Body Mass Index and Complication Rates Among Patients Undergoing Gender-Affirming Surgeries: An Analysis of the National Surgical Quality Improvement Project Database.

Purpose: To determine the relationship between body mass index (BMI) and complication rates among patients undergoing gender-affirming surgeries (GAS).

Methods: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database was queried from 2015 to 2021. Patients who underwent a GAS were identified using International Classification of Diseases Ninth (ICD-9) and Tenth (ICD-10) codes.

The Sick, Control, One Stone, Fat, Food (SCOFF) is a Valid Eating Disorder Questionnaire to Use With Transgender Youth.

Transgender youth experience elevated rates of eating disorders, yet few screening measures have been validated with transgender patients. The purpose of this study was to provide initial evidence for the internal consistency and convergent validity of the Sick, Control, One Stone, Fat, Food (SCOFF) in a sample of transgender youth. Two hundred eight participants completed the SCOFF as part of a routine screening protocol.

Validation of the adolescent binge eating disorder measure (ADO-BED) among transgender youth and young adults.

Background: Transgender youth and young adults are at increased risk for eating disorders, including binge eating disorder, yet few measures have been validated for screening purposes with the transgender population.

Methods: The purpose of this study was to provide initial evidence for the internal consistency and convergent validity of the Adolescent Binge Eating Disorder questionnaire (ADO-BED) in a sample of transgender youth and young adults. 208 participants completed the ADO-BED as part of a routine nutrition screening protocol at a gender center.

Advancing Inclusion of Transgender Identities in Health Professional Education Programs: The Interprofessional Transgender Health Education Day.

Purpose: The purpose of this study was to explore the impact of an Interprofessional Transgender Health Education Day (ITHED) on student knowledge and attitudes towards the transgender population.

Methods: This mixed-methods study involved a pre-test and post-test survey administered to students (n=84 pre-test and n=66 post-test) in four health professional education programs (medicine, family therapy, speech, language, and hearing sciences, nutrition and dietetics.) surrounding participation in the ITHED.

A meta-analysis of exercise intervention and the effect on Parkinson's Disease symptoms.

Parkinson's disease (PD) is a progressive neurodegenerative disease that is distinguished by tremors at rest, bradykinesia, hypokinesia, and postural instability, resulting in a progressive decline in performance of everyday activities. The non-motor symptoms that occur can include pain, depression, cognitive dysfunction, sleep issues, and anxiety (among others). Functionality is tremendously impaired by physical as well as non-motor symptoms.

Implementation of the CAPABLE Program With Older Adults During the COVID-19 Pandemic.

This study explores the implementation and impact of an evidence-based client-driven program, CAPABLE (Community Aging in Place Advancing Better Living for Elders), during the COVID-19 pandemic. The study reviews outcomes related to client engagement and retainment, client-directed goals, therapeutic intervention, home modifications, and functional outcomes of older adult participants. The CAPABLE program addresses basic and instrumental activities of daily living, medication use, pain, mobility, fall prevention, and environmental modifications within the home.

Effect of Hearing Device Use on Speech-in-Noise Performance in Children with Severe-to-Profound Unilateral Hearing Loss.

Objectives: Limited evidence exists for the use of rerouting devices in children with severe-to-profound unilateral sensorineural hearing loss. Many laboratory studies to date have evaluated hearing-in-noise performance in specific target-masker spatial configurations within a small group of participants and with only a subset of available hearing devices. In the present study, the efficacy of all major types of nonsurgical devices was evaluated within a larger group of pediatric subjects on a challenging speech-in-noise recognition task.

FGF1 Signaling Modulates Biliary Injury and Liver Fibrosis in the Mdr2 Mouse Model of Primary Sclerosing Cholangitis.

Fibroblast growth factor 1 (FGF1) belongs to a family of growth factors involved in cellular growth and division. MicroRNA 16 (miR-16) is a regulator of gene expression, which is dysregulated during liver injury and insult. However, the role of FGF1 in the progression of biliary proliferation, senescence, fibrosis, inflammation, angiogenesis, and its potential interaction with miR-16, are unknown.

Managing Human Subjects Research During a Global Pandemic at an Academic Center: Lessons Learned From COVID-19.

By March 2020, New York City became the early epicenter of the COVID-19 pandemic in the United States. Consequently, Columbia University, with its large portfolio of human subjects research, had to address the challenges of protecting thousands of research participants and research staff from potential exposure to COVID-19 while facilitating essential biomedical research, especially pandemic-related studies. The authors describe, from the perspective of Columbia's research administration leadership, how the University and its primary teaching hospital ramped down-and later ramped up-human subjects research and reflect on lessons learned.

Hearing Aid Use in Children With Unilateral Hearing Loss: A Randomized Crossover Clinical Trial.

Objectives/hypothesis: In children with mild to moderately severe unilateral hearing loss (UHL), assess whether subject-reported quality of life (QOL) and teacher- and parent-reported perception of listening difficulty are affected by use of a hearing aid (HA) with baseline accommodations, compared to children receiving only baseline accommodations.

Study Design: Randomized crossover clinical trial.

Methods: Thirty-seven children 6-12 years of age with mild to moderately severe UHL and ≥80% word recognition scores in the poorer hearing ear were randomized into arm 1, using baseline accommodations (frequency-modulated system and strategic seating) for 12 weeks, followed by addition of a HA for 12 weeks.

A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months.

Background: The aim of this study is to evaluate whether a dedicated Institutional Review Board (IRB) Liaison Service situated at our Institute's central location could provide additional useful staff support to the investigator community for interactions with the IRB at various levels of protocol submission and review.

Materials And Methods: Over a period of 2½ years, from January 2015 to June 2017, a total of 501 in-person consultations were performed during office hours, usually 25-30 per month. Most requests concerned new protocol development, IRB policy questions, and strategies for compliance or assistance in addressing IRB comments on returned protocols.

Obesity as a Possible Risk Factor for Pediatric Sensorineural Hearing Loss.

Objectives/hypothesis: Childhood hearing loss impacts linguistic, academic, social, and psychologic development, and may have lasting implications for future workforce performance. Current evidence for obesity as a pediatric sensorineural hearing loss (SNHL) risk factor is intriguing but equivocal. We hypothesized that obesity is associated with a higher risk of SNHL.

Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review.

Genomic discovery of an evolutionarily programmed modality for small-molecule targeting of an intractable protein surface.

The vast majority of intracellular protein targets are refractory toward small-molecule therapeutic engagement, and additional therapeutic modalities are needed to overcome this deficiency. Here, the identification and characterization of a natural product, WDB002, reveals a therapeutic modality that dramatically expands the currently accepted limits of druggability. WDB002, in complex with the FK506-binding protein (FKBP12), potently and selectively binds the human centrosomal protein 250 (CEP250), resulting in disruption of CEP250 function in cells.

When IRBs Say No to Participating in Research about Single IRBs.

In response to a policy of the National Institutes of Health and requirements in the revised Common Rule, a protocol for a multisite study must be reviewed by a single institutional review board (IRB), rather than by the IRB at each study site. The goal of the single IRB approach is to increase the efficiency of IRB review of multisite research without jeopardizing protections for research subjects. Yet the extent to which these joint goals are being achieved is unclear.

Audibility-Based Hearing Aid Fitting Criteria for Children With Mild Bilateral Hearing Loss.

Purpose Because of uncertainty about the level of hearing where hearing aids should be provided to children, the goal of the current study was to develop audibility-based hearing aid candidacy criteria based on the relationship between unaided hearing and language outcomes in a group of children with hearing loss who did not wear hearing aids. Method Unaided hearing and language outcomes were examined for 52 children with mild-to-severe hearing losses. A group of 52 children with typical hearing matched for age, nonverbal intelligence, and socioeconomic status was included as a comparison group representing the range of optimal language outcomes.

Reducing the primate pet trade: Actions for primatologists.

This commentary emerged from a panel presentation at the International Primatological Society Congress in Nairobi, Kenya, 2018. The goal was to provide regional updates on the status of primate removal from habitat countries, especially for the pet trade, and develop guidelines that could help primatologists address this critical problem. The trade in live primates includes those used as pets, in entertainment, and as subjects of biomedical experimentation, but here we focus on those primates destined for the pet trade.

Cases in Precision Medicine: Should You Participate in a Study Involving Genomic Sequencing of Your Patients?

Internists and other physicians may be asked to participate in research studies that include genomic screening of their patients. Because genomic studies can identify many variants with potential clinical or personal implications, physicians should carefully consider the effect of participation on their patients, as well as the time and effort needed for the physicians to interpret the results and decide how best to use the information. Among the questions they will need to explore is whether testing will be done in a laboratory that is certified under the Clinical Laboratory Improvement Amendments and authorized to generate results for clinical purposes.

Researching the Effectiveness of Tree of Life: an Imbeleko Approach to Counseling Refugee Youth.

With the growing worldwide refugee crisis, there is a need for evidence-based interventions that specifically deal with the consequences of cumulative trauma-exposure in refugee youth. Refugee children have unique service needs and differ from their non-refugee peers in terms of sociocultural trauma, language, culture, and educational barriers. This article explains the complexities associated with understanding refugee youth and presents a proposal for studying the possible benefits of Tree of Life therapy.

Perspective on the Development of a Large-Scale Clinical Data Repository for Pediatric Hearing Research.

The use of "big data" for pediatric hearing research requires new approaches to both data collection and research methods. The widespread deployment of electronic health record systems creates new opportunities and corresponding challenges in the secondary use of large volumes of audiological and medical data. Opportunities include cost-effective hypothesis generation, rapid cohort expansion for rare conditions, and observational studies based on sample sizes in the thousands to tens of thousands.

A phase 3 study of tezacaftor in combination with ivacaftor in children aged 6 through 11 years with cystic fibrosis.

Background: Tezacaftor/ivacaftor is a new treatment option in many regions for patients aged ≥12 years who are homozygous (F/F) or heterozygous for the F508del-CFTR mutation and a residual function (F/RF) mutation. This Phase 3, 2-part, open-label study evaluated the pharmacokinetics (PK), safety, tolerability, and efficacy of tezacaftor/ivacaftor in children aged 6 through 11 years with these mutations.

Methods: Part A informed weight-based tezacaftor/ivacaftor dosages for part B.

Cases in Precision Medicine: Concerns About Privacy and Discrimination After Genomic Sequencing.

Patients and research participants have indicated that privacy of their genetic test results is an important concern, particularly with respect to insurance coverage. Internists and other physicians whose patients ask about legal protections for information generated by genome sequencing for clinical purposes can provide both reassurance and caution. Protections for medical information in general, as well as laws in some states that provide additional safeguards for genetic data, should reassure patients that this information will remain private.

Cases in Precision Medicine: When Patients Present With Direct-to-Consumer Genetic Test Results.

A couple is planning to start a family, and they decide to order a 23andMe test after reading about the company's carrier screening test and the new BRCA1/BRCA2 test. They bring the results to their internist for advice on how to proceed. Given the rise in public interest in human genetics and precision medicine, direct-to-consumer genetic testing is becoming increasingly popular, and clinicians should expect patients to present the results of these tests more frequently.