David R. Rovner

Do Patient Decision Aids Meet Effectiveness Criteria of the International Patient Decision Aid Standards Collaboration? A Systematic Review and Meta-analysis

Objective. To describe the extent to which patient decision aids (PtDAs) meet effectiveness standards of the International Patient Decision Aids Collaboration (IPDAS). Data sources. Five electronic databases (to July 2006) and personal contacts (to December 2006). Results. Among 55 randomized controlled trials, 38 (69%) used at least 1 measure that mapped onto an IPDAS effectiveness criterion. Measures of decision quality were knowledge scores (27 trials), accurate risk perceptions (12 trials), and value congruence with the chosen option (3 trials). PtDAs improved knowledge scores relative to usual care (weighted mean difference [WMD] = 15.2%, 95% confidence interval [CI] = 11.7 to 18.7); detailed PtDAs were somewhat more effective than simpler PtDAs (WMD = 4.6%, 95% CI = 3.0 to 6.2). PtDAs with probabilities improved accurate risk perceptions relative to those without probabilities (relative risk = 1.6, 95% CI = 1.4 to 1.9). Relative to simpler PtDAs, detailed PtDAs improved value congruence with the chosen option. Only 2 of 6 IPDAS decision process criteria were measured: feeling informed (15 trials) and feeling clear about values (13 trials). PtDAs improved these process measures relative to usual care (feeling uninformed WMD = —8.4, 95% CI = —11.9 to —4.8; unclear values WMD = —6.3, 95% CI = —10.0 to —2.7). There was no difference in process measures when detailed and simple PtDAs were compared. Conclusions. PtDAs improve decision quality and the decision processs measures of feeling informed and clear about values; however, the size of the effect varies across studies. Several IPDAS decision process measures have not been used. Future trials need to use a minimum data set of IPDAS evaluation measures. The degree of detail PtDAs require for positive effects on IPDAS criteria should be explored.

An Educational Intervention as Decision Support for Menopausal Women

The purpose of this study was to develop and test a decision support intervention (DSI) to assist women to make and act on informed decisions that are consistent with their values in the area of menopause and hormone replacement therapy (HRT). Mode and intensity of intervention were tested in midlife women (N = 248), randomly assigned to one of three intervention formats: written information only, guided discussion, or personalized decision exercise. Data were collected over 12 months. Knowledge, decisional conflict, satisfaction with health care provider, and self-efficacy improved following intervention and were maintained for 12 months for all groups. Womens adherence to their own plans over 12 months was 59% (exercise), 76% (calcium intake), and 89% (HRT). Carefully written information is effective in promoting knowledge, adherence, and satisfaction among well-educated, interested women. It was concluded that women can understand complex information, including tradeoffs regarding treatment options. Women will adhere to their own plans, suggesting that consumer rather than provider plans may be the more appropriate gold standard for measuring adherence.

Decision analysis in patient care

To help patients to fully participate in shared decision making is becoming an important goal in clinical practice and one which is receiving increasing attention in terms of the requisite skills and technological development. We discuss the potential application of decision analysis-a specific technology that has been introduced into clinical practice but to date only within research contexts-and examine the usefulness and feasibility of the technique for patients, particularly in settings where clinical presentations are diverse and characterised by uncertainty.

Comparison of physicians' decisions regarding estrogen replacement therapy for menopausal women and decisions derived from a decision analytic model

Decisions regarding estrogen replacement therapy were obtained from 50 physicians for 12 cases representing menopausal women with systematically varying levels of cancer risk, fracture risk, and symptom severity. Their decisions were compared with a decision analytic model for which each physician provided needed quantities--subjective probabilities, utilities of various outcomes, and weightings of the importance of the outcome categories. The majority of observed decisions were not to treat. By contrast, the decision analysis based on physician-provided estimates indicated that the optimal strategy was either to treat or a toss-up. Sensitivity analysis showed that these conclusions would hold over all possible utilities, over all plausible probabilities of cancer, and so long as symptom relief and fracture prevention were also considered as treatment objectives. The increased probability of early detection of cancer by regular follow-up was systematically incorporated into the decision analysis but apparently neglected in unaided clinical judgment, which follows the principle of minimizing the most important risk, regardless of its probability.

Patient education materials about the treatment of early-stage prostate cancer: a critical review.

Prostate cancer is the most prevalent noncutaneous malignant condition and, after lung cancer, the second leading cause of cancer deaths among U.S. men (1). Localized prostate cancer is typically treated with watchful waiting, radical prostatectomy, radiation therapy (external and brachytherapy), and, more rarely, hormone therapy. Men receiving a diagnosis of localized prostate cancer face a difficult treatment decision because most randomized, controlled trials are still in progress. However, a recent Swedish randomized, controlled trial found that while radical prostatectomy reduced mortality from prostate cancer more than did watchful waiting, men who had surgery lived no longer than those who were treated with watchful waiting (2). Because specialists disagree and the literature is inconclusive, patients are increasingly expected to participate in treatment decisions. Patients must learn the risks and benefits of each treatment and choose which risks they can tolerate and which benefits they prefer. Decision aids have become the evidence-based medicine information source for patients who face choices that 1) have clinically important differences in the balance between outcomes and complication rates, 2) require tradeoffs between near-term and long-term outcomes, 3) include treatments that may result in a grave outcome, or 4) have only marginal differences in outcomes. Decision aids are one form of patient education materials. A recent Cochrane review of randomized trials of decision aids showed that compared with usual care, decision aids improve patient knowledge and realistic expectations and reduce decisional conflict. Exposure to decision aids also seemed to increase patient participation in decisions and improve decision quality (3). We sought to determine the adequacy of publicly available patient education materials to offer these identified advantages to patients. More particularly, we first evaluated whether the needed information was presented (content review) and then evaluated how well the information was presented (quality review). Methods Development of Review Criteria We developed the criteria for evaluating the content of patient education materials by first examining the empirical and theoretical literature on informed consent and decision aids. For a primary-level analysis, we adopted the Cochrane definition of balanced presentation: 1) Are all options presented (including, if appropriate, watchful waiting)? and 2) Are potential harms as well as potential benefits presented (4)? We used the Cochrane criteria to eliminate all patient education materials that 1) did not discuss the 4 standard prostate cancer treatments (watchful waiting, radical prostatectomy, radiation therapy, and hormone therapy), 2) discussed only cancer in general, or 3) discussed only prostate cancer screening. In a second-level detailed analysis, we applied previously developed generic criteria specific to prostate cancer (5). Additional items to reflect patient needs were obtained through a literature review and through review of our criteria from a local prostate cancer support group and from prostate cancer experts (urologists, oncologists, nurses, researchers, and activists) from the Michigan Cancer Consortium Prostate Cancer Action Committee. Four of the authors independently developed common definitions and coded test documents. An initial list of 85 criteria was reduced to 54 criteria by consensus and was operationalized (Tables 1, 2, and 3). A weighting system was considered but was not implemented because no gold standard could be identified from the literature on decision aids or risk communication. Similarly, the Cochrane criteria provide an empirically validated set of criteria for the second-level detailed analysis. Table 1. Frequency of Clinical Condition Content Table 2. Frequency of Treatment Option Content Table 3. Frequency of Quantitative Elements and Other Factors In previous work, we have shown that decision aids can produce decisions that better reflect patient preferences (6, 7). The parallel criteria selected for prostate cancer are the categories of treatment outcomes and side effects. Traditional patient education elements of description of the anatomy and disease progression were also included. Identification of Patient Education Materials Print Materials, Videotapes, and CD-ROMs To identify these materials (identified between September and December 2001), we asked national organizations (including patient advocacy groups, government organizations, pharmaceutical companies, insurance companies, health maintenance organizations, universities, and comprehensive cancer centers) for their materials. To be included, all materials must be widely available to the public at no cost. Internet Search Strategy We first reviewed Web sites of prominent organizations (including all of those identified during the print material, videotape, and CD-ROM search). Second, we reviewed Web sites of pharmaceutical companies that had received approval from the U.S. Food and Drug Administration to produce prostate cancer drugs. Third, a naive patient with prostate cancer strategy used an open (broad-based) search strategy with Google and Yahoo, which located more than 300 000 Web sites. We reviewed at least the first 100 links provided and discontinued our search when relevance decreased. We did not evaluate Web sites composed of links to other Web sites or duplicated print materials previously reviewed (for example, the Web site of the National Cancer Institute). The initial review set of 546 materials was reduced by 502 materials after applying the Cochrane criteria for all standard treatment options to be presented (see the Appendix Table, for list of print materials not eligible for review). The remaining 44 materials (19 print materials, 19 Web sites, 4 videotapes, and 2 CD-ROMs) underwent a formal content and quality review (Table 4). Table 4. Full Review Documents Appendix Table. Print Materials Rejected for Formal Analysis Content Review Three coding teams composed of 2 coders were each responsible for reviewing one third of the materials. Thus, each material was independently scored by 2 coders. Criteria were rated as present if they were mentioned in the text, even if briefly (8). Paired ratings were compared, and differences were resolved by a second review and, in rare occasions, by a third reviewer. Percentage agreement achieved by the teams ranged from 91% to 94%. Quality Review The quality review evaluated 1) the accuracy of the information contained in the patient education material, 2) whether presentation of treatment options was balanced, and 3) whether the information was comprehensible to the average reader. An experienced clinician with previous prostate cancer research experience performed the accuracy and balance review. The clinician did not participate in the content review and was blind to content scores. Accuracy criteria were developed from the prostate cancer literature on the natural history of the disease and the efficacy and side effects of treatments. The estimates of balance were subjective, graded from minimal to marked bias toward any particular treatment method. To further evaluate the best materials identified through the simple content inclusion criteria, a health literacy expert performed an extensive plain-language review on the top 5 print materials and top 5 Web sites. To determine these top-rated materials, we developed a scoring system that identified how many of the 54 essential criteria each piece of patient education material contained but did not prioritize further. Those materials that contained inaccurate information or were strongly biased toward a particular treatment were excluded from consideration. Only 1 of the print materials was eliminated from the top rating because of presence of bias. The review assessed characteristics of text and design that affect reading ease and comprehension, incorporating the widely used Suitability Assessment of Materials system (9). Criteria include 1) readability; 2) amount and organization of content; 3) writing style as it affects literacy demands; 4) graphics, layout, and typography; 5) evidence of learning stimulation; and 6) cultural appropriateness. Each criterion was evaluated according to specific subcharacteristics rated on a 0- to 2-point scale (0 = unsuitable; 1 = adequate; 2 = superior; or not applicable). Final scores were calculated as percentages based on a denominator of 44 possible points. The 0- to 2-point scale was then translated into grade level. Web sites were evaluated by using similar criteria. Updating the Materials Several Web sites changed during the 4-month review period. The review described later in this paper reflects assessment of Web sites between 1 September 2001 and 14 December 2001. In April 2003, we rescored the top 5 and bottom 5 Web sites and brochures to determine whether they had changed substantially since our review. Role of the Funding Source The funding source was not involved in the design, conduct, or reporting of the study or in the decision to submit the manuscript for publication. Results Tables 1, 2, and 3 show the proportion of criteria (in consolidated form) scored as present in the 44 patient education materials. Although videotape and the CD-ROM materials are reported in Tables 1, 2, and 3, discussion in the paper is restricted to print materials and Web sites because these are the tools most available to public audiences. We found some differences while rescoring the top 5 and bottom 5 print materials and Web sites, but they were small and did not change the rankings of the materials. Content Review Disease Process Most patient education materials included basic information on prostate anatomy and physiology (95% and 80% of print materials and Web sites, respectively). Most print materials and Web sites also discussed prostate cancer staging (100% and 95%, respectively)

Evidence-based patient choice: A prostate cancer decision aid in plain language

BackgroundDecision aids (DA) to assist patients in evaluating treatment options and sharing in decision making have proliferated in recent years. Most require high literacy and do not use plain language principles. We describe one of the first attempts to design a decision aid using principles from reading research and document design. The plain language DA prototype addressed treatment decisions for localized prostate cancer. Evaluation assessed impact on knowledge, decisions, and discussions with doctors in men newly diagnosed with prostate cancer.MethodsDocument development steps included preparing an evidence-based DA in standard medical parlance, iteratively translating it to emphasize shared decision making and plain language in three formats (booklet, Internet, and audio-tape). Scientific review of medical content was integrated with expert health literacy review of document structure and design. Formative evaluation methods included focus groups (n = 4) and survey of a new sample of men newly diagnosed with prostate cancer (n = 60), compared with historical controls (n = 184).ResultsA transparent description of the development process and design elements is reported. Formative evaluation among newly diagnosed prostate cancer patients found the DA to be clear and useful in reaching a decision. Newly diagnosed patients reported more discussions with doctors about treatment options, and showed increases in knowledge of side effects of radiation therapy.ConclusionThe plain language DA presenting medical evidence in text and numerical formats appears acceptable and useful in decision-making about localized prostate cancer treatment. Further testing should evaluate the impact of all three media on decisions made and quality of life in the survivorship period, especially among very low literacy men.

Postural Augmentation of Plasma Renin Activity and Aldosterone Excretion in Normal People

Peripheral plasma renin activity and aldosterone excretion rates have been measured in normal people during recumbency, recumbent exercise, tilting, and continuous ambulation. Upright posture induces a prompt elevation in peripheral plasma renin activity beginning in 15 minutes and peaking between 60 and 120 minutes. Aldosterone excretion is increased during 120 minutes of upright posture and correlates directly with the elevation in renin activity. Upright posture induces increased plasma renin activity regardless of the level of sodium intake in the preparatory diet. Concomitant measurements of endogenous creatinine clearance and the rates of excretion of sodium and potassium suggest that a fall in renal arterial perfusion resulting from upright posture induces increased release of renin and the subsequent secondary stimulation of aldosterone secretion. Our data indicate that the changes in plasma renin activity are due to changes in the amount of the enzyme rather than to changes in other elements of the reninangiotensin systm. This report discusses the physiologic importance of postural augmentation of renin production, emphasizing that for proper interpretation of values of plasma renin activity, posture as well as dietary factors must be considered and controlled.

Addressing health literacy in patient decision aids.

BackgroundEffective use of a patient decision aid (PtDA) can be affected by the user’s health literacy and the PtDA’s characteristics. Systematic reviews of the relevant literature can guide PtDA developers to attend to the health literacy needs of patients. The reviews reported here aimed to assess:1. a) the effects of health literacy / numeracy on selected decision-making outcomes, and b) the effects of interventions designed to mitigate the influence of lower health literacy on decision-making outcomes, and2. the extent to which existing PtDAs a) account for health literacy, and b) are tested in lower health literacy populations.MethodsWe reviewed literature for evidence relevant to these two aims. When high-quality systematic reviews existed, we summarized their evidence. When reviews were unavailable, we conducted our own systematic reviews.ResultsAim 1: In an existing systematic review of PtDA trials, lower health literacy was associated with lower patient health knowledge (14 of 16 eligible studies). Fourteen studies reported practical design strategies to improve knowledge for lower health literacy patients. In our own systematic review, no studies reported on values clarity per se, but in 2 lower health literacy was related to higher decisional uncertainty and regret. Lower health literacy was associated with less desire for involvement in 3 studies, less question-asking in 2, and less patient-centered communication in 4 studies; its effects on other measures of patient involvement were mixed. Only one study assessed the effects of a health literacy intervention on outcomes; it showed that using video to improve the salience of health states reduced decisional uncertainty. Aim 2: In our review of 97 trials, only 3 PtDAs overtly addressed the needs of lower health literacy users. In 90% of trials, user health literacy and readability of the PtDA were not reported. However, increases in knowledge and informed choice were reported in those studies in which health literacy needs were addressed.ConclusionLower health literacy affects key decision-making outcomes, but few existing PtDAs have addressed the needs of lower health literacy users. The specific effects of PtDAs designed to mitigate the influence of low health literacy are unknown. More attention to the needs of patients with lower health literacy is indicated, to ensure that PtDAs are appropriate for lower as well as higher health literacy patients.

Cost-effectiveness analysis in heart disease, part III: Ischemia, congestive heart failure, and arrhythmias

Cost-effectiveness analyses were reviewed in the following diagnostic and treatment categories: acute myocardial infarction (MI) and diagnostic strategies for coronary artery disease (CAD), coronary artery bypass graft (CABG) surgery, percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (CHF), and arrhythmias. In the case of acute MI, coronary care units, as presently used, are rather expensive but could be made much more efficient with more effective triage and resource utilization; reperfusion via thrombolysis is cost-effective, as are beta-blockers and angiotensin-converting enzyme (ACE) inhibitors post-MI in appropriate patients. Cost-effectiveness of CAD screening tests depends strongly on the prevalence of disease in the population studied. Cost-effectiveness of CABG surgery depends on targeting; eg, it is highly effective for such conditions as left-main and three-vessel disease but not for lesser disease. PTCA appears to be cost-effective in situations where there is clinical consensus for its use, eg, severe ischemia and one-vessel disease, but requires further analysis based on randomized data; coronary stents also appear to be cost-effective. In preliminary analysis, ACE inhibition for CHF dominates, ie, saves both money and lives. Cardiac transplant appears to be cost-effective but requires further study. For arrhythmias, implantable cardioverter defibrillators are cost-effective, especially the transvenous device, in life-threatening situations; radiofrequency ablation is also cost-effective in patients with Wolff-Parkinson-White syndrome apart from asymptomatic individuals; and pacemakers have not been analyzed except in the case of biofascicular block, where results were variable depending on the situation and preceding tests.

PATIENT DECISION SUPPORT INTERVENTION : INCREASED CONSISTENCY WITH DECISION ANALYTIC MODELS

BACKGROUND Patient Decision Support (PDS) tools assist patients in using medical evidence to make choices consistent that are with their values and in using evidence about consequences of medical alternatives. OBJECTIVE To evaluate a PDS intervention for perimenopausal hormone replacement therapy. We assessed the impact of the PDS on (1) consistency between the decision to take estrogen replacement therapy (ERT) or progesterone/estrogen replacement therapy (PERT) and the expected utility of treatment and (2) likelihood to take ERT and PERT pre- and postintervention. DESIGN Content of the PDS was standardized. Randomized trial of three intensities of intervention: (1) brochure; (2) lecture/discussion; and (3) active decision support. SUBJECTS Participants were perimenopausal community volunteers between the ages of 40 and 65 (n = 248). MEASURES (1) Consistent with values (correlation between expected utility (EU) and likelihood of taking hormones); and (2) Likelihood to take hormone replacement therapy. RESULTS (1) The brochure group was less consistent with the decision analytic model than the lecture/discussion and active decision support groups. (2) Influence on decisions: PDS tools increased the number of women certain about whether or not to take hormones. There were no differences among experimental groups. Of 99 women uncertain about ERT pre-PDS, 65% changed. Twenty-one (32%) decided against ERT and 44 (68%) decided for ERT. (3) More intensive interventions produced modest gains in a normative direction. CONCLUSIONS PDSs using any of 3 formats reduce uncertainty and assist women to make informed decisions. Increased consistency with decision analytic models appears to be driven by better estimates of likelihood of outcomes.