Changes in biomechanics, strength, physical function, and daily steps after extended-release corticosteroid injections in knee osteoarthritis: a responder analysis.

INTRODUCTION/OBJECTIVE: To determine changes in gait biomechanics, quadricep strength, physical function, and daily steps after an extended-release corticosteroid knee injection at 4 and 8 weeks post-injection in individuals with knee osteoarthritis as well as between responders and non-responders based on changes in self-reported knee function. METHOD: The single-arm, clinical trial included three study visits (baseline, 4 weeks, and 8 weeks post-injection), where participants received an extended-release corticosteroid injection following the baseline visit. Time-normalized vertical ground reaction force (vGRF), knee flexion angle (KFA), knee abduction moment (KAM), and knee extension moment (KEM) waveforms throughout stance were collected during gait biomechanical assessments. Participants also completed quadricep strength, physical function (chair-stand, stair-climb, 20-m fast-paced walk) testing, and free-living daily step assessment for 7 days following each visit. RESULTS: All participants demonstrated increased KFA excursion (i.e., greater knee extension angle at heel strike and KFA at toe-off), increased KEM during early stance, improved physical function (all p < 0.001), and increased quadricep strength at 4 and 8 weeks. KAM increased throughout most of stance at 4 and 8 weeks post-injection (p < 0.001) but appears to be driven by gait changes in non-responders. Non-responders demonstrated lesser vGRF during late stance and lesser KEM and KFA throughout stance compared to responders at baseline. CONCLUSIONS: Extended-release corticosteroid injections demonstrated short-term improvements in gait biomechanics, quadricep strength, and physical function for up to 4 weeks. However, non-responders demonstrated gait biomechanics associated with osteoarthritis progression prior to the corticosteroid injection, suggesting that non-responders demonstrate more deleterious gait biomechanics prior to corticosteroid injection. Key Points • Individuals with knee osteoarthritis who were treated with extended-release corticosteroid injections demonstrated improvements in gait biomechanics and physical function for 8 weeks. • Individuals with knee osteoarthritis, who walked with aberrant walking biomechanics before treatment, failed to respond to extended-release corticosteroid treatment. • Future research should determine the mechanisms contributing to the short-term changes in gait biomechanics and physical function such as reduced inflammation.

Do Black birthing persons prefer a Black health care provider during birth? Race concordance in birth.

BACKGROUND: For many years in the United States, there has been an active discussion about whether race concordance between care providers and patients contributes to better health outcomes. Although beneficial provider-patient communication effects have been associated with concordance, there is minimal evidence for concordance benefits to health outcomes. METHODS: A cross-sectional survey was conducted including 200 Black mothers who had given birth within the last 2 years asking about the perceived racial identity of their birth health provider, whether they preferred to have Black women providers, and the intersection between race and gender concordance on birth outcomes. In addition to race and gender concordance, other variables were tested for their impact on birth satisfaction including respect, trust for the care provider, perceived competence, care provider empathy, and inclusive communication. RESULTS: Forty-one percent of the mothers in this study were assisted in birth by a Black woman provider. Although patient-provider concordance did not result in measurable health outcomes, it is clear that compared to other studies of birth satisfaction among Black birthing persons, this study showed relatively higher levels of satisfaction, perceived trust, empathy, perceived provider competence, inclusive communication, and equal respect for both concordant and discordant care providers. CONCLUSIONS: Although many participants showed a preference for race concordance, participants equally valued respect, competence, and trust with their care providers. Further community-based research needs to be conducted to examine whether race, gender, and cultural concordance results in other beneficial health outcomes.

Type 2 diabetes patient activation and mHealth interventions decreased cardiovascular disease risk.

OBJECTIVES: Cardiovascular disease (CVD) deaths in patients with type 2 diabetes (T2D) are 2 to 4 times higher than among those without T2D. Our objective was to determine whether a patient activation program (Office-Guidelines Applied to Practice [Office-GAP]) plus a mobile health (mHealth) intervention compared with mHealth alone improved medication use and decreased 10-year atherosclerotic CVD (ASCVD) risk score in patients with T2D. STUDY DESIGN: Quasi-experimental design; Office-GAP plus mHealth vs mHealth only. METHODS: The Office-GAP intervention included (1) a patient activation group visit, (2) provider training, and (3) a decision support checklist used in real time during the encounter. The mHealth intervention included daily text messages for 15 weeks. Patients with T2D (hemoglobin A1c ≥ 8%) attending internal medicine residency clinics were randomly assigned to either the combined Office-GAP + mHealth group (Green) or mHealth-only group (White). After group visits, patients followed up with providers at 2 and 4 months. A generalized estimating equation regression model was used to compare change in medication use and ASCVD risk scores between the 2 arms at 0, 2, and 4 months. RESULTS: Fifty-one patients with diabetes (26 in Green team and 25 in White team) completed the study. The 10-year ASCVD risk score decreased in both groups (Green: -3.23; P = .06; White: -3.98; P = .01). Medication use increased from baseline to 4-month follow-up (statin: odds ratio [OR], 2.20; 95% CI, 1.32-3.67; aspirin: OR, 3.21, 95% CI, 1.44-7.17; angiotensin-converting enzyme inhibitor/angiotensin receptor blocker: OR, 2.67, 95% CI, 1.09-6.56). There was no significant difference in impact of the combined intervention (Office-GAP + mHealth) compared with mHealth alone. CONCLUSIONS: Both Office-GAP + mHealth and mHealth alone increased the use of evidence-based medications and decreased 10-year ASCVD risk scores for patients with T2D in 4 months.

Improving diabetic patients' adherence to treatment and prevention of cardiovascular disease (Office Guidelines Applied to Practice-IMPACT Study)-a cluster randomized controlled effectiveness trial.

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.

On the Shoulders of Giants: A Reckoning with Social Justice.

As a field, bioethics has failed to adequately change in a direction that pursues and addresses continually shifting contemporary social problems, in particular, anti-Black racism. In this essay, we draw from interviews with four senior Black scholars-Anita L. Allen, Claretta Y. Dupree, Patricia A. King, and Lawrence J. Prograis, Jr.-to learn from their experiences in this field dominated by White-majority thought and to consider thematically how best to recalibrate bioethics to imagine a braver, broader, and better bioethics, one that centers social justice and is equipped to work against anti-Black racism.

Developing Nursing and Midwifery Informatics Position Statements: Why Do They Matter for Our Workforce?

Nursing and midwifery informatics position statements are important to guide and inform our workforce. Australasian position statements have been developed to establish the place of nursing and midwifery informatics in the health system and progress the development of senior roles.

Relationship between blood pressure and kidney diseases in large randomized controlled trials: secondary analyses using SPRINT and ACCORD-BP trials.

Hypertension is a risk factor for acute kidney injury. In this study, we aimed to identify the optimal blood pressure (BP) targets for CKD and non-CKD patients. We analyzed the data of the Systolic Blood Pressure Intervention Trial (SPRINT) and the Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial (ACCORD BP) to determine the nonlinear relationship between BP and renal disease development using the Generalized Additive Model (GAM). Optimal systolic BP/diastolic BP (SBP/DBP) with lowest renal risk were estimated using GAM. Logistic regression was employed to find odds ratios (ORs) of adverse renal outcomes by three BP groups (high/medium/low). Both study trials have demonstrated a "U"-shaped relationship between BP and renal outcomes. For non-CKD patients in SPRINT trial, risk of 30% reduction in eGFR among intensive group patients with DBP ≤ 70 mmHg was significantly higher than the group with DBP between 71 and 85 mmHg (OR = 2.31, 95% CI = 1.51-3.53). For non-CKD patients in ACCORD trial, risk of doubling of serum creatinine (SCr) or >20 mL/min decrease in eGFR among intensive group patients with DBP ≤ 70 mmHg was significantly higher than the group with DBP between 71 and 85 mmHg (OR = 1.49, 95% CI = 1.12-1.99). For CKD patients in SPRINT trial, there are no significant differences in renal outcomes by different SBP/DBP levels. Our analysis of both SPRINT and ACCORD datasets demonstrated that lower-than-optimal DBP may lead to poor renal outcomes in non-CKD patients. Healthcare providers should be cautious of too low DBP level in intensive BP management due to poor renal outcomes for non-CKD patients.

Perspectives on Deep Brain Stimulation and Its Earlier Use for Parkinson's Disease: A Qualitative Study of US Patients.

BACKGROUND: Deep brain stimulation (DBS) is being used earlier than was previously the case in the disease progression in people with Parkinson's disease (PD). To explore preferences about the timing of DBS, we asked PD patients with DBS whether they would have preferred the implantation procedure to have occurred earlier after diagnosis. METHODS: Twenty Michigan-based patients were interviewed about both their experiences with DBS as well as their attitudes regarding the possible earlier use of DBS. We used a structured interview, with both closed and open-ended questions. Interviews were transcribed verbatim and analyzed using a mixed-methods approach. RESULTS: We found that the majority of our participants (72%) had high overall satisfaction with DBS in addressing motor symptoms (mean of 7.5/10) and quality of life (mean of 8.25/10). Participants were mixed about whether they would have undergone DBS earlier than they did, with five participants being unsure and the remaining nearly equally divided between yes and no. CONCLUSION: Patient attitudes on the early use of DBS were mixed. Our results suggest that while patients were grateful for improvements experienced with DBS, they would not necessarily have endorsed its implementation earlier in their disease progression. Larger studies are needed to further examine our findings.

The influence of overhanging restoration margins on interproximal alveolar bone levels in general dental practice.

Aim To determine the prevalence of restoration overhangs in a general dental practice and investigate if these are associated with an increase in the rate of alveolar bone loss locally.Methods Historical dental records were randomly and anonymously selected from the records of patients in a general dental practice. The most recent bitewing radiographs were examined and any overhangs were recorded along with location. Sequential bitewing radiographs were examined so that the restored tooth with an overhang could be compared over time with a similar but unrestored tooth which acted as a control.Results A total of 111 dental records were audited and an overhang was observed in 67 cases. The prevalence of overhangs was greatest on upper molar teeth. Bone loss was calculated from 35 historical sets of bitewing radiographs over a period of up to 25 years. The mean bone loss on the unrestored control teeth was 0.06 mm/year and on the teeth adjacent to the overhangs it was 0.16 mm/year. This difference of 0.1 mm/year was statistically significant (paired t-test, P = 0.01). There was no significant difference between males and females. The mean size of the overhang was 0.9 mm (range 0.4-2.0 mm) with the bigger overhangs being associated with greater bone loss; however, not all ledges were associated in bone loss.Conclusions Restoration overhangs can be associated with increased bone loss and larger overhangs may be most problematic, although other factors are involved as not all ledges caused bone loss.

Interactivity in a Decision Aid: Findings From a Decision Aid to Technologically Enhance Shared Decision Making RCT.

INTRODUCTION: Colorectal cancer screening (CRCS) remains underutilized. Decision aids (DAs) can increase patient knowledge, intent, and CRCS rates compared with "usual care," but whether interactivity further increases CRCS rate remains unknown. STUDY DESIGN: A two-armed RCT compared the effect of a web-based DA that interactively assessed patient CRC risk and clarified patient preference for specific CRCS test to a web-based DA with the same content but without the interactive tools. SETTING/PARTICIPANTS: The study sites were 12 community- and three university-based primary care practices (56 physicians) in southeastern Michigan. Participants were men and women aged 50-75 years not current on CRCS. INTERVENTION: Random allocation to interactive DA (interactive arm) or non-interactive DA (non-interactive arm). MAIN OUTCOME MEASURES: Primary outcome was medical record documentation of CRCS 6 months after the intervention. Secondary outcome was patient decision quality (i.e., knowledge, preference clarification, and intent) measured immediately before and after DA use, and immediately after the office visit. To determine that either DA had a positive effect on CRCS adherence, usual care CRCS rates were determined from the three university-based practices among patients eligible for but not participating in the study. RESULTS: Data were collected between 2012 and 2014; analysis began in 2015. At 6 months, CRCS rate was 36.1% (95% CI=30.5%, 42.2%) in the interactive arm (n=284) and 40.5% (95% CI=34.7%, 46.6%) in the non-interactive arm (n=286, p=0.29). Usual care CRCS rate (n=440) was 18.6% (95% CI=15.2%, 22.7%), significantly lower than both arms (p<0.001). Knowledge, attitude, self-efficacy, test preference, and intent increased significantly within each arm versus baseline, but the rate was not significantly different between the two arms. CONCLUSIONS: The interactive DA did not improve the outcome compared to the non-interactive DA. This suggests that the resources needed to create and maintain the interactive components are not justifiable. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01514786.

Sex Differences in Statin Prescribing in Diabetic and Heart Disease Patients in FQHCs: A Comparison of the ATPIII and 2013 ACC/AHA Cholesterol Guidelines.

PURPOSE: The purpose of this study was to determine the difference in the rate of statin prescribing based on the Adult Treatment Panel (ATP) III and 2013 American College of Cardiology (ACC)/American Heart Association cholesterol guidelines across sex in Federally Qualified Health Centers (FQHCs), and to determine the proportion of patients on recommended statin dosage based on the 2013 cholesterol guideline. METHODS: The Office Guidelines Applied to Practice (Office-GAP) study is a quasi-experimental, 2 FQHCs center study that enrolled patients with coronary heart disease and diabetes mellitus (DM). We computed 10-year atherosclerotic cardiovascular disease (ASCVD) risks scores based on ACC guidelines and determined the rate of statin prescribing across sex in FQHCs using both guidelines. Main outcomes measures were (1) rate of statin prescribing based on ATPIII and 2013 cholesterol guidelines across sex and (2) proportion of patients on recommended statin dosage based on the 2013 cholesterol guideline. RESULTS: The 2013 cholesterol guideline did not increase the rate of eligibility of statin for men and women compared to ATPIII guideline. No significant difference between men and women in statin prescribing under ATPIII (67% vs 57%, P = .13) and 2013 cholesterol guidelines (66% vs 63%, P = .69) and in the recommended dosage of statin per the 2013 cholesterol guidelines between men and women in FQHCs (12% vs 22%, P = .22). CONCLUSIONS: We found statin underprescribing for both men and women with ASCVD and DM in FQHCs. Utilizing both the ATPIII and the 2013 cholesterol guidelines, men with ASCVD and DM were prescribed statin more than women. However, fewer men were found to be on the recommended dosage of statin based on the 2013 cholesterol guideline. Our findings suggest that Office-GAP may have improved the prescription/use of statin in both men and women.

Rationales for expanding minority physician representation in the workforce: a scoping review.

OBJECTIVES: The purpose of this study was to conduct a scoping review of the literature and to categorically map a 15-year trajectory of US undergraduate medical education rationales for and approaches to expanding under-represented minority (URM) physician representation in the medical workforce. Further aims were to comparatively examine related justifications and to consider international implications. METHODS: From 1 June to 31 July 2015, the authors searched the Cochrane Library, ERIC, PsycINFO, PubMed, Scopus, Web of Science and Google Scholar for articles published between 2000 and 2015 reporting rationales for and approaches to increasing the numbers of members of URMs in undergraduate medical school. RESULTS: A total of 137 articles were included in the scoping review. Of these, 114 (83%) mentioned workforce diversity and 73 (53%) mentioned concordance. The patient-physician relationship (n = 52, 38%) and service commitment (n = 52, 38%) were the most commonly cited rationales. The most frequently mentioned approaches to increasing minority representation were pipeline programmes (n = 59, 43%), changes in affirmative action laws (n = 32, 23%) and changes in admission policies (n = 29, 21%). CONCLUSIONS: This scoping review of the 2000-2015 literature on strategies for and approaches to expanding URM representation in medicine reveals a repetitive, amplifying message of URM physician service commitment to vulnerable populations in medically underserved communities. Such message repetition reinforces policies and practices that might limit the full scope of URM practice, research and leadership opportunities in medicine. Cross-nationally, service commitment and patient-physician concordance benefits admittedly respond to recognised societal need, yet there is an associated risk for instrumentally singling out members of URMs to fulfil that need. The proceedings of a 2001 US Institute of Medicine symposium warned against creating a deterministic expectation that URM physicians provide care to minority populations. Our findings suggest that the expanding emphasis on URM service commitment and patient-physician concordance benefits warrants ongoing scrutiny and, more broadly, represent a cautionary tale of unintended consequences for medical educators globally.

Correlates of Patient Intent and Preference on Colorectal Cancer Screening.

INTRODUCTION: Information is limited on patient characteristics that influence their preference among screening options and intent to be screened for colorectal cancer (CRC). A mechanistic pathway to intent and preference was examined through a formal mediation analysis. METHODS: From 2012 to 2014, a total of 570 adults aged 50-75 years were recruited from 15 primary care practices in Metro Detroit for a trial on decision aids for CRC screening. Confirmatory factor, regression, and mediation analyses were performed in 2015-2016 on baseline cross-sectional data. Main outcomes were patient intent and preference. Perceived risk and self-efficacy were secondary outcomes. Covariates included demographic information, health status, previous CRC screening experience, patient attitudes, and knowledge. RESULTS: Mean age was 57.7 years, 56.1% were women, and 55.1% white and 36.6% black. Women had 32% and 41% lower odds than men of perceiving CRC to be high/moderate risk (OR=0.68, 95% CI=0.47, 0.97, p=0.03) and having high self-efficacy (OR=0.59, 95% CI=0.42, 0.85, p=0.006), respectively. Whites had 63% and 47% lower odds than blacks of having high self-efficacy (OR=0.37, 95% CI=0.25, 0.57, p<0.001) and intent to undergo CRC screening (OR=0.53, 95% CI=0.34, 0.84, p=0.007), respectively. Younger age, higher knowledge, lower level of test worries, and medium/high versus low self-efficacy increased the odds of intent of being screened. Self-efficacy, but not perceived risk, significantly mediated the association between race, attitude, and test worries and patient screening intent. CONCLUSIONS: Self-efficacy mediated the association between race, attitude, and test worries and patient intent.

SAFE Medication Management for Patients With Physical Impairments of Stroke, Part Two.

PURPOSE: Part one of this series addressed impairments of stroke affecting motor skills. This second article focuses on the sensory impairments of stroke as they affect medication management: vision, hearing, memory and thinking, communication, and emotional disturbances. DESIGN: Each impairment is discussed, and possible interventions are proposed. Every patient is an individual and requires variable care plans. METHOD: Interventions and strategies, such as tools for assessment, practice tips, and assistive devices, aid patients, families, and their caregivers in practicing safe medication management. FINDINGS: Development of a comprehensive care plan will assist the patient to return as close to previous capabilities as possible. Patient outcomes and successes are variable. CONCLUSIONS AND CLINICAL RELEVANCE: The rehabilitation nurse uses observation, skills, and experience to assess stroke patients' needs and develop strategies to assist the patient in managing their medications. Involving patient, family, and caregivers in the teaching of SAFE (Systematic, Accurate, Functional, Effective) medication management increases safety, decreases the number of adverse drug events, and prevents hospitalizations.

Implementing shared decision making in federally qualified health centers, a quasi-experimental design study: the Office-Guidelines Applied to Practice (Office-GAP) program.

BACKGROUND: Use of Shared Decision-Making (SDM) and Decision Aids (DAs) has been encouraged but is not regularly implemented in primary care. The Office-Guidelines Applied to Practice (Office-GAP) intervention is an application of a previous model revised to address guidelines based care for low-income populations with diabetes and coronary heart disease (CHD). OBJECTIVE: To evaluate Office-GAP Program feasibility and preliminary efficacy on medication use, patient satisfaction with physician communication and confidence in decision in low-income population with diabetes and coronary heart disease (CHD) in a Federally Qualified Healthcare Center (FQHC). METHOD: Ninety-five patients participated in an Office-GAP program. A quasi-experimental design study, over 6 months with 12-month follow-up. Office-GAP program integrates health literacy, communication skills education for patients and physicians, patient/physician decision support tools and SDM into routine care. MAIN MEASURES: 1) Implementation rates of planned program elements 2) Patient satisfaction with communication and confidence in decision, and 3) Medication prescription rates. We used the GEE method for hierarchical logistic models, controlling for confounding. RESULTS: Feasibility of the Office-GAP program in the FQHC setting was established. We found significant increase in use of Aspirin/Plavix, statin and beta-blocker during follow-up compared to baseline: Aspirin OR 1.5 (95 % CI: 1.1, 2.2) at 3-months, 1.9 (1.3, 2.9) at 6-months, and 1.8 (1.2, 2.8) at 12-months. Statin OR 1.1 (1.0, 1.3) at 3-months and 1.5 (1.1, 2.2) at 12-months; beta-blocker 1.8 (1.1, 2.9) at 6-months and 12-months. Program elements were consistently used (≥ 98 % clinic attendance at training and tool used). Patient satisfaction with communication and confidence in decision increased. CONCLUSIONS: The use of Office-GAP program to teach SDM and use of DAs in real time was demonstrated to be feasible in FQHCs. It has the potential to improve satisfaction with physician communication and confidence in decisions and to improve medication use. The Office-GAP program is a brief, efficient platform for delivering patient and provider education in SDM and could serve as a model for implementing guideline based care for all chronic diseases in outpatient clinical settings. Further evaluation is needed to establish feasibility outside clinical study, reach, effectiveness and cost-effectiveness of this approach.

SAFE Medication Management for Patients with Physical Impairments of Stroke, Part One.

PURPOSE: This article focuses on the extensive impairments of stroke and their influence on medication management. The impairments of motor skills due to paralysis-loss of mobility and balance, lack of hand-to-mouth coordination, and difficulty swallowing-are discussed. A future article will discuss sensory impairments of vision, hearing, cognition, comprehension, communication, and emotional disorders and how these impairments influence medication management. DESIGN: Each of the impairments are presented and discussed, and possible interventions are proposed. Every patient is an individual and requires variable care plans. METHOD: Intervention strategies that include tools for patient assessment, practice tips, and devices available to assist the patient and family in safe medication management are presented. FINDINGS: Patient outcomes and successes vary, but the strategies outlined will return the patient to as close to previous capabilities as possible. CONCLUSION AND CLINICAL RELEVANCE: Teaching SAFE (Systematic, Accurate, Functional, Effective) medication management to the patient, family, and caregivers will increase medication safety and decrease the number of adverse effects. The rehabilitation nurse is charged with evaluating the patients' needs and developing strategies to assist them to manage their medications.

Refining a brief decision aid in stable CAD: cognitive interviews.

BACKGROUND: We describe the results of cognitive interviews to refine the "Making Choices©" Decision Aid (DA) for shared decision-making (SDM) about stress testing in patients with stable coronary artery disease (CAD). METHODS: We conducted a systematic development process to design a DA consistent with International Patient Decision Aid Standards (IPDAS) focused on Alpha testing criteria. Cognitive interviews were conducted with ten stable CAD patients using the "think aloud" interview technique to assess the clarity, usefulness, and design of each page of the DA. RESULTS: Participants identified three main messages: 1) patients have multiple options based on stress tests and they should be discussed with a physician, 2) take care of yourself, 3) the stress test is the gold standard for determining the severity of your heart disease. Revisions corrected the inaccurate assumption of item number three. CONCLUSIONS: Cognitive interviews proved critical for engaging patients in the development process and highlighted the necessity of clear message development and use of design principles that make decision materials easy to read and easy to use. Cognitive interviews appear to contribute critical information from the patient perspective to the overall systematic development process for designing decision aids.

Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial.

BACKGROUND: Clinicians face challenges in promoting colorectal cancer screening due to multiple competing demands. A decision aid that clarifies patient preferences and improves decision quality can aid shared decision making and be effective at increasing colorectal cancer screening rates. However, exactly how such an intervention improves shared decision making is unclear. This study, funded by the National Cancer Institute, seeks to provide detailed understanding of how an interactive decision aid that elicits patient's risks and preferences impacts patient-clinician communication and shared decision making, and ultimately colorectal cancer screening adherence. METHODS/DESIGN: This is a two-armed single-blinded randomized controlled trial with the target of 300 patients per arm. The setting is eleven community and three academic primary care practices in Metro Detroit. Patients are men and women aged between 50 and 75 years who are not up to date on colorectal cancer screening. ColoDATES Web (intervention arm), a decision aid that incorporates interactive personal risk assessment and preference clarification tools, is compared to a non-interactive website that matches ColoDATES Web in content but does not contain interactive tools (control arm). Primary outcomes are patient uptake of colorectal cancer screening; patient decision quality (knowledge, preference clarification, intent); clinician's degree of shared decision making; and patient-clinician concordance in the screening test chosen. Secondary outcome incorporates a Structural Equation Modeling approach to understand the mechanism of the causal pathway and test the validity of the proposed conceptual model based on Theory of Planned Behavior. Clinicians and those performing the analysis are blinded to arms. DISCUSSION: The central hypothesis is that ColoDATES Web will improve colorectal cancer screening adherence through improvement in patient behavioral factors, shared decision making between the patient and the clinician, and concordance between the patient's and clinician's preferred colorectal cancer screening test. The results of this study will be among the first to examine the effect of a real-time preference assessment exercise on colorectal cancer screening and mediators, and, in doing so, will shed light on the patient-clinician communication and shared decision making 'black box' that currently exists between the delivery of decision aids to patients and subsequent patient behavior. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT01514786.