Karen Sepucha

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

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

Measurement of shared decision making - a review of instruments

The last years have seen a clear move towards shared decision making (SDM) and increased patient involvement in many countries. However, as the field of SDM research is still relatively young, new instruments for the measurement of (shared) decision making (process, outcome and surrounding elements) are constantly being developed. Thus, the aims of this structured review were to give an update on current developments regarding the measurement in the field of SDM, as well as to give a short overview of published and unpublished instruments. We conducted an electronic literature search in PubMed and the Web of Science database, performed hand searches of relevant journals and contacted key authors in the field. We found eight scales that have been subjected to further psychometric testing, eleven new and psychometrically tested instruments and nine developments that are still in the publishing process. The results show that there is a trend towards measuring SDM processes from a dyadic approach (assessing both the patients and the clinicians perspective). More and more scales have been developed and tested in languages other than English, which indicates the growing research efforts in various countries. While reliability of most scales is good, they differ in their extent of validation. Further psychometric testing is needed, as well as the development of a theoretical measurement framework in order to improve consistency of measured constructs across research groups.

Perceptions, Knowledge, and Satisfaction With Contralateral Prophylactic Mastectomy Among Young Women With Breast Cancer: A Cross-sectional Survey

UNLABELLED Chinese translation BACKGROUND Rates of contralateral prophylactic mastectomy (CPM) have increased dramatically, particularly among younger women with breast cancer, but little is known about how women approach the decision to have CPM. OBJECTIVE To examine preferences, knowledge, decision making, and experiences of young women with breast cancer who choose CPM. DESIGN Cross-sectional survey. SETTING 8 academic and community medical centers that enrolled 550 women diagnosed with breast cancer at age 40 years or younger between November 2006 and November 2010. PATIENTS 123 women without known bilateral breast cancer who reported having bilateral mastectomy. MEASUREMENTS A 1-time, 23-item survey that included items related to decision making, knowledge, risk perception, and breast cancer worry. RESULTS Most women indicated that desires to decrease their risk for contralateral breast cancer (98%) and improve survival (94%) were extremely or very important factors in their decision to have CPM. However, only 18% indicated that women with breast cancer who undergo CPM live longer than those who do not. BRCA1 or BRCA2 mutation carriers more accurately perceived their risk for contralateral breast cancer, whereas women without a known mutation substantially overestimated this risk. LIMITATIONS The survey, which was administered a median of 2 years after surgery, was not validated, and some questions might have been misinterpreted by respondents or subject to recall bias. Generalizability of the findings might be limited. CONCLUSION Despite knowing that CPM does not clearly improve survival, women who have the procedure do so, in part, to extend their lives. Many women overestimate their actual risk for cancer in the unaffected breast. Interventions aimed at improving risk communication in an effort to promote evidence-based decision making are warranted. PRIMARY FUNDING SOURCE Susan G. Komen for the Cure.

Establishing the effectiveness of patient decision aids: key constructs and measurement instruments

BackgroundEstablishing the effectiveness of patient decision aids (PtDA) requires evidence that PtDAs improve the quality of the decision-making process and the quality of the choice made, or decision quality. The aim of this paper is to review the theoretical and empirical evidence for PtDA effectiveness and discuss emerging practical and research issues in the measurement of effectiveness.MethodsThis updated overview incorporates: a) an examination of the instruments used to measure five key decision-making process constructs (i.e., recognize decision, feel informed about options and outcomes, feel clear about goals and preferences, discuss goals and preferences with health care provider, and be involved in decisions) and decision quality constructs (i.e., knowledge, realistic expectations, values-choice agreement) within the 86 trials in the Cochrane review; and b) a summary of the 2011 Cochrane Collaboration’s review of PtDAs for these key constructs. Data on the constructs and instruments used were extracted independently by two authors from the 86 trials and any disagreements were resolved by discussion, with adjudication by a third party where required.ResultsThe 86 studies provide considerable evidence that PtDAs improve the decision-making process and decision quality. A majority of the studies (76/86; 88%) measured at least one of the key decision-making process or decision quality constructs. Seventeen different measurement instruments were used to measure decision-making process constructs, but no single instrument covered all five constructs. The Decisional Conflict Scale was most commonly used (n = 47), followed by the Control Preference Scale (n = 9). Many studies reported one or more constructs of decision quality, including knowledge (n = 59), realistic expectation of risks and benefits (n = 21), and values-choice agreement (n = 13). There was considerable variability in how values-choice agreement was defined and determined. No study reported on all key decision-making process and decision quality constructs.ConclusionsEvidence of PtDA effectiveness in improving the quality of the decision-making process and decision quality is strong and growing. There is not, however, consensus or standardization of measurement for either the decision-making process or decision quality. Additional work is needed to develop and evaluate measurement instruments and further explore theoretical issues to advance future research on PtDA effectiveness.

A systematic review of information in decision aids

Objective  We completed a systematic review of information reported as included in decision aids (DAs) for adult patients, to determine if it is complete, balanced and accurate.

Building bridges between physicians and patients : Results of a pilot study examining new tools for collaborative decision making in breast cancer

PURPOSE To present the results of a pilot study testing an intervention designed to improve the quality of medical consultations between breast cancer patients and physicians and, in particular, to report the effects of the intervention on the quality of treatment decisions, the quality of communication, and the satisfaction of patients and physicians. PATIENTS AND METHODS We enrolled 24 predominantly white, well-educated, early-stage breast cancer patients who were facing local or systemic treatment decisions in a sequential, controlled trial. All patients received a visit preparation session before the consultation in which a trained researcher helped patients organize their questions and concerns. In the control, a researcher observed the consultation. In the intervention, a researcher helped create an agenda, facilitated the discussion, and created a record of the consultation in real time. Valid and reliable surveys measured the quality of treatment decisions and satisfaction with the consultation. RESULTS Patients in the intervention achieved significantly higher final decision quality scores compared with control patients (median score, 14 v 10, respectively; P =.008) and a significantly higher level of intersubjective agreement with their physicians about decision quality (Cohens kappa, 0.49 v 0.285, respectively; P <.0001). Consultation recording methods did not affect the length of time required for the consultation. CONCLUSION Consultation recording methods provide a promising innovation for medical consultations. Further studies are warranted to broaden the findings, assess impacts on the quality of decisions, cost, and health, and develop practical ways to integrate consultation recording methods into clinics.

Patients' knowledge about 9 common health conditions: the DECISIONS survey.

Background To make informed decisions, patients must have adequate knowledge of key decision-relevant facts. Objective To determine adults’ knowledge about information relevant to common types of medication, screening, or surgery decisions they recently made. Setting National sample of US adults identified by random-digit dialing. Design Cross-sectional survey conducted between November 2006 and May 2007. Participants A total of 2575 English-speaking adults aged 40 y or older who reported having discussed the following medical decisions with a health care provider within the previous 2 y: prescription medications for hypertension, hypercholesterolemia, or depression; screening tests for colorectal, breast, or prostate cancer; or surgeries for knee/hip replacement, cataracts, or lower back pain. Measurements Participants answered knowledge questions and rated the importance of their health care provider, family/friends, and the media as sources of information. Results Accuracy rates varied widely across questions and decision contexts. For example, patients considering cataract surgery were more likely to correctly estimate recovery time than those patients considering lower back pain or knee/hip replacement (78% v. 29% and 39%, P < 0.001). Similarly, participants were more knowledgeable of facts about colorectal cancer screening than those who were asked about breast or prostate cancer. Finally, respondents were consistently more knowledgeable on comparable questions about blood pressure medication than cholesterol medication or antidepressants. The impact of demographic characteristics and sources of information also varied substantially. For example, blacks had lower knowledge than whites about cancer screening decisions (odds ratio [OR] = 0.57; 95% confidence interval [CI] = 0.43, 0.75; P = 0.001) and medication (OR = 0.77; 95% CI = 0.60, 0.97; P = 0.03) even after we controlled for other demographic factors. The same was not true for surgical decisions. Limitations The questions did not measure all knowledge relevant to informed decision making, were subject to recall biases, and may have assessed numeracy more than knowledge. Conclusions Patient knowledge of key facts relevant to recently made medical decisions is often poor and varies systematically by decision type and patient characteristics. Improving patient knowledge about risks, benefits, and characteristics of medical procedures is essential to support informed decision making.

How does feeling informed relate to being informed? The DECISIONS survey.

Background An important part of delivering high-quality, patient-centered care is making sure patients are informed about decisions regarding their health care. The objective was to examine whether patients’ perceptions about how informed they were about common medical decisions are related to their ability to answer various knowledge questions. Methods A cross-sectional survey was conducted November 2006 to May 2007 of a national sample of US adults identified by random-digit dialing. Participants were 2575 English-speaking US adults aged 40 and older who had made 1 of 9 medication, cancer screening, or elective surgery decisions within the previous 2 years. Participants rated how informed they felt on a scale of 0 (not at all informed) to 10 (extremely well-informed), answered decision-specific knowledge questions, and completed standard demographic questions. Results Overall, 36% felt extremely well informed (10), 30% felt well informed (8–9), and 33% felt not at all to somewhat informed (0–7). Multivariate logistic regression analyses showed no overall relationship between knowledge scores and perceptions of being extremely well informed (odds ratio [OR] = 0.94, 95% confidence interval [CI] 0.63–1.42, P = 0.78). Three patterns emerged for decision types: a negative relationship for cancer screening decisions (OR = 0.58, CI 0.33–1.02, P = 0.06), no relationship for medication decisions (OR = 0.99, CI 0.54–1.83, P = 0.98), and a positive relationship for surgery decisions (OR = 3.07, 95% CI 0.90–10.54, P = 0.07). Trust in the doctor was associated with feeling extremely well-informed for all 3 types of decisions. Lower education and lower income were also associated with feeling extremely well informed for medication and screening decisions. Retrospective survey data are subject to recall bias, and participants may have had different perspectives or more factual knowledge closer to the time of the decision. Conclusions Patients facing common medical decisions are not able to accurately assess how well informed they are. Clinicians need to be proactive in providing adequate information to patients and testing patients’ understanding to ensure informed decisions.

Decision Making about Surgery for Early Stage Breast Cancer

BACKGROUND Practice variation in breast cancer surgery has raised concerns about the quality of treatment decisions. We sought to evaluate the quality of decisions about surgery for early-stage breast cancer by measuring patient knowledge, concordance between goals and treatments, and involvement in decisions. STUDY DESIGN A mailed survey of stage I/II breast cancer survivors was conducted at 4 sites. The Decision Quality Instrument measured knowledge, goals, and involvement in decisions. A multivariable logistic regression model of treatment was developed. The model-predicted probability of mastectomy was compared with treatment received for each patient. Concordance was defined as having mastectomy and predicted probability >0.5 or partial mastectomy and predicted probability <0.5. Frequency of discussion about partial mastectomy was compared with discussion about mastectomy using chi-square tests. RESULTS Four hundred and forty patients participated (59% response rate). Mean overall knowledge was 52.7%; 45.9% knew that local recurrence risk is higher after breast conservation and 55.7% knew that survival is equivalent for the 2 options. Most participants (89.0%) had treatment concordant with their goals. Participants preferring mastectomy had lower concordance (80.5%) than those preferring partial mastectomy (92.6%; p = 0.001). Participants reported more frequent discussion of partial mastectomy and its advantages than of mastectomy, and 48.6% reported being asked their preference. CONCLUSIONS Breast cancer survivors had major knowledge deficits, and those preferring mastectomy were less likely to have treatment concordant with goals. Patients perceived that discussions focused on partial mastectomy, and many were not asked their preference. Improvements in the quality of decisions about breast cancer surgery are needed.

Implementing breast cancer decision aids in community sites: barriers and resources

Objective  To assess the feasibility of implementing four patient decision aids (PtDAs) for early stage breast cancer treatment decisions into routine clinical care in community settings.