Jeanne M. Sears

Programmable intrathecal opioid delivery systems for chronic noncancer pain: a systematic review of effectiveness and complications.

ObjectivesWe conducted a systematic review of the literature on the effectiveness and complications of programmable intrathecal opioid and ziconotide drug delivery systems (IDDS) for patients with chronic noncancer pain. MethodsWe searched MEDLINE, Cochrane, and other bibliographic databases to identify English-language journal articles reporting programmable IDDS complications or effects on pain or functioning. Additional study methodology criteria were applied for the effectiveness review. Two authors independently abstracted data from each included article. ResultsSix articles met the inclusion criteria for the effectiveness and complications reviews, and 4 others met the criteria only for the complications review; none were randomized trials or of ziconotide. All 6 articles reviewed for effectiveness reported improvement in pain and functioning on average among patients who received a permanent IDDS. Two articles reported the proportion of patients with ≥50% improvement in pain at 6 months (38%, 56%) and 2 at longer follow-ups (30%, 44%). Intrathecal morphine-equivalent doses increased over time. The most commonly reported permanent IDDS drug side effects were nausea/vomiting (mean rate weighted by sample size=33%), urinary retention (24%), and pruritus (26%). Catheter problems were also reported commonly. Rare but serious complications included intrathecal catheter tip granulomas. ConclusionsThe studies reviewed found improvement in pain and functioning on average among patients with chronic noncancer pain who received permanent IDDS. However, their methodologic limitations preclude conclusions concerning the effectiveness of this technology long-term and as compared with other treatments. Drug side effects and hardware complications were common. Suggestions are made for methodologic improvements in future studies.

The Partnership Access Line: Evaluating a Child Psychiatry Consult Program in Washington State

OBJECTIVE To evaluate a telephone-based child mental health consult service for primary care providers (PCPs). DESIGN Record review, provider surveys, and Medicaid database analysis. SETTING Washington State Partnership Access Line (PAL) program. PARTICIPANTS A total of 2285 PAL consultations by 592 PCPs between April 1, 2008, and April 30, 2011. INTERVENTIONS Primary care provider-initiated consultations with PAL service. MAIN OUTCOME MEASURES The PAL call characteristics, PCP feedback surveys, and Medicaid claims between April 2007 and December 2009 for fee-for-service Medicaid children before and after a PAL call. RESULTS Sixty-nine percent of calls were about children with serious emotional disturbances, and 66% of calls were about children taking psychiatric medications. Primary care providers nearly always received new psychosocial treatment advice (87% of calls) and were more likely to receive advice to start rather than stop a medication (46% vs 24% of calls). Primary care provider feedback surveys reported uniformly positive satisfaction with the program. Among Medicaid children, there was significant increases in attention-deficit/hyperactivity disorder and antidepressant medication use after the PAL call but no significant change in reimbursements for mental health medications (P < .05). Children with a history of foster care experienced a 132% increase in outpatient mental health visits after the PAL call (P < .05). CONCLUSIONS Primary care providers used PAL for psychosocial and medication treatment assistance for particularly high-needs children and were satisfied with the service. Furthermore, PAL was associated with increased use of outpatient mental health care for some children.

Occupational Injury Surveillance Using the Washington State Trauma Registry

Objective:Traumatic injuries are a leading cause of death and disability among US workers, yet state trauma registries are rarely used for occupational research. Many, including the Washington State Trauma Registry, include information about work-relatedness. The objective is to explore and document the Washington State Trauma Registry as a resource for occupational injury surveillance and research. Methods:State-designated trauma facilities report traumatic injuries meeting specific inclusion criteria to the Washington State Trauma Registry. This study included 16+ year-olds injured in Washington during 1998 to 2008. Results:Of 125,625 injuries, 7.3% were work related. We found no evidence of downward trends in traumatic occupational injuries (2003 to 2008). Conclusions:Capturing industry and occupation would enhance utility for occupational injury surveillance and research. Trauma registry data could contribute to prevention planning/evaluation, improve case ascertainment for severe occupational injuries, and aid identification of high-risk populations and emerging trends.

Predicting Work-Related Disability and Medical Cost Outcomes: Estimating Injury Severity Scores from Workers’ Compensation Data

Purpose Acute work-related trauma is a leading cause of death and disability among US workers. The research objectives were to assess: (1) the feasibility of estimating Abbreviated Injury Scale-based injury severity scores (ISS) from ICD-9-CM codes available in workers’ compensation (WC) medical billing data, (2) whether ISS predicts work-related disability and medical cost outcomes, (3) whether ISS adds value over other injury severity proxies, and (4) whether the utility of ISS differs for an all-injury sample compared with three specific injury samples (amputations, extremity fractures, traumatic brain injury). Methods ISS was estimated from ICD-9-CM codes using Stata’s user-written -icdpic- program for 208,522 compensable nonfatal WC claims for workers injured in Washington State from 1998 to 2008. The Akaike Information Criterion and R2 were used to compare severity measures. Competing risks survival analysis was used to evaluate work disability outcomes. Adjusted total medical costs were modeled using linear regression. Results Work disability and medical costs increased monotonically with injury severity. For a subset of 4,301 claims linked to the Washington State Trauma Registry (WTR), there was moderate agreement between WC-based ISS and WTR-based ISS. Including ISS together with an early hospitalization indicator resulted in the most informative models; however, early hospitalization is a more downstream measure. Conclusions ISS was significantly associated with work disability and medical cost outcomes for work-related injuries. Injury severity should be considered as a potential confounder for occupational injury intervention, program evaluation, or outcome studies, and can be estimated using existing software when ICD-9-CM codes are available.

Nurse practitioners as attending providers for injured workers: evaluating the effect of role expansion on disability and costs.

Background:A 3-year pilot program to expand the role of nurse practitioners (NPs) in the Washington State workers’ compensation system was implemented on July 1, 2004. This legislation authorized NPs to independently perform most functions of an attending physician. Objective:The purpose of this study was to assess the impact of this legislation by examining medical costs and disability outcomes for injured workers in the care of NPs benchmarked against those in the care of primary care physicians (PCPs). Research Design:This observational study compared NPs and PCPs in the role of attending provider based on the medical costs and disability outcomes of injured workers in their care. Comparisons controlled for sociodemographics, geographic location, injury, employment, and provider characteristics. Data Source:The Washington State Department of Labor and Industries provided claim and medical billing data for 29,949 injured workers who had an accident report filed by an NP or PCP between July 1, 2004 and June 30, 2005. Data were collected through June 30, 2006. Results:NPs were more likely than PCPs to be located in rural areas and counties with high unemployment. The distributions of injury type and severity/complexity indicators were similar across provider types. The likelihood of any time loss was lower for NP claims, but duration of lost work time and medical costs did not significantly differ by provider type. Conclusions:Attending provider type is not a significant predictor of disability or medical costs for injured workers in Washington State.

Nurse practitioners as attending providers for workers with uncomplicated back injuries: using administrative data to evaluate quality and process of care.

Objective: The objectives of this study were 1) to identify quality and process of care indicators available in administrative workers’ compensation data and to document their association with work disability outcomes, and 2) to use these indicators to assess whether nurse practitioners (NPs), recently authorized to serve as attending providers for injured workers in Washington State, performed differently than did primary care physicians (PCPs). Methods: Quality and process of care indicators for NP and PCP back injury claims from Washington State were compared using direct standardization and logistic regression. Results: This study found little evidence of differences between NP and PCP claims in case mix or quality of care. Conclusions: The process of care indicators that we identified were highly associated with the duration of work disability and have potential for further development to assess and promote quality improvement.

The use of administrative data as a substitute for individual screening scores in observational studies related to problematic alcohol or drug use

Administrative data provide a rich resource for improving our understanding of individuals with substance use disorders. The validation of administrative proxies for moderate or high risk alcohol or drug (AOD) use could enhance the ability to carry out rigorous observational research (for example, for use in the construction of comparison groups). This study used receiver operating characteristic (ROC) curve techniques to assess how well AOD-related administrative indicators predicted self-reported AOD use obtained from AUDIT/DAST screening scores. An administrative AOD indicator, derived from a combination of medical encounter and billing data, arrest records, and publicly funded AOD-related services data, demonstrated discrimination in the acceptable range (AUC: 0.72-0.78) for identifying self-reported AOD use consistent with potential need for either (1) any AOD-related intervention, or (2) intensive AOD-related intervention or treatment. These findings held up in two distinct samples: a statewide Medicaid-only sample and a single-site mixed-payer sample that included the uninsured. Our findings suggest that indicators of AOD-related problems derived from administrative data can be useful for identifying moderate or high risk AOD use in a research context. The findings further suggest that proxies for substance use disorders, such as those evaluated here, can enhance future observational studies intended to improve health care for this population.

Context is key for voluntary and informed consent.

Rhodes (2005) touches on a number of important themes in her critique. I agree that society would benefit by the promotion of participation in research as an altruistic and socially responsible activity; in fact, I have previously suggested the possibility of encouraging voluntary research participation through a model similar to a jury duty system, whereby subjects could be allotted paid time off work to participate (Sears 2001). However, I share London’s (2005) concern that research is not currently planned and carried out within an explicit framework that ensures social justice, rendering Rhodes’ thought experiment of mandatory participation unpalatable. I am particularly concerned with Rhodes’ portrayal of informed consent. I would agree with both Rhodes (2005) and Miller (2005) that there has been undue emphasis on informed consent as an event. However, we are still learning how to understand and implement informed consent as a contextual process rather than just as an event or as a signed document. Rhodes identifies yet understates the importance of context in making informed and careful decisions about research participation. One can be “autonomous,” yet be exquisitely vulnerable to contextual influences. Vulnerability is often situational rather than categorical. For example, in her analogy of the captain at sea, she states that because we would likely all agree that the captain made a reasonable choice in throwing his goods overboard given the situation in which he found himself, she finds it hard to see why autonomous individuals in groups considered vulnerable should have special limitations imposed on their ability to make choices in accord with their own priorities. However, although we are likely to agree that the captain was making a reasonable choice regarding the best method of saving himself, his crew, and his ship, we may not agree that he was in the best position to make an informed decision about optional participation in a research study, whether or not it bore directly on ships in a storm. Perhaps he would have even been most vulnerable to making a misguided decision about participation in a research study if he (erroneously) believed that the purpose of the research was to save his particular ship. This is analogous to the therapeutic misconception. The issue here is not so much whether the captain (or a person in a “vulnerable” category) is capable of or entitled to an autonomous decision regarding his ship’s survival, but rather whether this is an appropriate context in which to approach him (or a person in a “vulnerable” category) for a decision to participate in a research study. The primary concern is not to limit choices about research participation or to denigrate decisional capacity, but rather to enhance the context whenever possible to be most conducive to optimal decision-making. Since research is an admittedly important but optional activity, researchers generally have choices about when and how to approach potential subjects, with attendant accountability for those choices. Often, the decision that a person faces about whether to participate in a research study is not one that directly bears on his or her most pressing best interests, but is somewhat tangential. The priorities imposed by the research design may or may not be evident to a potential subject, and may or may not happen to coincide with his or her personal priorities, whether he or she perceives them to or not. Depending on contextual vulnerabilities, an autonomous person can easily misconstrue the purpose of the research and its importance to his or her own best interests as he or she filters information and incorporates the option of participation into the narrative of his or her own needs and priorities. This is particularly true if the person happens to be in a patient role and the option of research participation has been presented by the patient’s treatment team (Appelbaum et al. 1987). It may also be particularly true for other vulnerable groups. However, relying on the identification and protection of vulnerable groups in a categorical way may contribute to losing sight of how we all are vulnerable in different ways at different times. Ensuring a context that allows the optimal absorption of information and weighing of choices is key to ensuring voluntary and informed consent. Recognizing the importance of context also requires viewing informed consent as a continuing process, as priorities and vulnerabilities change over time (Berry et al. 1996). The nursing literature contains many discussions of contextual vulnerability and the consent process (e.g., Berry et al. 1996; Bujorian 1988; Martin 1994; Rosse 1999; Rusnak 1999; Sears 2001). This is unsurprising, given nursing’s multifaceted role in research activities (Ocker and Pawlik Plank 2000; Xanthos et al. 1998). There are a number of practical ways to enhance the context for optimal decision-making about participation in research, given social, institutional, and financial support for researchers to implement such activities (Bujorian 1988, Hewlett 1996). Respect for autonomy not only requires respecting the right of autonomous individuals to make choices, but also implies accountability for the context in which those choices are to be made.

Enhancing the policy impact of evaluation research: A case study of nurse practitioner role expansion in a state workers' compensation system

In 2004, the Washington State Legislature enacted a 3-year pilot program that authorized nurse practitioners to function as attending providers for injured workers. The bill required an evaluation and report to the Legislature to address stakeholder concerns regarding potential impacts on system quality and costs. Subsequent to the reports dissemination, permanent legislation extending the program was passed. The specific objectives of this case study are (1) to document an example of policy-relevant research that had features facilitating direct policy impact and (2) to describe environmental facilitators/barriers and best practices for enhancing the effective impact of evaluation research on policy. Researchers often seek to have an impact on health, health care, and/or healthcare policy. This case study reinforces the importance of (1) ensuring early and ongoing communication with stakeholders, (2) conducting stakeholder analysis to understand underlying interests and values, and (3) encouraging meaningful stakeholder input into the evaluation design process.

Occupational injury trends derived from trauma registry and hospital discharge records: lessons for surveillance and research

Objective: The suitability of the Washington State Trauma Registry (WTR) for occupational injury surveillance was assessed via comparing estimated rates and trends with those derived from state hospital discharge data. Methods: Descriptive methods and negative binomial regression were used to model occupational injury trends (1998 to 2009). Results: Nonlinear trends based on WTR data closely tracked those based on hospital discharge data, beginning about 2002. Rate estimates differed somewhat by data source and were most similar when a severity threshold was applied. Conclusions regarding temporal trends in work-related injury rates were the same using either data source. Conclusions: This study found substantial similarity between occupational injury trends estimated using either WTR or hospital discharge data. We conclude that a mature state trauma registry with mandatory reporting requirements can be used for surveillance of severe work-related traumatic injuries.