The PRO-ACTIVE trial protocol: a randomized study comparing the effectiveness of PROphylACTic swallow InterVEntion for patients receiving radiotherapy for head and neck cancer.

BACKGROUND: Swallowing therapy is commonly provided as a treatment to lessen the risk or severity of dysphagia secondary to radiotherapy (RT) for head and neck cancer (HNC); however, best practice is not yet established. This trial will compare the effectiveness of prophylactic (high and low intensity) versus reactive interventions for swallowing in patients with HNC undergoing RT. METHODS: This multi-site, international randomized clinical trial (RCT) will include 952 adult patients receiving radiotherapy for HNC and who are at high risk for post-RT dysphagia. Participants will be randomized to receive one of three interventions for swallowing during RT: RE-ACTIVE, started promptly if/when dysphagia is identified; PRO-ACTIVE EAT, low intensity prophylactic intervention started before RT commences; or, PRO-ACTIVE EAT+EXERCISE, high intensity prophylactic intervention also started before RT commences. We hypothesize that the PRO-ACTIVE therapies are more effective than late RE-ACTIVE therapy; and, that the more intensive PRO-ACTIVE (EAT + EXERCISE) is superior to the low intensive PRO-ACTIVE (EAT). The primary endpoint of effectiveness is duration of feeding tube dependency one year post radiation therapy, selected as a pragmatic outcome valued equally by diverse stakeholders (e.g., patients, caregivers and clinicians). Secondary outcomes will include objective measures of swallow physiology and function, pneumonia and weight loss, along with various patient-reported swallowing-related outcomes, such as quality of life, symptom burden, and self-efficacy. DISCUSSION: Dysphagia is a common and potentially life-threatening chronic toxicity of radiotherapy, and a priority issue for HNC survivors. Yet, the optimal timing and intensity of swallowing therapy provided by a speech-language pathologist is not known. With no clearly preferred strategy, current practice is fraught with substantial variation. The pragmatic PRO-ACTIVE trial aims to specifically address the decisional dilemma of when swallowing therapy should begin (i.e., before or after a swallowing problem develops). The critical impact of this dilemma is heightened by the growing number of young HNC patients in healthcare systems that need to allocate resources most effectively. The results of the PRO-ACTIVE trial will address the global uncertainty regarding best practice for dysphagia management in HNC patients receiving radiotherapy. TRIAL REGISTRATION: The protocol is registered with the US Patient Centered Outcomes Research Institute, and the PRO-ACTIVE trial was prospectively registered at ClinicalTrials.gov , under the identifier NCT03455608 ; First posted: Mar 6, 2018; Last verified: Jun 17, 2021. Protocol Version: 1.3 (January 27, 2020).

Association of preoperative anaemia with cardiopulmonary exercise capacity and postoperative outcomes in noncardiac surgery: a substudy of the Measurement of Exercise Tolerance before Surgery (METS) Study.

BACKGROUND: Preoperative anaemia is associated with elevated risks of postoperative complications. This association may be explained by confounding related to poor cardiopulmonary fitness. We conducted a pre-specified substudy of the Measurement of Exercise Tolerance before Surgery (METS) study to examine the associations of preoperative haemoglobin concentration with preoperative cardiopulmonary exercise testing performance (peak oxygen consumption, anaerobic threshold) and postoperative complications. METHODS: The substudy included a nested cross-sectional analysis and nested cohort analysis. In the cross-sectional study (1279 participants), multivariate linear regression modelling was used to determine the adjusted association of haemoglobin concentration with peak oxygen consumption and anaerobic threshold. In the nested cohort study (1256 participants), multivariable logistic regression modelling was used to determine the adjusted association of haemoglobin concentration, peak oxygen consumption, and anaerobic threshold with the primary endpoint (composite outcome of death, cardiovascular complications, acute kidney injury, or surgical site infection) and secondary endpoint (moderate or severe complications). RESULTS: Haemoglobin concentration explained 3.8% of the variation in peak oxygen consumption and anaerobic threshold (P<0.001). Although not associated with the primary endpoint, haemoglobin concentration was associated with moderate or severe complications after adjustment for peak oxygen consumption (odds ratio=0.86 per 10 g L-1 increase; 95% confidence interval, 0.77-0.96) or anaerobic threshold (odds ratio=0.86; 95% confidence interval, 0.77-0.97). Lower peak oxygen consumption was associated with moderate or severe complications without effect modification by haemoglobin concentration (P=0.12). CONCLUSION: Haemoglobin concentration explains a small proportion of variation in exercise capacity. Both anaemia and poor functional capacity are associated with postoperative complications and may therefore be modifiable targets for preoperative optimisation.

The higher risk of death on peritoneal dialysis in the United States is not explained by background general population mortality: the CANUSA study revisited.

The CANUSA investigators reported a near doubling of the risk of death in peritoneal dialysis patients treated at U.S. sites compared to Canadian centers. Recently, evidence has suggested that background mortality rates in the general population might be responsible for differences in death rates on dialysis. The objective of this study was to determine if differences in background mortality in the general population were responsible for the increased risk of death observed in American patients in the CANUSA study. The CANUSA study was a prospective cohort study of 680 consecutive peritoneal dialysis patients at 14 centers in the U.S. and Canada. Extensive baseline data were available for all patients. The expected mortality rate of an individual of the same age, sex, and country of residence was determined at the time of enrollment in the CANUSA study. Cox proportional hazards models were used to determine if background mortality rates were responsible for the observed differences in survival between the two countries. Background mortality rate in the general population was associated with an increased risk of death on peritoneal dialysis, but after adjustment for other baseline factors, it was no longer significant. The adjusted, relative hazard of dying in the U.S. compared to Canada was unchanged after further adjusting for background mortality rate in statistical models (HR = 1.93; 95% confidence interval: 1.13 - 3.28). In conclusion, the increased risk of mortality in U.S. patients enrolled in the CANUSA study was not explained by differences in the background mortality rate in the general population.

Prehospital cooling to improve successful targeted temperature management after cardiac arrest: A randomized controlled trial.

RATIONALE: Targeted temperature management (TTM) improves survival with good neurological outcome after out-of-hospital cardiac arrest (OHCA), but is delivered inconsistently and often with delay. OBJECTIVE: To determine if prehospital cooling by paramedics leads to higher rates of 'successful TTM', defined as achieving a target temperature of 32-34°C within 6h of hospital arrival. METHODS: Pragmatic RCT comparing prehospital cooling (surface ice packs, cold saline infusion, wristband reminders) initiated 5min after return of spontaneous circulation (ROSC) versus usual resuscitation and transport. The primary outcome was rate of 'successful TTM'; secondary outcomes were rates of applying TTM in hospital, survival with good neurological outcome, pulmonary edema in emergency department, and re-arrest during transport. RESULTS: 585 patients were randomized to receive prehospital cooling (n=279) or control (n=306). Prehospital cooling did not increase rates of 'successful TTM' (30% vs 25%; RR, 1.17; 95% confidence interval [CI] 0.91-1.52; p=0.22), but increased rates of applying TTM in hospital (68% vs 56%; RR, 1.21; 95%CI 1.07-1.37; p=0.003). Survival with good neurological outcome (29% vs 26%; RR, 1.13, 95%CI 0.87-1.47; p=0.37) was similar. Prehospital cooling was not associated with re-arrest during transport (7.5% vs 8.2%; RR, 0.94; 95%CI 0.54-1.63; p=0.83) but was associated with decreased incidence of pulmonary edema in emergency department (12% vs 18%; RR, 0.66; 95%CI 0.44-0.99; p=0.04). CONCLUSIONS: Prehospital cooling initiated 5min after ROSC did not increase rates of achieving a target temperature of 32-34°C within 6h of hospital arrival but was safe and increased application of TTM in hospital.

Progression to chronic atrial fibrillation after pacing: the Canadian Trial of Physiologic Pacing. CTOPP Investigators.

OBJECTIVES: This study examined the effect of physiologic pacing on the development of chronic atrial fibrillation (CAF) in the Canadian Trial Of Physiologic Pacing (CTOPP). BACKGROUND: The role of physiologic pacing to prevent CAF remains unclear. Small randomized studies have suggested a benefit for patients with sick sinus syndrome. No data from a large randomized trial are available. METHODS: The CTOPP randomized patients undergoing first pacemaker implant to ventricular-based or physiologic pacing (AAI or DDD). Patients who were prospectively found to have persistent atrial fibrillation (AF) lasting greater than or equal to one week were defined as having CAF. Kaplan-Meier plots for the development of CAF were compared by log-rank test. The effect of baseline variables on the benefit of physiologic pacing was evaluated by Cox proportional hazards modeling. RESULTS: Physiologic pacing reduced the development of CAF by 27.1%, from 3.84% per year to 2.8% per year (p = 0.016). Three clinical factors predicted the development of CAF: age > or =74 years (p = 0.057), sinoatrial (SA) node disease (p < 0.001) and prior AF (p < 0.001). Subgroup analysis demonstrated a trend for patients with no history of myocardial infarction or coronary disease (p = 0.09) as well as apparently normal left ventricular function (p = 0.11) to derive greatest benefit. CONCLUSIONS: Physiologic pacing reduces the annual rate of development of chronic AF in patients undergoing first pacemaker implant. Age > or =74 years, SA node disease and prior AF predicted the development of CAF. Patients with structurally normal hearts appear to derive greatest benefits.

Paying the medical cost of the HIV epidemic: a review of policy options.

The complex health care needs of people with HIV infection highlight inadequacies in our health care financing system and raise the question of how best to pay for care. AIDS requires a broad continuum of care to maintain high quality and reasonable costs. A simultaneous need is to assure access to care for patients with HIV infection who lack insurance or entitlement to health care benefits. We suggest new and practical payment mechanisms that can encourage the availability of comprehensive care for people with HIV infection. We suggest changes in state and federal payment policies that would make the cost of providing AIDS care more of a collective, community responsibility. We recommend mandated workplace insurance, extension of Medicaid eligibility to all with incomes below the federal poverty level, an opportunity for individuals with incomes to 200% of the poverty level to purchase Medicaid coverage, mechanisms to encourage public and private agencies to pay for continued health insurance after loss of employment, and a shortened waiting period for Medicare disability.

Incremental approaches to covering uninsured children: design and policy issues.

More than 10.5 million children were uninsured throughout 1995. The number of uninsured children remains high, even in the face of continued expansions of Medicaid designed to cover low-income children. As a result, interest persists in developing additional approaches for covering uninsured children. Efforts to attract more uninsured children will entail important trade-offs between the federal costs of the program (and its political viability) and the number of uninsured children who enroll.

Income-related cost sharing in health insurance.

The vast majority of health plans in the United States require patients to meet cost-sharing requirements that are unrelated to income. Because this is highly inequitable, the authors propose a new system in which cost sharing is explicitly linked to income levels. This proposal differs from earlier proposals to relate cost sharing to income, which relied on the federal income tax system. In this plan, employers and insurers (both public and private) would collect the information necessary to relate cost sharing amounts to income. The proposal could be applied to nearly any health system reform proposal currently under discussion. The authors examine the experience of a number of U.S. firms that have already incorporated income-related cost sharing, as possible models to apply to health insurance nationwide.

Why are workers uninsured? Employer-sponsored health insurance in 1997.

This study examines the number of workers in firms offering employee health plans, the number of workers eligible for such plans, and participation in employer-sponsored insurance. Data from the February 1997 Contingent Worker Supplement to the Current Population Survey indicate that 10.1 million workers are employed by firms offering insurance but are not eligible. Not all of these workers are eligible for coverage, most often because of hours of work. Our results indicate that 11.4 million workers rejected coverage when it was offered. Of those, 2.5 million workers were uninsured. Workers cited high cost of insurance most often as the primary factor for refusing coverage.

Market incentives, plan choice, and price increases.

The Federal Employees Health Benefits Program (FEHBP) has attracted considerable interest for its ability to control health care costs. We examine the impact of the FEHBP's maximum dollar contribution on incentives to select low-cost plans and the growth in insurance premiums over time. Unless the maximum dollar contribution is pegged to a low-price plan, few enrollees select such plans. Moreover, premiums rise at least five percentage points per year faster among plans below this fixed subsidy level than they do in plans above it. Our results have important implications for the design of similar market-based approaches.

Comparison of hospital costs in California, New York, and Canada.

When the components of health care spending are broken down, hospital spending accounts for the largest portion of the total. This DataWatch compares hospital spending in two U.S. states with spending in two Canadian provinces, to gain better understanding of the recurring differences in hospital spending reported by the two countries. To make the data comparable, the study combines different hospital output measures into a composite measure that is converted into U.S. dollars and applied to data from both countries. In 1987 hospital costs per person were about one-third higher in the United States than in Canada. Results suggest that the higher U.S. costs are due primarily to higher unit costs rather than to differences in output.

How well do Americans understand their health coverage?

Data from two surveys are used in this DataWatch to explore Americans' understanding of their health insurance. First, data from a national survey of consumers are used to examine if people with private health insurance correctly report their coverage for six services. Second, information from an evaluation of a pilot project of subsidized insurance in New York is used to investigate how well newly insured persons understand their coverage. Based on these surveys, almost all privately insured people understand the basic elements of their insurance plans but underestimate their coverage for mental health, substance abuse, and prescription drug benefits and overestimate their coverage for long-term care. People who are newly insured in physician networks or health maintenance organizations seem uncertain about what services their plan covers and restrictions on their choice of hospitals.

Regulatory intensity and hospital cost growth.

This article parameterizes and examines the regulatory intensity of New York's all-payer rate setting system. The model, using hospital level data, compares the effects of specific features of rate-setting designed to promote cost containment. Two indicators measuring regulatory intensity were examined; the extent of hospital-specific disallowances, and how frequently the base year was adjusted (the degree of prospectivity). The results indicate that both the degree of prospectivity and the extent of disallowances importantly affect cost growth. Hospitals, when constrained, primarily achieved cost savings through reductions in non-medical personnel.

Covering uninsured children and their parents: estimated costs and number of newly insured.

The Child Health Insurance Program (CHIP) supplies $20.4 billion over 5 years and nearly $50 billion over 10 years to extend health insurance to uninsured children with family incomes up to 200 percent of poverty. This article analyzes the March 1997 Current Population Survey, estimating the number of children likely to be eligible for CHIP or currently eligible for Medicaid. Of the 8.6 million parents of uninsured children, four out of five were uninsured at the time of the survey. Expanding coverage to parents as well as children could make program participation more attractive and simplify the enrollment process. If 75 percent of uninsured parents of CHIP eligible children participated, 1.7 million parents could be insured, costing federal and state governments $4 billion. Another 3.4 million parents would be insured by expanding Medicaid to cover uninsured parents of Medicaid-eligible children.

Why are urban hospital costs so high? The relative importance of patient source of admission, teaching, competition, and case mix.

This article examines factors accounting for higher costs in urban hospitals as well as their relative contribution to those costs. The costs of urban hospitals are influenced by case mix, wages, competition, the ratio of forecasted to actual admissions, teaching, and the percentage of patients admitted through the emergency room. The bulk of the higher costs in urban hospitals are linked to graduate medical education. Treatment of poor patients and the admission of patients through the emergency room also contribute to the higher costs. Higher inpatient costs stemming from outpatient activities pose distributional problems for hospitals when these costs are not accounted for in prospective (inpatient) rate-setting programs.

Matching health policy with data: data and analytic requirements for federal policymakers.

The health data and statistical needs of our health care system continue to grow. Though we are expected to spend approximately $1.4 trillion on health care next year, we know little about where the dollars are spent and what they are purchasing. Our national health statistics are currently collected through a patchwork of claims data and survey data. These data are collected periodically, are often out of date, and do not contain several key data elements critical for serious evaluation of the performance of our health care system. Failure to collect more timely and comprehensive data will undermine ongoing efforts for controlling the growth in costs and improving quality.

Are the diagnosis-related group case weights compressed?

One problem noted recently with the diagnosis-related group payment system is that the distribution of Medicare case weights and case-mix indexes are compressed; that is, the payment rates for high-cost procedures are too low and those for low-cost procedures are too high. Despite the attention compression has received, there are no direct estimates of its magnitude or importance. Presented in this article are an empirical test for compression and a suggestion for a simple correction to decompress the relative prices.

Relative size and agonistic behaviour in the female velvet swimming crab, Necora puber (L.) (Brachyura, Portunidae).

Female velvet swimming crabs (Necora puber) fight readily in the laboratory, with interactions being initiated equally often by the larger and smaller of the two opponents, but with the larger usually being victorious. In 17 out of 65 interactions, however, a smaller crab won against a larger one, and possible reasons for this are discussed. In two respects our results are surprising in the context of insights gained from games theory: firstly, the fights do not show a gradual pattern of escalation through display to overt physical violence; and secondly, fights do not become more costly in terms of either potential for injury (intensity) or duration as the contestants became more evenly matched; indeed, as the contestants became more evenly matched, fight duration decreased.

Costs and distributional impacts of employer health insurance mandates and Medicaid expansion.

A large number of Americans are uninsured. A number of recent proposals have been developed to extend coverage to the 31 to 37 million individuals currently without health insurance. This article examines two recent proposals. The first is to mandate coverage through the workplace. Two different methods of mandating workplace coverage are explored: the recent Kennedy-Waxman bill and the approach adopted in Massachusetts. Although both approaches cover the same number of uninsured, both the aggregate costs and their distribution differ dramatically. The article also explores the coverage and cost implications of an expansion of Medicaid alone and in conjunction with the employer mandate options.

The distributional implications of using relative prices in DRG payment systems.

Decisions by state Medicaid programs and other third-party payers to use DRGs as the basis of hospital payment require the resolution of numerous technical design issues, including determining relative price schedules, that are likely to have important distributional implications for payers and hospitals. At issue is the development of price schedules that reflect average resource use in the populations using DRG reimbursement. An examination of differences between the Medicare relative prices and other relative prices based on different populations in New York State revealed that significant cross-subsidies among payers and hospitals would occur if Medicare relative prices were used as the basis of payment for patients outside the Medicare program. Such unintended cross-subsidies would compromise a major goal of DRG payment: to reduce "inequitable" charge and cost differentials among third-party payers.