Health Services Research Studies Research Articles

Shifting paradigms in health services research ethics consent, privacy, and the challenges for IRBs

Shifting paradigms in health services research ethics consent, privacy, and the challenges for IRBs

Variation in Institutional Review processes for a multisite observational study

Background The Veterans Administration is an ideal setting for multisite studies; however, individual VA Institutional Review Board (IRB) approval is necessary. This study examines the burden of multisite IRB approval on a Health Services Research and Development (HSRD) ventral hernia outcomes observational study. Methods Data gathered on the IRB process per site included time required for application completion, staff training and compliance, IRB affiliation (VA or university), approval status, and time to IRB approval. Wilcoxon rank sum tests were used to determine differences in median times for application completion and approval. Financial and temporal expenses were calculated. Results Significant differences were found in median time to complete applications by IRB affiliation ( P < .01) and median time to approval by changes required to the consent letter ( P < .05). Conclusions The IRB process for a multisite observational study is expensive in both time and money. A VA national IRB for multisite studies would significantly decrease the financial and temporal burden for observational studies.

Impact of institutional review board practice variation on observational health services research.

To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. DATA SOURCE AND SETTING: Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics. Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. DATA COLLECTION AND ABSTRACTION METHODS: Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data. Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: (1) Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites. (2) Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants. (3) Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document. (4) Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site. Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.

Acting on Imperfect Evidence: How Much Regret Are We Ready to Accept?

Benjamin Djulbegovic H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa, FL Andrew Frohlich and Charles L. Bennett, Jesse Brown VA Medical Center and the VA Midwest Center for Health Services Research and Policy Studies, the Division of Hematology/Oncology of the Department of Medicine, the Institute for Health Services Research and Policy Studies, and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL

The development of a comorbidity index with physical function as the outcome

Background and Objectives Physical function is an important measure of success of many medical and surgical interventions. Ability to adjust for comorbid disease is essential in health services research and epidemiologic studies. Current indices have primarily been developed with mortality as the outcome, and are not sensitive enough when the outcome is physical function. The objective of this study was to develop a self-administered Functional Comorbidity Index with physical function as the outcome. Methods The index was developed using two databases: a cross-sectional, simple random sample of 9,423 Canadian adults and a sample of 28,349 US adults seeking treatment for spine ailments. The primary outcome measure was the SF-36 physical function (PF) subscale. Results The Functional Comorbidity Index, an 18-item list of diagnoses, showed stronger association with physical function (model R 2 = 0.29) compared with the Charlson (model R 2 = 0.18), and Kaplan-Feinstein (model R 2 = 0.07) indices. The Functional Comorbidity Index correctly classified patients into high and low function, in 77% of cases. Conclusion This new index contains diagnoses such as arthritis not found on indices used to predict mortality, and the FCI explained more variance in PF scores compared to indices designed to predict mortality.

Nutzenbewertung der Therapie chronisch rezidivierender Atemwegsinfekte mit Echinacin

Echinacea purpurea (echinacin) is frequently used in the therapy of chronic recurrent respiratory disease. The aim of this study was to show whether treatment of chronic recurrent respiratory disease with echinacin has a greater benefit in terms of effectiveness than therapy without an immunomodulator. Frequency, duration of recurrence, resources used and patients' satisfaction was documented in order to assess benefit. In this prospective, non-randomised, multi-centre, nationwide, two-armed health services research study, data of 995 patients (782 echinacin-, 213 standard-cohort) with chronic recurrent respiratory disease were collected. The perspectives of statutory health insurance (SHI), patients and health policy were taken into consideration. The risk of falling ill was 2.3 fold higher and the duration of relapse 1.4 days more compared to the standard-cohort. There was a clinical and economical benefit from the therapy with echinacin for SHI and health policies. In contrast, patients experienced a greater financial burden. Average total costs per patient during the observation period of 3 months amounted to 238.35 in the standard-cohort and to 228.95 in the echinacin-cohort. Results of the intent-to-treat-analysis were reconfirmed in a per-protocol-analysis. This health services-research-study taking the therapy of chronic recurrent respiratory disease with echinacin as an example has shown that even non-prescription drugs can have clinical and economic benefits.

Institutional Review Boards and Multisite Studies in Health Services Research: Is There a Better Way?

The following paper examines the issue of whether the current system for ethics review of multisite health services research protocols is adequate, or whether there exist alternative methods that should be considered. (1) Investigators at different sites in a multisite project often have very different experiences with respect to the requirements and requests of the review board. Other problems include the waste of time and resources spent on document preparation for review boards, and delays in the commencement of research activities. (2) There are several possible reasons why there is variability in ethics review. These include the absence of standardized forms, differences in the background and experiences of board members, the influence of institutional or professional culture, and regional thinking. (3) Given the limited benefits derived from the variability in recommendations of multiple boards and the numerous problems encountered in seeking ethics approval from multiple boards suggest that some sort of reform is in order. The increasing number of multisite, health services research studies calls for a centralized system of ethics review. The local review model is simply not conducive to multisite studies, and jeopardizes the integrity of the research process. Centralized multisite review boards, together with standardized documents and procedure, electronic access to documentation, and training for board members are all possible solutions. Changes to the current system are necessary not only to facilitate the conduct of multisite research, but also to preserve the integrity of the ethics approval process in general.

Adversity among drug users: relationship to impulsivity

Illicit substance users experience adverse life events, but few studies have examined the role of impulsivity in these events. The present investigation sought to establish a link between negative life experiences and a trait measure of impulsivity and demonstrate that this association remains even accounting for potential confounds. Participants were 330 heroin and cocaine users recruited from the community for a health service research study. Participants completed a structured interview that assessed topics including drug and alcohol use, impulsivity, and negative life events. This group of drug users reported high rates of adverse life events in the 6 months prior to the assessment. No specific substance abuse/dependence diagnosis or combination of diagnoses was associated with adversity. Number of substance-related diagnoses was associated with adverse life events, but not when adjusting for impulsivity. Experience of these events was significantly associated with impulsivity ( p < .001), above and beyond the shared relation with demographic variables, substance abuse and dependence, and number of substance-related diagnoses. These findings document the high frequencies of recent adverse life events among illicit drug users and indicate that trait impulsivity is associated with increased risk of these life events.

Optimal search strategies for detecting health services research studies in MEDLINE

Evidence from health services research (HSR) is currently thinly spread through many journals, making it difficult for health services researchers, managers and policy-makers to find research on clinical practice guidelines and the appropriateness, process, outcomes, cost and economics of health care services. We undertook to develop and test search terms to retrieve from the MEDLINE database HSR articles meeting minimum quality standards. The retrieval performance of 7445 methodologic search terms and phrases in MEDLINE (the test) were compared with a hand search of the literature (the gold standard) for each issue of 68 journal titles for the year 2000 (a total of 25,936 articles). We determined sensitivity, specificity and precision (the positive predictive value) of the MEDLINE search strategies. A majority of the articles that were classified as outcome assessment, but fewer than half of those in the other categories, were considered methodologically acceptable (no methodologic criteria were applied for cost studies). Combining individual search terms to maximize sensitivity, while keeping specificity at 50% or more, led to sensitivities in the range of 88.1% to 100% for several categories (specificities ranged from 52.9% to 97.4%). When terms were combined to maximize specificity while keeping sensitivity at 50% or more, specificities of 88.8% to 99.8% were achieved. When terms were combined to maximize sensitivity and specificity while minimizing the differences between the 2 measurements, most strategies for HSR categories achieved sensitivity and specificity of at least 80%. Sensitive and specific search strategies were validated for retrieval of HSR literature from MEDLINE. These strategies have been made available for public use by the US National Library of Medicine at www.nlm.nih.gov/nichsr/hedges/search.html.

Analysis of Longitudinal Data with Irregular, Outcome-Dependent Follow-Up

SummaryA frequent problem in longitudinal studies is that subjects may miss scheduled visits or be assessed at self-selected points in time. As a result, observed outcome data may be highly unbalanced and the availability of the data may be directly related to the outcome measure and/or some auxiliary factors that are associated with the outcome. If the follow-up visit and outcome processes are correlated, then marginal regression analyses will produce biased estimates. Building on the work of Robins, Rotnitzky and Zhao, we propose a class of inverse intensity-of-visit process-weighted estimators in marginal regression models for longitudinal responses that may be observed in continuous time. This allows us to handle arbitrary patterns of missing data as embedded in a subject's visit process. We derive the large sample distribution for our inverse visit-intensity-weighted estimators and investigate their finite sample behaviour by simulation. Our approach is illustrated with a data set from a health services research study in which homeless people with mental illness were randomized to three different treatments and measures of homelessness (as percentage days homeless in the past 3 months) and other auxiliary factors were recorded at follow-up times that are not fixed by design.

Latent pattern mixture models for informative intermittent missing data in longitudinal studies.

A frequently encountered problem in longitudinal studies is data that are missing due to missed visits or dropouts. In the statistical literature, interest has primarily focused on monotone missing data (dropout) with much less work on intermittent missing data in which a subject may return after one or more missed visits. Intermittent missing data have broader applicability that can include the frequent situation in which subjects do not have common sets of visit times or they visit at nonprescheduled times. In this article, we propose a latent pattern mixture model (LPMM), where the mixture patterns are formed from latent classes that link the longitudinal response and the missingness process. This allows us to handle arbitrary patterns of missing data embodied by subjects' visit process, and avoids the need to specify the mixture patterns a priori. One assumption of our model is that the missingness process is assumed to be conditionally independent of the longitudinal outcomes given the latent classes. We propose a noniterative approach to assess this key assumption. The LPMM is illustrated with a data set from a health service research study in which homeless people with mental illness were randomized to three different service packages and measures of homelessness were recorded at multiple time points. Our model suggests the presence of four latent classes linking subject visit patterns to homeless outcomes.

Children of migratory agricultural workers: the ecological context of acute care for a mobile population of immigrant children

Migratory and seasonal agricultural workers fill the labor needs of United States farmers. Although migrant workers are a culturally and ethnically diverse population, presently, they are predominantly immigrants of Hispanic ethnicity. Migrant farm workers are increasingly young, financially impoverished, male, undocumented immigrants from Mexico. Families with children constitute 45% of this population. The ecological context of migrant children’s lives is characterized by poverty, social isolation, heightened inter- and intra-national mobility, limited protections from occupational safety and health legislation, and health access barriers. Moreover, the linkage of citizenship and immigration status to the receipt of public insurance and selected social services benefits has the potential to increase access barriers for migrant workers and their families. Despite these obvious vulnerabilities, few health services research studies address this population. Most of what is known relates to adults, with very little known about migrant children’s health services utilization patterns or health morbidities. In the emergency department setting, the differential approach required to care for children, as compared to adults, must be modified further in order to address the unique needs of this vulnerable population. The effective delivery of acute care to the children of migratory agricultural workers requires awareness of and attention to their unique health access barriers, issues of continuity and compliance with care, and their unique health and injury risks.

Reporting of clinical trials in the International Endodontic Journal– the CONSORT guidelines

Reporting of clinical trials in the <i>International Endodontic Journal</i>– the CONSORT guidelines

Economic evaluations of HIV treatment and health research with people diagnosed with HIV infection and co-occurring mental health and substance use disorders

This paper describes the research challenges involved in measuring costs in economic evaluations of patients who are coping simultaneously with HIV/AIDS and co-occurring mental health and substance abuse disorders—especially in multi-site studies. We describe the general issues that arise in measuring costs for this population and suggest some operational solutions for their resolution, drawing from our experience in a recent multi-site health services research study focused on this population. We show that while reliance on patient self-report data may be unavoidable to provide a common denominator in multi-site studies, there are also some practical ways of improving the accuracy of such data and the cost estimates that result from them. We also provide readers with a means for securing the data collection instruments developed for the cost component of this study in the hope that these may serve as templates for researchers doing similar work.

The Depression Care Manager and Mental Health Specialist as Collaborators Within Primary Care

The authors reviewed the implications of the latest generation of health services research studies on primary care practice system changes for depression management, especially in the roles of care managers and mental health specialists. Authors conducted a review of four large, related, multisite trials testing system changes in the delivery of care to depressed, mostly older, primary care patients. These studies confirm that older patients are more likely to accept collaborative mental health treatment within primary care than within mental health specialty care. The study results published to date suggest that these system changes produce better outcomes than usual care for depression in a wide range of patients and healthcare organizations. Two key partners in implementing these system changes are a care manager to assist the primary care physician in patient education, treatment, and treatment monitoring, and a mental health specialist to provide care-manager consultation and collaborative care with the primary care physician for more complex cases. Most patients with depression first seek attention for their symptoms in primary care, rather than in the mental health specialty sector. Since primary care visits are necessarily brief and pressured by competing demands to manage other medical problems, practice system changes are necessary. For mental health specialists, these studies emphasize the importance of joining and being integrated into primary care. Consultative and supervisory roles allow the specialist to indirectly but effectively serve a larger number of patients.

The use of large administrative data sets in nursing research

A NALYSIS OF large administrative data sets has been a method used primarily by health services researchers to examine issues such as access, regional differences in care, and health outcomes. Most administrative data sets were first developed in the 1970s for the collection of data regarding health plans, health system utilization, and claims data. Although they were not originally intended for conducting research, administrative data sets were found to be an attractive avenue for health services research studies. Technologic advances in personal computers, modern statistical analysis software, and uniform International Classification of Diseases, Ninth Revision nomenclature have widened the horizons for researchers. In the past, investigations using national or state data sets required access to mainframe computer resources, but today, analyses of this type may be conducted using one’s personal computer. The purpose of this article is to discuss the use of large administrative data sets as a tool in nursing research. As early as 1985, the limited use of secondary data analysis in nursing research was noted (McArt & McDougal, 1985). Jacobson et al.,1993 conducted a Medline search (1986-1992) for nursing citations using the key words secondary data analysis and identified 11 citations, 3 of which appeared in nursing journals. We conducted a similar literature search (1997-2003) using PUBMED with the key words secondary data analysis and nursing and identified 82 nursing studies using secondary data analysis. Of those, only 15 used existing administrative data sets. Fourteen of the 15 were published in nursing journals. Although the use of secondary analysis as a research method has increased in nursing, the use of administrative data sets has not kept equal tempo. Large administrative data sets embody information about groups of people and often describe entire populations at either state and/or national levels, thus enhancing generalizability of research findings. The data are representative of care delivered in many settings and can be useful to examine patterns of health service and resource utilization. Longitudinal administrative data sets, which collect person-level information, can be used to track subjects both over time and across settings of care. Finally, these data sets already exist, can be obtained inexpensively, and are easily adapted for use with analytical software. Various types of administrative data sets are available. Thirty-six states presently are legislatively mandated as part of public health law to collect discharge information on all hospitalized patients. Patient identifiers are removed from the data to protect patient confidentiality, and most state hospital inpatient data sets lack identifiers to track recurrent hospitalizations. Two examples of state data sets are the New York State Department

Economic evaluation of zinc and copper use in treating acute diarrhea in children: A randomized controlled trial

BackgroundThe therapeutic effects of zinc and copper in reducing diarrheal morbidity have important cost implications. This health services research study evaluated the cost of treating a child with acute diarrhea in the hospital, the impact of micronutrient supplementation on the mean predicted costs and its cost-effectiveness as compared to using only standard oral rehydration solution (ORS), from the patient's and government's (providers) perspective.MethodsChildren aged 6 months to 59 months with acute diarrhea were randomly assigned to receive either the intervention or control. The intervention was a daily dose of 40 mg of zinc sulfate and 5 mg of copper sulfate powder dissolved in a liter of standard ORS (n = 102). The control was 50 mg of standard ORS powder dissolved in a liter of standard ORS (n = 98). The cost measures were the total mean cost of treating acute diarrhea, which included the direct medical, the direct non-medical and the indirect costs. The effectiveness measures were the probability of diarrhea lasting ≤ 4 days, the disability adjusted life years (DALYs) and mortality.ResultsThe mean total cost of treating a child with acute diarrhea was US $14 of which the government incurred an expenditure of 66%. The factors that increased the total were the number of stools before admission (p = 0.01), fever (p = 0.01), increasing grade of dehydration (p = 0.00), use of antibiotics (p = 0.00), use of intra-venous fluids (p = 0.00), hours taken to rehydrate a child (p = 0.00), the amount of oral rehydration fluid used (p = 0.00), presence of any complications (p = 0.00) and the hospital stay (p = 0.00). The supplemented group had a 8% lower cost of treating acute diarrhea, their cost per unit health (diarrhea lasting ≤ 4 days) was 24% less and the incremental cost-effectiveness ratio indicated cost savings (in Rupees) with the intervention [-452; 95%CI (-11306, 3410)]. However these differences failed to reach conventional levels of significance.ConclusionAn emphasis on the costs and economic benefits of an alternative therapy is an important aspect of health services research. The cost savings and the attractive cost-effectiveness indicates the need to further assess the role of micronutrients such as zinc and copper in the treatment of acute diarrhea in a larger and more varied population.

Using administrative data to study persons with disabilities.

Administrative data result from administering health plans--tracking service utilization, paying claims, monitoring costs and quality--and have been used extensively for health services research. This article examines the strengths and limitations of administrative data for health services research studies of people with disabilities. Administrative data offer important advantages: encompassing large populations over time, ready availability, low cost, and computer readability. Questions arise about how to identify people with disabilities, capture disability-related services, and determine meaningful health care outcomes. Potentially useful administrative data elements include eligibility for Medicare or Medicaid through Social Security disability determinations, diagnosis and procedure codes, pharmacy claims, and durable medical equipment claims. Linking administrative data to survey or other data sources enhances the utility of administrative data for disability studies.

Health Services Research: An Evolving Definition of the Field

Health Services Research: An Evolving Definition of the Field

Quasi-Likelihood Analysis of Patient Satisfaction with Medical Care

In health services research studies, a score for satisfaction with care is often determined for a patient by summing several items, each measured on a Likert scale with ordered response options indicating satisfaction with some aspect of medical care (e.g., five categories ordered 1-poor to 5-excellent). A common goal is to determine patient and physician level predictors of patient satisfaction using regression analysis. The large number of categories in the ordinal summed response variable may present obstacles to traditional analytic methods for ordinal data such as the proportional odds model for cumulative logits. Further, linear regression is generally known to be inappropriate. Quasi-likelihood methods provide a flexible and tractable alternative modelling procedure. Weak assumptions about the measurement scale may be made by estimating parameters that define a family of link functions. A quasi-likelihood analysis of data from a study of elderly patients' satisfaction with communication with their primary care physician is presented. Although several factors are significantly related to satisfaction, a diagnostic plot based upon cumulative deviances reveals inadequacy of fit for the patients with the lowest observed satisfaction.