Measuring the quality of surgical decisions for Latina breast cancer patients.

BACKGROUND: A high-quality decision for breast cancer surgery requires that patients are well informed, meaningfully involved in decision making, and receive treatments that match their goals. There is little in the existing literature that examines a comprehensive measure of decision quality for Latina breast cancer patients. OBJECTIVE: To examine the quality of surgical decisions among Latina breast cancer survivors and explore factors associated with decision quality and decision regret. DESIGN: Cross-sectional mailed survey. MAIN OUTCOME MEASURES: English and certified Spanish translations of Breast Cancer Surgery Decision Quality Instrument (BCS-DQI), Short Acculturation Scale for Hispanics (SASH) and decision regret. PARTICIPANTS AND SETTING: Ninety-seven breast cancer survivors of Hispanic or Spanish descent identified through the cancer registry from Orange or San Diego Counties in California. RESULTS: The 97 respondents were on average 55.7 years old, 39.1% had high school diploma or more education, and 62.9% had low acculturation (SASH scores < 2.99). The average knowledge score was 48.2%, the average decision process score was 67.5%, and many (77.3%) received treatments that matched their goals. In multivariable models, there were no significant associations with education, age, acculturation and any aspect of decision quality or decision regret in this sample. Respondents who had higher decision process scores, indicating more involvement in decision making, had significantly lower decision regret. CONCLUSIONS: The BCS-DQI may require some adaptation for Latina populations to improve acceptability. The different aspects of decision quality, including knowledge, decision process and concordance, did not vary by level of acculturation.

Development and evaluation of a new survey instrument to measure the quality of colorectal cancer screening decisions.

BACKGROUND: Guidelines for colorectal cancer screening recommend that patients be informed about options and be able to select preferred method of screening; however, there are no existing measures available to assess whether this happens. METHODS: Colorectal Cancer Screening Decision Quality Instrument (CRC-DQI) includes knowledge items and patients' goals and concerns. Items were generated through literature review and qualitative work with patients and providers. Hypotheses relating to the acceptability, feasibility, discriminant validity and retest reliability of the survey were examined using data from three studies: (1) 2X2 randomized study of participants recruited online, (2) cross-sectional sample of patients recruited in community health clinics, and (3) cross-sectional sample of providers recruited from American Medical Association Master file. RESULTS: 338 participants were recruited online, 94 participants were recruited from community health centers, and 115 physicians were recruited. The CRC-DQI was feasible and acceptable with low missing data and high response rates for both online and paper-based administrations. The knowledge score was able to discriminate between those who had seen a decision aid or not (84% vs. 64%, p < 0.001) and between providers, online patients and clinic patients (89% vs. 74% vs. 41%, p < 0.001 for all comparisons). The knowledge score and most of the goals had adequate retest reliability. About half of the participants received a test that matched their goals (47% and 51% in online and clinic samples respectively). Many respondents who had never been screened had goals that indicated a preference for colonoscopy. A minority of respondents in the online (21%) and in clinic (2%) samples were both well informed and received a test that matched their goals. CONCLUSIONS: The CRC-DQI demonstrated good psychometric properties in diverse samples, and across different modes of administration. Few respondents made high quality decisions about colon cancer screening.

Decision aid reduces misperceptions about hormone therapy: a randomized controlled trial.

OBJECTIVE: This study aims to evaluate the role of a decision aid intervention in knowledge of menopausal symptom management. METHODS: Five hundred fifteen U.S. women who had menopausal symptoms and had discussed symptom management with providers within the past 12 months were assigned to either receive a decision aid or not. Participants completed a telephone survey 2 weeks after enrollment to assess knowledge. Overall knowledge scores and knowledge scores for general symptoms, benefits of hormone therapy, and risks of HT were compared between the decision aid arm and the control arm. RESULTS: Four hundred one women completed the survey. Participants in the decision aid arm had a significantly higher mean (SD) knowledge score (63.3% [18.4%]) compared with the control arm (57.5% [16.4%]; P = 0.001). Specifically, participants in the decision aid arm had significantly higher scores for general symptoms (mean difference, 11.0; 95% CI, 5.3 to 16.6; P < 0.001) and knowledge about benefits of HT (mean difference, 4.2; 95% CI, 0.03 to 8.5; P = 0.048) compared with the control arm. However, scores on knowledge about HT risks were not different between the arms (mean difference, 2.1; 95% CI, -3.0 to 7.2; P = 0.422). CONCLUSIONS: The decision aid arm has greater knowledge of menopausal symptom management compared with the control arm, although the difference is small. In general, there is a considerable lack of knowledge about menopausal symptoms and HT risks.

Factors associated with the quality of patients' surgical decisions for treatment of hip and knee osteoarthritis.

BACKGROUND: Shared decision making requires informing patients and ensuring that treatment decisions reflect their goals. It is not clear to what extent this happens for patients considering total joint replacement (TJR) for hip or knee osteoarthritis. STUDY DESIGN: We conducted a cross-sectional mail survey of osteoarthritis patients at 4 sites, who made a decision about TJR. The survey measured knowledge and goals, the decision making process, decision confidence, and decision regret. Decision quality was defined as the percentage of patients who had high knowledge scores and received treatments that matched their goals. Multivariable regression models examined factors associated with knowledge and decision quality. RESULTS: There were 382 patients who participated (78.6% response rate). Mean knowledge score was 61% (SD 20.7%). In multivariate linear regression, higher education, having TJR, and site were associated with higher knowledge. Many patients (73%) received treatments that matched their goals. Thirty-one percent of patients met our definition for high decision quality. Higher decision making process scores, higher quality of life scores, and site were associated with higher decision quality. Patients who had high decision quality had less regret (73.1% vs 58.5%, p = 0.007) and greater confidence (9.0 [SD 1.6] vs 8.2 [SD 2.3] out of 10, p < 0.001). CONCLUSIONS: A third of patients who recently made a decision about osteoarthritis treatment met both criteria for a high quality decision. Controlling for treatment, patients reporting more involvement in the decision making process, higher quality of life, and being seen at a site that uses decision aids were associated with higher decision quality.

Is there shared decision making when the provider makes a recommendation?

OBJECTIVE: To compare the amount of shared decision making in breast cancer surgery interactions when providers do and do not make a treatment recommendation. METHODS: We surveyed breast cancer survivors who were eligible for mastectomy and lumpectomy. Patients reported whether the provider made a recommendation and the recommendation given. They completed items about their interaction including discussion of options, pros, cons, and treatment preference. A total involvement score was calculated with higher scores indicating more shared decision making. RESULTS: Most patients (85%) reported that their provider made a recommendation. Patients who did not receive a recommendation had higher involvement scores compared to those who did (52% vs. 39.1%, p=0.004). Type of recommendation was associated with involvement. Patients given different recommendations had the highest total involvement scores followed by those who received mastectomy and lumpectomy recommendations (65.5% vs. 42.5% vs. 33.2%, respectively, p<0.001). CONCLUSION: Providers were less likely to present a balanced view of the options when they gave a recommendation for surgery. Patients who received a recommendation for lumpectomy had the lowest involvement score. PRACTICE IMPLICATIONS: Providers need to discuss both mastectomy and lumpectomy and elicit patients' goals and treatment preferences regardless of whether or not a recommendation is given.

Psychometric evaluation of a decision quality instrument for treatment of lumbar herniated disc.

STUDY DESIGN: Retrospective and prospective patient surveys and a physician survey using a sample from American Medical Association master file. OBJECTIVE: To evaluate the performance of a new instrument designed to measure the quality of decisions about treatment of herniated disc. SUMMARY OF BACKGROUND DATA: There is growing consensus on the importance of engaging and informing patients to improve the quality of significant medical decisions, yet there are no instruments currently available to measure decision quality. METHODS: The herniated disc-decision quality instrument (HD-DQI) was developed with input from clinical experts, survey research experts, and patients. The HD-DQI produces 2 scores each scaled to 0% to 100%, with higher scores indicating better quality: (1) a total knowledge score and (2) a concordance score (indicating the percentage of patients who received treatments that matched their goals). We examined hypotheses relating to the acceptability, feasibility, validity, and reliability of the instrument, using data from 3 samples. RESULTS: The HD-DQI survey was feasible to implement and acceptable to patients, with good response rates and low missing data. The knowledge score discriminated between patients who had seen a decision aid or no decision aid (55% vs. 38%, P < 0.001) and between providers and patients (73% vs. 46%, P < 0.001). The knowledge score also had good retest reliability (intraclass correlation coefficient = 0.85). Most patients (78%) received treatments that matched their goals. Patients who received treatments that matched their goals were less likely to regret the decision than those who did not (13% vs. 39%, P = 0.004). CONCLUSION: The HD-DQI met several criteria for high-quality patient-reported survey instruments. It can be used to determine the quality of decisions for treatment of herniated disc. More work is needed to examine acceptability for use as part of routine patient care.

Decision quality instrument for treatment of hip and knee osteoarthritis: a psychometric evaluation.

BACKGROUND: A high quality decision requires that patients who meet clinical criteria for surgery are informed about the options (including non-surgical alternatives) and receive treatments that match their goals. The aim of this study was to evaluate the psychometric properties and clinical sensibility of a patient self report instrument, to measure the quality of decisions about total joint replacement for knee or hip osteoarthritis. METHODS: The performance of the Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI) was evaluated in two samples: (1) a cross-sectional mail survey with 489 patients and 77 providers (study 1); and (2) a randomized controlled trial of a patient decision aid with 138 osteoarthritis patients considering total joint replacement (study 2). The HK-DQI results in two scores. Knowledge items are summed to create a total knowledge score, and a set of goals and concerns are used in a logistic regression model to develop a concordance score. The concordance score measures the proportion of patients whose treatment matched their goals. Hypotheses related to acceptability, feasibility, reliability and validity of the knowledge and concordance scores were examined. RESULTS: In study 1, the HK-DQI was completed by 382 patients (79%) and 45 providers (58%), and in study 2 by 127 patients (92%), with low rates of missing data. The DQI-knowledge score was reproducible (ICC = 0.81) and demonstrated discriminant validity (68% decision aid vs. 54% control, and 78% providers vs. 61% patients) and content validity. The concordance score demonstrated predictive validity, as patients whose treatments were concordant with their goals had more confidence and less regret with their decision compared to those who did not. CONCLUSIONS: The HK-DQI is feasible and acceptable to patients. It can be used to assess whether patients with osteoarthritis are making informed decisions about surgery that are concordant with their goals.

What does it take to have sustained use of decision aids? A programme evaluation for the Breast Cancer Initiative.

BACKGROUND: The Breast Cancer Initiative (BCI) was started in 2002 to disseminate breast cancer decision aids (PtDAs) to providers. METHODS: We analysed BCI programme data for 195 sites and determined the proportion of sites involved in each of five stages of dissemination and implementation of PtDAs. We conducted cross-sectional mail and telephone surveys of 79 sites with the most interest in implementation. We examined barriers associated with sustained use of the PtDAs. RESULTS: Since 2002 we attempted contact with 195 sites to join the BCI. The majority indicated interest in using PtDAs 172 of 195 (88%), 93 of 195 signed up for the BCI (48%), 57 of 195 reported distributing PtDAs to at least one patient (57%), and 46 of 195 reported sustained use (24%). We analysed data from interviews with 59 of 79 active sites (75% response rate). The majority of providers 49 of 59 (83%) had watched the PtDAs, and 46 of 59 (78%) distributed them to patients. The most common barriers were lack of a reliable way to identify patients before decisions are made (37%), a lack of time to distribute the PtDAs (22%) and having too many educational materials (15%). Sites that indicated a lack of clinician support as a barrier were significantly less likely to have sustained use compared to sites that didn't (33% vs. 74%, P = 0.02). CONCLUSIONS: Community breast cancer providers, both physicians and non-physicians, express a high interest in using PtDAs with their patients. About a quarter of sites report sustained use of the PtDAs in routine care.

Risk perceptions among participants undergoing lung cancer screening: baseline results from the National Lung Screening Trial.

BACKGROUND: Lung cancer screening could present a "teachable moment" for promoting smoking cessation and relapse prevention. Understanding the risk perceptions of older individuals who undergo screening will guide these efforts. PURPOSE: This paper examines National Lung Screening Trial (NLST) participants' perceptions of risk for lung cancer and other smoking-related diseases. We investigated (1) whether risk perceptions of lung cancer screening participants differed between current and former smokers and (2) which factors (sociodemographic, smoking and medical history, cognitive, emotional, and knowledge) were associated with these risk perceptions. METHODS: We analyzed baseline data collected from 630 NLST participants prior to their initial screen. Participants were older (55-74 years), heavy (minimum 30 pack years) current or former smokers. A ten-item risk perception measure was developed to assess perceived lifetime risk of lung cancer and other smoking-related diseases. RESULTS: The risk perception measure had excellent internal consistency (alpha = 0.93). Former smokers had lower risk perceptions compared to current smokers. Factors independently associated with high risk perceptions among current smokers included having a personal history of a smoking-related disease, higher lifetime maximum number of cigarettes smoked daily, having lived with a smoker, high worry, high perceived severity of lung cancer and smoking-related diseases, and accurate knowledge of tenfold increased risk of lung cancer for a one pack per day smoker. Factors independently associated with high risk perceptions among former smokers included being White, past history of smoking within 30 min of waking, high worry, and accurate knowledge of tenfold increased risk of lung cancer for a one pack per day smoker. CONCLUSIONS: Using a comprehensive risk perception measurement, we found that current and former smokers held different risk perceptions. Former and current smokers' smoking and medical history, race, emotional concerns, behavior change cognitions, and knowledge should be considered during a prescreening risk communication session. We highlight the theoretical and risk communication implications for former and current smokers undergoing lung cancer screening.

Comparing patient-reported hospital adverse events with medical record review: do patients know something that hospitals do not?

BACKGROUND: Hospitals routinely survey patients about the quality of care they receive, but little is known about whether patient interviews can detect adverse events that medical record reviews do not. OBJECTIVE: To compare adverse events reported in postdischarge patient interviews with adverse events detected by medical record review. DESIGN: Random sample survey. SETTING: Massachusetts, 2003. PATIENTS: Recently hospitalized adults. MEASUREMENTS: By using parallel methods, physicians reviewed postdischarge interviews and medical records to classify hospital adverse events. RESULTS: Among 998 study patients, 23% had at least 1 adverse event detected by an interview and 11% had at least 1 adverse event identified by record review. The kappa statistic showed relatively poor agreement between interviews and medical records for occurrence of any type of adverse event (kappa = 0.20 [95% CI, 0.03 to 0.27]) and somewhat better agreement between interviews and medical records for life-threatening or serious events (kappa = 0.33 [CI, 0.20 to 0.45]). Record review identified 11 serious, preventable events (1.1% of patients). Interviews identified an additional 21 serious and preventable events that were not documented in the medical record, including 12 predischarge events and 9 postdischarge events, in which symptoms occurred after the patient left the hospital. LIMITATIONS: Patients had to be healthy enough to be interviewed. Delay in reaching patients (6 to 12 months after discharge) may have resulted in poor recall of events during the hospital stay. CONCLUSION: Patients report many events that are not documented in the medical record; some are serious and preventable. Hospitals should consider monitoring patient safety by adding questions about adverse events to postdischarge interviews.

Responses of medical schools to institutional conflicts of interest.

CONTEXT: Institutional financial conflicts of interest may affect research results. No national data exist on the extent to which US medical schools have formally responded to challenges associated with institutional conflicts of interest (ICOI). OBJECTIVE: To assess the current state of ICOI policies and practices in US medical schools using the recommendations issued by 2 national higher education and research organizations as the standard. DESIGN, SETTING, AND PARTICIPANTS: National survey of deans of all 125 accredited allopathic medical schools in the United States, administered between February 2006 and December 2006. MAIN OUTCOME MEASURES: The extent to which medical schools have adopted ICOI policies applicable to their institution and to their institutional officials; the scope of these policies in terms of those covered entities, offices, and financial relationships; the existence of recommended organizational structures as means to address ICOI; and the institutions' linkages between ICOI and their institutional review boards (IRBs). RESULTS: Responses were received from a total of 86 (69%) of 125 US medical schools. Although only 30 (38%) respondents (not all overall respondents answered all questions) have adopted an ICOI policy applicable to financial interests held by the institutions, a much higher number have adopted ICOI policies applicable to the financial interests of the officials: 55 (71%) for senior officials, 55 (69%) for midlevel officials, 62 (81%) for IRB members, and 51 (66%) for governing board members. Most institutions treat as potential ICOI the financial interests held by an institutional research official for a research sponsor (43 [78%]) or for a product that is the subject of research (43 [78%]). The majority of institutions have adopted organizational structures that separate research responsibility from investment management and from technology transfer responsibility. Gaps exist in institutions informing their IRBs of potential ICOI in research projects under review. CONCLUSIONS: This study provides the first national data on the existence and nature of policies and practices of US medical schools for addressing potential ICOI. The gaps identified suggest the need for continuing attention by the academic medical community to address the challenges presented by ICOI more consistently and comprehensively.

Institutional academic industry relationships.

CONTEXT: Institutional academic-industry relationships have the potential of creating institutional conflicts of interest. To date there are no empirical data to support the establishment and evaluation of institutional policies and practices related to managing these relationships. OBJECTIVE: To conduct a national survey of department chairs about the nature, extent, and consequences of institutional-academic industry relationships for medical schools and teaching hospitals. DESIGN, SETTING, AND PARTICIPANTS: National survey of department chairs in the 125 accredited allopathic medical schools and the 15 largest independent teaching hospitals in the United States, administered between February 2006 and October 2006. MAIN OUTCOME MEASURE: Types of relationships with industry. RESULTS: A total of 459 of 688 eligible department chairs completed the survey, yielding an overall response rate of 67%. Almost two-thirds (60%) of department chairs had some form of personal relationship with industry, including serving as a consultant (27%), a member of a scientific advisory board (27%), a paid speaker (14%), an officer (7%), a founder (9%), or a member of the board of directors (11%). Two-thirds (67%) of departments as administrative units had relationships with industry. Clinical departments were more likely than nonclinical departments to receive research equipment (17% vs 10%, P = .04), unrestricted funds (19% vs 3%, P < .001), residency or fellowship training support (37% vs 2%, P < .001), and continuing medial education support (65% vs 3%, P < .001). However, nonclinical departments were more likely to receive funding from intellectual property licensing (27% vs 16%, P = .01). More than two-thirds of chairs perceived that having a relationship with industry had no effect on their professional activities, 72% viewed a chair's engaging in more than 1 industry-related activity (substantial role in a start-up company, consulting, or serving on a company's board) as having a negative impact on a department's ability to conduct independent unbiased research. CONCLUSION: Overall, institutional academic-industry relationships are highly prevalent and underscore the need for their active disclosure and management.

Barriers to repeat mammography: cultural perspectives of African-American, Asian, and Hispanic women.

Women of minority races and ethnicities have lower mammography return rates compared to Caucasians. To better understand barriers to mammography, we conducted six focus groups with 49 women of minority races and ethnicities (19 Asian, 16 African-American, and 14 Hispanic) recruited from outpatient medical clinics in Boston. Eligible women had at least one prior mammogram and no personal history of cancer. Discussions were recorded and transcribed, and thematic content analyses were performed. African-Americans and Hispanics felt that lack of insurance was not a barrier to mammography as they were aware of free programs. Some African-Americans avoided mammograms because they were fatalistic and believed that a breast cancer diagnosis would inevitably lead to death. African-Americans agreed that social issues, such as drug and domestic abuse, made obtaining preventive health care less important. Asian participants agreed that mammogram return rates were poor because appointments took time away from work. Asian and Hispanic women identified discourteous behavior by hospital staff as a barrier. Cultural barriers to repeat mammography appear to vary among different racial groups. Interventions to improve screening among minority populations may be more successful if they address group-specific concerns.

Error reporting and disclosure systems: views from hospital leaders.

CONTEXT: The Institute of Medicine has recommended establishing mandatory error reporting systems for hospitals and other health settings. OBJECTIVE: To examine the opinions and experiences of hospital leaders with state reporting systems. DESIGN AND SETTING: Survey of chief executive and chief operating officers (CEOs/COOs) from randomly selected hospitals in 2 states with mandatory reporting and public disclosure, 2 states with mandatory reporting without public disclosure, and 2 states without mandatory systems in 2002-2003. MAIN OUTCOME MEASURES: Perceptions of the effects of mandatory systems on error reporting, likelihood of lawsuits, and overall patient safety; attitudes regarding release of incident reports to the public; and likelihood of reporting incidents to the state or to the affected patient based on hypothetical clinical vignettes that varied the type and severity of patient injury. RESULTS: Responses were received from 203 of 320 hospitals (response rate = 63%). Most CEOs/COOs thought that a mandatory, nonconfidential system would discourage reporting of patient safety incidents to their hospital's own internal reporting system (69%) and encourage lawsuits (79%) while having no effect or a negative effect on patient safety (73%). More than 80% felt that the names of both the hospital and the involved professionals should be kept confidential, although respondents from states with mandatory public disclosure systems were more willing than respondents from the other states to release the hospital name (22% vs 4%-6%, P = .005). Based on the vignettes, more than 90% of hospital leaders said their hospital would report incidents involving serious injury to the state, but far fewer would report moderate or minor injuries, even when the incident was of sufficient consequence that they would tell the affected patient or family. CONCLUSIONS: Most hospital leaders expressed substantial concerns about the impact of mandatory, nonconfidential reporting systems on hospital internal reporting, lawsuits, and overall patient safety. While hospital leaders generally favor disclosure of patient safety incidents to involved patients, fewer would disclose incidents involving moderate or minor injury to state reporting systems.

Physicians report on patient encounters involving direct-to-consumer advertising.

We surveyed a national sample of 643 physicians on events associated with visits during which patients discussed an advertised drug. Physicians perceived improved communication and education but also thought that direct-to-consumer advertising (DTCA) led patients to seek unnecessary treatments. Physicians prescribed the advertised drug in 39 percent of DTCA visits but also recommended lifestyle changes and suggested other treatments. Referring to visits when the DTCA drug was prescribed, 46 percent said that it was the most effective drug, and 48 percent said that others were equally effective. Prescribing DTCA drugs when other effective drugs are available warrants further study.

Institutional academic industry relationship: results of interviews with university leaders.

The purpose of this study was to explore qualitatively the nature, consequences and management of institutional academic industry relationships (IAIRs) in the life and health sciences. The results of our interviews suggest that in the institutions we visited IAIRs are common and deeply embedded in the academic enterprise both among institutional officials and the organization itself. Many believe these relationships have potential benefits for the research and education mission while creating the potential for conflicts of interest. Further tracking and study of the IAIRs is required to understand and anticipate the full effects of these relationships on the scientific enterprise in the United States.