Robert J. Volk

Developing a quality criteria framework for patient decision aids: online international Delphi consensus process

Abstract Objective To develop a set of quality criteria for patient decision support technologies (decision aids). Design and setting Two stage web based Delphi process using online rating process to enable international collaboration. Participants Individuals from four stakeholder groups (researchers, practitioners, patients, policy makers) representing 14 countries reviewed evidence summaries and rated the importance of 80 criteria in 12 quality domains ona1to9 scale. Second round participants received feedback from the first round and repeated their assessment of the 80 criteria plus three new ones. Main outcome measure Aggregate ratings for each criterion calculated using medians weighted to compensate for different numbers in stakeholder groups; criteria rated between 7 and 9 were retained. Results 212 nominated people were invited to participate. Of those invited, 122 participated in the first round (77 researchers, 21 patients, 10 practitioners, 14 policy makers); 104/122 (85%) participated in the second round. 74 of 83 criteria were retained in the following domains: systematic development process (9/9 criteria); providing information about options (13/13); presenting probabilities (11/13); clarifying and expressing values (3/3); using patient stories (2/5); guiding/coaching (3/5); disclosing conflicts of interest (5/5); providing internet access (6/6); balanced presentation of options (3/3); using plain language (4/6); basing information on up to date evidence (7/7); and establishing effectiveness (8/8). Conclusions Criteria were given the highest ratings where evidence existed, and these were retained. Gaps in research were highlighted. Developers, users, and purchasers of patient decision aids now have a checklist for appraising quality. An instrument for measuring quality of decision aids is being developed.

American Cancer Society Guideline for the Early Detection of Prostate Cancer: Update 2010

In 2009, the American Cancer Society (ACS) Prostate Cancer Advisory Committee began the process of a complete update of recommendations for early prostate cancer detection. A series of systematic evidence reviews was conducted focusing on evidence related to the early detection of prostate cancer, test performance, harms of therapy for localized prostate cancer, and shared and informed decision making in prostate cancer screening. The results of the systematic reviews were evaluated by the ACS Prostate Cancer Advisory Committee, and deliberations about the evidence occurred at committee meetings and during conference calls. On the basis of the evidence and a consensus process, the Prostate Cancer Advisory Committee developed the guideline, and a writing committee drafted a guideline document that was circulated to the entire committee for review and revision. The document was then circulated to peer reviewers for feedback, and finally to the ACS Mission Outcomes Committee and the ACS Board of Directors for approval. The ACS recommends that asymptomatic men who have at least a 10‐year life expectancy have an opportunity to make an informed decision with their health care provider about screening for prostate cancer after they receive information about the uncertainties, risks, and potential benefits associated with prostate cancer screening. Prostate cancer screening should not occur without an informed decision‐making process. Men at average risk should receive this information beginning at age 50 years. Men in higher risk groups should receive this information before age 50 years. Men should either receive this information directly from their health care providers or be referred to reliable and culturally appropriate sources. Patient decision aids are helpful in preparing men to make a decision whether to be tested. CA Cancer J Clin 2010;60:70–98.

Effectiveness of the AUDIT-C as a Screening Test for Alcohol Misuse in Three Race/Ethnic Groups

SummaryBackgroundThe Alcohol Use Disorders Identification Test—Consumption (AUDIT-C) is a brief validated screen for risky drinking and alcohol abuse and dependence (alcohol misuse). However, the AUDIT-C was validated in predominantly White populations, and its performance in different racial/ethnic groups is unclear.ObjectiveTo evaluate the validity of the AUDIT-C among primary care patients from the predominant racial/ethnic subgroups within the United States: White, African American, and Hispanic.DesignCross-sectional interview validation study.Participants1,292 outpatients from an academic family practice clinic in Texas (90% of randomly sampled eligible).Measurements and Main ResultsRace/ethnicity was self-reported. Areas under the receiver operating curve (AuROCs) evaluated overall AUDIT-C performance in the 3 racial/ethnic groups compared to diagnostic interviews for alcohol misuse. AUDIT-C sensitivities and specificities at recommended screening thresholds were compared across racial/ethnic groups. AuROCs were greater than 0.85 in all 3 groups, with no significant differences across racial/ethnic groups in men (P = .43) or women (P = .12). At previously recommended cut points, there were statistically significant differences by race in AUDIT-C sensitivities but not specificities. In women, the sensitivity was higher in Hispanic (85%) than in African-American (67%; P = .03) or White (70%; P = .04) women. In men, the sensitivity was higher in White (95%) than in African-American men (76%; P = .01), with no significant difference from Hispanic men (85%; P = .11).ConclusionsThe overall performance of the AUDIT-C was excellent in all 3 racial/ethnic groups as reflected by high AuROCs. At recommended cut points, there were significant differences in the AUDIT-C’s sensitivity but not in specificity across the 3 racial/ethnic groups.

Preferences for colorectal cancer screening among racially/ethnically diverse primary care patients.

Background:Incorporating patients’ preferences into colorectal cancer (CRC) screening recommendations has been identified as a potential mechanism for increasing adherence. This study used conjoint analysis to describe variation in CRC screening preferences among racially/ethnically diverse primary care patients. Methods:We recruited patients ages 50–80 of a large practice-based research network stratified by white, African American, or Hispanic race/ethnicity to complete a preference assessment instrument. Participants were asked to rate 8 hypothetical CRC screening test scenarios comprised of different combinations of 5 attributes and 6 scenarios designed to depict guideline-recommended CRC screening tests (eg, fecal occult blood test, flexible sigmoidoscopy, colonoscopy, and double contrast barium enema) including new technology (eg, virtual colonoscopy, fecal immunochemical test). Responses were used to calculate the overall importance of test attributes, the relative importance of attribute levels, and to identify factors associated with preferences. Results:Two hundred twelve primary care patients were recruited to the study (74 white, 60 African American, 78 Hispanic). Of the guideline-recommended tests, 37% preferred COL, 31% FOBT, 15% BE, and 9% SIG. Ratings of new technology tests were significantly (P < 0.05) higher than ratings of guideline-recommended tests. The order of the importance of attributes was: what the test involved (37%), accuracy (19%), frequency (17%), discomfort (15%), and preparation (13%). Part-worth utilities for 1 attribute showed that collecting a stool sample was most preferable and endoscopy without sedation least preferable. Multivariate regression found that race/ethnicity and specific test attributes were independently associated (P < 0.05) with test preferences. Conclusions:Primary care patients have distinct preferences for CRC screening tests that can be linked to test attributes. Racial/ethnic variations in test preferences persist when controlling for attributes. Tailoring screening recommendations to patients’ preferences may increase screening adherence.

Management of type 2 diabetes in the primary care setting: A practice-based research network study

PURPOSE We wanted to describe how primary care clinicians care for patients with type 2 diabetes. METHODS We undertook a cross-sectional study of 95 primary care clinicians and 822 of their established patients with type 2 diabetes from 4 practice-based, primary care research networks in the United States. Clinicians were surveyed about their training and practice. Patients completed a self-administered questionnaire about their care, and medical records were reviewed for complications, treatment, and diabetes-control indicators. RESULTS Participating clinicians (average age, 45.7 years) saw an average of 32.6 adult patients with diabetes per month. Patients (average age, 59.7 years) reported a mean duration of diabetes of 9.1 years, with 34.3% having had the disease more than 10 years. Nearly one half (47.5%) of the patients had at least 1 diabetes-related complication, and 60.8% reported a body mass index greater than 30. Mean glycosylated hemoglobin (HbA1c) level was 7.6% (SD 1.73), and 40.5% of patients had values <7%. Only 35.3% of patients had adequate blood pressure control (<130/85 mm Hg), and only 43.7% had low-density lipoprotein cholesterol (LDL-C) levels <100 mg/dL. Only 7.0% of patients met all 3 control targets. Multilevel models showed that patient ethnicity, practice type, involvement of midlevel clinicians, and treatment were associated with HbA1c level; patient age, education level, and practice type were associated with blood pressure control; and patient ethnicity was associated with LDL-C control. CONCLUSIONS Only modest numbers of patients achieve established targets of diabetes control. Reengineering primary care practice may be necessary to substantially improve care.

Ethnic and Sex Bias in Primary Care Screening Tests for Alcohol Use Disorders

Alcohol use is the third leading cause of preventable death in the United States [1], and alcohol-related morbidity is substantial [2]. For many persons with alcohol problems, a primary care provider is the first contact with the health care system [3]. Unfortunately, the problem often goes unrecognized until it has had significant consequences for physical health [4]. Many professional organizations recommend questioning patients about alcohol use [5-7]. The routine use of biochemical markers as the primary method for screening for alcohol problems in asymptomatic patients is discouraged by the U.S. Preventive Services Task Force because the accuracy of such tests is poor compared with that of self-report measures [6]. Many self-report screening tests have been developed to help identify patients with alcohol use disorders. Nevertheless, concern is growing over the lack of validation of these tests in patients who are female, elderly, or nonwhite [8]. Concerns about potential ethnic and sex bias in screening accuracy are particularly important because patterns of alcohol use [9, 10], the prevalence of alcohol use disorders [11, 12], and the consequences of alcohol consumption [2, 13] vary in men and women from different ethnic backgrounds in the United States. We tested for bias in the accuracy of three common self-report screening tests across sex and ethnic subgroups of primary care patients. The CAGE questionnaire was selected for evaluation because it is one of the most widely used screening tests for alcoholism. It was developed originally to identify the hidden alcoholic in hospital settings [14] and has also been evaluated in primary care settings [15, 16]. We also selected the Self-Administered Alcoholism Screening Test (SAAST), a self-administered version of the Michigan Alcoholism Screening Test, for evaluation (Appendix Figure 1). The SAAST was developed to screen for alcoholism in general medical patients and is available in a 9-item version with response options in a yes/no format. The final instrument selected for evaluation was the Alcohol Use Disorders Identification Test (AUDIT), developed by the World Health Organization [17] (Appendix Figure 2). The 10-item AUDIT was developed to detect persons with early alcohol use problems who do not necessarily meet the diagnostic criteria for alcohol dependence. In our study, the criterion variable was a current alcohol use disorder, including alcohol abuse and alcohol dependence, as defined by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) [18]. Recommended methodologic standards for evaluating diagnostic tests guided this analysis [19]. Appendix Figure 1. Appendix Figure 2. Methods Patients and Procedures Participants were adult primary care patients presenting to the Family Practice Center at the University of Texas Medical Branch, Galveston, Texas. This family medicine clinic, which is a residency-training site, serves an ethnically diverse community and has an annual patient-visit volume in excess of 30 000; the patients are a mix of privately insured, managed care, Medicaid, Medicare, and uninsured patients. Faculty and resident practices are located at the Center, which has approximately 12 faculty physicians and 20 resident providers. The sampling strategy was designed to ensure adequate representation of minority and female patients. Adult family medicine patients were randomly selected from the Family Practice Center appointment lists. For each clinic session, a patient was selected at random by using a table of random numbers from among those patients who had appointment times within the first 60 minutes of the session. Thereafter, patients were selected according to appointment time at fixed intervals (for example, 45 minutes after the previously selected patient) to allow for a manageable flow of patients through the interview process. Patients were contacted about participating in the study by telephone on the day before their scheduled appointments. Patients who could not be reached by telephone (30%) were approached directly in the clinics waiting area on the day of their appointment. If a patient refused to participate in the study, the next patient on the appointment schedule was approached. Sampling continued until at least 100 men and 250 women in each ethnic group had participated. The sampling strategy is described in more detail elsewhere [20]. Data were collected between October 1993 and December 1994. While waiting to see their physicians, patients completed self-report questionnaires that included questions about sociodemographic indicators and the SAAST. After their office visits, patients participated in an interview that was administered by project interviewers and included the CAGE questionnaire, the AUDIT, and a diagnostic schedule used to determine the presence of an alcohol use disorder. Interviewers were not given the results of the diagnostic interview, which was scored by computer algorithm after the questionnaire and interview had been completed. All study materials were translated into Spanish, and Spanish-speaking interviewers were used with Mexican-American patients (30 patients selected Spanish administration). Patients were reimbursed

Patient Education for Informed Decision Making About Prostate Cancer Screening: A Randomized Controlled Trial with 1-Year Follow-Up

10 for their time. Written informed consent was obtained from each patient, and the project was approved by our institutional review board. Instruments CAGE The acronym CAGE represents four brief questions: Have you ever felt you should Cut down on your drinking? Have people Annoyed you by criticizing your drinking? Have you ever felt bad or Guilty about your drinking? Have you ever had a drink first thing in the morning (Eye-opener) to steady your nerves or to get rid of a hangover? The CAGE was developed as a device to screen for alcoholism in hospital settings, where high rates of alcohol abuse are often seen [14]. It is also widely used in clinical settings and community-based studies and is considered an indirect measure of alcoholism because it addresses the consequences of drinking (with the exception of the eye-opener question) rather than alcohol consumption per se [21]. The CAGE can be used during the clinical interview (self-administered) or as part of a broader assessment of alcohol use (as was done in this study). A yes answer to two or more questions is generally considered a positive result [21], although an approach that uses likelihood ratios has also been proposed [15]. The time frame for the CAGE is lifetime. Self-Administered Alcoholism Screening Test The SAAST [22-24] is a modified, self-administered version of the Michigan Alcoholism Screening Test. In our study, we used the 9-item version of the SAAST (completed by patients before the diagnostic interview) because its reduced length is more amenable to primary care settings [25]. The Michigan Alcoholism Screening Test is a structured, 25-item questionnaire that has been used to detect alcoholism in many groups, including persons suspected of driving while under the influence of alcohol [26]. The 9-item version of the SAAST was developed for use in medical settings and has shown consistency in U.S. and Mexican samples [27]. Three items are similar to the annoyed, eye-opener, and cut down questions from the CAGE; the rest address the consequences of drinking and indicators of dependence. The instrument is scored by summing responses to the questions (the annoyed and cut-down questions each receive a weight of 2, and all others receive a weight of 1), and a score of 3 or more is considered a positive result [25]. The time frame for the SAAST is lifetime. Alcohol Use Disorders Identification Test The AUDIT is a 10-item, self-report screening test that identifies patients at risk for alcohol use disorders by using procedures appropriate for the variety of health care facilities in developed and developing counties [17, 28, 29]. The AUDIT was developed by the World Health Organization (WHO) for the express purpose of avoiding ethnic and cultural bias. An extensive, multinational instrument development study of primary health care patients was coordinated by WHO (the WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption) to eliminate such bias [17]. The AUDIT has three important advantages over other screening tests: It 1) identifies at-risk alcohol users who do not meet criteria for alcohol dependence, 2) includes both consumption-based indicators of alcohol problems and indicators of harmful use and dependence, and 3) uses both current (defined as within the past month) and lifetime time frames. Response options range from 0 to 4, and a positive result is a score of 8 or more [28] (alternative cut-points and approaches using likelihood ratios have been suggested [20, 30, 31]). The instrument can be self-administered or given orally (as was done in our study). Alcohol Use Disorders Diagnostic Schedule The patient interview included the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS), a structured diagnostic schedule developed for use in the National Longitudinal Alcohol Epidemiologic Survey, which was started in 1992 by the National Institute on Alcohol Abuse and Alcoholism [32]. The AUDADIS has shown reliability in clinical and general population studies, applicability for cross-cultural research, and concordance with other diagnostic instruments [33-36]. It was designed to be administered by trained lay interviewers, as was done in our study. We used the AUDADIS Alcohol Experiences module to determine the presence of alcohol abuse or dependence according to the DSM-IV criteria [18]. Alcohol dependence, as defined by DSM-IV, is a maladaptive pattern of alcohol use leading to clinically significant impairment or distress as manifested by three or more of the following criteria: increased tolerance, withdrawal, impaired control, neglect of activities, increased time spent drinking, and drinking despite problems.

Factors associated with herbal use among urban multiethnic primary care patients: a cross-sectional survey

PURPOSE The efficacy of prostate cancer screening is uncertain, and professional organizations recommend educating patients about potential harms and benefits. We evaluated the effect of a videotape decision aid on promoting informed decision making about prostate cancer screening among primary care patients. METHODS A group of 160 men, 45 to 70 years of age, with no history of prostate cancer, were randomized to view or not to view a 20-minute educational videotape before a routine office visit at a university-based family medicine clinic. The subjects were contacted again 1 year after their visit to assess their receipt of prostate cancer screening (digital rectal examination [DRE] or prostate-specific antigen [PSA] testing), their satisfaction with their screening decision, and knowledge retention since the baseline assessment. RESULTS Follow-up assessments were completed for 87.5% of the intervention subjects and 83.8% of the control subjects. The rate of DRE did not differ between the 2 groups. Prostate-specific antigen testing was reported by 24 of 70 (34.3%) intervention subjects and 37 of 67 (55.2%) control subjects (P = .01). African American men were more likely to have had PSA testing (9 of 16, 56.3%) than were white men (13 of 46, 28.3%) (P = .044). Satisfaction with the screening decision did not differ between the study groups. Intervention subjects were more knowledgeable of prostate cancer screening than were control subjects, although these differences declined within 1 year (P < .001). CONCLUSIONS Decision aids for prostate cancer screening can have a long-term effect on screening behavior and appear to promote informed decision making.

Estimating risk of alcohol dependence using alcohol screening scores

BackgroundThe use of herbal supplements in the United States has become increasingly popular. The prevalence of herbal use among primary care patients varies in previous studies; the pattern of herbal use among urban racially/ethnically diverse primary care patients has not been widely studied. The primary objectives of this study were to describe the use of herbs by ethnically diverse primary care patients in a large metropolitan area and to examine factors associated with such use. The secondary objective was to investigate perceptions about and patterns of herbal use.MethodsData for a cross-sectional survey were collected at primary care practices affiliated with the Southern Primary-care Urban Research Network (SPUR-Net) in Houston, Texas, from September 2002 to March 2003. To participate in the study, patients had to be at least 18 years of age and visiting one of the SPUR-Net clinics for routine, nonacute care. Survey questions were available in both English and Spanish.ResultsA total of 322 patients who had complete information on race/ethnicity were included in the analysis. Overall, 36% of the surveyed patients (n = 322) indicated use of herbs, with wide variability among ethnic groups: 50% of Hispanics, 50% of Asians, 41% of Whites, and 22% of African-Americans. Significant factors associated with an individuals herbal use were ethnicity other than African-American, having an immigrant family history, and reporting herbal use by other family members. About 40% of survey respondents believed that taking prescription medications and herbal medicines together was more effective than taking either alone. One-third of herbal users reported using herbs on a daily basis. More Whites (67%) disclosed their herbal use to their health-care providers than did African-Americans (45%), Hispanics (31%), or Asians (31%).ConclusionsRacial/ethnic differences in herbal use were apparent among this sample of urban multiethnic adult primary care patients. Associated factors of herbal use were non-African-American ethnicity, immigrant family history, and herbal use among family members. Whereas Hispanics and Asians reported the highest rates of herbal use, they were the least likely to disclose their use to health-care professionals. These findings are important for ensuring medication safety in primary care practices.

Toward Minimum Standards for Certifying Patient Decision Aids A Modified Delphi Consensus Process

Brief alcohol counseling interventions can reduce alcohol consumption and related morbidity among non-dependent risky drinkers, but more intensive alcohol treatment is recommended for persons with alcohol dependence. This study evaluated whether scores on common alcohol screening tests could identify patients likely to have current alcohol dependence so that more appropriate follow-up assessment and/or intervention could be offered. This cross-sectional study used secondary data from 392 male and 927 female adult family medicine outpatients (1993-1994). Likelihood ratios were used to empirically identify and evaluate ranges of scores of the AUDIT, the AUDIT-C, two single-item questions about frequency of binge drinking, and the CAGE questionnaire for detecting DSM-IV past-year alcohol dependence. Based on the prevalence of past-year alcohol dependence in this sample (men: 12.2%; women: 5.8%), zones of the AUDIT and AUDIT-C identified wide variability in the post-screening risk of alcohol dependence in men and women, even among those who screened positive for alcohol misuse. Among men, AUDIT zones 5-10, 11-14 and 15-40 were associated with post-screening probabilities of past-year alcohol dependence ranging from 18 to 87%, and AUDIT-C zones 5-6, 7-9 and 10-12 were associated with probabilities ranging from 22 to 75%. Among women, AUDIT zones 3-4, 5-8, 9-12 and 13-40 were associated with post-screening probabilities of past-year alcohol dependence ranging from 6 to 94%, and AUDIT-C zones 3, 4-6, 7-9 and 10-12 were associated with probabilities ranging from 9 to 88%. AUDIT or AUDIT-C scores could be used to estimate the probability of past-year alcohol dependence among patients who screen positive for alcohol misuse and inform clinical decision-making.