Emergency transfusion with whole blood versus packed red blood cells: A study of 1400 patients.

BACKGROUND: Low-titer group O whole blood (LTOWB) is increasingly used for emergency transfusion. We studied whether initial release of LTOWB compared with packed red blood cells (pRBCs) reduced overall blood requirements for patients needing emergency transfusion. Secondary outcomes examined included survival and non-lethal adverse clinical outcomes. STUDY DESIGN AND METHODS: A retrospective, single-center, before-versus-after study compared patients transfused with emergency-release, uncrossmatched pRBC followed by component therapy (2016-2019) versus patients transfused with emergency-release, uncrossmatched LTOWB followed by component therapy (2019-2022). RESULTS: Outcomes were available for 602 patients in the pRBC group versus 749 in the whole blood group. The two groups were similar for age, sex, race, estimated blood volume, ABO blood groups, and underlying diagnosis. Use of LTOWB was associated with increased blood product use at 24 h (4.0 (2.0-12.0) in pRBC group versus 6.5 (4.2-12.7) in LTOWB group, p < .0001) and at 7 days (5.5 (3.0-13.0) in pRBC group versus 7.3 (4.3-14.3) in LTOWB group, p < .0001). Initial use of LTOWB was not associated with improved 24 h or 30 day survival nor lower incidence of non-lethal adverse clinical outcomes compared with pRBC. DISCUSSION: Our study showed a statistically significant increase in total blood use and blood acquisition costs for patients receiving initial emergency transfusion with LTOWB compared with pRBC. The initial use of LTOWB offered no advantage over component therapy for 30 day survival or selected non-lethal adverse outcomes.

Platelet transfusion in critical care: A new method to analyze transfusion practice based on decision time intervals.

BACKGROUND: While prior studies of platelet transfusion in critical care have focused on transfusions given, proper analysis of clinical transfusion practice also requires consideration of the decision not to transfuse. STUDY DESIGN AND METHODS: We introduce a new method to assess transfusion practice based on decision time intervals (DTIs). Each patient's intensive care (ICU) stay was segmented into a series of DTIs defined by a time interval following results of a complete blood count (CBC). We studied the presence of 17 clinical factors during each DTI whether transfusion was given or not. We used a generalized linear mixed model to assess the most influential clinical triggers for platelet transfusion. RESULTS: Among 6125 ICU patients treated between October 2016 and October 2021, we analyzed 39,745 DTIs among patients (n = 2921) who had at least one DTI with thrombocytopenia (≤150,000/µL). We found no association between platelet count and two markers of bleeding: drop in hemoglobin and chest tube drainage. We found that the majority of DTIs were associated with no platelet transfusion regardless of the platelet count; that no specific platelet value triggered transfusion; but rather that multiple clinical factors in conjunction with the platelet count influenced the decision to transfuse. DISCUSSION: DTI analysis represents a new method to assess transfusion practice that considers both transfusions given and not given, and that analyzes clinical circumstances present when decisions regarding transfusion are made. The method is easily adapted to blood components other than platelet transfusions and is easily extended to other ICU and other hospital settings.

The process and challenges of language translation and cultural adaptation of study instruments: a case study from the NIDA CTN CHOICES-2 trial.

BACKGROUND: As the U.S. grows more diverse, researchers decide how to include non-English speakers. Budget limitations may not allow for translation of all instruments. Study teams must determine which instruments must receive certified translations. This paper describes the procedures utilized in one U.S.-based, multi-site clinical trial to decide which study instruments should undergo certified translation and discusses dialect review procedures. METHODS: The team determined which instruments (n = 31) would be translated using a qualitative evaluation to determine the need to obtain a Spanish-language certified translation: 1) "Could the meaning of these questions change (and potentially elicit a different response) if the translations were not consistent?" and 2) "Is it acceptable to have potential inconsistencies in these data?" Instruments for which question 1 was "yes" and question 2 was "no" (e.g., eligibility, outcomes, safety) were marked for certified translation. A dialect committee reviewed all translated patient-reported outcome measures to ensure that the translations had accounted for different meanings of words based on respondents' countries or regions of origin and recommended changes where necessary. RESULTS: Fourteen interview-based instruments underwent certified forward-only translation into U.S. Spanish. The remaining 2 interview-based instruments were translated via real-time conversation with participants by bilingual staff. Six forms were administrative and not translated. Five out of 9 professionally translated patient-reported outcome measures were amended to better reflect relevant dialects. CONCLUSIONS: In the absence of specific guidance, it is feasible for study team members to 1) determine which instruments should undergo certified translation and 2) incorporate dialect into translations.

Retrospective analysis of outcomes in patients with acute hypertriglyceridemic pancreatitis treated without therapeutic plasma exchange.

BACKGROUND: Therapeutic plasma exchange (TPE) is often used to decrease serum triglyceride levels in hypertriglyceridemic pancreatitis (HTGP), although there is a lack of high-quality data directly attributing improved clinical outcomes to TPE. There are currently no large studies evaluating the treatment of HTGP without TPE. STUDY DESIGN AND METHODS: This study retrospectively analyzes clinical and laboratory outcomes of 115 encounters at Massachusetts General Hospital (MGH) wherein a HTGP patient was treated without TPE and compares these outcomes to those of HTGP patients in the literature treated with TPE. RESULTS: After management without TPE, the median reduction in serum triglycerides was 48% (IQR 29%-63%) on day one and 74% (IQR 60%-84%) on day two in 115 episodes of acute HTGP. The reductions were comparable to those reported in several large published case series after a course of TPE (65.8% to 81% reduction). In 25 episodes among 24 patients, treatment included admission to an intensive care unit. There was no significant difference in mortality or rates of local complication, mechanical ventilation, or use of vasoactive medication or renal replacement therapy between this ICU subset and published cohorts (all P > .05). CONCLUSIONS: HTGP patients who do not receive TPE do not experience inferior outcomes compared to patients in the literature treated with TPE. The added value of TPE in HTGP, if any exists, needs to be demonstrated in controlled trials.

Minimally Invasive Aortic Valve Replacement.

With the advent of transcatheter aortic valve replacement and the emergence of rapid deployment aortic valves, there is a resurgent interest in minimizing the trauma of surgical aortic valve replacement (AVR). The present review summarizes the history of minimal access AVR and attempts to collate the existing evidence regarding minimal access AVR.

Auditing plasma transfusion in intensive care: Use of decision time interval analysis.

OBJECTIVES: To present a new method for displaying blood utilization data based on analysis of decision time intervals (DTIs). METHODS: Retrospective study of patients treated in a medical intensive care unit (ICU), surgical ICU, or postcardiac surgery ICU at an academic hospital between January 2018 and June 2023. Each patient's episode of care was divided into a series of DTIs. Transfusions during each time interval were recorded. RESULTS: In total, 16,562 patients received 6980 units of plasma and 21,034 units of red blood cells during 111,557 time intervals of care. Patients had international normalized ratio (INR) values ranging from less than 1.0 to more than 4.0. Data on plasma transfusion at different INR values were displayed as the number of transfusion episodes, number of units given, or the proportion of DTIs with transfusion. Clinicians transfused plasma on 1.5% of occasions when the INR was 1.5 or less and on 2.2% of occasions when the INR was less than 2.0. Plasma was transfused without red blood cells in only 0.75% of DTIs. Transfusion practice was statistically different among the 3 ICUs. CONCLUSIONS: Compared with traditional methods of displaying the results of blood audits, DTI analysis displays information regarding the decision both to transfuse and to not transfuse. Utilization reviews that display data based on decision time analysis reveal clinical practice patterns very different from those suggested by traditional displays of plasma audit data.

Assessment of Screening Tools to Identify Substance Use Disorders Among Adolescents.

Importance: Efficient screening tools that effectively identify substance use disorders (SUDs) among youths are needed. Objective: To evaluate the psychometric properties of 3 brief substance use screening tools (Screening to Brief Intervention [S2BI]; Brief Screener for Tobacco, Alcohol, and Drugs [BSTAD]; and Tobacco, Alcohol, Prescription Medication, and Other Substances [TAPS]) with adolescents aged 12 to 17 years. Design, Setting, and Participants: This cross-sectional validation study was conducted from July 1, 2020, to February 28, 2022. Participants aged 12 to 17 years were recruited virtually and in person from 3 health care settings in Massachusetts: (1) an outpatient adolescent SUD treatment program at a pediatric hospital, (2) an adolescent medicine program at a community pediatric practice affiliated with an academic institution, and (3) 1 of 28 participating pediatric primary care practices. Participants were randomly assigned to complete 1 of the 3 electronic screening tools via self-administration, followed by a brief electronic assessment battery and a research assistant-administered diagnostic interview as the criterion standard measure for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnoses of SUDs. Data were analyzed from May 31 to September 13, 2022. Main Outcomes and Measures: The main outcome was a DSM-5 diagnosis of tobacco/nicotine, alcohol, or cannabis use disorder as determined by the criterion standard World Mental Health Composite International Diagnostic Interview Substance Abuse Module. Classification accuracy of the 3 substance use screening tools was assessed by examining the agreement between the criterion, using sensitivity and specificity, based on cut points for each tool for use disorder, chosen a priori from previous studies. Results: This study included 798 adolescents, with a mean (SD) age of 14.6 (1.6) years. The majority of participants identified as female (415 [52.0%]) and were White (524 [65.7%]). High agreement between screening results and the criterion standard measure was observed, with area under the curve values ranging from 0.89 to 1 for nicotine, alcohol, and cannabis use disorders for each of the 3 screening tools. Conclusions and Relevance: These findings suggest that screening tools that use questions on past-year frequency of use are effective for identifying adolescents with SUDs. Future work could examine whether these tools have differing properties when used with different groups of adolescents in different settings.

Computer vision quantitation of erythrocyte shape abnormalities provides diagnostic, prognostic, and mechanistic insight.

Examination of red blood cell (RBC) morphology in peripheral blood smears can help diagnose hematologic diseases, even in resource-limited settings, but this analysis remains subjective and semiquantitative with low throughput. Prior attempts to develop automated tools have been hampered by their poor reproducibility and limited clinical validation. Here, we present a novel, open-source machine-learning approach (denoted as RBC-diff) to quantify abnormal RBCs in peripheral smear images and generate an RBC morphology differential. RBC-diff cell counts showed high accuracy for single-cell classification (mean AUC, 0.93) and quantitation across smears (mean R2, 0.76 compared with experts, interexperts R2, 0.75). RBC-diff counts were concordant with the clinical morphology grading for 300 000+ images and recovered the expected pathophysiologic signals in diverse clinical cohorts. Criteria using RBC-diff counts distinguished thrombotic thrombocytopenic purpura and hemolytic uremic syndrome from other thrombotic microangiopathies, providing greater specificity than clinical morphology grading (72% vs 41%; P < .001) while maintaining high sensitivity (94% to 100%). Elevated RBC-diff schistocyte counts were associated with increased 6-month all-cause mortality in a cohort of 58 950 inpatients (9.5% mortality for schist. >1%, vs 4.7% for schist; <0.5%; P < .001) after controlling for comorbidities, demographics, clinical morphology grading, and blood count indices. RBC-diff also enabled the estimation of single-cell volume-morphology distributions, providing insight into the influence of morphology on routine blood count measures. Our codebase and expert-annotated images are included here to spur further advancement. These results illustrate that computer vision can enable rapid and accurate quantitation of RBC morphology, which may provide value in both clinical and research contexts.

HIV clinic-based extended-release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non-blinded, randomized non-inferiority trial.

BACKGROUND AND AIM: Opioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. We tested whether outpatient antagonist treatment with naltrexone could achieve similar results. DESIGN: Open-label, non-inferiority randomized trial. SETTING: Six US HIV primary care clinics. PARTICIPANTS: A total of 114 participants with untreated HIV and OUD (62% male; 56% black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%) and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment. INTERVENTION: HIV clinic-based extended-release naltrexone (XR-NTX; n = 55) versus treatment as usual (TAU) with buprenorphine or methadone (TAU; n = 59). MEASUREMENTS: Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA ≤ 200 copies/ml) at 24 weeks and secondary outcomes included past 30-day use of opioids at 24 weeks. FINDINGS: Fewer XR-NTX participants initiated medication compared with TAU participants (47 versus 73%). The primary outcome of viral suppression was comparable for XR-NTX (52.7%) and TAU (49.2%) [risk ratio (RR) = 1.064; 95% confidence interval (CI) = 0.748, 1.514] at 24 weeks. Non-inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the pre-specified margin of 0.75 in intention-to-treat (ITT) analysis. The main secondary outcome of past 30-day opioid use was comparable for XR-NTX versus TAU (11.7 versus 14.8 days; mean difference = -3.1; 95% CI = -8.7, 1.1) in ITT analysis. Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 versus 13.6, mean difference = -7.6; 95% CI = -13.8, -0.2). CONCLUSIONS: A randomized controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus clinic-based extended-release naltrexone is not inferior to treatment as usual for facilitating human immunodeficiency virus viral suppression. Participants who initiated extended-release naltrexone used fewer opioids than those who received treatment as usual.

An Examination of the Feasibility of Detecting Cocaine Use Using Smartwatches.

As digital technology increasingly informs clinical trials, novel ways to collect study data in the natural field setting have the potential to enhance the richness of research data. Cocaine use in clinical trials is usually collected via self-report and/or urine drug screen results, both of which have limitations. This article examines the feasibility of developing a wrist-worn device that can detect sufficient physiological data (i.e., heart rate and heart rate variability) to detect cocaine use. This study aimed to develop a wrist-worn device that can be used in the natural field setting among people who use cocaine to collect reliable data (determined by data yield, device wearability, and data quality) that is less obtrusive than chest-based devices used in prior research. The study also aimed to further develop a cocaine use detection algorithm used in previous research with an electrocardiogram on a chestband by adapting it to a photoplethysmography sensor on the wrist-worn device which is more prone to motion artifacts. Results indicate that wrist-based heart rate data collection is feasible and can provide higher data yield than chest-based sensors, as wrist-based devices were also more comfortable and affected participants' daily lives less often than chest-based sensors. When properly worn, wrist-based sensors produced similar quality of heart rate and heart rate variability features to chest-based sensors and matched their performance in automated detection of cocaine use events. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02915341.

Towards detecting cocaine use using smartwatches in the NIDA clinical trials network: Design, rationale, and methodology.

Cocaine use in clinical trials is often measured via self-report, which can be inaccurate, or urine drug screens, which can be intrusive and burdensome. Devices that can automatically detect cocaine use and can be worn conveniently in daily life may provide several benefits. AutoSense is a wearable, physiological-monitoring suite that can detect cocaine use, but it may be limited as a method for monitoring cocaine use because it requires wearing a chestband with electrodes. This paper describes the design, rationale, and methodology of a project that seeks to build upon and extend previous work in the development of methods to detect cocaine use via wearable, unobtrusive mobile sensor technologies. To this end, a wrist-worn sensor suite (i.e., MotionSense HRV) will be developed and evaluated. Participants who use cocaine (N = 25) will be asked to wear MotionSense HRV and AutoSense for two weeks during waking hours. Drug use will be assessed via thrice-weekly urine drug screens and self-reports, and will be used to isolate periods of cocaine use that will be differentiated from other drug use. The present study will provide information on the feasibility and acceptability of using a wrist-worn device to detect cocaine use.