Launching a virtual decision lab: development and field-testing of a web-based patient decision support research platform.

BACKGROUND: Over 100 trials show that patient decision aids effectively improve patients' information comprehension and values-based decision making. However, gaps remain in our understanding of several fundamental and applied questions, particularly related to the design of interactive, personalized decision aids. This paper describes an interdisciplinary development process for, and early field testing of, a web-based patient decision support research platform, or virtual decision lab, to address these questions. METHODS: An interdisciplinary stakeholder panel designed the web-based research platform with three components: a) an introduction to shared decision making, b) a web-based patient decision aid, and c) interactive data collection items. Iterative focus groups provided feedback on paper drafts and online prototypes. A field test assessed a) feasibility for using the research platform, in terms of recruitment, usage, and acceptability; and b) feasibility of using the web-based decision aid component, compared to performance of a videobooklet decision aid in clinical care. RESULTS: This interdisciplinary, theory-based, patient-centered design approach produced a prototype for field-testing in six months. Participants (n = 126) reported that: the decision aid component was easy to use (98%), information was clear (90%), the length was appropriate (100%), it was appropriately detailed (90%), and it held their interest (97%). They spent a mean of 36 minutes using the decision aid and 100% preferred using their home/library computer. Participants scored a mean of 75% correct on the Decision Quality, Knowledge Subscale, and 74 out of 100 on the Preparation for Decision Making Scale. Completing the web-based decision aid reduced mean Decisional Conflict scores from 31.1 to 19.5 (p < 0.01). CONCLUSIONS: Combining decision science and health informatics approaches facilitated rapid development of a web-based patient decision support research platform that was feasible for use in research studies in terms of recruitment, acceptability, and usage. Within this platform, the web-based decision aid component performed comparably with the videobooklet decision aid used in clinical practice. Future studies may use this interactive research platform to study patients' decision making processes in real-time, explore interdisciplinary approaches to designing web-based decision aids, and test strategies for tailoring decision support to meet patients' needs and preferences.

Decision support for patients: values clarification and preference elicitation.

Providing a patient with decision support involves helping that person to choose among two or more elective health care options. "Values Clarification" and "Preference Elicitation" are integral to the full decision-support process. During values clarification, the patient and clinician gain insight into the importance that the patient ascribes to the options' positive and negative characteristics. During preference elicitation, the patient identifies which options are, overall, personally most favored (and, by corollary, which are least favored). This article identifies the roles that values clarification/preference elicitation (VC/PE) play in the full process of patients' decision support, outlines various approaches to fostering VC/PE, and poses some fundamental and applied research questions about VC/PE. It also argues that, in order to proceed to answer the posed research questions, investigators in the field of patients' decision support require a systematic set of criteria for comparing the performance of different VC/PE techniques.

The importance of measuring strength-of-preference scores for health care options in preference-sensitive care.

OBJECTIVE: The objective was to determine whether a paired-comparison/Leaning Scale (LS) method: 1) could feasibly be used to elicit strength-of-preference scores for elective health care options in large community-based survey settings and 2) could reveal preferential subgroups that would have been overlooked if only a categorical-response format had been used. STUDY DESIGN: Medicare beneficiaries in four different regions of the United States were interviewed in person. Participants considered eight clinical scenarios, each with two to three different health care options. For each scenario, participants categorically selected their favored option, then indicated how strongly they favored that option relative to the alternative on a paired-comparison bidirectional LS. RESULTS: Two hundred two participants were interviewed. For seven of the eight scenarios, a clear majority (>50%) indicated that, overall, they categorically favored one option over the alternative(s). However, the bidirectional strength-of-preference LS scores revealed that, in four scenarios, for half of those participants, their preference for the favored option was actually "weak" or "neutral." CONCLUSION: Investigators aiming to assess population-wide preferential attitudes toward different elective health care scenarios should consider gathering ordinal-level strength-of-preference scores and could feasibly use the paired-comparison/bidirectional LS to do so.

Assessing Medicare beneficiaries' strength-of-preference scores for health care options: how engaging does the elicitation technique need to be?

OBJECTIVE: The objective was to determine if participants' strength-of-preference scores for elective health care interventions at the end-of-life (EOL) elicited using a non-engaging technique are affected by their prior use of an engaging elicitation technique. DESIGN: Medicare beneficiaries were randomly selected from a larger survey sample. During a standardized interview, participants considered four scenarios involving a choice between a relatively less- or more-intense EOL intervention. For each scenario, participants indicated their favoured intervention, then used a 7-point Leaning Scale (LS1) to indicate how strongly they preferred their favoured intervention relative to the alternative. Next, participants engaged in a Threshold Technique (TT), which, depending on the participant's initially favoured intervention, systematically altered a particular attribute of the scenario until the participant switched preferences. Finally, they repeated the LS (LS2) to indicate how strongly they preferred their initially-favoured intervention. RESULTS: Two hundred and two participants were interviewed (189-198 were included in this study). The concordance of individual participants' LS1 and LS2 scores was assessed using Kendall tau-b correlation coefficients; scores of 0.74, 0.84, 0.85 and 0.89 for scenarios 1-4, respectively, were observed. CONCLUSION: Kendall tau-b statistics indicate a high concordance between LS scores, implying that the interposing engaging TT exercise had no significant effects on the LS2 strength-of-preference scores. Future investigators attempting to characterize the distributions of strength-of-preference scores for EOL care from a large, diverse community could use non-engaging elicitation methods. The potential limitations of this study require that further investigation be conducted into this methodological issue.

Can women with early-stage breast cancer make an informed decision for mastectomy?

PURPOSE: The purpose of this study was to measure the degree to which informed women chose mastectomy, and to reveal their reasons for this choice. PATIENTS AND METHODS: This was a prospective cohort study of patients radiographically and pathologically eligible for either mastectomy or breast-conserving surgery (BCS; n = 125). Participants completed questionnaires at three time points: baseline, after viewing a decision aid, and after a surgical consultation. Questionnaires assessed clinical history, preference for participation in decision making, information comprehension, values, decisional conflict, and preferred treatment. RESULTS: Of 125 participants, 44 (35%) chose mastectomy. Most understood that BCS and mastectomy offer an equivalent survival benefit (98%) and that BCS has a slightly higher local recurrence risk (63%); most accurately identified the magnitude of ipsilateral local recurrence risk (91%). Values assigned to three treatment attributes/outcomes ("remove breast for peace of mind," "avoid radiation," and "keep breast") clearly discriminated between patients choosing mastectomy or BCS. High decisional conflict scores improved after both the decision aid and surgical consultation. CONCLUSION: Although conventional wisdom may view BCS as the preferred treatment, a notable proportion of well informed women choose mastectomy. Whereas prior studies have linked objective factors to treatment choice, this study reveals subjective preferences that underlie decision making. The systematic use of a decision aid before the surgical consultation may help women make informed, values-based decisions, while clearly reducing decisional conflict.

Do patients consider postoperative maintenance therapy for Crohn's disease worthwhile?

BACKGROUND: Treatment decision making for postoperative Crohn's disease is complex because of the increasing number of maintenance therapies available with competing risk-benefit profiles. The main objective of this study was to determine the distribution of patients' preferences for selected postoperative maintenance therapies. METHODS: The study was a cross-sectional survey in which patients with Crohn's disease completed a standardized interview. Each participant completed 5 tasks that compared: (1) no medication and 5-ASA, (2) fish oil and 5-ASA, (3) metronidazole and 5-ASA, (4) budesonide and 5-ASA, and (5) azathioprine and 5-ASA. For each task, the minimum change in treatment effect size between the 2 treatments that the participant considered worthwhile was determined. RESULTS: The distribution of the participants' preference scores varied widely for each task. When fish oil, metronidazole, budesonide, and azathioprine were considered equally effective to 5-ASA, 92.9%, 28.8%, 38.4%, and 19% of the participants, respectively, preferred these medications relative to 5-ASA. These percentages increased to 98.4%, 54.8%, 61.9%, and 50.8%, respectively, when fish oil, metronidazole, budesonide, and azathioprine were considered to offer a 5% absolute risk reduction relative to 5-ASA. Regression analysis did not identify any clinical or demographic variables predictive of the participants' treatment preferences. CONCLUSIONS: The participants' preferences for postoperative maintenance therapies were widely distributed, and no clinical or demographic factors predicted these preferences. This emphasizes the need for effective communication between physician and patient in order to select the treatment options most consistent with a patient's informed preferences.

Communication and decision making in cancer care: setting research priorities for decision support/patients' decision aids.

The following is a summary report from a special symposium titled, "Translating Research into Practice: Setting a Research Agenda for Clinical Decision Tools in Cancer Prevention, Early Detection, and Treatment," that was held on 23 October 2005 in San Francisco at the Annual Meeting of the Society for Medical Decision Making (SMDM). The symposium was designed to answer the question: "What are the top 2 research priorities in the field of patients' cancer-related decision aids?" After introductory remarks by Dr. Barry, each of four panelists-Drs. Hilary Llewellyn-Thomas, Ellen Peters, Laura Siminoff, and Dale Collins-addressed the question and provided their rationale during prepared remarks. The moderator, Dr. Michael Barry, then facilitated a discussion between the panelists, with input from the audience, to further explore and add to the various proposed research questions. Finally, Dr. Amber Barnato conducted a simple vote count (see Table 1) to prioritize the panelists' and the audience's recommendations.

Pain relief in osteoarthritis: patients' willingness to risk medication-induced gastrointestinal, cardiovascular, and cerebrovascular complications.

OBJECTIVE: Information concerning patients' preferences for the treatment of osteoarthritis (OA) is limited. We examined patients' attitudes toward the acceptability of gastrointestinal, cardiac, and cerebrovascular events in order to obtain pain relief from OA. METHODS: Patients responded to a set of threshold technique tasks. Each task described 2 treatment options, their levels of pain relief, and the risks of side effects. The risk for the side effect under investigation was then systematically increased to reveal the maximal acceptable risk increment associated with the pain reduction. RESULTS: Of 196 patients, 22.3% and 14.7% were unwilling to accept any additional risk of stomach bleed or heart attack/stroke for 2-point and 5-point pain reductions, respectively. Patients were willing to accept significantly more risk for a 5-point pain reduction than for a 2-point pain reduction in stomach bleed and heart attack/stroke scenarios. Patients also accepted significantly greater additional risks of stomach bleed compared to heart attack/stroke for 2-point and 5-point pain reductions. CONCLUSION: Most patients with OA are willing to accept some additional risk of stomach bleed and heart attack/stroke to gain pain relief. Patients are willing to accept greater additional risk of stomach bleed than heart attack/stroke. However, there exists considerable variation in risk-taking attitudes across patients. We recommend that clinicians examine the risk attitude and treatment preferences of each patient on an individual basis when deciding on a treatment regimen.

Toward the 'tipping point': decision aids and informed patient choice.

Preference-sensitive treatment decisions involve making value trade-offs between benefits and harms that should depend on informed patient choice. There is strong evidence that patient decision aids not only improve decision quality but also prevent the overuse of options that informed patients do not value. This paper discusses progress in implementing decision aids and the policy prospects for reaching a "tipping point" in the adoption of "informed patient choice" as a standard of practice.

Parental decision making in pediatric cancer end-of-life care: using focus group methodology as a prephase to seek participant design input.

The ultimate aim of our research program is to provide strategies that facilitate parental decision-making for parents of children with cancer receiving end-of-life care. As a first step to develop this program, we needed insight into parents' reactions and opinions about the research methods planned for a larger study. In particular, we needed their opinions about the general experience of making the decision between palliative cytotoxic chemotherapy and supportive care alone and the factors that parents regard as important when making this decision. In addition, we wished to know whether the methodology proposed for the future study was easy to understand and whether it might cause unnecessary emotional trauma. Finally, we asked their opinions regarding the appropriate target sample of parents to include in the future study. Qualitative data about these issues were collected using focus group methodology involving seven participants. The comments made during the focus group discussions were content-analyzed for common themes. The results from the focus group discussion led to particular modifications in the proposed design and interview strategies planned for the future larger study. We found it was extremely beneficial to include a focus group pre-phase in a study that will interview parents in a high sensitivity area.

Modifying unwarranted variations in health care: shared decision making using patient decision aids.

Shared decision making is the process of interacting with patients in arriving at informed values-based choices when options have features that patients value differently. Patient decision aids (PtDAs) are evidence-based tools designed to facilitate that process. Numerous randomized trials indicate that PtDAs improve decision quality and prevent overuse of options that informed patients do not value. Therefore, they have a potential role in reducing unwarranted variations in the use of preference-sensitive health care options. However, barriers to their widespread use need to be addressed with coherent plans for ensuring good standards, improving access to PtDAs, training practitioners, testing practice models, and launching demonstration projects.

Inpatient versus outpatient management of low-risk pediatric febrile neutropenia: measuring parents' and healthcare professionals' preferences.

PURPOSE: Our primary objective was to describe and compare parents' and healthcare professionals' strength of preference scores for outpatient oral antibiotic relative to inpatient parenteral antibiotic treatment for low-risk febrile neutropenic children. Our secondary objective was to identify predictors of strength of preference for oral outpatient treatment. METHODS: Respondents were parents of children receiving cancer chemotherapy, and pediatric oncology healthcare professionals. First, the inpatient and outpatient options were described, and the respondent indicated their initially preferred option. The respondent next ranked how important seven factors (including "fear/anxiety" and "comfort") were in making their initial choice. The threshold technique was then used to elicit the respondent's strength of preference score for oral outpatient, relative to parenteral inpatient management. RESULTS: There were 75 parent and 42 healthcare-professional respondents. There was no significant difference (P =.08) in the proportions of parents (40 of 75; 53%) and healthcare professionals (30 of 42; 71%) who initially would choose outpatient management. For parents, stronger preference for oral outpatient therapy was associated with higher anticipated quality of life for the parent and child at home relative to hospital, lower importance rank for "fear/anxiety," and higher importance rank for "comfort." Conversely, for professionals, only lower importance rank for "fear/anxiety" was associated with higher strength of preference scores for outpatient oral antibiotic management. CONCLUSION: Only 53% of parents would choose outpatient oral antibiotic management for low-risk febrile neutropenia. Predictors of strength of preference scores for outpatient oral antibiotic relative to inpatient parenteral antibiotic treatment differed between parent and professional respondents.

Quality of life in a randomized trial of group psychosocial support in metastatic breast cancer: overall effects of the intervention and an exploration of missing data.

PURPOSE: To evaluate the effect of a standardized group psychosocial intervention on health-related quality of life (HrQOL) in women with metastatic breast cancer and to explore the effect of missing data in HrQOL analyses. PATIENTS AND METHODS: Between 1993 and 1998, seven Canadian centers randomly assigned 235 eligible women to participate in a weekly, 90-minute, therapist-led support group that adhered to principles of supportive-expressive (SE) therapy or to a control arm (no SE). All women received educational material and any type of medical or psychosocial care deemed necessary. HrQOL data were prospectively collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) at baseline, 4, 8, and 12 months. The primary HrQOL analyses compared scores in the two study arms. Analyses were limited to women with appropriate baseline HrQOL information (n = 215). RESULTS: Baseline EORTC QLQ-C30 scores were not different between the two study arms (all P >.05). Primary analysis of all subscales failed to show a significant influence of the intervention on HrQOL (all P >.05). There was a significant deterioration over time in several functional scales of the EORTC QLQ-C30: global (P =.03), physical (P =.0002), role (P =.01), and cognitive functioning (P =.04); and in symptom scales: dyspnea (P =.007), appetite loss (P =.04), and fatigue (P =.003); these changes were independent of randomization allocation. Results were similar in additional analyses of overall HrQOL using a variety of approaches to handling missing data. CONCLUSION: Supportive-expressive group therapy in patients with metastatic breast cancer does not appear to influence HrQOL, as measured by the EORTC QLQ-C30.

Healthy-year equivalents in major joint replacement. Can patients provide meaningful responses?

OBJECTIVES: Healthy-years equivalents (HYEs) have been proposed as an evaluative measure with advantages over quality-adjusted life-years (QALYs). The main purpose was to assess the feasibility of eliciting HYEs from patients who have undergone major joint replacement; a secondary objective was to examine relationships with postsurgical health status. METHODS: Pre- and postsurgical reports of perceived comorbidity and current arthritic burden were obtained from 194 patients, using a comorbidity checklist, summary scores from the Western Ontario/McMaster Osteoarthritis Questionnaire (WOMAC), summary scores derived from six Likert scales, and holistic utility scores for the same attributes. After surgery, HYEs for the full across-time health profile were also elicited. RESULTS: All measures of arthritic burden were sensitive to pre/postsurgical changes (p = .0001), and comorbidity scores were stable. Two HYE subgroups emerged. An HYE-invariant subgroup ascribed full HYEs to their profiles, while reporting higher Likert (t = 2.1309; p = .0344) and utility (s = 4.1504; p = .0001) scores for their postsurgical health state. An HYE-variant subgroup reported HYEs that were weakly but significantly (p < .009) correlated with Likert (r = .30), utility (rs = .25), and comorbidity (r = -.26) scores for their postsurgical state. CONCLUSIONS: Our results indicate that patients can understand the HYE assessment procedures and provide interpretable responses. However, a significant proportion reports invariant HYEs that could inflate estimates of the overall mean HYE. Further exploration of the HYEs reported by different clinical and attitudinal populations is needed before widespread adoption of this measure.

Primary prevention drug therapy: can it meet patients' requirements for reduced risk?

The objective was to identify, in primary prevention, patients whose "required risk reduction" (ReqRR) is greater than the "achievable risk reduction" (ARR) that cholesterol-lowering or antihypertensive medication could provide. Individualized estimates of 10-year coronary heart disease or stroke risk were derived for 66 hypercholesterolemic (HC) and 64 hypertensive (HT) patients without symptomatic cardiovascular disease. These estimates were used in trade-off tasks identifying each individual's ReqRR. Then individual ARRs were estimated (in HC patients by assuming total cholesterol/high density lipoprotein ratio reductions to 5.0; in HT patients by assuming systolic blood pressure reductions to 120 mmHg). 12 (18%) HC and 12 (19%) HT subjects would refuse medication regardless of the risk reduction offered. Of the remaining patients, 15/54 (28%; 95% C.I.:16-40%) HC and 19/52 (37%; 95% C.I: 24-51%) HT subjects were "over-requirers," in that their ReqRR/ARR ratio was 1.5. There maybe a notable proportion of patients whose ReqRR is considerably greater than what is achievable, implying that decision aids may help individuals clarify preferences about accepting/refusing medication for the primary prevention of cardiovascular disease.

Comparing the benefits of diet and exercise in the treatment of dyslipidemia.

BACKGROUND: Lifestyle changes are advocated as a first line of treatment for dyslipidemia. However, few studies have directly compared various combinations of diets and exercise. METHODS: In a randomized controlled pilot study, we compared the standard lifestyle recommendations (NCEP step I diet with regular exercise) and more intense interventions including the NCEP step I diet with a supervised aerobic exercise program and the step II diet with and without a supervised aerobic exercise program. We measured risk factors, dietary intake, time on treadmill, and health-related quality of life at baseline and after 3 months. RESULTS: Out of 198 eligible subjects, 47 (24%) were willing to participate and 41 completed the study. No significant change were observed with standard lifestyle recommendations. In contrast, participants in the more intense interventions lost weight (-1.7 to -3.7 kg) and reduced their total cholesterol (-4% to -6%), low-density lipoprotein cholesterol (-6%), and systolic blood pressure (-7.3 to -8.8 mmHg). Participants in the exercise program significantly increased their exercise capacity (1.6 to 1.9 METS). Overall, each 10% reduction in body weight was associated with a 7.6% reduction in low-density lipoprotein cholesterol. CONCLUSION: Standard lifestyle recommendations had little effect on blood lipid levels but more intense lifestyle interventions may be effective at improving blood lipids, other risk factors, and quality of life.

Using disease risk estimates to guide risk factor interventions: field test of a patient workbook for self-assessing coronary risk.

OBJECTIVE: To assess the feasibility and acceptability of a patient workbook for self-assessing coronary risk. DESIGN: Pilot study, with post-study physician and patient interviews. SETTING AND SUBJECTS: Twenty southern Ontario family doctors and 40 patients for whom they would have used the workbook under normal practice conditions. INTERVENTIONS: The study involved convening two sequential groups of family physicians: the first (n=10) attended focus group meetings to help develop the workbook (using algorithms from the Framingham Heart Study); the second (n=20) used the workbook in practice with 40 patients. Follow-up interviews were by interviewer-administered questionnaire. MAIN OUTCOMES MEASURES: Physicians' and patients' opinions of the workbook's format, content, helpfulness, feasibility, and potential for broad application, as well as patients' perceived 10-year risk of a coronary event measured before and after using the workbook. RESULTS: It took an average of 18 minutes of physician time to use the workbook: roughly 7 minutes to introduce it to patients, and about 11 minutes to discuss the results. Assessments of the workbook were generally favourable. Most patients were able to complete it on their own (78%), felt they had learned something (80%) and were willing to recommend it to someone else (98%). Similarly, 19 of 20 physicians found it helpful and would use it in practice with an average of 18% of their patients (range: 1-80%). The workbook helped to correct misperceptions patients had about their personal risk of a coronary event over the next 10 years (pre-workbook (mean (SD) %): 35.2 (16.9) vs. post-workbook: 17.3 (13.5), P < 0.0001; estimate according to algorithm: 10.6 (7.6)). CONCLUSIONS: Given a simple tool, patients can and will assess their own risk of CHD. Such tools could help inform otherwise healthy individuals that their risk is increased, allowing them to make more informed decisions about their behaviours and treatment.