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1.
J Robot Surg ; 18(1): 48, 2024 Jan 20.
Article En | MEDLINE | ID: mdl-38244145

The effect of robotic-assisted cholecystectomy (RAC), when performed after hours, on perioperative outcomes has not been evaluated against outcomes achieved during normal business hours. Subjects 18-80 years old who underwent da Vinci robotic-assisted cholecystectomy from August 2018 to February 2021 were included. Baseline and 30-day perioperative outcomes were retrospectively and consecutively collected and analyzed. Inverse probability treatment weighting (IPTW) was performed to balance patient characteristics between groups. A weighted comparative analysis was followed. Outcomes from 505 patients (after hours, n = 169; business hours, n = 336) undergoing RAC across 5 U.S. medical institutions were analyzed. The higher rates of acute cholecystitis and gallbladder inflammation, gangrene, and intraoperative abnormalities in the after-hours group were associated with higher rates of urgent cases and longer operative times-but not increased complication rates-compared to the business-hours group. There were no significant differences in rates of intraoperative or postoperative complications, readmissions, or reoperations. Integrated da Vinci Firefly fluorescence imaging system was used extensively, and the critical view of safety was achieved in > 96% of cases in both groups. No conversions occurred in the after-hours group compared to four conversions in the business-hours group (p = 0.0266). After-hours patients had shorter outpatient lengths of stay. No mortalities were reported for either group (p = 0.0139). After-hours RAC with integrated da Vinci Firefly imaging performed by surgeons experienced in RAC is associated with similar or improved outcomes than the same procedures during business hours in terms of complications, conversions, readmissions, reoperations, and length of stay. ClinicalTrials.gov identifier: NCT04551820; August 5, 2020.


Robotic Surgical Procedures , Adolescent , Adult , Aged , Aged, 80 and over , Humans , Middle Aged , Young Adult , Cholecystectomy/methods , Operative Time , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective Studies , Robotic Surgical Procedures/methods , Treatment Outcome
2.
JAMA Intern Med ; 183(12): 1334-1342, 2023 Dec 01.
Article En | MEDLINE | ID: mdl-37902744

Importance: Despite guideline recommendations, clinicians do not systematically use prior screening or health history to guide colorectal cancer (CRC) screening decisions in older adults. Objective: To evaluate the effect of a personalized multilevel intervention on screening orders in older adults due for average-risk CRC screening. Design, Setting, and Participants: Interventional 2-group parallel unmasked cluster randomized clinical trial conducted from November 2015 to February 2019 at 2 US Department of Veterans Affairs (VA) facilities: 1 academic VA medical center and 1 of its connected outpatient clinics. Randomization at the primary care physician/clinician (PCP) level, stratified by study site and clinical full-time equivalency. Participants were 431 average-risk, screen-due US veterans aged 70 to 75 years attending a primary care visit. Data analysis was performed from August 2018 to August 2023. Intervention: The intervention group received a multilevel intervention including a decision-aid booklet with detailed information on screening benefits and harms, personalized for each participant based on age, sex, prior screening, and comorbidity. The control group received a multilevel intervention including a screening informational booklet. All participants received PCP education and system-level modifications to support personalized screening. Main Outcomes and Measures: The primary outcome was whether screening was ordered within 2 weeks of clinic visit. Secondary outcomes were concordance between screening orders and screening benefit and screening utilization within 6 months. Results: A total of 436 patients were consented, and 431 were analyzed across 67 PCPs. Patients had a mean (SD) age of 71.5 (1.7) years; 424 were male (98.4%); 374 were White (86.8%); 89 were college graduates (21.5%); and 351 (81.4%) had undergone prior screening. A total of 258 (59.9%) were randomized to intervention, and 173 (40.1%) to control. Screening orders were placed for 162 of 258 intervention patients (62.8%) vs 114 of 173 control patients (65.9%) (adjusted difference, -4.0 percentage points [pp]; 95% CI, -15.4 to 7.4 pp). In a prespecified interaction analysis, the proportion receiving orders was lower in the intervention group than in the control group for those in the lowest benefit quartile (59.4% vs 71.1%). In contrast, the proportion receiving orders was higher in the intervention group than in the control group for those in the highest benefit quartile (67.6% vs 52.2%) (interaction P = .049). Fewer intervention patients (106 of 256 [41.4%]) utilized screening overall at 6 months than controls (96 of 173 [55.9%]) (adjusted difference, -13.4 pp; 95% CI, -25.3 to -1.6 pp). Conclusions and Relevance: In this cluster randomized clinical trial, patients who were presented with personalized information about screening benefits and harms in the context of a multilevel intervention were more likely to receive screening orders concordant with benefit and were less likely to utilize screening. Trial Registration: ClinicalTrials.gov Identifier: NCT02027545.


Colorectal Neoplasms , Early Detection of Cancer , Humans , Male , Aged , Female , Employment , Colorectal Neoplasms/diagnosis , Ambulatory Care Facilities , Mass Screening
3.
J Gen Intern Med ; 37(10): 2429-2437, 2022 08.
Article En | MEDLINE | ID: mdl-34731436

BACKGROUND: The ability of latent class models to identify clinically distinct groups among high-risk patients has been demonstrated, but it is unclear how healthcare data can inform group-specific intervention design. OBJECTIVE: Examine how utilization patterns across latent groups of high-risk patients provide actionable information to guide group-specific intervention design. DESIGN: Cohort study using data from 2012 to 2015. PATIENTS: Participants were 934,787 patients receiving primary care in the Veterans Health Administration, with predicted probability of 12-month hospitalization in the top 10th percentile during 2014. MAIN MEASURES: Patients were assigned to latent groups via mixture-item response theory models based on 28 chronic conditions. We modeled odds of all-cause mortality, hospitalizations, and 30-day re-hospitalizations by group membership. Detailed outpatient and inpatient utilization patterns were compared between groups. KEY RESULTS: A total of 764,257 (81.8%) of patients were matched with a comorbidity group. Groups were characterized by substance use disorders (14.0% of patients assigned), cardiometabolic conditions (25.7%), mental health conditions (17.6%), pain/arthritis (19.1%), cancer (15.3%), and liver disease (8.3%). One-year mortality ranged from 2.7% in the Mental Health group to 14.9% in the Cancer group, compared to 8.5% overall. In adjusted models, group assignment predicted significantly different odds of each outcome. Groups differed in their utilization of multiple types of care. For example, patients in the Pain group had the highest utilization of in-person primary care, with a mean (SD) of 5.3 (5.0) visits in the year of follow-up, while the Substance Use Disorder group had the lowest, with 3.9 (4.1) visits. The Substance Use Disorder group also had the highest rates of using services for housing instability (25.1%), followed by the Liver group (10.1%). CONCLUSIONS: Latent groups of high-risk patients had distinct hospitalization and utilization profiles, despite having comparable levels of predicted baseline risk. Utilization profiles pointed towards system-specific care needs that could inform tailored interventions.


Hospitalization , Substance-Related Disorders , Cohort Studies , Humans , Inpatients , Pain , Substance-Related Disorders/epidemiology , Substance-Related Disorders/therapy
4.
JAMA Netw Open ; 4(10): e2127827, 2021 10 01.
Article En | MEDLINE | ID: mdl-34596670

Importance: Recognition of iron deficiency anemia (IDA) is important to initiate timely evaluation for gastrointestinal tract cancer. Retrospective studies have reported delays in diagnostic evaluation of IDA as a common factor associated with delayed diagnosis of colorectal cancer. Objective: To assess how US primary care physicians (PCPs) approach testing for anemia, interpret iron laboratory studies, and refer patients with IDA for gastrointestinal endoscopy. Design, Setting, and Participants: This survey study, conducted in August 2019, included members of the American College of Physicians Internal Medicine Insiders Panel, a nationally representative group of American College of Physicians membership, who self-identified as PCPs. Participants completed a vignette-based survey to assess practices related to screening for anemia, interpretation of laboratory-based iron studies, and appropriate diagnostic evaluation of IDA. Main Outcomes and Measures: Descriptive statistics based on survey responses were evaluated for frequency of anemia screening, correct interpretation of iron laboratory studies, and proportion of patients with new-onset IDA referred for gastrointestinal tract evaluation. Results: Of 631 PCPs who received an invitation to participate in the survey, 356 (56.4%) responded and 31 (4.9%) were excluded, for an adjusted eligible sample size of 600, yielding 325 completed surveys (response rate, 54.2%). Of the 325 participants who completed surveys, 180 (55.4%) were men; age of participants was not assessed. The mean (SD) duration of clinical experience was 19.8 (11.2) years (range, 1.0-45.0 years). A total of 250 participants (76.9%) screened at least some patients for anemia. Interpretation of iron studies was least accurate in a scenario of a borderline low ferritin level (40 ng/mL) with low transferrin saturation (2%); 86 participants (26.5%) incorrectly responded that this scenario did not indicate IDA, and 239 (73.5%) correctly identified this scenario as IDA. Of 312 participants, 170 (54.5%) recommended bidirectional endoscopy (upper endoscopy and colonoscopy) for new IDA for women aged 65 years; of 305 respondents, 168 (55.1%) recommended bidirectional endoscopy for men aged 65 years. Conclusions and Relevance: In this survey study, US PCPs' self-reported testing practices for anemia suggest overuse of screening laboratory tests, misinterpretation of iron studies, and underuse of bidirectional endoscopy for evaluation of new-onset IDA. Both misinterpretation of iron studies and underuse of bidirectional endoscopy can lead to delayed diagnosis of gastrointestinal tract cancers and warrant additional interventions.


Anemia, Iron-Deficiency/diagnosis , Clinical Laboratory Techniques/methods , Physicians, Primary Care/standards , Adult , Clinical Laboratory Techniques/statistics & numerical data , Female , Humans , Male , Mass Screening/methods , Mass Screening/statistics & numerical data , Middle Aged , Physicians, Primary Care/statistics & numerical data , Retrospective Studies , Surveys and Questionnaires , United States
5.
Ann Intern Med ; 174(7): 985-993, 2021 07.
Article En | MEDLINE | ID: mdl-33900792

DESCRIPTION: The American College of Physicians (ACP) developed this guideline to provide clinical recommendations on the appropriate use of point-of-care ultrasonography (POCUS) in patients with acute dyspnea in emergency department (ED) or inpatient settings to improve the diagnostic, treatment, and health outcomes of those with suspected congestive heart failure, pneumonia, pulmonary embolism, pleural effusion, or pneumothorax. METHODS: The ACP Clinical Guidelines Committee based this guideline on a systematic review on the benefits, harms, and diagnostic test accuracy of POCUS; patient values and preferences; and costs of POCUS. The systematic review evaluated health outcomes, diagnostic timeliness, treatment decisions, and test accuracy. The critical health, diagnostic, and treatment outcomes evaluated were in-hospital mortality, time to diagnosis, and time to treatment. The important outcomes evaluated were intensive care unit admissions, correctness of diagnosis, disease-specific outcomes, hospital readmissions, length of hospital stay, and quality of life. The critical test accuracy outcomes included false-positive results for suspected pneumonia, pneumothorax, and pulmonary embolism and false-negative results for suspected congestive heart failure, pneumonia, pneumothorax, and pulmonary embolism. Important test accuracy outcomes included false-positive results for suspected congestive heart failure and false-negative and false-positive results for suspected pleural effusion. This guideline was developed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. TARGET AUDIENCE AND PATIENT POPULATION: The target audience is all clinicians, and the target patient population is adult patients with acute dyspnea in ED or inpatient settings. RECOMMENDATION: ACP suggests that clinicians may use point-of-care ultrasonography in addition to the standard diagnostic pathway when there is diagnostic uncertainty in patients with acute dyspnea in emergency department or inpatient settings (conditional recommendation; low-certainty evidence).


Dyspnea/diagnostic imaging , Dyspnea/etiology , Point-of-Care Testing , Ultrasonography , Acute Disease , Critical Pathways , Hospital Mortality , Humans , Length of Stay , Patient Readmission , Sensitivity and Specificity , Ultrasonography/adverse effects
6.
Ann Intern Med ; 174(7): 977-984, 2021 07.
Article En | MEDLINE | ID: mdl-33900796

DESCRIPTION: The American College of Physicians (ACP) developed this guideline to provide clinical recommendations on the appropriate use of high-flow nasal oxygen (HFNO) in hospitalized patients for initial or postextubation management of acute respiratory failure. It is based on the best available evidence on the benefits and harms of HFNO, taken in the context of costs and patient values and preferences. METHODS: The ACP Clinical Guidelines Committee based these recommendations on a systematic review on the efficacy and safety of HFNO. The patient-centered health outcomes evaluated included all-cause mortality, hospital length of stay, 30-day hospital readmissions, hospital-acquired pneumonia, days of intubation or reintubation, intensive care unit (ICU) admission and ICU transfers, patient comfort, dyspnea, delirium, barotrauma, compromised nutrition, gastric dysfunction, functional independence at discharge, discharge disposition, and skin breakdown. This guideline was developed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. TARGET AUDIENCE AND PATIENT POPULATION: The target audience is all clinicians, and the target patient population is adult patients with acute respiratory failure treated in a hospital setting (including emergency departments, hospital wards, intermediate or step-down units, and ICUs). RECOMMENDATION 1A: ACP suggests that clinicians use high-flow nasal oxygen rather than noninvasive ventilation in hospitalized adults for the management of acute hypoxemic respiratory failure (conditional recommendation; low-certainty evidence). RECOMMENDATION 1B: ACP suggests that clinicians use high-flow nasal oxygen rather than conventional oxygen therapy for hospitalized adults with postextubation acute hypoxemic respiratory failure (conditional recommendation; low-certainty evidence).


Oxygen Inhalation Therapy/methods , Respiratory Insufficiency/therapy , Acute Disease , Airway Extubation , Continuous Positive Airway Pressure , Hospitalization , Humans , Intermittent Positive-Pressure Breathing , Noninvasive Ventilation/economics , Outcome Assessment, Health Care , Oxygen Inhalation Therapy/adverse effects , Oxygen Inhalation Therapy/economics , Patient Preference
7.
Ann Intern Med ; 173(9): 739-748, 2020 11 03.
Article En | MEDLINE | ID: mdl-32805126

DESCRIPTION: The American College of Physicians (ACP) and American Academy of Family Physicians (AAFP) developed this guideline to provide clinical recommendations on nonpharmacologic and pharmacologic management of acute pain from non-low back, musculoskeletal injuries in adults in the outpatient setting. The guidance is based on current best available evidence about benefits and harms, taken in the context of costs and patient values and preferences. This guideline does not address noninvasive treatment of low back pain, which is covered by a separate ACP guideline that has also been endorsed by AAFP. METHODS: This guideline is based on a systematic evidence review on the comparative efficacy and safety of nonpharmacologic and pharmacologic management of acute pain from non-low back, musculoskeletal injuries in adults in the outpatient setting and a systematic review on the predictors of prolonged opioid use. We evaluated the following clinical outcomes using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system: pain (at ≤2 hours and at 1 to 7 days), physical function, symptom relief, treatment satisfaction, and adverse events. TARGET AUDIENCE AND PATIENT POPULATION: The target audience is all clinicians, and the target patient population is adults with acute pain from non-low back, musculoskeletal injuries. RECOMMENDATION 1: ACP and AAFP recommend that clinicians treat patients with acute pain from non-low back, musculoskeletal injuries with topical nonsteroidal anti-inflammatory drugs (NSAIDs) with or without menthol gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient's treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence). RECOMMENDATION 2A: ACP and AAFP suggest that clinicians treat patients with acute pain from non-low back, musculoskeletal injuries with oral NSAIDs to reduce or relieve symptoms, including pain, and to improve physical function, or with oral acetaminophen to reduce pain (Grade: conditional recommendation; moderate-certainty evidence). RECOMMENDATION 2B: ACP and AAFP suggest that clinicians treat patients with acute pain from non-low back, musculoskeletal injuries with specific acupressure to reduce pain and improve physical function, or with transcutaneous electrical nerve stimulation to reduce pain (Grade: conditional recommendation; low-certainty evidence). RECOMMENDATION 3: ACP and AAFP suggest against clinicians treating patients with acute pain from non-low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).


Acute Pain/therapy , Musculoskeletal System/injuries , Acupressure , Acute Pain/drug therapy , Acute Pain/etiology , Adult , Analgesics, Opioid/adverse effects , Analgesics, Opioid/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Humans , Transcutaneous Electric Nerve Stimulation , United States
8.
Ann Intern Med ; 172(10): 705, 2020 05 19.
Article En | MEDLINE | ID: mdl-32422103
9.
Ann Intern Med ; 172(2): 126-133, 2020 01 21.
Article En | MEDLINE | ID: mdl-31905405

Description: The American College of Physicians (ACP) developed this guideline to provide clinical recommendations based on the current evidence of the benefits and harms of testosterone treatment in adult men with age-related low testosterone. This guideline is endorsed by the American Academy of Family Physicians. Methods: The ACP Clinical Guidelines Committee based these recommendations on a systematic review on the efficacy and safety of testosterone treatment in adult men with age-related low testosterone. Clinical outcomes were evaluated by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system and included sexual function, physical function, quality of life, energy and vitality, depression, cognition, serious adverse events, major adverse cardiovascular events, and other adverse events. Target Audience and Patient Population: The target audience includes all clinicians, and the target patient population includes adult men with age-related low testosterone. Recommendation 1a: ACP suggests that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual function (conditional recommendation; low-certainty evidence). The discussion should include the potential benefits, harms, costs, and patient's preferences. Recommendation 1b: ACP suggests that clinicians should reevaluate symptoms within 12 months and periodically thereafter. Clinicians should discontinue testosterone treatment in men with age-related low testosterone with sexual dysfunction in whom there is no improvement in sexual function (conditional recommendation; low-certainty evidence). Recommendation 1c: ACP suggests that clinicians consider intramuscular rather than transdermal formulations when initiating testosterone treatment to improve sexual function in men with age-related low testosterone, as costs are considerably lower for the intramuscular formulation and clinical effectiveness and harms are similar. Recommendation 2: ACP suggests that clinicians not initiate testosterone treatment in men with age-related low testosterone to improve energy, vitality, physical function, or cognition (conditional recommendation; low-certainty evidence).


Hypogonadism/drug therapy , Testosterone/therapeutic use , Adult , Humans , Male , Quality of Life , United States
10.
J Clin Endocrinol Metab ; 105(4)2020 04 01.
Article En | MEDLINE | ID: mdl-31825487

CONTEXT: Hypoglycemia in the outpatient setting has a significant financial impact on the health care system and negative impact on a person's quality of life. Primary care physicians must address a multitude of issues in a visit with a person with type 2 diabetes mellitus (T2DM), often leaving little time to ask about hypoglycemia. OBJECTIVE: To develop quality measures that focus on outpatient hypoglycemia episodes for patients 65 and older with T2DM, which facilitate a clinician's ability to identify opportunities to improve the quality of care and reduce hypoglycemic episodes. PARTICIPANTS AND PROCESS: A technical expert panel established by the Endocrine Society in March 2019, which includes endocrinologists, primary care physicians, a diabetes care and education specialist/pharmacist, and a patient, developed 3 outpatient hypoglycemia quality measures. The measure set is intended to improve quality of care for patients with T2DM who are at greatest risk for hypoglycemia. The measures were available for public comment in July 2019. A fourth measure on shared decision-making was removed from the final measure set based on public feedback. CONCLUSION: A lack of outpatient hypoglycemia measures focusing on older adults with T2DM is a barrier to improving care of people with diabetes and reducing hypoglycemic episodes. This paper provides measure specifications for 3 measures that may be used to focus quality improvement efforts on patients at greatest risk for hypoglycemia.


Diabetes Mellitus, Type 2/drug therapy , Endocrinology/standards , Hypoglycemia/diagnosis , Hypoglycemic Agents/adverse effects , Practice Guidelines as Topic/standards , Quality of Life , Aged , Humans , Hypoglycemia/blood , Hypoglycemia/chemically induced , Prognosis , Societies, Medical
11.
Ann Emerg Med ; 75(4): 459-470, 2020 04.
Article En | MEDLINE | ID: mdl-31866170

STUDY OBJECTIVE: We evaluated a strategy to increase use of the test (Dix-Hallpike's test [DHT]) and treatment (canalith repositioning maneuver [CRM]) for benign paroxysmal positional vertigo in emergency department (ED) dizziness visits. METHODS: We conducted a stepped-wedge randomized trial in 6 EDs. The population was visits with dizziness as a principal reason for the visit. The intervention included educational sessions and decision aid materials. Outcomes were DHT or CRM documentation (primary), head computed tomography (CT) use, length of stay, admission, and 90-day stroke events. The analysis was multilevel logistic regression with intervention, month, and hospital as fixed effects and provider as a random effect. We assessed fidelity with monitoring intervention use and semistructured interviews. RESULTS: We identified 7,635 dizziness visits during 18 months. The DHT or CRM was documented in 1.5% of control visits (45/3,077; 95% confidence interval 1% to 1.9%) and 3.5% of intervention visits (159/4,558; 95% confidence interval 3% to 4%; difference 2%, 95% confidence interval 1.3% to 2.7%). Head CT use was lower in intervention visits compared with control visits (44.0% [1,352/3,077] versus 36.9% [1,682/4,558]). No differences were observed in admission or 90-day subsequent stroke risk. In fidelity evaluations, providers who used the materials typically reported positive clinical experiences but provider engagement was low at facilities without an emergency medicine residency program. CONCLUSION: These findings provide evidence that an implementation strategy of a benign paroxysmal positional vertigo-focused approach to ED dizziness visits can be successful and safe in promoting evidence-based care. Absolute rates of DHT and CRM use, however, were still low, which relates in part to our broad inclusion criteria for dizziness visits.


Benign Paroxysmal Positional Vertigo/diagnosis , Benign Paroxysmal Positional Vertigo/therapy , Emergency Service, Hospital , Evidence-Based Practice , Patient Positioning , Adult , Benign Paroxysmal Positional Vertigo/diagnostic imaging , Dizziness/etiology , Dizziness/therapy , Female , Guideline Adherence , Humans , Incidence , Kaplan-Meier Estimate , Male , Middle Aged , Patient Positioning/adverse effects , Patient Positioning/methods , Proportional Hazards Models , Stroke/epidemiology
12.
Ann Intern Med ; 171(9): ITC65-ITC80, 2019 11 05.
Article En | MEDLINE | ID: mdl-31683294

Type 2 diabetes is a prevalent illness that causes major vascular, renal, and neurologic complications. Prevention and treatment of diabetes and its complications are of paramount importance. Many new treatments have emerged over the past 5-10 years. Recent evidence shows that newer treatments may substantially reduce risk for cardiac and renal disease, suggesting that it may be necessary to change existing treatment paradigms. This review summarizes the evidence supporting diabetes prevention and treatment, focusing on aspects that are commonly in the purview of primary care physicians.


Cardiovascular Diseases/etiology , Diabetes Mellitus, Type 2 , Disease Management , Kidney Diseases/etiology , Mass Screening/methods , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/epidemiology , Diabetes Mellitus, Type 2/therapy , Global Health , Humans , Kidney Diseases/epidemiology , Kidney Diseases/prevention & control , Morbidity/trends , Risk Factors
13.
Ann Intern Med ; 171(11): 785-795, 2019 12 03.
Article En | MEDLINE | ID: mdl-31658472

Background: Most guidelines for major depressive disorder recommend initial treatment with either a second-generation antidepressant (SGA) or cognitive behavioral therapy (CBT). Although most trials suggest that these treatments have similar efficacy, their health economic implications are uncertain. Objective: To quantify the cost-effectiveness of CBT versus SGA for initial treatment of depression. Design: Decision analytic model. Data Sources: Relative effectiveness data from a meta-analysis of randomized controlled trials; additional clinical and economic data from other publications. Target Population: Adults with newly diagnosed major depressive disorder in the United States. Time Horizon: 1 to 5 years. Perspectives: Health care sector and societal. Intervention: Initial treatment with either an SGA or group and individual CBT. Outcome Measures: Costs in 2014 U.S. dollars, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Results of Base-Case Analysis: In model projections, CBT produced higher QALYs (3 days more at 1 year and 20 days more at 5 years) with higher costs at 1 year (health care sector, $900; societal, $1500) but lower costs at 5 years (health care sector, -$1800; societal, -$2500). Results of Sensitivity Analysis: In probabilistic sensitivity analyses, SGA had a 64% to 77% likelihood of having an incremental cost-effectiveness ratio of $100 000 or less per QALY at 1 year; CBT had a 73% to 77% likelihood at 5 years. Uncertainty in the relative risk for relapse of depression contributed the most to overall uncertainty in the optimal treatment. Limitation: Long-term trials comparing CBT and SGA are lacking. Conclusion: Neither SGAs nor CBT provides consistently superior cost-effectiveness relative to the other. Given many patients' preference for psychotherapy over pharmacotherapy, increasing patient access to CBT may be warranted. Primary Funding Source: Department of Veterans Affairs, National Institute of Mental Health.


Antidepressive Agents, Second-Generation/economics , Cognitive Behavioral Therapy/economics , Cost-Benefit Analysis , Depressive Disorder, Major/therapy , Adult , Antidepressive Agents, Second-Generation/adverse effects , Antidepressive Agents, Second-Generation/therapeutic use , Decision Support Techniques , Female , Humans , Male , Quality-Adjusted Life Years , Sensitivity and Specificity , Uncertainty , United States
14.
Am J Manag Care ; 25(9): e274-e281, 2019 09 01.
Article En | MEDLINE | ID: mdl-31518099

OBJECTIVES: Many healthcare systems use prediction models to estimate and manage patient-level probability of hospitalization. Patients identified as high-risk at one point in time may not, however, remain high-risk. We aimed to describe subgroups of patients with distinct longitudinal risk score patterns to inform interventions tailored to patients' needs. STUDY DESIGN: Retrospective national cohort study. METHODS: Using a previously validated prediction algorithm, we identified a cohort of 258,759 patients enrolled in the Veterans Health Administration (VHA) who were in the top 5% of risk for hospitalization within 90 days. During each of the following 24 months, patients were placed in 1 of 6 categories: death, hospitalized, no VHA care, persistently high-risk for hospitalization (≥10% probability), initially high-risk then persistently low-risk (<10% probability), and intermittently high-risk. We used multivariable logistic regression to identify characteristics predictive of being persistently high-risk through the last study month. RESULTS: After 2 years, 17.7% had died, 13.8% had remained persistently high-risk for hospitalization, 41.5% had become persistently low-risk, and 19.9% were intermittently high-risk. Predictors of being persistently high-risk included urban residence, chronic medical comorbidities, auditory and visual impairment, chronic pain, any cancer diagnosis, and social instability. CONCLUSIONS: Few patients who were high-risk for hospitalization at baseline remained so. Nonrandomized evaluations of interventions that identify patients based on a single high-risk score may spuriously appear to have positive effects. Clinical interventions may need to focus on individuals who are persistently high-risk.


Hospitalization/statistics & numerical data , Hospitals, Veterans/statistics & numerical data , Risk Assessment/statistics & numerical data , Adult , Aged , Aged, 80 and over , Cohort Studies , Female , Humans , Logistic Models , Male , Middle Aged , Retrospective Studies , United States
15.
Ann Intern Med ; 171(5): 354-361, 2019 09 03.
Article En | MEDLINE | ID: mdl-31426089

One of the hallmarks of a trustworthy clinical guideline or guidance statement is a comprehensive process for disclosure of interests (DOI) and management of conflicts of interest (COIs). The American College of Physicians (ACP) Clinical Guidelines Committee (CGC) aims to disclose all health care-related interests and manage conflicts in a manner that is transparent, proportional, and consistent. Any person involved in the development of an ACP clinical guideline or guidance statement must disclose all financial and intellectual interests related to health care from the previous 3 years. Persons complete disclosures at the start of their participation and are required to update them over the course of their involvement with the CGC, including before each CGC meeting. A DOI-COI Review and Management Panel reviews the disclosures; flags potential conflicts; grades the COI as low-, moderate-, or high-level; and manages the person's participation accordingly. A high-level COI results in recusal from authorship, voting, and all committee discussions. Participants with a moderate-level COI are recused from authorship and voting for clinically relevant topics but may participate in all discussions. A low-level COI results in no role restrictions. All disclosures and COI management decisions are publicly reported.


Authorship , Conflict of Interest , Disclosure , Practice Guidelines as Topic/standards , Humans , Publishing/standards , Time Factors
16.
Ann Intern Med ; 170(12): 863-870, 2019 06 18.
Article En | MEDLINE | ID: mdl-31181568

The American College of Physicians (ACP) was one of the first organizations in the United States to develop evidence-based clinical guidelines and has been developing guidelines since 1981. ACP's Clinical Guidelines Committee (CGC), in collaboration with staff from the Clinical Policy department, develops clinical guidelines and guidance statements and continues to refine and enhance its methodology. This article presents an update of the CGC's 2010 paper outlining policies, methods, and presentation format of ACP's clinical guidelines and guidance statements. Updated methods include more stringent policies about disclosure of interests and conflict management; inclusion of public perspective; full adoption of GRADE (Grading of Recommendations Assessment, Development and Evaluation) methods; more standardized reporting formats that consider value of care, patient comorbid conditions, patient values and preferences, and costs; and further clarification of guidance statement methods.


Evidence-Based Medicine , Practice Guidelines as Topic/standards , Advisory Committees/organization & administration , Conflict of Interest , Disclosure , Humans , Information Dissemination , Organizational Objectives , Peer Review, Research , Policy , Societies, Medical/organization & administration , United States
17.
Ann Intern Med ; 170(8): 547-560, 2019 04 16.
Article En | MEDLINE | ID: mdl-30959525

Description: The purpose of this guidance statement is to provide advice to clinicians on breast cancer screening in average-risk women based on a review of existing guidelines and the evidence they include. Methods: This guidance statement is derived from an appraisal of selected guidelines from around the world that address breast cancer screening, as well as their included evidence. All national guidelines published in English between 1 January 2013 and 15 November 2017 in the National Guideline Clearinghouse or Guidelines International Network library were included. In addition, the authors selected other guidelines commonly used in clinical practice. Web sites associated with all selected guidelines were checked for updates on 10 December 2018. The AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument was used to evaluate the quality of guidelines. Target Audience and Patient Population: The target audience is all clinicians, and the target patient population is all asymptomatic women with average risk for breast cancer. Guidance Statement 1: In average-risk women aged 40 to 49 years, clinicians should discuss whether to screen for breast cancer with mammography before age 50 years. Discussion should include the potential benefits and harms and a woman's preferences. The potential harms outweigh the benefits in most women aged 40 to 49 years. Guidance Statement 2: In average-risk women aged 50 to 74 years, clinicians should offer screening for breast cancer with biennial mammography. Guidance Statement 3: In average-risk women aged 75 years or older or in women with a life expectancy of 10 years or less, clinicians should discontinue screening for breast cancer. Guidance Statement 4: In average-risk women of all ages, clinicians should not use clinical breast examination to screen for breast cancer.


Breast Neoplasms/prevention & control , Early Detection of Cancer , Mammography , Mass Screening , Adult , Age Factors , Aged , Breast Density , Breast Neoplasms/diagnosis , Breast Neoplasms/mortality , Early Detection of Cancer/adverse effects , Early Detection of Cancer/methods , Female , Humans , Life Expectancy , Mammography/adverse effects , Mass Screening/adverse effects , Mass Screening/methods , Medical Overuse , Middle Aged , Physical Examination , Risk Assessment , Risk Factors
18.
Clin Gastroenterol Hepatol ; 17(13): 2806-2807, 2019 12.
Article En | MEDLINE | ID: mdl-30880272

High-quality bowel preparation (prep) before colonoscopy is essential for the success of the procedure.1 Bowel preps should be safe, tolerable, efficacious, and allow for visualization of polyps 5 mm or larger.2 Full-volume (4 L) polyethylene glycol-3350 with electrolyte solution (PEG-ELS) has been considered a standard bowel prep regimen, with good safety and efficacy profiles, and is available as a generic.2.


Cathartics/economics , Drug Costs/trends , Medicare Part D/economics , Citrates/economics , Colonoscopy , Drugs, Generic/economics , Electrolytes/economics , Humans , Organometallic Compounds/economics , Phosphates/economics , Picolines/economics , Polyethylene Glycols/economics , Sulfates/economics , United States
19.
J Gen Intern Med ; 34(4): 583-590, 2019 04.
Article En | MEDLINE | ID: mdl-30623388

BACKGROUND: Bridging anticoagulation is commonly prescribed to patients with atrial fibrillation during initiation and interruption of warfarin. Guidelines recommend bridging patients at high risk of stroke, while a recent randomized trial demonstrated overall harm in a population at comparatively low risk of ischemic stroke. Theory suggests that patients at high risk of stroke and low risk of hemorrhage may benefit from bridging, but data informing patient selection are scant. OBJECTIVE: To estimate the utility and cost-effectiveness of bridging anticoagulation among patients with nonvalvular atrial fibrillation, stratified by thromboembolic and hemorrhagic risk DESIGN: Cost-effectiveness analysis with lifelong time horizon, from the perspective of a third-party payer MAIN MEASURES: Quality-adjusted life years (QALYs) per bridged patient; US dollars per QALY gained KEY RESULTS: Unselected patients with nonvalvular atrial fibrillation may be harmed by bridging anticoagulation. Hospital admission for bridging is almost never cost-effective, and generally harmful. Among patients carefully selected by both thromboembolic and hemorrhagic risks, outpatient bridging can be beneficial and cost-effective. Results were sensitive to how effectively heparin products reduce stroke risk. CONCLUSIONS: Outpatient bridging anticoagulation can be beneficial and cost-effective for a subset of patients with nonvalvular atrial fibrillation during interruption or initiation of warfarin. Admission for bridging should be avoided.


Anticoagulants/economics , Atrial Fibrillation/drug therapy , Anticoagulants/therapeutic use , Atrial Fibrillation/economics , Blood Coagulation/drug effects , Cost-Benefit Analysis , Databases, Factual , Humans , Quality-Adjusted Life Years , Risk Assessment , Stroke/prevention & control
20.
Trials ; 19(1): 697, 2018 Dec 22.
Article En | MEDLINE | ID: mdl-30577834

BACKGROUND: Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder, and accounts for 8% of individuals with moderate or severe dizziness. BPPV patients experience substantial inconveniences and disabilities during symptomatic periods. BPPV therapeutic processes - the Dix-Hallpike Test (DHT) and the Canalith Repositioning Maneuver (CRM) - have an evidence base that is at the clinical practice guideline level. The most commonly used CRM is the modified Epley maneuver. The DHT is the gold standard test for BPPV and the CRM is supported by numerous randomized controlled trials and systematic reviews. Despite this, BPPV care processes are underutilized. METHODS/DESIGN: This is a stepped-wedge, randomized clinical trial of a multi-faceted educational and care-process-based intervention designed to improve the guideline-concordant care of patients with BPPV presenting to the emergency department (ED) with dizziness. The unit of randomization and target of intervention is the hospital. After an initial observation period, the six hospitals will undergo the intervention in five waves (two closely integrated hospitals will be paired). The order will be randomized. The primary endpoint is measured at the individual patient level, and is the presence of documentation of either the Dix-Hallpike Test or CRM. The secondary endpoints are referral to a health care provider qualified to treat dizziness for CRM and 90-day stroke rates following an ED dizziness visit. Formative evaluations are also performed to monitor and identify potential and actual influences on the progress and effectiveness of the implementation efforts. DISCUSSION: If this study safely increases documentation of the DHT/CRM, this will be an important step in implementing the use of these evidenced-based processes of care. Positive results will support conducting larger-scale follow-up studies that assess patient outcomes. The data collection also enables evaluation of potential and actual influences on the progress and effectiveness of the implementation efforts. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02809599 . The record was first available to the public on 22 June 2016 prior to the enrollment of the first patients in October 2016.


Benign Paroxysmal Positional Vertigo/therapy , Evidence-Based Medicine , Patient Positioning/methods , Benign Paroxysmal Positional Vertigo/diagnosis , Benign Paroxysmal Positional Vertigo/physiopathology , Emergency Service, Hospital , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Texas , Time Factors , Treatment Outcome
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