Biomedical subjects

Nancy Roberts

Publications and source records attributed to Nancy Roberts.

18 recordsLinked to original sources

PubMed2006

Disease management interventions II: What else is in the black box?

The success of any disease management (DM) program ultimately depends upon the ability and willingness of participants to change and maintain desired health behaviors. To achieve those results, DM program administrators have several issues to consider, including the type of behavioral change desired, the scope of intervention that the organization is willing and capable of implementing, and whether the appropriate support structures are available to ensure successful achievement of program goals. An understanding of these issues will assist program designers in selecting the appropriate change models. This paper serves as an extension of our prior paper in which eight core psychosocial behavioral change models were described. Here, five more recently developed theory-based approaches are introduced, providing readers with up-to-date information in this area.

Community Networks↗

PubMed2006

Evaluating disease management programme effectiveness: an introduction to the regression discontinuity design.

Although disease management (DM) has been in existence for over a decade, there is still much uncertainty as to its effectiveness in improving health status and reducing medical cost. The main reason is that most programme evaluations typically follow weak observational study designs that are subject to bias, most notably selection bias and regression to the mean. The regression discontinuity (RD) design may be the best alternative to randomized studies for evaluating DM programme effectiveness. The most crucial element of the RD design is its use of a 'cut-off' score on a pre-test measure to determine assignment to intervention or control. A valuable feature of this technique is that the pre-test measure does not have to be the same as the outcome measure, thus maximizing the programme's ability to use research-based practice guidelines, survey instruments and other tools to identify those individuals in greatest need of the programme intervention. Similarly, the cut-off score can be based on clinical understanding of the disease process, empirically derived, or resource-based. In the RD design, programme effectiveness is determined by a change in the pre-post relationship at the cut-off point. While the RD design is uniquely suitable for DM programme evaluation, its success will depend, in large part, on fundamental changes being made in the way DM programmes identify and assign individuals to the programme intervention.

Disease Management↗

PubMed2006

Strengthening the case for disease management effectiveness: un-hiding the hidden bias.

As is the case with most health care program evaluations, disease management (DM) programs typically follow an observational study design, indicating that randomization to treatment or control was not performed. The foremost limitation of observational studies, compared to randomized studies, is that the only biases that can be controlled for are those associated with observed variables. Hidden bias refers to all those unobserved covariates that may distort the conclusions of the study. This paper introduces a sensitivity analysis that is used to determine the magnitude of hidden bias necessary to alter the conclusion that a DM program intervention was indeed effective.

Bias↗

PubMed2006

The Philadelphia Episiotomy Intervention Study.

OBJECTIVE: To lower the episiotomy rate through physician education and documentation of indication when episiotomy was performed. STUDY DESIGN: The intervention consisted of an evidence-based lecture recommending limited usage of episiotomy and requesting documentation of any episiotomy's indication. Data 3 months prior to the intervention were compared to those of the year following. Adjusted comparisons of episiotomy rates were completed using multivariate logistic regression models. RESULTS: For all vaginal deliveries, there was a 17% decrease in the rate of episiotomy, from 46.9% to 38.8%. For spontaneous vaginal deliveries, there was a 25% decrease in the episiotomy rate, from 40.8% to 30.8%. The most common indications for episiotomy reported were routine/elective, 41.0%; vacuum, 18.6%; forceps, 16.4%; and nonreassuring fetal heart tracing, 10.9%. CONCLUSION: Episiotomy rates may be effectively reduced through physician education and documentation of procedure indication.

Adult↗

PubMed2005

Genetic predispositions for thromboembolism as a possible etiology for gastroschisis.

OBJECTIVE: Occlusion of the omphalomesenteric artery in utero, leading to disruption of the umbilical ring with subsequent herniation of intestines, has been proposed as the mechanism by which gastroschisis occurs. We hypothesized that affected fetuses have a predisposition to arterial or venous thromboembolism. STUDY DESIGN: Thirty-one children born with gastroschisis were tested for Factor V Leiden, prothrombin, and methylene tetrahydrofolate reductase (MTHFR) mutations. Fifty-two appropriately grown term neonates whose mothers were matched by maternal age and race served as control neonates. RESULTS: Of children with gastroschisis, 6.45% were heterozygous for Factor V Leiden. No infants with gastroschisis had prothrombin gene mutations. Thirty-six percent of affected infants were heterozygous, and 16% were homozygosity for MTHFR. Among control infants, 42% were heterozygous, and 14% were homozygous for MTHFR. CONCLUSION: The mutation rate for MTHFR did not differ in children with and without gastroschisis when mothers were matched by race and age.

Case-Control Studies↗

PubMed2005

Prevalence of diarrheagenic Escherichia coli in acute childhood enteritis: a prospective controlled study.

OBJECTIVE: Since diarrheagenic E. coli are not identified by common clinical laboratory techniques, we hypothesized that these organisms might be an unrecognized cause of enteritis in children in the U.S. STUDY DESIGN: 1327 children with acute gastroenteritis were identified prospectively by active surveillance in the Emergency Department (ED) and the inpatient units at Cincinnati Children's Hospital Medical Center. Stool samples were evaluated for diarrheagenic E. coli using a panel of DNA probes and adherence pattern to HEp-2 cells. Stool samples from a reference group of 555 well children were studied for comparison. RESULTS: Gene probe studies, but not HEp-2 cell adherence, demonstrated that enteroaggregative, diffusely adherent and enteropathogenic E. coli were associated with clinical illness. Each was isolated significantly more often from study subjects in the ED than controls. In children <1 year of age, enteroaggregative E. coli were isolated significantly more often from both inpatients (4.7%, Odds Ratio = 3.4, 95% confidence intervals 1.3-9.1, p <0.03) and ED patients (10.0%, Odds Ratio = 7.2, 95% confidence intervals 2.9-18.2, p <0.001) than from well children (1.4%). CONCLUSIONS: Diarrheagenic E. coli , especially enteroaggregative E. coli , may be an important, unrecognized cause of childhood diarrhea in the U.S.

Adolescent↗

PubMed2005

Using visual displays as a tool to demonstrate disease management program effectiveness.

With the rapid introduction of new medical and information technologies, there are much more data available today than ever before. Translating data into useful information for a wide variety of audiences is a challenge for health care in general and disease management programs in particular. This paper addresses these issues by introducing several visual displays that illustrate important data elements in an unencumbered fashion. Examples are provided using the various stages of a hypothetical congestive heart failure (CHF) disease management program (ie, patient identification, program enrollment, intervention process, and outcomes evaluation).

Coronary Disease↗

PubMed2005

Drug-therapy problems, inconsistencies and omissions identified during a medication reconciliation and seamless care service.

Seamless care is the desirable continuity of care delivered to a patient in the healthcare system across the spectrum of caregivers and their environments. Medication Reconciliation is one component of seamless pharmaceutical care. A randomized controlled trial, carried out over nine months with a six-month follow-up period, investigated the impact of a pharmacist-directed seamless care service. Intervention patients admitted to one of two general medicine units were subjected to a comprehensive seamless care discharge process as they were discharged from a regional, academically affiliated hospital in Moncton, NB. The number, type and potential clinical impact of drug-therapy problems for seamless monitoring (DTPsm) and drug-therapy inconsistencies and omissions (DTIOs) in hospital discharge medications were measured. A total of 253 patients, with 134 patients in the intervention group and 119 in the control group, completed the study. An average of 3.59 DTPsm per intervention patient, with 72.1% of these being scored as having a significant or very significant clinical impact level, were communicated to community pharmacists. Ninety-nine DTIOs were identified and resolved in intervention patients before discharge. A retrospective medical chart review demonstrated that the intervention resolved almost all DTIOs. In conclusion, a pharmacist-directed seamless care service had a significant impact on drug-related clinical outcomes and processes of care.

Aged↗

PubMed2005

Use of active surveillance to validate international classification of diseases code estimates of rotavirus hospitalizations in children.

OBJECTIVE: National estimates of hospitalizations for rotavirus, the leading cause of acute gastroenteritis (AGE) in children, have been used to establish the need for rotavirus vaccines. A previous method directly estimated discharges by using the rotavirus-specific International Classification of Diseases (ICD) code, but this method has not been validated. Our study evaluated the sensitivity of the rotavirus ICD code among children hospitalized for AGE by using active surveillance for rotavirus at a tertiary children's hospital. DESIGN: We compared data for rotavirus-coded hospital discharges in 2000-2001 at Cincinnati Children's Hospital Medical Center with data on laboratory-confirmed cases of rotavirus obtained from active surveillance. We estimated additional rotavirus hospitalizations by extrapolating the proportion of rotavirus-positive results from active-surveillance cases to those with an unknown rotavirus status. RESULTS: Of 767 cases of AGE-related discharge codes, 103 (13%) were coded as rotavirus, 91% (94 of 103) of which were laboratory-confirmed diagnoses. Among all children discharged with an AGE-related illness, 260 (34%) were enrolled in active surveillance, of whom 155 (60%) tested positive for rotavirus. An additional 47 laboratory-confirmed rotavirus-case patients not enrolled in active surveillance yielded a total of 202 rotavirus cases and a maximum sensitivity of the rotavirus code of 47%. Extrapolation indicated that an additional 170 untested children might be rotavirus-positive, yielding a total of 372 rotavirus hospitalizations and a minimum sensitivity of the rotavirus code of 25%. CONCLUSIONS: Measurement of rotavirus-coded hospital discharges alone seems to greatly underestimate the true burden of rotavirus-associated hospitalizations. The numbers of national rotavirus hospitalization discharges may be substantially greater than previously estimated.

Acute Disease↗

PubMed2005

A user's guide to the disease management literature: recommendations for reporting and assessing program outcomes.

Recently there has been tremendous growth in the number of lay-press articles and peer-reviewed journal articles reporting extraordinary improvements in health status and financial outcomes due to disease management (DM) interventions. However, closer scrutiny of these reports reveals serious flaws in research design and/or analysis, leaving many to question the veracity of the claims. In recent years, there have been numerous contributions to the literature on how to assess the quality of medical research papers. However, these guidelines focus primarily on randomized controlled trials, with little attention given to the observational study designs typically used in DM outcome studies. As such, general guides to evaluating the medical literature are inadequate in their utility to assist authors and readers of DM outcomes research. The purpose of this paper is to provide authors with a clear and comprehensive guide to the reporting of DM outcomes, as well as to educate readers of the DM literature (both lay and peer reviewed) in how to assess the quality of the findings presented.

Disease Management↗

PubMed2004

Using an empirical method for establishing clinical outcome targets in disease management programs.

The disease management (DM) industry is being scrutinized now more than ever before, with programs being asked to demonstrate improvement in clinical quality in addition to the expected reduction in medical costs. In healthcare, clinical improvement targets are often set at levels considered to be clinically meaningful. This difference may or may not be statistically significant. The term "effect size" refers to the smallest difference that could be detected statistically. This paper proposes a simple empirical method for determining the minimum expected improvement level for DM clinical outcome measures in which two proportions are being compared. This method is useful in situations where the outcome measure does not lend itself to be determined by the subjective judgment of medical expertise. Graphical displays are provided for the reader to use to help determine appropriate effect sizes for studies in lieu of, or in addition to, the statistical calculations.

Cost Control↗

PubMed2004

Evaluating disease management program effectiveness: an introduction to survival analysis.

Currently, the most widely used method in the disease management industry for evaluating program effectiveness is the "total population approach." This model is a pretest-posttest design, with the most basic limitation being that without a control group, there may be sources of bias and/or competing extraneous confounding factors that offer plausible rationale explaining the change from baseline. Survival analysis allows for the inclusion of data from censored cases, those subjects who either "survived" the program without experiencing the event (e.g., achievement of target clinical levels, hospitalization) or left the program prematurely, due to disenrollement from the health plan or program, or were lost to follow-up. Additionally, independent variables may be included in the model to help explain the variability in the outcome measure. In order to maximize the potential of this statistical method, validity of the model and research design must be assured. This paper reviews survival analysis as an alternative, and more appropriate, approach to evaluating DM program effectiveness than the current total population approach.

Disease Management↗

PubMed2004

Disease management interventions: what's in the black box?

In discussing evaluation techniques to assess disease management (DM) program outcomes, it is often assumed that DM program interventions are premised on sound clinical judgment, an understanding of the disease process, and knowledge of the psychosocial models of behavioral change that must be used to effect those processes and ultimately improve the health outcomes that are being evaluated. This paper describes eight commonly used behavioral change models applied in the healthcare industry today. They represent programs designed to address individual, interpersonal, and community level factors as well as "packaged" comprehensive approaches. These models illustrate the breadth of approaches to consider when designing or assessing DM program interventions. Careful consideration of the type of behavioral change desired and the theories of how to effect such change should be an integral part of designing disease management program interventions.

Attitude to Health↗

PubMed2004

Generalizing disease management program results: how to get from here to there.

For a disease management (DM) program, the ability to generalize results from the intervention group to the population, to other populations, or to other diseases is as important as demonstrating internal validity. This article provides an overview of the threats to external validity of DM programs, and offers methods to improve the capability for generalizing results obtained through the program. The external validity of DM programs must be evaluated even before program selection and implementation are begun with a prospective new client. Any fundamental differences in characteristics between individuals in an established DM program and in a new population/environment may limit the ability to generalize.

Disease Management↗

PubMed2003

The complete "how to" guide for selecting a disease management vendor.

Decision-makers in health plans, large medical groups, and self-insured employers face many challenges in selecting and implementing disease management programs. One strategy is the "buy" approach, utilizing one or more of the many vendors to provide disease management services for the purchasing organization. As a relatively new field, the disease management vendor landscape is continually changing, uncovering the many uncertainties about demonstrating outcomes, corporate stability, or successful business models. Given the large investment an organization may make in each disease management program (many cost 1 million dollars or more in annual fees for a moderately sized population), careful consideration must be given in selecting a disease management partner. This paper describes, in detail, the specific steps necessary and the issues to consider in achieving a successful contract with a vendor for full-service disease management.

Contract Services↗

PubMed2003

An assessment of the total population approach for evaluating disease management program effectiveness.

A key challenge currently facing the disease management industry is accurately demonstrating program effectiveness at controlling utilization of services and medical costs of populations with chronic disease. The most common method used in the disease management industry to date for determining financial outcomes is referred to as the "total population approach." This model is a pretest-posttest design, which is a relatively weak research and evaluation technique. This paper describes the "total population approach," details many of the biases and confounding factors that may influence outcomes using this method, and illustrates the potential consequences of these factors.

Bias↗

PubMed2003

Evaluating disease management program effectiveness: an introduction to time-series analysis.

Currently, the most widely used method in the disease management (DM) industry for evaluating program effectiveness is referred to as the "total population approach." This model is a pretest-posttest design, with the most basic limitation being that without a control group, there may be sources of bias and/or competing extraneous confounding factors that offer a plausible rationale explaining the change from baseline. Furthermore, with the current inclination of DM programs to use financial indicators rather than program-specific utilization indicators as the principal measure of program success, additional biases are introduced that may cloud evaluation results. This paper presents a non-technical introduction to time-series analysis (using disease-specific utilization measures) as an alternative, and more appropriate, approach to evaluating DM program effectiveness than the current total population approach.

Disease Management↗

PubMed2002

Clinical presentations of rotavirus infection among hospitalized children.

BACKGROUND: Although rotaviruses (RVs) are the most common cause of severe gastroenteritis in children, there is a lack of information detailing the spectrum of clinical manifestations of RV disease resulting in hospitalization. OBJECTIVE: To characterize the clinical spectrum of RV-associated hospitalizations, including short stay visits in children. METHODS: Active RV disease surveillance was conducted at three children's hospitals Sundays through Thursdays in children 15 days through 4 years of age admitted with diarrhea (D), vomiting (V) and/or unexplained fever (F) between November, 1997, and June, 1998. Stool specimens were collected and tested for RV by enzyme immunoassay. RESULTS: Of the 862 children enrolled, 763 (88%) had a stool specimen tested for RV. Overall 31% of children excreted RV. RV excretion was highest when all 3 symptoms (D, V and F) occurred in the same child (56%), lower when 2 symptoms occurred together (38% DV; 19% DF; 13% VF) and lowest when each symptom occurred alone (3% D; 11% V; 6% F). Nine percent of the children without diarrhea excreted RV. Children admitted without diarrhea were more likely to have rotavirus if they developed diarrhea during their hospitalization. CONCLUSIONS: RV detection was greatest when diarrhea, vomiting and fever occurred together and lowest when each symptom occurred alone. The spectrum of symptoms of rotavirus disease in children at the time of admission to the hospital or short stay unit may be broader than previously recognized.

California↗