Obtaining Patient Consent Research Articles

The Conflict between Accountability and Confidentiality in Medicare's Access to Psychiatrists' Notes

The aims of this paper were to identify a conflict between psychiatrists? obligations regarding patient confidentiality and Medicare's auditing procedures, and to examine potential resolutions to the conflict. While it is reasonable for Medicare, as a taxpayer-funded instrumentality, to require documentary evidence to substantiate and justify claims, such a requirement constitutes a significant breach of patient confidentiality. Obtaining patient consent appears to be the only ethical resolution of the issue.

Impact of Pharmacists’ Intervention on the knowledge of HIV infected patients in a public sector hospital of KwaZulu-Natal

BackgroundThe study site started its roll-out of the human immunodeficiency virus (HIV) prevention of mother-to-child transmission in 2006. All patients were counselled by trained counsellors, before seeing a doctor. At the pharmacy the medicines were collected with no intense counselling by a pharmacist as the patients would have visited the trained counsellors first. Subsequently it was found that there were many queries regarding HIV and acquired immune deficiency syndrome (AIDS). Thus a dedicated antiretroviral pharmacy managed by a pharmacist was established to support the counsellors.ObjectivesThe objective of the study was to assess the impact of a pharmacist intervention on the knowledge gained by HIV and AIDS patients with regard to the disease, antiretroviral drug use (i.e. how the medication is taken, its storage and the management of side effects) as well as adherence to treatment.MethodThis study was undertaken at a public sector hospital using anonymous structured questionnaires and was divided into three phases: pre-intervention, intervention and post-intervention phases. After obtaining patient consent the questionnaires were administered during the first phase. A month later all patients who visited the pharmacy were counselled intensely on various aspects of HIV and antiretroviral medication. Thereafter patients who participated in Phase 1 were asked to participate in the second phase. After obtaining their consent again, the same questionnaire was administered to them. Quantitative variables were compared between pre-intervention and post-intervention stages by using paired t-tests or Wilcoxon signed ranks tests. Categorical variables were compared using McNemar's Chi-square test (Binary) or McNemar-Bowker test for ordinal variables.ResultsOverall the mean knowledge score on the disease itself had increased significantly (s.d. 6.6%), (p < 0.01), after the pharmacists’ intervention (pre-intervention was 82.1% and post-intervention was 86.3%). A significant improvement was noted in the overall knowledge score with regard to medicine taking and storage (p < 0.05) and the management of the side effects. There was a non-significant difference between the adherence in pre-intervention and in post-intervention (p = 0.077).ConclusionPharmacists’ intervention had a positive impact on HIV infected patients’ HIV and AIDS knowledge on both the disease and on the antiretroviral drug use and storage.

Protecting privacy during peer-to-peer exchange of medical documents

Privacy is an important aspect of interoperable medical information systems. Governments and health care organizations have established privacy policies to prevent abuse of personal health data. These policies often require organizations to obtain patient consent prior to exchanging personal information with other interoperable systems. The consents are defined in form of so-called disclosure directives. However, policies are often not precise enough to address all possible eventualities and exceptions. Unanticipated priorities and other care contexts may cause conflicts between a patient's disclosure directives and the need to receive treatments from informed caregivers. It is commonly agreed that in these situations patient safety takes precedence over information privacy. Therefore, caregivers are typically given the ability to override the patient's disclosure directives to protect patient safety. These overrides must be logged and are subject to privacy audits to prevent abuse. Centralized "shared health record" (SHR) infrastructures include consent management systems that enact the above functionality. However, consent management mechanisms do not extend to information systems that exchange clinical information on a peer-to-peer basis, e.g., by secure messaging. Our article addresses this gap by presenting a consent management mechanism for peer-to-peer interoperable systems. The mechanism restricts access to sensitive, medical data based on defined consent directives, but also allows overriding the policies when needed. The overriding process is monitored and audited in order to prevent misuse. The mechanism has been implemented in an open source project called CDAShip and has been made available on SourceForge.

Ethics and Human Experimentation

Oregon Anesthesiology Group, McKenzie-Willamette Medical Center, Springfield, Oregon. susan.palmer@comcast.netAlthough I thank Dr. Butterworth for his comments concerning my commentary,1I do not agree with his opinion that US medical researchers consistently obtained informed consent from human subjects before the 1980s. The Nuremburg Code (1947), the Declaration of Helsinki (1964), and Beecher (1966)2describe research without consent from human subjects and were all published before the 1980s. However, printed copies of these documents were not readily available to US physicians. Until the 1980s, even fewer physicians thought that the Nuremburg Code or Helsinki Declaration had much to do with medical research or clinical practice within the United States.The Nuremburg Code was composed subsequent to the conviction of Nazi physicians who defended their horrific research, claiming it was similar to medical research being done all over the world.3That code stated as its very first basic principle that human experimentation should involve the “voluntary consent of the subject.”The World Medical Assembly meeting in Helsinki published what became known as the Declaration of Helsinki. It contained 22 “basic principles” for guiding human subject research. The Declaration was later revised in 1975 and 1983.The medical community did not develop sanctions for researchers who disregarded the Nuremburg Code or the Helsinki Declaration.Beecher's2comments in the New England Journal of Medicine were not welcomed by some in the medical research community because prominent researchers thought his ideas about obtaining informed consent from human subjects would stifle medical research. His article was originally refused publication in JAMA 4and the New England Journal of Medicine agreed to publish it only after more than half of the cases he described were removed.I agree with Butterworth that Beecher—along with many of his distinguished anesthesiologist colleagues—rightly deserves a place of honor in the development of the understanding of clinical research ethics. However, I certainly did not know specifically of Beecher's New England Journal of Medicine article2when I started doing human subject research in 1976. It was not until I took the time and effort to research ethical issues in anesthesiology practice that I began to understand the development of medical ethics in the United States.The medical literature of the 1970s is, unfortunately, replete with clinical studies that did not meet the standards of the Declaration of Helsinki.5Even today, many physicians do not value the study of medical ethics because they do not believe it is an academic discipline. Many surgeons believed that consent was not routinely required and that medical ethics was a waste of time that served only to “raise doubts where there were none before.”6Multidisciplinary panels that composed Federal regulations for human research had more ethicists and members of the public than physicians because US society wanted consistent treatment of human subjects of research.The community of professional physicians failed to agree on required elements of consent or enforce consistency in obtaining patient consent. Beecher2himself stated that achieving truly “informed consent” was probably not possible. He acknowledged the pressure on researchers to publish combined and an explosion of research funds to coerce researchers to proceed without trying too hard to fully inform research subjects.2Federal standards were defined in the late 1970s, published in 1981, and enforced thereafter. They defined the requirements for informed consent for research subjects, which, until that time, were pretty much up to individual researchers—some of whom had more defensibly ethical practices than others.Oregon Anesthesiology Group, McKenzie-Willamette Medical Center, Springfield, Oregon. susan.palmer@comcast.net

Informed consent to microsatellite instability and immunohistochemistry screening for Lynch syndrome

ObjectiveRoutine microsatellite instability and immunohistochemistry screening of colorectal cancers can assist in identifying a significant proportion of cancers attributable to Lynch syndrome. This article considers whether it is necessary to obtain patient informed consent for microsatellite instability and immunohistochemistry screening. ResultsAlthough microsatellite instability screening examines genetic features of a tumor, it lacks several important characteristics that typically mandate formal informed consent to genetic testing. Microsatellite instability screening describes discrete tissue samples and does not provide information about the rest of the patient's body or germline. In contrast, immunohistochemistry screening is a proteomic test that may reveal information about the patient's germline. As such, immunohistochemistry screening can be viewed as similar to other forms of genetic testing, in which explicit patient consent is regarded as an ethical prerequisite. ConclusionThere is no ethical requirement to obtain explicit informed consent for microsatellite instability screening of colorectal tumor samples for Lynch syndrome. There is support for obtaining patient consent to immunohistochemistry testing, given its similarities with other genetic analyses for which informed consent is typically deemed necessary. Regardless of which screening test is used, it is important to prepare patients and their families for the possibility of a positive screening test. Genet Med 2011:13(4):356–360.

Noninvasive predictors for liver fibrosis in patients with nonalcoholic steatohepatitis.

To evaluate certain anthropometric, clinical and laboratory features indicating liver fibrosis in nonalcoholic steatohepatitis and to establish the noninvasive markers for liver fibrosis. Eighty-one patients (40 male, 41 female) who were diagnosed with fatty liver by ultrasonographic examination and fulfilled the inclusion criteria participated in the study. Anamnesis, anthropometric, clinical and laboratory features of all cases were recorded and then liver biopsy was performed after obtaining patient consent. Steatosis, necroinflammation and liver fibrosis were examined according to age ≥ 45, gender, body mass index, central obesity, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 1, γ-glutamyltransferase (GGT)/ALT > 1, platelet count, insulin, c-peptide levels and the presence of hypertension, diabetes, hypertriglyceridemia and insulin resistance. Eighty-one patients with non-alcoholic steatohepatitis (NASH) enrolled in the study. 69 of 81 patients were diagnosed with NASH, 11 were diagnosed with simple fatty liver and 1 was diagnosed with cirrhosis. AST/ALT > 1, GGT/ALT > 11, high serum ferritin and fasting insulin levels, the presence of diabetes, hypertension, hypertriglyceridemia and insulin resistance seemed to enhance the severity of steatosis, necroinflammation and fibrosis but these results were not statistically significant. Liver steatosis and fibrosis can occur in individuals with normal weight. There was no significant concordance between severity of liver histology and the presence of predictors for liver fibrosis including metabolic risk factors.

Off-label use of rhBMP-2

Off-label use of rhBMP-2

Changes in surgical consent practices for common otolaryngology procedures: impact of Modernising Medical Careers

To assess elective surgery consent practices amongst senior house officers from a selection of UK ENT departments, and to compare results with similar surveys in 2002 and 2005. A telephone survey of senior house officers in 40 UK ENT departments was conducted to assess departmental consent policies and knowledge of complications of common ENT operations. A total of 77.5 per cent of responding senior house officers were responsible for consenting, reduced from 92.5 per cent in 2002 (p = 0.06). There had been a significant improvement in the use of patient information sheets, from 25 per cent of departments in 2002 to 65 per cent in 2008 (p = 0.0002). There had been no improvement in training or in the use of standard National Health Service consent forms, and the senior house officers' knowledge of specific complications remained poor. Of the senior house officers surveyed, 37.5 per cent were foundation trainees. There has been some improvement in information delivery to patients during the consent process, in accordance with General Medical Council, Department of Health and Modernising Medical Careers guidelines. However, most senior house officers are still required to obtain patient consent without appropriate training.

Peritoneal Metastasis: Detection with 16– or 64–Detector Row CT in Patients Undergoing Surgery for Gastric Cancer

To retrospectively measure the diagnostic performance of prospective computed tomographic (CT) results obtained by using 16- or 64-detector row scanners in the detection of peritoneal metastases (PMs) in patients with advanced gastric cancer. The institutional review board approved this retrospective study and waived the need to obtain patient consent. In 498 patients with gastric cancer (stage >or= T2) who were undergoing surgery, the presence of PM was prospectively rated as grade 0 (absent), grade 1 (equivocal), or grade 2 (present) on CT scans (0.67 or 2 mm thick) that were interpreted by interactively adjusting the viewing thickness and viewing plane. The CT readings were retrospectively compared with surgical and pathologic findings. In patients in whom the presence of PM was rated as grade 1 or less, factors predictive of PM were identified by testing variables, including patient and tumor characteristics, with univariate tests and multivariate logistic regression analysis. Fifty-three patients (10.6%) had confirmed PM. When only grade 2 was considered to indicate a positive CT reading, sensitivity and specificity were 28.3% (15 of 53) and 98.9% (440 of 445), respectively. With the threshold of grade 1 or greater indicating a positive reading, sensitivity and specificity were 50.9% (27 of 53) and 96.2% (428 of 445), respectively. In the patients with grades of 1 or less, the significant factors predictive of PM were greater tumor size and T stage. The sensitivity of PM detection is limited, even with modern CT techniques. In patients whose CT results are not definitely positive for PM, staging laparoscopy is still recommended if the aforementioned two predictive factors (greater tumor size and T stage) are suspected.

Abstract No. 365: Reality Check: What We Are Doing to Prevent Contrast-Induced Nephropathy and Why

Abstract No. 365: Reality Check: What We Are Doing to Prevent Contrast-Induced Nephropathy and Why

Who Gets “Kicked Out” of the Exam Room? Factors Associated With Patients Declining Medical Student Participation

Background: Research on patients' decision to have medical students participate in clinical care has been examined predominantly from the patients' perspective rather than the students' perspective. Purpose: This study investigated 3rd-year medical students' experiences with and perceptions of patients declining medical student participation in clinical care and identified factors associated with this decision. Methods: Third-year medical students (n = 103) completed a survey assessing demographic background, experiences with patients declining medical student participation in clinical care, preceptors' approach to obtaining patient consent for student participation, and ratings of preceptors' clinical education skills. Results: Fifty-nine percent, 22%, and 25% of students encountered patients declining student involvement in care (3 times or more) based on student's training status, student's gender, and in the context of a gynecological/urological exam, respectively. Patient consent obtained by clinic staff (r =.661, p < .001) was a significant predictor for patients declining based on training status. Gender (d = 40, p < .003) and patient consent obtained by clinic staff (r = .349, p < .001) were predictors of patients declining in the context of a gynecological/urological exam. Conclusions: A majority of medical students have encountered multiple experiences with patients declining student participation in outpatient clinical care. The approach preceptors use to obtain patient consent may be important in increasing training opportunities for students.

When patients decline medical student participation: the preceptors’ perspective

Patients' receptivity towards medical student participation has been examined predominantly from the patient and/or the medical student perspective. Few studies have investigated the preceptor's perspective. The study examined preceptors' experience with patients declining medical student participation in clinical care and identified preceptor-related factors associated with this experience. Preceptors (n = 42) were recruited from a Family Medicine educational presentation and completed a survey assessing encounters with patients declining medical student participation, methods for obtaining patient consent, and self-rated clinical education skills. Forty-eight percent and 62% of preceptors have "sometimes" or "often" had patients decline student involvement due to student's status and in the context of a gynecological/urological exam, respectively. Fifty-eight percent "never" or "seldom" obtain patient consent with the student outside the exam room, while 46% "often" or "always" have the student directly inform patients about his/her involvement. Being a faculty preceptor (versus resident preceptor) (r = 0.463, p = 0.026) and feeling uncomfortable talking to patients about students performing the exam (r = -0.482, p = 0.020) were associated with patients declining student participation for a genital exam. Findings indicate that preceptors encounter patients declining medical student involvement in general and sensitive exam scenarios. In addition, patients are more likely to decline student participation when preceptors are faculty members and less comfortable discussing student involvement.

The surgical sales representative: examining a new role in urogynecology

The face of the gynecologists’ sales representative is expanding from the all-too-familiar attractive, well-dressed, female office representative to include a new breed with a slightly different look. This is the young surgical device representative who is stereotypically male, muscular, tanned, and aggressive about “being there to observe a surgical case.” I was first introduced to this idea of case observation when a confident man in surgical attire approached me on my way into the operating room and asked if he could watch my scheduled cases that morning. I didn’t quite know what to say. How had he gained access to my schedule? Who had admitted him to the surgical suite? What exactly did he want to accomplish by being there? Did HIPPA exist? This was the first of many subsequent encounters initiated by him and his competitors, all vying to somehow get into my operating room “to provide support.” The presence of surgical device representatives in the operating theatre is increasingly common as surgical technologies become more complex and innovative. An anonymous survey of senior nurses in charge of surgical suites in the UK found that device representatives visited operating departments approximately every 2 weeks and attended actual operations every 10 weeks. Only 42% of units surveyed reported obtaining patient consent for visits and 82% had no existing guidelines for this process [1]. No published data currently exist regarding standards and procedures for surgical representatives in the USA. How and why have urogynecologists become a targeted demographic for this new breed of salesman? Two reasons seemingly exist. Firstly, in this era of expensive surgical “kits” and materials with little data demonstrating superiority of any, much less one over the other, for the treatment of pelvic organ prolapse, the responsibility to move the product rests squarely on the broad shoulders of the device representative. The ability of a sales representative to exert some pressure both in and outside the operating room as they tout the usefulness of their new product likely translates into significantly more sales of one brand over the other. The second reason, however, is potentially more alarming. As technology evolves and new materials and devices are rapidly introduced into the market, surgeons may elect a procedure with which they have no clinical experience. In an editorial regarding the introduction of new surgical procedures, Gates raises the important question of how surgeons should approach the balance to learn new skills with the fundamental obligation to benefit his or her patients and avoid harm [2]. She astutely points out that no surgical approach can benefit a patient if her surgeon has not yet acquired adequate knowledge about the procedure and the skill necessary to perform it safely. Following completion of a single half-day cadaver course prior to placement of a new kit product, the device representative may serve as a valuable and necessary resource for which anatomic landmarks to identify and how exactly this arm and that trocar all fit together. How does someone with no medical degree and certainly no live surgical training morph into a resource for troubleshooting and direction during a surgical procedure? Because, in reality, they probably have far more experience with their particular product than you do. They have completed a rigorous training curriculum on models and cadavers and carry with them tips and tricks learned from watching other surgeons battle through the learning curve of Int Urogynecol J (2009) 20:131–132 DOI 10.1007/s00192-008-0762-0

472 A cardiac technician - Led transoesophageal echocardiography service

Objective: We report the development of a Cardiac Technician based, unsupervised transoesophageal echocardiography (TOE) service, a procedure traditionally performed by medical staff and examined its feasibility and safety in a busy cardiothoracic unit. Methods: Following development of a programme for technician led TOE, an experienced (MTO5) sonographer was trained in obtaining consent, venous cannulation, sedation administration, probe intubation and manipulation, data acquisition and interpretation over a 12 month period. Unsupervised midazolam sedation and local anaesthetic administration was approved by the hospital trust pharmacy committee under cardiac anaesthesia guidance. The sonographer attended the Clinical Skills Department cannulation course. The principles and practice of obtaining patient consent were learnt under the guidance of trust risk management. We present the data for the first 146 unsupervised cases over a subsequent 16 month period. All TOEs were included for a technician led study apart from those with suspected aortic dissection, haemodynamic instability or intraoperative cases. Results: In total 146 procedures were performed unsupervised. These included mitral valve assessment (n=27), aortic valve assessment (n=7), suspected endocarditis (n=38), thromboembolic cause (n=25), prosthetic valve assessment (n=6), Grown Up Congenital Heart Disease (n=27), other (n=16). There were no significant adverse events related to the procedure. Probe intubation was unsuccessful in 5 patients of which 2 could not be passed by an experienced cardiologist. Mean procedure time was 30 minutes. Mean number of patients per list was 4. Mean midazolam dose was 3mg per patient. When data interpretation was compared with an experienced doctor, interobserver agreement was 95% (k=0.87). The differences (n=7) were minor and predominantly related to scallop assessment of the mitral valve (n=4), anomalous pulmonary venous drainage (n=2), post Fontan repair assessment (n=1). No significant lesions were missed that affected patient management. Conclusion: A fully unsupervised TOE list by an appropriately trained cardiac technician is safe and feasible allowing modernisation of traditional TOE services and extended roles for advanced echo technicians.

Dermatology: obtaining patient consent in clinical trials

This article considers the law which applies to the conduct of research on health service patients. It considers the ethical approvals which are required and the necessity to obtain consent from the patient. It must be made clear to the patient that a refusal to participate in a research project should have no adverse effect on their ongoing care and treatment.

충분한 설명에 근거한 동의에서 환자의 의사결정능력 판단의 기준

In current medical area, it has become a common process that physicians obtain patients' clear consent after transfer of information on treatment to patients prior to start treatment, and there seems to be no problem in appearance. However, if the process to obtain patient consent is observed, it can easily be found that the process is merely a conventional process and, if the pattern obtaining the consents is more deeply reviewed, it can be found that requirements to be importantly treated in the process of obtaining consents are omitted. In the world of our medical society, the process that patients agree in treatment is hearing the information from physicians and signing on consent forms where such information is described in detail, at all. They believe that they have done their duties because patients read and signed and, therefore, requirements to be deeply considered in practice are not reviewed in the process to obtain consents. The author reviewed the requirements for patients' decision-making competence among the requirements for patient consent. Despite patients' decision-making competence is the precondition of consent, procedure or standard to measure competence is not yet established. If medical information is disclosed and signature on consent forms is asked with no confirmation whether patients have the competence to make decisions, such an action cannot be considered to fulfill the liability to respect for patient's autonomy that is the original purpose. Therefore, the author intend to introduce what are used as the standards for assessment of patients' decision-making competence in the Western and intends to review what kind of limits such standards have in assessment of patients' decision-making competence by reviewing the characteristics of patient's decision-making in practical medicine. While, one of the questions made by current medical area is that Western standards on decision-making are settled with exceedingly individual-centered decision-making, thus, there cannot be no limit in application in our medical area; this will also be reviewed together. Through the review of such limits, it will be reviewed how the physicians' standards on patients' decision-making competence should be settled, when physicians obtain patients' consent, for appropriate use in clinical practice and what requirements should be considered in assessment of patients' decision-making competence.

Practice-Based Research Network Studies in the Age of HIPAA

We wanted to explore potential effects of the Health Insurance Portability and Accountability Act (HIPAA) on research activities of practice-based research networks (PBRNs). To understand the approaches PBRNs are using to advance their research while adhering to HIPAA standards, we combined a literature review, our experiences, and discussions with local HIPAA officers, PBRN researchers in the United States, and individuals involved in drafting HIPAA. HIPAA requires researchers to pay special attention to how they handle patients' protected health information (PHI). For researchers working within PBRNs, which collect information from patients and health care professionals in multiple institutions, the HIPAA Privacy Rule presents additional challenges. PBRN researchers can obtain patient authorization to use PHI, but this process is difficult and may taint the findings of some research studies. Some institutions may allow patients to provide a blanket authorization for study recruitment. PBRNs additionally can collect only "de-identified" data (data with identifying information removed) or, with a data use agreement, can work with a limited data set. PBRNs that blend quality improvement and research can work with PHI, but the researcher and practices must enter into a business agreement. PBRN researchers may need to play active, educational roles in institutional privacy boards to facilitate their research. There are a number of ways for PBRN researchers to comply with HIPAA short of obtaining patient consent and authorization for every study. Careful planning and consideration of HIPAA issues during study design can go a long way toward reducing frustration later.

Bush, Kerry Take Stand On Key Mental Health Issues

Bush, Kerry Take Stand On Key Mental Health Issues

Comparison of Butorphanol and Fentanyl for Patient-controlled Epidural Analgesia after Gastrectomy

Background: Epidural butorphanol produces effective analgesia with fewer side effects than morphine in obstetric patients. The analgesic efficacy and side effects of epidural butorphanol were compared with epidural fentanyl for patient-controlled epidural analgesia (PCEA) after gastrectomy. Methods: After obtaining patient consent, 75 patients undergoing elective gastrectomy were randomly allocated to epidural butorphanol and epidural fentanyl groups. An epidural catheter was introduced at the T7-8 or T9-10 intervertebral spaces before operation. General anesthesia was maintained with N2O / O2, enflurane and vecuronium. Postop-erative analgesia was provided using a PCEA with either fentanyl 5μg/ml or butorphanol 50μg/ml in a 0.05% bupivacaine solution. When patients first required analgesics after complete recovery of conscious-ness from general anesthesia, a bolus of 5 ml of PCEA solution was initially administered in both groups. The PCEA was set to deliver a bolus of 2 ml, with a lockout interval of 10 min, and no basal infusion. PCEA consumption, pain intensity using a visual analog score (VAS), patient's satisfaction to PCEA, and side effects were evaluated. Results: No significant difference in PCEA consumption, VAS pain score, or patient's satisfaction to PCEA was found between the two groups. The incidence of pruritus in the butorphanol g roup was less than that in the fentanyl group (P ＜ 0.05). Conclusions: PCEA with butorphanol provided similar postoperative analgesia with less pruritus than fentanyl in gastrectomized

Biomarker investigations from the ATAC trial: the role of TA01

cDNA arrays and proteomic analyses have allowed the rapid identification of specific genes and proteins implicated in multiple tumor types. These molecules must then be validated as clinically relevant prognostic and predictive markers, and this translational research is best conducted in the context of clinical trials. Outcomes data and clinical specimens collected in the 'Arimidex', Tamoxifen, Alone or in Combination (ATAC) study, for example, can now be used to compare the expression of biomarkers with clinical outcomes. In this study, adjuvant tamoxifen and anastrozole ('Arimidex') were compared alone and in combination in more than 9000 women with breast cancer. Anastrozole was found to be superior to tamoxifen in terms of disease-free survival, time to recurrence, and reduction in the incidence of contralateral tumors. Importantly, tissue specimens from surgical excision, local relapse, and contralateral breast cancer were collected and paraffin-embedded for storage. In the TA01 (TransATAC) program, these specimens will be studied (after obtaining patient consent) using tissue microarrays; tissue biopsy cores 0.6 mm in diameter will be removed from donor blocks and placed on recipient blocks, which will be sectioned to allow the simultaneous analysis of the same samples for multiple biomarkers. These analyses can help determine differential benefits of treatment with anastrozole or tamoxifen, depending on the expression of particular biomarkers in tumor cells. This research also should clarify de novo and acquired resistance mechanisms, and the validation of relevant molecular pathways could guide the development of new drugs. Ultimately, the TA01 program has the potential to favorably impact treatment choices for breast cancer.