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Biomedical subjects

D M Studdert

Publications and source records attributed to D M Studdert.

16 recordsLinked to original sources

Relationship between complaints and quality of care in New Zealand: a descriptive analysis of complainants and non-complainants following adverse events.

OBJECTIVES: To estimate the proportion and characteristics of patients injured by medical care in New Zealand public hospitals who complain to an independent health ombudsman, the Health and Disability Commissioner ("the Commissioner"). DESIGN: The percentage of injured patients who lodge complaints was estimated by linking the Commissioner's complaints database to records reviewed in the New Zealand Quality of Healthcare Study (NZQHS). Bivariate and multivariate analyses investigated sociodemographic and socioeconomic differences between complainants and non-complainants. SETTING: New Zealand public hospitals and the Office of the Commissioner in 1998. POPULATION: Patients who lodged claims with the Commissioner (n = 398) and patients identified by the NZQHS as having suffered an adverse event who did not lodge a complaint with the Commissioner (n = 847). MAIN OUTCOME MEASURES: Adverse events, preventable adverse events, and complaints lodged with the Commissioner. RESULTS: Among adverse events identified by the NZQHS, 0.4% (3/850) resulted in complaints; among serious, preventable adverse events 4% (2/48) resulted in complaints. The propensity of injured patients to complain increased steeply with the severity of the injury: odds of complaint were 11 times greater after serious permanent injuries than after temporary injuries, and 18 times greater after deaths. Odds of complaining were significantly lower for patients who were elderly (odds ratio (OR) 0.2, 95% confidence interval (CI) 0.1 to 0.4), of Pacific ethnicity (OR 0.3, 95% CI 0.1 to 0.9), or lived in the most deprived areas (OR 0.3, 95% CI 0.2 to 0.6). CONCLUSION: Most medical injuries never trigger a complaint to the Commissioner. Among complaints that are brought, severe and preventable injuries are common, offering a potentially valuable "window" on serious threats to patient safety. The relatively low propensity to complain among patients who are elderly, socioeconomically deprived, or of Pacific ethnicity suggests troubling disparities in access to and utilisation of complaints processes.

Adolescent↗

No-fault compensation for medical injuries: the prospect for error prevention.

Leading patient safety proposals promote the design and implementation of error prevention strategies that target systems used to deliver care and eschew individual blame. They also call for candor among practitioners about the causes and consequences of medical injury. Both goals collide with fundamental tenets of the medical malpractice system. Thus, the challenge of addressing error in medicine demands a thorough reconsideration of the legal mechanisms currently used to deal with harms in health care. In this article, we describe an alternative to litigation that does not predicate compensation on proof of practitioner fault, suggest how it might be operationalized, and argue that there is a pressing need to test its promise. We tackle traditional criticisms of "no-fault" compensation systems for medical injury-specifically, concerns about their cost and the presumption that eliminating liability will dilute incentives to deliver high-quality care. Our recent empirical work suggests that a model designed around avoidable or preventable injuries, as opposed to negligent ones, would not exceed the costs of current malpractice systems in the United States. Implementation of such a model promises to promote quality by harmonizing injury compensation with patient safety objectives, especially if it is linked to reforms that make institutions, rather than individuals, primarily answerable for injuries.

Actuarial Analysis↗

A comparison of iatrogenic injury studies in Australia and the USA. I: Context, methods, casemix, population, patient and hospital characteristics.

OBJECTIVE: To better understand the differences between two iatrogenic injury studies of hospitalized patients in 1992 which used ostensibly similar methods and similar sample sizes, but had quite different findings. The Quality in Australian Health Care Study (QAHCS) reported that 16.6% of admissions were associated with adverse events (AE), whereas the Utah, Colorado Study (UTCOS) reported a rate of 2.9%. SETTING: Hospitalized patients in Australia and the USA. DESIGN: Investigators from both studies compared methods and characteristics and identified differences. QAHCS data were then analysed using UTCOS methods. MAIN OUTCOME MEASURES: Differences between the studies and the comparative AE rates when these had been accounted for. RESULTS: Both studies used a two-stage chart review process (screening nurse review followed by confirmatory physician review) to detect AEs; five important methodological differences were found: (i) QAHCS nurse reviewers referred records that documented any link to a previous admission, whereas UTCOS imposed age-related time constraints; (ii) QAHCS used a lower confidence threshold for defining medical causation; (iii) QAHCS used two physician reviewers, whereas UTCOS used one; (iv) QAHCS counted all AEs associated with an index admission whereas UTCOS counted only those determining the annual incidence; and (v) QAHCS included some types of events not included in UTCOS. When the QAHCS data were analysed using UTCOS methods, the comparative rates became 10.6% and 3.2%, respectively. CONCLUSIONS: Five methodological differences accounted for some of the discrepancy between the two studies. Two explanations for the remaining three-fold disparity are that quality of care was worse in Australia and that medical record content and/or reviewer behaviour was different.

Adolescent↗

A comparison of iatrogenic injury studies in Australia and the USA. II: Reviewer behaviour and quality of care.

OBJECTIVE: To better understand the remaining three-fold disparity between adverse event (AE) rates in the Quality in Australia Health Care Study (QAHCS) and the Utah-Colorado Study (UTCOS) after methodological differences had been accounted for. SETTING: Iatrogenic injury in hospitalized patients in Australia and America. DESIGN: Using a previously developed classification, all AEs were assigned to 98 exclusive descriptive categories and the relative rates compared between studies; they were also compared with respect to severity and death. MAIN OUTCOME MEASURES: The distribution of AEs amongst the descriptive and outcome categories. RESULTS: For 38 categories, representing 67% of UTCOS and 28% of QAHCS AEs, there were no statistically significant differences. For 33, representing 31% and 69% respectively, there was seven times more AEs in QAHCS than in UTCOS. Rates for major disability and death were very similar (1.7% and 0.3% of admissions for both studies) but the minor disability rate was six times greater in QAHCS (8.4% versus 1.3%). CONCLUSIONS: A similar 2% core of serious AEs was found in both studies, but for the remaining categories six to seven times more AEs were reported in QAHCS than in UTCOS. We hypothesize that this disparity is due to different thresholds for admission and discharge and to a greater degree of under-reporting of certain types of problems as AEs by UTCOS than QAHCS reviewers. The biases identified were consistent with, and appropriate for, the quite different aims of each study. No definitive difference in quality of care was identified by these analyses or a literature review.

Adolescent↗

Negligent care and malpractice claiming behavior in Utah and Colorado.

BACKGROUND: Previous studies relating the incidence of negligent medical care to malpractice lawsuits in the United States may not be generalizable. These studies are based on data from 2 of the most populous states (California and New York), collected more than a decade ago, during volatile periods in the history of malpractice litigation. OBJECTIVES: The study objectives were (1) to calculate how frequently negligent and nonnegligent management of patients in Utah and Colorado in 1992 led to malpractice claims and (2) to understand the characteristics of victims of negligent care who do not or cannot obtain compensation for their injuries from the medical malpractice system. DESIGN: We linked medical malpractice claims data from Utah and Colorado with clinical data from a review of 14,700 medical records. We then analyzed characteristics of claimants and nonclaimants using evidence from their medical records about whether they had experienced a negligent adverse event. MEASURES: The study measures were negligent adverse events and medical malpractice claims. RESULTS: Eighteen patients from our study sample filed claims: 14 were made in the absence of discernible negligence and 10 were made in the absence of any adverse event. Of the patients who suffered negligent injury in our study sample, 97% did not sue. Compared with patients who did sue for negligence occurring in 1992, these nonclaimants were more likely to be Medicare recipients (odds ratio [OR], 3.5; 95% CI [CI], 1.3 to 9.6), Medicaid recipients (OR, 3.6; 95% CI, 1.4 to 9.0), > or =75 years of age (OR, 7.0; 95% CI, 1.7 to 29.6), and low income earners (OR, 1.9; 95% CI, 0.9 to 4.2) and to have suffered minor disability as a result of their injury (OR, 6.3; 95% CI, 2.7 to 14.9). CONCLUSIONS: The poor correlation between medical negligence and malpractice claims that was present in New York in 1984 is also present in Utah and Colorado in 1992. Paradoxically, the incidence of negligent adverse events exceeds the incidence of malpractice claims but when a physician is sued, there is a high probability that it will be for rendering nonnegligent care. The elderly and the poor are particularly likely to be among those who suffer negligence and do not sue, perhaps because their socioeconomic status inhibits opportunities to secure legal representation.

Adolescent↗

Incidence and types of adverse events and negligent care in Utah and Colorado.

BACKGROUND: The ongoing debate on the incidence and types of iatrogenic injuries in American hospitals has been informed primarily by the Harvard Medical Practice Study, which analyzed hospitalizations in New York in 1984. The generalizability of these findings is unknown and has been questioned by other studies. OBJECTIVE: We used methods similar to the Harvard Medical Practice Study to estimate the incidence and types of adverse events and negligent adverse events in Utah and Colorado in 1992. DESIGN AND SUBJECTS: We selected a representative sample of hospitals from Utah and Colorado and then randomly sampled 15,000 nonpsychiatric 1992 discharges. Each record was screened by a trained nurse-reviewer for 1 of 18 criteria associated with adverse events. If > or =1 criteria were present, the record was reviewed by a trained physician to determine whether an adverse event or negligent adverse event occurred and to classify the type of adverse event. MEASURES: The measures were adverse events and negligent adverse events. RESULTS: Adverse events occurred in 2.9+/-0.2% (mean+/-SD) of hospitalizations in each state. In Utah, 32.6+/-4% of adverse events were due to negligence; in Colorado, 27.4+/-2.4%. Death occurred in 6.6+/-1.2% of adverse events and 8.8+/-2.5% of negligent adverse events. Operative adverse events comprised 44.9% of all adverse events; 16.9% were negligent, and 16.6% resulted in permanent disability. Adverse drug events were the leading cause of nonoperative adverse events (19.3% of all adverse events; 35.1% were negligent, and 9.7% caused permanent disability). Most adverse events were attributed to surgeons (46.1%, 22.3% negligent) and internists (23.2%, 44.9% negligent). CONCLUSIONS: The incidence and types of adverse events in Utah and Colorado in 1992 were similar to those in New York State in 1984. Iatrogenic injury continues to be a significant public health problem. Improving systems of surgical care and drug delivery could substantially reduce the burden of iatrogenic injury.

Adolescent↗

The jury is still in: Florida's Birth-Related Neurological Injury Compensation Plan after a decade.

Florida's Birth-Related Neurological Injury Compensation Plan (NICA) is the most significant experiment with compensation for medical injury yet undertaken in the United States. As NICA enters its second decade of operation, maintaining the scheme's jurisdictional integrity has emerged as a key challenge for policy makers in Florida. We explore the relationship that has emerged between NICA and the tort system as competing avenues for families to obtain compensation for severe birth-related neurological injury. By linking NICA claims data with data on malpractice claims filed in Florida, we found a lively persistence of "bad baby" litigation despite NICA's implementation. Many families pursued claims in both fora. An explanation for these results can be traced to key features of the plan's design--primarily, the way in which "exclusive" jurisdiction over injuries is determined and the restrictive nature of the compensation criteria used. Our findings may help efforts to consolidate NICA's role in injury compensation and inform future design of alternative compensation systems.

Birth Injuries↗

Legal issues in the delivery of alternative medicine.

As use of alternative therapies grows, there appears to be heightened concern among health care professionals about the liability implications of delivering these therapies. Little is known about malpractice law in this area. We begin by reviewing the type and frequency of claims brought against alternative medicine practitioners and by analyzing the standard of care to which these practitioners are held when sued. Next we turn to the standard of care question as it relates to physicians (MDs/DOs) who incorporate alternative therapies into their practices. Few cases have addressed this question to date. We argue, however, that when courts decide cases at the intersection between conventional and alternative medicine, they may judge conduct according to standards enunciated by: 1) alternative medicine practitioners who regularly deliver the treatment at issue, 2) physicians who have established similar practices, or 3) conventional practitioners. This latter possibility should be taken seriously; it raises troubling questions for physicians at the outset of the negligence inquiry. Available case law highlights the importance of ensuring that patients are fully informed about any alternative therapies they elect to receive, as well as any conventional treatments they may be foregoing, and that patients expressly consent to treatment in light of this information, preferably in writing.

Complementary Therapies↗

Costs of medical injuries in Utah and Colorado.

Patient injuries are thought to have a substantial financial impact on the health care system, but recent studies have been limited to estimating the costs of adverse drug events in teaching hospitals. This analysis estimated the costs of all types of patient injuries from a representative sample of hospitals in Utah and Colorado. We detected 459 adverse events (of which 265 were preventable) by reviewing the medical records of 14,732 randomly selected 1992 discharges from 28 hospitals. The total costs (all results are discounted 1996 dollars) were $661,889,000 for adverse events, and $308,382,000 for preventable adverse events. Health care costs totaled $348,081,000 for all adverse events and $159,245,000 for the preventable adverse events. Fifty-seven percent of the adverse event health care costs, and 46% of the preventable adverse event costs were attributed to outpatient medical care. Surgical complications, adverse drug events, and delayed or incorrect diagnoses and therapies were the most expensive types of adverse events. The costs of adverse events were similar to the national costs of caring for people with HIV/AIDS, and totaled 4.8% of per capita health care expenditures in these states.

Colorado↗

Clinical trials in developing countries: scientific and ethical issues.

Since the 1994 finding that intensive zidovudine treatment of mothers and infants can dramatically reduce perinatal transmission of human immunodeficiency virus, this treatment has been widely adopted in developed countries. In developing countries, trials of less-intensive (and cheaper) regimens have gone ahead, many funded by foreign governments and the United Nations. Controversy has erupted over these trials, particularly over their use of placebo controls. Do differences in healthcare needs and budgets justify different ethical standards in the developed and the developing world?

Anti-HIV Agents↗

Medical malpractice implications of alternative medicine.

Although use of alternative therapies in the United States is widespread and growing, little is known about the malpractice experience of practitioners who deliver these therapies or about the legal principles that govern the relationship between conventional and alternative medicine. Using data from malpractice insurers, we analyzed the claims experience of chiropractors, massage therapists, and acupuncturists for 1990 through 1996. We found that claims against these practitioners occurred less frequently and typically involved injury that was less severe than claims against physicians during the same period. Physicians who may be concerned about their own exposure to liability for referral of patients for alternative treatments can draw some comfort from these findings. However, liability for referral is possible in certain situations and should be taken seriously. Therefore, we review relevant legal principles and case law to understand how malpractice law is likely to develop in this area. We conclude by suggesting some questions for physicians to ask themselves before referring their patients to alternative medicine practitioners.

Complementary Therapies↗

Expanded managed care liability: what impact on employer coverage?

Policymakers are considering legislative changes that would increase managed care organizations' exposure to civil liability for withholding coverage or failing to deliver needed care. Using a combination of empirical information and theoretical analysis, we assess the likely responses of health plans and Employee Retirement Income Security Act (ERISA) plan sponsors to an expansion of liability, and we evaluate the policy impact of those moves. We conclude that the direct costs of liability are uncertain but that the prospect of litigation may have other important effects on coverage decision making, information exchange, risk contracting, and the extent of employers' involvement in health coverage.

Costs and Cost Analysis↗