Head to head randomized trial of two decision aids for prostate cancer.

BACKGROUND: While many studies have tested the impact of a decision aid (DA) compared to not receiving any DA, far fewer have tested how different types of DAs affect key outcomes such as treatment choice, patient-provider communication, or decision process/satisfaction. This study tested the impact of a complex medical oriented DA compared to a more simplistic decision aid designed to encourage shared decision making in men with clinically localized prostate cancer. METHODS: 1028 men at 4 VA hospitals were recruited after a scheduled prostate biopsy. Participants completed baseline measures and were randomized to receive either a simple or complex DA. Participants were men with clinically localized cancer (N = 285) by biopsy and who completed a baseline survey. Survey measures: baseline (biopsy); immediately prior to seeing the physician for biopsy results (pre- encounter); one week following the physician visit (post-encounter). Outcome measures included treatment preference and treatment received, knowledge, preference for shared decision making, decision making process, and patients' use and satisfaction with the DA. RESULTS: Participants who received the simple DA had greater interest in shared decision making after reading the DA (p = 0.03), found the DA more helpful (p's < 0.01) and were more likely to be considering watchful waiting (p = 0.03) compared to those receiving the complex DA at Time 2. While these differences were present before patients saw their urologists, there was no difference between groups in the treatment patients received. CONCLUSIONS: The simple DA led to increased desire for shared decision making and for less aggressive treatment. However, these differences disappeared following the physician visit, which appeared to change patients' treatment preferences. Trial registration This trial was pre-registered prior to recruitment of participants.

Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.

Prioritizing Initiatives for Institutional Review Board (IRB) Quality Improvement.

BACKGROUND: Institutional Review Boards (IRBs) have been criticized for inconsistency, delay, and bias, suggesting an opportunity for quality improvement. To aid such quality improvement, this study aimed at determining IRB members' and investigators' priorities regarding IRB review at 10 Veterans Affairs (VA) IRBs. METHODS: 680 anonymous internet surveys were sent to 252 IRB members and staff, and 428 principal investigators and project coordinators at 9 VA Medical Centers and the VA Central IRB. Surveys included 27 statements adapted from Koocher and Kieth-Spiegel's IRB-RAT describing IRB activities or functions (e.g., "An IRB that is open to reversing its earlier decisions"). Respondents indicated how each statement described both their "ideal" and "actual" IRBs. The difference between the ratings of the actual and ideal IRBs was calculated for each item along with estimated 95% confidence intervals. Ratings outside those intervals indicated activities or functions with relatively good or poor performance compared to the ideal IRB. RESULTS: 390 (57.4%) responses from 165 IRB members and staff (65.5%) and 225 investigators and project coordinators (52.6%) demonstrated that these IRBs were closest to the ideal when protecting human subjects, treating investigators with respect, and taking appropriate action for alleged scientific misconduct. The IRBs were furthest from the ideal regarding duplicative forms, timeliness of review, and provision of complete rationales for decisions. Although IRB members reported near-ideal willingness to reverse earlier decisions, investigators rated this capacity far from ideal. Investigators rated IRB members' knowledge about procedures and policy as nearly ideal, but IRB members themselves rated this aspect far from ideal. Noteworthy site-level differences in the ratings of IRB functions and activities were also identified. CONCLUSIONS: Although these VA IRBs perform well in some areas, these data support the need for ongoing quality improvement. The described method of administering and analyzing the IRB-RAT may help identify and monitor site- and activity- specific initiatives for quality improvement.

Using the IRB Researcher Assessment Tool to Guide Quality Improvement.

Institutional Review Boards (IRBs) are intended to protect those who participate in research. However, because there is no established measure of IRB quality, it is unclear whether these committees achieve their goal. The IRB Researcher Assessment Tool is a previously validated, internally normed, proxy measure of IRB quality that assesses 45 distinct IRB activities and functions. We administered this instrument to a sample of investigators and IRB members at a large urban VA Medical Center. We describe a systematic approach to analyze and interpret survey responses that can identify the IRB activities and functions most in need of quality improvement. The proposed approach to empirical data analysis and presentation could inform local initiatives to improve the quality of IRB review.

Time required for institutional review board review at one Veterans Affairs medical center.

IMPORTANCE: Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research. OBJECTIVE: To measure the overall and incremental process times for IRB review as a process of quality improvement. DESIGN, SETTING, AND PARTICIPANTS: After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation. MAIN OUTCOMES AND MEASURES: Calendar days from initial submission to final approval of research protocols. RESULTS: Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23-631] and 82 [16-437] days, respectively) than full board reviews (median [range], 131 [64-296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0-74 days), and review by the research and development committee took a median of 15 days (range, 0-184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair. CONCLUSIONS AND RELEVANCE: Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research programs. The review times observed at this IRB are substantially longer than the 60-day target recommended by expert panels. The method described here could be applied to other IRBs to begin identifying and improving inefficiencies.

Proteomic studies in breast cancer (Review).

Breast cancer is one of the most common types of invasive cancer in females worldwide. Despite major advances in early cancer detection and emerging therapeutic strategies, further improvement has to be achieved for precise diagnosis to reduce the chance of metastasis and relapses. Recent proteomic technologies have offered a promising opportunity for the identification of new breast cancer biomarkers. Matrix-assisted laser desorption/ionization, time-of-flight mass spectrometry (MALDI-TOF MS) and the derived surface-enhanced laser desorption/ionization mass spectrometry (SELDI-TOF MS) enable the development of high-throughput proteome analysis based on comprehensive reliable biomarkers. In this review, we examined proteomic technologies and their applications, and provided focus on the proteomics-based profiling analyses of tumor tissues/cells in order to identify and confirm novel biomarkers of breast cancer.

An affective booster moderates the effect of gain- and loss-framed messages on behavioral intentions for colorectal cancer screening.

Previous research has demonstrated that loss-framed messages are more effective than gain-framed messages in motivating detection behaviors such as screening. The present study examined whether affective context moderates the degree to which message frame is associated with behavioral intentions to engage in colorectal cancer screening. In particular, we buttressed a framing manipulation with an "affective booster" to increase anticipated and anticipatory emotions associated with the framed messages. Consistent with previous research, we found that loss-framed messages are more effective in increasing intentions to screen. However, we found that among individuals who received gain-framed messages (but not loss-framed messages), the affective booster increased message persuasiveness. This effect on intentions was partially mediated by self-efficacy for engaging in screening. This study indicates that in the presence of emotional boosters, loss-framed messages may lose their advantage over gain-framed messages in motivating detection behaviors, and that self-efficacy may partially explain these effects.

Relationships among health perceptions vary depending on stage of readiness for colorectal cancer screening.

OBJECTIVE: We explored whether relationships among health perceptions differ depending on individuals' stage of readiness for colorectal cancer screening (CRCS). METHODS: Data from the National Cancer Institute's Health Information National Trends Survey (HINTS) were used to stage adults over 50 years of age (N = 2324) using a modified version of the Precaution Adoption Process Model (PAPM) staging algorithm. Health perceptions examined included perceived risk of cancer, worry about cancer, fatalism, and beliefs about ambiguity of cancer prevention recommendations. RESULTS: Meaningful differences in patterns of relationships among health perceptions by stage were found. CONCLUSIONS: The nonlinear patterns that emerged indicate support for the role of these health perceptions in screening, the idea that behavioral readiness may moderate the relationship between important health perceptions, and the use of the stage construct in this context.

Orthopedic communication about osteoarthritis treatment: Does patient race matter?

OBJECTIVE: To understand racial disparities in the use of total joint replacement, we examined whether there were racial differences in patient-provider communication about treatment of chronic knee and hip osteoarthritis in a sample of African American and white patients referred to Veterans Affairs orthopedic clinics. METHODS: Audio recorded visits between patients and orthopedic surgeons were coded using the Roter Interaction Analysis System and the Informed Decision-Making model. Racial differences in communication outcomes were assessed using linear regression models adjusted for study design, patient characteristics, and clustering by provider. RESULTS: The sample (n = 402) included 296 white and 106 African American patients. Most patients were men (95%) and ages 50-64 years (68%). Almost half (41%) reported an income <$20,000. African American patients were younger and reported lower incomes than white patients. Visits with African American patients contained less discussion of biomedical topics (ß = -9.14; 95% confidence interval [95% CI] -16.73, -1.54) and more rapport-building statements (ß = 7.84; 95% CI 1.85, 13.82) than visits with white patients. However, no racial differences were observed with regard to length of visit, overall amount of dialogue, discussion of psychosocial issues, patient activation/engagement statements, physician verbal dominance, display of positive affect by patients or providers, or discussion related to informed decision making. CONCLUSION: In this sample, communication between orthopedic surgeons and patients regarding the management of chronic knee and hip osteoarthritis did not, for the most part, vary by patient race. These findings diminish the potential role of communication in Veterans Affairs orthopedic settings as an explanation for well-documented racial disparities in the use of total joint replacement.

Now is the chance: patient-provider communication about unplanned pregnancy during the first prenatal visit.

OBJECTIVE: Unplanned pregnancy is associated with psychosocial stress, post-partum depression, and future unplanned pregnancies. Our study describes how topics related to unplanned pregnancy were addressed with patients during the first prenatal visit. METHODS: We audio-recorded and transcribed initial prenatal visits between 48 patients and 16 providers from a clinic serving racially diverse, lower-socio-economic patients. We conducted a fine-grained thematic analysis of cases in which the patient's pregnancy was unplanned. RESULTS: Of the 48 patients, 35 (73%) had unplanned pregnancies. Twenty-nine visits for unplanned pregnancies (83%) included discussion of the patient's feelings about the pregnancy. Approximately half (51%) of the visits touched on partner or other types of social support. Six patients (17%) were offered referrals to counseling or social services. Only four visits (11%) touched on future birth control options. CONCLUSION: Most initial prenatal visits for unplanned pregnancies included discussion of patient feelings about the pregnancy. However, opportunities to discuss future birth control and for more in-depth follow-up regarding social support and psychological risks associated with unplanned pregnancy were typically missed. PRACTICE IMPLICATIONS: Obstetrics care providers should be cautious about making assumptions and should consider discussing pregnancy circumstances and psychosocial issues in more depth when treating patients facing unplanned pregnancy.

The effect of patient race on total joint replacement recommendations and utilization in the orthopedic setting.

BACKGROUND: The extent to which treatment recommendations in the orthopedic setting contribute to well-established racial disparities in the utilization of total joint replacement (TJR) in the treatment of advanced knee/hip osteoarthritis has not been explored. OBJECTIVE: To examine whether orthopedic surgeons are less likely to recommend TJR to African-American patients compared to white patients with similar clinical indications, and whether there are racial differences in the receipt of TJR within six months of study enrollment. DESIGN: Prospective, observational study. PARTICIPANTS: African-American (AA; n = 120) and white (n = 337) patients seeking treatment for knee or hip osteoarthritis in Veterans Affairs orthopedic clinics. MAIN MEASURES: Patients completed surveys that assessed socio-demographic and clinical variables that could influence osteoarthritis treatment. Orthopedic surgeons' notes were reviewed to determine whether patients had been recommended for TJR and whether they underwent the procedure within 6 months of study enrollment. RESULTS: Rate of TJR recommendation was 19.5%. Odds of receiving a TJR recommendation were lower for AA than white patients of similar age and disease severity (OR = 0.46, 95% CI = 0.26-0.83; P = 0.01). However, this difference was not significant after adjusting for patient preference for TJR (OR = 0.69, 95% CI = 0.36-1.31, P = 0.25). Overall, 10.3% of patients underwent TJR within 6 months. TJR was less likely for AA patients than for white patients of similar age and disease severity (OR = 0.41, 95% CI = 0.16-1.05, P = 0.06), but this difference was reduced after adjusting for whether patients had received a recommendation for the procedure at the index visit (OR = 0.57, 95% CI = 0.21-1.54, P = 0.27). CONCLUSIONS: In this study, race differences in patient preferences for TJR appeared to underlie race differences in TJR recommendations, which led to race differences in utilization of the procedure. Our findings suggest that patient treatment preferences play an important role in racial disparities in TJR utilization in the orthopedic setting.

Behind closed doors: physician-patient discussions about colorectal cancer screening.

BACKGROUND: Despite the availability of multiple effective screening tests for colorectal cancer, screening rates remain suboptimal. The literature documents patient preferences for different test types and recommends a shared decision-making approach for physician-patient colorectal cancer screening (CRCS) discussions, but it is unknown whether such communication about CRCS preferences and options actually occurs in busy primary-care settings. OBJECTIVE: Describe physician-patient CRCS discussions during a wellness visit. DESIGN: Cross-sectional; patients audio-recorded with physicians. PARTICIPANTS: A subset of patients (N = 64) participating in a behavioral intervention trial designed to increase CRCS who completed a wellness visit during the trial with a participating physician (N = 8). APPROACH: Transcripts were analyzed using qualitative methods. RESULTS: Physicians in this sample consistently recommended CRCS, but focused on colonoscopy. Physicians did not offer a fecal occult blood test alone as a screening choice, which may have created missed opportunities for some patients to get screened. In this single visit, physicians' communication processes generally precluded discussion of patients' test preferences and did not facilitate shared decision-making. Patients' questions indicated their interest in different CRCS test types and appeared to elicit more information from physicians. Some patients remained resistant to CRCS after discussing it with a physician. CONCLUSION: If a preference for colonoscopy is widespread among primary-care physicians, the implications for intervention are either to prepare patients for this preference or to train physicians to offer options when recommending screening to patients.

Physicians encouraging colorectal screening: a randomized controlled trial of enhanced office and patient management on compliance with colorectal cancer screening.

BACKGROUND: Colorectal cancer screening is underused. Our objective was to evaluate methods for promoting colorectal cancer screening in primary care practice. METHODS: A 2 x 2 factorial randomized clinical trial measured the effects of a tailored vs nontailored physician recommendation letter and an enhanced vs nonenhanced physician office and patient management intervention on colorectal cancer screening adherence. The enhanced and nonenhanced physician office and patient management interventions varied the amount of external support to help physician offices develop and implement colorectal cancer screening programs. The study included 10 primary care physician office practices and 599 screen-eligible patients aged 50 to 79 years. The primary end point was medical-record-verified flexible sigmoidoscopy or colonoscopy. Statistical end-point analysis (according to randomization intent) used generalized estimating equations to account for correlated outcomes according to physician group. RESULTS: During a 1-year period, endoscopy in the lower gastrointestinal tract (lower endoscopy) occurred in 289 of 599 patients (48.2%). This finding included the following rates of lower endoscopy: 81 of 152 patients (53.3%) in the group that received the tailored letter and enhanced management; 103 of 190 (54.2%) in the group that received the nontailored letter and enhanced management; 58 of 133 (43.6%) in the group that received the tailored letter and nonenhanced management; and 47 of 124 (37.9%) in the group that received the nontailored letter and nonenhanced management. Enhanced office and patient management increased the odds of completing a colonoscopy or flexible sigmoidoscopy by 1.63-fold (95% confidence interval, 1.11-2.41; P = .01). However, the tailored letter increased the odds of completion by only 1.08-fold (95% confidence interval, 0.72-1.62; P = .71). CONCLUSIONS: Approximately one-half of the screen-eligible primary medical care patients aged 50 to 79 years obtained lower endoscopic colorectal cancer screening within 1 year of recommendation. An enhanced office and patient management system significantly improved colorectal cancer screening adherence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00327457.

Informed decision-making and colorectal cancer screening: is it occurring in primary care?

BACKGROUND: Current recommendations advise patients to participate in the decision-making for selecting a colorectal cancer (CRC) screening option. The degree to which providers communicate the information necessary to prepare patients for participation in this process is not known. OBJECTIVE: To assess the level of informed decision-making occurring during actual patient-provider communications on CRC screening and test for the association between informed decision-making and screening behavior. RESEARCH DESIGN: Observational study of audiotaped clinic visits between patients and their providers in the primary care clinic at a Veterans Administration Medical Center. SUBJECTS: Male patients, age 50-74 years, presenting to a primary care visit at the study site. MEASURES: The Informed Decision-Making (IDM) Model was used to code the audiotapes for 9 elements of communication that should occur to prepare patients for participation in decision-making. The primary outcome is completion of CRC screening during the study period. RESULTS: The analytic cohort consisted of 91 patients due for CRC screening who had a test ordered at the visit. Six of the 9 IDM elements occurred in < or =20% of the visits with none addressed in > or =50%. CRC screening occurred less frequently for those discussing "pros and cons" (12% vs. 46%, P = 0.01) and "patient preferences" (6% vs. 47%, P = 0.001) compared with those who did not. CONCLUSIONS: We found that a lack of informed decision-making occurred during CRC screening discussions and that particular elements of the process were negatively associated with screening. Further research is needed to better understand the effects of informed decision-making on screening behavior.

When pregnant patients disclose substance use: missed opportunities for behavioral change counseling.

OBJECTIVE: The first obstetric visit is an opportunity to provide counseling to women with substance abuse risks, including smoking, drug use, and alcohol use. Little is known about how obstetric care providers and patients discuss these issues. Our objective was to examine patient-provider communication about substance use behaviors during these visits. METHODS: We audio-taped and transcribed verbatim first prenatal visits in an outpatient hospital clinic, then qualitatively analyzed them for content and process of communication using modified grounded theory methods. RESULTS: Twenty-nine providers (21 residents, 5 midwives, 3 nurse practitioners) and 51 patients participated. Twenty-five patients were smokers, 4 used alcohol, and 11 used drugs. Provider responses to smoking disclosures included discussions of risks, encouragement to quit-cut down, affirmation of attempts to quit-cut down, and referral to smoking cessation programs. Responses to alcohol or drug disclosures included only a general statement regarding risks and referral to genetics. CONCLUSION: Providers were less attentive to alcohol and drugs than smoking where they had pre-established patterns of response. PRACTICE IMPLICATIONS: Providers should discuss behavioral change strategies and motivations with pregnant patients who use drugs and/or alcohol as well as those who smoke.

Patients with Complex Chronic Diseases: perspectives on supporting self-management.

A Complex Chronic Disease (CCD) is a condition involving multiple morbidities that requires the attention of multiple health care providers or facilities and possibly community (home)-based care. A patient with CCD presents to the health care system with unique needs, disabilities, or functional limitations. The literature on how to best support self-management efforts in those with CCD is lacking. With this paper, the authors present the case of an individual with diabetes and end-stage renal disease who is having difficulty with self-management. The case is discussed in terms of intervention effectiveness in the areas of prevention, addiction, and self-management of single diseases. Implications for research are discussed.

Relationship of communication and information measures to colorectal cancer screening utilization: results from HINTS.

Utilization of colorectal cancer screening tests is suboptimal. Knowledge of colorectal cancer screening has been associated with completion of screening. Thus, increasing awareness of colorectal cancer screening may lead to significant improvements in screening rates. We assessed for the association among provider-patient interaction, information-seeking patterns, sources of information, trust in cancer information, and Internet usage on colorectal cancer screening behavior using data obtained by the Health Information National Trends Survey (HINTS). From a cohort of 2,670 respondents greater than 50 years of age, we found that they (1) desired cancer information from personalized reading materials, meeting in person with a health care professional, and published materials; and (2) had great trust of information from their provider. Having trust in cancer information from the doctor or other health care professional was most predictive (OR 2.08, 95% CI 1.49-2.94) of being up to date. Other predictive factors include having a desire for cancer information from personalized reading materials (OR 1.56, 95% CI 1.24-1.95) and using the Internet from home (OR 1.32, 95% CI 1.04-1.67). We conclude that personalized communications from a health care provider are desired and trusted. Another promising information delivery approach is the Internet. Dedicated efforts using these approaches for information exchange may be most beneficial toward increasing utilization of colorectal cancer screening.

Missing race/ethnicity data in Veterans Health Administration based disparities research: a systematic review.

Many studies evaluating racial disparities in health come from the Veterans Health Administration (VHA) and are based on secondary and administrative data. Often race/ethnicity data are missing in these sources. Knowing how investigators treat missing data is critical in evaluating potential biases. The objectives of this systematic review were to quantify: (1) the data sources for VHA racial/ethnic disparity studies; (2) how missing race/ethnicity data were handled; and (3) the extent of missing race/ethnicity data. Two trained reviewers independently abstracted 114 articles. The Patient Treatment File was the most common source of race/ethnicity data (n=49). For just over half of the articles we were unable to determine if there were missing race/ethnicity data (n=58). When missing race/ethnicity data were quantified, the proportion of instances for which the data were missing ranged from 0% to 48%. Missing race/ethnicity data are frequently present in VHA secondary and administrative data sources, but, the proportion of instances for which such data are missing is explicitly discussed or quantified in only about 50% of all articles using these sources.

Using the transtheoretical model to stage screening behavior for colorectal cancer.

This study sought to describe the colorectal cancer (CRC)-screening behavior of a population of two lower income communities near Pittsburgh, Pennsylvania. The transtheoretical model was used to characterize individuals according to their stage of readiness to engage in one of two recommended CRC screening tests--the Fecal Occult Blood Test (FOBT) or Flexible Sigmoidoscopy (FSG) test. A telephone survey was conducted of 50- to 79-year-old men and women in Aliquippa and Clairton in the spring of 1999. Analyses based on 414 survey respondents showed associations between FOBT or FSG behavioral stage and factors including gender, age, recent doctor checkup, chronic need for prescription medications, history of cervical Pap smear testing, history of prostate-specific antigen blood testing, and prior doctor recommendation in favor of FOBT or FSG testing. This study appears to be one of the first applications of this theory to understanding CRC screening behavior in a community intervention.

Adherence to repeat screening flexible sigmoidoscopy in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial.

BACKGROUND: Acceptance of screening flexible sigmoidoscopy has been poor, in part because of providers' concerns regarding the acceptability of the procedure. In the current prospective study, the authors used adherence to repeat testing to assess the acceptability of screening flexible sigmoidoscopy. METHODS: The current study was a prospective study of a randomized clinical trial drawing volunteers from the community. Subjects included 10,164 Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial participants who were available for follow-up 3 years after undergoing a baseline screening flexible sigmoidoscopy examination. The authors measured adherence and identified those factors that appeared to affect adherence to repeat sigmoidoscopy. RESULTS: Overall, 18.3% of women and 10.0% of men did not undergo a repeat sigmoidoscopy. Among individuals who attended the Year-3 clinic, 10.4% of women and 5.1% of men specifically refused repeat sigmoidoscopy when it was offered (risk of refusal in women compared with men, 2.04; 95% confidence interval, 1.76-2.36). Another factor found to be associated with refusal included a technically inadequate baseline sigmoidoscopy. CONCLUSIONS: Gender and past experiences with sigmoidoscopy may impact adherence to repeat screening. Nonetheless, among research volunteers in a randomized clinical trial of screening, excellent adherence to repeat screening flexible sigmoidoscopy could be achieved.