. CDC remains committed to supporting evidence-based guidelines for safe use of contraception, as the basis for improving access to contraception and high-quality family planning services, reducing unintended pregnancy, and improving reproductive health in the United States.

Non-contact infrared thermometers compared with current approaches in primary care for children aged 5 years and under: a method comparison study.

BACKGROUND: Current options for temperature measurement in children presenting to primary care include either electronic axillary or infrared tympanic thermometers. Non-contact infrared thermometers could reduce both the distress of the child and the risk of cross-infection. OBJECTIVES: The objective of this study was to compare the use of non-contact thermometers with the use of electronic axillary and infrared tympanic thermometers in children presenting to primary care. DESIGN: Method comparison study with a nested qualitative study. SETTING: Primary care in Oxfordshire. PARTICIPANTS: Children aged ≤ 5 years attending with an acute illness. INTERVENTIONS: Two types of non-contact infrared thermometers [i.e. Thermofocus (Tecnimed, Varese, Italy) and Firhealth (Firhealth, Shenzhen, China)] were compared with an electronic axillary thermometer and an infrared tympanic thermometer. MAIN OUTCOME MEASURES: The primary outcome was agreement between the Thermofocus non-contact infrared thermometer and the axillary thermometer. Secondary outcomes included agreement between all other sets of thermometers, diagnostic accuracy for detecting fever, parental and child ratings of acceptability and discomfort, and themes arising from our qualitative interviews with parents. RESULTS: A total of 401 children (203 boys) were recruited, with a median age of 1.6 years (interquartile range 0.79-3.38 years). The readings of the Thermofocus non-contact infrared thermometer differed from those of the axillary thermometer by -0.14 °C (95% confidence interval -0.21 to -0.06 °C) on average with the lower limit of agreement being -1.57 °C (95% confidence interval -1.69 to -1.44 °C) and the upper limit being 1.29 °C (95% confidence interval 1.16 to 1.42 °C). The readings of the Firhealth non-contact infrared thermometer differed from those of the axillary thermometer by -0.16 °C (95% confidence interval -0.23 to -0.09 °C) on average, with the lower limit of agreement being -1.54 °C (95% confidence interval -1.66 to -1.41 °C) and the upper limit being 1.22 °C (95% confidence interval 1.10 to 1.34 °C). The difference between the first and second readings of the Thermofocus was -0.04 °C (95% confidence interval -0.07 to -0.01 °C); the lower limit was -0.56 °C (95% confidence interval -0.60 to -0.51 °C) and the upper limit was 0.47 °C (95% confidence interval 0.43 to 0.52 °C). The difference between the first and second readings of the Firhealth thermometer was 0.01 °C (95% confidence interval -0.02 to 0.04 °C); the lower limit was -0.60 °C (95% confidence interval -0.65 to -0.54 °C) and the upper limit was 0.61 °C (95% confidence interval 0.56 to 0.67 °C). Sensitivity and specificity for the Thermofocus non-contact infrared thermometer were 66.7% (95% confidence interval 38.4% to 88.2%) and 98.0% (95% confidence interval 96.0% to 99.2%), respectively. For the Firhealth non-contact infrared thermometer, sensitivity was 12.5% (95% confidence interval 1.6% to 38.3%) and specificity was 99.4% (95% confidence interval 98.0% to 99.9%). The majority of parents found all methods to be acceptable, although discomfort ratings were highest for the axillary thermometer. The non-contact thermometers required fewer readings than the comparator thermometers. LIMITATIONS: A method comparison study does not compare new methods against a reference standard, which in this case would be central thermometry requiring the placement of a central line, which is not feasible or acceptable in primary care. Electronic axillary and infrared tympanic thermometers have been found to have moderate agreement themselves with central temperature measurements. CONCLUSIONS: The 95% limits of agreement are > 1 °C for both non-contact infrared thermometers compared with electronic axillary and infrared tympanic thermometers, which could affect clinical decision-making. Sensitivity for fever was low to moderate for both non-contact thermometers. FUTURE WORK: Better methods for peripheral temperature measurement that agree well with central thermometry are needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15413321. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 53. See the NIHR Journals Library website for further project information.

General practitioners commonly measure children's temperature using a thermometer placed in the armpit or ear canal. New 'non-contact' thermometers use infrared light to measure temperature without touching the child. They are easy to use and there is no risk of passing on infections. However, we do not know how well they measure temperature compared with thermometers that use the armpit or the ear. This study aimed to compare two non-contact thermometers with current thermometers. We measured children's temperature with all thermometer types, and asked children and their parents about their views. The study was performed in general practices in Oxfordshire with children aged ≤ 5 years who had come to see their general practitioner because they had recently become unwell. Both the cheaper and more expensive non-contact thermometers gave slightly lower temperature readings on average than current thermometers. The vast majority of readings ranged from 1.6 °C lower to 1.3 °C higher than current thermometers. The detection of fever of at least 38 °C was low to moderate for both non-contact thermometers. Most parents did not think that their child was distressed by having their temperature taken using any of the thermometers, but the armpit thermometer was rated as the least comfortable. When interviewed, parents were more negative about the armpit thermometers, although still willing to use them if they were recommended by doctors. Although we found that the readings from the different thermometers did not match, we do not know whether the non-contact or the current thermometers were giving readings that were closer to the real temperature of the child. To understand this, we would need to do a study that included a more invasive procedure for temperature assessment.

A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol.

BACKGROUND: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops, or 'delayed' orally administered antibiotics, could be at least as effective and safe as immediate orally administered antibiotics for children with AOMd. METHODS/DESIGN: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 175 GP practices across the United Kingdom (UK). The study aims to recruit 399 children aged (≥ 12 months and < 16 years) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow-up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day-14 and at 3 months. DISCUSSION: It is unclear whether prescribing orally administered antibiotics to children with AOMd results in a reduction in symptoms or a shorter duration of illness. The REST trial should allow us to compare the non-inferiority of: immediate topically administered ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin) against immediate orally administered amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the TRANSFoRm software to randomise participants to the trial will enable recruitment for a relatively uncommon condition. TRIAL REGISTRATION: Name of Registry: ISCRTN Registration Number: ISRCTN12873692. This contains all items required to comply with the World Health Organization Trial Registration Data Set Date of Registration: 24 April 2018 Name of Registry: EudraCT Registration Number: 2017-003635-10 Date of Registration: 6 September 2017.