FDA's proposed rule for the regulation of laboratory-developed tests.

In October 2023, the Food and Drug Administration (FDA) released a proposed rule that ends enforcement discretion for laboratory-developed tests (LDTs). The FDA's proposal outlines a five-stage implementation to begin regulating LDTs as they do for commercial in vitro diagnostics (IVDs), including modified FDA-approved/cleared tests. We outline here concerns from the clinical and public health microbiology laboratory perspective. It is our opinion that LDTs performed by individual Clinical Laboratory Improvement Amendments-certified diagnostic laboratories should not be regulated in the same way as commercial IVDs. This rule, if finalized, will negatively impact the diagnostic services currently offered by clinical and public health laboratories and, therefore, patients and the providers who care for them. Ending enforcement discretion will likely stifle diagnostic innovation and decrease access to diagnostic testing and health equity. Furthermore, the lack of infrastructure, including personnel and funding, at the FDA and diagnostic laboratories to support the required submissions for review is an obstacle. Like the FDA, diagnostic laboratories prioritize patient safety, accurate clinical diagnostics, and health equity. Since the scope of the LDT landscape is currently unknown, we are supportive of a registration process, along with non-burdensome adverse event reporting, to first understand the scope of clinical use of LDTs and any associated safety concerns. Any regulatory rule should be based on data that have been gathered systematically, not anecdotes or case reports. A rule must also balance the potential negative impact to patient care with realistic safety risks for infectious disease diagnostics.

Evaluation of analyte-specific reagents for the direct detection of Pneumocystis jirovecii.

Pneumocystis jirovecii pneumonia (PJP) is a serious and sometimes fatal infection occurring in immunocompromised individuals. High-risk patients include those with low CD4 counts due to human immunodeficiency virus infection and transplant recipients. The incidence of PJP is increasing, and rapid detection of PJP is needed to effectively target treatment and improve patient outcomes. A common method used is an immunofluorescent assay (IFA), which has limitations, including labor costs, low sensitivity, and requirement for expert interpretation. This study evaluates the performance of the DiaSorin Molecular Pneumocystis jirovecii analyte-specific reagent (ASR) in a laboratory-developed test (LDT) for the direct detection of P. jirovecii DNA without prior nucleic acid extraction. Respiratory samples (n = 135) previously tested by IFA from 111 patients were included. Using a composite standard of in-house IFA and reference lab PJP PCR, the percent positive agreement for the LDT using the DiaSorin ASR was 97.8% (90/92). The negative percent agreement was 97.7% (42/43). The lower limit of detection of the assay was determined to be 1,200 copies/mL in bronchoalveolar lavage fluid. Analytical specificity was assessed using cultures of oropharyngeal flora and common respiratory bacterial and fungal pathogens. No cross-reactivity was observed. Our study suggests that the DiaSorin Pneumocystis ASR accurately detects P. jirovecii DNA and demonstrates improved sensitivity compared to the IFA method. IMPORTANCE: Our study is unique compared to other previously published studies on the DiaSorin analyte-specific reagent (ASR) because we focused on microbiological diagnostic methods commonly used (immunofluorescent assay) as opposed to pathology findings or reference PCR. In addition, in our materials and methods, we describe the protocol for the use of the DiaSorin ASR as a singleplex assay, which will allow other users to evaluate the ASR for clinical use in their lab.

A randomized controlled trial of a distress screening, consultation, and targeted referral system for family caregivers in oncologic care.

OBJECTIVE: Distress screening is standard practice among oncology patients, yet few routine distress screening programs exist for cancer caregivers. The objective of this study was to demonstrate the feasibility, acceptability, and preliminary efficacy of Cancer Support Source-CaregiverTM (CSS-CG, 33-item), an electronic distress screening and automated referral program with a consultation (S + C) to improve caregiver unmet needs, quality of life, anxiety, depression, and distress relative to Enhanced Usual Care (EUC; access to educational materials). METHOD: 150 caregivers of patients with varying sites/stages of cancer were randomized to S + C or EUC and completed assessments at baseline, 3-months post-baseline, and 6-months post-baseline. A subset of participants (n = 10) completed in-depth qualitative interviews. RESULTS: S + C was feasible: among 75 caregivers randomized to S + C, 66 (88%) completed CSS-CG and consultation. Top concerns reported were: (1) patient's pain and/or physical discomfort; (2) patient's cancer progressing/recurring; and (3) feeling nervous or afraid. Differences between groups in improvements on outcomes by T2 and T3 were modest (ds < 0.53) in favor of S + C. Qualitative data underscored the helpfulness of S + C in connecting caregivers to support and helping them feel cared for and integrated into cancer care. CONCLUSIONS: S + C is feasible, acceptable, and yields more positive impact on emotional well-being than usual care. Future studies will examine programmatic impact among caregivers experiencing higher acuity of needs, and benefits of earlier integration of S + C on caregiver, patient, and healthcare system outcomes.

HIV Support Source: Development of a Distress Screening Measure for Adults with HIV.

To provide an effective, multidimensional, and psychometrically valid measure to screen for distress among people with HIV, we developed and assessed the psychometric properties of HIV Support Source, a distress screening, referral, and support program designed to identify the unmet needs of adults with HIV and link them to desired resources and support. Development and testing were completed in three phases: (1) item generation and initial item pool testing (N = 375), (2) scale refinement via exploratory factor analysis (N = 220); external/internal item quality, and judging theoretical and practical implications of items, and (3) confirmatory validation (N = 150) including confirmatory factor analysis along with reliability and validity analyses to corroborate dimensionality and psychometric properties of the final measure. Nonparametric receiver operating characteristic (ROC) curve analyses determined scoring thresholds for depression and anxiety risk subscales. The final measure comprises 17-items representing four domains of concern: emotional well-being, financial and practical needs, physical well-being, and HIV treatment and sexual health, plus one screening item assessing tobacco and substance use. Our analyses showed strong internal consistency reliability, a replicable factor structure, and adequate convergent, discriminant, and known groups validity. Sensitivity of 2-item depression and 2-item anxiety risk subscales was 0.90 and 0.79, respectively. HIV Support Source is a reliable and valid multidimensional measure of distress that also screens for risk for clinically significant depression and anxiety. It can be implemented within a distress screening, referral, and follow-up program to rapidly assess and support the unmet needs of adults with HIV.

Financial toxicity among people with metastatic cancer: findings from the Cancer Experience Registry.

PURPOSE: This study describes financial toxicity (FT) reported by people with metastatic cancer, characteristics associated with FT, and associations between FT and compensatory strategies to offset costs. METHODS: Cancer Support Community's Cancer Experience Registry data was used to identify respondents with a solid tumor metastatic cancer who completed the Functional Assessment of Chronic Illness Therapy COmprehensive Score for Financial Toxicity (FACIT-COST) measure. Multivariable logistic regression analyses examined associations between respondent characteristics and FT, and FT and postponing medical visits, nonadherence to medications, and postponing supportive and/or psychosocial care. RESULTS: 484 individuals were included in the analysis; the most common cancers included metastatic breast (31%), lung (13%), gynecologic (10%), and colorectal (9%). Approximately half of participants (50.2%) reported some degree of FT. Those who were non-Hispanic White, Hispanic, or multiple races (compared to non-Hispanic Black), and who reported lower income, less education, and being less than one year since their cancer diagnosis had greater odds of reporting FT. Individuals with any level of FT were also more likely to report postponing medical visits (Adjusted Odds Ratio [OR] 2.58; 95% Confidence Interval [CI] 1.45-4.58), suboptimal medication adherence (Adjusted OR 5.05; 95% CI 2.77-9.20) and postponing supportive care and/or psychosocial support services (Adjusted OR 4.16; 95% CI 2.53-6.85) compared to those without FT. CONCLUSIONS: With increases in the number of people living longer with metastatic cancer and the rising costs of therapy, there will continue to be a need to systematically screen and intervene to prevent and mitigate FT for these survivors.

Barriers to pregnancy prevention for adolescents in rural Haiti: perceptions of healthcare providers.

BACKGROUND: Little is known about healthcare providers' (HCPs) contraceptive views for adolescents in Haiti, who experience high rates of unintended pregnancy. We sought to describe HCPs' perspectives on barriers and facilitators to contraceptive care delivery in rural Haiti. METHODS: We conducted a cross-sectional survey and qualitative interviews with HCPs in two rural communities in Haiti from 08/2021-03/2022. We assessed demographics, clinical practice behaviors and explored contraception perspectives according to Theory of Planned Behavior constructs: attitudes, subjective norms, and perceived behavioral control (e.g., people's perceptions of their ability to perform a given behavior, barriers and facilitators of a behavior).15-17 We used descriptive statistics to report proportions and responses to Likert scale and multiple-choice questions. Guided by content analysis, we analyzed interview transcripts through thematic inductive coding and team debriefing. RESULTS: Among 58 respondents, 90% (n = 52) were female and 53% (n = 31) were nurses. Most reported always (n = 16, 28%) or very often (n = 21, 36%) obtaining a sexual history for adolescents. A majority agreed/strongly agreed that clinicians should discuss pregnancy prevention (n = 45, 78%), high-risk sexual behaviors (n = 40, 69%), and should prescribe contraception (n = 41, 71%) to adolescents. The most frequently cited provider-level barriers (i.e., significant or somewhat of a barrier) included insufficient contraception knowledge (n = 44, 77%) and time (n = 37, 64%). HCPs were concerned about barriers at the patient-level (e.g. adolescents' fear of parental notification [n = 37, 64%], adolescents will give inaccurate information about sexual behaviors [n = 25, 43%]) and system-level (e.g. resistance to providing care from administration [n = 33, 57%]). In interviews (n = 17), HCPs generally supported contraception care for adolescents. Many HCPs echoed our quantitative findings on concerns about privacy and confidentiality. HCPs reported concerns about lack of contraception education leading to misconceptions, and community and parental judgement. HCPs expressed interest in further contraception training and resources and noted the importance of providing youth-friendly contraceptive care. CONCLUSIONS: While HCPs support contraceptive care, we identified actionable barriers to improve care for adolescents in rural Haiti. Future efforts should include increasing HCP knowledge and training, community and parent coalition building to increase contraception support and offering youth-friendly contraceptive care to offset risk for related adverse health outcomes in adolescents in rural Haiti.

Thoracic Outlet Syndrome in the Pediatric and Young Adult Population.

PURPOSE: This study aimed to assess both nonsurgical and operative treatment outcomes of pediatric and young adult patients with thoracic outlet syndrome (TOS) at a tertiary care pediatric hospital. METHODS: A retrospective chart review of patients diagnosed with TOS, who were seen between January 2010 and August 2022 at a tertiary care pediatric hospital, was conducted. Collected pre- and postoperative data included symptoms, provocative testing (ie, Roo's, Wright's, and Adson's tests), participation in sports or upper-extremity activities, additional operations, and surgical complications. Assessment of operative treatment efficacy was based on pre- and post-provocative testing, pain, venogram results, alleviation of symptoms, and return to previous activity level 6 months after surgery. RESULTS: Ninety-six patients, (70 females and 26 males) with an average age at onset of 15 ± 4 (4-25) years, met the inclusion criteria for TOS. Among them, 27 had neurogenic TOS, 29 had neurogenic and vasculogenic TOS, 20 had vasculogenic TOS, 19 had Paget-Schroetter Syndrome, and one was asymptomatic. Twenty-six patients were excluded because of less than 6 months of follow-up. Of the remaining 70, 6 (8.6%) patients (4 bilateral and 2 unilateral) underwent nonoperative management with activity modification and physical therapy only, and one was fully discharged because of complete relief of symptoms. Sixty-four (90.1%) patients (45 bilateral and 19 unilateral) underwent surgery. A total of 102 operations were performed. Substantial improvements were observed in provocative maneuvers after surgery. Before surgery, 79.7% were involved in sports or playing musical instruments with repetitive overhead activity, and after surgery, 86.2% of these patients returned to their previous activity level. CONCLUSIONS: Few patients were successfully managed with nonoperative activity modification and physical therapy. In those requiring surgical intervention, first or cervical rib resection with scalenectomy using a supraclavicular approach provided resolution of symptoms with 86.2% of patients being able to return to presymptom sport or activity level. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Participation in a social cluster program among persons in residential living at a continuing care retirement community during COVID.

A Continuing Care Retirement Community (CCRC) initiated a voluntary cohort or "social cluster" (SC) program during the pre-vaccination phase of COVID. SCs are self-selected small groups of persons who decide about types of social interactions. The program began in April 2020, and a cross-sectional survey of residents was conducted in November 2020 to assess perceptions of COVID (e.g., worry and prevention) and of program participation. A secondary goal was to explore if program involvement was associated with perceptions of social isolation. Participants (n = 85) were "somewhat" (49 %) or "very" (11 %) worried about COVID, and 34 % participated in a SC. 89 % of the SC participants indicated that "Dining within 6ft" was most preferred. Improvement in boredom, social isolation, activity level, mental health, hope, and fear was noted among some SC participants (55 %, 52 %, 41 %, 38 %, and 14 %, respectively). Findings contribute to understanding social engagement needs amidst COVID.

Surgical Safety Does Not Happen By Accident: Learning From Perioperative Near Miss Case Studies.

Adverse surgical events cause negative patient health outcomes and harm that can often overshadow the safe and effective patient care provided daily by nurses as members of interprofessional healthcare teams. Near misses occur far more frequently than adverse events and are less visible to nurse leaders because patient harm is avoided due to chance, prevention, or mitigation. However, near misses have comparable root causes to adverse events and exhibit the same underlying patterns of failure. Reviewing near misses provides nurses with learning opportunities to identify patient care weaknesses and build appropriate solutions to enhance care. As the operating room is one of the most complex work settings in healthcare, identifying potential weaknesses or sources for errors is vital to reduce healthcare-associated risks for patients and staff. The purpose of this manuscript is to educate, inform, and stimulate critical thinking by discussing perioperative near miss case studies and the underlying factors that lead to errors. Our authors discuss 15 near miss case studies occurring across the perioperative patient experience of care and discuss barriers to near miss reporting. Nurse leaders can use our case studies to stimulate discussion among perioperative and perianesthesia nurses in their hospitals to inform comprehensive risk reduction programs.

Liver, visceral and subcutaneous fat in men and women of South Asian and white European descent: a systematic review and meta-analysis of new and published data.

AIMS/HYPOTHESIS: South Asians have a two- to fivefold higher risk of developing type 2 diabetes than those of white European descent. Greater central adiposity and storage of fat in deeper or ectopic depots are potential contributing mechanisms. We collated existing and new data on the amount of subcutaneous (SAT), visceral (VAT) and liver fat in adults of South Asian and white European descent to provide a robust assessment of potential ethnic differences in these factors. METHODS: We performed a systematic review of the Embase and PubMed databases from inception to August 2021. Unpublished imaging data were also included. The weighted standardised mean difference (SMD) for each adiposity measure was estimated using random-effects models. The quality of the studies was assessed using the ROBINS-E tool for risk of bias and overall certainty of the evidence was assessed using the GRADE approach. The study was pre-registered with the OSF Registries ( https://osf.io/w5bf9 ). RESULTS: We summarised imaging data on SAT, VAT and liver fat from eight published and three previously unpublished datasets, including a total of 1156 South Asian and 2891 white European men, and 697 South Asian and 2271 white European women. Despite South Asian men having a mean BMI approximately 0.5-0.7 kg/m2 lower than white European men (depending on the comparison), nine studies showed 0.34 SMD (95% CI 0.12, 0.55; I2=83%) more SAT and seven studies showed 0.56 SMD (95% CI 0.14, 0.98; I2=93%) more liver fat, but nine studies had similar VAT (-0.03 SMD; 95% CI -0.24, 0.19; I2=85%) compared with their white European counterparts. South Asian women had an approximately 0.9 kg/m2 lower BMI but 0.31 SMD (95% CI 0.14, 0.48; I2=53%) more liver fat than their white European counterparts in five studies. Subcutaneous fat levels (0.03 SMD; 95% CI -0.17, 0.23; I2=72%) and VAT levels (0.04 SMD; 95% CI -0.16, 0.24; I2=71%) did not differ significantly between ethnic groups in eight studies of women. CONCLUSIONS/INTERPRETATION: South Asian men and women appear to store more ectopic fat in the liver compared with their white European counterparts with similar BMI levels. Given the emerging understanding of the importance of liver fat in diabetes pathogenesis, these findings help explain the greater diabetes risks in South Asians. FUNDING: There was no primary direct funding for undertaking the systematic review and meta-analysis.

QIAstat-Dx gastrointestinal panel and Luminex xTAG gastrointestinal pathogen panel comparative evaluation.

The diagnosis of acute gastroenteritis is an ongoing clinical challenge in terms of identification of the etiologic agent, time to results, and appropriate treatment. Rapid detection of gastrointestinal pathogens is needed to improve patient care. This study evaluates the performance of the QIAstat-Dx gastrointestinal panel (Q-GP; Investigational Use Only) compared to the Luminex xTAG gastrointestinal pathogen panel (L-GPP; US-IVD). Using 245 stool specimens, we evaluated 10 different targets including rotavirus, norovirus, Salmonella, Shigella, Campylobacter, Giardia, Cryptosporidium, Escherichia coli O157, enterotoxigenic E. coli (ETEC), and Shiga toxin-producing E. coli (STEC). For the viral targets, the percent positive agreement (PPA) for rotavirus was 100% (n = 19) and that for norovirus was 91% (20/22). For the parasitic targets, the PPA was 100% for Giardia and Cryptosporidium (n = 18 and n = 23, respectively). The PPA was 96% for Salmonella (22/23) and Campylobacter (22/23), and the PPA for Shigella was 100% (n = 23). For the E. coli targets, a PPA of 94% was achieved for STEC (32/34) and 96% for ETEC (24/25). We did not assess PPA for the E. coli O157 target as the Q-GP O157 call is stx dependent. The negative percent agreement across all targets was 99.1%. Our study suggests that QIAstat-Dx GP provides comparable results to Luminex GPP based on the analysis of targets found on both panels.

Pandemic Demand for SARS-CoV-2 Testing Led to Critical Supply and Workforce Shortages in U.S. Clinical and Public Health Laboratories.

COVID-19 has brought unprecedented challenges to clinical and public health laboratories. While U.S. laboratories have continued striving to provide quality test results during the pandemic, the uncertainty and lack of supplies became a significant hurdle, hindering day-to-day laboratory operations and the ability to increase testing capacity for both SARS-CoV-2 and non-COVID-19 testing. In addition, long-standing laboratory workforce shortages became apparent, hindering the ability of clinical and public health laboratories to rapidly increase testing. The American Society for Microbiology, the College of American Pathologists, the National Coalition of STD Directors, and the Emerging Infections Network independently conducted surveys in 2020 and early 2021 to assess the capacity of the nation's clinical laboratories to respond to the increase in demand for testing during the COVID-19 pandemic. The results of these surveys highlighted the shortages of crucial supplies for SARS-CoV-2 testing and supplies for other routine laboratory diagnostics, as well as a shortage of trained personnel to perform testing. The conclusions are based on communications, observations, and the survey results of the clinical laboratory, public health, and professional organizations represented here. While the results of each survey considered separately may not be representative of the entire community, when considered together they provide remarkably similar results, further validating the findings and highlighting the importance of laboratory supply chains and the personnel capable of performing these tests for any response to a large-scale public health emergency.

The clinical epidemiology, management, and outcomes of patients diagnosed with encephalitis in North Carolina, 2015-2020.

IMPORTANCE: Despite the relatively high mortality and the difficulty in diagnosis, nearly one-third of patients hospitalized with a documented diagnosis of encephalitis did not undergo a lumbar puncture (LP). When an LP was performed, pathogen-specific testing was greatly underutilized. Infectious etiologies were most common, but over 40% of cases were idiopathic at discharge. These findings suggest that there is a substantial opportunity to improve the quality of care through more accurate and timely diagnosis.

CancerSupportSourceTM -Caregiver: Development of a distress screening measure for cancer caregivers.

OBJECTIVE: Given the substantial demands of cancer caregiving, practical and psychometrically sound tools to evaluate distress among cancer caregivers are needed. CancerSupportSourceTM -Caregiver is a distress screening, referral, and support program designed to identify the unmet needs of cancer caregivers and link caregivers to desired resources and support. This study refined and finalized the CancerSupportSource-Caregiver screening measure and examined its psychometric properties. METHODS: Using an analytic sample of 400 caregivers to people with cancer, we first performed item reduction by assessing exploratory factor analysis, external/internal item quality, and judging theoretical and practical implications of items. Confirmatory factor analysis along with reliability and validity analyses were then conducted to corroborate dimensionality and psychometric properties of the final measure. Nonparametric receiver operating characteristic curve analyses determined scoring thresholds for depression and anxiety risk subscales. RESULTS: Scale refinement resulted in an 18-item measure plus one screening item assessing tobacco and substance use. Items represented five domains of caregiver concerns: emotional well-being, patient well-being, caregiving tasks, finances, and healthy lifestyle. Our analyses showed strong internal consistency and test-retest reliability, a replicable factor structure, and adequate convergent, discriminant, and known groups validity. Sensitivity of 2-item depression and 2-item anxiety risk subscales were 0.95 and 0.87, respectively. CONCLUSIONS: CancerSupportSource-Caregiver is a reliable and valid multidimensional measure of caregiver distress that also screens for risk for clinically significant depression and anxiety. It can be implemented within a distress screening, referral, and follow-up program to rapidly assess caregivers' unmet needs and enhance caregiver well-being across the care continuum.

The psychometric properties of a caregiving-related strain scale in oncology.

BACKGROUND: Caregivers are rarely assessed for caregiving-related strain. This study explored the psychometric properties of the caregiving-related physical, emotional, and financial strain questions in the National Alliance for Caregiving's (NAC) survey and a new total score (NAC-3). METHODS: Comparisons were made to existing caregiver quality of life, distress, and burden instruments through an online, cross-sectional survey of U.S. adult cancer caregivers. RESULTS: Findings from 299 caregivers showed that the NAC-3 was moderately to strongly associated with each of the comparison instruments. Similar concepts were also shown to be more strongly correlated (except physical health construct) and dissimilar concepts items had weaker correlations. CONCLUSION: Findings suggest that the total score and individual items are psychometrically sound for use as compared to established caregiving-related instruments. The total score and items provide a concise option, potentially beneficial for clinical use, and can be compared to nationally representative samples of caregivers through NAC's surveys.

Sexual behaviors, contraception use and barriers among adolescents and young adults in rural Haiti.

BACKGROUND: Adolescents and young adults (AYAs) in Haiti experience a high unintended pregnancy rate, in part due to unmet contraception needs. Little is known about AYA opinions of and experiences with contraception that may explain remaining gaps in coverage. We aimed to describe barriers and facilitators to contraception use among AYAs in Haiti. METHODS: We conducted a cross-sectional survey and semi-structured qualitative interviews with a convenience sample of AYA females aged 14-24 in two rural communities in Haiti. The survey and semi-structured interviews assessed demographics, sexual health and pregnancy prevention behaviors and explored contraception opinions and experiences according to Theory of Planned Behavior constructs: attitudes, subjective norms, and perceived behavioral control. We used descriptive statistics to report means and responses to Likert scale and multiple-choice questions. Guided by content analysis, we analyzed interview transcripts through inductive coding and team debriefing. RESULTS: Among 200 survey respondents, 94% reported any past vaginal sexual activity, and 43% reported ever being pregnant. A large majority were trying to avoid pregnancy (75%). At last sexual activity, 127 (64%) reported use of any contraceptive method; Among them, condoms were the most common method (80%). Among those with previous condom use, most reported use less than half the time (55%). AYAs were concerned about parental approval of birth control use (42%) and that their friends might think they are looking for sex (29%). About one-third felt uncomfortable going to a clinic to ask for birth control. In interviews, AYAs desired pregnancy prevention but frequently noted concerns about privacy and parental, community and healthcare provider judgement for seeking care for reproductive health needs. AYAs also noted a lack of contraception knowledge, evident by frequent misconceptions and associated fears. CONCLUSION: Among AYAs in rural Haiti, a large majority were sexually active and desire pregnancy avoidance, but few were using effective contraception due to numerous concerns, including privacy and fear of judgement. Future efforts should address these identified concerns to prevent unintended pregnancy and improve maternal and reproductive health outcomes in this population.

Contraception use among individuals with substance use disorder increases tenfold with patient-centered, mobile services: a quasi-experimental study.

BACKGROUND: Individuals with substance use disorders (SUD) have disproportionately high rates of unintended pregnancy. Reducing harm associated with this risk and its biopsychosocial consequences requires evidence-based, non-coercive interventions that ensure access to contraception for individuals who choose to prevent pregnancy. We examined feasibility and impact of SexHealth Mobile, a mobile unit-based intervention that aimed to increase access to patient-centered contraceptive care for individuals in SUD recovery programs. METHODS: We conducted a quasi-experimental study (enhanced usual care [EUC] followed by intervention) at three recovery centers with participants (n = 98) at risk for unintended pregnancy. EUC participants were offered printed information on community locations where they could access contraception care. SexHealth Mobile participants were offered same-day, onsite clinical consultation on a medical mobile unit and contraception if desired. The primary outcome was use of contraception (hormonal or intrauterine device) at one-month post-enrollment. Secondary outcomes were at two-weeks and three-months. Confidence in preventing unintended pregnancy, reasons for non-use of contraception at follow-up, and intervention feasibility were also assessed. RESULTS: Participants (median age = 31, range 19-40) enrolled in the intervention period were almost 10 times more likely to be using contraception at one-month (51.5%) versus the those enrolled in the EUC period (5.4%) (unadjusted relative risk [URR] = 9.3 [95%CI: 2.3-37.1]; adjusted relative risk [ARR] = 9.8 [95%CI: 2.4-39.2]). Intervention participants were also more likely to be using contraception at 2-weeks (38.7% vs. 2.6%; URR = 14.3 [95%CI: 2.0-104.1]) and three-months (40.9% vs. 13.9%; URR = 2.9 [95% CI: 1.1-7.4]). EUC participants reported more barriers (cost, time) and less confidence in preventing unintended pregnancies. Mixed-methods feasibility data indicated high acceptability and feasible integration into recovery settings. CONCLUSIONS: Mobile contraceptive care based on principles of reproductive justice and harm reduction reduces access barriers, is feasible to implement in SUD recovery settings, and increases contraception use. Expanding interventions like SexHealth Mobile may help reduce harm from unintended pregnancies among individuals in SUD recovery. Trial Registration NCT04227145.

Valued Outcomes in the Cancer Experience (VOICE)™: Development and validation of a multidimensional measure of perceived control.

OBJECTIVE: Enhancing cancer patients' sense of control can positively impact psychological well-being. We developed and assessed the psychometric properties of Valued Outcomes in the Cancer Experience (VOICE)TM, a measure of patients' perceived control over key personal priorities within their cancer experience. METHODS: VOICE construction and testing were completed in three phases with separate participant samples: (1) item generation and initial item pool testing (N = 459), (2) scale refinement (N = 623), and (3) confirmatory validation (N = 515). RESULTS: A 21-item measure was developed that captures cancer patients' sense of control in seven key domains: (1) Purpose and Meaning, (2) Functional Capacity, (3) Longevity, (4) Quality Care, (5) Illness Knowledge, (6) Social Support, and (7) Financial Capability. VOICE demonstrated adequate internal consistency (full-scale α = 0.93; factor α = 0.67-0.89) and adequate to strong convergent and discriminatory validity. SIGNIFICANCE OF RESULTS: VOICE measures cancer patients' perceived control across a diverse range of personal priorities, creating a platform for elevating patient perspectives and identifying pathways to enhance patient well-being. VOICE is positioned to guide understanding of the patient experience and aid the development and evaluation of supportive care interventions to enhance well-being.

Clinical and Infection Prevention Applications of Severe Acute Respiratory Syndrome Coronavirus 2 Genotyping: An Infectious Diseases Society of America/American Society for Microbiology Consensus Review Document.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged into a world of maturing pathogen genomics, with >2 million genomes sequenced at this writing. The rise of more transmissible variants of concern that affect vaccine and therapeutic effectiveness has led to widespread interest in SARS-CoV-2 evolution. Clinicians are also eager to take advantage of the information provided by SARS-CoV-2 genotyping beyond surveillance purposes. Here, we review the potential role of SARS-CoV-2 genotyping in clinical care. The review covers clinical use cases for SARS-CoV-2 genotyping, methods of SARS-CoV-2 genotyping, assay validation and regulatory requirements, clinical reporting for laboratories, and emerging issues in clinical SARS-CoV-2 sequencing. While clinical uses of SARS-CoV-2 genotyping are currently limited, rapid technological change along with a growing ability to interpret variants in real time foretell a growing role for SARS-CoV-2 genotyping in clinical care as continuing data emerge on vaccine and therapeutic efficacy.

Collaboration between Clinical and Academic Laboratories for Sequencing SARS-CoV-2 Genomes.

Genomic sequencing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to provide valuable insight into the ever-changing variant makeup of the COVID-19 pandemic. More than three million SARS-CoV-2 genome sequences have been deposited in Global Initiative on Sharing All Influenza Data (GISAID), but contributions from the United States, particularly through 2020, lagged the global effort. The primary goal of clinical microbiology laboratories is seldom rooted in epidemiologic or public health testing, and many laboratories do not contain in-house sequencing technology. However, we recognized the need for clinical microbiologists to lend expertise, share specimen resources, and partner with academic laboratories and sequencing cores to assist in SARS-CoV-2 epidemiologic sequencing efforts. Here, we describe two clinical and academic laboratory collaborations for SARS-CoV-2 genomic sequencing. We highlight roles of the clinical microbiologists and the academic laboratories, outline best practices, describe two divergent strategies in accomplishing a similar goal, and discuss the challenges with implementing and maintaining such programs.