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Biomedical subjects

David Lansky

Publications and source records attributed to David Lansky.

12 recordsLinked to original sources
PubMed2005

Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.

The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants.

Calibration↗
PubMed2005

Prospective evaluation of total hip arthroplasty with a cementless, anatomically designed, porous-coated femoral implant: mean 11-year follow-up.

The performance of an anatomically designed femoral implant with porous titanium mesh coating was assessed in patients undergoing total hip arthroplasty. The stem, with built-in 12 degrees anteversion, was implanted in neutral position relative to the long axis of the femur through a cementless press-fit application. The only requirement was the presence of sufficient thickness within the cortical bone of the femoral metaphysis to support the stem. Ninety-one evaluable patients were followed up for a minimum of 10 years. Patients tolerated weight-bearing activity within 24 hours after surgery. Only 1 femoral component required revision because of loosening. Most patients showed uniform bony ingrowth. Quality of life was markedly improved. The anatomically designed, porous-coated implant provides robust performance which has general utility in a wide range of patients.

Aged↗
PubMed2005

How accurate is information that patients contribute to their Electronic Health Record?

Increased patient interaction with medical records and the advent of personal health records (PHRs) may increase patients' ability to contribute valid information to their Electronic Medical Record (EHR) medical record. Patient input through a secure connection, whether it be a patient portal or PHR, will integrate many aspects of a patient's health and may help lessen the information gap between patients and providers. Patient reported data should be considered a viable method of enhancing documentation but will not likely be as complete and accurate as more comprehensive data-exchange between providers.

Ambulatory Care↗
PubMed2004

Online consumer surveys as a methodology for assessing the quality of the United States health care system.

BACKGROUND: Interest in monitoring the quality of health care in the United States has increased in recent years. However, the policy objectives associated with collecting this information are constrained by the limited availability of timely and relevant data at a reasonable cost. Online data-collection technologies hold the promise of gathering data directly and inexpensively from large, representative samples of patients and consumers. These new information technologies also permit efficient, real-time assessment in such areas as health status, access to care, and other aspects of the care experience that impact health outcomes. OBJECTIVE: This study investigates the feasibility, validity, and generalizability of consumer online surveys to measure key aspects of health care quality in the United States. METHODS: Surveys about the health and health care experiences of a general adult population and of adults with diabetes were administered online and by telephone. The online survey drew from a sample frame of nearly 1 million consumers and used a single e-mail notification. The random-digit-dial methodology included 6 follow-up calls. Results from the online sample were compared to the telephone sample and to national benchmark data. RESULTS: Survey responses about quality of care collected using online and telephone methods were commensurate once they were weighted to represent the demographic distribution of the 2000 United States Census. Expected variations in health and health care quality across demographic and socioeconomic groups were largely observed, as were hypothesized associations among quality indicators and other variables. Fewer individuals were required to be contacted to achieve target sample sizes using online versus telephone methods. Neither method yielded representative cohorts of nonwhite individuals. CONCLUSIONS: Conclusions about the level and variations in health care quality in the United States are similar using data collected in this study compared to data collected using other telephone-based survey methods. As is typical for national telephone surveys conducted by the National Center for Health Statistics, stratified sampling and weighting of survey responses is necessary for results to be generalizable. Online methods are more appropriate for understanding health care quality than for conducting epidemiologic assessments of health in the United States.

Adolescent↗
PubMed2002

Understanding the continuum of palliative care for patients and their caregivers.

We describe a process for assisting seriously ill patients and their caregivers in prioritizing their preferences for care during advanced illness. Thirty-two seriously ill patients and their caregivers participated in seven 90-minute focus groups conducted cross-sectionally in Denver, Colorado; San Francisco, California; and Washington State. Fourteen expert-defined end-of-life quality indicators were presented to each group, and quantitative unweighted rankings were obtained through patient and caregiver preferences. Aggregated weightings were used to rank the top five quality measures for exploration of open-ended questions. Pain management was the most important quality indicator among all three groups. Overlap in preferences were found for at least two of the groups for symptom management, monitoring medical issues, advance care preferences and assessment of family and caregiver involvement. Caregivers were more focused on bereavement support. Variation in preferences for end-of-life care by patients and their caregivers reflects the need to understand the individual decision-making regarding end-of-life care. Quality improvement activities are beginning to address these needs.

Adult↗
PubMed1984

Pain measurement and pain behavior.

This study examined relationships between chronic pain patients' ratings of pain severity, and other patient ratings about severity of associated impairment, and a series of behavioral measures of health care utilization and activity patterns. Prior to being evaluated, a sample of 150 chronic pain patients completed diary forms on which they recorded severity of pain on a 0-10 scale. Subjects were divided into high-medium-low on mean pain ratings, and were compared on the other measures obtained either from diary forms or at time of evaluation. Patient generated statements about severity of pain and extent of functional impairment from pain interrelated positively. However, these measures showed few relationships to medication consumption, health care utilization, diary recorded activity level, or to patient reported frequency counts of engaging in a set of commonplace activities. The results were interpreted to suggest that, in chronic pain, there may be a questionable relationship between what people say about their pain and what they do. Accordingly, the evaluation of chronic pain should include analyses of patient behavior.

Activities of Daily Living↗
PubMedDate not supplied

Quality Care for People with HIV/AIDS: patients' perspectives.

PURPOSE: To explore patient preferences to aid in the development of quality measures to assess quality of health care for people living with human immunodeficiency virus/acquired immunodeficiency disease (HIV/AIDS). METHOD: This study involved three 2-hour focus groups with 29 people living with HIV/AIDS in Portland, Oregon, and San Francisco, California. Eighteen quality of care indicators for HIV/AIDS health care were presented to each group and quantitative rankings were obtained. Aggregated weightings were used to rank and prioritize the quality measures for further exploration. RESULTS: Participants identified 38 themes relevant to high-quality care for HIV/AIDS. Patients ranked the following candidate measures most important: effective relationship with provider, prevention of opportunistic infections, involvement in care and treatment decisions, being offered antiretroviral treatment, and access to health care services. We observed attitudinal differences among focus group participants that corresponded to gender and race/ethnicity. CONCLUSION: Participants favored quality information that rated the experience of care and outcome measures including indicators of access to services, standard treatments, and competence of the providers. Patient perspectives can inform the development of quality measures that are meaningful to consumers and can assist in the design of services that meet patients' demographic and socioeconomic needs.

Adult↗
PubMedDate not supplied

Improving quality through public disclosure of performance information.

Despite a growing consensus that serious quality problems afflict U.S. health care, state and federal governments have done little to improve the quality of care. Proposed health insurance reforms, including a Medicare prescription drug benefit and the use of tax credits for insurance expansion, could create a mechanism for stimulating and then monitoring improvements in quality. We propose legislative requirements that any new expenditure of federal funds for health benefits be accompanied by public disclosure of performance information regarding quality, effectiveness, and safety. Such disclosure could yield diverse public and institutional benefits.

Attitude to Health↗
PubMedDate not supplied

Consumers and quality-driven health care: a call to action.

A key strategy for driving improvements in health care quality is providing comparative quality information to consumers. This strategy will not work, and could even be counterproductive, unless (1) consumers are convinced that quality problems are real and consequential and that quality can be improved; (2) purchasers and policymakers make sure that quality reporting is standardized and universal; (3) consumers are given quality information that is relevant and easy to understand and use; (4) the dissemination of quality information is improved; and (5) purchasers reward quality improvements and providers create the information and organizational infrastructure to achieve them.

Benchmarking↗
PubMedDate not supplied

The missing link: bridging the patient-provider health information gap.

Widespread adoption of information technology is now regarded as a pathway to improving health care and achieving the Institute of Medicine's highly regarded six aims for redesigning care. Achieving these aims requires fresh approaches to health system design, including continuous healing relationships between physicians and patients and provision of tools to help patients be more active participants in their own care. Personal health records (PHRs) might allow patients and providers to develop new ways of collaborating and provide the basis for broader transformation of the health care system. Federal policies can be key catalysts in accelerating PHR development and adoption.

Diffusion of Innovation↗
PubMedDate not supplied

Assessing parallelism prior to determining relative potency.

In the course of preparing a revision to Chapter (111) of the U.S. Pharmacopeia, the revision committee came to a unanimous agreement that the method for assessing parallelism that is currently presented in (111) and in the European Pharmacopeia's Chapter 5.3 is flawed and should be replaced. The symptoms are that perfectly acceptable assay results may fail due to good precision and that obviously faulty assay results may pass due to poor precision. The flaw is that the wrong statistical technique has been used. We propose an alternative approach based on the equivalence testing paradigm that does not have these shortcomings. Equivalence testing requires the establishment of equivalence limits. Specific approaches for establishing equivalence limits are discussed.

Data Interpretation, Statistical↗