Cochlear implant referral patterns in the UK suggest a postcode lottery with inequitable access for older adults; results of a pilot audit in five Audiology sites.

OBJECTIVE: To use a standardised reporting tool to identify potential eligible candidates for cochlear implant (CI) referral and quantify the proportion of adults who had a CI referral discussion after presenting with an audiogram within United Kingdom (UK) audiometric criteria. DESIGN: Retrospective multicentre 6-month audit of Audiology clinic databases. STUDY SAMPLE: A total of 810 adults from five geographically diverse UK Audiology sites. RESULTS: Data were collected in late 2019 after UK CI audiometric candidacy criteria changed; one site collected only 3 months of data. The proportion of potential eligible adults (based only on audiometry) considered for CI referral was 64% (521 out of 810) and varied by site (from 50% to 83%). About 24% of patients (123 out of 521) declined CI referral; this also varied across sites (12-45%). The median age of patients where CI referral was not considered was 80 years - significantly higher than the group where CI referral was considered (73 years). CONCLUSIONS: CI referral is dependent on where adults live, and how old they are. Older adults are significantly less likely to be considered for CI referral by Audiologists. Audiology clinics need more support to empower staff to talk to patients about CI referral.

Management of Early Pregnancy Loss.

This JAMA Insights Clinical Update discusses the management of early pregnancy loss, including expectant, medical, and surgical management regimens.

Sustained Reduction in Bloodstream Infections in Infants at a Large Tertiary Care Neonatal Intensive Care Unit.

BACKGROUND: Bloodstream infections (BSI) cause significant morbidity and mortality among hospitalized infants. PURPOSE: Reduction of BSIs has emerged as an important patient safety goal. Implementation of central line insertion bundles, standardized line care protocols, and health care provider education programs have reduced BSI in NICUs around the country. The ability of large tertiary care centers to decrease nosocomial infections, including BSI, has been demonstrated. However, long-term BSI reductions in infants are not well documented. We sought to demonstrate that a low incidence of BSI can be maintained over time in a tertiary care NICU. RESULTS: Baseline BSI incidence for infants admitted to the NICU was 5.15 and 6.08 episodes per 1000 infant-days in 2005 and 2006, respectively. After protocol implementation, the incidence of BSI decreased to 2.14/1000 infant-days and 2.44/1000 infant-days in 2008 and 2009, respectively. Yearly incidence remained low over the next 4 years and decreased even further to 0.20 to 0.45 infections per 1000 infant-days. This represents a 92% decrease in BSI over a period of more than 5 years. IMPLICATIONS FOR PRACTICE: Implementation of a nursing-led comprehensive infection control initiative can effectively produce and maintain a reduction in the incidence of BSI in infants at a large tertiary care NICU. IMPLICATIONS FOR RESEARCH: Additional research is needed to effectively expand prevention of central line-associated BSIs to BSIs of all etiologies.

A pilot phase II RCT of a home-based exercise intervention for survivors of AML.

BACKGROUND: Fatigue is the most common and disabling symptom affecting quality of life (QOL) and daily function in patients who have completed treatment for acute myeloid leukemia (AML). Although trials in patients with various solid tumors have reported improved fatigue and QOL following exercise interventions, there have been no studies in AML patients post treatment. METHODS: Forty patients aged ≥ 40 years who had completed treatment for AML were enrolled in a 12-week randomized phase II exercise intervention to determine feasibility (recruitment, retention, and adherence), efficacy, and safety of the intervention. Patients assigned to the exercise group received an individualized, moderate-intensity, 12-week home-based exercise program with weekly telephone support from a certified exercise physiologist. QOL, fatigue, and fitness outcomes were measured at baseline, 6 weeks, and 12 weeks. Between-group differences in 12-week change scores were calculated using linear regression adjusting for age and baseline function. RESULTS: Recruitment and retention rates were 38% and 91%, respectively. Adherence was low at 28%. Analyses did not suggest statistically significant or clinically important benefits in QOL, fatigue, or physical fitness with the intervention. The level of adherence did not appear to impact outcomes. There were no adverse events. CONCLUSION: A home-based exercise program for post-treatment AML patients age 40 years or older can be safely delivered with reasonable recruitment and high retention. However, feasibility was hampered by low adherence. Further research and program modification are needed to better understand and overcome barriers to exercise delivery and adherence in AML survivors.

Mifepristone Use Among Obstetrician-Gynecologists in Massachusetts: Prevalence and Predictors of Use.

OBJECTIVES: We estimated the prevalence of mifepristone use for evidence-based indications among obstetrician-gynecologists in independent practice in Massachusetts and explored the demographic and practice-related factors associated with use. METHODS: We used data from a cross-sectional survey administered to Massachusetts obstetrician-gynecologists identified from the American Medical Association Physician Masterfile. We measured the prevalence of mifepristone use for four clinical scenarios: early pregnancy loss, medication abortion, cervical preparation before dilation and evacuation procedures, and cervical preparation before induction of labor. Multivariate regression was used to calculate the odds of mifepristone use for these scenarios based on practice type, years in practice, physician sex, and history of medication abortion training. RESULTS: A total of 198 obstetrician-gynecologists responded to the survey (response rate = 29.0%); this analysis was limited to 158 respondents who were not in residency or fellowship. Overall, 46.0% used mifepristone for early pregnancy loss and 38.6% for medication abortion. Fewer used mifepristone for cervical preparation before dilation and evacuation (26.0%) or before induction of labor (26.4%). Respondents in academic practice settings, with more years in practice, of female sex, and with sufficient medication abortion training were significantly more likely to use mifepristone for one or more evidence-based clinical indications. CONCLUSIONS: Sufficient medication abortion training during residency significantly predicts whether obstetrician-gynecologists use mifepristone in practice. The U.S. Supreme Court's overturning of Roe v. Wade will allow state-level abortion bans and restrictions to be in effect, which will reduce exposure to abortion training during residency. Increasing training in and utilization of mifepristone are critical for equitable access to reproductive health services. Further interventions may need to be developed to increase mifepristone use in nonacademic practice settings.

Management of early pregnancy loss among obstetrician-gynecologists in Massachusetts and barriers to mifepristone use.

OBJECTIVES: To measure the prevalence of early pregnancy loss management types among obstetrician-gynecologists in Massachusetts, and delineate barriers, facilitators, demographic and practice-related factors associated with mifepristone use for early pregnancy loss. STUDY DESIGN: We surveyed a census of obstetrician-gynecologists in Massachusetts. Descriptive statistics measured the prevalence of offering expectant, misoprostol-alone, mifepristone and misoprostol, dilation and curettage in the office and operating room, and multivariate logistic regression analysis evaluated barriers and facilitators to mifepristone use. Data were weighted to account for nonresponders. RESULTS: 198 obstetrician-gynecologists responded to the survey (response rate=29%). Participants most commonly offered expectant management (98%), dilation and curettage in the operating room (94%), and misoprostol-only medication management (80%). Fewer offered mifepristone-misoprostol (51%) or dilation and curettage in an office setting (45%). Those in private practice or other practice types had lower odds of offering mifepristone-misoprostol than those in academic practice (private practice: aOR 0.34, 95% confidence interval [CI] [0.19, 0.61]). Female physicians had higher odds of offering mifepristone-misoprostol (aOR 1.97, 95% CI [1.11, 3.49]). Obstetrician-gynecologists who included medication abortion in their practice had much higher odds of using mifepristone for early pregnancy loss (aOR 25.06, 95% CI [14.52, 43.24]). The Food and Drug Administration Risk and Evaluation Management Strategies Program was a primary barrier among those not using mifepristone (54%). CONCLUSIONS: Many obstetrician-gynecologists do not offer mifepristone-based regimens for early pregnancy loss, which are more efficacious than misoprostol-only regimens. The Food and Drug Administration Risk Evaluation and Mitigation Strategies Program is a major barrier to mifepristone use. IMPLICATIONS: Half of obstetrician-gynecologists in Massachusetts do not use mifepristone for early pregnancy loss management. Major barriers include lack of experience with mifepristone and the Food and Drug Administration Risk Evaluation and Mitigation Strategies Program regulations. Removing medically unnecessary regulations and increasing education on mifepristone via access to abortion care experts may increase uptake of this practice.

Mifepristone use for early pregnancy loss: A qualitative study of barriers and facilitators among OB/GYNS in Massachusetts, USA.

CONTEXT: Early pregnancy loss (EPL) affects 1 million patients in the United States (US) annually, but integration of mifepristone into EPL care may be complicated by regulatory barriers, practice-related factors, and abortion stigma. METHODS: We conducted qualitative, semi-structured interviews among obstetrician-gynecologists in independent practice in Massachusetts, US on mifepristone use for EPL. We recruited participants via professional networks and purposively sampled for mifepristone use, practice type, time in practice, and geographic location within Massachusetts until we reached thematic saturation. We analyzed interviews using inductive and deductive coding under a thematic analysis framework to identify facilitators of and barriers to mifepristone use. RESULTS: We interviewed 19 obstetrician-gynecologists; 12 had used mifepristone for EPL and 7 had not. Participants were in private practice (n = 12), academic practice (n = 6), or worked at a federally qualified health center (n = 1). Seven had fellowship training, including four in complex family planning. The most common facilitators of mifepristone use for EPL were access to the expertise or protocols of local-regional experts, leadership from a "champion," prior experience with abortion care, and hospital capacity constraints during the COVID-19 pandemic. The most common barriers were related to the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program imposed by the US Food and Drug Administration (FDA). Additionally, mifepristone's affiliation with abortion was a barrier to its use in EPL for some obstetrician-gynecologists. CONCLUSION: The FDA Mifepristone REMS Program presents substantial barriers to obstetrician-gynecologists incorporating mifepristone into their EPL care.

Is clinical expertise a conflict of interest in research?

PURPOSE: Doctors who research and provide abortion care have had their work characterized as a conflict of interest. We investigated whether surgeons who perform medical procedures other than abortion also routinely conduct research on that procedure and whether they disclose this as a relevant "conflict of interest." METHOD: We conducted a two-step literature review of five medical procedures-abortion, rhinoplasty, Mohs micrographic surgery, transurethral resection of the prostate, and laminectomy. We identified articles published between June 2011 and May 2012, and we calculated the proportion of articles authored by clinicians who also perform that procedure as well as the percentage that reported clinical care as a conflict of interest. We then screened conflict of interest statements on publications on said procedures from the same journals between 2012 and 2019 and calculated the proportion of publications that reported clinical work as a conflict of interest. RESULTS: We identified 135 publications that met inclusion criteria. We calculated that 100% of publications on rhinoplasty, transurethral resection of the prostate, and Mohs included a clinician who performs that procedure. Seventy-five percent of publications on laminectomy and 78% of publications on abortion included a clinician. None of the reviewed research articles included a disclosure that the authors also performed the procedure. From 2012 to 2019, there were 1,903 published articles on these procedures. None included a conflict of interest that disclosed clinical work as a conflict of interest. CONCLUSION: Although abortion providers publish as clinician-researchers at rates similar to surgeons in other areas of medicine, they alone face accusations that their clinical expertise is a potential conflict of interest. This stigmatizing practice could have wide-ranging consequences including delegitimization of the scientific method and peer review process broadly.

State and federal abortion restrictions increase risk of COVID-19 exposure by mandating unnecessary clinic visits.

OBJECTIVE: To quantify the number of medically unnecessary clinical visits and in-clinic contacts monthly caused by US abortion regulations. STUDY DESIGN: We estimated the number of clinical visits and clinical contacts (any worker a patient may come into physical contact with during their visit) under the current policy landscape, compared to the number of visits and contacts if the following regulations were repealed: (1) State mandatory in-person counseling visit laws that necessitate two visits for abortion, (2) State mandatory-ultrasound laws, (3) State mandates requiring the prescribing clinician be present during mifepristone administration, (4) Federal Food and Drug Administration Risk Evaluation and Mitigation Strategy for mifepristone. If these laws were repealed, "no-test" telemedicine abortion would be possible for some patients. We modeled the number of visits averted if a minimum of 15 percent or a maximum of 70 percent of medication abortion patients had a "no-test" telemedicine abortion. RESULTS: We estimate that 12,742 in-person clinic visits (50,978 clinical contacts) would be averted each month if counseling visit laws alone were repealed, and 31,132 visits (142,910 clinical contacts) would be averted if all four policies were repealed and 70 percent of medication abortion patients received no-test telemedicine abortions. Over 2 million clinical contacts could be averted over the projected 18-month COVID-19 pandemic. CONCLUSION: Medically unnecessary abortion regulations result in a large number of excess clinical visits and contacts. POLICY IMPLICATIONS: Repeal of medically unnecessary state and federal abortion restrictions in the United States would allow for evidence-based telemedicine abortion care, thereby lowering risk of SARS-CoV-2 transmission.

Early administration of oropharyngeal colostrum to extremely low birth weight infants.

BACKGROUND: Human milk reduces morbidities in extremely low birth weight (ELBW) infants. However, clinical instability often precludes ELBW infants from receiving early enteral feeds. This study compared clinical outcomes before and after implementing an oropharyngeal colostrum (COL) protocol in a cohort of inborn (born at our facility) ELBW infants. STUDY DESIGN: This is a retrospective cohort study of inborn ELBW infants admitted to the Duke Intensive Care Nursery from January 2007 to September 2011. In November 2010, we initiated a COL protocol for infants not enterally fed whose mothers were providing breastmilk. Infants received 0.1 mL of fresh COL to each cheek every 4 hours for 5 days beginning in the first 48 postnatal hours. We assessed demographics, diagnoses, feeding history, and mortality and for the presence of medical necrotizing enterocolitis (NEC), surgical NEC, and spontaneous perforation. Between-group comparisons were made using Fisher's exact test or Wilcoxon rank sum testing where appropriate. RESULTS: Of the 369 infants included, 280 (76%) were born prior to the COL protocol (Pre-COL Cohort [PCC]), and 89 (24%) were born after (COL Cohort [CC]). Mortality and the percentage of infants with surgical NEC and spontaneous perforations were statistically similar between the groups. The CC weighed an average (interquartile range) of 1,666 (1,399, 1,940) g at 36 weeks versus 1,380 (1,190, 1,650) g for the PCC (p<0.001). In a multivariable analysis with birth weight as a covariable, weight at 36 weeks was significantly greater (37 g; p<0.01). CONCLUSIONS: Initiating oropharyngeal COL in ELBW infants in the first 2 postnatal days appears feasible and safe and may be nutritionally beneficial. Further research is needed to determine if early COL administration reduces neonatal morbidity and mortality.

A clinical trial of supervised exercise for adult inpatients with acute myeloid leukemia (AML) undergoing induction chemotherapy.

Patients with acute myeloid leukemia (AML) receiving induction chemotherapy (IC) were enrolled in a supervised exercise intervention to determine safety, feasibility, and efficacy. Physical fitness measures, quality of life (QOL) and fatigue were assessed using standardized measures at baseline, post-induction, and post first consolidation. Retention was excellent, the intervention was safe, and efficacy estimates suggested benefits in physical fitness and QOL outcomes. Exercise is a safe, promising intervention for improving fitness and QOL in this patient population. These results provide a foundation for a randomized trial to better understand the impact of exercise during IC on clinically important outcomes.