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Patient decision aids have been used in many clinical situations to improve the patient centeredness of care. A patient decision aid for patients with posttraumatic stress disorder (PTSD) has not been developed or tested. The authors evaluated the effects of a patient decision aid on the patient centeredness of PTSD treatment.The study was a randomized trial of a patient decision aid for PTSD versus treatment as usual (control group). The participants were 132 male and female veterans who presented to a single U.S. Department of Veterans Affairs hospital with a new diagnosis of PTSD. Patient centeredness was assessed by knowledge of PTSD and its treatment, level of decisional uncertainty, and ability to state a preferred treatment option. Secondary outcomes included treatments received and PTSD symptoms in the six months after study entry.Compared with the control group (N=65), participants who reviewed the patient decision aid (N=63) had higher scores for PTSD knowledge (p=.002) and less conflict about their choice of treatment (p=.003). In addition, participants who reviewed the patient decision aid were more likely to select and receive an evidence-based treatment for PTSD (p=.04) and had superior PTSD outcomes (p=.004) compared with the control group.Use of a patient decision aid was associated with improvements in patient-centered PTSD treatment. The patient decision aid was also associated with greater use of evidence-based treatments and improvement of PTSD symptoms. This study suggests that clinics should consider using a patient decision aid for patients with PTSD.

To develop a patient decision aid (PtDA) for older women with Stage I, pathologically node negative, estrogen receptor-positive progesterone receptor-positive breast cancer who are considering adjuvant radiotherapy after lumpectomy and to examine its impact on patients' decision making.A PtDA was developed and evaluated in three steps according to the Ottawa Decision Support Framework: (1) needs assessment (n = 16); (2) Pilot I to examine PtDA acceptability (n = 12); and (3) Pilot II, a pretest posttest (n = 38) with older women with estrogen receptor-positive progesterone receptor-positive breast cancer after lumpectomy who were receiving adjuvant radiation therapy. Measures included patients' satisfaction with the PtDA, self-reported decisional conflict, level of distress, treatment-related knowledge, and choice predisposition.The PtDA is a booklet that details each adjuvant treatment option's benefits, risks, and side effects tailored to the patient's clinical profile; includes a values clarification exercise; and includes steps to guide patients towards their decision. On the basis of qualitative comments and satisfaction ratings, all women thought that the PtDA was helpful and informative. In comparison with their baseline scores, patients had a statistically significant (p0.05) reduction in decisional conflict (adjusted mean difference [AMD], -7.18; 95% confidence interval [CI], -13.50 to 12.59); increased clarity of the benefits and risks (AMD, -10.86; CI, -20.33 to 21.49); and improved general treatment knowledge (AMD, 8.99; CI, 2.88-10.28) after using the PtDA. General trends were also reported in the patients' choice predisposition scores that suggested potential differences in treatment decision after PtDA use.This study provides evidence that this PtDA may be a helpful educational tool for this group of women. The quality of care for older breast cancer patients may be enhanced by the use of a tailored PtDA to help patients be better informed about their treatment options.

Background: The choice between palliative chemotherapy (defined as the use of cytotoxic medications delivered intravenously for the purpose of our study) and supportive care alone is one of the most difficult decisions in pediatric oncology, yet little is known about the preferences of parents and health care professionals. We compared the strength of these preferences by considering children’s quality of life and survival time as key attributes. In addition, we identified factors associated with the reported preferences. Methods: We included parents of children whose cancer had no reasonable chance of being cured and health care professionals in pediatric oncology as participants in our study. We administered separate interviews to parents and to health care professionals. Visual analogue scales were shown to respondents to illustrate the anticipated level of the child’s quality of life, the expected duration of survival and the probability of cure (shown only to health care professionals). Respondents were then asked which treatment option they would favour given these baseline attributes. In addition, respondents reported what factors might affect such a decision and ranked all factors identified in order of importance. The primary measure was the desirability score for supportive care alone relative to palliative chemotherapy, as obtained using the threshold technique. Results: A total of 77 parents and 128 health care professionals participated in our study. Important factors influencing the decision between therapeutic options were child quality-of-life and survival time among both parents and health care professionals. Hope was particularly important to parents. Parents significantly favoured chemotherapy (42/77, 54.5%) compared with health care professionals (20/128, 15.6%; p Interpretation: Compared with health care professionals, parents more strongly favour aggressive treatment in the palliative phase and rank hope as a more important factor for making decisions about treatment. Understanding the differences between parents and health care professionals in the relative desirability of supportive care alone may aid in communication and improve end-of-life care for children with cancer.

Purpose To elicit neck pain (NP) patients’ preference scores for their current health, and investigate the association between their scores and NP disability. Methods Rating scale scores (RSs) and standard gamble scores (SGs) for current health were elicited from chronic NP patients (n = 104) and patients with NP following a motor vehicle accident (n = 116). Patients were stratified into Von Korff Pain Grades: Grade I (low-intensity pain, few activity limitations); Grade II (high-intensity pain, few activity limitations); Grade III (pain with high disability levels, moderate activity limitations); and Grade IV (pain with high disability levels, several activity limitations). Multivariable regression quantified the association between preference scores and NP disability. Results Mean SGs and RSs were as follows: Grade I patients: 0.81, 0.76; Grade II: 0.70, 0.60; Grade III: 0.64, 0.44; Grade IV: 0.57, 0.39. The association between preference scores and NP disability depended on type of NP and preference-elicitation method. Chronic NP patients’ scores were more strongly associated with depressive symptoms than with NP disability. In both samples, NP disability explained little more than random variance in SGs, and up to 51% of variance in RSs. Conclusion Health-related quality-of-life is considerably diminished in NP patients. Depressive symptoms and preference-elicitation methods influence preference scores that NP patients assign to their health.

Objectives Therapeutic decisions in osteoarthritis (OA) often involve trade-offs between accepting risks of side effects and gaining pain relief. Our objectives were (1) to determine patients' maximum acceptable risk increments (MARI) for different adverse effects from OA medication and (2) to identify the predictors of these preferences. Study Design and Setting MARI were measured with a probabilistic threshold technique (TT). Risk and pain levels in the TT scenarios were controlled for in a 2 × 2 randomized factorial design. Clinical, sociodemographic, and psychological characteristics (decisional conflict and locus of control) of the participants were assessed using a self-administered questionnaire. Results For 196 subjects, MARI varied by type of adverse effect, level of pain relief, and baseline risk. Mean MARI ranged from 3% to 5% for heart attack/stroke, 5% to 8% for stomach bleed, 13% to 21% for hypertension, 22% to 33% for fluid retention, and 23% to 35% for dyspepsia. Age, gender, education, physical and mental health, pain, disability, and locus of control were not associated with MARI. Conclusion Participants varied widely in the level of risk they would accept, but their clinical, sociodemographic, and psychological characteristics did not explain this variation. These observations are important for the development of practice guidelines for physicians and patients' decision aids that can foster individualized, evidence-based yet preference-sensitive care for patients with OA.

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.

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 may be 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.

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

This study assessed family physicians' and pulmonary specialists' approaches to the treatment of adult outpatient asthma using a self-administered questionnaire consisting of six asthma scenarios of varying severity levels. One hundred sixty-three randomly selected family physicians and pulmonary specialists completed the questionnaire (response rate of 80%). We observed that, regardless of asthma severity, more than 75% of physicians (regardless of specialty) would not include oral theophylline or nonsteroidal anti-inflammatory preparations in their treatment approach. Pulmonary specialists' and family physicians' approaches to mild asthma were similar (more than 90% recommended an inhaled beta2-agonist). However, considerable differences existed among and between physician groups for the remaining scenarios. For example, with an exacerbation associated with an upper respiratory tract infection, family physicians were more likely to recommend oral antibiotics (p

The objective of this study was to determine whether patients with Crohn's disease (CD) value the absolute reduction in postoperative recurrence risk attributable to therapy with mesalamine (5-ASA). One hundred subjects evaluated state A (taking 5-ASA; 25% risk of recurrence), state B (not taking 5-ASA; 40% risk of recurrence), and state C (100% risk of recurrence) by rank order, visual analog scale (VAS), and standard gamble (SG). Sixty-five of 91 patients (71 %) with completed and usable questionnaires had the same preference order for state A (25% risk), state B (40% risk), and state C (100% risk) on both the VAS and the SG. The mean scores for state A (25% risk), state B (40% risk), and state C (100% risk), respectively, were 67.5, 49.8, and 19.8 on the VAS and 0.977, 0.972, and 0.910 on the SG. Subgroup analyses using stepwise logistic regression showed that risk attitude seemed to be predictive of subjects' preferences for 5-ASA. These results suggest that most subjects seem to value the 15% absolute risk reduction offered by 5-ASA. Furthermore, the SG seems to be a feasible method for measuring utilities for uncertain health states in patients with CD. Key words: standard gamble; risk attitude; treatment interventions; uncertain health states. (Med Decis Making 2000;20:72-78)

The objectives of this study were to describe physicians' self-reported approaches to providing disease-specific education to adults with asthma in an outpatient setting and their opinions about the level of patient involvement in management decisions. A mailed questionnaire was completed by 163 randomly selected physicians, representing an 80% response rate. The educational actions provided most frequently included information about prescribed medications (90%-100% of physicians), general asthma information (87%-98%), and inhaler demonstration (85%-95%). Educational activities provided least frequently were action plans (7%-74%) and referral to a nonprofit community asthma organization for further information (18%-36%). The reported provision of asthma education was related to patients' asthma severity (p0.0001) and physician specialty (p0.005). Physicians indicated that their patients were less involved in asthma management decisions than they would prefer (p0.001). The results suggest that physicians vary markedly in their approaches to providing asthma education to patients. Future descriptive and intervention studies are needed to identify the most effective models for providing education and patient involvement.

Objectives. To assess the Threshold Technique's (TT) feasibility in community-wide surveys of U.S. Medicare beneficiaries' preferences for end-of-life (EOL) care options. Study Setting. Study participants were community-dwelling Medicare beneficiaries in four different regions in the United States. Study Design. During personal interviews, participants considered four EOL scenarios, each presenting a choice between a less intense and more intense care option. Data Collection. Participants selected their initially favored option. Depending on that choice, in the subsequent TT the length of life offered by the more intense option was systematically increased or decreased until the participant “switched” to his or her initially rejected option. Principal Findings. Participants were able to select an initially favored option (in 3 of the 4 scenarios; this was the less intense option). The majority of participants were able to engage with the subsequent TT. In all scenarios, regardless of the increase/decrease in the length of life offered by the more intense option, the majority of participants were unwilling to “switch” to their initially rejected option. Conclusions. In surveys of populations' preferential attitudes toward EOL care options, the TT was a feasible elicitation method, engaging most participants and measuring the strength of their attitudes. Further methodological work is merited, involving (1) populations with various participant characteristics, and (2) different attributes in the TT task itself.

Forty-one angina patients with coronary disease were interviewed to examine the correlation between prespecified and individualized weights for disease-specific measures of the effects of angina on the patients' well-being. Modifications of the Canadian Cardiovascular Society (CCS) scale for angina and the Duke Activity Specific Index (DASI) were used to rate functional capacity with prespecified items. Disease-specific utilities based on descriptions of functional status were obtained directly, and again indirectly with different anchoring conditions to control for noncardiac comorbidity. Correlations between the functional-capacity measures and the derived utilities were not strong, ranging from -0 25 (p > 0.1) to -0.35 (p = 0.02). Correlation between the two prespecified measures was higher (r = -0.51 or -0.69, both p < 0.01, for DASI versus CCS graded from walking and stair-climbing, re spectively). The direct and indirect disease-specific utility scores were similar (r = 0.92, p < 0.01). The method described provides an approach to measuring disease-specific utilities by adapting existing scales for use in a standard gamble. It confirms that prespecified functional status scores inconsistently reflect patients' valuations of functional states. Further investigation should address whether the observed null effect of comorbidity on disease- specific utilities arose from inadequate coverage of the comorbidity issues in patient inter views or from lack of power given the small size of the feasibility study. Key words: cardiac patients' utilities; cardiac functional capacity; utilities for angina; comorbidity. (Med Decis Making 1996;16:78-85)

Despite increasing emphasis on advance directives, there has been little methodologic work to assess preferences about the "do not resuscitate" (DNR) order. This developmental work assessed, in a non-patient group, the performance of a probability-trade-off task designed to assess DNR attitudes, in terms of framing effects and stability of preferences. 105 female nursing students each completed one of two versions of the task. In version I ( n = 58), the trade-off moved to increasingly negative descriptions of the outcomes of resuscitation (de creasing chance of survival and increasing risk of brain death), whereas in version II ( n = 47), the trade-off moved to increasingly positive descriptions. One week later, repeat as sessments were obtained for versions I ( n = 35) and II (n = 28). The DNR preference scores were lower and more stable when the task moved to increasingly positive descriptions; perhaps this version of the task tends to weaken risk aversion. These results imply that care should be used in applying a probability trade-off task to the assessment of DNR preferences, since artefactual effects could be induced. Key words : patients' decision making; prefer ences; trade-offs; resuscitation; anchoring effect. (Med Decis Making 1995;15:209-216)

The study objective was to assess the relative effects of 2 approaches to teaching about a clinical trial, in terms of patients' satisfaction, information understanding, and whether or not they would enter such a trial. One hundred patients receiving radiation therapy for a variety of cancer diagnoses were randomized to receive information about a hypothetical trial, either by audio tape or interactive computer program. A day later, information understanding was assessed. One week later, method satisfaction and whether respondents would enter such a trial were assessed. There were no differences in understanding or satisfaction. Members of the computer program group tended to report a more positive attitude towards trial entry (chi 2 = 4.0; 1 df; P = 0.05). Overall, refusers tended to be women with higher understanding scores. The results suggest that teaching with interactive components might not adversely affect trial accrual. Further work involving an actual trial entry decision is merited; the sex of the respondent should be controlled in designing this future work.

The study purpose was to determine whether the framing of treatment information influenced patients' reported preferences for participating in treatment decision making and for trial entry. Ninety cancer patients read either neutrally-, positively-, or negatively-framed infor mation about a chemotherapeutic treatment, then indicated their preferences for participating in the treatment decision, and whether they would participate in a clinical trial incorporating this protocol. There was no difference across information groups in preferences for partici pating in treatment decision making or willingness to enter such a clinical trial. Preference for participation in treatment decision making was significantly related to age (t = 2.54; p = 0.022), sex (x2 = 3.89; p = 0.05), and education (t = 2.54; p = 0.018); trial entry preferences were unrelated to these demographic variables. These results imply that, in this clinical context, attitudes towards participation in treatment decision making may be asso ciated with characteristics of the patient, and attitudes towards trial entry may be dependent upon the clinical characteristics of a particular trial, but neither set of attitudes is influenced by the framing of protocol information. Key words: framing effect; patients' preferences; quality of life; decision making; clinical trials. (Med Decis Making 1995;15:4-12)

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.

Fundamental to using utilities for future health states for clinical decision analysis is the assumption that the utilities are stable. The purpose of this study was to determine if cancer patients' prior evaluations of a treatment-induced health state remain stable when they later experience that state. Before a four-week course of radiation therapy, 66 laryngeal cancer patients evaluated three common treatment-induced outcome scenarios (mild/moderate/severe) using rating scales and the time trade-off, and provided self-assessments of voice symptoms, voice function, and general health. Evaluations and self-assessments were repeated at the end of therapy, and respondents indicated which outcome scenario described their actual end-of-therapy state. Twenty-four patients identified the mild scenario as their outcome state, 36 the moderate, and 6 the severe. No across-time differences in evaluations were detected, although significant (P.0001) downward shifts in scores for voice symptoms (t = 5.67), voice function (t = 5.10), and general health (t = 6.69) indicated that actual change in health status had occurred. These results imply that patients' evaluations of imagined short-term health states encountered during radiation therapy for laryngeal cancer remain consistent when those states are experienced at a later time. The design of this project provides a model for determining if this consistency appears in other clinical situations.

A study was done to determine the extent to which patients' subjective evaluations of their current health are determined by their expectations, their actual health, and how they compare themselves with others. At the initiation of radiation therapy, 61 laryngeal cancer patients described the health status they expected at the end of therapy, using standardized and individualized dimensions. Objective summative scores were derived for these descriptions. At the end of therapy, these respondents described their current health status and the status they believed others their age were experiencing, on the same dimensions, and objective summative scores were derived for these actual and social comparison states Rating scales and standard gambles were used to obtain values and utilities ("subjective evaluations") for current health at the end of therapy. Multiple linear regression was used to determine the extent to which variation in the subjective evaluations was explained by the objective scores for actual, expected, and social comparison states, under these different methodologic con ditions Actual health state was a consistently significant predictor. Most variance was ex plained in the model using individualized dimensions and value scores (r2 = 46 0%). Further investigation is needed to determine whether differences in the amounts of variance explained are due to aversion to gambling, dimension salience, order effects, or respondent fatigue Key Words. health status, health utilities, health values, prospect theory (Med Decis Making 1992;12:115-122)

The study purpose was to determine whether differences in the weights assigned to various dimensions of health by 90 women in three subgroups (benign breast disease, breast cancer receiving chemotherapy, and breast cancer receiving other therapies) were associated with differences in self-reported health status in these dimensions. Two methods, one direct and the other indirect, were used to elicit values for mobility, depression, and social support. Two different scales also provided self-reports of health status in each of these dimensions. These measures, in conjunction with sociodemographic variables, were used to test for status- value relationships. No statistically significant association between health values and health status was observed. The absence of any detectable association may have been a result of methodologic difficulties in assessing broadly defined dimensions of health. A possible solution would be to use "individualized" dimensions that are uniquely important to the individual, and to take into account such factors as possible influences of past health status and values, and possible gaps between expected health status and health status actually experienced. Key words: health status measurement; patients' values; utility assessment. (Med Decis Making 1991 ;11 :180-188)

The major purpose was to explore the use of written case scenarios to investigate factors associated with regional variations in referral for consultation. Data were collected in Nova Scotia, where extensive computer-based records of utilization of health services are kept, and the nine health care regions are in sufficient proximity to make visits and interviews feasible. Interviews with 9 x 25 = 225 randomly-selected family physicians, using scenarios analogous to ICD-9 codes, permitted testing of hypotheses about the effects of selected variables on referral rates for hypothetical cases. The family physicians' self-reported referral behavior for the written case scenarios was compared, region by region, with the actual referral of analogous cases by physicians in the same region, as determined from Nova Scotia Health Services and Insurance Commission records. The results indicated that written scenarios provide a useful tool for studies of such variables. Generally, the family physicians responded appropriately to the information that described the hypothetical patients ("case cues"). However, comparisons of hypothetical and actual referral rates indicated that appropriate information about the environment within which referral decisions take place ("environmental cues") may be needed to explain actual regional variations in referral rates.

STUDY DESIGN: Decision analysis. OBJECTIVE: To identify the best treatment for nonspecific neck pain. SUMMARY OF BACKGROUND DATA: In Canada and the United States, the most commonly prescribed neck pain treatments are nonsteroidal anti-inflammatory drugs (NSAIDs), exercise, and manual therapy. Deciding which treatment is best is difficult because of the trade-offs between beneficial and harmful effects, and because of the uncertainty of these effects. METHODS: (Quality-adjusted) life expectancy associated with standard NSAIDs, Cox-2 NSAIDs, exercise, mobilization, and manipulation were compared in a decision-analytic model. Estimates of the course of neck pain, background risk of adverse events in the general population, treatment effectiveness and risk, and patient-preferences were input into the model. Assuming equal effectiveness, we conducted a baseline analysis using risk of harm only. We assessed the stability of the baseline results by conducting a second analysis that incorporated effectiveness data from a high-quality randomized trial. RESULTS: There were no important differences across treatments. The difference between the highest and lowest ranked treatments predicted by the baseline model was 4.5 days of life expectancy and 3.4 quality-adjusted life-days. The difference between the highest and lowest ranked treatments predicted by the second model was 7.3 quality-adjusted life-days. CONCLUSION: When the objective is to maximize life expectancy and quality-adjusted life expectancy, none of the treatments in our analysis were clearly superior

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. (Inflamm Bowel Dis 2007)

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 process's 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.

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.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.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.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.

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.

The purpose of this study was to explore O'Connor's four factors contributing to mothers' uncertainty concerning gastrostomy tube (G-tube) insertion in their children (lack of information; unclear value trade-offs; lack of support; social pressure) in a substitute decision-making context. Fifty mothers participated in one semi-structured interview at the time of their children's G-tube insertion. Children's ages ranged from 2 weeks to 17 years, slightly more than half were male, and most had a primary diagnosis related to a neurological (n = 27) or cardiac (n = 10) condition. Two-thirds of the mothers identified topics about which they wanted more information, the majority reported both gains and losses associated with their decision, three-quarters reported that they had received support during decision making, and half reported that they had felt pressure from family and health care professionals. Results indicate that mothers' decisions about G-tube insertion are complex and difficult. The existence and importance of O'Connor's factors in this context are confirmed by mothers' accounts. Because these factors are believed to be modifiable, health care professionals have the opportunity to potentially minimize the extent to which the factors contribute to decision uncertainly. It is recommended that health care professionals implement interventions focused on minimizing uncertainty.

This study evaluates the effects of prenatal genetic group counselling on women's anxiety, decisional conflict and levels of knowledge. Participants (N=271) were aged 35 years and older. ANOVA results indicated that pre/postcounselling scores for anxiety did not change significantly, while decisional conflict decreased significantly (P

This study examines women's psychological responses to prenatal group genetic counseling, and to subsequent individualized risk counseling. All women (N=123) aged 35 and older underwent nuchal translucency screening (NTS), a prenatal ultrasound screening test. After group counseling, decisional conflict decreased significantly among those reporting at baseline having made a decision about invasive testing (t(222)=2.0, P=0.014) and for those who were uncertain (t(222)=5.74, P

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.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.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.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.

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.

To assess the feasibility and acceptability of a patient workbook for self-assessing coronary risk.Pilot study, with post-study physician and patient interviews.Twenty southern Ontario family doctors and 40 patients for whom they would have used the workbook under normal practice conditions.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.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.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), P0.0001; estimate according to algorithm: 10.6 (7.6)).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.

Objectives: To elicit patients' maximal acceptable waiting times (MAWT) for non-urgent coronary artery bypass grafting (CABG), and to determine if MAWT is related to prior expectations of waiting times, symptom burden, expected relief, or perceived risks of myocardial infarction while waiting. Methods: Seventy-two patients on an elective CABG waiting list chose between two hypothetical but plausible options: a 1-month wait with 2% risk of surgical mortality, and a 6-month wait with 1% risk of surgical mortality. Waiting time in the 6-month option was varied up if respondents chose the 6-month/lower risk option, and down if they chose the 1-month/higher risk option, until the MAWT switch point was reached. Patients also reported their expected waiting time, perceived risks of myocardial infarction while waiting, current function, expected functional improvement and the value of that improvement. Results: Only 17 (24%) patients chose the 6-month/1% risk option, while 55 (76%) chose the 1-month/2% risk option. The median MAWT was 2 months; scores ranged from 1 to 12 months (with two outliers). Many perceived high cumulative risks of myocardial infarction if waiting for 1 (upper quartile, ≥ 1.45%) or 6 (upper quartile, ≥ 10%) months. However, MAWT scores were related only to expected waiting time ( r= 0.47; P < 0.0001). Conclusions: Most patients reject waiting 6 months for elective CABG, even if offered along with a halving in surgical mortality (from 2% to 1%). Intolerance for further delay seems to be determined primarily by patients' attachment to their scheduled surgical dates. Many also have severely inflated perceptions of their risk of myocardial infarction in the queue. These results suggest a need for interventions to modify patients' inaccurate risk perceptions, particularly if a scheduled surgical date must be deferred.

PURPOSE Along with evidence, clinical policies must take patients' values into account. Particularly where evidence is limited and where assumptions of utility-maximizing behavior may not be valid, new methods such as trade-off techniques (TOTs), which allow elicitation of patients' treatment alternatives, might be useful in policy formulation. We used TOTs to assess breast cancer patients' attitudes toward two clinical policies designed to ration adjuvant postlumpectomy breast radiation therapy. METHODS Cross-sectional interviews were performed in a tertiary cancer center. A total of 102 patients were presented with information about the side effects and benefits associated with two hypothetical decisions: (1) willingness to receive treatment elsewhere to shorten the wait for radiation therapy, and (2) foregoing radiation therapy in the face of small marginal benefits. For each scenario, a TOT was used to identify the maximal acceptable wait time (MAWT) for therapy and the benefit threshold at which the patient would forego therapy. Associations of clinical and demographic factors with these decisions were determined by regression analysis. RESULTS Patients would be willing to wait, on average, 7 weeks before wanting to leave their city for radiation therapy, less than the 13-week delay our patients actually faced. Older patients were less willing to wait (P = .013); 46% of patients would not give up radiation therapy, even in the face of no stated benefit. Willingness to give up radiation therapy was predicted by willingness to accept delay (odds ratio [OR], 1.84; 95% confidence interval [CI], 1.05 to 3.37) and being employed (OR, 2.61; 95% CI, 1.08 to 6.54). Patients with larger tumors were less willing to give up radiation therapy (OR, 0.57; 95% CI, 0.31 to 0.97). CONCLUSION Even in difficult decisions such as rationing postlumpectomy breast cancer radiation therapy, TOTs can inform policy formulation by indicating the distributions of patients' preferences.

Patients who agree and those who refuse clinical trial entry may differ in attitudes towards decision control and the benefits associated with the trial arms. These differences, if they exist, have implications for the process of obtaining informed consent and for the generalization of the results of a clinical trial. This paper describes the development and initial application of methods designed to detect such differences. Developmental work involved creating an inventory of instruments designed to determine patients' attitudes towards participating in treatment decision making, permitting random selection of treatment, and undertaking the risks and benefits associated with the various treatments in a trial. Initial application involved modifying these instruments in terms of an actual chemotherapeutic trial for colonic adenocarcinoma, seeking responses to these measures from 60 non-eligible colorectal cancer patients, then determining whether those who would agree to trial entry differed systematically on these measures from those who indicated that they would refuse such a trial. Twenty-five of the respondents reported that, if faced with the actual decision, they would agree to trial entry: 35 would refuse. Refusers demanded more participation in decision making (Chi-square; P= 0.01) and a greater increment in treatment benefit (t-test; P= 0.0001). Twenty-two of the 35 refusers reported aversion to randomization as their primary reason for trial refusal. Since their particular content can be modified, these measures may be applicable to all clinical trials. They could be used to study the reasons patients accept or refuse trial entry and to determine if agreer-refuser attitude differences undermine the generalizability of a trial's results.

Although quantitative estimates of patients' attitudes toward the relative importance of different aspects of health are of great potential usefulness in medical decision making, there is little information about the stability of such values over time, particularly in patients whose clinical state is changing. To examine these questions, we selected a group of patients with laryngeal cancer undergoing treatment with radiotherapy. In this group of patients clinical problems are relatively circumscribed and related to the voice, and a temporary deterioration in voice-related symptoms and abilities is expected during treatment. Thirty patients were interviewed at the start and completion of a month's course of treatment. At each interview patients rated the quality of their own voices using a number of visual analogue scales and also provided both holistic and decomposed quantitative values for the importance of different aspects of voice function and sound. Although the analogue scales demonstrated the anticipated deterioration in the quality of the patients' voices, these changes in clinical state were not accompanied by any changes in the values the patients assigned to each aspect of voice sound and function. These results indicate that at least in the short term the values expressed by patients appear to be stable and uninfluenced by changes in their own clinical state. Longer term studies involving more systemic illnesses should now be carried out.

This study evaluated the reliability and sensitivity of laryngeal cancer patients' linear analogue self-assessments (LASA) of voice quality. Thirty patients completed LASA scales for a number of voice-related symptoms and abilities several times during a standard treatment programme. The study design allowed evaluation of the scales' reliability, both early and late in treatment, and sensitivity to the changes expected during irradiation. Another 29 post-treatment patients completed the same scales in interviews separated by several weeks. Results indicate that LASA scores were generally reliable, sensitive to clinical change, yet stable when clinical status is unaltered. Though further demonstrations of the validity of these scales are required, their possible use as outcome measures in future clinical trials comparing treatments for laryngeal cancer is feasible.

The standard gamble, derived from decision theory, is considered a criterion method for obtaining patients' values for different health states. In this method, a rater's value for a health state is obtained by determining, in a hypothetical setting, his readiness to remain in that state or take a risky choice with different outcomes of known value. According to the expected utility criterion, a rater's utility or value for a particular state should not be influenced by changes in the gamble outcomes. The standard gamble was used to obtain 64 patients' judgments of a set of health states, first with the outcomes of perfect health or death, and subsequently with other health states as outcomes. The changes in gamble outcomes significantly influenced reported values for health states, indicating that the standard gamble is internally inconsistent. This observation poses a major limitation to its use as a value measurement method in medicine.