A systematic review of validated methods for identifying cerebrovascular accident or transient ischemic attack using administrative data.

PURPOSE: To perform a systematic review of the validity of algorithms for identifying cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs) using administrative and claims data. METHODS: PubMed and Iowa Drug Information Service searches of the English language literature were performed to identify studies published between 1990 and 2010 that evaluated the validity of algorithms for identifying CVAs (ischemic and hemorrhagic strokes, intracranial hemorrhage, and subarachnoid hemorrhage) and/or TIAs in administrative data. Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to pre-specified criteria. RESULTS: A total of 35 articles met the criteria for evaluation. Of these, 26 articles provided data to evaluate the validity of stroke, seven reported the validity of TIA, five reported the validity of intracranial bleeds (intracerebral hemorrhage and subarachnoid hemorrhage), and 10 studies reported the validity of algorithms to identify the composite endpoints of stroke/TIA or cerebrovascular disease. Positive predictive values (PPVs) varied depending on the specific outcomes and algorithms evaluated. Specific algorithms to evaluate the presence of stroke and intracranial bleeds were found to have high PPVs (80% or greater). Algorithms to evaluate TIAs in adult populations were generally found to have PPVs of 70% or greater. CONCLUSIONS: The algorithms and definitions to identify CVAs and TIAs using administrative and claims data differ greatly in the published literature. The choice of the algorithm employed should be determined by the stroke subtype of interest.

A systematic review of validated methods for identifying heart failure using administrative data.

PURPOSE: To identify and describe the validity of algorithms used to detect heart failure (HF) using administrative and claims data sources. METHODS: A systematic review of PubMed and Iowa Drug Information Service searches of the English language was performed to identify studies published between 1990 and 2010 that evaluated the validity of algorithms for the identification of patients with HF using and claims data. Abstracts and articles were reviewed by two study investigators to determine their relevance on the basis of predetermined criteria. RESULTS: The initial search strategy identified 887 abstracts. Of these, 499 full articles were reviewed and 35 studies included data to evaluate the validity of identifying patients with HF. Positive predictive values (PPVs) were in the acceptable to high range, with most being very high (>90%). Studies that included patients with a primary hospital discharge diagnosis of International Classification of Diseases, Ninth Revision, code 428.X had the highest PPV and specificity for HF. PPVs for this algorithm ranged from 84% to 100%. This algorithm, however, may compromise sensitivity because many HF patients are managed on an outpatient basis. The most common 'gold standard' for the validation of HF was the Framingham Heart Study criteria. CONCLUSIONS: The algorithms and definitions used to identify HF using administrative and claims data perform well, particularly when using a primary hospital discharge diagnosis. Attention should be paid to whether patients who are managed on an outpatient basis are included in the study sample. Including outpatient codes in the described algorithms would increase the sensitivity for identifying new cases of HF.

Exclusion of older adults and women from recent trials of acute coronary syndromes.

OBJECTIVES: To determine whether the participation of older adults and women in published clinical trials has increased during recent years. DESIGN: Systematic review to identify clinical trials of acute coronary syndromes (ACSs) published from May 2007 to May 2009. Trials were excluded if they enrolled fewer than 50 participants, were substudies of previously published trials, or initiated treatment more than 3 weeks after the acute cardiac event. SETTING: A search of MEDLINE and the Cochrane Central Register of Controlled Trials. PARTICIPANTS: Sixty-eight thousand sixteen participants of 80 trials. MEASUREMENTS: Information on the age of trial participants, percentage of participants who were female, and whether there were specific exclusions based on age were abstracted from all included trials. RESULTS: Twenty-three trials (29.7%) had explicit exclusion criteria based on age. Only 13.8% of study participants were aged 75 and older, and 27.7% were women. These percentages are below the representation of all U.S. adults experiencing an ACS in recent years who were aged 75 and older (41.9%) or female (41.5%). The average age of all study participants was 61.6 ± 3.8. There was a significant association between the mean age of a study population and the proportion of women enrolled in the trial. CONCLUSION: Older adults and women remain underrepresented in recent clinical trials of people hospitalized with an ACS. These exclusions may hinder efforts to inform evidence-based clinical decision-making in these high-risk populations.

Parents' perceptions of medical errors.

OBJECTIVES: The purpose of this study was to explore parents' experiences related to events which they believed to be medical errors in their child's care. METHODS: In-depth qualitative interviews were conducted with parents who believed their child had experienced a medical error; responses were analyzed using qualitative methods. RESULTS: In 35 interviews, parents reported a variety of events that they believed to be errors. They described physical harm, emotional distress, life disruptions, changes in behavior, and damage to the relationship with the provider as a result of these events. Most parents felt that they had received no explanation of what had happened, no acknowledgement of the impact of the event, no apology and no acceptance of responsibility by a provider. Parents wanted providers to offer these responses, to express caring for the patient and to feel remorse. They also wanted to know that steps would be taken to prevent recurrences. CONCLUSIONS: Perceived medical errors can impact both the patient and the family in many ways. We recommend that providers acknowledge the full impact of a perceived error and tailor their response to meet the specific needs of the patient and family.

A qualitative study of consumers' views on public reporting of health care-associated infections.

Recent interest in publicly reporting health care-associated infections (HAIs) makes it important to develop reports that consumers can understand and evaluate. In-depth qualitative interviews were conducted with 59 consumers. Interviews focused on responses to existing and prototypical reports and on recommendations for improvements. Many interviewees were unfamiliar with HAIs and were distressed to learn HAIs occur and can result in death. Public reporting was seen as unlikely to affect hospital choice; other factors were considered more influential. Interviewees recommended that reports be brief and include information on prevention as well as performance data. Additional recommendations on format and content were identified. For public reporting of HAIs to be successful, attention to report content and format are necessary. Consumer involvement can help to identify potential sources of confusion and methods of improving reporting.

Cluster randomized trials to study the comparative effectiveness of therapeutics: stakeholders' concerns and recommendations.

PURPOSE: To describe the concerns raised by health plan members, providers and purchasers related to studying the comparative effectiveness of therapeutics using cluster randomized trials (CRTs) within health plans. An additional goal was to develop recommendations for increasing acceptability. METHODS: Eighty-four qualitative in-depth telephone interviews were conducted; 50 with health plan members, 21 with providers, and 13 with purchasers. Interviews focused on stakeholders' concerns about and recommendations for conducting CRTs in health plans. RESULTS: Members expressed concerns that CRTs might compromise their healthcare. Providers and purchasers recognized the value of and the need for comparative effectiveness research. Providers expressed concerns that they would not have sufficient time to discuss a CRT with patients, and that participation in such a study could negatively impact their relationships with patients. Purchasers would want assurances that study participation would not result in members receiving lesser care, and that benefits would remain equitable for all members. CONCLUSIONS: This study provides insight into how health plan members, providers and purchasers might react to a CRT being conducted in their health plan. The recommendations reported here provide guidance for researchers and policy makers considering this methodological approach and suggest that with sufficient preparation and planning CRTs can be an acceptable and efficient methodology for studying the comparative effectiveness of therapeutics in real world settings.

Communicating hospital infection data to the public: a study of consumer responses and preferences.

There is growing interest in public reporting of health care performance data relating to healthcare-associated infections (HAIs). This study evaluated different approaches for reporting hospital-level comparative data on HAIs and the extent to which such data might influence hospital choice. Eight versions of a report were developed, varying whether data were consistent across indicators, whether data were presented in text or graphs, and whether confidence intervals were included. A report and a questionnaire were mailed to a randomly selected sample of local residents. Findings provide no evidence that consistency of indicators, data presentation, report format, or inclusion of confidence intervals significantly impacted consumers' understanding. More educated consumers reported greater understanding of the reports. Responses suggested that public reporting of comparative data on HAIs could influence hospital choice, but other factors including prior experience, reputation, physicians' recommendations, and insurance coverage are also influential. Most consumers understand information on HAIs when it is presented in a short, simple report, and most correctly select the best or worst hospital. Consumers may be influenced by such data, but other factors are likely to be as or more important.

Medication errors among adults and children with cancer in the outpatient setting.

PURPOSE: Outpatients with cancer receive complicated medication regimens in the clinic and home. Medication errors in this setting are not well described. We aimed to determine rates and types of medication errors and systems factors associated with error in outpatients with cancer. METHODS: We retrospectively reviewed records from visits to three adult and one pediatric oncology clinic in the Southeast, Southwest, Northeast, and Northwest for medication errors using established methods. Two physicians independently judged whether an error occurred (kappa = 0.65), identified its severity (kappa = 0.76), and listed possible interventions. RESULTS: Of 1,262 adult patient visits involving 10,995 medications, 7.1% (n = 90; 95% CI, 5.7% to 8.6%) were associated with a medication error. Of 117 pediatric visits involving 913 medications, 18.8% (n = 22; 95% CI, 12.5% to 26.9%) were associated with a medication error. Among all visits, 64 of the 112 errors had the potential to cause harm, and 15 errors resulted in injury. There was a range in the rates of chemotherapy errors (0.3 to 5.8 per 100 visits) and home medication errors (0 to 14.5 per 100 visits in children) at different sites. Errors most commonly occurred in administration (56%). Administration errors were often due to confusion over two sets of orders, one written at diagnosis and another adjusted dose on the day of administration. Physician reviewers selected improved communication most often to prevent error. CONCLUSION: Medication error rates are high among adult and pediatric outpatients with cancer. Our findings suggest some practical targets for intervention, including improved communication about medication administration in the clinic and home.