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Background Decision Aids (DAs) effectively translate medical evidence for patients but are not routinely used in clinical practice. Little is known about how DAs are used during patient‐clinician encounters. Objective To characterize the content and communicative function of high‐quality DAs during diagnostic clinic visits for prostate cancer. Participants 252 men newly diagnosed with localized prostate cancer who had received a DA, 45 treating physicians at 4 US Veterans Administration urology clinics. Methods Qualitative analysis of transcribed audio recordings was used to inductively develop categories capturing content and function of all direct references to DAs (booklet talk). The presence or absence of any booklet talk per transcript was also calculated. Results Booklet talk occurred in 55% of transcripts. Content focused on surgical procedures (36%); treatment choice (22%); and clarifying risk classification (17%). The most common function of booklet talk was patient corroboration of physicians’ explanations (42%), followed by either physician or patient acknowledgement that the patient had the booklet. Codes reflected the absence of DA use for shared decision‐making. In regression analysis, predictors of booklet talk were fewer years of patient education (P = .027) and more time in the encounter (P = .027). Patient race, DA type, time reading the DA, physician informing quality and physician age did not predict booklet talk. Conclusions Results show that good decision aids, systematically provided to patients, appeared to function not to open up deliberations about how to balance benefits and harms of competing treatments, but rather to allow patients to ask narrow technical questions about recommended treatments.

To describe the development, validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies (decision aids). Scale development study, involving construct, item and scale development, validation and reliability testing. There has been increasing use of decision support technologies--adjuncts to the discussions clinicians have with patients about difficult decisions. A global interest in developing these interventions exists among both for-profit and not-for-profit organisations. It is therefore essential to have internationally accepted standards to assess the quality of their development, process, content, potential bias and method of field testing and evaluation. Scale development study, involving construct, item and scale development, validation and reliability testing. Twenty-five researcher-members of the International Patient Decision Aid Standards Collaboration worked together to develop the instrument (IPDASi). In the fourth Stage (reliability study), eight raters assessed thirty randomly selected decision support technologies. IPDASi measures quality in 10 dimensions, using 47 items, and provides an overall quality score (scaled from 0 to 100) for each intervention. Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sampled (n = 30), enabling discrimination. The inter-rater intraclass correlation for the overall quality score was 0.80. Correlations of dimension scores with the overall score were all positive (0.31 to 0.68). Cronbach's alpha values for the 8 raters ranged from 0.72 to 0.93. Cronbach's alphas based on the dimension means ranged from 0.50 to 0.81, indicating that the dimensions, although well correlated, measure different aspects of decision support technology quality. A short version (19 items) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 (CI 0.79 to 0.92). This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies. The existing IPDASi provides an assessment of the quality of a DST's components and will be used as a tool to provide formative advice to DSTs developers and summative assessments for those who want to compare their tools against an existing benchmark.

Background Despite nationwide improvements in cardiovascular disease (CVD) mortality and morbidity, CVD deaths in adults with type 2 diabetes (T2DM) are 2–4 times higher than among those without T2DM. A key contributor to these poor health outcomes is medication non-adherence. Twenty-one to 42% of T2DM patients do not take blood sugar, blood pressure (BP), or statin medications as prescribed. Interventions that foster and reinforce patient-centered communication show promise in improving health outcomes. However, they have not been widely implemented, in part due to a lack of compelling evidence for their effectiveness in real-life primary care settings. Methods This pragmatic cluster-randomized trial randomizes 17 teams in 12 Federally Qualified Healthcare Centers (FQHCs) to two experimental groups: intervention (group 1): Office-Gap + Texting vs. control (group 2): Texting only. Office-GAP (Office-Guidelines Applied to Practice) is a patient activation intervention to improve communication and patient-provider partnerships through brief patient and provider training in shared decision-making (SDM) and use of a guideline-based checklist. The texting intervention (Way2Health) is a cell phone messaging service that informs and encourages patients to adhere to goals, adhere to medication use and improve communication. After recruitment, patients in groups 1 and 2 will both attend (1) one scheduled group visit, (90–120 min) conducted by trained research assistants, and (2) follow-up visits with their providers after group visit at 0–1, 3, 6, 9, and 12 months. Data will be collected over 12-month intervention period. Our primary outcome is medication adherence measured using eCAP electronic monitoring and self-report. Secondary outcomes are (a) diabetes-specific 5-year CVD risk as measured with the UK Prospective Diabetes Study (UKPDS) Engine score, (b) provider engagement as measured by the CollaboRATE Shared-Decision Making measure, and (c) patient activation measures (PAM). Discussion This study will provide a rigorous pragmatic evaluation of the effectiveness of combined mHealth, and patient activation interventions compared to mHealth alone, targeting patients and healthcare providers in safety net health centers, in improving medication adherence and decreasing CVD risk. Given that 20–50% of adults with chronic illness demonstrate medication non-adherence, increasing adherence is essential to improve CVD outcomes as well as healthcare cost savings. Trial registration The ClinicalTrials.gov registration number is NCT04874116.

Background While many studies have tested the impact of a decision aid (DA) compared to not receiving any DA, far fewer have tested how different types of DAs affect key outcomes such as treatment choice, patient–provider communication, or decision process/satisfaction. This study tested the impact of a complex medical oriented DA compared to a more simplistic decision aid designed to encourage shared decision making in men with clinically localized prostate cancer. Methods 1028 men at 4 VA hospitals were recruited after a scheduled prostate biopsy. Participants completed baseline measures and were randomized to receive either a simple or complex DA. Participants were men with clinically localized cancer (N = 285) by biopsy and who completed a baseline survey. Survey measures: baseline (biopsy); immediately prior to seeing the physician for biopsy results (pre- encounter); one week following the physician visit (post-encounter). Outcome measures included treatment preference and treatment received, knowledge, preference for shared decision making, decision making process, and patients’ use and satisfaction with the DA. Results Participants who received the simple DA had greater interest in shared decision making after reading the DA (p = 0.03), found the DA more helpful (p’s < 0.01) and were more likely to be considering watchful waiting (p = 0.03) compared to those receiving the complex DA at Time 2. While these differences were present before patients saw their urologists, there was no difference between groups in the treatment patients received. Conclusions The simple DA led to increased desire for shared decision making and for less aggressive treatment. However, these differences disappeared following the physician visit, which appeared to change patients’ treatment preferences. Trial registration This trial was pre-registered prior to recruitment of participants.

Recent guidelines on cancer screening have provided not only more screening options but also conflicting recommendations. Thus, patients, with their clinicians' support, must decide whether to get screened, which modality to use, and how often to undergo screening. Decision aids could potentially lead to better shared decision-making regarding screening between the patient and the clinician. A total of 73 decision aids concerning screening for breast, cervical, colorectal, and prostate cancers were reviewed. The goal of this review was to assess the effectiveness of such decision aids, examine areas in need of more research, and determine how the decision aids can be currently applied in the real-world setting. Most studies used sound study designs. Significant variation existed in the setting, theoretical framework, and measured outcomes. Just over one-third of the decision aids included an explicit values clarification. Other than knowledge, little consistency was noted with regard to which patient attributes were measured as outcomes. Few studies actually measured shared decision-making. Little information was available regarding the feasibility and outcomes of integrating decision aids into practice. In this review, the implications for future research, as well as what clinicians can do now to incorporate decision aids into their practice, are discussed. [PUBLICATION ABSTRACT]

Background The search for a reliable, valid and cost-effective comorbidity risk adjustment method for outcomes research continues to be a challenge. The most widely used tool, the Charlson Comorbidity Index (CCI) is limited due to frequent missing data in medical records and administrative data. Patient self-report data has the potential to be more complete but has not been widely used. The purpose of this study was to evaluate the performance of the Self-Administered Comorbidity Questionnaire (SCQ) to predict functional capacity, quality of life (QOL) health outcomes compared to CCI medical records data. Method An SCQ-score was generated from patient interview, and the CCI score was generated by medical record review for 525 patients hospitalized for Acute Coronary Syndrome (ACS) at baseline, three months and eight months post-discharge. Linear regression models assessed the extent to which there were differences in the ability of comorbidity measures to predict functional capacity (Activity Status Index [ASI] scores) and quality of life (EuroQOL 5D [EQ5D] scores). Results The CCI (R 2 = 0.245; p = 0.132) did not predict quality of life scores while the SCQ self-report method (R 2 = 0.265; p < 0.0005) predicted the EQ5D scores. However, the CCI was almost as good as the SCQ for predicting the ASI scores at three and six months and performed slightly better in predicting ASI at eight-month follow up (R 2 = 0.370; p < 0.0005 vs. R 2 = 0.358; p < 0.0005) respectively. Only age, gender, family income and Center for Epidemiologic Studies-Depression (CESD) scores showed significant association with both measures in predicting QOL and functional capacity. Conclusions Although our model R-squares were fairly low, these results show that the self-report SCQ index is a good alternative method to predict QOL health outcomes when compared to a CCI medical record score. Both measures predicted physical functioning similarly. This suggests that patient self-reported comorbidity data can be used for predicting physical functional capacity and QOL and can serve as a reliable risk adjustment measure. Self-report comorbidity data may provide a cost-effective alternative method for risk adjustment in clinical research, health policy and organizational improvement analyses. Trial registration Clinical Trials.gov NCT00416026

Objective. (i) To examine the sustainability of an in-hospital quality improvement (QI) intervention, the American College of Cardiology's Guideline Applied to Practice (GAP) in acute myocardial infarction (AMI). (ii) To determine the predictors of physician adherence to AMI guidelines-recommended medication prescribing. Design. Prospective observational study. Setting. Five mid-Michigan community hospitals. Participants. 516 AMI patients admitted consecutively 1 year after the GAP intervention. These patients were compared with 499 post-GAP patients. Main Outcome Measures. The main outcome was adherence to medication use guidelines. Predictors of medication use were determined using multivariable logistic regression analysis. Results. 1 year after GAP implementation, adherence to most medications remained high. We found a significant increase in beta-blocker (BB) use in-hospital (87.9 vs. 72.1%, P < 0.001) whereas cholesterol assessment within 24 h (79.5 vs. 83.6%, P > 0.225) did not change significantly. However, discharge aspirin (83 vs. 90%, P < 0.018) and BB prescriptions (84 vs. 92% P < 0.016) dropped to preintervention rates. Discharge angiotensin-converting enzyme inhibitor and treatment of patients with low-density lipoprotein of ≥100 were unchanged. Predictors of receiving appropriate medications were male gender (for aspirin and BBs) and treatment with percutaneous coronary intervention compared with coronary artery bypass graft. Notably, prescription rates for discharge medications differed significantly by hospital. Conclusions. Early benefits of the Mid-Michigan GAP intervention on guideline use were only partially sustained at 1 year. Differences in guideline adherence by treatment modality and hospital demonstrate challenges for follow-up phases of GAP. Additional strategies to improve sustainability of QI efforts are urgently needed.

Context Advances in screening and treatment of prostate cancer have dramatically increased the number of survivors in the US population. Yet the effect of screening is controversial, and in some instances may not be beneficial. Previous studies have typically only reported outcomes of treatment and symptoms within a short time frame following treatment. The persistence of such symptoms over time necessitates an improvement of survivor care so that the medical and support needs of these patients are met. Objective This study aims to perform a patient-centered survey of prostate cancer survivors in the Michigan Cancer Registry to identify treatment side effect rates, evaluate survivors' access to preventive care services post-prostate cancer treatment, and assess the informational needs of these survivors regarding their prostate cancer. Design, setting, and patients Linking case files of the Michigan Cancer Registry with records from the National Death Index, we identified prostate cancer patients diagnosed between 1985 and 2004 and alive on 31 December 2005. Participants were selected using a stratified cross-sectional sampling strategy to ensure adequate inclusion of survivors based upon race and ethnicity, urban versus rural location, and number of years since diagnosis of prostate cancer. A total of 2,499 surveys were completed and returned. Main outcome measures (1) Physical symptoms—assessing bowel, sexual, urinary, and vitality symptoms by treatment modality. (2) Access to care—identifying whether diagnostic tests for prostate cancer (prostate-specific antigen (PSA) and digital rectal examination) were performed. Determining whether the survivors had knowledge of the “watchful waiting” paradigm for prostate cancer surveillance. (3) Informational needs—assessing whether the informational needs of patients were addressed by providers. Evaluating the significant predictors associated with seeking information about prostate cancer from any other source. Identifying what factors influenced a person to actively seek out information and what factors guide which primary information source a survivor would use. Results Median duration between prostate cancer diagnosis and survey response was 9 years. Of the study population, 80 % was diagnosed at an early stage. Survivors had reported significant problems in the 4 weeks prior to survey. Of the survivors, 88.1 % reported having a PSA test since diagnosis of prostate cancer, with 93 % of them having it done at least once per year. Of the survivors, 82.6 % reported that a healthcare provider gave them information on prostate cancer. Of this 82.6 %, 86.4 % had this information provided by a urologist, 45.4 % by a primary care physician, and 29.2 % by an oncologist. The primary source of information for these survivors was “healthcare provider” (59.2 %). Conclusion Persistent symptoms subsequent to prostate cancer treatment suggest a gap in symptom management. Future research should support long-term studies of active surveillance versus active treatment outcomes to understand the feasibility of minimizing the burden of long-term physical symptoms arising from prostate cancer treatment. Clinicians must assess post-treatment distress long after treatment has ended to identify when supportive care is needed. More informational resources should be allocated to prostate cancer survivors to ensure that they are well-educated about their prognosis. Implications for Cancer Survivors This study is needed to ensure that the post-treatment symptoms of prostate cancer survivors are properly addressed and managed by healthcare providers over the long term.

OBJECTIVE:  To examine changes in the rate of beta‐blocker (BB) use at admission, in hospital, and at discharge between 1994 and 1995 (MICH I) and 1997 (MICH II) in patients with acute myocardial infarction (AMI). DESIGN:  Comparison of two prospectively enrolled cohorts. SETTING:  Five mid‐Michigan community hospitals. PATIENTS:  We studied 287 MICH I patients and 121 MICH II patients with AMI who had no contraindications to BB use from cohorts of consecutively admitted cases of AMI (814 in MICH I; 500 in MICH II). RESULTS:  Prescription of BBs to ideal patients with AMI increased in patients with previous history of myocardial infarction on arrival at the hospital (12.5% vs 36.0%; P= .01), in hospital (47.0% vs 76%; P < .01), and at discharge (34.0% vs 61.9%; P < .01). Neither race nor gender was a predictor of BB use. Younger age predicted BB prescription at discharge (odds ratio [OR], 2.07; 95% confidence interval [CI], 1.32 to 3.23). Later study cohort was the most important predictor of BB use in hospital (OR, 3.4; 95% CI, 2.09 to 5.25). CONCLUSION:  BB use improved dramatically over the study period, but additional work is needed to improve use of BB after discharge and among elderly patients with AMI.

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