Implementation Science Perspectives on Implementing Telemedicine Interventions for Hypertension or Diabetes Management: Scoping Review.

BACKGROUND: Hypertension and diabetes are becoming increasingly prevalent worldwide. Telemedicine is an accessible and cost-effective means of supporting hypertension and diabetes management, especially as the COVID-19 pandemic has accelerated the adoption of technological solutions for care. However, to date, no review has examined the contextual factors that influence the implementation of telemedicine interventions for hypertension or diabetes worldwide. OBJECTIVE: We adopted a comprehensive implementation research perspective to synthesize the barriers to and facilitators of implementing telemedicine interventions for the management of hypertension, diabetes, or both. METHODS: We performed a scoping review involving searches in Ovid MEDLINE, Embase, CINAHL, Cochrane Library, Web of Science, and Google Scholar to identify studies published in English from 2017 to 2022 describing barriers and facilitators related to the implementation of telemedicine interventions for hypertension and diabetes management. The coding and synthesis of barriers and facilitators were guided by the Consolidated Framework for Implementation Research. RESULTS: Of the 17,687 records identified, 35 (0.2%) studies were included in our scoping review. We found that facilitators of and barriers to implementation were dispersed across the constructs of the Consolidated Framework for Implementation Research. Barriers related to cost, patient needs and resources (eg, lack of consideration of language needs, culture, and rural residency), and personal attributes of patients (eg, demographics and priorities) were the most common. Facilitators related to the design and packaging of the intervention (eg, user-friendliness), patient needs and resources (eg, personalized information that leveraged existing strengths), implementation climate (eg, intervention embedded into existing infrastructure), knowledge of and beliefs about the intervention (eg, convenience of telemedicine), and other personal attributes (eg, technical literacy) were the most common. CONCLUSIONS: Our findings suggest that the successful implementation of telemedicine interventions for hypertension and diabetes requires comprehensive efforts at the planning, execution, engagement, and reflection and evaluation stages of intervention implementation to address challenges at the individual, interpersonal, organizational, and environmental levels.

Adaptations to the current ECCO/ESPGHAN guidelines on the management of paediatric acute severe colitis in the context of the COVID-19 pandemic: a RAND appropriateness panel.

OBJECTIVE: Paediatric acute severe colitis (ASC) management during the novel SARS-CoV-2/COVID-19 pandemic is challenging due to reliance on immunosuppression and the potential for surgery. We aimed to provide COVID-19-specific guidance using the European Crohn's and Colitis Organisation/European Society for Paediatric Gastroenterology, Hepatology and Nutrition guidelines for comparison. DESIGN: We convened a RAND appropriateness panel comprising 14 paediatric gastroenterologists and paediatric experts in surgery, rheumatology, respiratory and infectious diseases. Panellists rated the appropriateness of interventions for ASC in the context of the COVID-19 pandemic. Results were discussed at a moderated meeting prior to a second survey. RESULTS: Panellists recommended patients with ASC have a SARS-CoV-2 swab and expedited biological screening on admission and should be isolated. A positive swab should trigger discussion with a COVID-19 specialist. Sigmoidoscopy was recommended prior to escalation to second-line therapy or colectomy. Methylprednisolone was considered appropriate first-line management in all, including those with symptomatic COVID-19. Thromboprophylaxis was also recommended in all. In patients requiring second-line therapy, infliximab was considered appropriate irrespective of SARS-CoV-2 status. Delaying colectomy due to SARS-CoV-2 infection was considered inappropriate. Corticosteroid tapering over 8-10 weeks was deemed appropriate for all. After successful corticosteroid rescue, thiopurine maintenance was rated appropriate in patients with negative SARS-CoV-2 swab and asymptomatic patients with positive swab but uncertain in symptomatic COVID-19. CONCLUSION: Our COVID-19-specific adaptations to paediatric ASC guidelines using a RAND panel generally support existing recommendations, particularly the use of corticosteroids and escalation to infliximab, irrespective of SARS-CoV-2 status. Consideration of routine prophylactic anticoagulation was recommended.

Characteristics and Risk Factors of Hospitalized and Nonhospitalized COVID-19 Patients, Atlanta, Georgia, USA, March-April 2020.

We compared the characteristics of hospitalized and nonhospitalized patients who had coronavirus disease in Atlanta, Georgia, USA. We found that risk for hospitalization increased with a patient's age and number of concurrent conditions. We also found a potential association between hospitalization and high hemoglobin A1c levels in persons with diabetes.

Management of the major complications of cirrhosis: Beyond guidelines.

Along with a growing understanding of the pathophysiology of cirrhosis and its complications, new therapies and management strategies have emerged in recent years. Many of these advances have helped inform the current EASL clinical practice guidelines1 on the management of some of the key complications of cirrhosis, such as ascites, variceal bleeding and infection. However, there are still some aspects of management where the evidence base is less clear, and/or where opinions amongst practitioners remain divided. Some of these more controversial areas are explored in this section, wherein we present evidence culminating in a suggested management approach based on expert opinion and extending beyond the current guidelines.

State-of-the-Art Management of Hyperphosphatemia in Patients With CKD: An NKF-KDOQI Controversies Perspective.

Phosphate binders are among the most common medications prescribed to patients with kidney failure receiving dialysis and are often used in advanced chronic kidney disease (CKD). In patients with CKD glomerular filtration rate category 3a (G3a) or worse, including those with kidney failure who are receiving dialysis, clinical practice guidelines suggest "lowering elevated phosphate levels towards the normal range" with possible strategies including dietary phosphate restriction or use of binders. Additionally, guidelines suggest restricting the use of oral elemental calcium often contained in phosphate binders. Nutrition guidelines in CKD suggest<800-1,000mg of calcium daily, whereas CKD bone and mineral disorder guidelines do not provide clear targets, but<1,500mg in maintenance dialysis patients has been previously recommended. Many different classes of phosphate binders are now available and clinical trials have not definitively demonstrated the superiority of any class of phosphate binders over another with regard to clinical outcomes. Use of phosphate binders contributes substantially to patients' pill burden and out-of-pocket costs, and many have side effects. This has led to uncertainty regarding the use and best choice of phosphate binders for patients with CKD or kidney failure. In this controversies perspective, we discuss the evidence base around binder use in CKD and kidney failure with a focus on comparisons of available binders.

Improving clinical documentation of evaluation and management care and patient acuity improves reimbursement as well as quality metrics.

OBJECTIVE: Accurate documentation of patient care and acuity is essential to determine appropriate reimbursement as well as accuracy of key publicly reported quality metrics. We sought to investigate the impact of standardized note templates by inpatient advanced practice providers (APPs) on evaluation and management (E/M) charge capture, including outside of the global surgical package (GSP), and quality metrics including case mix index (CMI) and mortality index (MI). We hypothesized this clinical documentation initiative as well as improved coding of E/M services would result in increased reimbursement and quality metrics. METHODS: A documentation and coding initiative on the heart and vascular service line was initiated in 2016 with focus on improving inpatient E/M capture by APPs outside the GSP. Comprehensive training sessions and standardized documentation templates were created and implemented in the electronic medical record. Subsequent hospital care E/M (current procedural terminology codes 99231, 99232, 99233) from the years 2015 to 2017 were audited and analyzed for charge capture rates, collections, work relative value units (wRVUs), and billing complexity. Data were compared over time by standardizing CMS values and reimbursement rates. In addition, overall CMI and MI were calculated each year. RESULTS: One year following the documentation initiative, E/M charges on the vascular surgery service line increased by 78.5% with a corresponding increase in APP charges from 0.4% of billable E/M services to 70.4% when compared with pre-initiative data. The charge capture of E/M services among all inpatients rose from 21.4% to 37.9%. Additionally, reimbursement from CMS increased by 65% as total work relative value units generated from E/M services rose by 78.4% (797 to 1422). The MI decreased over the study period by 25.4%. Additionally, there was a corresponding 5.6% increase in the cohort CMI. Distribution of E/M encounter charges did not vary significantly. Meanwhile, the prevalence of 14 clinical comorbidities in our cohort as well as length of stay (P = .88) remained non-statistically different throughout the study period. CONCLUSIONS: Accurate clinical documentation of E/M care and ultimately inpatient acuity is critical in determining quality metrics that serve as important measures of overall hospital quality for CMS value-based payments and rankings. A system-based documentation initiative and expanded role of inpatient APPs on vascular surgery teams significantly improved charge capture and reimbursement outside the GSP as well as CMI and MI in a consistently complex patient population.

Enhancing communication between foundation doctors and radiologists: a quality improvement project.

Facilitating radiological imaging for patients is an essential task for foundation year (FY) doctors. Achieving competence in this task can significantly enhance patient management. We evaluated the confidence and skills of FY doctors in facilitating radiological imaging before and after introduction of formal training. Twenty surgical FYs working at a large teaching hospital were surveyed to evaluate their baseline level of competence in booking and discussing imaging with radiology colleagues. Parameters were measured on a Likert scale, including confidence in discussing requests and satisfaction of their own performance following discussions with radiologists. Eight radiology consultants were surveyed to evaluate their opinions on FYs' communication and established areas for improvement. A teaching session was then delivered to improve communication skills. Furthermore, Previous investigation results, Answer you need from the scan, Clinical status and story, Crucial: how urgent is the scan, Safety (PACCSS) poster was introduced to remind the FYs of the salient information required when discussing imaging. One month after the intervention, the initial participants were resurveyed. Based on a 10-point Likert scale, the FYs demonstrated a mean improvement in self-reported confidence (2.1±1.1, p<0.01), and in satisfaction of own performance after a discussion (1.7±1.1, p<0.01). We identified deficiencies in surgical FY doctors' confidence and skills in facilitating radiological imaging. There was a demonstrable benefit with focused training in improving these skills. This could potentially provide significant benefits in patient care and management. Interspecialty communication should be introduced into undergraduate and postgraduate educational curriculum.

EASL recommendations on treatment of hepatitis C: Final update of the series☆.

Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Clinical care for patients with HCV-related liver disease has advanced considerably thanks to an enhanced understanding of the pathophysiology of the disease, as well as developments in diagnostic procedures and improvements in therapy and prevention. These therapies make it possible to eliminate hepatitis C as a major public health threat, as per the World Health Organization target, although the timeline and feasibility vary from region to region. These European Association for the Study of the Liver recommendations on treatment of hepatitis C describe the optimal management of patients with recently acquired and chronic HCV infections in 2020 and onwards.

The completeness and accuracy of the Norwegian Female Incontinence Registry.

INTRODUCTION: Medical quality registries have gained popularity as tools for monitoring the quality of medical treatments and they serve as data sources for research. The Norwegian Female Incontinence Registry (NFIR) was established in 1998 to monitor and improve the quality of surgery for women with stress and mixed urinary incontinence in Norway and to collect data for research. This study aimed to assess the completeness and accuracy of the Norwegian Female Incontinence Registry, and potential differences in data accuracy over time and according to surgical volume of the reporting hospitals. MATERIAL AND METHODS: A random selection of 300 women from a total of 20 610 operated for urinary incontinence between 1998 and 2016 reported to the Norwegian Female Incontinence Registry from 28 public hospitals were selected for validation. The database completeness was estimated for 2008-2017 by comparing surgical procedures registered both in the Norwegian Female Incontinence Registry and the Norwegian National Patient Registry. Historical data recorded in the Registry for 10 selected key variables were extracted and compared with the patients' individual medical records at the reporting hospitals as reference. The reviewers were blinded to the previously stored information. The intraclass correlation coefficient for continuous variables and Cohen's kappa for categorical variables were calculated. RESULTS: Primary source data on 285 of the 300 women selected from Norwegian Female Incontinence Registry were successfully retrieved. The completeness of the registry has increased from 61% in 2008 to 99% in 2017. The national coverage has increased from 12 reporting departments in 1998 to all 38 public departments performing female incontinence surgery in 2017. Excellent accuracy was found for both continuous variables (intraclass correlation coefficient >0.94) and categorical variables (Cohen's kappa >0.86). No differences in data accuracy were found comparing high-volume hospitals with low-volume hospitals, or when comparing data accuracy over time. CONCLUSIONS: The Norwegian Female Incontinence Registry is a reliable tool for quality assessment of incontinence surgery and research. The registry completeness has improved over time and now contains data on nearly all women undergoing incontinence surgery in Norway.

Impact of chronic kidney disease on mortality and cardiovascular outcomes after acute coronary syndrome: A nationwide data linkage study (ANZACS-QI 44).

AIMS: Chronic kidney disease (CKD) is associated with an increased risk of cardiovascular disease (CVD). We examined the characteristics, management and outcomes of patients with CKD in the All New Zealand Acute Coronary Syndrome Quality Improvement (ANZACS-QI) national registry. METHODS: The cohort comprised New Zealand (NZ) patients with an acute coronary syndrome undergoing coronary angiography between January 2013 and December 2016. Patients were categorized according to their stage of CKD. Outcomes included all-cause and cause-specific mortality and hospitalization with myocardial infarction (MI), stroke and major bleeding. RESULTS: Of the 20 604 patients, 20.3% had normal renal function, with 53.3%, 23.3%, 1.7% and 1.4% having CKD stages 2, 3, 4 and 5 CKD, respectively. Patients with severe CKD were more likely to be Maori or Pacific and live in an area with greater socioeconomic deprivation. Death, recurrent MI or stroke, and major bleeding all increased incrementally with each worsening stage of CKD severity. Compared with those with normal renal function, patients with stage 5 CKD had a much higher all-cause (hazard ratio [HR] 16.41, 95% CI 13.06-20.61), cardiovascular (HR 16.38, 95% CI 12.17-22.04) and non-cardiovascular mortality (HR 13.66 9, 95% CI.56-19.51). In addition, patients with stage 5 CKD were at a higher risk of recurrent MI or stroke (HR 4.73, 95% CI 3.86-5.80) and bleeding (HR 5.84, 95% CI 4.39-7.76). CONCLUSION: CKD was associated with increased mortality and a high incidence of morbidity in patients undergoing coronary angiography in New Zealand. Initiatives to understand and improve outcomes in this group of patients are urgently needed.

Medical informed choice: understanding the element of time to meet the standard of care for valid informed consent.

Medical informed choice is essential for a physician meeting their fiduciary duty when proposing medical and surgical actions, and necessary for a patient to consent or cull the outlined therapeutic approaches. Informed choice, as part of a shared decision-making model, allows widespread give-and-take of ideas between the patient and physician. This sharing of ideas results in a partnership for decision-making and a responsibility for medical and surgical outcomes.Informed choice is indispensible to the patient education process that meets the desired outcome of any covenant-an offer of and acceptance of the proposed treatment. The covenant anchors a true patient-physician partnership with parity and equality in decision-making and medical/surgical outcomes.Medical informed choice flows from ethical and legal principles necessary to meet the acknowledged standard of care. This is codified by statute and fortified in general common law. This espouses a fiduciary relationship where the patient and physician understand and accede to the degree of autonomy the patient requests.The growth of an equal patient-physician relationship requires time. There is no alternative to the time variable when developing a physician-patient relationship. Despite physicians being under pressures to perform more clinical and administrative duties in less time in the corporate model of medicine, time remains the most critical variable when considering informed choice and shared decision-making. Videos, pamphlets and alternate healthcare providers cannot and should not substitute for physician time.

General practitioners' management of patients with psychological stress: audit results from Denmark.

BACKGROUND: In western countries, psychological stress is among the most common causes of long-lasting sick leave and a frequent reason to consult the general practitioner (GP). This study aimed to investigate how GPs manage patients with psychological stress and how the management is associated with the patient's sex, the GP's assessment of causality, and coexisting mental disorders. METHODS: We conducted an audit of consecutive cases in Danish general practice. The GPs used electronic medical records to fill in a registration form for each 18-65-year-old patient with whom they had had at least one consultation regarding stress during the past 6 months. Only patients initially in the workforce were included. Age- and sex-adjusted binary regression was applied. RESULTS: Fifty-six GPs (61% women) identified 785 cases. The patients' mean age was 44 years and 70% were women. The cause of stress was considered at least partially work-related in 69% of the cases and multifactorial in a third of cases. The management included sick leave (54%), counselling (47%), pharmaceutical treatment (37%), and referral to psychologist (38%). Compared to women, stress in men was less often considered work-related (RR: 0.84, CI95%: 0.77-0.92) and men were less often sick-listed (RR: 0.83 CI95%: 0.73-0.96) but were more often prescribed tranquilizers (RR: 1.72 CI95%: 1.08-2.74). CONCLUSIONS: GPs' management of patients with stress usually involve elements of counselling, sick leave, referral to psychologist, and medication. Women and men with stress are perceived of and managed differently.

A classification-based approach to low back pain in primary care - protocol for a benchmarking controlled trial.

BACKGROUND: Guidelines recommend a biopsychosocial framework for low back pain (LBP) management and the avoidance of inappropriate imaging. In clinical practice, care strategies are often inconsistent with evidence and guidelines, even though LBP is the most common disabling health condition worldwide. Unhelpful beliefs, attitudes and inappropriate imaging are common. LBP is understood to be a complex biopsychosocial phenomenon with many known multidimensional risk factors (symptom- and lifestyle-related, psychological and social) for persistent or prolonged disability, which should be identified and addressed by treatment. The STarT Back Tool (SBT) was developed for early identification of individual risk factors of LBP to enable targeted care. Stratified care according SBT has been shown to improve the effectiveness of care in a primary care setting. A biopsychosocially-oriented patient education booklet, which includes imaging guidelines and information, is one possible way to increase patients' understanding of LBP and to reduce inappropriate imaging. Premeditated pathways, education of professionals, written material, and electronic patient registry support in health care organizations could help implement evidence-based care. METHODS: We will use a Benchmarking Controlled Trial (BCT) design in our study. We will prospectively collect data from three health care regions before and after the implementation of a classification-based approach to LBP in primary care. The primary outcome will be change in PROMIS (Patient-Reported Outcomes Measurement Information System) (short form 20a) over 12-month follow-up. DISCUSSION: The implementation of a classification-based biopsychosocial approach can potentially improve the care of LBP patients, reduce inappropriate imaging without increasing health-care costs, and decrease indirect costs by reducing work disability. Using the BCT we will be able to evaluate the effectiveness of the improvement strategy for the entire care pathway. TRIAL REGISTRATION: ISRCTN,ISRCTN13273552, retrospectively registered 13/05/2019.

Incorporating the patient-centered approach into clinical practice helps improve quality of care in cases of hypertension: a retrospective cohort study.

BACKGROUND: Treating hypertensive patients by integrating the patient-centered approach would influence the practice and outcome of treatment. Our purpose was to determine whether the implementation of a patient-centered approach in health care delivery can improve adhering to guidelines and the quality-of-care. METHODS: A retrospective study was conducted using secondary data from the electronic medical records of the patients treated in the two primary care outpatient settings at the Family Medicine (FM) and Social Security (SS) clinics. A key feature of the FM clinic is the incorporation of a patient-centered approach in its service delivery. Individual information regarding initial assessment and treatment at the follow-up visits was reviewed for 1 year. Comparison of adherence to treatment guidelines between the two primary care clinics was performed by using chi-square, Fisher's exact test or a t-test. To explore the difference in blood pressure and BP control between the two clinics, linear and logistic regression analysis respectively were performed with an adjustment for CV risk score in 2016 as a key confounder. RESULTS: The evidence included 100 records from each clinic, showed variation between the two primary care sites. The FM clinic had more complete records regarding family history of hypertension, assessment for secondary causes, prescription for lifestyle modification and appropriate adjustment of medication. Higher levels of blood pressure control were recorded in the FM clinic, specifically systolic pressure 2.92 mmHg (p = 0.073) and diastolic pressure 5.38 mmHg (p <  0.001) lower than those recorded in the SS clinic. There was a 2.96 times higher chance for BP goals to be achieved in patients in receipt of hypertensive care at the FM clinic (p = 0.004). CONCLUSIONS: Adopting a patient-centered approach in service delivery could improve the quality of care for hypertension patients in primary care in Thailand.

Cervical Colposcopy: Indications and Risk Assessment.

The practice of colposcopy, a diagnostic procedure to evaluate for vaginal, vulvar, and cervical dysplasia, has evolved to incorporate patient risk factors for high-grade cervical intraepithelial neoplasia (CIN) and cancer. Changes in cervical cancer screening and guidelines, human papillomavirus (HPV) vaccination recommendations, and colposcopy standards from the American Society for Colposcopy and Cervical Pathology (ASCCP) have implications for all primary care clinicians, not only those who perform colposcopies. Primary care clinicians should offer HPV vaccination to all patients between the ages of nine and 26, in addition to cervical cancer screening and follow-up guidance. Primary care clinicians should recognize the degrees of risk of high-grade CIN and cancer conferred by cytology, HPV subtype, and persistence of HPV infection. Clinicians should address modifiable risk factors such as tobacco use, and provide counseling to patients about colposcopy based on their individual risks. Clinicians should conduct shared decision-making about immediate loop electrosurgical excision procedure vs. colposcopy with multiple biopsies and endocervical sampling for patients with the highest risk of cervical cancer, and for patients who are older than 25 years with at least two of the following: HPV-16, HPV-18, and high-grade squamous intraepithelial lesion cytology. Primary care clinicians should be familiar with the 2019 ASCCP guidelines and develop clinic-based systems to ensure appropriate follow-up of abnormal cytology, positive high-risk HPV testing, diagnosed CIN, and cervical cancer. Patients with an abnormal cervical cancer screening history require surveillance, which differs from routine screening for patients with normal prior screening results. Long-term surveillance is recommended for patients with CIN 2 or worse.

Management of suspected COVID-19 patients in a low prevalence region.

The spread of the SARS-CoV-2 infection among population has imposed a re-organization of healthcare services, aiming at stratifying patients and dedicating specific areas where patients with suspected COVID-related respiratory disease could receive the necessary health care assistance while waiting for the confirmation of the diagnosis of COVID-19 disease. In this scenario, the pathway defined as a "grey zone" is strongly advocated. We describe the application of rules and pathways in a regional context with low diffusion of the infection among the general population in the attempt to provide the best care to respiratory patients with suspected COVID-19. To date, this process has avoided the worst-case scenario of intra-hospital epidemic outbreak.

Contemporary Management of Acute Decompensated Heart Failure and Cardiogenic Shock.

Cardiogenic shock (CS) is a life-threatening condition characterized by end-organ hypoperfusion and hypoxia primarily due to cardiac dysfunction and low cardiac output. Unfortunately, the mortality and morbidity associated with CS have remained high despite notable advances in heart failure management. Treatment should be carefully guided by hemodynamics assessment. Although inotropes, vasopressors, mechanical circulatory support, and catheter intervention for critical valve lesion are not always recommended, they are helpful in selected patients. Early diagnosis, accurate hemodynamic assessment, and prompt therapeutic intervention are crucial in the management of acute decompensated heart failure with CS.

[Treatment strategies of Budd-Chiari syndrome during the epidemic period of 2019 coronavirus disease].

Prevention and control about the situation of 2019 coronavirus disease (COVID-19) are grim at present. In addition to supporting the frontline actively, medical workers in general surgery spare no efforts in making good diagnosis and treatment of specialized diseases by optimizing treatment process, providing medical advice online, mastering indications of delayed operation and emergency operation reasonably, etc. Budd-Chiari syndrome is a complex disorder, and severity of the disease varies, serious cases can be life threatening. While fighting the epidemic, medical workers should also ensure the medical needs of patients. However, instead of continuing the traditional treatment, a new management system should be developed. Based on the characteristics of Budd-Chiari syndrome patients in China and our experience, patients are divided into ordinary cases and critical cases, and treatment strategies suitable for the epidemic period of COVID-19 are put forward for reference and discussion by physicians.

[Consideration of surgeons participating in 2019 coronavirus disease emergency medical rescue].

As a newly epidemic, 2019 coronavirus disease (COVID-19) with a concentrated outbreak poses a great challenge to medical treatment. The severe and critical patients are complex complicatied with the psychological problems, and the medical staff are overworked and under tremendous psychological pressure. The surgeon participated in emergency medical rescue could provide professional treatment for the patients combined with surgical diseases, as well as specialized training for the non-surgeon crew, to reduce surgical-related mortality. With the advantages of good team consciousness, strong aseptic concept and good psychological quality, the surgeons can quickly adapt to and carry out rescue work under the premise of good self-protection. Surgeons need to develop critical care management concepts and focus on the critical care support equipment. Some suggestions are put forward for the standardized training of resident surgeons to cultivate compound talents. It is hoped that this article can lead to the thinking of how to participate in the emergency medical rescue of infectious diseases among surgeons and provide some enlightenment for future surgical education.

Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals.

BACKGROUND: A previous analysis of 113 National Comprehensive Cancer Network® (NCCN®) recommendations reported that NCCN frequently recommends beyond Food and Drug Administration (FDA)-approved indications (44 off-label recommendations) and claimed that the evidence for these recommendations was weak. METHODS: In order to determine the strength of the evidence, we carried out an in-depth re-analysis of the 44 off-label recommendations listed in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). RESULTS: Of the 44 off-label recommendations, 14 were later approved by the FDA and/or are supported by randomized controlled trial (RCT) data. In addition, 13 recommendations were either very minor extrapolations from the FDA label (n = 8) or were actually on-label (n = 5). Of the 17 remaining extrapolations, 8 were for mechanism-based agents applied in rare cancers or subsets with few available treatment options (median response rate = 43%), 7 were based on non-RCT data showing significant efficacy (>50% response rates), and 2 were later removed from the NCCN Guidelines because newer therapies with better activity and/or safety became available. CONCLUSION: Off-label drug use is a frequent component of care for patients with cancer in the United States. Our findings indicate that when the NCCN recommends beyond the FDA-approved indications, the strength of the evidence supporting such recommendations is robust, with a significant subset of these drugs later becoming FDA approved or supported by RCT. Recommendations without RCT data are often for mechanism-based drugs with high response rates in rare cancers or subsets without effective therapies.