Comparison of COVID-19 hospitalization costs across care pathways: a patient-level time-driven activity-based costing analysis in a Brazilian hospital.

BACKGROUND: The COVID-19 pandemic raised awareness of the need to better understand where and how patient-level costs are incurred in health care organizations, as health managers and other decision-makers need to plan and quickly adapt to the increasing demand for health care services to meet patients' care needs. Time-driven activity-based costing offers a better understanding of the drivers of cost throughout the care pathway, providing information that can guide decisions on process improvement and resource optimization. This study aims to estimate COVID-19 patient-level hospital costs and to evaluate cost variability considering the in-hospital care pathways of COVID-19 management and the patient clinical classification. METHODS: This is a prospective cohort study that applied time-driven activity-based costing (TDABC) in a Brazilian reference center for COVID-19. Patients hospitalized during the first wave of the disease were selected for their data to be analyzed to estimate in-hospital costs. The cost information was calculated at the patient level and stratified by hospital care pathway and Ordinal Scale for Clinical Improvement (OSCI) category. Multivariable analyses were applied to identify predictors of cost variability in the care pathways that were evaluated. RESULTS: A total of 208 patients were included in the study. Patients followed five different care pathways, of which Emergency + Ward was the most followed (n = 118, 57%). Pathways which included the intensive care unit presented a statistically significant influence on costs per patient (p <  0.001) when compared to Emergency + Ward. The median cost per patient was I$2879 (IQR 1215; 8140) and mean cost per patient was I$6818 (SD 9043). The most expensive care pathway was the ICU only, registering a median cost per patient of I$13,519 (IQR 5637; 23,373) and mean cost per patient of I$17,709 (SD 16,020). All care pathways that included the ICU unit registered a higher cost per patient. CONCLUSIONS: This is one of the first microcosting study for COVID-19 that applied the TDABC methodology and demonstrated how patient-level costs vary as a function of the care pathways followed by patients. These findings can be used to develop value reimbursement strategies that will inform sustainable health policies in middle-income countries such as Brazil.

Understanding Hospital-Level Patterns of Nonoperative Management for Low-risk Thyroid and Kidney Cancer.

Importance: There is a growing trend toward conservative management for certain low-risk cancers. Hospital and health-system factors may play a role in determining how these patients are managed. Objective: To explore the contribution of hospitals on patients' odds of nonoperative management for low-risk cancer. Design, Setting, and Participants: In this cross-sectional study, individuals with low-risk papillary thyroid cancer and solitary kidney masses were identified, and those receiving nonoperative management vs surgery were compared. Patients with low-risk thyroid cancer and kidney cancer from 2015 to 2017 eligible for nonoperative management according to National Comprehensive Cancer Network guidelines within the National Cancer Database were included. Data were analyzed from October 2021 to March 2022. Main Outcomes and Measures: For each facility, the proportion of these patients who received operative and nonoperative management was calculated. A mixed-effects logistic regression model with a hospital-level random effects term was used to calculate factors associated with nonoperative management. Between-hospital variability was assessed using ranked caterpillar plots. Results: There were 19 570 individuals with low-risk thyroid cancer (15 344 women [78.4%]; mean [SD] age, 51.74 [95% CI, 51.39-52.08] years) and 41 403 with kidney cancer (25 253 men [61.0%]; mean [SD] age, 61.93 [95% CI, 61.70-62.17] years). In the group with low-risk thyroid cancer, 2.1% (419 patients) received nonoperative management, and in the group with kidney cancer, 9.5% (3928 patients) received nonoperative management. This varied between hospitals from 1.1% (95% CI, 1.0%-1.1%) in the bottom decile to 10.3% (95% CI, 8.0%-12.4%) in the top decile for low-risk thyroid cancer, and from 4.3% (95% CI, 4.1%-4.4%) in the bottom decile to 24.6% (95% CI, 22.7%-26.5%) in the top decile for small kidney masses. For both cancers, age was associated with increased odds of nonoperative treatment. The hospital-level odds of nonoperative management of thyroid and kidney cancer using unadjusted probabilities (observed proportions) were minimally correlated (Spearman ρ = .33; P < .001). Conclusions and Relevance: The findings of this study suggest that although health systems factors may be associated with the tendency to pursue nonoperative management, hospital-level factors may differ when comparing unrelated cancers.

Immune checkpoint inhibitor monotherapy is associated with less cardiac toxicity than combination therapy.

BACKGROUND: Treatment options for many cancers include immune checkpoint inhibitor (ICI) monotherapy and combination therapy with impressive clinical benefit across cancers. We sought to define the comparative cardiac risks of ICI combination and monotherapy. METHODS: We used VigiBase, the World Health Organization pharmacovigilance database, to identify cardiac ADRs (cADRs), such as carditis, heart failure, arrhythmia, myocardial infarction, and valvular dysfunction, related to ICI therapy. To explore possible relationships, we used the reporting odds ratio (ROR) as a proxy of relative risk. A lower bound of a 95% confidence interval of ROR &gt; 1 reflects a disproportionality signal that more ADRs are observed than expected due to chance. RESULTS: We found 2278 cADR for ICI monotherapy and 353 for ICI combination therapy. Combination therapy was associated with significantly higher odds of carditis (ROR 6.9, 95% CI: 5.6-8.3) versus ICI monotherapy (ROR 5.0, 95% CI: 4.6-5.4). Carditis in ICI combination therapy was fatal in 23.4% of reported ADRs, compared to 15.8% for ICI monotherapy (P = 0.058). CONCLUSIONS: Using validated pharmacovigilance methodology, we found increased odds of carditis for all ICI therapies, with the highest odds for combination therapy. Given the substantial risk of severe ADR and death, clinicians should consider these findings when prescribing checkpoint inhibitors.

Sociodemographic and clinical profile of patients receiving disability certificates for psychiatric disorders: An Indian Psychiatric Society Multicentric study.

Aim: To study the sociodemographic and clinical profile of subjects receiving disability certificates (DCs) issued for psychiatric disorders across multiple centres in India. Materials and Methods: Eleven centres, including ten government and one non-governmental organization spread across the country, participated in the study. Data on the sociodemographic and clinical profiles of patients who were issued DC in the calendar year 2019 were collected on a proforma designed for the study. Results: Overall, 2018 patients were issued DC for various psychiatric disorders across 11 centres in 2019. The number of certificates issued across different centres varied from 34 to 622. In terms of diagnostic profile, intellectual disability accounted for most of the certificates issued. In terms of psychiatric diagnosis, schizophrenia was the most common psychiatric diagnosis, followed by bipolar disorder, for which a DC was issued. When the diagnosis was considered, centre wise, intellectual disability (6 centres), mental illness (MI; 4 centres), and autism and specific learning disability (1 centre) accounted for the most DCs issued. Schizophrenia (9 centres), bipolar affective disorder (1 centre), and dementia (1 centre) were the most common MI for which DC was issued. Across centres, more than two-thirds of DC were issued to males. Conclusion: There is a wide variation in the number and clinical profile of DC issued across centres.

Moving the Brazilian ischaemic stroke pathway to a value-based care: introduction of a risk-adjusted cost estimate model for stroke treatment.

The unsustainable increases in healthcare expenses and waste have motivated the migration of reimbursement strategies from volume to value. Value-based healthcare requires detailed comprehension of cost information at the patient level. This study introduces a clinical risk- and outcome-adjusted cost estimate model for stroke care sustained on time-driven activity-based costing (TDABC). In a cohort and multicentre study, a TDABC tool was developed to evaluate the costs per stroke patient, allowing us to identify and describe differences in cost by clinical risk at hospital arrival, treatment strategies and modified Rankin Score (mRS) at discharge. The clinical risk was confirmed by multivariate analysis and considered patients' National Institute for Health Stroke Scale and age. Descriptive cost analyses were conducted, followed by univariate and multivariate models to evaluate the risk levels, therapies and mRS stratification effect in costs. Then, the risk-adjusted cost estimate model for ischaemic stroke treatment was introduced. All the hospitals collected routine prospective data from consecutive patients admitted with ischaemic stroke diagnosis confirmed. A total of 822 patients were included. The median cost was I$2210 (interquartile range: I$1163-4504). Fifty percent of the patients registered a favourable outcome mRS (0-2), costing less at all risk levels, while patients with the worst mRS (5-6) registered higher costs. Those undergoing mechanical thrombectomy had an incremental cost for all three risk levels, but this difference was lower for high-risk patients. Estimated costs were compared to observed costs per risk group, and there were no significant differences in most groups, validating the risk and outcome-adjusted cost estimate model. By introducing a risk-adjusted cost estimate model, this study elucidates how healthcare delivery systems can generate local cost information to support value-based reimbursement strategies employing the data collection instruments and analysis developed in this study.

A Standardized Framework for Evaluating Surgical Enhanced Recovery Pathways: A Recommendations Statement from the TDABC in Health-care Consortium.

Background: Innovative methodologies to redesign care delivery are being applied to increase value in health care, including the creation of enhanced recovery pathways (ERPs) for surgical patients. However, there is a lack of standardized methods to evaluate ERP implementation costs. Objectives: This Recommendations Statement aims to introduce a standardized framework to guide the economic evaluation of ERP care-design initiatives, using the Time-Driven Activity-Based Costing (TDABC) methodology. Methods: We provide recommendations on using the proposed framework to support the decision-making processes that incorporate ERPs. Since ERPs are usually composed of activities distributed throughout the patient care pathway, the framework can demonstrate how the TDABC may be a valuable method to evaluate the incremental costs of protocol implementation. Our recommendations are based on the review of available literature and expert opinions of the members of the TDABC in Healthcare Consortium. Results: The ERP framework, composed of 11 steps, was created describing how the techniques and methods can be applied to evaluate the economic impact of an ERP and guide health-care leaders to optimize the decision-making process of incorporating ERPs into health-care settings. Finally, six recommendations are introduced to demonstrate that using the suggested framework could increase value in ERP care-design initiatives by reducing variability in care delivery, educating multidisciplinary teams about value in health, and increasing transparency when managing surgical pathways. Conclusions: Our proposed standardized framework can guide decisions and support measuring improvements in value achieved by incorporating the perioperative redesign protocols.

Cardiovascular toxicities associated with abiraterone compared to enzalutamide-A pharmacovigilance study.

BACKGROUND: Androgen deprivation therapy (ADT) is standard-of-care for advanced prostate cancer. Studies have generally found increased cardiovascular risks associated with ADT, but the comparative risk of newer agents is under-characterized. We defined the cardiac risks of abiraterone and enzalutamide, using gonadotropic releasing hormone (GnRH) agonists to establish baseline ADT risk. METHODS: We used VigiBase, the World Health Organization pharmacovigilance database, to identify cardiac adverse drug reactions (ADRs) in a cohort taking GnRH agonists, abiraterone, or enzalutamide therapy for prostate cancer, comparing them to all other patients. To examine the relationship, we used an empirical Bayes estimator to screen for significance, then calculated the reporting odds ratio (ROR), a surrogate measure of association. A lower bound of a 95% confidence interval (CI) of ROR > 1 reflects a disproportionality signal that more ADRs are observed than expected due to chance. FINDINGS: We identified 2,433 cardiac ADRs, with higher odds for abiraterone compared to all other VigiBase drugs for overall cardiac events (ROR 1•59, 95% CI 1•48-1•71), myocardial infarction (1•35, 1•16-1•58), arrythmia (2•04, 1•82-2•30), and heart failure (3•02, 2•60-3•51), but found no signal for enzalutamide. Patients on GnRH agonists also had increased risk of cardiac events (ROR 1•21, 95% CI 1•12-1•30), myocardial infarction (1•80, 1•61-2•03) and heart failure (2•06, 1•76-2•41). INTERPRETATION: We found higher reported odds of cardiac events for abiraterone but not enzalutamide. Our data may suggest that patients with significant cardiac comorbidities may be better-suited for therapy with enzalutamide over abiraterone. FUNDING: None.

Is the current referral trend a threat to the Military Health System? Perioperative outcomes and costs after colorectal surgery in the Military Health System versus civilian facilities.

BACKGROUND: TRICARE military beneficiaries are increasingly referred for major surgeries to civilian hospitals under "purchased care." This loss of volume may have a negative impact on the readiness of surgeons working in the "direct-care" setting at military treatment facilities and has important implications under the volume-quality paradigm. The objective of this study is to assess the impact of care source (direct versus purchased) and surgical volume on perioperative outcomes and costs of colorectal surgeries. METHODS: We examined TRICARE claims and medical records for 18- to 64-year-old patients undergoing major colorectal surgery from 2006 to 2015. We used a retrospective, weighted estimating equations analysis to assess differences in 30-day outcomes (mortality, readmissions, and major or minor complications) and costs (index and total including 30-day postsurgery) for colorectal surgery patients between purchased and direct care. RESULTS: We included 20,317 patients, with 24.8% undergoing direct-care surgery. Mean length of stay was 7.6 vs 7.7 days for direct and purchased care, respectively (P = .24). Adjusted 30-day odds between care settings revealed that although hospital readmissions (odds ratio 1.40) were significantly higher in direct care, overall complications (odds ratio 1.05) were similar between the 2 settings. However, mean total costs between direct and purchased care differed ($55,833 vs $30,513, respectively). Within direct care, mean total costs ($50,341; 95% confidence interval $41,509-$59,173) were lower at very high-volume facilities compared to other facilities ($54,869; 95% confidence interval $47,822-$61,916). CONCLUSION: Direct care was associated with higher odds of readmissions, similar overall complications, and higher costs. Contrary to common assumptions regarding volume and quality, higher volume in the direct-care setting was not associated with fewer complications.

Temporal Trends in the Incidence of Testicular Cancer in the United States over the Past Four Decades.

Testicular cancer is the most commonly diagnosed solid-organ neoplasm among young men, with variable incidence across racial groups. Testicular cancer incidence has increased since the 1970s, most notably among white men. Such trends in testicular cancer remain poorly understood. We investigated age-adjusted incidence rates of testicular cancer from 1975 to 2015 using Surveillance, Epidemiology and End Results data to further understand the nature of the temporal trends and potential drivers of disease. Across this time period, white men had the highest incidence and the largest increase in rate; however, we also note more recent increases in the incidence of testicular cancer across all racial groups being examined. PATIENT SUMMARY: We analyzed the rate of testicular cancer in the United States between 1975 and 2015. In that time, white patients had the highest rate and increase in rate of testicular cancer, but non-white patients also had increasing rates of disease.

Access denied: The relationship between patient insurance status and access to high-volume hospitals.

BACKGROUND: Underinsured patients face significant barriers in accessing high-quality care. Evidence of whether access to high-volume surgical care is mediated by disparities in health insurance coverage remains wanting. METHODS: The authors used the National Cancer Data Base to identify all adult patients who had a confirmed diagnosis of breast, prostate, lung, or colorectal cancer during 2004 through 2016. The odds of receiving surgical care at a high-volume hospital were estimated according to the type of insurance using multivariable logistic regression analyses for each malignancy. Then, the interactions between study period and insurance status were assessed. RESULTS: In total, 1,279,738 patients were included in the study. Of these, patients with breast cancer who were insured by Medicare (odds ratio [OR], 0.75; P < .001), Medicaid (OR, 0.55; P < .001), or uninsured (OR, 0.50; P < .001); patients with prostate cancer who were insured by Medicare (OR, 0.87; P = .003), Medicaid (OR, 0.58; P = .001), or uninsured (OR, 0.36; P < .001); and patients with lung cancer who were insured by Medicare (OR, 0.84; P = .020), Medicaid (OR, 0.74; P = .001), or uninsured (OR, 0.48; P < .001) were less likely to receive surgical care at high-volume hospitals compared with patients who had private insurance. For patients with colorectal cancer, the effect of insurance differed by study period, and improved since 2011. For those on Medicaid, the odds of receiving care at a high-volume hospital were 0.51 during 2004 through 2007 and 0.99 during 2014 through 2016 (P for interaction = .001); for uninsured patients, the odds were 0.45 during 2004 through 2007 and 1.19 during 2014 through 2016 (P for interaction < .001) compared with patients who had private insurance. CONCLUSIONS: Uninsured, Medicare-insured, and Medicaid-insured patients are less likely to receive surgical care at high-volume hospitals. For uninsured and Medicaid-insured patients with colorectal cancer, the odds of receiving care at high-volume hospitals have improved since implementation of the Patient Protection and Affordable Care Act of 2010.

Trends in Surgical Volume in the Military Health System-A Potential Threat to Mission Readiness.

INTRODUCTION: The Military Health System (MHS) is tasked with a dual mission both to provide medical services for covered patients and to ensure that its active duty medical personnel maintain readiness for deployment. Knowledge, skills, and attitudes (KSA) is a metric evaluating the transferrable skills incorporated into a given surgery or medical procedure that are most relevant for surgeons deployed to a theatre of war. Procedures carrying a high KSA value are those utilizing skills with high relevance for maintaining deployment readiness. Given ongoing concerns regarding surgical volumes at MTFs and the potential adverse impact on military surgeon mission readiness were high-value surgeries to be lost to the civilian sector, we evaluated trends in the setting of high-value surgeries for beneficiaries within the MHS. METHODS: We retrospectively analyzed inpatient admissions data from MTFs and TRICARE claims data from civilian hospitals, 2005-2019, to identify TRICARE-covered patients covered under "purchased care" (referred to civilian facilities) or receiving "direct care" (undergoing treatment at MTFs) and undergoing seven high-value/high-KSA surgeries: colectomy, pancreatectomy, hepatectomy, open carotid endarterectomy, abdominal aortic aneurysm (AAA) repair, esophagectomy, and coronary artery bypass grafting (CABG). Overall and procedure-specific counts were captured, MTFs were categorized into quartiles by volume, and independence between trends was tested with a Cochran-Armitage test, hypothesizing that the proportion of cases referred for purchased care was increasing. RESULTS: We captured 292,411 cases, including 7,653 pancreatectomies, 4,177 hepatectomies, 3,815 esophagectomies, 112,684 colectomies, 92,161 CABGs, 26,893 AAA repairs, and 45,028 carotid endarterectomies. The majority of cases included were referred for purchased care (90.3%), with the proportion of cases referred increasing over the study period (P < .01). By procedure, all cases except AAA repairs were increasingly referred for treatment over the study period (all P < .01, except esophagectomy P = .04). On examining volume, we found that even the highest-volume-quartile MTFs performed a median of less than one esophagectomy, hepatectomy, or pancreatectomy per month. The only included procedure performed once a month or more at the majority of MTFs was CABG. CONCLUSION: On examining volume and referral trends for high-value surgeries within the MHS, we found low surgical volumes at the vast majority of included MTFs and an increasing proportion of cases referred to civilian hospitals over the last 15 years. Our findings illustrate missed opportunities for maintaining the mission readiness of military surgical personnel. Prioritizing the recapture of lost surgical volume may improve the surgical teams' mission readiness.

Assessment of Time-to-Treatment Initiation and Survival in a Cohort of Patients With Common Cancers.

Importance: Resource limitations because of pandemic or other stresses on infrastructure necessitate the triage of time-sensitive care, including cancer treatments. Optimal time to treatment is underexplored, so recommendations for which cancer treatments can be deferred are often based on expert opinion. Objective: To evaluate the association between increased time to definitive therapy and mortality as a function of cancer type and stage for the 4 most prevalent cancers in the US. Design, Setting, and Participants: This cohort study assessed treatment and outcome information from patients with nonmetastatic breast, prostate, non-small cell lung (NSCLC), and colon cancers from 2004 to 2015, with data analyzed January to March 2020. Data on outcomes associated with appropriate curative-intent surgical, radiation, or medical therapy were gathered from the National Cancer Database. Exposures: Time-to-treatment initiation (TTI), the interval between diagnosis and therapy, using intervals of 8 to 60, 61 to 120, 121 to 180, and greater than 180 days. Main Outcomes and Measures: 5-year and 10-year predicted all-cause mortality. Results: This study included 2 241 706 patients (mean [SD] age 63 [11.9] years, 1 268 794 [56.6%] women, 1 880 317 [83.9%] White): 1 165 585 (52.0%) with breast cancer, 853 030 (38.1%) with prostate cancer, 130 597 (5.8%) with NSCLC, and 92 494 (4.1%) with colon cancer. Median (interquartile range) TTI by cancer was 32 (21-48) days for breast, 79 (55-117) days for prostate, 41 (27-62) days for NSCLC, and 26 (16-40) days for colon. Across all cancers, a general increase in the 5-year and 10-year predicted mortality was associated with increasing TTI. The most pronounced mortality association was for colon cancer (eg, 5 y predicted mortality, stage III: TTI 61-120 d, 38.9% vs. 181-365 d, 47.8%), followed by stage I NSCLC (5 y predicted mortality: TTI 61-120 d, 47.4% vs 181-365 d, 47.6%), while survival for prostate cancer was least associated (eg, 5 y predicted mortality, high risk: TTI 61-120 d, 12.8% vs 181-365 d, 14.1%), followed by breast cancer (eg, 5 y predicted mortality, stage I: TTI 61-120 d, 11.0% vs. 181-365 d, 15.2%). A nonsignificant difference in treatment delays and worsened survival was observed for stage II lung cancer patients-who had the highest all-cause mortality for any TTI regardless of treatment timing. Conclusions and Relevance: In this cohort study, for all studied cancers there was evidence that shorter TTI was associated with lower mortality, suggesting an indirect association between treatment deferral and mortality that may not become evident for years. In contrast to current pandemic-related guidelines, these findings support more timely definitive treatment for intermediate-risk and high-risk prostate cancer.

Mobile Health App for Prostate Cancer Patients on Androgen Deprivation Therapy: Qualitative Usability Study.

BACKGROUND: Androgen deprivation therapy (ADT) increases the risk of metabolic adverse effects among patients with prostate cancer. The transformative impact of mobile health (mHealth) apps may benefit men managing activity and nutrition at home. OBJECTIVE: This study aimed to evaluate the usability and patient experience of a newly developed mHealth app among prostate cancer patients on ADT and physicians' beliefs about the potential benefits of using this app. METHODS: This study took place over 2 months, beginning in March 2019. A sample of 5 patients (age 45-75 years) initiating ADT participated in a semistructured focus group discussion with a facilitator. The study participants also included 5 specialist physicians who provided in-depth interviews. An institutional review board-approved script was used to guide both the focus group and physician interviews. Usability was tested through specific scenarios presented to the patients, including downloading the mHealth app, entering information on physical activity and meals, and navigating the app. The focus group and interviews were audio recorded and transcribed. Content analysis was used to analyze the transcripts iteratively and exhaustively. Thematic discrepancies between reviewers were resolved through consensus. RESULTS: The mean age of the patients was 62 years. This group included 4 White and 1 Latin American patients. The physician specialists included 2 urologists, 2 medical oncologists, and 1 radiation oncologist. Analyses revealed that the patients appreciated the holistic care enabled by the app. Difficulties were observed with registration of the app among 60% (3/5) of the patients; however, all the patients were able to input information about their physical activity and navigate the options within the app. Most patients (4/5, 80%) were able to input data on their recent meal. Among the health care physicians, the dominant themes reflected in the interviews included undermining of patients ability to use technology, patients' fear of technology, and concern for the ability of older patients to access technology. CONCLUSIONS: The patients reported an overall positive experience of using an mHealth app to record and track diet and exercise. Usability was observed to be an important factor for adoption and was determined by ease of registration and use, intuitive appearance of the app, and focus on holistic cancer care. The physicians believed that the app was easy to use but raised concerns about usability among older men who may not typically use smartphone apps.

Thyroid hormone levels and Thyroid Hormone Levels and Ultrasonographic Changes in the Thyroid Gland of Patients on Long-Term Lithium Treatment for Affective Disorders: A Controlled Study.

BACKGROUND: Although lithium is known to cause thyroid dysfunction and increased thyroid gland volume, clinical examination and biochemical assessment are fundamental to thyroid workup of patients on lithium treatment. We aimed to determine thyroid gland volume and the Thyroid hormone levels of patients who have been receiving lithium treatment for affective disorders in comparison to voluntary healthy controls. METHODS: This was a cross-sectional, hospital-based observational study which was performed in 43 patients on long-term lithium treatment for bipolar disorder, major depressive and schizoaffective disorders. Patients with documented continuous and adequate serum lithium levels for more than or equal to 6 months recruited consecutively underwent the ultrasonographic examination of the thyroid gland. Ultrasonographic examinations were also done in all gender- and age-matched healthy controls. All cases and controls underwent biochemical thyroid function tests. RESULTS: There were no statistically significant differences in gender (P = 0.198; Chi-square = 1.654) of cases and controls. Most of the cases were married, maximum number of them unemployed and belonged to the lower socioeconomic status. Total thyroid volume was significantly greater in the lithium-treated group than the controls (9.40 ± 1.41 vs. 4.79 ± 0.45). Clinical inspection and palpation only detected goiter in six (n = 6, 13.95%) of patients on lithium and none among controls. The mean triiodothyronine, mean thyroxine, and mean scores for thyroid-stimulating hormone were significantly increased in patients receiving lithium therapy as compared to controls. CONCLUSION: It would seem wise from a clinical point of view to include ultrasonographic examination of the thyroid gland as part of the standard thyroid workup before initiating lithium treatment.