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Decreased use of adjuvant breast cancer therapy in a randomized controlled trial of a decision aid with individualized risk information.

OBJECTIVE: Oncology patients often seek involvement in their medical consultations. Such involvement is endorsed by most health care providers and mirrored in practice guidelines. However, oncologists exhibit great variation in how they provide patients with disease-relevant information, and many remain reluctant to do so at all. The authors examined the impact of a patient-specific decision aid on women's decisions about adjuvant therapy for breast cancer. METHOD: 386 women with breast cancer were randomized to receive either an informational pamphlet about adjuvant therapy (usual care) or a patient-specific, evidence-based decision aid about adjuvant therapy. The authors compared rates of adjuvant therapy between the groups controlling for age, education, marital status, race, tumor severity, and practice type of their physician (university-based or community-based). RESULTS: Among women with low tumor severity, only 58% (35/60) of women in the decision aid group chose adjuvant therapy, compared to 87% (33/38) of their counterparts in usual care (P<0.01). CONCLUSIONS: This study illustrates the important impact of medical decision aids on treatment choices, particularly for patients for whom treatment has little benefit. In the case of adjuvant therapy for breast cancer, providing individualized, evidence-based risk information for shared decision making resulted in fewer women with low tumor severity choosing adjuvant treatment.

Aged↗

Validation of a clinical decision aid to discontinue in-hospital cardiac arrest resuscitations.

CONTEXT: Most patients undergoing in-hospital cardiac resuscitation do not survive to hospital discharge. In a previous study, we developed a clinical decision aid for identifying all patients undergoing resuscitation who survived to hospital discharge. OBJECTIVE: To validate our previously derived clinical decision aid. DESIGN, SETTING, AND PARTICIPANTS: Data from a large registry of in-hospital resuscitations at a community teaching hospital in Georgia were analyzed to determine whether patients would be predicted to survive to hospital discharge (ie, whether their arrest was witnessed or their initial cardiac rhythm was either ventricular tachycardia or ventricular fibrillation or they regained a pulse during the first 10 minutes of chest compressions). Data from 2181 in-hospital cardiac resuscitation attempts in 1987-1996 involving 1884 pulseless patients were analyzed. MAIN OUTCOME MEASURE: Comparison of predictions based on the decision aid with whether patients were actually discharged alive from the hospital. RESULTS: For 327 resuscitations (15.0%), the patient survived to hospital discharge. For 324 of these resuscitations, the patients were predicted to survive to hospital discharge (sensitivity = 99.1%, 95% confidence interval, 97.1%-99.8%). In 269 resuscitations, patients did not satisfy the decision aid and were predicted to have no chance of being discharged from the hospital. Only 3 of these patients (1.1%) were discharged from the hospital (negative predictive value = 98.9%), none of whom were able to live independently following discharge from the hospital. CONCLUSION: This decision aid can be used to help physicians identify patients who are extremely unlikely to benefit from continued resuscitative efforts.

Aged↗

Reading and decision aids for improved accuracy and standardization of mammographic diagnosis.

Image-reading and decision aids were designed to improve the accuracy of mammogram interpretation. The reading aid was a list of diagnostic radiographic features and scales for quantification of each feature. The decision aid, a computer program, converted the reader's scaled values, weighted for predictive power, into an advisory estimate of the probability of malignancy. The features were identified and their importance was assigned in four steps: (a) interviews of five expert readers to establish an initial set of features, (b) perceptual tests to refine the feature set, (c) a consensus meeting to refine this set and establish nomenclature and scales, and (d) the expert's scaling of each feature in a set of 150 mammograms. Those scaled judgments were analyzed to provide the final list of features and their relative importance and to program the computer decision aid. To test the enhancement effect, six other radiologists interpreted a different set of mammograms without, and later with, the two aids. Receiver operating characteristic analysis showed a gain of approximately 0.05 in sensitivity or specificity when the other value remained at 0.85. In a subset of the more difficult cases, the enhancement effect was approximately 0.15 in either sensitivity or specificity.

Humans↗

Searching for diabetes decision aids and related background information.

AIMS: Patient decision aids (DAs) are interventions designed to help patients making informed decisions. DAs are complex interventions comprising a number of active components each essential to the proper functioning of the aid. Critical appraisal of DAs therefore requires access to information describing the incremental assessment of each stage in their development, including information about the theoretical funding, development processes, efficacy trials and long-term implementation. We explored the feasibility of identifying such information with conventional database search strategies. Our study was conducted only in the field of diabetes care. METHODS: The 'Inventory of Existing Patient Decision Aids', medline (PubMed) and the World Wide Web were used to identify DAs relevant for diabetes care. For tracking information concerning each developmental stage, the reference lists of the DAs, home pages of the authors, medline, embase, PsycINFO, cinahl, and the Cochrane database were searched systematically. RESULTS: A total of 13 DAs relevant for diabetes care were identified. The search for publications concerning their development yielded more than 3000 results, only 10 of which referred to at least one of the 13 DAs. No additional background information was found on the home pages of the authors. CONCLUSIONS: Conventional database search strategies do not allow the extraction of information about the stages in development of a DA. To facilitate critical appraisal of DAs, we propose the creation of an electronic database which provides information about available DAs, together with the relevant background literature, or to incorporate such a system into existing databases.

Decision Making↗

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

OBJECTIVE: To develop a set of quality criteria for patient decision support technologies (decision aids). DESIGN AND SETTING: Two stage web based Delphi process using online rating process to enable international collaboration. PARTICIPANTS: Individuals from four stakeholder groups (researchers, practitioners, patients, policy makers) representing 14 countries reviewed evidence summaries and rated the importance of 80 criteria in 12 quality domains on a 1 to 9 scale. Second round participants received feedback from the first round and repeated their assessment of the 80 criteria plus three new ones. MAIN OUTCOME MEASURE: Aggregate ratings for each criterion calculated using medians weighted to compensate for different numbers in stakeholder groups; criteria rated between 7 and 9 were retained. RESULTS: 212 nominated people were invited to participate. Of those invited, 122 participated in the first round (77 researchers, 21 patients, 10 practitioners, 14 policy makers); 104/122 (85%) participated in the second round. 74 of 83 criteria were retained in the following domains: systematic development process (9/9 criteria); providing information about options (13/13); presenting probabilities (11/13); clarifying and expressing values (3/3); using patient stories (2/5); guiding/coaching (3/5); disclosing conflicts of interest (5/5); providing internet access (6/6); balanced presentation of options (3/3); using plain language (4/6); basing information on up to date evidence (7/7); and establishing effectiveness (8/8). CONCLUSIONS: Criteria were given the highest ratings where evidence existed, and these were retained. Gaps in research were highlighted. Developers, users, and purchasers of patient decision aids now have a checklist for appraising quality. An instrument for measuring quality of decision aids is being developed.

Decision Support Techniques↗

A decision aid for autologous pre-donation in cardiac surgery--a randomized trial.

OBJECTIVES: The objective of this randomized, controlled study was to determine the usefulness of a decision aid on pre-donation of autologous blood before elective open heart surgery. METHODS: The decision aid (DA) group received a tape and booklet which described the options for peri-operative transfusion in detail. The no decision aid (NDA) group received information usually given to patients about autologous donation. RESULTS: A total of 120 patients were randomized. The DA group rated themselves better prepared for decision making and showed significant improvements in knowledge (p = 0.001) and realistic risk perceptions (p = 0.001). In both groups there was an increase in the proportion of patients choosing allogeneic blood between baseline and follow-up (p = 0.001). Patients in the DA group were significantly more satisfied with the amount of information they received, how they were treated and with the decision they made, than patients in the NDA group. CONCLUSION: The decision aid is useful in preparing patients for decision making. PRACTICE IMPLICATIONS: The next stage is to explore strategies to make it available to all appropriate patients.

Adult↗

The effect of an illustrated pamphlet decision-aid on the use of prostate cancer screening tests.

BACKGROUND: Prostate cancer screening with serum prostate-specific antigen (PSA) and digital rectal examination (DRE) continues to increase. Our goal was to test the effect of a prostate cancer screening decision-aid on patients' knowledge, beliefs, and use of prostate cancer screening tests. METHODS: Our study was a randomized controlled trial of a prostate cancer screening decision-aid consisting of an illustrated pamphlet as opposed to a comparison intervention. We included 257 men aged 50 to 80 years who were receiving primary care at a Department of Veterans Affairs Hospital in Milwaukee, Wisconsin. The decision-aid provided quantitative outcomes of prostate cancer screening with DRE and PSA. We subsequently evaluated prostate cancer screening knowledge, beliefs, and test use. RESULTS: The illustrated pamphlet decision-aid was effective in improving knowledge of prostate cancer screening tests: 95% of the experimental group were aware of the possibility of false-negative test results compared with 85% of the comparison group (P <.01). Ninety-one percent of the experimental group were aware of the possibility of a false-positive screening test result compared with 65% of the comparison group (P <.01). However, there was no difference in the use of prostate cancer screening between the experimental (82%) and comparison (84%) groups, (P >.05). CONCLUSIONS: When used in a primary care setting, an illustrated pamphlet decision-aid was effective in increasing knowledge of prostate cancer screening tests but did not change the use of these tests.

Aged↗

A randomized trial among women with heavy menstruation -- impact of a decision aid on treatment outcomes and costs.

OBJECTIVE: To evaluate the effects of a decision aid for menorrhagia on treatment outcomes and costs over a 12-month follow-up. DESIGN: Randomized trial and pre-trial prospective cohort study. SETTING AND PARTICIPANTS: Gynaecology outpatient clinics in 14 Finnish hospitals, 363 (randomized trial) plus 206 (cohort study) patients with menorrhagia. INTERVENTION: A decision aid booklet explaining menorrhagia and treatment options, mailed to patients before their first clinic appointment. MAIN OUTCOME MEASURES: Health related quality of life, psychological well-being, menstrual symptoms, satisfaction with treatment outcome, use and cost of health care services. RESULTS: All study groups experienced overall improvement in health-related quality of life, anxiety, and psychosomatic and menstrual symptoms, but not in sexual life. Treatment in the intervention group was more active than in the control group, with more frequent course of medication and less undecided treatments. However, there were no marked disparities in health outcomes, satisfaction with treatment outcome and costs. Total costs (including productivity loss) per woman because of menorrhagia over the 12-month follow-up were 2760 and 3094 in the intervention and control group, respectively (P = 0.1). The pre-trial group also had a significantly lower rate of uterus saving surgery compared with the control group, but no difference in costs because of menorrhagia treatment. CONCLUSION: Despite some differences in treatment courses, a decision aid for menorrhagia in booklet form did not increase the use of health services or treatment costs, nor had it impact on health outcomes or satisfaction with outcome of treatment.

Adult↗

Regional chemotherapy directed by individual chemosensitivity testing in vitro: a prospective decision-aiding trial.

A prospective decision-aiding trial was performed to select drugs for regional chemotherapy of various liver tumors (n = 36) by individual drug testing. The drugs were chosen for hepatic artery infusion according to the individual chemosensitivity of tumor biopsies in the human tumor colony-forming assay (HTCA). In vitro HTCA sensitivity correlated with complete response (CR) + partial response (PR) + no change (NC) 93% of the time and with CR + PR 55% of the time. The test sensitivity was 90%, and the specificity was 67% for CR + PR + NC versus progressive disease (PD), whereas the sensitivity and specificity were 89% and 28%, respectively, for CR + PR versus NC + PD. The overall predictive accuracy of the test was 86% for CR + PR + NC versus PD and 58% for CR + PR versus NC + PD. Overall, 83% of this heterogenous patient group with various tumors achieved CR + PR + NC and a 50% clinical response (CR + PR). In vitro-sensitive patients showed a significantly lower intrahepatic progression rate (7% PD) than in vitro-resistant patients (57%; P < 0.05). These results indicate that the HTCA could identify active drugs for individualized hepatic artery infusion, and patients may profit from the use of in vitro-sensitive drugs.

Adult↗

Protocol for a randomised controlled trial of a decision aid for the management of pain in labour and childbirth [ISRCTN52287533].

BACKGROUND: Women report fear of pain in childbirth and often lack complete information on analgesic options prior to labour. Preferences for pain relief should be discussed before labour begins. A woman's antepartum decision to use pain relief is likely influenced by her cultural background, friends, family, the media, literature and her antenatal caregivers. Pregnant women report that information about analgesia was most commonly derived from hearsay and least commonly from health professionals. Decision aids are emerging as a promising tool to assist practitioners and their patients in evidence-based decision making.Decision aids are designed to assist patients and their doctors in making informed decisions using information that is unbiased and based on high quality research evidence. Decision aids are non-directive in the sense that they do not aim to steer the user towards any one option, but rather to support decision making which is informed and consistent with personal values. METHODS/DESIGN: We aim to evaluate the effectiveness of a Pain Relief for Labour decision aid, with and without an audio-component, compared to a pamphlet in a three-arm randomised controlled trial. Approximately 600 women expecting their first baby and planning a vaginal birth will be recruited for the trial.The primary outcomes of the study are decisional conflict (uncertainty about a course of action), knowledge, anxiety and satisfaction with decision-making and will be assessed using self-administered questionnaires. The decision aid is not intended to influence the type of analgesia used during labour, however we will monitor health service utilisation rates and maternal and perinatal outcomes. This study is funded by a competitive peer-reviewed grant from the Australian National Health and Medical Research Council (No. 253635). DISCUSSION: The Pain Relief for Labour decision aid was developed using the Ottawa Decision Support Framework and systematic reviews of the evidence about the benefits and risks of the non-pharmacological and pharmacological methods of pain relief for labour. It comprises a workbook and worksheet and has been developed in two forms - with and without an audio-component (compact disc). The format allows women to take the decision aid home and discuss it with their partner.

Journal Article↗

Randomized trial of a portable, self-administered decision aid for postmenopausal women considering long-term preventive hormone therapy.

Although practice guidelines suggest that postmenopausal women learn about the benefits and risks and consider their values when deciding about hormone therapy, the optimal decision-support method has not been established. In a randomized controlled trial, the authors compared the efficacy of a general educational pamphlet with that of a tailored decision aid. The pamphlet briefly summarized benefits, risks, and likely beneficiaries in general terms. The decision aid, delivered via booklet and audiotape, provided: detailed benefits and risks using functional terms and probabilities tailored to clinical risk; and steps for considering the issue in a woman's own situation, including a value-clarification exercise. Compared with the pamphlet group, the decision-aid group had statistically significant (p < 0.05) improvements in terms of realistic personal expectations of the benefits and risks, decisional conflict, and perceived acceptability of the intervention. Levels of general knowledge about the main benefits and risks were comparable for the two interventions. It is concluded that tailored decision aids prepare women for decision making better than do general pamphlets.

Aged↗

Impact of a patient decision aid on care among patients with nonvalvular atrial fibrillation: a cluster randomized trial.

BACKGROUND: Too few patients with nonvalvular atrial fibrillation (NVAF) receive appropriate antithrombotic therapy. We tested the short-term (primary outcome) and long-term (secondary outcome) effect of a patient decision aid on the appropriateness of antithrombotic therapy among patients with NVAF. METHODS: We conducted a cluster randomized trial with blinded outcome assessment involving 434 NVAF patients from 102 community-based primary care practices. Patients in the intervention group received a self-administered booklet and audiotape decision aid tailored to their personal stroke risk profile. Patients in the control group received usual care. The primary outcome measure was change in antithrombotic therapy at 3 months. Appropriateness of therapy was defined using the American College of Chest Physicians (ACCP) recommendations. RESULTS: The mean patient age was 72 years, and the median duration of NVAF was 5 years. In the control group, there was a 3% decrease over 3 months in the number of patients receiving therapy appropriate to their risk of stroke (40% [85/215] at baseline v. 37% [79/215] at 3 months). In the intervention group, the number of patients receiving therapy appropriate to their stroke risk increased by 9% (32% [69/219] at baseline v. 41% [89/219] at 3 months). Although the proportion of patients whose therapy met the ACCP treatment recommendations did not differ between study arms at baseline (p = 0.11) or 3 months (p = 0.44), there was a 12% absolute improvement in the number of patients receiving appropriate care in the intervention group compared with the control group at 3 months (p = 0.03). The beneficial effect of the decision aid did not persist (p = 0.44 for differences between study arms after 12 months). INTERPRETATION: There was short-term improvement in the appropriateness of antithrombotic care among patients with NVAF who were exposed to a decision aid, but the improvement did not persist.

Aged↗

Evaluation of a decision aid for making choices about intubation and mechanical ventilation in chronic obstructive pulmonary disease.

To assist patients with chronic obstructive pulmonary disease (COPD) in advance planning for life-threatening exacerbations, we developed a structured decision aid that describes the process, risks, and outcomes of intubation and mechanical ventilation (MV). Thirty-three patients with severe COPD took part in a before-after evaluation study. At baseline, only two participants (6%) reported that they had already made an advance decision about MV. After reviewing the decision aid, 31 participants (94%) reported that they had made a choice, which in 23 cases (74% of those deciding) was to forego MV. These choices were associated with more accurate expectations of MV outcome, and reduced decisional conflict. Qualitatively, participants who would accept MV emphasized their wish to prolong life, whereas those who would forego MV were more influenced by the burdens of treatment and the perception of a poor long-term outcome. However, there was evidence that 24% of participants did not completely comprehend the decision aid and 27% found the experience to be stressful. These findings indicate that a decision aid for MV helps patients plan for life-threatening exacerbations, and may be a useful adjunct to counseling for some patients with severe COPD.

Adult↗

Decision aids in routine practice: lessons from the breast cancer initiative.

BACKGROUND: Many decision aids have been developed to help patients make treatment and screening decisions; however, little is known about implementing them into routine clinical practice. OBJECTIVE: To assess the feasibility of implementing a patient decision aid (PtDA) for the early stage breast cancer surgical decision into routine clinical care. DESIGN: Structured individual interviews. SETTING AND PARTICIPANTS: A convenience sample of providers from nine sites, including two community resource centres, a community hospital and six academic centres. MAIN OUTCOME MEASURES: Usage data, barriers to and resources for implementing the PtDAs. RESULTS: Six of the nine sites were using the PtDAs with patients. Two sites were primarily using a scheduling system and four sites relied on a lending system. For the academic centres, the keys to successful implementation included integrating the PtDA into the flow of patients through the centre and having physicians who recommended it to patients. At the community centres, the keys to successful implementation included an informed staff and the flexibility to get the PtDAs to patients in different ways. Barriers that limited or prevented sites from using the PtDA included a lack of clinical support, a lack of system support, competing priorities and scheduling problems. CONCLUSIONS: It is feasible to implement a breast cancer PtDA into routine clinical care at academic centres and community resource centres. Future research should assess the effectiveness of PtDAs in routine clinical care as well as resources and barriers to their implementation in community hospitals.

Academic Medical Centers↗

Phase I study of a decision aid for patients with locally advanced non-small-cell lung cancer.

PURPOSE: Many patients with locally advanced non-small-cell lung cancer (LA-NSCLC) are eligible for combined-modality therapy (CMT; chemotherapy and radiotherapy). Although CMT offers slightly higher chances of survival than radiotherapy alone (RT), it also carries a higher probability of toxicity, raising the possibility that some patients may prefer to decline CMT. We report a pilot study of a decision aid designed for patients in this setting. PATIENTS AND METHODS: The aid included a structured description of the treatment options and trade-off exercises designed to help clarify the patient's values for the relevant outcomes by determining the patient's survival advantage threshold (SAT; the increase in survival conferred by CMT over RT that the patient deemed necessary for choosing CMT). Additional outcome measures included each patient's strength of treatment preference, decisional conflict, objective understanding of survival information, and decisional role preference. RESULTS: Twenty-seven patients met the eligibility criteria for the study. Of these, seven declined the decision aid because they had a clear treatment preference. The remaining 20 participants completed the decision aid; 18 chose CMT, and two chose RT. All 20 patients wished to participate in the decision to some extent. All patients reported that using the decision support was useful to them and recommended its use for others. No patient or physician reported that the aid interfered with the physician-patient relationship. Patients' 3-year SATs and median SATs were each strongly correlated with their strengths of treatment preference (rho = 0.83, P <.001 and rho = 0.67, P =.02, respectively). For all but one patient, either their 3-year or median survival threshold was consistent with their final treatment choice. Ten patients reported a stronger treatment preference after using the decision aid. CONCLUSION: We conclude that implementing the decision-aid for patients with LA-NSCLC is feasible, that it demonstrates convergent validity, and that it is favorably evaluated by patients and their physicians. The aid seems to help patients understand the benefits and risks of treatment and to choose the treatment that is most consistent with their values. Further evaluation of the aid is warranted.

Aged↗

Assessment of a decision aid to assist genetic testing research participants in the informed consent process.

Limited attention has been given to applying decision-making theories from psychology to the content and process of informed consent in genetic testing research. Data are presented from a study that developed and assessed a psychological theory-based decision aid as part of the informed consent process. This innovative approach assisted at-risk women in assessing the consequences of participating in a research project that offered them free hemophilia A genetic carrier testing. Results suggest: (1) the decision aid can be incorporated into the consent process with few problems; (2) women of varying educational backgrounds can complete the decision aid; (3) while women consider many consequences of genetic testing, their primary focus is on the implications for their family; and (4) this is in marked contrast to the typical benefit-harm statements prepared by researchers for genetic testing.

Consent Forms↗

Computer-aided decision support in hepatology.

The aim of this study was to describe and to evaluate the publications of the last 30 years devoted to computer-aided decision support in clinical hepatology. The search used Medlars and references of articles. Computer-aided decision support (CADS) was classified in two categories: statistical systems and knowledge-based systems. Two specific questionnaires were used for methodologic evaluation, one for statistical systems and one for knowledge-based systems. They were filled out independently by two observers. A total of 31 papers were selected among 55 identified between 1960 and 1991. The maximum possible for the two scores was 24. The methodologic quality ranged from 4 to 22 (median, 12) for statistical systems and from 8 to 12 (median, 9) for knowledge-based systems. The poor level of methodology could explain in part the lack of utilization of computer-aided decision support in the daily clinical practice of hepatologists.

Bayes Theorem↗

The effects of an 'explicit' values clarification exercise in a woman's decision aid regarding postmenopausal hormone therapy.

OBJECTIVE: To evaluate the incremental effect of a graphic weigh-scale values clarification exercise to explicitly consider the personal importance of the benefits versus the risks in a woman's decision aid regarding postmenopausal hormone therapy. DESIGN: Randomized controlled trial. Intervention Decision aid including information on options, benefits and risks, and their probabilities either followed by: (1) a graphic weigh-scale values clarification exercise to explicitly consider the personal importance of each benefit and risk; or (2) a summary of the main benefits and risks to implicitly consider benefits versus the risks. SAMPLE: Two-hundred and one women aged 50-69 years from Ottawa, Canada, who had never used hormone therapy. OUTCOME: Perceived clarity of values, a sub-scale of the decisional conflict scale; congruence between personal values of benefits and risks (measured on 0-10 importance rating scale) and choices (accept, decline, unsure regarding preventive hormone therapy [HRT]) using discriminant function analysis. RESULTS: There were no statistically significant differences between interventions in perceived clarity of values and overall congruence between values and choices. Amongst those choosing HRT, there was a trend in those exposed to the graphic weigh-scale exercise to have better congruence between values and choices compared to implicit values clarification (P = 0.06). CONCLUSION: The use of the graphic weigh-scale exercise in a decision aid conveys no overall short-term benefit. Further study is needed to specifically determine effects in those changing the status quo and on the quality of patient-practitioner communication and persistence with decisions.

Journal Article↗