SPH Health Law, Policy & Management Papers

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The Challenges of Multimorbidity from the Patient Perspective
(Springer-Verlag, 2007-11-16) Noël, Polly Hitchcock; Parchman, Michael L.; Williams, John W.; Cornell, John E.; Shuko, Lee; Zeber, John E.; Kazis, Lewis E.; Lee, Austin F. S.; Pugh, Jacqueline A.
BACKGROUND Although multiple co-occurring chronic illnesses within the same individual are increasingly common, few studies have examined the challenges of multimorbidity from the patient perspective. OBJECTIVE The aim of this study is to examine the self-management learning needs and willingness to see non-physician providers of patients with multimorbidity compared to patients with single chronic illnesses. DESIGN. This research is designed as a cross-sectional survey. PARTICIPANTS Based upon ICD-9 codes, patients from a single VHA healthcare system were stratified into multimorbidity clusters or groups with a single chronic illness from the corresponding cluster. Nonproportional sampling was used to randomly select 720 patients. MEASUREMENTS Demographic characteristics, functional status, number of contacts with healthcare providers, components of primary care, self-management learning needs, and willingness to see nonphysician providers. RESULTS Four hundred twenty-two patients returned surveys. A higher percentage of multimorbidity patients compared to single morbidity patients were "definitely" willing to learn all 22 self-management skills, of these only 2 were not significant. Compared to patients with single morbidity, a significantly higher percentage of patients with multimorbidity also reported that they were "definitely" willing to see 6 of 11 non-physician healthcare providers. CONCLUSIONS Self-management learning needs of multimorbidity patients are extensive, and their preferences are consistent with team-based primary care. Alternative methods of providing support and chronic illness care may be needed to meet the needs of these complex patients.
Institutionalizing Evidence-Based Practice: An Organizational Case Study Using a Model of Strategic Change
(BioMed Central, 2009-11-30) Stetler, Cheryl B.; Ritchie, Judith A.; Rycroft-Malone, Jo; Schultz, Alyce A.; Charns, Martin P.
BACKGROUND. There is a general expectation within healthcare that organizations should use evidence-based practice (EBP) as an approach to improving the quality of care. However, challenges exist regarding how to make EBP a reality, particularly at an organizational level and as a routine, sustained aspect of professional practice. METHODS. A mixed method explanatory case study was conducted to study context; i.e., in terms of the presence or absence of multiple, inter-related contextual elements and associated strategic approaches required for integrated, routine use of EBP ('institutionalization'). The Pettigrew et al. Content, Context, and Process model was used as the theoretical framework. Two sites in the US were purposively sampled to provide contrasting cases: i.e., a 'role model' site, widely recognized as demonstrating capacity to successfully implement and sustain EBP to a greater degree than others; and a 'beginner' site, self-perceived as early in the journey towards institutionalization. RESULTS. The two sites were clearly different in terms of their organizational context, level of EBP activity, and degree of institutionalization. For example, the role model site had a pervasive, integrated presence of EBP versus a sporadic, isolated presence in the beginner site. Within the inner context of the role model site, there was also a combination of the Pettigrew and colleagues' receptive elements that, together, appeared to enhance its ability to effectively implement EBP-related change at multiple levels. In contrast, the beginner site, which had been involved for a few years in EBP-related efforts, had primarily non-receptive conditions in several contextual elements and a fairly low overall level of EBP receptivity. The beginner site thus appeared, at the time of data collection, to lack an integrated context to either support or facilitate the institutionalization of EBP. CONCLUSION. Our findings provide evidence of some of the key contextual elements that may require attention if institutionalization of EBP is to be realized. They also suggest the need for an integrated set of receptive contextual elements to achieve EBP institutionalization; and they further support the importance of specific interactions among these elements, including ways in which leadership affects other contextual elements positively or negatively.
Can We Transplant Conceptual Frameworks of Healthcare Quality Evaluation from Developed Countries into Developing Countries?
(Medknow Publications, 2009-04) Ramani, Sudha
Measurement of treatment adherence with antipsychotic agents in patients with schizophrenia
(Dove Medical Press, 2009-10-12) Ren, Xinhua S.; Herz, Lawrence; Qian, Shirley; Smith, Eric; Kazis, Lewis E.
The importance of medication adherence in sustaining control of schizophrenic symptoms has generated a great deal of interest in comparing levels of treatment adherence with different antipsychotic agents. However, the bulk of the research has yielded results that are often inconsistent. In this prospective, observational study, we assessed the measurement properties of 3 commonly used, pharmacy-based measures of treatment adherence with antipsychotic agents in schizophrenia using data from the Veterans Health Administration during 2000 to 2005. Patients were selected if they were on antipsychotics and diagnosed with schizophrenia (N = 18,425). A gap of ≥30 days (with no filled index medication) was used to define discontinuation of treatment as well as medication "episodes," or the number of times a patient returned to the same index agent after discontinuation of treatment within a 1-year period. The study found that the 3 existing measures differed in their approaches in measuring treatment adherence, suggesting that studies using these different measures would generate different levels of treatment adherence across antipsychotic agents. Considering the measurement problems associated with each existing approach, we offered a new, medication episode-specific approach, which would provide a fairer comparison of the levels of treatment adherence across different antipsychotic agents.
A Critical Synthesis of Literature on the Promoting Action on Research Implementation in Health Services (PARIHS) Framework
(BioMed Central, 2010-10-25) Helfrich, Christian D.; Damschroder, Laura J.; Hagedorn, Hildi J.; Daggett, Ginger S.; Sahay, Anju; Ritchie, Mona; Damush, Teresa; Guihan, Marylou; Ullrich, Philip M.; Stetler, Cheryl B.
BACKGROUND. The Promoting Action on Research Implementation in Health Services framework, or PARIHS, is a conceptual framework that posits key, interacting elements that influence successful implementation of evidence-based practices. It has been widely cited and used as the basis for empirical work; however, there has not yet been a literature review to examine how the framework has been used in implementation projects and research. The purpose of the present article was to critically review and synthesize the literature on PARIHS to understand how it has been used and operationalized, and to highlight its strengths and limitations. METHODS. We conducted a qualitative, critical synthesis of peer-reviewed PARIHS literature published through March 2009. We synthesized findings through a three-step process using semi-structured data abstraction tools and group consensus. RESULTS. Twenty-four articles met our inclusion criteria: six core concept articles from original PARIHS authors, and eighteen empirical articles ranging from case reports to quantitative studies. Empirical articles generally used PARIHS as an organizing framework for analyses. No studies used PARIHS prospectively to design implementation strategies, and there was generally a lack of detail about how variables were measured or mapped, or how conclusions were derived. Several studies used findings to comment on the framework in ways that could help refine or validate it. The primary issue identified with the framework was a need for greater conceptual clarity regarding the definition of sub-elements and the nature of dynamic relationships. Strengths identified included its flexibility, intuitive appeal, explicit acknowledgement of the outcome of 'successful implementation,' and a more expansive view of what can and should constitute 'evidence.' CONCLUSIONS. While we found studies reporting empirical support for PARIHS, the single greatest need for this and other implementation models is rigorous, prospective use of the framework to guide implementation projects. There is also need to better explain derived findings and how interventions or measures are mapped to specific PARIHS elements; greater conceptual discrimination among sub-elements may be necessary first. In general, it may be time for the implementation science community to develop consensus guidelines for reporting the use and usefulness of theoretical frameworks within implementation studies.
Measuring Perceived Effects of Drinking an Extract of Basidiomycetes Agaricus Blazei Murill: A Survey of Japanese Consumers with Cancer
(BioMed Central, 2007-10-29) Talcott, James A.; Clark, Jack A.; Lee, Insu P.
BACKGROUND. To survey cancer patients who consume an extract of the Basidiomycetes Agaricus blazei Murill mushroom (Sen-Sei-Ro) to measure their self-assessment of its effects and to develop an instrument for use in future randomized trials. METHODS. We designed, translated and mailed a survey to 2,346 Japanese consumers of Sen-Sei-Ro self-designated as cancer patients. The survey assessed consumer demographics, cancer history, Sen-Sei-Ro consumption, and its perceived effects. We performed exploratory psychometric analyses to identify distinct, multi-item scales that could summarize perceptions of effects. RESULTS. We received completed questionnaires from 782 (33%) of the sampled Sen-Sei-Ro consumers with a cancer history. Respondents represented a broad range of cancer patients familiar with Sen-Sei-Ro. Nearly all had begun consumption after their cancer diagnosis. These consumers expressed consistently positive views, though not extremely so, with more benefit reported for more abstract benefits such as emotional and physical well-being than relief of specific symptoms. We identified two conceptually and empirically distinct and internally consistent summary scales measuring Sen-Sei-Ro consumers' perceptions of its effects, Relief of Symptoms and Functional Well-being (Cronbach's alpha: Relief of Symptoms, α = .74; Functional Well-Being, α = .91). CONCLUSION. Respondents to our survey of Sen-Sei-Ro consumers with cancer reported favorable perceived effects from its use. Our instrument, when further validated, may be a useful outcome in trials assessing this and other complementary and alternative medicine (CAM) substances in cancer patients.
Assessing an organizational culture instrument based on the competing values framework: exploratory and confirmatory factor analyses
(BioMed Central, 2007-4-25) Helfrich, Christian D.; Li, Yu-Fang; Mohr, David C.; Meterko, Mark; Sales, Anne E.
BACKGROUND. The Competing Values Framework (CVF) has been widely used in health services research to assess organizational culture as a predictor of quality improvement implementation, employee and patient satisfaction, and team functioning, among other outcomes. CVF instruments generally are presented as well-validated with reliable aggregated subscales. However, only one study in the health sector has been conducted for the express purpose of validation, and that study population was limited to hospital managers from a single geographic locale. METHODS. We used exploratory and confirmatory factor analyses to examine the underlying structure of data from a CVF instrument. We analyzed cross-sectional data from a work environment survey conducted in the Veterans Health Administration (VHA). The study population comprised all staff in non-supervisory positions. The survey included 14 items adapted from a popular CVF instrument, which measures organizational culture according to four subscales: hierarchical, entrepreneurial, team, and rational. RESULTS. Data from 71,776 non-supervisory employees (approximate response rate 51%) from 168 VHA facilities were used in this analysis. Internal consistency of the subscales was moderate to strong (α = 0.68 to 0.85). However, the entrepreneurial, team, and rational subscales had higher correlations across subscales than within, indicating poor divergent properties. Exploratory factor analysis revealed two factors, comprising the ten items from the entrepreneurial, team, and rational subscales loading on the first factor, and two items from the hierarchical subscale loading on the second factor, along with one item from the rational subscale that cross-loaded on both factors. Results from confirmatory factor analysis suggested that the two-subscale solution provides a more parsimonious fit to the data as compared to the original four-subscale model. CONCLUSION. This study suggests that there may be problems applying conventional CVF subscales to non-supervisors, and underscores the importance of assessing psychometric properties of instruments in each new context and population to which they are applied. It also further highlights the challenges management scholars face in assessing organizational culture in a reliable and comparable way. More research is needed to determine if the emergent two-subscale solution is a valid or meaningful alternative and whether these findings generalize beyond VHA.
Predicting Healthcare Employees' Participation in an Office Redesign Program: Attitudes, Norms and Behavioral Control
(BioMed Central, 2008-11-2) Mohr, David C; Lukas, Carol VanDeusen; Meterko, Mark
BACKGROUND. The study examined the extent to which components based on a modified version of the theory of planned behavior explained employee participation in a new clinical office program designed to reduce patient waiting times in primary care clinics. METHODS. We regressed extent of employee participation on attitudes about the program, group norms, and perceived behavioral control along with individual and clinic characteristics using a hierarchical linear mixed model. RESULTS. Perceived group norms were one of the best predictors of employee participation. Attitudes about the program were also significant, but to a lesser degree. Behavioral control, however, was not a significant predictor. Respondents with at least one year of clinic tenure, or who were team leaders, first line supervisor, or managers had greater participation rates. Analysis at the clinic level indicated clinics with scores in the highest quartile clinic scores on group norms, attitudes, and behavioral control scores were significantly higher on levels of overall participation than clinics in the lowest quartile. CONCLUSION. Findings suggest that establishing strong norms and values may influence employee participation in a change program in a group setting. Supervisory level was also significant with greater responsibility being associated with greater participation.
Use of angiotensin receptor blockers and risk of dementia in a predominantly male population: prospective cohort analysis
(BMJ Publishing Group Ltd., 2010-1-12) Li, Nien-Chen; Lee, Austin; Whitmer, Rachel A.; Kivipelto, Miia; Lawler, Elizabeth; Kazis, Lewis E.; Wolozin, Benjamin
Objective: To investigate whether angiotensin receptor blockers protect against Alzheimer's disease and dementia or reduce the progression of both diseases. Design Prospective cohort analysis. Setting Administrative database of the US Veteran Affairs, 2002-6. Population 819491 predominantly male participants (98%) aged 65 or more with cardiovascular disease. Main outcome measures Time to incident Alzheimer's disease or dementia in three cohorts (angiotensin receptor blockers, lisinopril, and other cardiovascular drugs, the "cardiovascular comparator") over a four year period (fiscal years 2003-6) using Cox proportional hazard models with adjustments for age, diabetes, stroke, and cardiovascular disease. Disease progression was the time to admission to a nursing home or death among participants with pre-existing Alzheimer's disease or dementia. Results Hazard rates for incident dementia in the angiotensin receptor blocker group were 0.76 (95% confidence interval 0.69 to 0.84) compared with the cardiovascular comparator and 0.81 (0.73 to 0.90) compared with the lisinopril group. Compared with the cardiovascular comparator, angiotensin receptor blockers in patients with pre-existing Alzheimer's disease were associated with a significantly lower risk of admission to a nursing home (0.51, 0.36 to 0.72) and death (0.83, 0.71 to 0.97). Angiotensin receptor blockers exhibited a dose-response as well as additive effects in combination with angiotensin converting enzyme inhibitors. This combination compared with angiotensin converting enzyme inhibitors alone was associated with a reduced risk of incident dementia (0.54, 0.51 to 0.57) and admission to a nursing home (0.33, 0.22 to 0.49). Minor differences were shown in mean systolic and diastolic blood pressures between the groups. Similar results were observed for Alzheimer's disease. Conclusions Angiotensin receptor blockers are associated with a significant reduction in the incidence and progression of Alzheimer's disease and dementia compared with angiotensin converting enzyme inhibitors or other cardiovascular drugs in a predominantly male population.
Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea
(Gunther Eysenbach, 2007-5-17) Stepnowsky, Carl J.; Palau, Joe J.; Marler, Matthew R.; Gifford, Allen L.
BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent and serious medical condition characterized by repeated complete or partial obstructions of the upper airway during sleep and is prevalent in 2% to 4% of working middle-aged adults. Nasal continuous positive airway pressure (CPAP) is the gold-standard treatment for OSA. Because compliance rates with CPAP therapy are disappointingly low, effective interventions are needed to improve CPAP compliance among patients diagnosed with OSA. OBJECTIVE: The aim was to determine whether wireless telemonitoring of CPAP compliance and efficacy data, compared to usual clinical care, results in higher CPAP compliance and improved OSA outcomes. METHODS. 45 patients newly diagnosed with OSA were randomized to either telemonitored clinical care or usual clinical care and were followed for their first 2 months of treatment with CPAP therapy. CPAP therapists were not blinded to the participants' treatment group. RESULTS: 20 participants in each group received the designated intervention. Patients randomized to telemonitored clinical care used CPAP an average of 4.1 ± 1.8 hours per night, while the usual clinical care patients averaged 2.8 ± 2.2 hours per night (P = .07). Telemonitored patients used CPAP on 78% ± 22% of the possible nights, while usual care patients used CPAP on 60% ± 32% of the nights (P = .07). No statistically significant differences between the groups were found on measures of CPAP efficacy, including measures of mask leak and the Apnea-Hypopnea Index. Patients in the telemonitored group rated their likelihood to continue using CPAP significantly higher than the patients in the usual care group. Patients in both groups were highly satisfied with the care they received and rated themselves as "not concerned" that their CPAP data were being wirelessly monitored. CONCLUSIONS: Telemonitoring of CPAP compliance and efficacy data and rapid use of those data by the clinical sleep team to guide the collaborative (ie, patient and provider) management of CPAP treatment is as effective as usual care in improving compliance rates and outcomes in new CPAP users. This study was designed as a pilot—larger, well-powered studies are necessary to fully evaluate the clinical and economic efficacy of telemonitoring for this population.
A web-based nutrition program reduces health care costs in employees with cardiac risk factors: before and after cost analysis
(Gunther Eysenbach, 2009-10-23) Sacks, Naomi; Cabral, Howard; Kazis, Lewis E.; Jarrett, Kelli M.; Vetter, Delia; Richmond, Russell; Moore, Thomas J.
BACKGROUND: Rising health insurance premiums represent a rapidly increasing burden on employer-sponsors of health insurance and their employees. Some employers have become proactive in managing health care costs by providing tools to encourage employees to directly manage their health and prevent disease. One example of such a tool is DASH for Health, an Internet-based nutrition and exercise behavior modification program. This program was offered as a free, opt-in benefit to US-based employees of the EMC Corporation. OBJECTIVE: The aim was to determine whether an employer-sponsored, Internet-based diet and exercise program has an effect on health care costs. METHODS. There were 15,237 total employees and spouses who were included in our analyses, of whom 1967 enrolled in the DASH for Health program (DASH participants). Using a retrospective, quasi-experimental design, study year health care costs among DASH participants and non-participants were compared, controlling for baseline year costs, risk, and demographic variables. The relationship between how often a subject visited the DASH website and health care costs also was examined. These relationships were examined among all study subjects and among a subgroup of 735 subjects with cardiovascular conditions (diabetes, hypertension, hyperlipidemia). Multiple linear regression analysis examined the relationship of program use to health care costs, comparing study year costs among DASH participants and non-participants and then examining the effects of increased website use on health care costs. Analyses were repeated among the cardiovascular condition subgroups. RESULTS: Overall, program use was not associated with changes in health care costs. However, among the cardiovascular risk study subjects, health care costs were US$827 lower, on average, during the study year (P = .05; t 729 = 1.95). Among 1028 program users, increased website use was significantly associated with lower health care costs among those who visited the website at least nine times during the study year (US$14 decrease per visit; P = .04; t 1022 = 2.05), with annual savings highest among 80 program users with targeted conditions (US$55 decrease per visit; P< .001; t 74 = 2.71). CONCLUSIONS: An employer-sponsored, Internet-based diet and exercise program shows promise as a low-cost benefit that contributes to lower health care costs among persons at higher risk for above-average health care costs and utilization.
The Epidemiology and Management of Severe Hypertension
(Nature Publishing Group, 2009-05-14) Borzecki, A. M.; Kader, B.; Berlowitz, D. R.
Hypertension guidelines stress that patients with severe hypertension (systolic blood pressure (BP)⩾180 or diastolic BP⩾110mmHg) require multiple drugs to achieve control and should have close follow-up to prevent adverse outcomes. However, little is known about the epidemiology or actual management of these patients. We retrospectively studied 59207 veterans with hypertension. Patients were categorized based on their highest average BP over an 18-month period (1 July 1999 to 31 December 2000) as controlled (<140/90mmHg), mild (140–159/90–99mmHg), moderate (160–179/100–109mmHg) and severe hypertension. We examined severe hypertension prevalence, pattern, duration, associated patient characteristics, time to subsequent visit, percentage of visits with a medication increase, and final BP control and antihypertensive medication adequacy. Twenty-three per cent had ⩾1 visit with severe hypertension, 42% of whom had at least two such visits; median day with severe hypertension was 80 (range 1–548). These subjects were significantly older, more likely black, and with more comorbidities than other hypertension subjects. Medication increases occurred at 20% of visits with mild hypertension compared to 40% with severe hypertension; P<0.05). At study end, 76% of patients with severe hypertension remained uncontrolled; severe hypertension subjects with uncontrolled BP were less likely to be on adequate therapy than those with controlled BP (43.7 vs 45.4%). Among hypertensive veterans, severe hypertension episodes are common. Many subjects had relatively prolonged elevations, with older, sicker subjects at highest risk. Although, follow-up times are shorter and antihypertensive medication use greater in severe hypertension subjects, they are still not being managed aggressively enough. Interventions to improve providers' management of these high-risk patients are needed.
Update in HIV Care
(Springer-Verlag, 2007-1-12) Berkenblit, Gail; Sullivan, Lynn; Sosman, James; Gifford, Allen; Cofrancesco, Joseph
Evaluation of the Sustainability of an Intervention to Increase HIV Testing
(Springer-Verlag, 2009-10-2) Goetz, Matthew Bidwell; Hoang, Tuyen; Henry, S. Randal; Knapp, Herschel; Anaya, Henry D.; Gifford, Allen L.; Asch, Steven M.
BACKGROUND Sustainability—the routinization and institutionalization of processes that improve the quality of healthcare—is difficult to achieve and not often studied. OBJECTIVE To evaluate the sustainability of increased rates of HIV testing after implementation of a multi-component intervention in two Veterans Health Administration healthcare systems. DESIGN Quasi-experimental implementation study in which the effect of transferring responsibility to conduct the provider education component of the intervention from research to operational staff was assessed. PATIENTS Persons receiving healthcare between 2005 and 2006 (intervention year) and 2006 and 2007 (sustainability year). MEASUREMENTS Monthly HIV testing rate, stratified by frequency of clinic visits RESULTS The monthly adjusted testing rate increased from 2% at baseline to 6% at the end intervention year and then declined reaching 4% at the end of the sustainability year. However, the stratified, visit-specific testing rate for persons newly exposed to the intervention (i.e., having their first through third visits during the study period) increased throughout the intervention and sustainability years. Increases in the proportion of visits by patients who remained untested despite multiple, prior exposures to the intervention accounted for the aggregate attenuation of testing during the sustainability year. Overall, the percentage of patients who received an HIV test in the sustainability year was 11.6%, in the intervention year 11.1%, and in the pre-intervention year 5.0% CONCLUSIONS Provider education combined with informatics and organizational support had a sustainable effect on HIV testing rates. The effect was most pronounced during patients' early contacts with the healthcare system.
A Surplus of Positive Trials: Weighing Biases and Reconsidering Equipoise
(BioMed Central, 2004-4-27) Felson, David T.; Glantz, Leonard
In this issue, Fries and Krishnan raise provocative new ideas to explain the surfeit of positive industry sponsored trials evaluating new drugs. They suggest that these trials were designed after so much preliminary work that they were bound to be positive (design bias) and that this violates clinical equipoise, which they characterize as an antiquated concept that should be replaced by a focus on subject autonomy in decision making and expected value for all treatments in a trial. We contend that publication bias, more than design bias, could account for the remarkably high prevalence of positive presented trials. Furthermore, even if all new drugs were efficacious, given the likelihood of type 2 errors, not all trials would be positive. We also suggest that clinical equipoise is a nuanced concept dependent on the existence of controversy about the relative value of two treatments being compared. If there were no controversy, then trials would be both unnecessary and unethical. The proposed idea of positive expected value is intriguing, but in the real world such clearly determinable values do not exist. Neither is it clear how investigators and sponsors, who are invested in the success of a proposed therapy, would (or whether they should) develop such a formula.
Can Health Care Databases Be Used to Identify Incident Cases of Osteonecrosis?
(BioMed Central, 2009-6-17) Vlad, Steven C.; Felson, David T.; Miller, Donald R.
INTRODUCTION. Osteonecrosis (ON) is a rare disease associated with alcohol and glucocorticoid use. Identifying additional risk factors is difficult as the number of cases at any single center is small. We investigated whether data available in large health care databases can be used to identify incident ON cases. METHODS. Using data from the Boston Veterans Affairs Healthcare system, we identified potential cases of ON. These records, including available radiographs and reports, were reviewed. Using published criteria, we evaluated whether the subjects had confirmed ON (radiographs/reports met criteria), incident ON (onset of symptoms within 6 months of first code), or prevalent ON (onset more than 6 months prior to first code or onset could not be determined). We tested different definitions for incident ON using information derived from administrative data. These were compared to the 'gold standard' (record review) and positive predictive values (PPVs) were derived. Since PPVs for incident cases were low, we found the number of incident cases expected for every 1,000 potential cases identified, using the definitions as an initial screening tool to reduce the number of medical records that required examination. RESULTS. We identified 87 potential cases. No case of jaw ON was identified. Only 15 (17%) incident cases of ON were identified. PPVs never exceed 50% for incident ON. However, if we used the definition '(at least 1 inpatient ON code) and (no prior codes for osteoarthritis)' as an initial screen, then for every 1,000 records, we would need to review only 150 to find 69 incident cases. CONCLUSIONS. Though the precise PPVs we found may not be generalizable to other databases, we believe that administrative data alone should not be used to identify incident cases of ON without confirming the diagnosis through a review of medical records. By applying the above definition, the number of records requiring review can be markedly reduced. This method can be used to find cases for valid case-control studies of risk factors for ON.
The Quality of Care for Adults with Epilepsy: An Initial Glimpse Using the QUIET Measure
(BioMed Central, 2011-1-3) Pugh, Mary Jo; Berlowitz, Dan R.; Rao, Jaya K.; Shapiro, Gabriel; Avetisyan, Ruzan; Hanchate, Amresh; Jarrett, Kelli; Tabares, Jeffrey; Kazis, Lewis E.
BACKGROUND: We examined the quality of adult epilepsy care using the Quality Indicators in Epilepsy Treatment (QUIET) measure, and variations in quality based on the source of epilepsy care. METHODS: We identified 311 individuals with epilepsy diagnosis between 2004 and 2007 in a tertiary medical center in New England. We abstracted medical charts to identify the extent to which participants received quality indicator (QI) concordant care for individual QI's and the proportion of recommended care processes completed for different aspects of epilepsy care over a two year period. Finally, we compared the proportion of recommended care processes completed for those receiving care only in primary care, neurology clinics, or care shared between primary care and neurology providers. RESULTS: The mean proportion of concordant care by indicator was 55.6 (standard deviation = 31.5). Of the 1985 possible care processes, 877 (44.2%) were performed; care specific to women had the lowest concordance (37% vs. 42% [first seizure evaluation], 44% [initial epilepsy treatment], 45% [chronic care]). Individuals receiving shared care had more aspects of QI concordant care performed than did those receiving neurology care for initial treatment (53% vs. 43%; X2 = 9.0; p = 0.01) and chronic epilepsy care (55% vs. 42%; X2 = 30.2; p <0.001). CONCLUSIONS: Similar to most other chronic diseases, less than half of recommended care processes were performed. Further investigation is needed to understand whether a shared-care model enhances quality of care, and if so, how it leads to improvements in quality.
Suicide-Related Behaviors in Older Patients with New Anti-Epileptic Drug Use: Data from the VA Hospital System
(BioMed Central, 2010-1-11) VanCott, Anne C.; Cramer, Joyce A.; Copeland, Laurel A.; Zeber, John E.; Steinman, Michael A.; Dersh, Jeffrey J.; Glickman, Mark E.; Mortensen, Eric M.; Amuan, Megan E.; Pugh, Mary Jo
BACKGROUND: The U.S. Food and Drug Administration (FDA) recently linked antiepileptic drug (AED) exposure to suicide-related behaviors based on meta-analysis of randomized clinical trials. We examined the relationship between suicide-related behaviors and different AEDs in older veterans receiving new AED monotherapy from the Veterans Health Administration (VA), controlling for potential confounders. METHODS: VA and Medicare databases were used to identify veterans 66 years and older, who received a) care from the VA between 1999 and 2004, and b) an incident AED (monotherapy) prescription. Previously validated ICD-9-CM codes were used to identify suicidal ideation or behavior (suicide-related behaviors cases), epilepsy, and other conditions previously associated with suicide-related behaviors. Each case was matched to controls based on prior history of suicide-related behaviors, year of AED prescription, and epilepsy status. RESULTS: The strongest predictor of suicide-related behaviors (N = 64; Controls N = 768) based on conditional logistic regression analysis was affective disorder (depression, anxiety, or post-traumatic stress disorder (PTSD); Odds Ratio 4.42, 95% CI 2.30 to 8.49) diagnosed before AED treatment. Increased suicide-related behaviors were not associated with individual AEDs, including the most commonly prescribed AED in the US - phenytoin. CONCLUSION: Our extensive diagnostic and treatment data demonstrated that the strongest predictor of suicide-related behaviors for older patients newly treated with AED monotherapy was a previous diagnosis of affective disorder. Additional, research using a larger sample is needed to clearly determine the risk of suicide-related behaviors among less commonly used AEDs.
Patient Recruitment to a Randomized Clinical Trial of Behavioral Therapy for Chronic Heart Failure
(BioMed Central, 2004-4-17) Chang, Bei-Hung; Hendricks, Ann M; Slawsky, Mara T; Locastro, Joseph S
BACKGROUND: Patient recruitment is one of the most difficult aspects of clinical trials, especially for research involving elderly subjects. In this paper, we describe our experience with patient recruitment for the behavioral intervention randomized trial, "The relaxation response intervention for chronic heart failure (RRCHF)." Particularly, we identify factors that, according to patient reports, motivated study participation. METHODS: The RRCHF was a three-armed, randomized controlled trial designed to evaluate the efficacy and cost of a 15-week relaxation response intervention on veterans with chronic heart failure. Patients from the Veterans Affairs (VA) Boston Healthcare System in the United States were recruited in the clinic and by telephone. Patients' reasons for rejecting the study participation were recorded during the screening. A qualitative sub-study in the trial consisted of telephone interviews of participating patients about their experiences in the study. The qualitative study included the first 57 patients who completed the intervention and/or the first follow-up outcome measures. Factors that distinguished patients who consented from those who refused study participation were identified using a t-test or a chi-square test. The reason for study participation was abstracted from the qualitative interview. RESULTS: We successfully consented 134 patients, slightly more than our target number, in 27 months. Ninety-five of the consented patients enrolled in the study. The enrollment rate among the patients approached was 18% through clinic and 6% through telephone recruitment. The most commonly cited reason for declining study participation given by patients recruited in the clinic was 'Lives Too Far Away'; for patients recruited by telephone it was 'Not Interested in the Study'. One factor that significantly distinguished patients who consented from patients who declined was the distance between their residence and the study site (t-test: p < .001). The most frequently reported reason for study participation was some benefit to the patient him/herself. Other reasons included helping others, being grateful to the VA, positive comments by trusted professionals, certain characteristics of the recruiter, and monetary compensation. CONCLUSIONS: The enrollment rate was low primarily because of travel considerations, but we were able to identify and highlight valuable information for planning recruitment for future similar studies.
Variation in antibiotic treatment for diabetic patients with serious foot infections: a retrospective observational study
(BioMed Central, 2010-7-6) Fincke, Benjamin G.; Miller, Donald R.; Christiansen, Cindy L.; Turpin, Robin S.
BACKGROUND: Diabetic foot infections are common, serious, and diverse. There is uncertainty about optimal antibiotic treatment, and probably substantial variation in practice. Our aim was to document whether this is the case: A finding that would raise questions about the comparative cost-effectiveness of different regimens and also open the possibility of examining costs and outcomes to determine which should be preferred. METHODS: We used the Veterans Health Administration (VA) Diabetes Epidemiology Cohorts (DEpiC) database to conduct a retrospective observational study of hospitalized patients with diabetic foot infections. DEpiC contains computerized VA and Medicare patient-level data for VA patients with diabetes since 1998, including demographics, ICD-9-CM diagnostic codes, antibiotics prescribed, and VA facility. We identified all patients with ICD-9-CM codes for cellulitis/abscess of the foot and then sub-grouped them according to whether they had cellulitis/abscess plus codes for gangrene, osteomyelitis, skin ulcer, or none of these. For each facility, we determined: 1) The proportion of patients treated with an antibiotic and the initial route of administration; 2) The first antibiotic regimen prescribed for each patient, defined as treatment with the same antibiotic, or combination of antibiotics, for at least 5 continuous days; and 3) The antibacterial spectrum of the first regimen. RESULTS: We identified 3,792 patients with cellulitis/abscess of the foot either alone (16.4%), or with ulcer (32.6%), osteomyelitis (19.0%) or gangrene (32.0%). Antibiotics were prescribed for 98.9%. At least 5 continuous days of treatment with an unchanged regimen of one or more antibiotics was prescribed for 59.3%. The means and (ranges) across facilities of the three most common regimens were: 16.4%, (22.8%); 15.7%, (36.1%); and 10.8%, (50.5%). The range of variation across facilities proved substantially greater than that across the different categories of foot infection. We found similar variation in the spectrum of the antibiotic regimen. CONCLUSIONS: The large variations in regimen appear to reflect differences in facility practice styles rather than case mix. It is unlikely that all regimens are equally cost-effective. Our methods make possible evaluation of many regimens across many facilities, and can be applied in further studies to determine which antibiotic regimens should be preferred.

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