ABSTRACT
Background The use of digital breast tomosynthesis (DBT) is increasing over digital mammography (DM) following studies demonstrating lower recall rates (RRs) and higher cancer detection rates (CDRs). However, inconsistent interpretation of evidence on the risks and benefits of mammography has resulted in varying screening mammography recommendations. Purpose To evaluate screening outcomes among women in the United States who underwent routine DM or DBT mammographic screening. Materials and Methods This retrospective cohort study included women aged 40-79 years who underwent DM or DBT screening mammograms between January 2014 and December 2020. Outcomes of RR, CDR, positive predictive value of recall (PPV1), biopsy rate, and positive predictive value of biopsy (PPV3) were compared between DM and DBT with use of adjusted multivariable logistic regression models. Results A total of 2 528 063 screening mammograms from 1 100 447 women (mean age, 57 years ± 10 [SD]) were included. In crude analyses, DBT (1 693 727 screening mammograms vs 834 336 DM screening mammograms) demonstrated lower RR (10.3% [95% CI: 10.3, 10.4] for DM vs 8.9% [95% CI: 8.9, 9.0] for DBT; P < .001) and higher CDR (4.5 of 1000 screening mammograms [95% CI: 4.3, 4.6] vs 5.3 of 1000 [95% CI: 5.2, 5.5]; P < .001), PPV1 (4.3% [95% CI: 4.2, 4.5] vs 5.9% [95% CI: 5.7, 6.0]; P < .001), and biopsy rates (14.5 of 1000 screening mammograms [95% CI: 14.2, 14.7] vs 17.6 of 1000 [95% CI: 17.4, 17.8]; P < .001). PPV3 was similar between cohorts (30.0% [95% CI: 29.2, 30.9] for DM vs 29.3% [95% CI: 28.7, 29.9] for DBT; P = .16). After adjustment for age, breast density, site, and index year, associations remained stable with respect to statistical significance. Conclusion Women undergoing digital breast tomosynthesis had improved screening mammography outcomes compared with women who underwent digital mammography. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Bae and Seo in this issue.
Subject(s)
Breast Neoplasms , Mammography , Female , Humans , Middle Aged , Breast Density , Early Detection of Cancer/methods , Mammography/methods , Mass Screening/methods , Retrospective StudiesABSTRACT
BACKGROUND: Cell-mediated immunity is a specific target of several medications used to prevent or treat rejection in orthotopic heart transplantation. Low absolute lymphocyte count (ALC) has potential to be a useful and accessible clinical indicator of overall infection risk. Though some studies have demonstrated this association in other transplant populations, it has not been assessed in heart transplant recipients. METHODS: A single-center retrospective cohort study examined adult heart transplant recipients transplanted between 2000 and 2018. The exposure of interest was ALC ≤0.75 × 103 cells/µL at 1 month posttransplant, and the primary endpoint was a composite outcome of infection (including cytomegalovirus [CMV], herpes simplex I/II or varicella zoster virus [HSV/VZV], bloodstream infection [BSI], invasive fungal infection [IFI]) or death occurring after 1 month and before 1 year posttransplant. A multivariable Cox proportional hazards model was created to control for confounders identified using clinical judgment and statistical criteria. RESULTS: Of 375 subjects analyzed, 101 (27%) developed the composite outcome (61 CMV, 3 HSV/VZV, 19 BSI, 10 IFI, 8 deaths). Lymphopenia (ALC ≤0.75 × 103 cells/µL) at 1 month was associated with a >2-fold higher rate of the composite outcome (hazard ratio [HR], 2.26 [95% confidence interval {CI}, 1.47-3.46]; P < .001) compared to patients without lymphopenia at 1 month. After adjustment for confounding variables, the presence of lymphopenia remained statistically significantly associated with the composite outcome (HR, 1.72 [95% CI, 1.08-2.75]; P = .02). CONCLUSIONS: ALC measured at 1 month after heart transplant is associated with an increased risk of infectious outcomes or death in the ensuing 11 months. This is a simple, accessible laboratory measure.
Subject(s)
Heart Transplantation , Lymphopenia , Adult , Cytomegalovirus , Heart Transplantation/adverse effects , Humans , Retrospective Studies , Risk Factors , Transplant RecipientsABSTRACT
BACKGROUND: Prognostic tools, such as risk calculators, improve the patient-physician informed decision-making process. These tools are limited for breast cancer patients when assessing surgical complication risk preoperatively. OBJECTIVE: In this study, we aimed to assess predictors associated with acute postoperative complications for breast cancer patients and then develop a predictive model that calculates a complication probability using patient risk factors. METHODS: We performed a retrospective cohort study using the National Surgical Quality Improvement Program (NSQIP) database from 2005 to 2017. Women diagnosed with ductal carcinoma in situ or invasive breast cancer who underwent either breast conservation or mastectomy procedures were included in this predictive modeling scheme. Four models were built using logistic regression methods to predict the following composite outcomes: overall, infectious, hematologic, and internal organ complications. Model performance, accuracy and calibration measures during internal/external validation included area under the curve, Brier score, and Hosmer-Lemeshow statistic, respectively. RESULTS: A total of 163,613 women met the inclusion criteria. The area under the curve for each model was as follows: overall, 0.70; infectious, 0.67; hematologic, 0.84; and internal organ, 0.74. Brier scores were all between 0.04 and 0.003. Model calibration using the Hosmer-Lemeshow statistic found all p-values to be > 0.05. Using model coefficients, individualized risk can be calculated on the web-based Breast Cancer Surgery Risk Calculator (BCSRc) platform ( www.breastcalc.org ). CONCLUSION: We developed an internally and externally validated risk calculator that estimates a breast cancer patient's unique risk of acute complications following each surgical intervention. Preoperative use of the BCSRc can potentially help stratify patients with an increased complication risk and improve expectations during the decision-making process.
Subject(s)
Breast Neoplasms , Breast , Breast Neoplasms/surgery , Female , Humans , Mastectomy , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective Studies , Risk Assessment , Risk FactorsABSTRACT
BACKGROUND: Studies on the impact of the novel SARS-CoV-2 virus (COVID) for healthcare workers (HCWs) rarely include the full spectrum of hospital workers, including less visible patient support roles. In the early days of the pandemic, COVID testing was preferentially available to HCWs. The objective of this study was to understand how individual experiences for all HCWs during the pandemic were associated with perceptions of access to, and receipt of COVID testing . METHODS: All hospital employees (n = 6736) in a single academic medical center in Boston, Massachusetts were invited to participate in a cross-sectional survey regarding perceived access to, and receipt of COVID testing during the first wave of the pandemic (March - August 2020). Responses were linked to human resources data. Log binomial univariate and multivariable models were used to estimate associations between individual and employment variables and COVID testing. RESULTS: A total of 2543 employees responded to the survey (38 %). The mean age was 40 years (± 14). Respondents were female (76 %), white (55 %), worked as nurses (27 %), administrators (22 %) and patient support roles (22 %); 56 % of respondents wanted COVID testing. Age (RR 0.91, CI 0.88-0.93), full time status (RR 0.85, CI 0.79-0.92), employment tenure (RR 0.96, CI 0.94-0.98), changes in quality of life (RR 0.94, CI 0.91-0.96), changes in job duties (RR 1.19, CI 1.03-1.37), and worry about enough paid sick leave (RR 1.21, CI 1.12-1.30) were associated with interest in testing. Administrators (RR 0.64, CI 0.58-0.72) and patient support staff (RR 0.85, CI 0.78-0.92) were less likely than nurses to want testing. Age (RR 1.04, CI 1.01-1.07), material hardships (RR 0.87, CI 0.79-0.96), and employer sponsored insurance (RR 1.10, CI 1.00-1.22) were associated with receiving a COVID test. Among all employees, only administrative/facilities staff were less likely to receive COVID testing (RR 0.69, CI 0.59-0.79). CONCLUSIONS: This study adds to our understanding of how hospital employees view availability of COVID testing. Hazard pay or other supports for hospital workers may increase COVID testing rates. These findings may be applicable to perceived barriers towards vaccination receipt.
Subject(s)
COVID-19 Testing , COVID-19 , Adult , Boston , Cross-Sectional Studies , Female , Health Personnel , Humans , Massachusetts , Quality of Life , SARS-CoV-2ABSTRACT
The PATH (Predictive Approaches to Treatment effect Heterogeneity) Statement was developed to promote the conduct of, and provide guidance for, predictive analyses of heterogeneity of treatment effects (HTE) in clinical trials. The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risk with versus without the intervention, taking into account all relevant patient attributes simultaneously, to support more personalized clinical decision making than can be made on the basis of only an overall average treatment effect. The authors distinguished 2 categories of predictive HTE approaches (a "risk-modeling" and an "effect-modeling" approach) and developed 4 sets of guidance statements: criteria to determine when risk-modeling approaches are likely to identify clinically meaningful HTE, methodological aspects of risk-modeling methods, considerations for translation to clinical practice, and considerations and caveats in the use of effect-modeling approaches. They discuss limitations of these methods and enumerate research priorities for advancing methods designed to generate more personalized evidence. This explanation and elaboration document describes the intent and rationale of each recommendation and discusses related analytic considerations, caveats, and reservations.
Subject(s)
Clinical Decision-Making , Randomized Controlled Trials as Topic/standards , Treatment Outcome , Clinical Decision Rules , Clinical Decision-Making/methods , Evidence-Based Medicine/standards , Humans , Individuality , Models, Statistical , Risk AssessmentABSTRACT
Heterogeneity of treatment effect (HTE) refers to the nonrandom variation in the magnitude or direction of a treatment effect across levels of a covariate, as measured on a selected scale, against a clinical outcome. In randomized controlled trials (RCTs), HTE is typically examined through a subgroup analysis that contrasts effects in groups of patients defined "1 variable at a time" (for example, male vs. female or old vs. young). The authors of this statement present guidance on an alternative approach to HTE analysis, "predictive HTE analysis." The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risks with versus without the intervention, taking into account all relevant patient attributes simultaneously. The PATH (Predictive Approaches to Treatment effect Heterogeneity) Statement was developed using a multidisciplinary technical expert panel, targeted literature reviews, simulations to characterize potential problems with predictive approaches, and a deliberative process engaging the expert panel. The authors distinguish 2 categories of predictive HTE approaches: a "risk-modeling" approach, wherein a multivariable model predicts the risk for an outcome and is applied to disaggregate patients within RCTs to define risk-based variation in benefit, and an "effect-modeling" approach, wherein a model is developed on RCT data by incorporating a term for treatment assignment and interactions between treatment and baseline covariates. Both approaches can be used to predict differential absolute treatment effects, the most relevant scale for clinical decision making. The authors developed 4 sets of guidance: criteria to determine when risk-modeling approaches are likely to identify clinically important HTE, methodological aspects of risk-modeling methods, considerations for translation to clinical practice, and considerations and caveats in the use of effect-modeling approaches. The PATH Statement, together with its explanation and elaboration document, may guide future analyses and reporting of RCTs.
Subject(s)
Randomized Controlled Trials as Topic/standards , Treatment Outcome , Clinical Decision Rules , Clinical Decision-Making , Evidence-Based Medicine/standards , Humans , Individuality , Models, Statistical , Risk AssessmentABSTRACT
BACKGROUND: Recent evidence suggests that there is often substantial variation in the benefits and harms across a trial population. We aimed to identify regression modeling approaches that assess heterogeneity of treatment effect within a randomized clinical trial. METHODS: We performed a literature review using a broad search strategy, complemented by suggestions of a technical expert panel. RESULTS: The approaches are classified into 3 categories: 1) Risk-based methods (11 papers) use only prognostic factors to define patient subgroups, relying on the mathematical dependency of the absolute risk difference on baseline risk; 2) Treatment effect modeling methods (9 papers) use both prognostic factors and treatment effect modifiers to explore characteristics that interact with the effects of therapy on a relative scale. These methods couple data-driven subgroup identification with approaches to prevent overfitting, such as penalization or use of separate data sets for subgroup identification and effect estimation. 3) Optimal treatment regime methods (12 papers) focus primarily on treatment effect modifiers to classify the trial population into those who benefit from treatment and those who do not. Finally, we also identified papers which describe model evaluation methods (4 papers). CONCLUSIONS: Three classes of approaches were identified to assess heterogeneity of treatment effect. Methodological research, including both simulations and empirical evaluations, is required to compare the available methods in different settings and to derive well-informed guidance for their application in RCT analysis.
Subject(s)
Research Design , Humans , Randomized Controlled Trials as TopicABSTRACT
PURPOSE: Distribution and outcomes of traumatic injury of the esophagus (TIE) in pediatric versus adult populations are unknown. Our study sought to perform a descriptive analysis of TIE in children and adults. METHODS: We reviewed the National Trauma Data Bank (NTDB) for the years 2010-2015. Demographics, characteristics, and outcomes of pediatric (age < 16 years) and adult TIE patients were described and compared. RESULTS: Among 526,850 pediatric and 3,838,895 adult trauma patients, 90 pediatric (0.02%) and 1,411 (0.04%) adult TIE patients were identified. Demographics and esophageal injury severity did not differ. Children were more likely to sustain blunt trauma (63% versus 37%), with the most common mechanism being transportation-related accidents, were less-severely injured (median ISS 14 versus 22), and had fewer associated injuries (79% versus 95%) and complications (30% versus 51%) (all p < 0.001). Children had shorter hospitalizations (median 5 versus 10 days) and were more likely to be discharged home (84% versus 64%) (both p = 0.01). In-hospital mortality did not differ significantly between children and adults (10% versus 19%, p = 0.09). CONCLUSION: TIE in the pediatric population has unique characteristics compared to adults: it is more likely to be a result of blunt trauma, has lower injury burden, and has more favorable clinical outcomes.
Subject(s)
Abdominal Injuries/epidemiology , Esophagus/injuries , Multiple Trauma , Registries , Thoracic Injuries/epidemiology , Trauma Centers/statistics & numerical data , Wounds, Nonpenetrating/epidemiology , Abdominal Injuries/diagnosis , Adolescent , Adult , Child , Child, Preschool , Female , Hospital Mortality/trends , Humans , Incidence , Infant , Infant, Newborn , Injury Severity Score , Length of Stay/trends , Male , Thoracic Injuries/diagnosis , United States/epidemiology , Wounds, Nonpenetrating/diagnosis , Young AdultABSTRACT
OBJECTIVE: The aim of this study was to assess the impact of a revolving loan fund (RLF) on timing of device insertion and long-acting reversible contraception (LARC) access among a high-risk urban population at 3 Boston community health centers. DESIGN: Three health centers were identified to implement a RLF. Each clinic received $5000 from the RLF to purchase LARC devices. Data collected through medical record review retrospectively 1 year prior to start of the RLF and prospectively for 1 year thereafter included patient demographics, type of LARC selected, patient's date of documented interest in a LARC device, and date of insertion. The effect of a RLF on delay to LARC insertion was tested using negative binomial regression, controlling for site and potential confounding variables between the pre- and post-RLF periods. SETTING: Three urban community health centers. PARTICIPANTS: Reproductive-aged women who received family planning services at the 3 participating health centers. MAIN OUTCOME MEASURES: Increasing access to LARC and decreasing wait times to LARC insertion after implementation of the RLF. RESULTS: Data on 133 patients in the pre-RLF group and 205 in the post-RLF group were collected. There were no statistically significant differences in demographic or clinical characteristics between the 2 time periods. LARC uptake increased significantly from the pre- to post-RLF period, specifically among implant users. There was a statistically significant decrease in the mean number of days in delay from interest to insertion from the pre- to post-RLF period (pre-RLF: 31.3 ± 50.6 days; post-RLF: 13.6 ± 16.7 days, adjusted P < .001). The reasons for the delay did not differ significantly between the 2 time periods. CONCLUSION: The RLF decreased wait time for the devices and increased overall insertion rates. This may serve as a promising solution to improve LARC access in community health centers. This project could be expanded to include more health centers, creating a city wide RLF. This expansion could allow for further data analysis, including unintended pregnancy rates with LARC delay, LARC continuation rates, and sustainability of a RLF.
Subject(s)
Community Health Centers/economics , Health Services Accessibility/standards , Long-Acting Reversible Contraception/statistics & numerical data , Adult , Boston , Community Health Centers/trends , Family Planning Services/economics , Family Planning Services/methods , Family Planning Services/organization & administration , Female , Health Planning Support/trends , Humans , Long-Acting Reversible Contraception/economics , Long-Acting Reversible Contraception/methods , Prospective Studies , Retrospective Studies , Urban Population/statistics & numerical dataABSTRACT
BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) affects millions of people worldwide. Vasopressin promotes disease progression. STUDY DESIGN: A randomized controlled trial with equal (1:1) allocation. SETTING & PARTICIPANTS: This trial examined the effect of combining a low-osmolar (low-sodium [1,500mg/d], low-protein [0.8g per kilogram of body weight]) diet and adjusted water intake on vasopressin secretion in 34 patients with ADPKD. INTERVENTION: Participants were randomly assigned to receive a low-osmolar diet followed by adjusted water intake to achieve urine osmolality ≤ 280mOsm/kg water versus no intervention for 2 weeks. OUTCOME: The primary outcome of the study was change (delta) in copeptin levels and urine osmolality between the intervention and control groups from baseline to 2 weeks. MEASUREMENTS: Fasting plasma copeptin level, 24-hour urine osmolality, and total solute intake. RESULTS: Baseline characteristics of the 2 groups were similar. Mean plasma copeptin levels and urine osmolality declined from 6.2±3.05 (SD) to 5.3±2.5pmol/L (P=0.02) and from 426±193 to 258±117mOsm/kg water (P=0.01), respectively, in the intervention group compared to a nonsignificant change in the control group (from 4.7±3.6 to 5.07±4pmol/L [P=0.2] and 329±159 to 349±139mOsm/kg water [P=0.3], respectively). The change in copeptin levels (primary outcome) and urine osmolality was statistically significant between the intervention and control groups (delta copeptin, -0.86±1.3 vs +0.39±1.2pmol/L [P=0.009]; delta urine osmolality, -167±264 vs +20±80mOsm/kg water [P=0.007], respectively). Total urinary solute decreased in only the intervention group and significantly differed between groups at week 1 (P=0.03), reducing mean water prescription from 3.2 to 2.6L/d. LIMITATIONS: Small sample size and short follow-up. CONCLUSIONS: We developed a stepwise dietary intervention that led to a significant reduction in vasopressin secretion in patients with ADPKD. Furthermore, this intervention led to a reduction in water required for vasopressin reduction.
Subject(s)
Arginine Vasopressin/metabolism , Drinking , Polycystic Kidney, Autosomal Dominant/diet therapy , Adolescent , Adult , Arginine Vasopressin/urine , Female , Humans , Male , Middle Aged , Osmolar Concentration , Pilot Projects , Polycystic Kidney, Autosomal Dominant/urine , Young AdultABSTRACT
BACKGROUND: Foregut duplication cysts are rare congenital anomalies that require surgical intervention with approximately 10%-15% of all gastrointestinal duplication cysts originating from the esophagus. Consensus is lacking among surgeons regarding closure of the esophageal muscle layer after resection of an esophageal duplication cyst and long-term outcomes are poorly documented. Therefore, we conducted the first study comparing complication rates in patients undergoing closure versus nonclosure of the esophageal muscle layer after esophageal duplication cyst resection. MATERIALS AND METHODS: A retrospective cohort study at Boston Children's Hospital, Massachusetts General Hospital, Brigham and Women's Hospital, and the Floating Hospital for Children at Tufts Medical Center was conducted. Patients undergoing resection of esophageal duplication cysts between 1990 and 2012 were classified according to whether the esophageal muscle layer was closed or left open. Demographic data, surgical technique, preoperative symptoms, and both short-term (<30 d) and long-term (≥30 d) complication rates were abstracted from patient medical records. RESULTS: Twenty-five patients were identified with a median age of 15-y old (range, 2 mo to 68-y old) and an average follow-up of 1 y. Eleven patients had the esophageal muscle layer closed after surgical resection (44%). Of those 11 patients, one developed a short-term complication, dysphagia (9%, 95% CI: 2%, 38%). Only one patient returned to the operating room, after 30 d, for an upper endoscopy after developing symptoms of gastroesophageal reflux disease. Of the 14 patients who had their muscle layer left open, three patients (21%, 95% CI: 8%, 48%) developed short-term complications, two of whom required surgical intervention within 30 d. Furthermore, two additional patients required surgical intervention after 30 d for a long-term complication (diverticulum and cyst recurrence). CONCLUSIONS: Surgical complications occurred more frequently in patients who had the muscle layer left open after resection of an esophageal duplication cyst. In addition, most patients requiring reoperation for both short-term and long-term complications occurred in this group. Though small, this study is the first to evaluate the complications after resecting esophageal duplication cysts. Our results suggest that closing the esophageal muscle layer after removal of an esophageal duplication cyst may be indicated to prevent both complications and the need for reoperations.
Subject(s)
Esophageal Cyst/congenital , Esophageal Cyst/surgery , Esophagoplasty/methods , Esophagus/abnormalities , Esophagus/surgery , Adolescent , Adult , Aged , Child , Child, Preschool , Female , Follow-Up Studies , Humans , Infant , Male , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Retrospective Studies , Treatment Outcome , Young AdultABSTRACT
OBJECTIVE: To assess the degree of agreement between propensity score studies and randomized clinical trials in critical care research. DATA SOURCES: Propensity score studies published in highly cited critical care or general medicine journals or included in a previous systematic review; corresponding randomized clinical trials included in Cochrane Systematic Reviews or published in PubMed. STUDY SELECTION: We identified propensity score studies of the effects of therapeutic interventions on short- or long-term mortality. We systematically matched propensity score studies to randomized clinical trials based on patient selection criteria, interventions, and outcomes. DATA EXTRACTION: We appraised the methods of included studies and extracted treatment effect estimates to compare the results of propensity score studies and randomized clinical trials. When multiple studies were identified for the same topic, we performed meta-analyses to obtain summary treatment effect estimates. DATA SYNTHESIS: We matched 21 propensity score studies with 58 randomized clinical trials in 18 distinct comparisons (median, one propensity score study and two randomized clinical trials per comparison), for short- and long-term mortality. We found one statistically significant difference between designs (hyperoncotic albumin vs crystalloid fluids) among these 18 comparisons. Propensity score studies did not produce systematically higher (or lower) treatment effect estimates compared with randomized clinical trials, but estimates from the two designs differed by more than 30% in one third of the comparisons examined. Observational studies in critical care met widely accepted methodological standards for propensity score analyses. CONCLUSIONS: Across diverse critical care topics, propensity score studies published in high-impact journals produced results that were generally consistent with the findings of randomized clinical trials. However, caution is needed when interpreting propensity score studies because occasionally their results contradict those of randomized clinical trials and there is no reliable way to predict disagreements.
Subject(s)
Critical Care , Critical Illness/mortality , Observational Studies as Topic/statistics & numerical data , Randomized Controlled Trials as Topic/statistics & numerical data , Humans , Propensity ScoreABSTRACT
OBJECTIVES: ß-Lactam antibiotics are commonly used in outpatient parenteral antimicrobial therapy (OPAT), but data regarding outcomes of long-term therapy are limited. The purpose of this study was to compare treatment success, readmission and antibiotic switch rates in patients treated with ß-lactam antibiotics as OPAT. METHODS: We carried out a retrospective review of all patients, discharged from Tufts Medical Center with cefazolin, ceftriaxone, ertapenem or oxacillin, between January 2009 and June 2013. A competing risks analysis was used to compare the cumulative incidence of first occurrence of treatment success, antibiotic switch and 30 day readmission for each drug. RESULTS: Four hundred patients were identified (cefazolin nâ=â38, ceftriaxone nâ=â104, ertapenem nâ=â128 and oxacillin nâ=â130). Baseline demographics were similar. Treatment success rates were higher for ceftriaxone and ertapenem (cefazolin 61%, ceftriaxone 81%, ertapenem 73% and oxacillin 58%; Pâ<â0.001). Thirty-day all-cause readmissions were similar (cefazolin 21%, ceftriaxone 14%, ertapenem 20% and oxacillin 15%; Pâ=â0.46). In 400 OPAT courses, 37 out of 50 antibiotic switches were accomplished without readmission. Adverse drug events (ADEs) were the most common reason for outpatient antibiotic switches (31/37, 84%). The ADE rate was higher for the oxacillin group (cefazolin 2.0 versus ceftriaxone 1.5 versus ertapenem 2.9 versus oxacillin 8.4 per 1000 OPAT days; Pâ<â0.001). CONCLUSIONS: OPAT with ß-lactam antibiotics is effective, but antibiotic switches for adverse events were more frequent with oxacillin use. Clinicians should be cognizant of the risk of readmissions and ADEs in OPAT patients, as the value of OPAT lies in reducing patient morbidity and readmissions by managing ADEs and preventing clinical failures.
Subject(s)
Ambulatory Care/methods , Anti-Bacterial Agents/therapeutic use , beta-Lactams/therapeutic use , Administration, Intravenous , Adult , Aged , Anti-Bacterial Agents/adverse effects , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Male , Middle Aged , Retrospective Studies , Treatment Outcome , beta-Lactams/adverse effectsABSTRACT
BACKGROUND: Communication errors are considered one of the major causes of sentinel events. Our aim was to assess the process of patient handoff among junior surgical residents and to determine ways in which to improve the handoff process. METHODS: We conducted nationwide surveys that included all accredited general surgery residency programs in the United States and Canada. RESULTS: Of the 244 American and 17 Canadian accredited surgical residency programs contacted, 65 (27%) and 12 (71%), respectively, participated in the survey. Of the American and Canadian respondents, 66% and 69%, respectively, were from postgraduate year (PGY) 1, and 32% and 29%, respectively, were from PGY 2; 85 (77%) and 50 (96%), respectively, had not received any training about patient handoff before their surgical residency, and 27% and 64%, respectively, reported that the existing handoff system at their institutions did not adequately protect patient safety. Moreover, 29% of American respondents and 37% of Canadian respondents thought that the existing handoffs did not support continuity of patient care. Of the American residents, 67% and 6% reported receiving an incomplete handoff that resulted in minor and major patient harm, respectively. These results mirrored those from Canadian residents (63% minor and 7% major harm). The most frequent factor reported to improve the patient handoff process was standardization of the verbal handoff. CONCLUSION: Our survey results indicate that the current patient handoff system contributes to patient harm. More efforts are needed to establish standardized forms of verbal and written handoff to ensure patient safety and continuity of care.
CONTEXTE: Les erreurs de communication sont considérées comme l'une des causes majeures des événements sentinelles. Notre but était d'évaluer le processus de transfert des patients chez les résidents junior en chirurgie et de trouver des façons de l'améliorer. MÉTHODES: Nous avons procédé à des sondages nationaux qui ont inclus tous les programmes agréés de résidence en chirurgie générale aux États Unis et au Canada. RÉSULTATS: Sur les 244 programmes agréés de résidence en chirurgie américains et les 17 canadiens, 65 (27 %) et 12 (71 %), respectivement, ont participé au sondage. Parmi les participants américains et canadiens, 66 % et 69 %, respectivement, étaient en première année de résidence (PGY 1) et 32 % et 29 %, respectivement, étaient en deuxième année de résidence (PGY 2); 85 (77 %) et 50 (96 %), respectivement, n'avaient reçu aucune formation sur le transfert des patients avant leur résidence en chirurgie et 27 % et 64 %, respectivement, ont déclaré que le système actuel de transfert de leur établissement n'assurait pas adéquatement la sécurité des patients. De plus, 29 % des participants américains et 37 % des participants canadiens ont dit estimer que le mode actuel de transfert ne favorisait pas la continuité des soins. Chez les résidents américains, 67 % et 6 % ont déclaré recevoir un rapport de transfert incomplet susceptible d'entraîner un préjudice mineur et majeur, respectivement, pour le patient. Ces réponses correspondaient à celles des résidents canadiens (63 % et 7 %, respectivement, en ce qui concerne les préjudices mineurs et majeurs). Le facteur mentionné comme le plus propice à une amélioration du processus de transfert des patients était la standardisation du rapport verbal. CONCLUSION: Les résultats de nos sondages indiquent que le système actuel de transfert des patients serait préjudiciable à ces derniers. Il faudra travailler à standardiser les processus de transfert et de rapports verbaux et écrits pour assurer la sécurité des patients et la continuité des soins.
Subject(s)
General Surgery/education , Internship and Residency , Patient Handoff/standards , Process Assessment, Health Care/statistics & numerical data , Adult , Attitude of Health Personnel , Canada , Cross-Sectional Studies , Female , Health Care Surveys/statistics & numerical data , Humans , Male , United StatesABSTRACT
BACKGROUND: Factors associated with readmission for patients prescribed outpatient parenteral antibiotic therapy (OPAT) at hospital discharge have not been definitively identified. The study aim was to develop a model of 30-day readmissions for OPAT patients. METHODS: A database comprising 782 OPAT patients treated between 2009 and 2011 at a single academic center was created. Variables collected included patient demographics, comorbidities, infections, and antibiotic classes. Final model discrimination was assessed using the c-statistic, and calibration was examined graphically. RESULTS: Mean patient age was 58 years (range, 18-95 years), 43% were women, and the most common diagnoses were bacteremia (24%), osteomyelitis (20%), and pyelonephritis (13%). The unplanned 30-day readmission rate was 26%. The leading indications for readmission were non-infection related (30%), worsening infection (29%), and new infection (19%). The final regression model consisted of age (odds ratio [OR], 1.09 per decade; 95% confidence interval [CI], 0.99-1.21), aminoglycoside use (OR, 2.33; 95% CI, 1.17-4.57), resistant organisms (OR, 1.57; 95% CI, 1.03-2.36), and number of prior hospital discharges without intravenous antibiotics in the past 12 months (OR, 1.20 per prior admission; 95% CI, 1.09-1.32). The c-statistic was 0.61 and the highest-risk quintile of patients had almost a 3-fold higher rate of readmission compared to the lowest. CONCLUSIONS: Patients prescribed OPAT are at risk for readmission. A subgroup of patients at especially high risk can be identified using easily obtainable clinical characteristics at the time of hospital discharge. More intensive interventions to prevent OPAT readmissions should be targeted and tested with those at highest risk.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Infusions, Parenteral/statistics & numerical data , Models, Statistical , Outpatients/statistics & numerical data , Patient Readmission/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Risk Factors , Young AdultABSTRACT
OBJECTIVE: To evaluate the longitudinal relationship between bone mineral density (BMD) and BMD changes and the progression of knee osteoarthritis (OA), as measured by cartilage outcomes. METHODS: We used observational cohort data from the Vitamin D for Knee Osteoarthritis trial. Bilateral femoral neck BMD values as well as knee magnetic resonance imaging (MRI) scans in each subject were obtained at baseline and subsequently at 12 months and 24 months. The change in total cartilage volume and tibial and femoral cartilage thickness was measured by manual cartilage segmentation of 2 sequential knee MRI scans in each subject. Multivariable linear regression models were used to examine the associations of baseline BMD and BMD change with the cartilage outcomes, adjusting for baseline age, sex, body mass index, malalignment, and vitamin D treatment. Model fit and assumptions were validated. RESULTS: A total of 127 subjects were eligible for analysis. Longitudinal BMD loss was associated with loss of cartilage volume (ß = 1.25 per 0.1 gm/cm(2) , P = 0.02) and loss of tibial cartilage thickness (ß = 0.028, P = 0.03). BMD loss of a magnitude greater than the least significant change (<-4.7%) was associated with 1.02% cartilage volume loss per year (P = 0.005), 0.014 mm femoral cartilage thickness loss (P = 0.04), and 0.021 mm tibial cartilage thickness loss per year (P = 0.009). There were no significant associations between baseline BMD and any of the cartilage outcomes. CONCLUSION: Longitudinal BMD loss is associated with progressive cartilage loss in knees with OA. Further work to clarify the basis of this relationship could reveal novel therapeutic targets for knee OA.
Subject(s)
Bone Density , Cartilage, Articular/pathology , Femur Neck/pathology , Knee Joint/pathology , Osteoarthritis, Knee/physiopathology , Aged , Cohort Studies , Disease Progression , Female , Follow-Up Studies , Humans , Magnetic Resonance Imaging , Male , Middle AgedABSTRACT
BACKGROUND: Spinal manipulation has been associated with cervical arterial dissection and stroke but a causal relationship has been questioned by population-based studies. Earlier studies identified cases using International Classification of Diseases Ninth Revision (ICD-9) codes specific to anatomic stroke location rather than stroke etiology. We hypothesize that case misclassification occurred in these previous studies and an underestimation of the strength of the association. We also predicted that case misclassification would differ by patient age. METHODS: We identified cases in the Veterans Health Administration database using the same strategy as the prior studies. The electronic medical record was then screened for the word "dissection." The presence of atraumatic dissection was determined by medical record review by a neurologist. RESULTS: Of 3690 patients found by ICD-9 codes over a 30-month period, 414 (11.2%) had confirmed cervical artery dissection with a positive predictive value of 10.5% (95% confidence interval [CI] 9.6%-11.5%). The positive predictive value was higher in patients less than 45 years of age vs 45 years of age or older (41% vs 9%, P < .001). We reanalyzed a previous study, which reported no association between spinal manipulation and cervical artery dissection (odds ratio [OR] = 1.12, 95% CI .77-1.63) and recalculated an odds ratio of 2.15 (95% CI .98-4.69). For patients less than 45 years of age, the OR was 6.91 (95% CI 2.59-13.74). CONCLUSIONS: Prior studies grossly misclassified cases of cervical dissection and mistakenly dismissed a causal association with manipulation. Our study indicates that the OR for spinal manipulation exposure in cervical artery dissection is higher than previously reported.
Subject(s)
Aging/pathology , Manipulation, Spinal/classification , Manipulation, Spinal/statistics & numerical data , Vertebral Artery Dissection/classification , Vertebral Artery Dissection/epidemiology , Adult , Aged , Electronic Health Records , Female , Humans , International Classification of Diseases/standards , Male , Middle Aged , Odds Ratio , Risk FactorsABSTRACT
INTRODUCTION: Keloids are lesions characterized by the growth of dense fibrous tissue extending beyond original wound boundaries. Research into the natural history of keloids and potential differences by sociodemographic factors in the USA is limited. This real-world, retrospective cohort study aimed to characterize a population of patients with keloids compared with matched dermatology and general cohorts. METHODS: Patients with ≥ 2 International Classification of Diseases codes for keloid ≥ 30 days apart and a confirmed keloid diagnosis from clinical notes enrolled in the OM1 Real-World Data Cloud between 1 January 2013 and 18 March 2022 were age- and sex-matched 1:1:1 to patients without keloids who visited dermatologists ("dermatology cohort") and those who did not ("general cohort"). Results are presented using descriptive statistics and analysis stratified by cohort, race, ethnicity, household income, and education. RESULTS: Overall, 24,453 patients with keloids were matched to 23,936 dermatology and 24,088 general patients. A numerically higher proportion of patients with keloids were Asian or Black. Among available data for patients with keloids, 67.7% had 1 keloid lesion, and 68.3% had keloids sized 0.5 to < 3 cm. Black patients tended to have larger keloids. Asian and Black patients more frequently had > 1 keloid than did white patients (30.6% vs. 32.5% vs. 20.5%). Among all patients with keloids who had available data, 56.4% had major keloid severity, with major severity more frequent in Black patients. Progression was not significantly associated with race, ethnicity, income, or education level; 29%, 25%, and 20% of the dermatology, keloid, and general cohorts were in the highest income bracket (≥ US$75,000). The proportion of patients with income below the federal poverty line (< US$22,000) and patterns of education level were similar across cohorts. CONCLUSION: A large population of patients in the USA with keloids was identified and characterized using structured/unstructured sources. A numerically higher proportion of patients with keloids were non-white; Black patients had larger, more severe keloids at diagnosis.
ABSTRACT
BACKGROUND: Case series suggest that long-term use of proton pump inhibitors (PPIs) is associated with hypomagnesemia, but the current literature lacks systematically collected data. Our aim was to examine whether hypomagnesemia at the time of hospital admission is associated with out-of-hospital use of PPIs. STUDY DESIGN: Nested case-control study matched for age and sex. SETTING & PARTICIPANTS: Data were collected retrospectively from a tertiary acute-care facility. Eligible cases consisted of 402 adults with hypomagnesemia (serum magnesium <1.4 mEq/L) at the time of hospital admission to medical services, age- and sex-matched with 402 control individuals with normal serum magnesium levels (1.4-2.0 mEq/L). PREDICTOR: Out-of-hospital PPI use was identified in the hospital record. An omeprazole equivalent dose was calculated when possible. Covariates included the Charlson-Deyo comorbidity index, diabetes, diuretic use, estimated glomerular filtration rate, and gastroesophageal reflux. OUTCOME: Multivariable conditional logistic regression analyses were used to examine the association of PPI use with hypomagnesemia at the time of hospital admission. RESULTS: PPI use was not associated with hypomagnesemia (adjusted OR, 0.82; 95% CI, 0.61-1.11). Neither PPI type nor omeprazole equivalent daily dose was associated with hypomagnesemia. Sensitivity analyses of PPI use restricted to patients with esophageal disorders (adjusted OR, 1.00; 95% CI, 0.69-1.45), severe hypomagnesemia (magnesium, ≤1.0 mEq/L; adjusted OR, 0.78; 95% CI, 0.13-4.61), or estimated glomerular filtration rate ≥60 mL/min/1.73 m(2) (adjusted OR, 0.84; 95% CI, 0.53-1.34) were unrevealing. LIMITATIONS: Exposure misclassification; hospitalized patients on medical services may not be representative of a broader ambulatory-based population. CONCLUSIONS: In a hospital-based adult population, out-of-hospital PPI use is not associated with hypomagnesemia at the time of hospital admission to medical services. In light of these inconclusive results, prospective cohort studies are needed to address this rare potential medication-related adverse effect.