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As a standard way for prevention and early detection of colorectal cancer (CRC), colonoscopy has been used for CRC screening in the United States for more than one decade. An article entitled “Assessing Colorectal Cancer Screening Adherence of Medicare Fee‐For‐Service Beneficiaries Age 76 to 95 Years” recently published at the Journal of Oncology Practice reports the trends in overuse of CRC screening services among average‐risk elderly populations at the age of 76–95 years. Several reasons for overusing colonoscopy have been postulated, and some strategies for reducing overuse of CRC screening services have also been proposed.

Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents—molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs—provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.

Individuals in the USA without private medical insurance are less likely to have access to medical care or participate in cancer screening programmes than those with private medical insurance. Smaller regional studies in the USA suggest that uninsured and Medicaid-insured individuals are more likely to present with advanced-stage cancer than privately insured patients; however, this finding has not been assessed using contemporary, national-level data. Furthermore, patients with cancer from ethnic minorities are more likely to be uninsured or Medicaid-insured than non-Hispanic white people. Separating the effects on stage of cancer at diagnosis associated with these two types of patient characteristics can be difficult. Patients with cancer in the USA, diagnosed between 1998 and 2004, were identified using the US National Cancer Database—a hospital-based registry that contains patient information from about 1430 facilities. Odds ratios and 95% CIs for the effect of insurance status (Medicaid, Medicare (65–99 years), Medicare (18–64 years), private, or uninsured) and ethnicity (white, Hispanic, black, or other) on disease stage at diagnosis for 12 cancer sites (breast [female], colorectal, kidney, lung, melanoma, non-Hodgkin lymphoma, ovary, pancreas, prostate, urinary bladder, uterus, and thyroid) were estimated, while controlling for patient characteristics. 3 742 407 patients were included in the analysis; patient characteristics were similar to those of the corresponding US population not included in the analysis. Uninsured and Medicaid-insured patients were significantly more likely to present with advanced-stage cancer compared with privately insured patients. This finding was most prominent for patients who had cancers that can potentially be detected early by screening or symptom assessment (eg, breast, colorectal, and lung cancer, as well as melanoma). For example, the odds ratios for advanced-stage disease (stage III or IV) at diagnosis for uninsured or Medicaid-insured patients with colorectal cancer were 2·0 (95% CI 1·9–2·1) and 1·6 (95% CI 1·5–1·7), respectively, compared with privately-insured patients. For advanced-stage melanoma, the odds ratios were 2·3 (2·1–2·5) for uninsured patients and 3·3 (3·0–3·6) for Medicaid-insured patients compared with privately insured patients. Black and Hispanic patients were noted to have an increased risk of advanced-stage disease (stage III or IV) at diagnosis, irrespective of insurance status, compared with White patients. In this US-based analysis, uninsured and Medicaid-insured patients, and those from ethnic minorities, had substantially increased risks of presenting with advanced-stage cancers at diagnosis. Although many factors other than insurance status also affect the quality of care received, adequate insurance is a crucial factor for receiving appropriate cancer screening and timely access to medical care.

To accelerate new drug, biologic, and medical device development and to improve efficiency of delivery of the latest breakthroughs of innovative, life-saving treatments to millions of patients, single-arm trial (SAT) applications of rare diseases or conditions supplemented by their external control arm (ECA) evidence for regulatory approvals have been surging since 2016. However, there have been increasing concerns over potential biases threatening the internal validity of these applications from regulatory authorities, payers, and research community. There are two main sources of potential biases. The first source is heterogeneity between two arms at the level of patients, and the second one at the level of systems (e.g., two entirely different sets of hospitals from which patients in a SAT and patients in an ECA are drawn separately). The currently commonly used study design is a post-intervention measurement only design that though mitigating the first source of bias, is utterly unable to control for the second one. This perspective article will propose a quasi-experimental design as an alternative that may mitigate the second source of bias, aiming to improve the internal validity of SAT and ECA studies. We will start summarizing the two main sources of biases that may impede the causal inference of these studies. Two approved therapies supported by SAT and ECA studies will be used as an example to illustrate these biases in detail. We will then introduce the intuition of the quasi-experimental design, underlying assumptions and data requirements, and empirical strategies for estimating interventional effects. We will conclude this article by discussing caveats of applying this alternative design for SAT and ECA studies.

The United States Constitution protects the right of citizens to petition the government for \"a redress of grievances.\" This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10-13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to \"redress grievances.\"

This paper examines the association of free-standing ambulatory surgery centers (ASCs) with hospital surgery volume, using data from the 2002 Medicare Online Survey Certification and Reporting System and the American Hospital Association Annual Surveys of Hospitals. From 1993 to 2001, the number of ASCs per 100,000 population in metropolitan statistical areas (MSAs) increased by 150%. During the same period, hospital outpatient surgeries increased 28%, while inpatient surgeries decreased by 4.5%. MSA and year fixed-effects regression analyses suggest that an increase of one ASC per 100,000 people was associated with a 4.3% reduction in hospital outpatient surgical volume, but was not associated with inpatient surgical volume.

Purpose The impact of adjuvant radiotherapy for pancreatic adenocarcinoma (PAC) remains controversial. We examined effects of adjuvant therapy on overall survival (OS) in PAC, using the National Cancer Data Base (NCDB). Methods Patients with resected PAC from 1998 to 2002 were queried from the NCDB. Factors associated with receipt of adjuvant chemotherapy (ChemoOnly) versus adjuvant chemoradiotherapy (ChemoRad) versus no adjuvant treatment (NoAdjuvant) were assessed. Cox proportional hazard modeling was used to examine effect of adjuvant therapy type on OS. Propensity scores (PS) were developed for each treatment arm and used to produce matched samples for analysis to minimize selection bias. Results From 1998 to 2002, a total of 11,526 patients underwent resection of PAC. Of these, 1,029 (8.9 %) received ChemoOnly, 5,292 (45.9 %) received ChemoRad, and 5,205 (45.2 %) received NoAdjuvant. On univariate analysis, factors associated with improved OS included: younger age, higher income, higher facility volume, lower tumor stage and grade, negative margins and nodes, and absence of adjuvant therapy. On multivariate analysis with matched PS, factors independently associated with improved OS included: younger age, higher income, higher facility volume, later year of diagnosis, smaller tumor size, lower tumor stage, and negative tumor margins and nodes. ChemoRad had the best OS (hazard ratio 0.70, 95 % confidence interval 0.61–0.80) in a PS matched comparison with ChemoOnly (hazard ratio 1.04, 95 % confidence interval 0.93–1.18) and NoAdjuvant (index). Conclusions Adjuvant chemotherapy with radiotherapy is associated with improved OS after PAC resection in a large population from the NCDB. On the basis of these analyses, radiotherapy should be a part of adjuvant therapy for PAC.

Summary To better understand the risk of secondary vertebral compression fracture (VCF) following a vertebroplasty or kyphoplasty, we compared patients treated with those procedures to patients with a previous VCF. The risk of subsequent fracture was significantly greater among treatment patients, especially within 90 days of the procedure. Introduction Predominantly uncontrolled studies suggest a greater risk of subsequent vertebral compression fractures (VCFs) associated with vertebroplasty/kyphoplasty. To further understand this risk, we conducted a population-based retrospective cohort study using data from a large regional health insurer. Methods Administrative claims procedure codes were used to identify patients receiving either a vertebroplasty or kyphoplasty (treatment group) and a comparison group of patients with a primary diagnosis of VCF who did not receive treatment during the same time period. The main outcomes of interest, validated by two independent medical record reviewers, were any new VCFs within (1) 90 days, (2) 360 days, and (3) at adjacent vertebral levels. Multivariable logistic regression examined the association of vertebroplasty/kyphoplasty with new VCFs. Results Among 48 treatment (51% vertebroplasty, 49% kyphoplasty) and 164 comparison patients, treated patients had a significantly greater risk of secondary VCFs than comparison patients for fractures within 90 days of the procedure or comparison group time point [adjusted odds ratio (OR) = 6.8; 95% confidence interval (CI) 1.7-26.9] and within 360 days (adjusted OR = 2.9; 95% CI 1.1-7.9). Conclusions Patients who had undergone vertebroplasty/kyphoplasty had a greater risk of new VCFs compared to patients with prior VCFs who did not undergo either procedure.

Background In the United States, post-mastectomy breast reconstruction is a state (all 51 jurisdictions) and federally mandated benefit. Outpatient mastectomy, which could lower use of breast reconstruction, may raise concerns about whether patients receive adequate post-mastectomy care. Methods Using linked surveillance, epidemiology, and end results (SEER)–Medicare data, we identified Medicare fee-for-service women aged 65–69 years, diagnosed with early-stage breast cancer, and receiving unilateral mastectomy from 1998–2002. The corresponding surgery delivery settings were determined from claims data. The outcome of interest was reconstruction within 4 months of diagnosis. We used multivariable logistic regression models to examine the association of outpatient mastectomy with the likelihood of post-mastectomy reconstruction, controlling for patient’s characteristics. Results Among the 3,419 patients in the sample, 717 (21%) patients received outpatient mastectomy. The proportions of patients receiving reconstruction were 13% for inpatient mastectomy patients and 4% for outpatient mastectomy patients. Outpatient mastectomy patients were younger and had less comorbidities than inpatient mastectomy patients. Multivariable regression analysis suggested that outpatient mastectomy patients were less likely to receive reconstruction (odds ratio = 0.247; 95% confidence interval (CI): 0.166–0.368). Additional analysis suggests that African American patients were less likely than white patients to undergo reconstruction (odds ratio = 0.515; 95% CI: 0.293–0.906) and that this ethnic difference was more manifest among patients undergoing inpatient mastectomies. Conclusions This study shows that outpatient mastectomy was associated with lower use of breast reconstruction. A better understanding of choice of delivery setting of mastectomy with a focus on younger and minority breast cancer patients should be explored in future research.