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The benefits of phosphonate therapy in older men relevant to prevention of fractures associated with osteoporosis are presented.

Objective neuropsychological outcomes of Iraq War deployment in a large military cohort are examined. Results suggest that deployment to Iraq is associated at least transiently with subtle alterations in neural functioning, as indicated by reduced proficiency in sustained attention and memory, heightened negative state affect reflecting increased feelings of confusion and tension and an advantage in reaction time, with further investigation of deployment on neural function needed.

The reliability of peer review when used to evaluate the care that patients receive needs to be improved. Researchers used the structured implicit review guidelines developed by RAND to evaluate the medical care received by 313 elderly patients with various conditions including arthritis, dementia, incontinence and hypertension. Evaluations were done by geriatricians and geriatric nurse practitioners and included measures of process as well as measures of outcome. Reliability of assessments between two or more raters was very poor on all measures of process but fair on several measures of outcome., Context.--Peer assessments have traditionally been used to judge the quality of care, but a major drawback has been poor interrater reliability. Objectives.--To compare the interrater reliability for outcome and process assessments in a population of frail older adults and to identify systematic sources of variability that contribute to poor reliability. Setting.--Eight sites participating in a managed care program that integrates acute and long-term care for frail older adults. Patients.--A total of 313 frail older adults. Design.--Retrospective review of the medical record with 180 charts randomly assigned to 2 geriatricians, 2 geriatric nurse practitioners, or 1 geriatrician and 1 geriatric nurse practitioner and 133 charts randomly assigned to either a geriatrician or a geriatric nurse practitioner. Main Outcome Measures.--Interrater reliabilities for structured implicit judgments about process and outcomes for overall care and care for each of 8 tracer conditions (eg, arthritis). Results.--Outcome measures had higher interrater reliability than process measures. Five outcome measures achieved fair to good reliability (more than 0.40), while none of the process measures achieved reliabilities more than 0.40. Three factors contributed to poorer reliabilities for process measures: (1) an inability of reviewers to differentiate among cases with respect to the quality of management, (2) systematic bias from individual reviewers, and (3) systematic bias related to the professional training of the reviewer (ie, physician or nurse practitioner). Conclusions.--Peer assessments can play an important role in characterizing the quality of care for complex patients with multiple interrelated chronic conditions, but reliability can be poor. Strategies to achieve adequate reliability for these assessments should be applied. These strategies include emphasizing outcomes measurement, providing more structured assessments to identify true differences in patient management, adjusting systematic bias resulting from the individual reviewer and their professional background, and averaging scores from multiple reviewers. Future research on the reliability of peer assessments should focus on improving the ability of process measures to differentiate among cases with respect to the quality of management and on identifying additional sources of systematic bias for both process and outcome measures. Explicit recognition of factors influencing reliability will strengthen efforts to develop sound measures for quality assurance. JAMA. 1997; 278:1573-1578

Measuring outcomes may be the best way to improve the quality of long-term care. Outcomes assessment involves determining whether patients in a treatment plan experience the outcome that is expected. Other proposals for improving long-term care involve staffing nursing homes with better-trained employees, but this approach will probably increase health care costs. Another approach to quality care is to develop clinical practice guidelines to assure that patients are treated appropriately. However, many elderly nursing home patients have many different health problems that cannot be treated by a single guideline. The Minimum Data Set was created to help determine nursing home patients' physical, social and emotional function. It could serve as a model of an outcomes assessment tool., Quality of long-term care can be improved by changing the strategies used to monitor it. Nursing home care has been the subject of intensive regulations, while it has been neglected by physicians. Newer forms of long-term care are coming under stricter oversight, which may stifle the innovations they offer. Greater but different attention is needed: more creativity can be fostered with better accountability by emphasizing long-term care outcomes. It is unrealistic to require that long-term care patients will improve; good outcomes are defined as doing as well as or better than expected. The Minimum Data Set for nursing homes offers a mechanism to generate data on many pertinent outcomes. An outcomes focus would encourage more collective action by the various parties involved in providing long-term care, including physicians. Clinicians are reluctant to assume responsibility for outcomes they feel unable to strongly influence, but they must recognize that part of their role is to engender cooperation from the myriad participants in long-term care, including patients and their families. Better-quality long-term care may cost more, but it may be possible to use less expensive personnel more creatively if current regulations are modified. Managed care arrangements offer one vehicle for reorganizing care and could provide the appropriate incentives to make positive changes. However, they could also lead to minimalist strategies. Accountability for realistic outcomes can provide the needed countervailing regulatory pressure.

There has been considerable concern about drug prescribing practices in nursing homes. Neuroleptics, which are antipsychotic drugs that produce passivity, anxiety and indifference to the surroundings, are most likely to be overused, exposing the patients to possible harm from side effects. Among the side effects of this class of drugs are tardive dyskinesia (uncontrollable tremors) and confusion, which may lead to falls and other accidents. Federal legislation regulated the use of these drugs in nursing homes certified by Medicare and Medicaid, in the Omnibus Budget Reconciliation Act, and guidelines were developed by the Health Care Financing Administration (HCFA). Neuroleptic drug use in nursing homes has been examined in several studies, but none have used the HCFA guidelines to judge the appropriateness of drug use over time. In this study, almost 996 of 4,756 nursing home patients (21 percent) were taking neuroleptic drugs on admission. Approximately half of the residents were not eligible to take neuroleptics, according to HCFA guidelines; either they were taking the drug for a mental disorder not included in the guidelines, or else the drugs had been prescribed for advanced age. The implication is that the drugs are being used as a restraint mechanism. Those taking the drugs were also more likely to have been admitted from a hospital. Almost every nursing home had at least one patient who was not eligible to take neuroleptics, according to the guidelines. (Consumer Summary produced by Reliance Medical Information, Inc.)

Nurse practitioners may deliver the same level of care as a primary care physician. Researchers randomly assigned 1,316 patients to see a primary care physician or a nurse practitioner. No significant differences in health care outcome was seen between the two groups six months or one year after the visit. Patients who saw the nurse practitioner were generally as satisfied with the care they received as those who saw a primary care physician.

The early discharge of patients from hospitals is creating an increase in long-term care expenditures because these costs now include care received immediately after discharge. Home health care and nursing home care covered by Medicare are rising. Hospitals may want to provide subacute care to fill empty hospital beds. Assisted living arrangements are a good option. Long-term care is becoming affected by cost-cutting managed care options including geriatric HMO programs. Another managed care option, The Program for All-Inclusive Care of the Elderly, uses a day care concept to improve the health of older people. Another program involves more intensive primary care to cut the need for hospital care.

Importance: All intravenous (IV) iron products are associated with anaphylaxis, but the comparative safety of each product has not been well established.Objective: To compare the risk of anaphylaxis among marketed IV iron products.Design, Setting, and Participants: Retrospective new user cohort study of IV iron recipients (n = 688,183) enrolled in the US fee-for-service Medicare program from January 2003 to December 2013. Analyses involving ferumoxytol were limited to the period January 2010 to December 2013.Exposures: Administrations of IV iron dextran, gluconate, sucrose, or ferumoxytol as reported in outpatient Medicare claims data.Main Outcomes and Measures: Anaphylaxis was identified using a prespecified and validated algorithm defined with standard diagnosis and procedure codes and applied to both inpatient and outpatient Medicare claims. The absolute and relative risks of anaphylaxis were estimated, adjusting for imbalances among treatment groups.Results: A total of 274 anaphylaxis cases were identified at first exposure, with an additional 170 incident anaphylaxis cases identified during subsequent IV iron administrations. The risk for anaphylaxis at first exposure was 68 per 100,000 persons for iron dextran (95% CI, 57.8-78.7 per 100,000) and 24 per 100,000 persons for all nondextran IV iron products combined (iron sucrose, gluconate, and ferumoxytol) (95% CI, 20.0-29.5 per 100,000) , with an adjusted odds ratio (OR) of 2.6 (95% CI, 2.0-3.3; P < .001). At first exposure, when compared with iron sucrose, the adjusted OR of anaphylaxis for iron dextran was 3.6 (95% CI, 2.4-5.4); for iron gluconate, 2.0 (95% CI 1.2, 3.5); and for ferumoxytol, 2.2 (95% CI, 1.1-4.3). The estimated cumulative anaphylaxis risk following total iron repletion of 1000 mg administered within a 12-week period was highest with iron dextran (82 per 100,000 persons, 95% CI, 70.5- 93.1) and lowest with iron sucrose (21 per 100,000 persons, 95% CI, 15.3- 26.4).Conclusions and Relevance: Among patients in the US Medicare nondialysis population with first exposure to IV iron, the risk of anaphylaxis was highest for iron dextran and lowest for iron sucrose. [ABSTRACT FROM AUTHOR]

Educating doctors with targeted programs and reinforcement through legislation may be the best solution for improving prescribing practices. The 1987 Omnibus Budget Reconciliation Act successfully reduced the administration of antipsychotic drugs to nursing home patients who did not have psychiatric illness. In addition, the act did not affect the number of prescriptions written for other mind-altering medications. This legislation is an example of successful regulation that applies to specific drugs and clinical symptoms. Direct financial incentives to change physician behavior have been successful, but have also adversely affected medical care and education. A proposal for change limits the prescribing of certain drugs to physicians who meet special qualifications. However, this approach may limit patient access to essential medications.

Many families considering posthospital care options are ill-prepared and in need of guidance. They may not know the range of available options, the relative benefits of each, or have considered their therapeutic goals. Physicians should be informants, advocates, and facilitators of this big leap for their patients. Making a good long-term care decision requires information and structure, but such decisions are often made under great time pressure as part of a hospital discharge. Professional intervention and guidance by an informed but disinterested facilitator may be needed, but hospital discharge planners may not be well suited for this role because their mandate is a rapid discharge. Physicians have 2 crucial roles in these transitions: to ensure the seamless delivery of primary care and to advocate for and facilitate, however possible, better decision making. Physicians need at least a rudimentary knowledge of the array of options and the implications of each. Even if the physician cannot serve as the planning facilitator, the physician should ensure that this task is done well. This review describes the range of options and the implications of each option for long-term care in the United States. It suggests the need for evaluating each patient's care goals, family circumstances and resources, and clinical status to determine if more aggressive medical care might improve an individual's clinical trajectory. [ABSTRACT FROM AUTHOR]

The article presents a study looking at how war-zone deployment to Iraq affects the neuropsychological health of U.S. military personnel. The study found that Iraq deployment is connected to a higher risk of neuropsychological dysfunction. Multiple linear regression analyses showed that deployment to Iraq is connected to higher states of confusion and tension as well as lower scores on sustained attention tasks, visual-spatial memory, and verbal learning. The implications of the findings for public health and postdeployment clinical and occupational management are discussed.

Presents several letters to the editors of 'The Journal of the American Medical Association,' and responses. Challenges facing family practice and primary care; How a previous article regarding primary care and family practice failed to include service to underserved communities; The need to re-establish a primary care home for patients; Safety of urinary catheters; Thoughts on an article regarding the Cincinnati Radiation Tests.

Presents letters submitted by readers on medical topics. Health outcomes for black and white patients in the Veterans Affairs (VA) health care system; Handheld cellular telephones and brain cancer risk; Association between changes in hormone replacement therapy and breast density; Others.

A response by J.J. Vasterling, S.P. Proctor, P. Amoroso, R. Kane, T. Heeren and R.F. White to a letter to the editor about their article "Neuropsychological outcomes of army personnel following deployment to the Iraq War," in the 2006 vol. 296 issue.

A reply is presented by Drs. John T. Schousboe, Brent C. Taylor, Douglas C. Bauer and colleagues to a letter to the editor about their article "Cost-effectiveness of bone densitometry followed by treatment of osteoporosis in older men."

Presents a response by Judith Garrard to a letter to the editor about her article 'Evaluation of Neuroleptic Drug Use by Elderly Nursing Home Patients Under Proposed Medicaid and Medicare Regulations' in a 1991 issue of the 'Journal of the American Medical Association.'

Importance: In a comparative clinical study with progression-free survival (PFS) or overall survival (OS) as the end point, the hazard ratio (HR) is routinely used to design the study and to estimate the treatment effect at the end of the study. The clinical interpretation of the HR may not be straightforward, especially when the underlying model assumption is not valid. A robust procedure for study design and analysis that enables clinically meaningful interpretation of trial results is warranted., Objective: To discuss issues of conventional trial design and analysis and to present alternatives to the HR using a recent immunotherapy study as an illustrative example., Design, Setting, and Participants: By comparing 2 groups in a survival analysis, we discuss issues of using the HR and present the restricted mean survival time (RMST) as a summary measure of patients’ survival profile over time. We show how to use the difference or ratio in RMST between 2 groups as an alternative for designing and analyzing a clinical study with an immunotherapy study as an illustrative example., Main Outcomes and Measures: Overall survival or PFS. Group contrast measures included HR, RMST difference or ratio, and the event rate difference., Results: For the illustrative example, the HR procedure indicates that nivolumab significantly prolonged patient OS and was numerically better than docetaxel for PFS. However, the median PFS time of docetaxel was significantly better than that of nivolumab. Therefore, it may be difficult to use median OS and/or PFS to interpret of the HR value clinically. On the other hand, using RMST difference, nivolumab was significantly better than docetaxel for both OS and PFS. We also provide details regarding design of a future study with RMST-based measures., Conclusions and Relevance: The design and analysis of a conventional cancer clinical trial can be improved by adopting a robust statistical procedure that enables clinically meaningful interpretations of the treatment effect. The RMST-based quantitative method may be used as a primary tool for future cancer trials or to help us to better understand the clinical interpretation of the HR even when its model assumption is plausible.

Importance: In 2011, the US Centers for Medicare & Medicaid Services (CMS) changed its reimbursement policy for hemodialysis to a bundled comprehensive payment system that included the cost of erythrocyte-stimulating agents (ESAs). Also in 2011, the US Food and Drug Administration revised the drug label for ESAs, recommending more conservative dosing in patients with chronic kidney disease. In response to concerns that these measures could have adverse effects on patient care and outcomes, the CMS and the FDA initiated a collaboration to assess the effect., Objective: To assess the effects of the changes in reimbursement policy and the ESA drug label on patients who underwent incident hemodialysis., Design, Setting, and Participants: For this retrospective cohort study, patients 66 years or older who had undergone incident hemodialysis, and were enrolled in Medicare parts A, B, or D for at least 12 months prior to hemodialysis initiation between January 1, 2008, and December 31, 2013, were recruited from hemodialysis centers across the United States. Patients were divided into 2 cohorts based on their date of hemodialysis initiation and followed: January 1, 2008, to December 31, 2009, for the prepolicy cohort and July 1, 2011, to June 30, 2013, for the postpolicy cohort, with the exclusion of January 1, 2010, to June 30, 2011, as a transition period., Interventions: Changes in CMS reimbursement policy for dialysis and the FDA label for ESAs., Main Outcomes and Measures: Major adverse cardiovascular events (MACEs), including acute myocardial infarction (AMI), stroke, and all-cause mortality; hospitalized congestive heart failure (H-CHF); venous thromboembolism; and red blood cell transfusions. Secondary outcomes included evaluating effects on black and other patient subgroups., Results: Baseline characteristics of the 69 718 incident hemodialysis patients were similar between cohorts. Compared with the prepolicy period, the risk of MACE, death, H-CHF, and venous thromboembolism were similar in the postpolicy period, and the risk of stroke decreased (hazard ratio [HR], 0.77; 95% CI, 0.64-0.93; P = .01); the use of ESAs also decreased, and the rate of blood transfusions increased (HR, 1.09; 95% CI, 1.07-1.12; P < .001). In the post-postpolicy period, black patients had a significant reduction in risk of MACE (HR, 0.82; 95% CI, 0.73-0.92; P < .001) and all-cause mortality (HR, 0.82; 95% CI, 0.73-0.93; P = .002)., Conclusions and Relevance: After the bundling policy and ESA labeling changes in 2011, the risks of MACE and death for patients 66 years or older and covered by fee-for-service Medicare who had undergone incident hemodialysis did not change; the risk of stroke was reduced, and the rate of blood transfusions modestly increased. Black patients had substantial reductions in the risks of MACE and death.

Importance: All intravenous (IV) iron products are associated with anaphylaxis, but the comparative safety of each product has not been well established., Objective: To compare the risk of anaphylaxis among marketed IV iron products., Design, Setting, and Participants: Retrospective new user cohort study of IV iron recipients (n = 688,183) enrolled in the US fee-for-service Medicare program from January 2003 to December 2013. Analyses involving ferumoxytol were limited to the period January 2010 to December 2013., Exposures: Administrations of IV iron dextran, gluconate, sucrose, or ferumoxytol as reported in outpatient Medicare claims data., Main Outcomes and Measures: Anaphylaxis was identified using a prespecified and validated algorithm defined with standard diagnosis and procedure codes and applied to both inpatient and outpatient Medicare claims. The absolute and relative risks of anaphylaxis were estimated, adjusting for imbalances among treatment groups., Results: A total of 274 anaphylaxis cases were identified at first exposure, with an additional 170 incident anaphylaxis cases identified during subsequent IV iron administrations. The risk for anaphylaxis at first exposure was 68 per 100,000 persons for iron dextran (95% CI, 57.8-78.7 per 100,000) and 24 per 100,000 persons for all nondextran IV iron products combined (iron sucrose, gluconate, and ferumoxytol) (95% CI, 20.0-29.5 per 100,000) , with an adjusted odds ratio (OR) of 2.6 (95% CI, 2.0-3.3; P < .001). At first exposure, when compared with iron sucrose, the adjusted OR of anaphylaxis for iron dextran was 3.6 (95% CI, 2.4-5.4); for iron gluconate, 2.0 (95% CI 1.2, 3.5); and for ferumoxytol, 2.2 (95% CI, 1.1-4.3). The estimated cumulative anaphylaxis risk following total iron repletion of 1000 mg administered within a 12-week period was highest with iron dextran (82 per 100,000 persons, 95% CI, 70.5- 93.1) and lowest with iron sucrose (21 per 100,000 persons, 95% CI, 15.3- 26.4)., Conclusions and Relevance: Among patients in the US Medicare nondialysis population with first exposure to IV iron, the risk of anaphylaxis was highest for iron dextran and lowest for iron sucrose.

Context: The effects of war-zone deployment on neuropsychological health remain poorly understood. Neuropsychological performance deficits serve as sensitive measures of neural dysfunction and are often associated with psychosocial and occupational problems. Previous studies have not conducted objective neuropsychological assessments both before and after a major war-zone deployment., Objective: To examine objective neuropsychological outcomes of Iraq War deployment in a large military cohort., Design, Setting, and Participants: The Neurocognition Deployment Health Study, a prospective, cohort-controlled study conducted at military installations. This report centers on 961 male and female active-duty Army soldiers drawn from the larger cohort. Deploying Army soldiers (n = 654) were examined prior to deployment to Iraq (April-December 2003) and shortly after return (within a mean of 73 days [median, 75 days]; January-May 2005) from Iraq deployment. A comparison group of soldiers (n = 307) similar in military characteristics but not deploying overseas during the study was assessed in sessions timed to be as close as possible to the assessment of deployers. Military unit sampling procedures facilitated representation of combat, combat support, and combat service support functions among both deployers and nondeployers., Main Outcome Measures: Individually administered, performance-based neuropsychological tasks. Estimates (beta; the unstandardized parameter estimate) for the absolute differences in adjusted mean outcome scores between deployed and nondeployed groups were determined using generalized estimating equations., Results: Multiple linear regression analyses adjusted for battalion membership revealed that Iraq deployment, compared with nondeployment, was associated with neuropsychological compromise on tasks of sustained attention (beta = 0.11; P<.001), verbal learning (beta = -1.51; P = .003), and visual-spatial memory (beta = -3.82; P<.001). Iraq deployment was also associated with increased negative state affect on measures of confusion (beta = 1.40; P<.001) and tension (beta = 1.24; P<.001). In contrast, deployment was associated with improved simple reaction time (beta = 4.30; P = .003). Deployment effects remained statistically significant after taking into account deployment-related head injury and stress and depression symptoms., Conclusions: Deployment to Iraq is associated with increased risk of neuropsychological compromise. Findings point to the need to investigate further the impact of deployment on neural functioning. Public health implications include consideration of neuropsychological compromise in health prevention and postdeployment clinical and occupational management.