Display and perception of risk: Analysis of decision support system display and its impact on perceived clinical risk of sepsis-induced health deterioration.

Despite acknowledging the value of clinical decision support systems (CDSS) in identifying risk for sepsis-induced health deterioration in-hospitalized patients, the relationship between display features, decision maker characteristics, and recognition of risk by the clinical decision maker remains an understudied, yet promising, area. The objective of this study is to explore the relationship between CDSS display design and perceived clinical risk of in-hospital mortality associated with sepsis. The study utilized data collected through in-person experimental sessions with 91 physicians from the general medical and surgical floors who were recruited across 12 teaching hospitals within the United States. Results of descriptive and statistical analyses provided evidence supporting the impact of display configuration and clinical case severity on perceived risk associated with in-hospital mortality. Specifically, findings showed that a high level of information (represented by the Predisposition, Infection, Response and Organ dysfunction (PIRO) score) and Figure display (as opposed to Text or baseline) increased awareness to recognizing the risk for in-hospital mortality of hospitalized sepsis patients. A CDSS display that synthesizes the optimal features associated with information level and design elements has the potential to enhance the quantification and communication of clinical risk in complex health conditions beyond sepsis.

Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.

Importance: Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results. Objective: To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year. Design, Setting, and Participants: Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020. Interventions: Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion. Main Outcomes and Measures: The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score. Results: Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%). Conclusions and Relevance: Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach. Trial Registration: ClinicalTrials.gov Identifier: NCT02076113.

Informatics and interaction: Applying human factors principles to optimize the design of clinical decision support for sepsis.

In caring for patients with sepsis, the current structure of electronic health record systems allows clinical providers access to raw patient data without imputation of its significance. There are a wide range of sepsis alerts in clinical care that act as clinical decision support tools to assist in early recognition of sepsis; however, there are serious shortcomings in existing health information technology for alerting providers in a meaningful way. Little work has been done to evaluate and assess existing alerts using implementation and process outcomes associated with health information technology displays, specifically evaluating clinician preference and performance. We developed graphical model displays of two popular sepsis scoring systems, quick Sepsis Related Organ Failure Assessment and Predisposition, Infection, Response, Organ Failure, using human factors principles grounded in user-centered and interaction design. Models will be evaluated in a larger research effort to optimize alert design to improve the collective awareness of high-risk populations and develop a relevant point-of-care clinical decision support system for sepsis.

Patient-Centered Approach to Develop the Patient's Preferences for Prostate Cancer Care (PreProCare) Tool.

Objectives. To describe the development of our Patient Preferences for Prostate Cancer Care (PreProCare) tool to aid patient-centered treatment decision among localized prostate cancer patients. Methods. We incorporated patient and provider experiences to develop a patient preference elicitation tool using adaptive conjoint analysis. Our patient-centered approach used systematic literature review, semistructured patient interviews, and provider focus groups to determine the treatment attributes most important for decision making. The resulting computer-based PreProCare tool was pilot tested in a clinical setting. Results. A systematic review of 56 articles published between 1995 and 2015 yielded survival, cancer recurrence, side effects, and complications as attributes of treatment options. We conducted one-on-one interviews with 50 prostate cancer survivors and 5 focus groups of providers. Patients reported anxiety, depression, treatment specifics, and caregiver burden as important for decision making. Providers identified clinical characteristics as important attribute. Input from stakeholders' advisory group, physicians, and researchers helped finalize 15 attributes for our PreProCare preference assessment tool. Conclusion. The PreProCare tool was developed using a patient-centered approach and may be a feasible and acceptable preference clarification intervention for localized prostate cancer patients. The PreProCare tool may translate into higher participant engagement and self-efficacy, consistent with patients' personal values.

"Implications of cost-sharing for observation care among Medicare beneficiaries: a pilot survey".

BACKGROUND: Medicare beneficiaries hospitalized under observation status have significant cost-sharing responsibilities under Medicare Part B. Prior work has demonstrated an association between increased cost-sharing and health care rationing among low-income Medicare beneficiaries. The objective of this study was to explore the potential impact of observation cost-sharing on future medical decision making of Medicare beneficiaries. METHODS: Single-center pilot cohort study. A convenience sample of Medicare beneficiaries hospitalized under observation status care was surveyed. RESULTS: Out of 144 respondents, low-income beneficiaries were more likely to be concerned about the cost of their observation stay than higher-income respondents (70.7% vs29.3%, p = 0.015). If hospitalized under observation status again, there was a trend among low-income beneficiaries to request completion of their workup outside of the hospital (56.3% vs 43.8%), and to consider leaving against medical advice (AMA) (100% vs 0%), though these trends were not statistically significant (p = 0.30). CONCLUSION: The results of this pilot study suggest that low-income Medicare beneficiaries hospitalized under observation status have greater concerns about their cost-sharing obligations than their higher income peers. Cost-sharing for observation care may have unintended consequences on utilization for low-income beneficiaries. Future studies should examine this potential relationship on a larger scale.

Patient-Centered Preference Assessment to Improve Satisfaction With Care Among Patients With Localized Prostate Cancer: A Randomized Controlled Trial.

PURPOSE: To study the effectiveness of the Patient Preferences for Prostate Cancer Care (PreProCare) intervention in improving the primary outcome of satisfaction with care and secondary outcomes of satisfaction with decision, decision regret, and treatment choice among patients with localized prostate cancer. METHODS: In this multicenter randomized controlled study, we randomly assigned patients with localized prostate cancer to the PreProCare intervention or usual care. Outcomes were satisfaction with care, satisfaction with decision, decision regret, and treatment choice. Assessments were performed at baseline and at 3, 6, 12, and 24 months, and were analyzed using repeated measures. We compared treatment choice across intervention groups by prostate cancer risk categories. RESULTS: Between January 2014 and March 2015, 743 patients with localized prostate cancer were recruited and randomly assigned to receive PreProCare (n = 372) or usual care (n = 371). For the general satisfaction subscale, improvement at 24 months from baseline was significantly different between groups (P < .001). For the intervention group, mean scores at 24 months improved by 0.44 (SE, 0.06; P < .001) from baseline. This improvement was 0.5 standard deviation, which was clinically significant. The proportion reporting satisfaction with decision and no regret increased over time and was higher for the intervention group, compared with the usual care group at 24 months (P < .05). Among low-risk patients, a higher proportion of the intervention group was receiving active surveillance, compared with the usual care group (P < .001). CONCLUSION: Our patient-centered PreProCare intervention improved satisfaction with care, satisfaction with decision, reduced regrets, and aligned treatment choice with risk category. The majority of our participants had a high income, with implications for generalizability. Additional studies can evaluate the effectiveness of PreProCare as a mechanism for improving clinical and patient-reported outcomes in different settings.

Surgical Consultation as Social Process: Implications for Shared Decision Making.

OBJECTIVE: This qualitative study examines surgical consultation as a social process and assesses its alignment with assumptions of the shared decision-making (SDM) model. SUMMARY OF BACKGROUND DATA: SDM stresses the importance of patient preferences and rigorous discussion of therapeutic risks/benefits based on these preferences. However, empirical studies have highlighted discrepancies between SDM and realities of surgical decision making. Qualitative research can inform understanding of the decision-making process and allow for granular assessment of the nature and causes of these discrepancies. METHODS: We observed consultations between 3 general surgeons and 45 patients considering undergoing 1 of 2 preference-sensitive elective operations: (1) hernia repair, or (2) cholecystectomy. These patients and surgeons also participated in semi-structured interviews. RESULTS: By the time of the consultation, patients and surgeons were predisposed toward certain decisions by preceding events occurring elsewhere. During the visit, surgeons had differential ability to arbitrate surgical intervention and construct the severity of patients' conditions. These upstream dynamics frequently displaced the centrality of the risk/benefit-based consent discussion. CONCLUSION: The influence of events preceding consultation suggests that decision-making models should account for broader spatiotemporal spans. Given surgeons' authority to define patients' conditions and control service provision, SDM may be premised on an overestimation of patients' power to alter the course of decision making once in a specialist's office. Considering the subordinate role of the risk/benefit discussion in many surgical decisions, it will be important to study if and how the social process of decision making is altered by SDM-oriented decision aids that foreground this discussion.

Knowledge and attitude for overactive bladder care among women: development and measurement.

BACKGROUND: Overactive bladder (OAB) affects millions of women. It is important to assess knowledge and attitude in affected patients. The study objective was to develop surveys to assess OAB knowledge and OAB related attitude, and its association with OAB treatment status. METHODS: Systematic literature review and qualitative analysis of patient and provider focus groups helped identify OAB knowledge and attitude survey items. We determined psychometric properties of the two surveys in a cross-sectional sample of 104 women, 27% of whom had received OAB treatment. RESULTS: The OAB-knowledge survey consisted of 16 items and 3 condition-related concepts: perception of OAB; cause and information; and signs of OAB. The OAB-attitude survey consisted of 16 items and its concepts were treatment seeking; decision-making and effects. Both surveys demonstrated good construct validity and test-retest reliability ((≥ 0.60). In the cross-sectional validation sample, OAB-knowledge and attitude discriminated between those with different levels of ICIQ-UI scores. We observed some difference in the OAB knowledge, OAB attitude, and severity of symptoms between those treated for OAB vs. treatment naive. CONCLUSIONS: OAB knowledge and attitude surveys provide a novel tool to assess OAB domains in women. Though we did not find statistical significance in OAB knowledge and attitude scores across treatment status, they may be potentially modifiable factors that affect OAB treatment uptake and treatment compliance. Refinement of these surveys in diverse sub-populations is necessary. Our study provides effect sizes for OAB knowledge and attitude. These effect sizes can help development of fully powered trials to study the association between OAB knowledge and attitude, type and length of treatment, treatment compliance, and quality of life, leading to interventions for enhancing OAB care.

Observation Status, Poverty, and High Financial Liability Among Medicare Beneficiaries.

BACKGROUND: Medicare beneficiaries hospitalized under observation status are subject to cost-sharing with no spending limit under Medicare Part B. Because low-income status is associated with increased hospital use, there is concern that such beneficiaries may be at increased risk for high use and out-of-pocket costs related to observation care. Our objective was to determine whether low-income Medicare beneficiaries are at risk for high use and high financial liability for observation care compared with higher-income beneficiaries. METHODS: We performed a retrospective, observational analysis of Medicare Part B claims and US Census Bureau data from 2013. Medicare beneficiaries with Part A and B coverage for the full calendar year, with 1 or more observation stay(s), were included in the study. Beneficiaries were divided into quartiles representing poverty level. The associations between poverty quartile and high use of observation care and between poverty quartile and high financial liability for observation care were evaluated. RESULTS: After multivariate adjustment, the risk of high use was higher for beneficiaries in the poor (Quartile 3) and poorest (Quartile 4) quartiles compared with those in the wealthiest quartile (Quartile 1) (adjusted odds ratio [AOR], 1.21; 95% confidence interval [CI], 1.13-1.31; AOR, 1.24; 95% CI, 1.16-1.33). The risk of high financial liability was higher in every poverty quartile compared with the wealthiest and peaked in Quartile 3, which represented the poor but not the poorest beneficiaries (AOR, 1.17; 95% CI, 1.10-1.24). CONCLUSIONS: Poverty predicts high use of observation care. The poor or near poor may be at highest risk for high liability.

Patient-centred outcomes research: perspectives of patient stakeholders.

OBJECTIVE: To elicit patient stakeholders' experience and perspectives about patient-centred care. DESIGN: Qualitative. SETTING: A large urban healthcare system. PARTICIPANTS: Four patient stakeholders who are prostate cancer survivors. MAIN OUTCOME MEASURES: Experience and perspectives of patient stakeholders regarding patient-centred care and treatment decisions. RESULTS: Our patient stakeholders represented a diverse socio-demographic group. The patient stakeholders identified engagement and dialogue with physicians as crucial elements of patient-centred care model. The degree of patient-centred care was observed to be dependent on the situations. High severity conditions warranted a higher level of patient involvement, compared to mild conditions. They agreed that patient-centred care should not mean that patients can demand inappropriate treatments. CONCLUSIONS: An important attribute of patient-centred outcomes research model is the involvement of stakeholders. However, we have limited knowledge about the experience of patient stakeholders in patient-centred outcomes research. Our study indicates that patient stakeholders offer a unique perspective as researchers and policy-makers aim to precisely define patient-centred research and care.

From Data to Improved Decisions: Operations Research in Healthcare Delivery.

BACKGROUND: The Operations Research Interest Group (ORIG) within the Society of Medical Decision Making (SMDM) is a multidisciplinary interest group of professionals that specializes in taking an analytical approach to medical decision making and healthcare delivery. ORIG is interested in leveraging mathematical methods associated with the field of Operations Research (OR) to obtain data-driven solutions to complex healthcare problems and encourage collaborations across disciplines. This paper introduces OR for the non-expert and draws attention to opportunities where OR can be utilized to facilitate solutions to healthcare problems. METHODS: Decision making is the process of choosing between possible solutions to a problem with respect to certain metrics. OR concepts can help systematically improve decision making through efficient modeling techniques while accounting for relevant constraints. Depending on the problem, methods that are part of OR (e.g., linear programming, Markov Decision Processes) or methods that are derived from related fields (e.g., regression from statistics) can be incorporated into the solution approach. This paper highlights the characteristics of different OR methods that have been applied to healthcare decision making and provides examples of emerging research opportunities. EXAMPLES: We illustrate OR applications in healthcare using previous studies, including diagnosis and treatment of diseases, organ transplants, and patient flow decisions. Further, we provide a selection of emerging areas for utilizing OR. CONCLUSIONS: There is a timely need to inform practitioners and policy makers of the benefits of using OR techniques in solving healthcare problems. OR methods can support the development of sustainable long-term solutions across disease management, service delivery, and health policies by optimizing the performance of system elements and analyzing their interaction while considering relevant constraints.

The Unmet Need for Postacute Rehabilitation Among Medicare Observation Patients: A Single-Center Study.

BACKGROUND: Medicare beneficiaries admitted under observation status must pay for postacute inpatient rehabilitation (PAIR) services, out of pocket, at potentially prohibitive costs. OBJECTIVE: To determine if there is an unmet need for PAIR among Medicare observation patients and if this care is associated with longer hospital stay and increased rehospitalization. DESIGN/SETTING: Observational study using electronic medical record and administrative data from a regional health system. PATIENTS: 1323 community-dwelling Medicare patients admitted under observation status. MEASUREMENTS: Summary statistics were calculated for demographic and administrative variables. Physical therapy (PT) and case management recommendations for a representative sample of 386 medical records were reviewed regarding need for PAIR services. Linear regression was used to measure the association between PT recommendation and hospital length of stay, adjusting for ICD-9 (International Classification of Diseases, Ninth Revision) diagnosis, age, sex, and provider. Chi-square test was used to determine the association between PT recommendation and 30-day hospital revisit. RESULTS: Of the 1323 study patients, 11 (0.83%) were discharged to PAIR facilities. However, 17 (4.4%) of the 386 patients whose charts were reviewed received a recommendation for this care. Adjusted mean hospital stay was longer (P ⟨ 0.001) for patients recommended for rehabilitation (75.9 h) than for patients with no PT needs (46.8 h). In addition, the 30-day hospital revisit rate was higher (P = 0.037) for the patients who had been recommended for rehabilitation (52.9%, 9/17) than for those who had not (25.4%, 30/118). CONCLUSIONS: Medicare observation patients' potential need for PAIR services is 5- to 6-fold higher than their use of these services. Observation patients recommended for this care may have worse outcomes. Journal of Hospital Medicine 2017;12:168-172.

A patient advocate to facilitate access and improve communication, care, and outcomes in adults with moderate or severe asthma: Rationale, design, and methods of a randomized controlled trial.

Few interventions to improve asthma outcomes have targeted low-income minority adults. Even fewer have focused on the real-world practice where care is delivered. We adapted a patient navigator, here called a Patient Advocate (PA), a term preferred by patients, to facilitate and maintain access to chronic care for adults with moderate or severe asthma and prevalent co-morbidities recruited from clinics serving low-income urban neighborhoods. We describe the planning, design, methodology (informed by patient and provider focus groups), baseline results, and challenges of an ongoing randomized controlled trial of 312 adults of a PA intervention implemented in a variety of practices. The PA coaches, models, and assists participants with preparations for a visit with the asthma clinician; attends the visit with permission of participant and provider; and confirms participants' understanding of what transpired at the visit. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice and transfer of information between providers and patients. PA activities are individualized, take account of comorbidities, and are generalizable to other chronic diseases. PAs are recent college graduates interested in health-related careers, research experience, working with patients, and generally have the same race/ethnicity distribution as potential participants. We test whether the PA intervention, compared to usual care, is associated with improved and sustained asthma control and other asthma outcomes (prednisone bursts, ED visits, hospitalizations, quality of life, FEV1) relative to baseline. Mediators and moderators of the PA-asthma outcome relationship are examined along with the intervention's cost-effectiveness.

Impact of Cost Sharing on Therapeutic Substitution: The Story of Statins in 2006.

BACKGROUND: Cost sharing is widely used to encourage therapeutic substitution. This study aimed to examine the impact of increases in patient cost-sharing differentials for brand name and generic drugs on statin utilization on entry into the Medicare Part D coverage gap. METHOD AND RESULTS: Using 5% Medicare Chronic Condition Warehouse files from 2006, this quasi-experimental study examined patients with hyperlipidemia who filled prescriptions for atorvastatin or rosuvastatin between January and March 2006. Propensity score matching and difference-in-difference regressions were used to compare changes in statin utilization for the study group (patients who were not eligible for low-income subsidies [non-LIS] and had generic-only gap coverage) to those of a control group (LIS patients who faced the same cost sharing before and during the Part D coverage gap). In the final sample, 801 patients in the study group were matched to 801 patients in the control group. We found that, compared to the control group, the study group had a larger decline in any monthly brand-name statin use (-0.24 30-day fills, P<0.001). This was only partially offset by increased monthly generic statin use (+0.06 30-day fill, P<0.001), with an overall drop in any monthly statin use (-0.18 30-day fills, P<0.001). Overall adherence with statins declined (OR 0.81, P<0.001), and statin discontinuation increased (OR 1.62, P<0.001) in the study group as compared to the control group. CONCLUSIONS: Increases in cost-sharing differentials for brand name and generic drugs on coverage gap entry were associated with discontinuation of statins in Medicare Part D patients with hyperlipidemia.

Race or Resource? BMI, Race, and Other Social Factors as Risk Factors for Interlimb Differences among Overweight Breast Cancer Survivors with Lymphedema.

Introduction. High BMI is a risk factor for upper body breast cancer-related lymphedema (BCRL) onset. Black cancer survivors are more likely to have high BMI than White cancer survivors. While observational analyses suggest up to 2.2 times increased risk of BCRL onset for Black breast cancer survivors, no studies have explored race or other social factors that may affect BCRL severity, operationalized by interlimb volume difference (ILD). Materials and Methods. ILD was measured by perometry for 296 overweight (25 > BMI < 50) Black (n = 102) or White (n = 194) breast cancer survivors (>6 months from treatment) in the WISER Survivor trial. Multivariable linear regression examined associations between social and physical factors and ILD. Results. Neither Black race (-0.26, p = 0.89) nor BMI (0.22, p = 0.10) was associated with ILD. Attending college (-4.89, p = 0.03) was the strongest factor associated with ILD, followed by having more lymph nodes removed (4.75, p = 0.01), >25% BCRL care adherence (4.10, p = 0.01), and years since treatment (0.55, p < 0.001). Discussion. Neither race nor BMI was associated with ILD among overweight cancer survivors. Education, a proxy for resource level, was the strongest factor associated with greater ILD. Tailoring physical activity and weight loss interventions designed to address BCRL severity by resource rather than race should be considered.