Salvation by registration.
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Aged, 80 and over↗
Biomedical subjects
Deborah A Zarin
Publications and source records attributed to Deborah A Zarin.
Clarifying a misunderstanding on clinical trial registry.
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Canada↗
Trial Registration at ClinicalTrials.gov between May and October 2005.
BACKGROUND: Clinical trial registration allows interested parties to obtain information about ongoing and completed trials, but there are few data indicating the quality of the information provided during the registration process. We used information in the publicly available ClinicalTrials.gov database to describe patterns of trial registration before and after the implementation by journal editors of a new policy requiring registration as a prerequisite for publication. METHODS: We reviewed ClinicalTrials.gov records to determine patterns of completion of the "Intervention Name" and "Primary Outcome Measure" data fields for trials registered on May 20 and October 11, 2005, and for trials registered during the interval between these two dates, inclusively. RESULTS: During the interval studied, the number of registrations in ClinicalTrials.gov increased by 73 percent from 13,153 to 22,714. The percentage of interventional trials registered by industry with nonspecific Intervention Name entries (attributable to four drug companies) decreased from 10 percent to 2 percent; all other industry and nonindustry records contained specific entries in this field. Of the 2670 studies registered by industry between the two dates, 76 percent provided information in the Primary Outcome Measure field, although these entries varied markedly in their degree of specificity. In the remaining 24 percent of the records, this field was blank. CONCLUSIONS: During the summer of 2005, there were large increases in the number of clinical trial registrations. Overall, the data contained in records were more complete in October than they were in May, but there still is room for substantial improvement.
Clinical Trials as Topic↗
Challenges in systematic reviews of diagnostic technologies.
Diagnostic tests are critical components of effective health care. They help determine treatments that are most beneficial for a given patient. Their assessment is a complex process that includes such challenges as a dearth of studies that evaluate clinical outcomes and lack of data on use of the test in realistic clinical settings. The methodologic quality of studies of diagnostic tests also lags behind the quality of studies of therapeutic interventions. Statistical methods to combine diagnostic accuracy data are more complex and not as well developed, leading to difficulties in the interpretation of results. The Agency for Healthcare Research and Quality Technology Assessment Program has adopted a 6-level framework for evaluating diagnostic technologies. The model emphasizes the need for systematic reviews of diagnostic test studies to go beyond the assessment of technical feasibility and accuracy to examine the impact of the test on health outcomes. In this paper, we use examples from 3 Evidence-based Practice Center reports to illustrate 3 challenges reviewers may face when reviewing diagnostic test literature: finding relevant studies, assessing methodologic quality of diagnostic accuracy studies, and synthesizing studies that evaluate tests in different patient populations or use different outcomes.
Diagnostic Techniques and Procedures↗
Clinical trial registration.
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Clinical Trials as Topic↗
Challenges to evidence-based medicine: a comparison of patients and treatments in randomized controlled trials with patients and treatments in a practice research network.
BACKGROUND: The practice of evidence-based medicine depends on the availability of clinically relevant research, yet questions have been raised about the generalizability of findings from randomized controlled trials (RCTs). OBJECTIVES: The aim of this study was to quantify differences between RCT patients and treatments and those in day-to-day clinical practice. RESEARCH DESIGN: Data from published reports of two key RCTs underlying recent treatment advances in psychiatry were compared with data on routine psychiatric practice collected through a Practice Research Network (PRN). SETTING: Hospital inpatient units (RCT) and the full range of psychiatric practice settings in the United States (PRN). SUBJECTS: Adults with bipolar I disorder and adults with schizophrenia. MEASURES: Demographic (age, gender, race), clinical (principal diagnoses, comorbid conditions, psychosocial functioning, and histories of hospitalization), and treatment (medication name and dosage) characteristics. RESULTS: PRN patients had more comorbid conditions and were more likely to be white, female, and older than RCT patients. In all, 38% of PRN patients with schizophrenia and 55% of PRN patients with bipolar I disorder would have been ineligible for the corresponding RCT. Most PRN patients receiving an RCT study medication were also receiving other medications not allowed by the RCT protocol. CONCLUSIONS: Findings support the assertion that RCT patients and treatments are not typical of those in clinical practice, and most patients in clinical practice are receiving treatments that do not have direct empirical support. Research is needed to determine the extent to which RCT findings should be used to guide routine clinical decisions.
Adult↗
Concomitant pharmacotherapy among youths treated in routine psychiatric practice.
OBJECTIVES: The aim of this study was to assess rates and correlates of concomitant pharmacotherapy in children and adolescents treated by psychiatrists in a broad range of clinical settings. METHODS: Cross-sectional data on 392 child and adolescent patients aged 2-17 years from the 1997 and 1999 American Psychiatric Practice Research Network Study of Psychiatric Patients and Treatments were used, and weighted estimates are provided. RESULTS: Findings indicate that 84% of child and adolescent patients received one or more psychopharmacologic medications; 52% of patients treated with medications received concomitant pharmacotherapy (i.e., two or more medications). Patients who were treated with psychopharmacologic treatments received a median of 2 medications (range, 1-6). Highest rates of concomitant pharmacotherapy were among patients with bipolar disorder (87%). Correlates of concomitant pharmacotherapy included: (1) having a diagnosis of bipolar disorder, (2) having co-occurring Axis I or II disorders or general medical conditions, and (3) currently receiving treatment in an inpatient setting. CONCLUSIONS: Over 40% of child and adolescent patients of psychiatrists were prescribed two or more psychopharmacologic medications. Patients with chronic and clinically complex conditions were more likely to receive concomitant pharmacotherapy. Most often, efficacy of U.S. Food and Drug Administration (FDA)-approved medications has been examined as monotherapy, and cautions on drug interactions and off-label use derived from multiple sources accompany each product. With high rates of concomitant pharmacotherapy among children and adolescents in psychiatric care, additional research on efficacy and safety of this treatment strategy is necessary.
Adolescent↗
Hyperbaric oxygen for treating wounds: a systematic review of the literature.
OBJECTIVE: To determine whether hyperbaric oxygen (HBO) therapy is an effective adjunct treatment for hypoxic wounds. METHODS: We identified studies from technology assessment reports on HBO and a MEDLINE search from mid-1998 to August 2001. We accepted randomized controlled trials (RCTs), cohorts, and case series that reported original data, included at least 5 patients, evaluated the use of HBO for wound care, and reported clinical outcomes. Demographics, wound conditions, HBO regimen, adverse events, and major clinical outcomes were extracted from each study. RESULTS: Fifty-seven studies, 7 RCTs, 16 nonrandomized studies, and 34 case series involving more than 2000 patients are included in this review. None of the studies used wound tissue hypoxia as a patient inclusion criterion. The study results suggest that HBO may be beneficial as an adjunctive therapy for chronic nonhealing diabetic wounds, compromised skin grafts, osteoradionecrosis, soft tissue radionecrosis, and gas gangrene compared with standard wound care alone. Serious adverse events associated with HBO include seizures and pressure-related traumas, such as pneumothorax. A few deaths in the studies were associated with these adverse events. CONCLUSIONS: The overall study quality is poor, with inadequate or no controls in most studies. The studies suggest that HBO may be helpful for some wounds, but there is insufficient evidence to ascertain the appropriate time to initiate therapy and to establish criteria that determine whether patients will benefit. Serious adverse events may occur. High-quality RCTs that evaluate the short- and long-term risks and benefits of HBO are necessary to better inform clinical decisions.
Diabetic Foot↗
A systematic review of pneumatic compression for treatment of chronic venous insufficiency and venous ulcers.
INTRODUCTION: As part of a reconsideration of coverage policy, the Centers for Medicare and Medicaid Services requested a systematic review of the evidence on the use of pneumatic compression devices in the home environment for treatment of chronic venous insufficiency (CVI) and venous ulcers. METHODS: Articles were found with a systematic literature search of MEDLINE, EMBASE, and AMED (Allied and Complementary Medicine) databases, hand searches of reference lists, and suggestions of experts. RESULTS: Eight trials that met the inclusion criteria, including several randomized control trials, were found. Most studies were small and may have been underpowered. However, several were well-designed randomized controlled trials. Three studies showed that the devices could alleviate symptoms of CVI. No studies directly measured whether the devices could prevent the occurrence of venous ulcers. Some studies on the treatment of venous ulcers did not show a benefit for pneumatic compression, but other studies showed a benefit for the devices in healing long-standing chronic ulcers that had not healed with other methods. No studies directly compared single-chamber and multiple-chamber devices or studied whether the effectiveness of the pump was dependent on types of treatment used concurrently with the pump. Few adverse events were reported in the trials. Patients generally expressed satisfaction with the pneumatic compression devices, and several studies reported higher compliance than with other compression methods. CONCLUSION: The available data cannot be relied on to inform the optimal choice of compression therapy or optimal protocol for patients with CVI or venous ulcers. Methodologically rigorous research designed to answer these questions would be useful for treatment decisions. The Centers for Medicare and Medicaid Services considered the results of this study and issued a decision that pneumatic compression will only be covered for patients with refractory edema with significant ulceration of the lower extremities after a 6-month trial of standard therapies, such as compression stockings, has failed.
Chronic Disease↗
Variation in routine psychiatric workload: the role of financing source, managed care participation, and mental health workforce competition.
This study was conducted to examine the association between psychiatrists' demographic characteristics, payment source, and managed care participation and psychiatrists' practice workload, and between the supply of other mental health providers in a psychiatrist's county of practice and psychiatrists' practice workload. Data from the 1996 American Psychiatric Association National Survey of Psychiatric Practice were merged with national countywide measures of mental health workforce and environmental data from the 1996 Area Resource File. In comparison to male psychiatrists, female psychiatrists treat fewer patients per week, provide less total hours of weekly patient care, and obtain fewer new monthly referrals. An increase in psychiatrists' managed care participation was associated with only minor increases in the number of patients per week, weekly time spent in clinical care, and number of new monthly referrals. The supply of other mental health providers was not associated with variation in practice workload. Once psychiatrists participate in managed care plans, an increase in their participation rate does not significantly expand clinical practice workload. The supply of other mental health providers was not significantly associated with variation in psychiatrists' workload, which suggests that substitution effects may not be evident with this aspect of psychiatric practice.
Adult↗
Characteristics of psychiatric patients for whom financial considerations affect optimal treatment provision.
This study assessed characteristics of psychiatric patients for whom financial considerations affected the provision of "optimal" treatment. Psychiatrists reported that for 33.8 percent of 1,228 patients from a national sample, financial considerations such as managed care limitations, the patient's personal finances, and limitations inherent in the public care system adversely affected the provision of optimal treatment. Patients were more likely to have their treatment adversely affected by financial considerations if they were more severely ill, had more than one behavioral health disorder or a psychosocial problem, or were receiving treatment under managed care arrangements. Patients for whom financial considerations affect the provision of optimal treatment represent a population for whom access to treatment may be particularly important.
Aged↗
When should functional neuroimaging techniques be used in the diagnosis and management of Alzheimer's dementia? A decision analysis.
BACKGROUND: Functional neuroimaging, including positron emission tomography (PET), has been proposed for use in diagnosing Alzheimer's disease-related dementia (AD). OBJECTIVE: The objective of this study was identify the circumstances under which PET scanning for the diagnosis of AD maximizes health outcomes. METHODS: A Markov-model-based decision analysis was conducted using estimates derived from the literature on AD epidemiology, the accuracy of PET, and donepezil treatment efficacy. The target population for the analysis was assumed to be US men and women who either have mild AD or are asymptomatic but at an elevated risk of developing AD owing to disease in a first-degree relative (parent or sibling). The time horizon was the patient lifetime. We compared treatment 1) based on an American Academy of Neurology (AAN) clinical evaluation either alone; 2) in combination with PET scanning; or 3) empirically based on a family history. Outcomes measures were life expectancy, quality-adjusted life-years (QALYs), and (severe) dementia-free life expectancy (SDFLE). RESULTS: For both patient populations, treating all patients based on an AAN evaluation without further testing using PET resulted in the greatest gains in life expectancy, QALYs, and SDFLEs. PET-based testing was the second preferred strategy compared to no intervention. The rankings of the strategies were sensitive to severity of treatment complications: analyses of hypothetical treatments with the potential for severe complications indicated that testing was preferred if the treatment was effective but had moderate complications. CONCLUSIONS: These results suggest that current treatments, which are relatively benign and may slow progression of disease, should be offered to patients who are identified as having AD based solely on an AAN clinical evaluation. A clinical evaluation that includes functional neuroimaging based testing will be warranted, however, when new treatments that are effective at slowing disease progression but have the potential for moderate to severe complications become available.
Aged↗