Addressing Conflicts of Interest in Health and Medicine: Current Evidence and Implications for Patient Decision Aid Development.

BACKGROUND: More stringent policies for addressing conflicts of interest have been implemented around the world in recent years. Considering the value of revisiting conflict of interest quality standards set by the International Patient Decision Aid Standards (IPDAS) Collaboration, we sought to review evidence relevant to 2 questions: 1) What are the effects of different strategies for managing conflicts of interest? and 2) What are patients' perspectives on conflicts of interest? METHODS: We conducted a narrative review of English-language articles and abstracts from 2010 to 2019 that reported relevant quantitative or qualitative research. RESULTS: Of 1743 articles and 118 abstracts identified, 41 articles and 2 abstracts were included. Most evidence on the effects of conflict of interest management strategies pertained only to subsequent compliance with the management strategy. This evidence highlighted substantial noncompliance with prevailing requirements. Evidence on patient perspectives on conflicts of interest offered several insights, including the existence of diverse views on the acceptability of conflicts of interest, the salience of conflict of interest type and monetary value to patients, and the possibility that conflict of interest disclosure could have unintended effects. We identified no published research on the effects of IPDAS Collaboration conflict of interest quality standards on patient decision making or outcomes. LIMITATIONS: Because we did not conduct a systematic review, we may have missed some evidence relevant to our review questions. In addition, our team did not include patient partners. CONCLUSIONS: The findings of this review have implications for the management of conflicts of interest not only in patient decision aid development but also in clinical practice guideline development, health and medical research reporting, and health care delivery.

Emphasizing High Value, Cost-Effective Care in Physical Examination Instruction - A Qualitative Content Analysis of Interviews with Expert Educators.

This article was migrated. The article was marked as recommended. Introduction Physical examination and cost consciousness are critical competencies for medical trainees, but the intersection of these two skill domains is not described. We aimed to elucidate the role of physical examination in providing high value, cost conscious care (HVC) and to explore how clinical skills curricula could integrate principles of HVC. Methods We conducted a qualitative study of semi-structured interviews with 20 experts in the instruction and clinical applications of physical examination. We identified experts through purposeful sampling and snowball sampling. Audio-recorded interviews were coded using qualitative content analysis. Coded passages were categorized and reported as key themes and recommendations. Results Experts affirmed physical examination's indispensable role in clinical reasoning. When integrated with history-taking and additional diagnostic data, physical examination can further the aims of HVC. However, experts noted that the pace and demands of contemporary clinical practice present barriers to the idealized application of physical examination. In turn, participants discussed how to improve clinical skills curricula, both broadly and to promote HVC. Discussion To advance HVC through physical examination curricula, the clinical relevance of bedside skills needs to be emphasized across the training spectrum. Key strategies include revisiting evidence-based medicine principles and integrating physical examination instruction with teaching clinical reasoning.

Physician behaviors to promote informed decisions for prostate cancer screening: a National Research Network study.

Clinical guidelines for prostate cancer screening (PCS) advise physicians to discuss the potential harms and benefits of screening. However, there is a lack of training programs for informed decision-making (IDM), and it is unknown which IDM behaviors physicians have the most difficulty performing. Identifying difficult behaviors can help tailor training programs. In the context of developing a physician-IDM program for PCS, we aimed to describe physicians' use of nine key IDM behaviors for the PCS discussion and to examine the relation between the behaviors and physician characteristics. A cross-sectional sample of The American Academy of Family Physicians National Research Network completed surveys about their behavior regarding PCS (N = 246; response rate = 58%). The surveys included nine physician key IDM behaviors for PCS and a single-item question describing their general practice style for PCS. The most common IDM behavior was to invite men to ask questions. The two least common reported behaviors concerned patients uncertain about screening (i.e., arrange follow-up and provide additional information for undecided men). Physicians reported difficulty with these two behaviors regardless whether they reported to discuss or not to discuss PCS with patients. Reported use of key IDM behaviors was associated with a general practice style for PCS and being affiliated with a residency-training program. Physician training programs for IDM should include physician skills to address the needs of patients uncertain about screening. Future research should determine if actual behavior is associated with self-reported behavior for the PCS discussion.

A community-based intervention to promote informed decision making for prostate cancer screening among Hispanic American men changed knowledge and role preferences: a cluster RCT.

OBJECTIVE: We assessed the short-term effects of a community-based intervention for Hispanic men to encourage informed decision making (IDM) about prostate cancer screening with prostate specific antigen (PSA). METHODS: All senior social and housing centers in El Paso, TX were randomized to intervention, a group-based Spanish language educational program facilitated by promotores (12 centers; 161 men) [I's], or to control, promotores-facilitated diabetes video and discussion (13 centers; 160 men) [C's]. RESULTS: Participants had low levels of schooling and baseline knowledge; 44% reported previous PSA testing. At post-test, the I's made large knowledge gains, increased their understanding that experts disagree about testing, shifted toward more active decision making roles, were more likely to believe that it is important to weigh the advantages and disadvantages of screening and to anticipate potential screening outcomes in making a decision, and were less likely to consider the screening decision easy. The I's did not change in their screening intention or the belief that choosing not to be screened could be a responsible choice. CONCLUSIONS: A community-based intervention to support IDM for prostate cancer screening can increase knowledge and may promote more active involvement in decision making about prostate cancer screening. Such an approach can increase knowledge and may promote more active involvement in decision making about prostate cancer screening. PRACTICE IMPLICATIONS: It is feasible to develop and implement a community-based intervention program to promote IDM for prostate cancer screening.

A structured implicit abstraction method to evaluate whether content of counseling before prostate cancer screening is consistent with recommendations by experts.

OBJECTIVE: To assess the content of counseling about prostate-specific antigen (PSA) screening. Guidelines recommend informed consent before screening because of concerns about benefits versus risks. As part of the professional practice standard for informed consent, clinicians should include content customarily provided by experts. METHODS: 40 transcripts of conversations between medicine residents and standardized patients were abstracted using an instrument derived from an expert Delphi panel that ranked 10 "facts that experts believe men ought to know." RESULTS: Transcripts contained definite criteria for an average of 1.7 facts, and either definite or partial criteria for 5.1 facts. Second- and third-year residents presented more facts than interns (p=0.01). The most common facts were "false positive PSA tests can occur" and "use of the PSA test as a screening test is controversial." There was an r=0.88 correlation between inclusion by residents and the experts' ranking. CONCLUSION: Counseling varied but most transcripts included some expert-recommended facts. The absence of other facts could be a quality deficit or an effort to prioritize messages and lessen cognitive demands on the patient. PRACTICE IMPLICATIONS: Clinicians should adapt counseling for each patient, but our abstraction approach may help to assess the quality of informed consent over larger populations.

What is needed for informed decisions about prostate cancer screening: perspectives of African-American and Hispanic men.

Professional guidelines suggest that men should learn about risks and benefits of screening to make informed decisions consistent with their preferences. We used concept mapping to investigate views of informed decision making (IDM) of minority men. Statements about what men need for IDM about prostate cancer screening were sorted by similarity and rated for importance by 16 Hispanic and 15 African-American men. Multidimensional scaling and cluster analysis were used to develop a concept map for IDM. The 10-cluster solution was selected. The clusters rated most important were labeled Future Considerations, What to Know and Decision to Make. Clusters labeled Social Support and Sharing Perspectives depicted social aspects of the decision and were intermediate in importance. There was strong correlation in relative importance ratings of clusters by African-American and Hispanic men. However, African-American men gave higher importance ratings than Hispanic men. Concept mapping, a method with strong participatory elements, was useful in identifying conceptual frameworks for IDM of African-American and Hispanic men. Health education to support IDM requires some shifts in focus and strategy. It is important that interventions with minority men build upon a strong conceptual framework.

Implementing an intervention to promote colon cancer screening through e-mail over the Internet: lessons learned from a pilot study.

BACKGROUND: Colon cancer screening (CRCS) tests are underused. Multiple CRCS options may confuse patients and lead to inaction. E-mail between patients and physicians may raise awareness about CRCS and allow physicians to answer questions about test options. OBJECTIVES: To develop and implement an electronic intervention, the InterNet LETter (NetLET), to increase interest in and use of CRCS among patients with and without e-mail access at home or work. RESEARCH METHODS: During 2004-2005, 97 patients over 49 years old were recruited during a clinic visit. Patients with e-mail at home or work were assigned to the private access arm; patients without e-mail but willing to use the public library system were assigned to the public access arm. Within each arm, patients were randomized to the NetLET or control group. The NetLET consisted of a personalized e-mail from the physician reminding the patient to undergo CRCS and providing a link to a webpage with information about CRCS. Control groups were mailed a reminder letter from their physician. All were mailed a fecal occult blood test (FOBT) kit. RESULTS: In the public access intervention group, only 1 of 11 patients viewed the NetLET. In the private access intervention group, 10 of 42 viewed it. Eleven of 42 (26%) private access intervention group participants, and 8 of 35 (23%) private access control group participants returned an FOBT. No public access intervention group patients, but 3 of 9 control group patients, returned an FOBT. CONCLUSIONS: We concluded that it was not feasible to implement the NetLET, but reasons for lack of success differed for the private and public access arms.

Brief report: physicians and their personal prostate cancer-screening practices with prostate-specific antigen. A national survey.

BACKGROUND: There is inconclusive evidence that prostate cancer screening with prostate-specific antigen (PSA) reduces mortality. Although PSA testing is widespread, it is unknown how many physicians have taken the PSA test themselves. OBJECTIVE: To determine the prevalence of PSA testing among physicians. DESIGN: Cross-sectional survey. SUBJECTS: A nationwide stratified random sample of urologists (response rate 61%, n=247), Internists (response rate 51%, n=273), and family physicians (response rate 64%, n=249) were surveyed by mail in 2000. After excluding female respondents and men who either reported a positive history of prostate cancer or did not respond to that query, there were 146 urologists, 96 Internists, and 118 family physicians. MEASUREMENTS: Whether physicians had undergone prostate cancer screening with PSA. RESULTS: Eighty-seven percent (155/178) of male physicians aged, 50 and older and 21% (31/150) of white male physicians under age 50 reported having had a PSA test. More urologists than nonurologists in both age groups reported having had a screening PSA test. CONCLUSION: Most physicians aged 50 and older report undergoing PSA testing. This may reflect a belief in its efficacy and contribute to its widespread use.

Promoting informed choice: transforming health care to dispense knowledge for decision making.

Ours is an era in which patients seek greater engagement in health care choices, increasing the demand for high-quality information about clinical options. Providing support for informed choice is not straightforward, however, because of challenges faced by clinicians, health systems, and consumers. Greater use of written or electronic tools can help to clarify choices for patients, but decision aids cannot replace the human element in facilitating informed choice. The ideal solution is to couple information with high-quality decision counseling to help patients understand the potential risks, benefits, and uncertainties of clinical options and to assist them in selecting the option that best accommodates their personal preferences. Decision counseling can be offered by 3 types of providers: clinicians who lack formal informed-choice training ("usual care"), clinicians with formal informed-choice training, or trained third parties who function as impartial decision counselors. Controlled studies are needed to determine which model is best, but none appears to be ideal. The health care system cannot truly support informed decision making without correcting the underlying obstacles that impede patient access to needed information. New information technology solutions, training programs, and reimbursement schemes are necessary. Patient demand for guidance will only increase as clinical options multiply and the world of information continues its rapid growth. Today's health care system is unprepared for the convergence of these 2 burgeoning domains, and the need to address systemic deficiencies will grow more urgent over time.

Promoting an ethical approach to unproven screening imaging tests.

The use of screening imaging technology such as electron beam computed tomography and computed tomographic scans for the early detection of coronary artery disease, lung cancer, and other diseases is rising, even though they have not been proven to reduce disease-specific mortality. Until randomized, controlled trials assess the efficacy of these tests as screening tests, they will remain controversial. It is unclear whether the potential benefits of these screening tests outweigh the risks. In a practice environment in which public demand and enthusiasm for screening is high, radiologists can recognize the ethical issues associated with unproven screening imaging tests; understand current national policies toward professionalism and informed and shared decision making for screening; draw on the lessons learned from the proliferation of another unproven screening test, the prostate-specific antigen blood test for prostate cancer; and work with others in the health care system to promote an ethical approach to screening imaging tests.

Informed decision making: what is its role in cancer screening?

Interest in informed decision making (IDM) has grown in recent years. Greater patient involvement in decision making is consistent with recommendations to improve health care quality. This report provides an overview of IDM; clarifies the differences between IDM, shared decision making (SDM), and informed consent; and reviews the evidence to date about IDM for cancer screening. The authors also make recommendations for research. We define IDM as occurring when an individual understands the disease or condition being addressed and comprehends what the clinical service involves, including its benefits, risks, limitations, alternatives, and uncertainties; has considered his or her preferences and makes a decision consistent with them; and believes he or she has participated in decision making at the level desired. IDM interventions are used to facilitate informed decisions. The authors reviewed the evidence to date for IDM and cancer screening based primarily on published meta-analyses and a recent report for the Centers for Disease Control and Prevention's Guide to Community Preventive Services. IDM and SDM interventions, such as decision aids, result in improved knowledge, beliefs, risk perceptions, and combinations of these. Little or no evidence exists, however, regarding whether these interventions result in 1) participation in decision making at a level consistent with patient preferences or 2) effects on patient satisfaction with the decision-making process. These variables generally either were not assessed or were not reported in the articles reviewed. Results of interventions on uptake of screening were variable. After exposure to IDM/SDM interventions, most studies showed small decreases in prostate cancer screening, whereas four studies on breast and colorectal cancer screening showed small increases. Few data are available by which to evaluate current practices in cancer screening IDM. Patient participation in IDM should be facilitated for those who prefer it. More research is needed to assess the benefits of IDM/SDM interventions and to tailor interventions to individuals who are most likely to desire and benefit from them. There are many system barriers to IDM/SDM and few tools. More work is needed in this area as well. In addition, research is needed to learn how to incorporate IDM into ongoing clinical practice and to determine whether there are unintended negative consequences of IDM.

Do men know that they have had a prostate-specific antigen test? Accuracy of self-reports of testing at 2 sites.

This study determined the accuracy of self-reports of prostate-specific antigen (PSA) testing. Men (N = 402) attending 2 outpatient clinics were asked: "Did you have a PSA test today?" and their medical records were checked. Concordance, sensitivity, and false-negative values were 65%, 67%, and 33%, respectively, at 1 clinic site and 88%, 64%, and 36% at the other. The accuracy of self-reports of PSA testing should be interpreted with caution.

Cultural sensitivity and informed decision making about prostate cancer screening.

Because informed consent for prostate cancer screening with prostate specific antigen (PSA) is recommended, we determined how African Americans, Hispanics, and Caucasians want information about screening with PSA and the digital rectal exam (DRE) presented in culturally sensitive brochures specific for each group. We analyzed focus group discussions using content analysis and compared themes across groups in a university outpatient internal medicine practice setting. The participants were twenty couples with men age 50 and older who participated in four focus groups. Main outcome measures were participants' views on the content and graphic design of culturally sensitive brochures promoting informed decision making about prostate cancer screening. There were content and graphic design differences in the way ethnic groups wanted information presented about the prostate, prostate cancer, risk, and screening. Caucasians likened the size of the prostate to a walnut; Hispanics, to a small lime. Hispanics emphasized how advanced prostate cancer can be symptomatic; Caucasians, how early prostate cancer can be asymptomatic. African Americans wanted risk information specific for them and the advantages and disadvantages of a PSA and DRE; Hispanics, did not. Caucasians and African Americans sought a more active role for men in informed decision making than Hispanics. Differences in the way African Americans, Hispanics, and Caucasians want information presented about prostate cancer screening suggest there may be cultural differences in the reasonable person standard of informed consent, in attitudes toward the physician-patient relationship, screening, and informed decision making. Physicians promoting informed decision making about controversial screening tests should take cultural sensitivity into account when designing educational interventions and using them.

Acute renal failure secondary to angiotensin II receptor blockade in a patient with bilateral renal artery stenosis.

A 54-year-old man with diabetes mellitus, peripheral vascular disease, and hypertension was admitted to the hospital for an acute exacerbation of chronic heart failure. Therapy with intravenous furosemide and oral losartan 100 mg twice/day was begun. Ten days later, the patient's blood urea nitrogen and serum creatinine levels rose and peaked at 110 and 6.0 mg/dl, respectively. His serum potassium level increased to 5.7 mg/dl, urine output dropped to 400 ml over 24 hours, and mental status changes occurred. Magnetic resonance angiography revealed bilateral renal artery stenosis. After losartan was discontinued and hemodialysis was performed for 3 consecutive days, the patient's renal function returned to his baseline level. Reports in the medical literature reinforce the importance of recognizing that angiotensin-converting enzyme inhibitors should be used with caution in patients with bilateral renal artery stenosis. However, the literature is not as definitive about using of angiotensin II receptor blockers (ARBs) in these patients. Our patient's experience suggests that ARBs should be used with caution in patients with bilateral renal artery stenosis. Clinicians should be aware that renal failure might occur when using ARBs in these patients.

Physician perspectives on the importance of facts men ought to know about prostate-specific antigen testing.

OBJECTIVE: To determine physicians' rating of the importance of key facts men ought to know about prostate-specific antigen (PSA) screening and whether there are differences by specialty. PARTICIPANTS: A nationwide random sample of internists, family physicians, and urologists stratified by physician specialty from The Official ABMS Directory of Board-Certified Medical Specialists 2000 Edition. MEASUREMENTS: Internists (N = 139), family physicians (N = 160), and urologists (N = 151) were asked to rate how important it is for men to know 17 facts about PSA screening using a 5-point Likert scale. MAIN RESULTS: Of 769 eligible physicians, 450 responded, for an overall response rate of 59%. Urologists and nonurologists differed in rating how important it was for men to know 9 of the 17 key facts. Eight of the nine statements that urologists and nonurologists disagreed upon concerned facts reflecting uncertainty. Nonurologists were more likely than urologists to rate facts reflecting uncertainty as highly important for men to know. These included statements about prostate cancer risk, screening with PSA, and treatment. CONCLUSIONS: Despite professional guidelines supporting informed decision making, the importance of facts men ought to know about PSA testing differ by physician specialty. Systematic differences may reflect differences in professional guidelines about PSA testing.

Informed consent for cancer screening with prostate-specific antigen: how well are men getting the message?

OBJECTIVES: This study examined knowledge about prostate-specific antigen (PSA) screening among African Americans and Whites. Because PSA screening for prostate cancer is controversial, professional organizations recommend informed consent for screening. METHODS: Men (n = 304) attending outpatient clinics were surveyed for their knowledge about and experience with screening. RESULTS: Most men did not know the key facts about screening with PSA. African Americans appeared less knowledgeable than Whites, but these differences were mediated by differences in educational level and experience with prostate cancer screening. CONCLUSIONS: Public health efforts to improve informed consent for prostate cancer screening should focus on highlighting the key facts and developing different approaches for men at different levels of formal education and prior experience with screening.