Empirical developments in retraction.

This study provides current data on key questions about retraction of scientific articles. Findings confirm that the rate of retractions remains low but is increasing. The most commonly cited reason for retraction was research error or inability to reproduce results; the rate from research misconduct is an underestimate, since some retractions necessitated by research misconduct were reported as being due to inability to reproduce. Retraction by parties other than authors is increasing, especially for research misconduct. Although retractions are on average occurring sooner after publication than in the past, citation analysis shows that they are not being recognised by subsequent users of the work. Findings suggest that editors and institutional officials are taking more responsibility for correcting the scientific record but that reasons published in the retraction notice are not always reliable. More aggressive means of notification to the scientific community appear to be necessary.

How the manner of presentation of data influences older patients in determining their treatment preferences.

OBJECTIVE: To assess how the manner of presentation of graphic data to older patients influences their treatment preferences. DESIGN: Cross-sectional structured interviews with patients. SETTING: A university-based Department of Veterans Affairs Medical Center. PATIENTS: One hundred sixty-six consecutive patients (mean age = 64.8 years, range of ages 29-82) seen in a Department of Veterans Affairs general medicine clinic. MEASUREMENTS: Five pairs of 5-year survival curves were presented to patients. Each pair was composed of two survival curves for alternative unidentified treatments for an unidentified medical condition. Curve A (LT = better long-term, worse short-term survival) was fixed throughout all curve pairs. Curve B (ST = better short-term, worse long-term survival) changed in each curve pair, showing incrementally better chances of short-term survival across the five curve pairs. Patients were randomly assigned to view the curve pairs in forward (increasing short-term survival) or backward (decreasing short-term survival) order. RESULTS: Order is a significant predictor of patients' initial preferences for the short-term survival curve (P = 0.0004) as well as their willingness to shift preferences during presentation of the five curve pairs. Patients > or = 65 were more likely to initially choose the ST curve in forward order presentation than patients < 65. More educated patients generally were less likely to prefer the ST curve under both elicitation orders. CONCLUSIONS: The data indicate that the method of eliciting patients' preferences strongly influenced their expressed preferences, and that these preferences may have predictable relationships with demographic characteristics such as age.

Older patients' willingness to trade off urologic adverse outcomes for a better chance at five-year survival in the clinical setting of prostate cancer.

OBJECTIVE: To assess whether patients report a willingness to trade-off urologic adverse outcomes--urinary incontinence and total impotence--for a better chance of 5-year survival in the clinical setting of prostate cancer; and, if so, whether patients' current levels of symptoms of urinary incontinence, impotence, and frequency of sexual activity influence their decisions. DESIGN: Structured interviews with a convenience sample of male patients. SETTING: A university-based Department of Veterans Affairs Medical Center. PATIENTS: One hundred sixty-three patients seen consecutively in General Medical Clinic at the Department of Veterans Affairs Medical Center in Portland, Oregon, were enrolled in the study. Mean age of the patients was 65.2 years (SD = 10.6, range - 35-84); mean level of formal education completed was 13 years (SD = 2.7, range = 5-19). MEASUREMENTS: In a hypothetical clinical setting of prostate cancer, patients were offered a choice of two procedures--Treatment A (surgery: worse short-term, better long-term survival) and Treatment B (radiation therapy: better short-term, worse long-term survival)--with varying benefit/risk trade-offs in time. Patients were presented with pairs of treatment curves that were developed from research data on survival for surgery versus radiation therapy for stage II prostate cancer confined to the prostate gland. Treatments were not identified to control for labeling effects. Patients were asked their willingness to accept a chance of immediate mortality for better 5-year survival in one of four treatment curve comparisons. Of those who accepted the net beneficial procedure, we then inquired as to whether urologic complications--urinary incontinence and wearing an appliance to collect urine or total impotence--altered the acceptability of that treatment. RESULTS: Ninety-four percent (153/163) of patients were willing to choose Treatment A (worse short-term, better long-term survival) on one of the four scenarios; the remainder (10/163) were unwilling to take Treatment A (worse short-term, better long-term survival) on any of the four scenarios. Sixty-two percent (95/153) of patients were willing to accept a 100% chance of urinary incontinence; 83% (127/153) were willing to accept a 100% chance of impotence (chi-square = 16.8 with 1 df, P = .0001). CONCLUSIONS: Our results in an older male veteran population suggest than many patients are more concerned with long-term survival in the clinical setting of prostate cancer than with short-term treatment risks. In addition, patients are more willing to accept an impotence outcome than a urinary incontinence outcome, but this result was not related to patients' reported frequency of sexual activity.

Patients' willingness to accept life-sustaining treatment when the expected outcome is a diminished mental health state: an exploratory study.

OBJECTIVE: To assess patients' willingness to accept life-sustaining treatment when the expected outcome is a diminished mental health state. DESIGN: Structured interviews with a consecutive series of patients. SETTING: A university-based Department of Veterans Affairs Medical Center. PATIENTS: One hundred four male patients (mean age = 65.4 years; range 37-82) seen consecutively in a general medicine clinic. MEASUREMENTS: We assessed the acceptability of temporary ventilatory support of a hypothetical case of severe pneumonia. Patients were asked to consider mental health states involving minor cognitive deficits that varied only in their expected frequency and duration. RESULTS: All patients except one were willing to accept temporary life support in the management of severe pneumonia. Of these 103 patients, 76 patients specified the number of days they would allow themselves to be continued on intubation and ventilatory support. The length of time varied from 1 day to 2 years and was longer when patients reported having had a stroke of reported being in fair of poor health. Fifty patients were willing to accept all diminished mental health states, including the most severe state (F). Patients who reported having been in a medical intensive care unit were more likely to accept intubation in the most severe state (F). CONCLUSIONS: In the case of "severe pneumonia", about half of our older male veterans reported a willingness to accept intubation and ventilatory support even if it resulted in persistent cognitive disability. These results suggest that experience in a medical intensive care unit with the ventilators and experience with strokes may make patients more tolerant of treatments that may result in impaired cognitive function.

How older patients' treatment preferences are influenced by disclosures about therapeutic uncertainty: surgery versus expectant management for localized prostate cancer.

OBJECTIVES: There is an ongoing debate about the proper management of localized prostate cancer in older men. We assessed whether older patients differ in their willingness to accept surgery versus expectant management for a hypothetical early stage, low grade, clinically localized prostate carcinoma, and whether patients' current levels or past history of urologic dysfunction (difficulties initiating urination, failing to empty the bladder, urinary dribbling, getting up at night to urinate, and frequency of sexual activity) influence their decisions. We assessed patients' willingness to choose surgery over expectant management by varying the expected survival benefit in years (ESBs-em) of surgery over expectant management. DESIGN: Structured interviews with a consecutive series of male patients. SETTING: A university-based Department of Veterans Affairs Medical Center. PATIENTS: One hundred forty-eight patients seen consecutively in General Medicine Clinic at the Department of Veterans Affairs Medical Center in Portland, Oregon, were enrolled in the study. Mean age of the patients was 66.3 years (SD = 10.3, range = 30-85); mean level of formal education was 12.6 years (SD = 2.7, range = 6-22). MEASUREMENTS: Patients were asked whether they would accept surgery or expectant management in one of 11 treatment comparisons. We varied the ESBs-em in 1-year increments from 0 years to 10 years. As described to patients, surgery carried a mortality risk at the time of treatment of 1 to 2%. Once any patient indicated a willingness to accept surgery at any of the treatment comparisons or if any patient reported preferring expectant management across all treatment comparisons, the elicitation procedure was stopped. All patients were asked to complete a urological and sexual functioning questionnaire to determine the presence of coexisting urological dysfunction and level of sexual activity both at present and in the past. RESULTS: Of the 148 patients enrolled in the study, 43.2% (64/148) preferred surgery with a zero expected life benefit over expectant management (ESBs-em = 0) and a 1 to 2% chance of dying within 1 month of surgery; 24.3% (36/148) rejected surgery as the expected life benefit of surgery was increased (0 < ESBs-em < or = 10 years); 26.4% (39/148) preferred expectant management even when there was a 10-year expected life benefit of surgery; 4.7% (7/148) preferred that their physician make the decision for them; and 1.4% (2/148) of patients reported that they preferred radiation therapy, an option that was not offered to them explicitly. Our results suggest that older patients are more likely to report a preference for expectant management (OR = 1.07). Further, our results suggest that patients who report current urinary dribbling (OR = 9.03) are much more likely to prefer expectant management but that this preference decreases with the amount of time they have had this problem. Similarly, we find that patients who have difficulty with starting urination are much more likely to prefer surgery (OR = 0.13), and this preference is also mediated by the number of years they have experienced this problem. Treatment choice was not associated with formal education, present health status, or the other urological symptoms we assessed. CONCLUSION: Our study in an older male veteran population showed preferences for a variety of options in prostate cancer. Although the majority of men preferred surgery, a significant number preferred expectant management. Our results show that preferences reflect patients' experiences with physical problems associated with disease and that these experiences need to be explored and considered by patients and their providers when making treatment decisions.

Verbal expressions of probability in informed consent litigation.

Informed consent litigation provides a forum in which probabilistic evidence is elicited from physicians as parties or as expert witnesses. The authors reviewed over 450 medical informed consent opinions reported by both trial and appellate courts in all 50 states over 40 years to determine 1) the extent to which verbal expressions of probability were used by testifying physicians to characterize the risks of medical procedures; 2) when such expressions were used, whether consistent numeric interpretations of the terms were being applied by the physicians; 3) whether the choice of expression was influenced by the severity of the consequences associated with the particular risk; and 4) whether the use of such terms was correlated with trial outcomes, inasmuch as the duty to disclose a risk is said to increase with the magnitude of the risk and probability is one measure of such magnitude. It was found that subjective verbal expressions of probability are used in the litigation setting, and that such expressions represent broad ranges of numeric probabilities. There was some correlation between the expression and the represented numeric probabilities. In general, expressions such as "extremely low" and "low" corresponded to probabilities lower than those represented by terms such as "high" and "very high." Further, verbal expressions appeared to be influenced by the severity of the consequences associated with the risks, but whether this increases or decreases the ambiguity of verbal expressions in the communication process warrants further research. The authors suggest a syntax of verbal expressions of probability as a means to reduce the numeric ambiguity of these terms.

Measuring decision sensitivity: a combined Monte Carlo-logistic regression approach.

Modeling of the uncertainty of multiple input variables for a complex decision problem complicates sensitivity analysis. A method of analysis comprising stochastic simulation of the model and logistic regression of the simulated dichotomous decision variable against all of the input variables yields a direct measure of the importance of input variables to the decision. This method is demonstrated on a previously analyzed clinical decision either to continue observation or to immediately treat with anticoagulants a woman presenting with deep vein thrombosis in the first trimester of pregnancy. A relative measure of the importance of each input variable in causing a change of decision is estimated by calculating the change in the log odds attributable to variation of each input variable over its range of uncertain values compared with the total change of log odds from variation of all input variables. This method is compared with alternative measures of input variable importance, and is found to be a simple yet powerful tool for gaining quantitative insight into the nuances of a decision model.

How preliminary data affect people's stated willingness to enter a hypothetical randomized controlled trial.

PURPOSE: To explore how preliminary trial data affect the general public's stated willingness to enter a randomized clinical trial. METHODS: We asked 165 prospective jurors to imagine that their physicians wanted them to enroll in a clinical trial. We then presented them with scenarios portraying preliminary trial results--for example, 9 out of 10 patients get better with drug A and 5 out of 10 get better with drug B--and asked after each scenario, whether they would choose to be part of the trial. We designed the scenarios to test how stated willingness to enter the trial would be influenced by: 1) the difference in effectiveness of the 2 treatments based on the patients enrolled thus far; and 2) by the chance that the difference in effectiveness was random (i.e., the P value). The subjects' willingness to enter the trial at various decision points was analyzed using logistic regression. RESULTS: Fewer subjects were willing to enter the trial as preliminary data indicated either an increasing difference in the effectiveness of the two treatments or an increasing statistical significance of that difference. For example 75% of subjects were willing to enter the research trial before any preliminary data were presented, but this number fell to 49% when subjects were presented with preliminary data showing that 9 out of 10 patients improved with one treatment and 5 out of 10 with the other. Multivariable logistic regression revealed that higher P values (odds ratio = 4.29; P < 0.001; 95% CI: 2.22-8.28) and smaller differences in effectiveness (odds ratio = 0.02; P < 0.001; 95% CI: 0.00-0.07) implicit in preliminary data presented to subjects made subjects less likely to agree to enter clinical trials. After adjustment for other relevant variables, male gender was associated with increased willingness to enter the trial. CONCLUSION: A subjects' willingness to enter the hypothetical trial was influenced by preliminary data. Fewer subjects were willing to enter the trial as the differences in benefit between 2 treatment groups increased. However, the majority of subjects were willing to enter the hypothetical trial even when preliminary evidence strongly favored one treatment over another. Given the importance of informed consent in entering patients in clinical trials, these results should be confirmed in actual trial settings.

Hospital consent for disclosure of medical records.

Disclosure of information clauses in general consent-to-treatment forms used by 202 large hospitals nationwide are described and mapped into a taxonomy to distinguish types of disclosures and to help structure consent documents.

A qualitative study of women's views on medical confidentiality.

CONTEXT: The need to reinvigorate medical confidentiality protections is recognised as an important objective in building patient trust necessary for successful health outcomes. Little is known about patient understanding and expectations from medical confidentiality. OBJECTIVE: To identify and describe patient views of medical confidentiality and to assess provisionally the range of these views. DESIGN: Qualitative study using indepth, open ended face-to-face interviews. SETTING: Southeastern Pennsylvania and southern New Jersey, USA. PARTICIPANTS: A total of 85 women interviewed at two clinical sites and three community/research centres. MAIN OUTCOME MEASURES: Subjects' understanding of medical confidentiality, beliefs about the handling of confidential information and concerns influencing disclosure of information to doctors. RESULTS: The subjects defined medical confidentiality as the expectation that something done or said would be kept "private" but differed on what information was confidential and the basis and methods for protecting information. Some considered all medical information as confidential and thought confidentiality protections functioned to limit its circulation to medical uses and reimbursement needs. Others defined only sensitive or potentially stigmatising information as confidential. Many of these also defined medical confidentiality as a strict limit prohibiting information release, although some noted that specific permission or urgent need could override this limit. CONCLUSIONS: Patients share a basic understanding of confidentiality as protection of information, but some might have expectations that are likely not met by current practice nor anticipated by doctors. Doctors should recognise that patients might have their own medical confidentiality models. They should address divergences from current practice and provide support to those who face emotional or practical obstacles to self-revelation.

Disease gene patents: overcoming unethical constraints on clinical laboratory medicine.

The rapidly growing number of disease gene patents--patents that claim all methods for diagnosis of a particular genetic condition--threatens the ability of physicians to provide medical care to their patients. In the past, patented diagnostic tests were made broadly available to the medical community in the form of test kits or licenses to use the patented test. Disease gene tests, however, are being monopolized by a small number of providers. Monopolization of medical testing services: (a) threatens to restrict research activities; (b) creates unacceptable conflicts of interest; (c) may reduce patient access to testing; (d) may lead to inequitable extensions of patent terms on tests and related discoveries; and (e) grants to patent holders the ability to dictate the standard of care for testing, and to otherwise interfere with the practice of medicine. Because of the risks raised by monopolization, amendment of the patent law to require compulsory licensing of physicians providing medical services is recommended.

How age, outcome severity, and scale influence general medicine clinic patients' interpretations of verbal probability terms.

OBJECTIVE: To assess whether the type of scale used (scaling effects) and the severity of outcome (outcome severity) influence patients' numerical interpretations of verbal probability expressions. DESIGN: Cross-sectional survey of patients in a general medicine clinic. SETTING: A university-based Department of Veterans Affairs Medical Center. PARTICIPANTS: 210 patients seen consecutively in a general medicine clinic. MEASUREMENTS AND RESULTS: The patients were randomized to scale and health outcome (complications of surgery). Two scales (a long form and a short form) were used to expressly allow patients to choose probabilities less than 1%. The long form had a lower bound of "< 1 out of 1,000,000"; the short form had a lower bound of "< 1 out of 1,000." Two complications were used: "death from anesthesia" and "severe pneumonia." In the context of being told that their surgeon believed that the chance the complication would occur was "rare," patients were asked to give the numerical estimate of that chance. The values elicited on both scales were significantly different for the two outcomes, with the "rare" risk of death from anesthesia being characterized as less likely than the "rare" risk of severe pneumonia (F = 5.24, p = 0.023). Linear regression and three-factor analysis of variance showed significant differences in the probabilities elicited for scale, outcome, and age, with older patients generally responding with higher probabilities than did younger patients. CONCLUSIONS: These findings suggest that the severity of the associated outcome and the scale used to elicit patients' numerical estimates of verbal probability expressions influence patients' quantitative interpretations of the verbal probability statement; and older patients respond with higher probabilities of negative outcomes than do younger patients. Future studies must continue to explore whether verbal probability expressions are adequate for communicating medical risk to patients or whether patients should be provided with numerical estimates of frequency.

Patients' interpretations of verbal expressions of probability: implications for securing informed consent to medical interventions.

Physicians often use verbal expressions of probability to characterize their uncertainty about outcomes and the risks or side effects of proposed therapies. However, there is an extensive literature that documents the inherent vagueness of such expressions. Because of the potential importance of probability terms to physician-patient communication and decision-making, we asked patients to tell us the odds they thought applicable to the term "rare," as used by their physician to discuss the likelihood of an adverse outcome from surgery. Patients were randomly assigned to one of three outcome groups: death, severe heart attack, or severe pneumonia. Demographic data were elicited from each subject, as were indicators of present health status, medical history for certain diseases and surgery, and life expectancy. Linear regression and ANOVA analyses of the responses indicate that patient age, education level, perceived health status, and recency of experience with disease and medical care influence patients' numeric interpretations. We discuss the implications of these results.

Informed consent for emergency contraception: variability in hospital care of rape victims.

There is growing concern that rape victims are not provided with emergency contraceptives in many hospital emergency rooms, particularly in Catholic hospitals. In a small pilot study, we examined policies and practices relating to providing information, prescriptions, and pregnancy prophylaxis in emergency rooms. We held structured telephone interviews with emergency department personnel in 58 large urban hospitals, including 28 Catholic hospitals, from across the United States. Our results showed that some Catholic hospitals have policies that prohibit the discussion of emergency contraceptives with rape victims, and in some of these hospitals, a victim would learn about the treatment only by asking. Such policies and practices are contrary to Catholic teaching. More seriously, they undermine a victim's right to information about her treatment options and jeopardize physicians' fiduciary responsibility to act in their patients' best interests. We suggest that institutions must reevaluate their restrictive policies. If they fail to do so, we believe that state legislation requiring hospitals to meet the standard of care for treatment of rape victims is appropriate.

Patient consent for release of sensitive information from their medical records: an exploratory study.

The disclosure of sensitive information concerning mental health, drug and alcohol use, and communicable diseases requires express patient consent under federal and state laws. This paper presents the results of a retrospective medical record abstraction of hospital consent-to-treatment and release-of-information forms, examining whether the forms are present in the records, and, if so, whether they are signed by patients. The results suggest that patients who have sensitive information in their medical records or pay out of pocket for their care are less likely to consent to disclosure of their records. We discuss the implications of these results and recommend further research to understand patients' perceptions of medical confidentiality and the processes used for securing consent to hospital treatment.